Notices. Notice of availability; request for comment

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BILLING CODE 8025-01-M SMALL BUSINESS ADMINISTRATION Availability of SBA Draft Strategic Plan for Fiscal Years 2008-2012 and Request for Public Comment AGENCY: U.S. Small Business Administration. ACTION: Notice of availability; request for comment. SUMMARY: This notice announces the availability of the Small Business Administration's draft Strategic Plan. The Government Performance and Results Act of 1993 requires that Federal agencies update their strategic plans every three years and, in doing so, solicit the views and suggestions of those entities potentially affected by or interested in the plan.

Therefore, the Agency is interested in receiving comments on our draft Strategic Plan. DATES: Comments must be received by September 10, 2007. If comments are received late, we will consider them to the extent practicable. ADDRESSES: To access the draft strategic plan, go to *http://www.sba.gov/aboutsba/budgetsplans/serv_budget_strategicplan.html.* You can provide your comments on-line through the Web site or by e-mail to *Performancereports@sba.gov.* If you wish to send written comments or have any questions, please direct them to:

Gordon Goeke, U.S. Small Business Administration, Strategic Plan Comments, Office of the Chief Financial Officer, 409 Third Street, SW., Suite 6000, Washington, DC 20416. FOR FURTHER INFORMATION CONTACT: Gordon Goeke, Financial Specialist, Office of Chief Financial Officer,

(202)205-6449. SUPPLEMENTARY INFORMATION: The Government Performance and Results Act requires that each Federal agency update their strategic plan every three years, (5 U.S.C. 306), and submit their plan to the Congress. This draft Strategic Plan describes our mission, strategic goals, objectives, and means and strategies to achieve those goals. To access the draft strategic plan, go to *http://www.sba.gov/aboutsba/budgetsplans/serv_budget_strategicplan.html.* For those who may not have Internet access, a paper copy can be requested from the contact point, Gordon Goeke. Public Participation Policy It is the policy of the Agency to ensure that public participation is an integral and effective part of SBA activities and that decisions are made with the benefit of significant public perspectives. The Agency recognizes the many benefits to be derived from public participation for both stakeholders and SBA. Public participation provides a means for SBA to gather a diverse collection of opinions, perspectives, and values from the broadest spectrum possible, enabling the Agency to make more informed decisions. Likewise, public participation benefits stakeholders by creating an opportunity to provide input on decisions that affect their communities and our nation. We anticipate publishing the final SBA Strategic Plan on September 28, 2007, and making it available on the Internet at that time. Authority: 5 U.S.C. 306. Dated: August 21, 2007. Jennifer E. Main, Chief Financial Officer. [FR Doc. E7-16917 Filed 8-24-07; 8:45 am] BILLING CODE 8025-01-P DEPARTMENT OF STATE [Public Notice: 5903] 30-Day Notice of Proposed Information Collection: DS-156, Nonimmigrant Visa Application, OMB Control Number 1405-0018 ACTION: Notice of request for public comment and submission to OMB of proposed collection of information. SUMMARY: The Department of State has submitted the following information collection request to the Office of Management and Budget

(OMB)for approval in accordance with the Paperwork Reduction Act of 1995. • *Title of Information Collection:* Nonimmigrant Visa Application. • *OMB Control Number:* 1405-0018. • *Type of Request:* Extension of a Currently Approved Collection. • *Originating Office:* Bureau of Consular Affairs (CA/VO). • *Form Number:* DS-156. • *Respondents:* Nonimmigrant visa applicants. • *Estimated Number of Respondents:* 12,000,000. • *Estimated Number of Responses:* 12,000,000. • *Average Hours Per Response:* 1 hour. • *Total Estimated Burden:* 12,000,000 hours per year. • *Frequency:* Once per respondent. • *Obligation to Respond:* Required to Obtain or Retain a Benefit. DATES: Submit comments to the Office of Management and Budget

(OMB)for up to 30 days from August 27, 2007. ADDRESSES: Direct comments and questions to Katherine Astrich, the Department of State Desk Officer in the Office of Information and Regulatory Affairs at the Office of Management and Budget (OMB), who may be reached at 202-395-4718. You may submit comments by any of the following methods: • *E-mail: Katherine_T._Astrich@omb.eop.gov.* You must include the DS form number, information collection title, and OMB control number in the subject line of your message. • *Mail (paper, disk, or CD-ROM submissions):* Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW., Washington, DC 20503. • *Fax:* 202-395-6974. FOR FURTHER INFORMATION CONTACT: Direct requests for additional information regarding the collection listed in this notice, including requests for copies of the proposed information collection and supporting documents, to Lauren Prosnik of the Office of Visa Services, U.S. Department of State, 2401 E. Street, NW., L-603, Washington, DC 20522, who may be reached at

(202)663-2951. SUPPLEMENTARY INFORMATION: We are soliciting public comments to permit the Department to: • Evaluate whether the proposed information collection is necessary to properly perform our functions. • Evaluate the accuracy of our estimate of the burden of the proposed collection, including the validity of the methodology and assumptions used. • Enhance the quality, utility, and clarity of the information to be collected. • Minimize the reporting burden on those who are to respond, Abstract of Proposed Collection Form DS-156 is completed by aliens seeking nonimmigrant visas to the U.S. The Department will use the DS-156 to elicit information necessary to determine an applicant's visa eligibility. Methodology The DS-156 is completed by applicants online or, in exceptional circumstances, applicants may submit a paper application to posts abroad. The applicant prints the application and a 2-D barcode. When the applicant appears at the interview the barcode is scanned and the information electronically received. Dated: August 6, 2007. Stephen A. Edson, Deputy Assistant Secretary, Bureau of Consular Affairs, Department of State. [FR Doc. E7-16900 Filed 8-24-07; 8:45 am] BILLING CODE 4710-06-P DEPARTMENT OF STATE [Public Notice 5885] Advisory Committee on Historical Diplomatic Documentation Notice of Meeting SUMMARY: The Advisory Committee on Historical Diplomatic Documentation will meet in the Department of State, 2201 “C” Street NW., Washington, DC, September 24-25, 2007, in Conference Room 1498. Prior notification and a valid government-issued photo ID (such as driver's license, passport, U.S. government or military ID) are required for entrance into the building. Members of the public planning to attend must notify Steven Galpern, Office of the Historian (202-663-1130) no later than September 20, 2007 to provide date of birth, valid government-issued photo identification number and type (such as driver's license number/state, passport number/country, or U.S. government ID number/agency or military ID number/branch), and relevant telephone numbers. If you cannot provide one of the enumerated forms of ID, please consult with Steven Galpern for acceptable alternative forms of picture identification. The Committee will meet in open session from 1:30 p.m. through 3 p.m. on Monday, September 24, 2007, in the Department of State, 2201 “C” Street, NW., Washington, DC, in Conference Room 1498, to discuss declassification and transfer of Department of State records to the National Archives and Records Administration and the status of the *Foreign Relations* series. The remainder of the Committee's sessions from 3:15 p.m. until 4:30 p.m. on Monday, September 24, 2007, and 8 a.m. until 12 p.m. on Tuesday, September 25, 2007, will be closed in accordance with Section 10(d) of the Federal Advisory Committee Act (Pub. L. 92-463). The agenda calls for discussions of agency declassification decisions concerning the *Foreign Relations* series and other declassification issues. These are matters not subject to public disclosure under 5 U.S.C. 552b(c)(1) and the public interest requires that such activities be withheld from disclosure. Questions concerning the meeting should be directed to Marc J. Susser, Executive Secretary, Advisory Committee on Historical Diplomatic Documentation, Department of State, Office of the Historian, Washington, DC, 20520, telephone

(202)663-1123, (e-mail *history@state.gov* ). Dated: August 13, 2007. Marc Susser, Executive Secretary, Department of State. [FR Doc. E7-16901 Filed 8-24-07; 8:45 am] BILLING CODE 4710-11-P DEPARTMENT OF STATE [Public Notice 5859] International Security Advisory Board

(ISAB)Meeting Notice; Closed Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. app 2 § 10(a)(2), the Department of State announces a meeting of the International Security Advisory Board

(ISAB)to take place on October 1, 2007, at the Department of State, Washington, DC. Pursuant to section 10

(d)of the Federal Advisory Committee Act, 5 U.S.C. app 2 § 10 (d), and to 5 U.S.C. 552b (c)(1), it has been determined that this Board meeting will be closed to the public in the interest of national defense and foreign policy because the Board will be reviewing and discussing matters classified in accordance with Executive Order 12958. The purpose of the ISAB is to provide the Department with a continuing source of independent advice on all aspects of arms control, disarmament and international security, and related aspects of public diplomacy. The agenda for this meeting will include classified discussions related to the Board's ongoing studies on current U.S. policy and issues regarding international security and nuclear proliferation. For more information, contact Brandy Buttrick, Deputy Executive Director of the International Security Advisory Board, Department of State, Washington, DC 20520, telephone:

(202)647-9336. Dated: August 14, 2007. George W. Look, Executive Director, International Security Advisory Board, Department of State. [FR Doc. E7-16902 Filed 8-24-07; 8:45 am] BILLING CODE 4710-27-P DEPARTMENT OF TRANSPORTATION Maritime Administration [Docket No. MARAD 2007 29076] Information Collection Available for Public Comments and Recommendations ACTION: Notice and request for comments. SUMMARY: In accordance with the Paperwork Reduction Act of 1995, this notice announces the Maritime Administration's (MARAD's) intention to request extension of approval for three years of a currently approved information collection. DATES: Comments should be submitted on or before October 26, 2007. FOR FURTHER INFORMATION CONTACT: Murray Bloom, Maritime Administration, 1200 New Jersey Avenue, SE., Washington, DC 20590. Telephone:

(202)366-5164; or e-mail: *Murray.Bloom@dot.gov.* Copies of this collection can also be obtained from that office. SUPPLEMENTARY INFORMATION: *Title of Collection:* Part 380, Subpart B—Application for Designation of Vessels as American Great Lakes Vessels. *Type of Request:* Extension of currently approved information collection. *OMB Control Number:* 2133-0521. *Form Numbers:* None. *Expiration Date of Approval:* Three years from the date of approval by the Office of Management and Budget. *Summary of Collection of Information:* In accordance with Public Law 101-624, the Secretary of Transportation issued requirements for the submission of applications for designation of vessels as American Great Lakes Vessels. Owners who wish to have this designation must certify that their vessel(s) meets certain criteria established in 46 CFR part 380. *Need and Use of the Information:* Application is mandated by statute to establish that a vessel meets statutory criteria for obtaining the benefits of eligibility to carry preference cargoes. *Description of Respondents:* Shipowners of merchant vessels. *Annual Responses:* One response. *Annual Burden:* 1.25 hours. *Comments:* Comments should refer to the docket number that appears at the top of this document. Written comments may be submitted to the Docket Clerk, U.S. DOT Dockets, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. Comments also may be submitted by electronic means via the Internet at *http://dms.dot.gov/submit.* Specifically address whether this information collection is necessary for proper performance of the functions of the agency and will have practical utility, accuracy of the burden estimates, ways to minimize this burden, and ways to enhance the quality, utility, and clarity of the information to be collected. All comments received will be available for examination at the above address between 10 a.m. and 5 p.m. EDT (or EST), Monday through Friday, except Federal holidays. An electronic version of this document is available on the World Wide Web at *http://dms.dot.gov.* *Privacy Act:* Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the **Federal Register** published on April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit *http://dms.dot.gov.* Authority: 49 CFR 1.66. By Order of the Maritime Administrator. Dated: August 21, 2007. Daron T. Threet, Secretary, Maritime Administration. [FR Doc. E7-16864 Filed 8-24-07; 8:45 am] BILLING CODE 4910-81-P DEPARTMENT OF TRANSPORTATION Maritime Administration [Docket No. MARAD-2007-29039] Requested Administrative Waiver of the Coastwise Trade Laws AGENCY: Maritime Administration, Department of Transportation. ACTION: Invitation for public comments on a requested administrative waiver of the Coastwise Trade Laws for the vessel ADIOS. SUMMARY: As authorized by Public Law 105-383 and Public Law 107-295, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below. The complete application is given in DOT docket MARAD-2007-29039 at *http://dms.dot.gov.* Interested parties may comment on the effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. If MARAD determines, in accordance with Public Law 105-383 and MARAD's regulations at 46 CFR part 388 (68 FR 23084; April 30, 2003), that the issuance of the waiver will have an unduly adverse effect on a U.S.-vessel builder or a business that uses U.S.-flag vessels in that business, a waiver will not be granted. Comments should refer to the docket number of this notice and the vessel name in order for MARAD to properly consider the comments. Comments should also state the commenter's interest in the waiver application, and address the waiver criteria given in § 388.4 of MARAD's regulations at 46 CFR part 388. DATES: Submit comments on or before September 26, 2007. ADDRESSES: Comments should refer to docket number MARAD-2007-29039. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. You may also send comments electronically via the Internet at *http://dmses.dot.gov/submit/.* All comments will become part of this docket and will be available for inspection and copying at the above address between 10 a.m. and 5 p.m., E.T., Monday through Friday, except Federal holidays. An electronic version of this document and all documents entered into this docket is available on the World Wide Web at *http://dms.dot.gov.* FOR FURTHER INFORMATION CONTACT: Joann Spittle, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue, SE., Room W21-203, Washington, DC 20590. Telephone 202-366-5979. SUPPLEMENTARY INFORMATION: As described by the applicant the intended service of the vessel ADIOS is: *Intended Use:* “Charters off the coast of Florida.” *Geographic Region:* “South Florida.” Privacy Act Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the **Federal Register** published on April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit *http://dms.dot.gov.* Dated: August 17, 2007. By order of the Maritime Administrator. Daron T. Threet, Secretary, Maritime Administration. [FR Doc. E7-16861 Filed 8-24-07; 8:45 am] BILLING CODE 4910-81-P DEPARTMENT OF TRANSPORTATION Maritime Administration [Docket No. MARAD-2007-29038] Requested Administrative Waiver of the Coastwise Trade Laws AGENCY: Maritime Administration, Department of Transportation. ACTION: Invitation for public comments on a requested administrative waiver of the Coastwise Trade Laws for the vessel BEACH HOUSE. SUMMARY: As authorized by Public Law 105-383 and Public Law 107-295, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below. The complete application is given in DOT docket MARAD-2007-29038 at *http://dms.dot.gov.* Interested parties may comment on the effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. If MARAD determines, in accordance with Public Law 105-383 and MARAD's regulations at 46 CFR Part 388 (68 FR 23084; April 30, 2003), that the issuance of the waiver will have an unduly adverse effect on a U.S.-vessel builder or a business that uses U.S.-flag vessels in that business, a waiver will not be granted. Comments should refer to the docket number of this notice and the vessel name in order for MARAD to properly consider the comments. Comments should also state the commenter's interest in the waiver application, and address the waiver criteria given in § 388.4 of MARAD's regulations at 46 CFR Part 388. DATES: Submit comments on or before September 26, 2007. ADDRESSES: Comments should refer to docket number MARAD-2007-29038. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. You may also send comments electronically via the Internet at *http://dmses.dot.gov/submit/.* All comments will become part of this docket and will be available for inspection and copying at the above address between 10 a.m. and 5 p.m., E.T., Monday through Friday, except federal holidays. An electronic version of this document and all documents entered into this docket is available on the World Wide Web at *http://dms.dot.gov.* FOR FURTHER INFORMATION CONTACT: Joann Spittle, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue, SE., Room W21-203, Washington, DC 20590. Telephone 202-366-5979. SUPPLEMENTARY INFORMATION: As described by the applicant the intended service of the vessel BEACH HOUSE is: *Intended Use:* “Less than 5% use, uninspected 6 passenger.” *Geographic Region:* “Washington, Oregon, California, Hawaii, and Florida.” Privacy Act Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the **Federal Register** published on April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit *http://dms.dot.gov.* Dated: August 17, 2007. By order of the Maritime Administrator. Daron T. Threet, Secretary, Maritime Administration. [FR Doc. E7-16851 Filed 8-24-07; 8:45 am] BILLING CODE 4910-81-P DEPARTMENT OF TRANSPORTATION Maritime Administration [Docket No. MARAD-2007 29040] Requested Administrative Waiver of the Coastwise Trade Laws AGENCY: Maritime Administration, Department of Transportation. ACTION: Invitation for public comments on a requested administrative waiver of the Coastwise Trade Laws for the vessel BLUEWATER. SUMMARY: As authorized by Public Law 105-383 and Public Law 107-295, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below. The complete application is given in DOT docket MARAD-2007-29040 at *http://dms.dot.gov.* Interested parties may comment on the effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. If MARAD determines, in accordance with Public Law 105-383 and MARAD's regulations at 46 CFR Part 388 (68 FR 23084; April 30, 2003), that the issuance of the waiver will have an unduly adverse effect on a U.S.-vessel builder or a business that uses U.S.-flag vessels in that business, a waiver will not be granted. Comments should refer to the docket number of this notice and the vessel name in order for MARAD to properly consider the comments. Comments should also state the commenter's interest in the waiver application, and address the waiver criteria given in § 388.4 of MARAD's regulations at 46 CFR Part 388. DATES: Submit comments on or before September 26, 2007. ADDRESSES: Comments should refer to docket number MARAD-2007-29040. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. You may also send comments electronically via the Internet at *http://dmses.dot.gov/submit/* . All comments will become part of this docket and will be available for inspection and copying at the above address between 10 a.m. and 5 p.m., E.T., Monday through Friday, except federal holidays. An electronic version of this document and all documents entered into this docket is available on the World Wide Web at *http://dms.dot.gov* . FOR FURTHER INFORMATION CONTACT: Joann Spittle, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue, SE., Room W21-203, Washington, DC 20590. Telephone 202-366-5979. SUPPLEMENTARY INFORMATION: As described by the applicant the intended service of the vessel BLUEWATER is: *Intended Use:* “To carry up to 12 passengers on San Francisco Bay day cruise.” *Geographic Region:* “San Francisco Bay.” Privacy Act Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the **Federal Register** published on April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit *http://dms.dot.gov.* Dated: August 16, 2007. By order of the Maritime Administrator. Daron T. Threet, Secretary, Maritime Administration. [FR Doc. E7-16859 Filed 8-24-07; 8:45 am] BILLING CODE 4910-81-P DEPARTMENT OF TRANSPORTATION Maritime Administration [Docket No. MARAD-2007-29041] Requested Administrative Waiver of the Coastwise Trade Laws AGENCY: Maritime Administration, Department of Transportation. ACTION: Invitation for public comments on a requested administrative waiver of the Coastwise Trade Laws for the vessel TIN TIN. SUMMARY: As authorized by Public Law 105-383 and Public Law 107-295, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below. The complete application is given in DOT docket MARAD-2007-29041 at *http://dms.dot.gov.* Interested parties may comment on the effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. If MARAD determines, in accordance with Public Law 105-383 and MARAD's regulations at 46 CFR Part 388 (68 FR 23084; April 30, 2003), that the issuance of the waiver will have an unduly adverse effect on a U.S.-vessel builder or a business that uses U.S.-flag vessels in that business, a waiver will not be granted. Comments should refer to the docket number of this notice and the vessel name in order for MARAD to properly consider the comments. Comments should also state the commenter's interest in the waiver application, and address the waiver criteria given in § 388.4 of MARAD's regulations at 46 CFR Part 388. DATES: Submit comments on or before September 26, 2007. ADDRESSES: Comments should refer to docket number MARAD-2007-29041. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. You may also send comments electronically via the Internet at *http://dmses.dot.gov/submit/.* All comments will become part of this docket and will be available for inspection and copying at the above address between 10 a.m. and 5 p.m., E.T., Monday through Friday, except federal holidays. An electronic version of this document and all documents entered into this docket is available on the World Wide Web at *http://dms.dot.gov.* FOR FURTHER INFORMATION CONTACT: Joann Spittle, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue, SE., Room W21-203, Washington, DC 20590. Telephone 202-366-5979. SUPPLEMENTARY INFORMATION: As described by the applicant the intended service of the vessel TIN TIN is: *Intended Use:* “Slipstream Maritime Services, LLC will operate Tin Tin as a chartered vessel for up to 6 passengers. Trips will range from one to five days and are specifically designed as therapeutic experiential sailing trips with sailing instruction included.” *Geographic Region:* “Puget Sound, WA.” Privacy Act Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the **Federal Register** published on April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit *http://dms.dot.gov.* Dated: August 16, 2007. By order of the Maritime Administrator. Daron T. Threet, Secretary, Maritime Administration. [FR Doc. E7-16857 Filed 8-24-07; 8:45 am] BILLING CODE 4910-81-P DEPARTMENT OF TRANSPORTATION Maritime Administration [USCG-2007-28535] Atlantic Sea Island Group LLC, Safe Harbor Energy Liquefied Natural Gas Deepwater Port License Application AGENCY: Maritime Administration, DOT. ACTION: Notice of application. SUMMARY: The Coast Guard and the Maritime Administration announce that they have received an application for the licensing of a natural gas deepwater port, and that the application appears to contain the required information. This notice summarizes the applicant's plans and the procedures that will be followed in considering the application. DATES: The Deepwater Port Act of 1974, as amended, requires any public hearing on this application to be held not later than 240 days after this notice, and requires a decision on the application to be made not later than 90 days after the final public hearing. ADDRESSES: The public docket for USCG-2007-28535 is maintained by the: Docket Management Facility, U.S. Department of Transportation, 1200 New Jersey Ave., SE., West Building Ground Floor W12-140, Washington, DC 20590-0001. Docket contents are available for public inspection and copying, at this address, in room W12-140, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Facility's telephone is 202-366-9329, its fax is 202-493-2251, and its website for electronic submissions or for electronic access to docket contents is *http://dms.dot.gov.* FOR FURTHER INFORMATION CONTACT: Mary K. Jager, U.S. Coast Guard, telephone: 202-372-1454, e-mail: *Mary.K.Jager@uscg.mil* or Andrew Tibbetts, U.S. Maritime Administration, telephone: 202-366-5473, e-mail: *andrew.tibbetts@dot.gov.* If you have questions on viewing the docket, call Renee V. Wright, Program Manager, Docket Operations, telephone: 202-493-0402. SUPPLEMENTARY INFORMATION: Receipt of Application On May 8, 2007, the Coast Guard and the Maritime Administration received an application from Atlantic Sea Island Group LLC (ASIG), Chrysler Building, 405 Lexington Avenue, 26th Floor, New York, NY 10174; for all Federal authorizations required for a license to own, construct, and operate a deepwater port governed by the Deepwater Port Act of 1974, as amended, 33 U.S.C. 1501 *et seq.* (the Act). On August 15, 2007, we determined that the application appears to contain all information required by the Act. Background According to the Act, a deepwater port is a fixed or floating manmade structure other than a vessel, or a group of structures, located beyond State seaward boundaries and used or intended for use as a port or terminal for the transportation, storage, and further handling of oil or natural gas for transportation to any State. A deepwater port must be licensed by the Maritime Administrator (by delegated authority of the Secretary of Transportation, published on June 18, 2003 (68 FR 36496)). Statutory and regulatory requirements for licensing appear in 33 U.S.C. 1501 *et seq.* and in 33 CFR part 148. Under delegations from and agreements between the Secretary of Transportation and the Secretary of Homeland Security, applications are processed by the Coast Guard and the Maritime Administration. Each application is considered on its merits. The Act requires adherence to a strict timeline for processing an application. Once we determine that an application contains the required information, we must hold public hearings on the application within 240 days, and the Maritime Administrator must render a decision on the application within 330 days. We will publish additional **Federal Register** notices to inform you of these public hearings and other procedural milestones, including environmental review. The Maritime Administrator's decision, and other key documents, will be filed in the public docket. At least one public hearing must take place in each adjacent coastal State. For purposes of the Act, New York is the adjacent coastal State for this application. Other States can apply for adjacent coastal State status in accordance with 33 U.S.C. 1508(a)(2). Summary of the Application Atlantic Sea Island Group LLC (ASIG), proposes to own, construct, and operate a deepwater port, named Safe Harbor Energy, in the Federal waters of the Atlantic Outer Continental Shelf in the area known as the New York Bight region in MMS lease area NK18-12 block 6655. The proposed location is approximately 13.5 miles south of the City of Long Beach on Long Island and 23 miles southeast of New York Harbor entrance, in an area between the Ambrose-to-Nantucket and Hudson Canyon-to-Ambrose shipping lanes, located at approximately 40°23′ N and 73°36′ E, in water depth of between 60 and 70 feet. The deepwater port, Safe Harbor Energy, consists of three components: An island to be constructed of natural sand, gravel, and rock materials surrounded by armored breakwaters, consisting of prefabricated caissons, armor units, and rock; an LNG receiving, storage, and regasification facility; and a subsea pipeline that would transport the natural gas to an offshore connection with the Transcontinental Gas Pipeline Corporation's pipeline system. The pipeline would consist of two parallel 36-inch-diameter pipe segments extending 12.8 miles from the island. Safe Harbor Energy will include berthing and offloading space for two conventional LNG vessels with capacity of 70,000 m 3 to 270,000 m 3 . Additionally, it would accommodate support vessels including docking/firefighting tugs and crew support launches. The storage portion would include four

(4)180,000 m 3 full-containment storage tanks. The regasification equipment would be an ambient air heat exchange type. Safe Harbor Energy would have an average throughput capacity of approximately 1.15 billion standard cubic feet per day (bscfd). A shore based facility will be used to facilitate movement of personnel, equipment, supplies, and disposable materials between the port and shore. Construction of the deepwater port would be expected to take approximately five

(5)years; with startup of commercial operations following construction, should a license be issued. The deepwater port would be designed, constructed, and operated in accordance with applicable codes and standards and would have an expected operating life of approximately 25 years. Privacy Act Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the **Federal Register** published on April 11, 2000, (Volume 65, Number 70; Pages 19477-78) or you may visit *http://dms.dot.gov.* Authority: 49 CFR 1.66. By Order of the Maritime Administrator. Dated: August 17, 2007. Daron T. Threet, Secretary, Maritime Administration. [FR Doc. E7-16875 Filed 8-24-07; 8:45 am] BILLING CODE 4910-81-P DEPARTMENT OF TRANSPORTATION Surface Transportation Board [STB Docket No. AB-55 (Sub-No. 680X)] CSX Transportation, Inc.—Abandonment Exemption—in Portsmouth County, VA CSX Transportation, Inc. (CSXT), has filed a notice of exemption under 49 CFR part 1152 subpart F— *Exempt Abandonments* to abandon a 0.50-mile rail line on its Southern Region, Florence Division, Portsmouth Subdivision, from railroad milepost SA 0.28 to railroad milepost SA 0.78, in Portsmouth, Portsmouth County, VA. The line traverses United States Postal Service Zip Code 23704. CSXT has certified that:

(1)No local traffic has moved over the line for at least 2 years;

(2)any overhead traffic on the line can be rerouted over other lines;

(3)no formal complaint filed by a user of rail service on the line (or by a state or local government entity acting on behalf of such user) regarding cessation of service over the line either is pending with the Board or with any U.S. District Court or has been decided in favor of complainant within the 2-year period; and

(4)the requirements at 49 CFR 1105.7 (environmental report), 49 CFR 1105.8 (historic report), 49 CFR 1105.11 (transmittal letter), 49 CFR 1105.12 (newspaper publication), and 49 CFR 1152.50(d)(1) (notice to governmental agencies) have been met. As a condition to this exemption, any employee adversely affected by the abandonment shall be protected under *Oregon Short Line R. Co.—Abandonment—Goshen,* 360 I.C.C. 91 (1979). To address whether this condition adequately protects affected employees, a petition for partial revocation under 49 U.S.C. 10502(d) must be filed. Provided no formal expression of intent to file an offer of financial assistance

(OFA)has been received, this exemption will be effective on September 26, 2007, unless stayed pending reconsideration. Petitions to stay that do not involve environmental issues, 1 formal expressions of intent to file an OFA under 49 CFR 1152.27(c)(2), 2 and trail use/rail banking requests under 49 CFR 1152.29 must be filed by September 6, 2007. Petitions to reopen or requests for public use conditions under 49 CFR 1152.28 must be filed by September 17, 2007, with the Surface Transportation Board, 395 E. Street, SW., Washington, DC 20423-0001. 1 The Board will grant a stay if an informed decision on environmental issues (whether raised by a party or by the Board's Section of Environmental Analysis

(SEA)in its independent investigation) cannot be made before the exemption's effective date. *See Exemption of Out-of-Service Rail Lines,* 5 I.C.C.2d 377 (1989). Any request for a stay should be filed as soon as possible so that the Board may take appropriate action before the exemption's effective date. 2 Each OFA must be accompanied by the filing fee, which currently is set at $1,300. *See* 49 CFR 1002.2(f)(25). A copy of any petition filed with the Board should be sent to CSXT's representative: Steven C. Armbrust, 500 Water Street, J-150, Jacksonville, FL 32202. If the verified notice contains false or misleading information, the exemption is void *ab initio.* CSXT has filed environmental and historic reports addressing the effects, if any, of the abandonment on the environment and historic resources. SEA will issue an environmental assessment

(EA)by August 31, 2007. Interested persons may obtain a copy of the EA by writing to SEA (Room 1100, Surface Transportation Board, Washington, DC 20423-0001) or by calling SEA, at

(202)245-0305. [Assistance for the hearing impaired is available through the Federal Information Relay Service

(FIRS)at 1-800-877-8339.] Comments on environmental and historic preservation matters must be filed within 15 days after the EA becomes available to the public. Environmental, historic preservation, public use, or trail use/rail banking conditions will be imposed, where appropriate, in a subsequent decision. Pursuant to the provisions of 49 CFR 1152.29(e)(2), CSXT shall file a notice of consummation with the Board to signify that it has exercised the authority granted and fully abandoned the line. If consummation has not been effected by CSXT's filing of a notice of consummation by August 27, 2008, and there are no legal or regulatory barriers to consummation, the authority to abandon will automatically expire. Board decisions and notices are available on our Web site at *http://www.stb.dot.gov.* Decided: August 20, 2007. By the Board, Joseph H. Dettmar, Acting Director, Office of Proceedings. Vernon A. Williams, Secretary. [FR Doc. E7-16867 Filed 8-24-07; 8:45 am] BILLING CODE 4915-01-P DEPARTMENT OF TRANSPORTATION Surface Transportation Board [STB Docket No. AB-33 (Sub-No. 256X); STB Docket No. AB-585 (Sub-No. 2X)] Union Pacific Railroad Company—Abandonment Exemption—in Dallas County, TX; Dallas, Garland & Northeastern Railroad Company—Discontinuance of Service Exemption—in Dallas County, TX On August 7, 2007, Union Pacific Railroad Company

(UP)and Dallas, Garland & Northeastern Railroad Company (DGNO), jointly filed with the Surface Transportation Board (Board) a petition under 49 U.S.C. 10502 for exemption from the provisions of 49 U.S.C. 10903. UP seeks to abandon and DGNO seeks to discontinue service over the Trinity Industrial Lead, between milepost 0.0 near Terminal Junction and milepost 4.1 near Mockingbird Lane, a distance of 4.1 miles in Dallas County, TX. The line traverses United States Postal Service Zip Codes 75207 and 75247, and includes no stations. The line does not contain Federally granted rights-of-way. Any documentation in UP's or DGNO's possession will be made available promptly to those requesting it. The interest of railroad employees will be protected by the conditions set forth in *Oregon Short Line R. Co.—Abandonment—Goshen,* 360 I.C.C. 91 (1979). By issuance of this notice, the Board is instituting an exemption proceeding pursuant to 49 U.S.C. 10502(b). A final decision will be issued by November 23, 2007. Any offer of financial assistance

(OFA)under 49 CFR 1152.27(b)(2) will be due no later than 10 days after service of a decision granting the petition for exemption. Each offer must be accompanied by a $1,300 filing fee. *See* 49 CFR 1002.2(f)(25). All interested persons should be aware that, following abandonment of rail service and salvage of the line, the line may be suitable for other public use, including interim trail use. Any request for a public use condition under 49 CFR 1152.28 or for trail use/rail banking under 49 CFR 1152.29 will be due no later than September 17, 2007. Each trail use request must be accompanied by a $200 filing fee. *See* 49 CFR 1002.2(f)(27). All filings in response to this notice must refer to STB Docket No. AB-33 (Sub-No. 256X) and AB-585 (Sub-No. 2X) and must be sent to:

(1)Surface Transportation Board, 395 E Street, SW., Washington, DC 20423-0001; and

(2)Mack H. Shumate, Jr., 101 North Wacker Drive, Room 1920, Chicago, IL 60606, and Louis E. Gitomer, 600 Baltimore Ave., Suite 301, Towson, MD 21204. Replies to the petition are due on or before September 17, 2007. Persons seeking further information concerning abandonment procedures may contact the Board's Office of Public Services at

(202)245-0230 or refer to the full abandonment or discontinuance regulations at 49 CFR part 1152. Questions concerning environmental issues may be directed to the Board's Section of Environmental Analysis

(SEA)at

(202)245-0305. [Assistance for the hearing impaired is available through the Federal Information Relay Service

(FIRS)at 1-800-877-8339.] An environmental assessment

(EA)(or environmental impact statement (EIS), if necessary), prepared by SEA will be served upon all parties of record and upon any agencies or other persons who commented during its preparation. Other interested persons may contact SEA to obtain a copy of the EA (or EIS). EAs in these abandonment proceedings normally will be made available within 60 days of the filing of the petition. The deadline for submission of comments on the EA will generally be within 30 days of its service. Board decisions and notices are available on our Web site at *http://www.stb.dot.gov.* Decided: August 20, 2007. By the Board, Joseph H. Dettmar, Acting Director, Office of Proceedings. Vernon A. Williams, Secretary. [FR Doc. E7-16881 Filed 8-24-07; 8:45 am] BILLING CODE 4915-01-P 72 165 Monday, August 27, 2007 Proposed Rules Part II Environmental Protection Agency 40 CFR Parts 52 and 81 Approval and Promulgation of Implementation Plans; Designation of Areas for Air Quality Planning Purposes; State of California; PM-10; Affirmation of Determination of Attainment for the San Joaquin Valley Nonattainment Area; Proposed Rule ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 52 and 81 [EPA-R09-OAR-2006-0583; FRL-8459-2] Approval and Promulgation of Implementation Plans; Designation of Areas for Air Quality Planning Purposes; State of California; PM-10; Affirmation of Determination of Attainment for the San Joaquin Valley Nonattainment Area AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: In a final rule published in the **Federal Register** on October 30, 2006, EPA determined that the San Joaquin Valley nonattainment area (SJV or the Valley) in California attained the National Ambient Air Quality Standards (NAAQS) for particulate matter with an aerodynamic diameter less than or equal to a nominal 10 micrometers (PM-10). Since that final determination of attainment, the State has flagged several exceedances of the PM-10 standard in 2006 as being caused by exceptional events, i.e., high winds, and requested that these data be excluded from attainment determinations. EPA is proposing to concur with the State's request to flag these exceedances and thus to exclude that data from use in determining PM-10 attainment for the SJV. EPA is also proposing to exclude from use in determining attainment for the SJV exceedances recorded at a monitor located at the Santa Rosa Rancheria, tribal lands within the boundaries of the SJV, on two bases: The exceedances occurred while the monitor was operating in very close proximity to construction activities and, as such, the monitor was not properly sited during that time for purposes of comparison to the NAAQS; and the exceedances were caused by an exceptional event. EPA is proposing to concur with the Santa Rosa Rancheria Tribe's request to flag these exceedances as due to an exceptional event. As a result, EPA is proposing to affirm its determination that the SJV has attained the PM-10 standard based on EPA's evaluation of quality-assured data through December 2006. In addition to providing the public with an opportunity to comment on EPA's evaluation and proposed concurrence on flagged exceedances that occurred through the end of calendar year 2006, EPA is in this proposed rule addressing issues raised in petitions for reconsideration and withdrawal of EPA's 2006 determination of attainment, filed by Earthjustice on behalf of the Sierra Club, Latino Issues Forum and others. DATES: Written comments must be received on or before September 26, 2007. ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-2006-0583, by one of the following methods:

(1)Federal eRulemaking portal: *http://www.regulations.gov.* Follow the on-line instructions.

(2)E-mail: *lo.doris@epa.gov.*

(3)Mail or deliver: Doris Lo (AIR-2), U.S. Environmental Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA 94105-3901. *Instructions:* All comments will be included in the public docket without change and may be made available online at *www.regulations.gov,* including any personal information provided, unless the comment includes Confidential Business Information

(CBI)or other information whose disclosure is restricted by statute. Information that you consider CBI or otherwise protected should be clearly identified as such and should not be submitted through the *www.regulations.gov* or e-mail. *www.regulations.gov* is an anonymous access system, and EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send e-mail directly to EPA, your e-mail address will be automatically captured and included as part of the public comment. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. *Docket:* The index to the docket for this action is available electronically at *www.regulations.gov* and in hard copy at EPA Region IX, 75 Hawthorne Street, San Francisco, California. While all documents in the docket are listed in the index, some information may be publicly available only at the hard copy location (e.g., copyrighted material), and some may not be publicly available in either location (e.g., CBI). To inspect the hard copy materials, please schedule an appointment during normal business hours with the contact listed directly below. FOR FURTHER INFORMATION CONTACT: Doris Lo, EPA Region IX,

(415)972-3959, *lo.doris@epa.gov.* SUPPLEMENTARY INFORMATION: Throughout this document, wherever “we,” “us,” or “our” are used, we mean EPA. Table of Contents I. Background II. EPA's Proposed Actions III. Summary of Litigation and Administrative Proceedings IV. EPA's Exceptional Events Rule V. EPA's Evaluation of Flagged Exceedances A. September 22, 2006 Exceedances at Corcoran, Bakersfield and Oildale 1. Procedural Requirements 2. Technical Criteria 3. Mitigation Requirements B. October 25, 2006 Exceedances at Corcoran and Bakersfield 1. Procedural Requirements 2. Technical Criteria 3. Mitigation Requirements C. December 8, 2006 Exceedances at Corcoran and Bakersfield 1. Procedural Requirements 2. Technical Criteria 3. Mitigation Requirements VI. EPA Evaluation of September 14, September 20 and October 26, 2006 Exceedances Recorded at the Santa Rosa Rancheria A. Evaluation Under Principles Established in 40 CFR Part 58, Appendix E B. Evaluation Under the Exceptional Events Rule 1. Procedural Requirements 2. Technical Criteria 3. Mitigation Requirements VII. Summary of Exceedances from 2004 through 2006 VIII. Petitions for Reconsideration and Withdrawal A. Winds and Wildfires on September 22 and October 25, 2006 B. Notice/Comment on September 22 and October 25, 2006 Exceedances C. Wind Conditions in the Valley D. EPA's Natural Events Policy 1. BACM Implementation 2. District's Natural Events Action Plan E. Harvest Activities F. Exceedances at Corcoran and Stockton in 2004, Bakersfield in 2005 and the Santa Rosa Rancheria in 2006 IX. Statutory and Executive Order Reviews I. Background On October 17, 2006, EPA finalized its determination that the SJV attained the NAAQS for PM-10, and on October 30, 2006, EPA published this determination in the **Federal Register** . 71 FR 63642. This determination was based upon monitored air quality data for the PM-10 NAAQS 1 during the years 2003-2005 and all available quality-assured data through July 31, 2006. For a more detailed discussion of the related background for the SJV, please refer to the proposed and final rules at 71 FR 40952 (July 19, 2006) and 71 FR 63642. Shortly before EPA issued the determination of attainment, EPA learned of preliminary data indicating that exceedances had occurred on September 22, 2006, at several monitors, and that the State intended to flag 2 them as caused by natural events and to request that EPA concur with these flags. EPA stated that because the data were preliminary and because they may qualify as natural events, EPA would proceed with its determination of attainment at that time. EPA further indicated that once quality-assured data were available EPA would review those data and consider whether the determination of attainment should be withdrawn. 1 EPA's final determination of attainment addressed both the 24-hour and annual PM-10 standards; however, on October 17, 2006, effective on December 18, 2006, EPA revoked the annual PM-10 standard. 71 FR 61144. 2 Once air quality data have been submitted to EPA, it is possible to “flag” specific values for various purposes. “Data flagging” refers to the act of making a notation in a designated field of an electronic data record. The principal purpose of the data flagging system in the Air Quality System

(AQS)data base is to identify those air quality measurements for which special attention or handling is warranted. These include, but are not limited to, those measurements that are influenced by exceptional events. See 71 FR 12592, 12598 (March 10, 2006). Since the October 2006 final determination of attainment, EPA has obtained information regarding the PM-10 exceedances summarized in Table 1, which were recorded at various monitors within the boundaries of the SJV: Table 1.—Summary of Exceedances Evaluated for Today's Proposed Rule Date of exceedance Monitor location (type(s)) Concentration (μg/m 3 ) September 22, 2006 Corcoran (FRM, FEM)* 215, 261 Bakersfield-Golden (FRM, FEM) 157, 170 Oildale

(FRM)162 October 25, 2006 Corcoran

(FEM)304 Bakersfield-Golden State Highway

(FEM)193 December 8, 2006 Corcoran

(FEM)162 Bakersfield-Golden State Highway

(FEM)213 September 14, 2006 Santa Rosa Rancheria

(FRM)190 September 20, 2006 Santa Rosa Rancheria

(FRM)158 October 26, 2006 Santa Rosa Rancheria

(FRM)157 * FRM = Federal Reference Method; FEM = Federal Equivalent Method. 3 On April 24, 2007, the State submitted to EPA documentation supporting its claim that the September 22, 2006 exceedances were caused by high winds and wildfires. This submittal was supplemented with additional documentation on July 10, 2007. On May 1, 2007, the State submitted to EPA documentation supporting its claim that the October 25, 2006 exceedances were caused by high winds. On June 12, 2007, the State submitted to EPA documentation supporting its claim that the December 8, 2006 exceedances were caused by high winds. The State believes that all of these exceedances qualify as natural events and that the data should thus be excluded from consideration in the attainment determination. 3 A federal reference method

(FRM)is an air sample collection and analysis method which follows the procedures detailed in the appendices to 40 CFR part 50. A federal equivalent method

(FEM)is an air sampling collection and analysis method which does not follow the reference procedures in 40 CFR part 50, but has been certified and designated by the EPA as obtaining “equivalent” results. On July 9, 2007, EPA met with a representative of the Santa Rosa Rancheria EPA to discuss exceedances recorded on September 14, September 20 and October 26, 2006. The Tribe has flagged these exceedances as being caused by an exceptional event related to construction activities and EPA has compiled documentation to support that claim. II. EPA's Proposed Actions In this proposed rule, EPA is proposing to concur with the State's request to flag exceedances of the PM-10 standard within the SJV on September 22, October 25 and December 8, 2006 as being caused by exceptional events, i.e., high winds, and thus to exclude these data from use in determining PM-10 attainment for the SJV. EPA is also proposing to exclude exceedances recorded at the Santa Rosa Rancheria, tribal lands within the SJV, on September 14, September 20 and October 26, 2006 from use in determining attainment for the SJV, on two bases:

(1)The exceedances occurred while the monitor was operating in very close proximity to construction activities and, as such, the monitor was not properly sited during that time for purposes of comparison to the NAAQS; and

(2)the exceedances were caused by an exceptional event, i.e., construction activity in very close proximity to the monitor. The Tribe has flagged those exceedances, and EPA is proposing to concur with those flags. As a result, EPA is proposing to affirm its October 2006 attainment determination based on its evaluation of quality-assured data from September 14 through December 31, 2006. After receiving and considering all relevant public comments on our proposed rule, we will publish our final determination as to whether we will concur with the State's and Tribe's requests to flag the exceedances discussed above as affected by exceptional events and to exclude them from consideration in our attainment determination. We will also publish our determination as to whether we will exclude the exceedances at the Santa Rosa Rancheria as a result of the monitor siting. EPA is not taking comment in these proposed actions on any issues that were the subject of the 2006 attainment determination rulemaking except to the extent that they affect EPA's ability to determine that the SJV continued to attain the PM-10 standard through 2006. In this proposed rule we are also addressing relevant issues raised in the petition for reconsideration and petition to withdraw the determination of attainment filed by the Latino Issues Forum and others. In our 2006 attainment determination we stated that if, after the September 22, 2006 data were quality-assured, and after further evaluating the State's request for exclusion of these data, we determine that the data do not qualify for exclusion and we believe that if included that they would establish that the area is in violation of the NAAQS, EPA would proceed with appropriate rulemaking action to withdraw its determination of attainment. 71 FR 63642. Both EPA's natural/exceptional events policies and its exceptional events rule anticipate that the Agency will concur or nonconcur on a state's request to exclude data by letter rather than rulemaking. Generally we would initiate rulemaking following an attainment determination for an area only if we had preliminarily concluded that a withdrawal of that determination would be appropriate. That is not the case here. However, in this instance both because EPA had indicated in its final action that it would reassess the attainment determination once it had quality-assured data for the September 22, 2006 exceedances and because of the issues raised by the petitions pending before the Agency and discussed below, we are proposing to concur with the State's and Tribe's requested flags and affirm our 2006 attainment determination via notice and comment rulemaking. Because we generally make determinations of attainment on a calendar year basis, our proposed rule addresses quality assured exceedances from September 14 through December 31, 2006. Moreover the petitions address exceedances within this timeframe. III. Summary of Litigation and Administrative Proceedings Earthjustice filed three petitions related to EPA's determination of attainment for the SJV. On December 27, 2006, Earthjustice, on behalf of Latino Issues Forum, Medical Advocates for Healthy Air and Sierra Club, filed in the U.S. Court of Appeals for the 9th Circuit a petition for review of EPA's October 2006 determination under the Clean Air Act that the SJV has attained the PM-10 standard. *Latino Issues Forum* v. *EPA,* No. 06-75831 (9th Cir.). On December 29, 2006, Earthjustice also filed with EPA a petition for reconsideration of our attainment determination. In the petition, Earthjustice alleges, among other things, that EPA improperly ignored September 22, 2006 PM-10 exceedances in the SJV that were not subject to public notice and comment. Finally, on March 21, 2007, Earthjustice filed a petition for withdrawal of our attainment determination. In this petition, Earthjustice alleges that the attainment determination must be withdrawn because, among other things, the exceedances that occurred in September and October 2006 do not qualify as exceptional events. EPA addresses issues raised in both of these administrative petitions in this proposed rule. IV. EPA's Exceptional Events Rule On March 22, 2007, EPA issued a final rule governing the review and handling of air quality data influenced by exceptional events. 72 FR 13560. The rule became effective on May 21, 2007 and implements section 319 of the CAA, as amended by section 6013 of the Safe Accountable Flexible Efficient-Transportation Equity Act: A Legacy for Users (SAFE-TEA-LU) of 2005. In the rule, EPA establishes procedures and criteria related to the identification, evaluation, interpretation, and use of air quality monitoring data related to the ozone and particulate matter NAAQS where states petition EPA to exclude data that are affected by exceptional events from certain regulatory actions under the CAA. The rule is codified at 40 CFR 50.1, 50.14, and 51.920. 72 FR at 13580-13581. In the preamble to the final rule, EPA also addresses its applicability to Indian Tribes. Where, as here, the Santa Rosa Rancheria Tribe operates an air quality monitor only in order to gather data for informational purposes but does not implement other programs such as mitigating the effects of exceptional events, it is EPA's responsibility to ensure that any exclusion or discounting of data in Indian country areas comports with the rule's procedures and requirements. EPA intends to work with tribes on the implementation of the rule. 72 FR at 13563. In 1986 and 1996 EPA issued guidance to address the use of data influenced by exceptional and natural events: “Guidance on the Identification and Use of Air Quality Data Affected by Exceptional Events” (July 1986) and “Areas Affected by PM-10 Natural Events,” May 30, 1996. CAA Section 319, as amended by SAFE-TEA-LU, states that these guidance documents continue to apply until the effective date of a final regulation promulgated under section 319(b)(2). See CAA Section 319(b)(4). SAFE-TEA-LU did not however address those situations where EPA had not made a determination prior to the effective date of the rule whether an exceptional event had occurred after a state had flagged data and submitted a demonstration in a timely manner to show that such data reflected NAAQS exceedances that were caused by an exceptional event. In these circumstances, EPA believes that in the interests of equity and administrative efficiency, a state seeking to exclude data affected by exceptional events should, for a limited period of time, be able to choose to comply with either the provisions of the rule or those of the guidance documents for a limited period of time. This approach would have some advantages, such as allowing the state to avoid duplicating its demonstration process and completing the decisionmaking process already underway. EPA believes that it is reasonable to use this approach until December 31, 2007 to complete the transition from the policies to the rule. However, unless the state in the circumstances described above, specifically requests that EPA evaluate a natural or exceptional event demonstration under the guidance documents, EPA will presume that the rule applies. Under 40 CFR 50.14(j), an “exceptional event,” with specified exceptions not relevant here, is defined as one “that affects air quality, is not reasonably controllable or preventable, is an event caused by human activity that is unlikely to recur at a particular location or a natural event, and is determined by the Administrator in accordance with 40 CFR 50.14 [‘treatment of air quality monitoring data influenced by exceptional events’] to be an exceptional event.” A “natural event” is defined as one “in which human activity plays little or no direct causal role.” 40 CFR 50.14(k). 4 4 In the preamble to the final rule, EPA discusses specific types of natural events, including high wind events (i.e., those that affect ambient particulate matter concentrations through the raising of dust or through the re-entrainment of material that has been deposited). See 72 FR at 13565-13566 and 13576-13577. EPA's interpretation of the rule with respect to high winds is addressed in section V. below. The rule establishes a multi-step process for identification by states, tribes and local agencies of data and submission of the requisite demonstrations to EPA. 72 FR at 13571. In short, a state must notify EPA of its intent to exclude measured exceedances of a NAAQS as being due to an exceptional event by “flagging” the data in EPA's AQS database. 40 CFR 50.14(c)(2)(i). For PM-10, the state should submit the flags, accompanied by an initial description of the event, by July 1st of the calendar year following the year in which the flagged measurement occurred. 40 CFR 50.14(c)(2)(iii). A state that has flagged data as being due to an exceptional event and is requesting its exclusion must, after notice and opportunity for public comment, submit a demonstration that to EPA's satisfaction shows that the flagged event caused a specific concentration in excess of the NAAQS at the particular location to justify data exclusion. This demonstration must be submitted to EPA within 3 years of the calendar quarter following the event, but no later than 12 months prior to an EPA regulatory decision. A state must submit the public comments it received along with its demonstration to EPA. 40 CFR 50.14(c)(3)(i). In the preamble to the final rule, EPA explained that it will generally review the state's demonstration and provide a concurrence or nonconcurrence on the flag in the AQS database within 60 days of the state's complete submission. EPA expects that, in most cases, this time period should be sufficient to review and provide a concurrence or nonconcurrence regarding a state's request to exclude data affected by an exceptional event. However, for more complex demonstrations, EPA may require additional time to make its decision and will notify the state of the additional time required. 72 FR at 13571. Upon its concurrence on a flag, EPA will exclude the data from use in determinations of NAAQS exceedances and violations. 40 CFR 50.14(b). The requirements for the demonstration to justify data exclusion that the state must submit, in this instance, to EPA are set forth at 40 CFR 50.14(a), (b)(1), and (c)(3)(iii). In order to be considered for exclusion, the state must show that the event satisfies the criteria in section 50.1(j), there is a clear causal connection between the exceedances and the claimed exceptional event, the event is associated with measured concentration in excess of normal historical fluctuations including background and there would have been no exceedance “but for” the event. 40 CFR 50.14(c)(iii)(A)-(D). One of the requirements of section 50.1(j) is that the exceptional event must be shown to affect air quality, which is met by establishing that the event is associated with a measured exceedance in excess of normal historical fluctuations, including background. 40 CFR 50.14(c)(iii)(B). In addition, as noted above there must be a clear causal relationship between the measurement under consideration and the event that is claimed to have affected the air quality in the area. 40 CFR 50.14(c)(iii)(C). Air quality impact and causal connection may be shown through a number of methods including modeling and speciation analysis. EPA will evaluate whether an event affected air quality and caused a particular concentration using the weight of available evidence and considering the historical frequency of such measured concentrations. States must compare contemporary concentrations with distribution of historical values and these may be presented on a seasonal or other temporal basis. 40 CFR 50.14(a)(2) and (c)(3)(iii)(A) and (C); 72 FR at 13569. Also, air quality data may not be excluded except where states, tribes, or local agencies show, through a weight of evidence approach, that exceedances or violations of applicable standards would not have occurred “but for” the influence of exceptional events. 40 CFR 50.14(c)(3)(iii)(D). 72 FR at 13570-13571. Finally, states must demonstrate that they have provided an opportunity for public comment and must submit any public comments it received to EPA. 40 CFR 50.14(c)(3)(i) and (iv). States, tribes, or local agencies must also demonstrate that the claimed exceptional event meets the other requirements of § 50.1(j)—that the event is not reasonably preventable or controllable and that the event is either caused by human activity that is unlikely to recur at a particular location or is a natural event. In this instance, the claimed events are high winds, i.e. natural events, and construction, i.e., an event caused by human activity that is unlikely to recur at the particular location. In order to concur on a state's request to exclude data, EPA must determine that the state's submission is complete and demonstrates to EPA's satisfaction that the exceptional event caused the exceedances. Although states must meet the minimum requirements (e.g. “but for” test), EPA did not specify a minimum level of documentation in the rule because the facts and circumstances could vary depending on, among others, meteorology, and geography. Instead, EPA illustrated through examples the kind of information that states could consider in meeting the demonstration requirements of the rule. In describing the documentation process and requirement, EPA also stated that acceptable documentation would be determined through consultation with the EPA regional offices. 72 FR at 13573. Finally, under 40 CFR 51.930, a state requesting to exclude air quality data due to exceptional events must take appropriate and reasonable actions, including public notification, public education and implementation of measures, to protect public health from exceedances or violations of the NAAQS. V. EPA's Evaluation of Flagged Exceedances The State and Tribe have not specifically requested that EPA evaluate the September 14 through December 31, 2006 exceedances (which occurred before the effective date of the Exceptional Events Rule) under EPA's natural events policy or exceptional events policy. Therefore we are evaluating the State's submittals and the Santa Rosa Rancheria exceedances under the Exceptional Events Rule to determine whether they meet both the procedural requirements and the technical criteria for showing that the exceedances are exceptional. We will discuss whether the State's submittal and the exceedances at Santa Rosa Rancheria meet each of these requirements and criteria separately. For each of the exceedances being discussed in today's proposal, EPA bases its evaluation on the procedural requirements and technical criteria and mitigation requirements of the Exceptional Events Rule, as discussed above and summarized below: Procedural Requirements: • Data are flagged in EPA's AQS database. • Public had an opportunity to review and comment on the state's documentation. • The documentation was submitted to EPA. • EPA concurs with the state's demonstration. Technical Criteria: • The state must show that the event satisfies the criteria in 40 CFR 50.1(j). 5 5 Section 50.1(j) provides the regulatory definition of an exceptional event. “Exceptional event” means an event that affects air quality, is not reasonably controllable or preventable, is an event caused by human activity that is unlikely to recur at a particular location or a natural event, and is determined by the Administrator in accordance with 40 CFR 50.14 to be an exceptional event. It does not include stagnation of air masses or meteorological inversions, a meteorological event involving high temperatures or lack of precipitation, or air pollution relating to source noncompliance. • There is a clear causal connection between the exceedance and the claimed exceptional event. • The event is associated with measured concentration in excess of normal historical fluctuations including background. • There would have been no exceedances “but for” the event. Mitigation Requirements: • Provide for prompt public notification of exceedance events. • Provide for public education on how to minimize exposure. • Provide for the implementation of appropriate measures to protect the public. A. September 22, 2006 Exceedances at Corcoran, Bakersfield, and Oildale The 24-hour PM-10 NAAQS was exceeded at three monitoring locations on September 22, 2006: The Corcoran monitoring site recorded concentrations of 215 μg/m 3 and 261 μg/m 3 with a FRM sampler and a FEM automated continuous analyzer, 6 respectively; the Bakersfield-Golden State Highway monitoring site recorded concentrations of 157 μg/m 3 and 170 μg/m 3 with its FRM sampler and FEM

(TEOM)analyzers, respectively; and the Oildale monitoring site recorded a concentration of 162 μg/m 3 with its FRM sampler. 6 The FEM monitor currently operated at the Corcoran site is an automated continuous analyzer known as a Tapered Element Oscillating Microbalance (TEOM). The State concludes that three sources of PM-10 contributed to exceedances of the 24-hour PM-10 NAAQS on this day: Wind-entrained dust from sources in the central and southern SJV, which is identified as the primary source of PM-10; wind-entrained dust from regional sources from the northern SJV; and emissions related to several wildfires which are identified as secondary sources of PM-10. 7 Based on the evidence submitted, EPA agrees with the State's demonstration that high wind-entrained dust from sources in the central and southern SJV caused the exceedances at the three monitoring locations on September 22, 2006. 7 “Natural Event Documentation, Corcoran, Oildale, and Bakersfield, California, September 22, 2006”, April 20, 2007 (NED for September 22, 2006) at 10. We do not however agree with the State that emissions from wildfires or regionally transported dust from the northern SJV were significant contributors. After evaluating the State's demonstration under the technical criteria established in the Exceptional Events Rule, EPA finds that for the Corcoran, Bakersfield and Oildale areas, the State does not demonstrate that emissions from wildfires had a significant impact on the PM-10 concentrations recorded on September 22, 2006. None of the fires cited in the documentation was within the boundaries of the SJV. Further, an independent review of PM-2.5 speciation data collected at Bakersfield and Fresno on the days preceding and after September 22 shows no unusual concentrations of carbon. See *http://www.epa.gov/cgi-bin/htmSQL/mxplorer/query_spe.hsql.* If the fires had had a significant effect on PM-10 concentrations, there would have been evidence of increased carbon (one of the chemical constituents of wood smoke) in the speciation data. The documentation submitted by the State includes mostly anecdotal evidence of the wildfires' impact and satellite photographs showing smoke over parts of California. The anecdotal evidence consists of newspaper reports of reduced visibility due to smoke and the odor of wood smoke, as well as observations from trained weather observers at Lemoore Naval Air Station. 8 EPA finds that the documentation lacks data linking the fires to the concentrations given the distance of the fires and the lack of corroborating speciation data and satellite photographs of the smoke, and newspaper reports do not rise above general or anecdotal evidence to establish a clear causal relationship between the exceedances on September 22, 2006 and the emissions from wildfires. 8 NED for September 22, 2006 at 11, Table 3, 14 and 37-44. Similarly, EPA believes that the State's documentation that regional sources of entrained dust impacted monitors in the Corcoran and Bakersfield areas does not show a clear causal relationship between the exceedances and regional transport of PM-10 from the northern SJV. EPA bases this conclusion on its review of the documentation which indicates that while there were high hourly averaged winds and gusts in the northern central valley of California, the State did not present any facts, corroborating evidence or any convincing argument to demonstrate how PM-10 from this area could have reached the southern SJV in concentrations sufficient to contribute to an exceedance of the 24-hour PM-10 NAAQS. Because EPA does not agree with the State's conclusions with respect to regional transport of PM-10 from the northern SJV and with respect to wildfires, in the following discussion regarding the September 22, 2006 exceedances we refer only to the State's conclusion that these exceedances were caused by wind-entrained dust from sources in the central and southern SJV. 1. Procedural Requirements a. Data Are Flagged in EPA's AQS Database All of the September 22, 2006 exceedances were flagged in EPA's AQS database as of July 2007. b. Public Had an Opportunity To Review and Comment on the State's Documentation In February 2007, the SJV Air Pollution Control District (SJVAPCD or District) notified the public in local newspapers and on its Web site of the availability of the document entitled “Natural Event Documentation, High Winds, Corcoran and Bakersfield, California, September 22, 2006,” SJV Unified Air Pollution Control District, February 2007 and requested public comments by March 5, 2007. The SJVAPCD subsequently revised the February 2007 document and submitted to the California Air Resources Board

(CARB)“Natural Event Documentation, Corcoran, Oildale and Bakersfield, California, September 22, 2006,” SJV Unified Air Pollution Control District, April 20, 2007 (NED for September 22, 2006) and posted it on its Web site. SJVAPCD thereafter provided additional information to CARB in “Addendum, Natural Event Documentation, Corcoran, Oildale and Bakersfield, California, September 22, 2006,” SJV Unified Air Pollution Control District, May 23, 2007 (NED Addendum for September 22, 2006) and posted it on its Web site. The District indicated that no public comments were received during the public process. c. The Documentation Was Submitted to EPA The NED for September 22, 2006 and the NED Addendum for September 22, 2006 were subsequently submitted by the State to EPA on April 24, 2007 and July 10, 2007, respectively, and are the documents upon which EPA is basing its evaluation below. d. EPA Concurs With the State's Demonstration In this proposed rule, EPA is proposing to concur with the State's demonstration in the NED for September 22, 2006 and the NED Addendum for September 22, 2006 that high wind-entrained dust from the central and southern SJV caused the exceedances at the three monitoring locations on September 22, 2006. 2. Technical Criteria a. Did this event satisfy the criteria in section 50.1(j) of the Rule? The State needs to show that the September 22, 2006 event, wind-entrained dust from sources in the central and southern SJV, affected air quality in the Corcoran and Bakersfield areas, 9 was not reasonably controllable or preventable, was a natural event, and is determined by EPA through the process established in the Rule to be an exceptional event. We believe the State has supported its claims that wind-driven dust from sources of PM-10 in the central and southern SJV was the cause of the September 22, 2006 exceedances, as discussed in detail below. 9 The Bakersfield-Golden State Highway and Oildale monitors are approximately 3.5 miles apart. For the purposes of this discussion, the analysis for the Bakersfield-Golden State Highway and Oildale monitors is the same. i. Affected Air Quality For an event to qualify as an exceptional event, the state must show that the event affected air quality. This criterion can be met by establishing that the event is associated with a measured exceedance in excess of normal historical fluctuations, including background, and there is a causal connection between the event and the exceedance. The demonstration of a clear causal relationship is necessary to establish that the event affected air quality and is also a separate statutory requirement as discussed above. In the NED for September 22, 2006 and the NED Addendum for September 22, 2006, the State provides documentation that the measured exceedances on September 22, 2006 were in excess of normal historical fluctuations. See subsection c. below. The State also establishes a causal connection between the high winds recorded at Lemoore and the high concentrations recorded at the Corcoran, Bakersfield, and Oildale monitors. The State's demonstration of the clear causal relationship between the event and the exceedances on this day is discussed in greater detail in subsection b. below. ii. Not Reasonably Controllable or Preventable Section 50.1(j) of the Exceptional Events Rule requires that for an event to qualify as an exceptional event, whether natural or anthropogenic, a state must show that the event was not reasonably preventable or controllable. Here this requirement is met by demonstrating that despite reasonable and appropriate measures in place, the September 22, 2006 wind event caused the exceedances. During this event there were no other unusual dust-producing activities occurring in the SJV and anthropogenic emissions were approximately constant before, during and after the event. In addition, the State shows that reasonable and appropriate measures were in place, including Regulation VIII (the District's general fugitive dust rules) and Rule 4550 which limits fugitive dust emissions specifically from agricultural operations through Conservation Management Practices. 10 Moreover, EPA has approved the District's best available control measure

(BACM)demonstration for all significant sources of PM-10 in the SJV as meeting CAA section 189(b)(1)(B). 11 10 NED for September 22, 2006 at 32. 11 69 FR 30006, 30035 (May 26, 2004); 71 FR 7683 (February 14, 2006). iii. Was a Natural Event In the preamble to the Exceptional Events Rule EPA states that ambient particulate matter concentrations due to dust being raised by unusually high winds will be treated as due to uncontrollable natural events where

(1)the dust originated from nonanthropogenic sources, or

(2)the dust originated from anthropogenic sources within the State, that are determined to have been reasonably well-controlled at the time that the event occurred, or from anthropogenic sources outside the State. 72 FR at 13576. In the preamble EPA also explains that “[s]tates must provide appropriate documentation to substantiate why the level of wind speed associated with the event in question should be considered unusual for the affected area during the time of year that the event occurred.” *Id.* at 13566. On September 22, 2006, the wind-entrained dust originated from anthropogenic sources within California, *i.e.* , from usual dust-generating activities such as agricultural and industrial operations. 12 We discuss the fugitive dust control measures in place in the SJV on September 22 above. 12 NED for September 22, 2006 at 32-33. With respect to the wind speed, EPA concurs with the State's demonstration that the wind speeds in the central SJV were unusually high on September 22, 2006. 13 Meteorological data show that the winds at Lemoore reached speeds of 29 mph with gusts of approximately 40 mph. According to the State, the Department of Water Resources' extreme annual wind statistics indicate that the mean annual peak gust for Lemoore is 42 mph. 14 Thus wind gusts observed at Lemoore were unusually high because they are close to the typical highest annual value of 42 mph. The State also provides documentation that shows that winds of approximately 18 mph will entrain and transport dust. 15 Winds greater than this speed occurred at Lemoore and Kettleman Hills, and were responsible for transporting this entrained dust. Meteorological data indicate that the wind direction was from the north and northwest and hence the entrained dust at that wind speed was transported towards Corcoran. Winds at Corcoran were not as intense during the peak hours at Lemoore. Table 3 of the State's submittal indicates the winds at Corcoran at 10 a.m. were 9 mph with gusts to 12 mph. 16 These wind speeds, though not sufficient to erode dust, were sufficient to keep the entrained and transported dust from the high winds at Lemoore suspended for the period during which the exceedances occurred. 13 NED for September 22, 2006 at 29; NED Addendum for September 22, 2006 at section 4. 14 NED for September 22, 2006 at 29. 15 NED for September 22, 2006 at 13; David Bush, T&B Systems Contribution to CRPAQS Initial Data Analysis of Field Program Measurements, Final Report Contract 2002-06PM Technical & Business Systems, Inc., November 9, 2004 (Bush Report). 16 NED Addendum for September 22, 2006 at 11, Table 3. iv. Determined by EPA To Be an Exceptional Event Finally, EPA must determine through the process established in the Exceptional Events Rule whether an exceptional event occurred. We believe that the State has met the procedural requirements of the rule including flagging of the data, submission of demonstration, evidence of the public opportunity to review and comment on the demonstration and mitigation requirements as discussed in section V.A.1. and 3. of this proposed rule. We further believe that the State has also met the technical criteria in the Exceptional Events Rule as discussed in section V.A.2. Therefore, we are proposing to concur with the State's determination that an exceptional event, i.e., a high wind event, occurred resulting in the exceedances on September 22, 2006. 17 17 Generally EPA concurs or nonconcurs by letter with requests to flag data as caused by exceptional events. See our explanation in section II. above regarding why we are proceeding by a rulemaking here. b. Does the State's documentation show a clear causal connection between the exceedances and the claimed exceptional event? Under 40 CFR 50.14(c)(3)(iii)(B), a state's demonstration must establish a clear causal relationship between the measured exceedance and the claimed exceptional event. In addressing this requirement for the September 22, 2006 exceedances, the State identifies a source region for the PM-10, an area northwest of Corcoran around the area of Lemoore. The State provides a convincing demonstration showing that the winds in the area of the central SJV were of sufficient speeds to erode soils and entrain dust and that the wind direction moved the PM-10 southeast towards Corcoran and further to the Bakersfield area. Meteorological measurements in Lemoore show that this area had the highest hourly averaged winds in the SJV that day, peaking at 10 a.m. with a speed of 29 mph from the NNW and gusts at the same time reaching 37 mph. 18 Lemoore is approximately 25 miles northwest of Corcoran. Meteorological measurements were also obtained from a site at Kettleman Hills, which showed a peak hourly wind at 11 am of 20 mph from the NNW with gusts up to 32 mph. 19 Kettleman Hills is approximately 28 miles west of Corcoran. The wind speed, direction, time and distance from monitors indicate that the high winds at Lemoore entrained the dust carrying it toward Corcoran. 20 The State cites a 2002 California Regional PM-10/PM-2.5 Air Quality Study (2002 CRPAQS study) that established a dust-generating wind speed threshold of 17.8 mph to support its conclusion that these wind speeds were sufficient to erode soils and entrain dust into the atmosphere as well as to exacerbate the entrainment of dust from the anthropogenic activities. 21 18 NED for September 22, 2006 at 11, Table 3. 19 *Id.* 20 *Id.* 21 *Id.* at 13; Bush Report. At about 9:30 a.m. and 10:30 a.m. the District received complaints about dust emissions in Lemoore. 22 This was at the time of peak winds in Lemoore. The District followed up on the complaints but did not issue notices of violation. The State indicates that there were PM-10 generating activities in the area of Lemoore on the morning of September 22, 2006 but that these activities were typical for the area and subject to the District's fugitive dust regulations. 23 22 NED for September 22, 2006 at 33, Table 15. 23 *Id.* at 5 and 32-33. The State shows a clear relationship between the wind speeds at Lemoore and Kettleman Hills and increased concentrations at the Corcoran monitoring site. The documentation clearly shows that as hourly average wind speeds increased at the three meteorological sites, hourly concentrations at Corcoran also increased. The peak hourly concentrations at Corcoran were at 10 a.m. and 11 a.m. (725 μg/m 3 and 695 μg/m 3 , respectively). 24 These concentrations coincide with the highest winds at Lemoore and Kettleman Hills. 24 *Id.* at 11, Table 3. The winds at Corcoran showed the same pattern of increasing wind speeds but at a lower intensity. Hourly average winds at Corcoran peaked at 8 a.m. at 11 mph with a peak average minute gust of 15 mph. While these wind speeds were not high enough to erode and entrain soil, based on the wind speed threshold referenced above, they were sufficient to keep the coarse particles suspended in the atmosphere. The winds were also consistently from the northwest, which demonstrates that the coarse particles which impacted Corcoran originated in the areas northwest of the monitor, e.g. Lemoore where the winds were unusually high. Using the threshold wind speed in the 2002 CRPAQS study, the State shows that most of the PM-10 was generated upwind of the Corcoran site and then transported to the Corcoran area. 25 Based on available data, wind speeds at Corcoran were not high enough to generate dust on their own but were high enough to sustain the entrainment of PM-10 from upwind areas. 25 *Id.* at 13; Bush Report. The wind-driven dust from sources in the central and southern SJV, beginning in Lemoore, also impacted the Bakersfield area on September 22, 2006. The State provides the analysis and supporting information needed to demonstrate that the winds between the Corcoran and Bakersfield areas were of sufficient intensity to transport the plume of PM-10 from Corcoran to the Bakersfield and Oildale monitors. The Bakersfield area monitors began to record hourly concentrations in excess of the level of the 24-hour PM-10 NAAQS two hours after the peak Corcoran hourly PM-10 concentration, with the Bakersfield hourly PM-10 concentrations peaking five hours after the Corcoran peak hourly PM-10 concentration. In order to transport a plume of dust from Corcoran to the Bakersfield area, approximately 55 miles, wind speeds would have to average approximately 11 mph in order for the maximum amount of PM-10 to impact the Bakersfield area monitors five hours later. 26 The winds at Alpaugh, which is located between Corcoran and Bakersfield, averaged 11 mph. 27 As would be expected, the concentration of PM-10 in the Bakersfield area was lower than in Corcoran, but still significant enough to exceed the NAAQS. The lower PM-10 concentrations at Bakersfield are likely due to the dispersion of the dust plume and possibly deposition of a portion of the dust particles along the path from the Corcoran area to Bakersfield. 26 NED Addendum for September 22, 2006 at 7. 27 *Id.* at 8, Table A-1. The State's demonstration for September 22, 2006 includes information on wind speed and direction 28 that shows the correlation between the hourly wind speeds at meteorological sites in Alpaugh and Bakersfield-Meadows Airfield and the hourly PM-10 concentrations recorded in the Bakersfield area. 29 28 NED Addendum for September 22, 2006 at 8, Table A-1. 29 The Oildale monitoring site does not record hourly PM-10 concentrations but uses a manual PM-10 sampler that provides only 24-hour average concentrations. The Bakersfield-Golden State Highway monitoring site utilizes both a manual sampler for average 24-hour PM-10 concentrations and a continuous PM-10 analyzer to provide hourly concentrations. Since the Bakersfield-Golden State Highway site and the Oildale site are relatively close to each other (see footnote 9 above), we believe it is appropriate to use the Bakersfield-Golden State Highway continuous analyzer to characterize the temporal distribution of hourly concentrations at both sites. The State also includes the results of a basic meteorological model known as Hybrid Single-Particle Lagrangian Integrated Trajectory model (HYSPLIT). 30 It is important to note that while this modeling is not meant to quantify the particle concentration recorded in the Bakersfield area, it does offer support of the State's demonstration that the winds on September 22, 2006 were of the appropriate intensity and direction to move a plume of dust from the central SJV to the Bakersfield area. 30 NED Addendum for September 22, 2006 at 10. c. Did the State demonstrate that the event is associated with measured concentration in excess of normal historical fluctuations including background? For EPA to concur with a state's claim that an exceptional event caused an exceedance, one of the requirements that the state must meet is to show that the event is associated with concentrations that are beyond the normal historical fluctuations. See 40 CFR 50.14(c)(3)(iii)(C). The NED for September 22, 2006 and NED Addendum for September 22, 2006 include sections that show the unusualness of the concentrations recorded on that date. Section 4 of the Addendum includes Figure A-5 that compares the peak 24-hour PM-10 concentrations recorded at Corcoran, Bakersfield and Oildale during the month of September for the years 2000 through 2006. 31 31 NED Addendum for September 22, 2006 at 14. The FRM monitor at the Corcoran site has mostly operated on a once-in-every-three-days schedule since 2000. 32 The Corcoran FRM has collected 786 samples since 2000 and has recorded only four exceedances of the 24-hour PM-10 NAAQS. 33 A further analysis shows that, with the exception of a flagged natural event in 2004, 24-hour PM-10 concentrations exceeded a level of 100 μg/m 3 only three times during the month of September for a seven year period, i.e, when we look at the 59 samples collected during the September for the past seven years, a concentration greater than 100 μg/m 3 occurred only five percent of the time. 34 Exceedances of the NAAQS have occurred twice in September, which is less than four percent of the days sampled. Comparisons for the month of September are more relevant than for the entire year because September has the highest concentration of dust but does not typically have the highest PM-10 concentrations, which occur in the winter season. Dust is typically less than 50% of the PM-10 during September. 35 During the winter season nitrates are the largest contributor, particularly in the southern part of the central valley. 32 From September 1, 2000 to March 22, 2001 the Corcoran monitor operated on a once-in-every-six-days schedule. 33 PM-10 Raw Data Report Corcoran 2000-2006, EPA AQS Database, July 30, 2007. 34 138 μg/m 3 on September 9, 2004, a 102 μg/m 3 on September 24, 2004 and a 112 μg/m 3 on September 23, 2006; See *Id.* 35 “What are the Sources of Particulate Matter”, Presentation by Karen L. Magliano, California Air Resources Board, May 17, 2006 (Magliano Presentation). For Bakersfield, which utilizes a FRM operating on a once-in-every-six-days schedule, 413 samples were collected since the year 2000. During this time the NAAQS was exceeded three times. Again, when we look at data collected during the September months from 2000 to 2006, only one day out of 33 days sampled recorded a level greater than 100 μg/m 3 (128 μg/m 3 on September 18, 2003), three percent of the time. 36 36 PM-10 Raw Data Report Bakersfield Golden 2000-2006, EPA AQS Database, July 30, 2007. For Oildale, also operating a FRM on a once-every-six-days schedule, 432 samples were collected from 2000 to 2006. The PM-10 NAAQS was exceeded once during this seven-year period. During the September months, only one day out of 35 days sampled recorded a level greater than 100 μg/m 3 (111 μg/m 3 on September 14, 2006), less than three percent of the time. 37 37 PM-10 Raw Data Report Oildale 2000-2006, EPA AQS Database, July 26, 2007. d. Did the State demonstrate that there would have been no exceedance “but for” the event? As discussed above, to qualify as an exceptional event the state must also demonstrate that there would have been no exceedance “but for” the event. 40 CFR 50.14 (c)(3)(iii)(D). To meet this “but for” criterion, states must include analyses to demonstrate that an exceedance or violation would not have occurred but for the event. Such analyses do not require a precise estimate of the estimated air quality impact from the event. 72 FR at 13570. To meet this “but for” criterion, the State first shows that there were no unusual activities occurring in the affected areas in the Valley on September 22, 2006 that could have resulted in the exceedances. Specifically, based on information from District field staff and discussions with representatives of agricultural and industrial operations in the Valley, anthropogenic emissions were approximately constant in the Valley immediately before, during and after the event. The State indicates that there were PM-10 generating activities, such as agricultural and construction operations, in the area of Lemoore on the morning of September 22, 2006. These types of activities are typical for the area. 38 38 NED for September 22, 2006 at 32-33. The State next indicates that the greatest fraction of PM-10 at the Corcoran and Bakersfield sites on September 22 consisted of particles in the size fraction between PM-10 and PM-2.5. 39 This information indicates that geologic dust, as opposed to secondary PM or PM from combustion sources, was the primary contributor to the exceedances. The fraction of coarse particles at Corcoran and Bakersfield on September 22 was 89% and 79% respectively. 40 These values must be compared to the typical geologic values for the Valley during September of approximately 30 μg/m 3 which are less than 50% of the measured PM-10. 41 Based on the reported 89% value, the estimated geologic material for Corcoran was approximately 190 to 230 μg/m 3 for September 22, 2006. The corresponding values for Bakersfield were 123-134 μg/m 3 . Compared to the typical September value of approximately 30 μg/m 3 , the September 22, 2006 values represent an excess geologic contribution of approximately 160 to 200 μg/m 3 for Corcoran and approximately 94 to 104 for Bakersfield. If the typical value of 30 μg/m 3 were used instead of the high estimated geologic values derived from the PM-10-2.5 size fraction, the resulting “adjusted” PM-10 values for Corcoran and Bakersfield would be 50-65 μg/m 3 . This result favorably compares to the typical average September concentration of less than 60 μg/m 3 . Allowing for a PM-10 geologic value of 60 μg/m 3 , which is twice the September norm, would only yield an “adjusted” concentration of 84 to 96 μg/m 3 . All of these sets of adjusted values for September 22 are consistent with the aforementioned historical September levels which rarely exceeded 100 μg/m 3 , showing that very few days in Bakersfield and Corcoran over the period 2000-2006 exceeded the level of 100 μg/m 3 . In addition, the NED for September 22, 2006 includes Table 2 that lists the PM-10 24-hour average concentrations recorded using continuous analyzers for the days immediately preceding and after September 22, 2006. 42 This table indicates that 24-hour average PM-10 concentrations at Corcoran were over 100% higher on September 22 as compared to September 20, 21, 23, and 24. At Bakersfield, concentrations on September 22 were over 100% higher than on September 20 and September 24 and 86% higher than on September 21. Compared to September 23 the increase was 14%. 39 *Id.* at 32, Figure 13. 40 *Id.* 41 Magliano Presentation. 42 NED for September 22, 2006 at 9. Finally, as discussed above, there were reasonable and appropriate measures in place to control PM-10 in the SJV on September 22, 2006, Regulation VIII and Rule 4550. 43 Moreover, EPA has approved the District's BACM demonstration for all significant sources of PM-10 in the SJV as meeting CAA section 189(b)(1)(B). 44 Furthermore, District staff performed 46 inspections in the Valley on September 22 to ensure that regulated sources were complying with the District's fugitive dust rules. 45 The District's Natural Events Action Plan, discussed below, also addresses the reasonable and appropriate measures that the District has implemented to address high wind events in the SJV. 43 *Id.* at 32. 44 69 FR 30006, 30035 (May 26, 2004); 71 FR 7683 (February 14, 2006). 45 NED for September 22, 2006 at 45-46. Based on the weight of evidence presented, EPA concludes that the State's documentation demonstrates that the exceedances at Corcoran, and Bakersfield and Oildale on September 22, 2006 would not have occurred but for the wind event on this day. 3. Mitigation Requirements Under 40 CFR 51.930, a state requesting to exclude air quality data due to exceptional events must take appropriate and reasonable actions, including public notification, public education, and implementation of measures, to protect public health from exceedances or violations of the NAAQS. The SJVAPCD adopted the “Natural Events Action Plan for High Wind Events in the San Joaquin Valley Air Basin”

(NEAP)on February 16, 2006. The NEAP provides the SJVAPCD's approach to forecasting high wind events, notifying the public prior to the event and educating the public on how to minimize exposure during high wind events. The document also discusses measures that are in place to help minimize exposure to elevated PM-10 levels. EPA believes that the detailed processes and measures described in the NEAP satisfy the mitigation requirements under 40 CFR 51.930. a. Provide for Prompt Public Notification of Exceedance Events Section 6 of the NEAP provides the meteorological forecasting criteria that the SJVAPCD uses to determine whether or not to declare NEAP episodes. When the criteria indicate that a NEAP episode should be declared, the SJVAPCD has a public notification program, discussed in Section 7 of the NEAP, which involves informing the local media, SJVAPCD staff and community groups. b. Provide for Public Education on How To Minimize Exposure Section 7 of the NEAP provides a list of precautions that can be taken to limit exposure during a NEAP episode. The list includes keeping windows shut, using air conditioners or heaters on the recycle/recirculating air mode, limiting strenuous activity, and other precautions. Section 8 of the NEAP discusses the SJVAPCD's general public outreach program on NEAP episodes which includes developing and providing a brochure and information about NEAP episodes by means of community events, health fairs, schools and civic engagements. c. Provide for the Implementation of Appropriate Measures To Protect the Public Section 10 of the NEAP discusses the SJVAPCD's measures that reduce PM-10 emissions. These measures, including those approved by EPA as BACM for the SJV, in combination with the SJVAPCD's process for declaring NEAP episodes and educating the public on how to minimize their exposure during a NEAP episode, meet the requirements for appropriate measures to protect the public during high wind exceptional events. Conclusion EPA believes that the high winds in the area of Lemoore on September 22, 2006 were an exceptional event as defined in 40 CFR 50.1(j). EPA also believes that the State has provided a sufficient weight of evidence demonstration to show that these high winds generated and transported PM-10 from the area of Lemoore to Corcoran, causing an exceedance of the 24-hour PM-10 NAAQS. Winds between Corcoran and the Bakersfield area were sufficient to transport the dust that originated in the Lemoore area such that they caused the monitors at Bakersfield-Golden State Highway and Oildale to also exceed the NAAQS. The documentation submitted by the State demonstrates that but for the high winds in the area of Lemoore, the Corcoran, Bakersfield and Oildale monitors would not have exceeded the 24-hour PM-10 NAAQS on September 22, 2006. Because EPA believes that the State has satisfied the provisions of the Exceptional Events Rule, EPA proposes to concur with the State's request to flag these exceedances as being due to exceptional events and to exclude the data from consideration in determining whether the area has attained the PM-10 standard. B. October 25, 2006 Exceedances at Corcoran and Bakersfield On October 25, 2006, the SJV recorded exceedances of the 24-hour PM-10 NAAQS at two sites, Corcoran and Bakersfield-Golden State Highway, using continuous PM-10 analyzers designated as FEM monitors. 46 The 24-hour average concentrations recorded were 304 μg/m 3 at Corcoran and 193 μg/m 3 at Bakersfield-Golden State Highway. The conditions that contributed to these exceedances were very similar to those that occurred on September 22, 2006. Based on the evidence submitted, EPA agrees with the State's demonstration that high wind-entrained dust from the central and southern SJV caused the exceedances at the two monitoring locations on October 25, 2006. 46 The District operates Tapered Element Oscillating Microbalance

(TEOM)continuous automated analyzers at these two sites in addition to the manual high-volume Federal Reference Method

(FRM)monitors. The FRMs operate at a less than everyday schedule, as allowed by EPA regulations, but neither of the FRM monitors was operating on October 25, 2006. The District operates the continuous analyzers so that they may report daily PM-10 air quality data to the public. 1. Procedural Requirements a. Data Are Flagged in EPA's AQS Database The October 25, 2006 exceedances were flagged in EPA's AQS database as of July 2007. b. Public Had an Opportunity To Review and Comment on the State's Documentation In February 2007, the SJVAPCD notified the public in local newspapers and on its Web site of the availability of the document entitled “Natural Event Documentation, High Winds, Corcoran and Bakersfield, California, October 25, 2006,” SJV Unified Air Pollution Control District, February 2007 and requested public comments by March 5, 2007. The SJVAPCD subsequently revised the February 2007 document and submitted to CARB the “Natural Event Documentation, Corcoran and Bakersfield, California, October 25, 2006,” San Joaquin Valley Unified Air Pollution Control District, April 23, 2007 (NED for October 25, 2006), and posted it on its Web site. The SJVAPCD indicated that no public comments were received during its public process. c. The Documentation Was Submitted to Epa The NED for October 25, 2006 was submitted by the State to EPA on May 1, 2007 and is the document upon which EPA is basing its evaluation below. d. EPA Concurs With the State's Demonstration In this proposed rule, EPA is proposing to concur with the State's demonstration in the NED for October 25, 2006 that high wind-entrained dust caused the exceedances at the two monitoring sites. 2. Technical Criteria a. Did this event satisfy the criteria in section 50.1(j) of the Rule? i. Affected Air Quality For an event to qualify as an exceptional event, the state must show that the event affected air quality. This criterion can be met by establishing that the event is associated with a measured exceedance in excess of normal historical fluctuations, including background, and there is a causal connection between the event and the exceedance. The demonstration of a clear causal relationship is necessary to establish that the event affected air quality and is also a separate statutory requirement as discussed above. In the NED for October 25, 2006, the State provides documentation that the measured exceedances recorded on October 25, 2006 were in excess of normal historical fluctuations. See subsection c. below. The State also establishes a causal connection between the high winds recorded at Lemoore and the high concentrations at the monitors recorded at Corcoran and Bakersfield. The State's demonstration of the clear causal relationship between the exceptional event and the exceedances on this day is discussed in greater detail in subsection b. below. ii. Not Reasonably Controllable or Preventable Section 50.1(j) requires that for an event to qualify as an exceptional event, whether natural or anthropogenic, a state must show that the event was not reasonably preventable or controllable. Here this requirement is met by demonstrating that despite reasonable and appropriate measures in place, the October 25, 2006 wind event caused the exceedances. During this event, there were no other unusual dust-producing activities occurring in the SJV and anthropogenic emissions were approximately constant before, during and after the event. In addition, the State showed that reasonable and appropriate measures were in place, including Regulation VIII (the District's general fugitive dust rules) and Rule 4550 which limits fugitive dust emissions specifically from agricultural operations through Conservation Management Practices. 47 Moreover, EPA has approved the District's BACM demonstration for all significant sources of PM-10 in the SJV as meeting CAA section 189(b)(1)(B). 48 47 NED for October 25, 2006 at 29. 48 69 FR at 30035; 71 FR 7683. iii. Was a Natural Event In the preamble to the Exceptional Events Rule, EPA states that ambient particulate matter concentrations due to dust being raised by unusually high winds will be treated as due to uncontrollable natural events where

(1)the dust originated from nonanthropogenic sources, or

(2)the dust originated from anthropogenic sources within the State, that are determined to have been reasonably well-controlled at the time that the event occurred, or from anthropogenic sources outside the State. 72 FR at 13576. In the preamble EPA also explains that “[s]tates must provide appropriate documentation to substantiate why the level of wind speed associated with the event in question should be considered unusual for the affected area during the time of year that the event occurred.” *Id.* at 13566. The wind-entrained dust on October 25, 2006 originated from anthropogenic sources within California, i.e., from usual dust-generating activities such as agricultural and industrial operations. 49 We discuss the fugitive dust control measures in place in the SJV on October 25 above. 49 NED for October 25, 2006 at 29. With respect to the wind speed, EPA concurs with the State's demonstration that the wind speeds in the central SJV were unusually high on October 25, 2006. 50 Table 1 of the NED for October 25, 2006 lists the wind speeds in the Hanford and Lemoore areas. The peak hourly averaged winds were in the range of 29 to 31 mph at Lemoore, with gusts reaching 40 mph. Peak hourly winds at Hanford were lower, in the range of 17 to 18 mph, but still in line with the threshold wind speed of 17.8 mph. Hanford also recorded peak gusts of 22 to 30 mph during the 10 a.m. to 12 noon period. 51 Tables 8, 9, and 11 of the NED for October 25, 2006 also include information on wind speeds throughout the central valley of California and the central and southern SJV. 52 The documentation also states that wind speeds of these intensities are relatively rare in the southwestern part of the SJV and occur less than 5% of the time, based on long-term monitoring records. 53 50 *Id.* at sections 4 and 5. 51 *Id.* at 11. 52 *Id.* at 22-23. 53 *Id.* at 24. EPA concurs with the State's demonstration in the NED for October 25, 2006 that the wind speeds occurring in the central SJV were unusually high on October 25, 2006. While the winds at Corcoran were not as high as those in Lemoore and Hanford, as described in the State's documentation, the winds at Corcoran during the peak hourly PM-10 concentrations (8 a.m. to 11 a.m.) ranged from 10 to 13 mph, which are unusual for this time of year in that area. These wind speeds, though not sufficient to erode dust, were sufficient to keep the entrained and transported dust from the high winds at Lemoore suspended for the period during which the exceedances occurred. iv. Determined by EPA To Be an Exceptional Event Finally, EPA must determine through the process established in the Exceptional Events Rule whether an exceptional event occurred. We believe that the State has met the procedural requirements of the Rule including flagging of the data, submission of demonstration, evidence of the public opportunity to review and comment on the demonstration and mitigation requirements as discussed at section V.B.1. and 3. of this proposed rule. We further believe that the State has also met the technical criteria of the Rule as discussed at section V.B.2. of this proposed rule. Therefore we are proposing to concur with the State's determination that an exceptional event, i.e., a high wind event, occurred resulting in the exceedances on October 25, 2006. b. Does the State's documentation show a clear causal connection between the exceedances and the claimed exceptional event? Under 40 CFR 50.14(c)(3)(iii)(B), a state's demonstration must establish a clear causal relationship between the measured exceedances and the claimed exceptional event. In addressing this requirement for the October 25, 2006 exceedances, the NED for October 25, 2006 submitted by the State identifies the area northwest of Corcoran as the source of PM-10 during the October 25, 2006 event. Winds in the Lemoore area were again in excess of the threshold wind speed for eroding and entraining dust as discussed above. Table 1 of the NED for October 25, 2006 shows a clear correlation between the wind speeds in the Hanford and Lemoore areas and the increased hourly concentrations at Corcoran. 54 In fact the peak wind speeds at Lemoore and Hanford, which occurred between 10 a.m. and 12 noon at Lemoore, coincide with the peak hourly concentrations at Corcoran. The peak hourly averaged winds were in the range of 29 to 31 mph at Lemoore, with gusts reaching 40 mph. Peak hourly winds at Hanford were lower, in the range of 17 to 18 mph, but still in line with the threshold wind speed of 17.8 mph. Hanford also recorded peak gusts during the 10 a.m. to 12 noon period of 22 to 30 mph. Figure 2 of NED for October 25, 2006 compares the hourly wind speed and PM-10 concentration data from Corcoran with the hourly wind speed data from Lemoore in a graphical format. 55 This graphic shows the almost perfect correlation between increased wind speeds at Corcoran and Lemoore with the increased PM-10 hourly concentrations at Corcoran. 54 NED for October 25, 2006 at 11. 55 *Id.* at 12. The dust plume that affected the Corcoran monitoring site on October 25, 2006 continued moving south and ultimately impacted the continuous PM-10 analyzer operating at the Bakersfield-Golden State Highway monitoring site. The State provides information on wind speed and direction from the Alpaugh meteorological monitoring station, located between Corcoran and Bakersfield about 16 miles south southeast of the Corcoran monitoring site. 56 Between the hours of 9 a.m. and 4 p.m., wind speeds at Alpaugh averaged about 12 mph. 57 Since the meteorological data measured at Alpaugh is taken at 2 meters Above Ground Level (AGL), the average wind speed at 10 meters AGL is about 15 mph. 58 EPA believes this average wind speed would have been sufficient to keep the dust plume suspended, and that it facilitated the transport of the dust plume to the Bakersfield area. 56 *Id.* at 22-26. 57 *Id.* at 58. 58 *Id.* at 24-26. The data in Table 1 of the NED for October 25, 2006 show the Bakersfield hourly PM-10 concentrations beginning to exceed the level of the 24-hour PM-10 NAAQS at 11 a.m. (177 μg/m 3 ) and peaking between the hours of 2 p.m. and 5 p.m. (415 μg/m 3 and 416 μg/m 3 , respectively). Figure 4 provides a graph of PM-10 hourly concentrations for three continuous PM-10 analyzers operated by the District at Corcoran, Bakersfield-Golden State Highway, and Tracy. 59 The graph shows hourly PM-10 concentrations at Bakersfield-Golden State Highway slowly increasing through the morning hours of October 25 until 8 a.m. Hourly concentrations increase at a higher rate between 8 a.m. and 1 p.m., mirroring the increase at Corcoran, but not as dramatic. As the Corcoran hourly concentrations are dropping between 11 a.m. 4 p.m. we see a corresponding sharp increase in hourly concentrations at Bakersfield-Golden State Highway. This behavior of the hourly concentrations supports the State's explanation that the dust plume that first affected Corcoran traveled south over a period of several hours and then impacted the Bakersfield monitor. 59 *Id.* at 14. As with the September 22, 2006 event, the State includes for the October 25, 2006 event the results of a basic meteorological model known as the Hybrid Single-Particle Lagrangian Integrated Trajectory model (HYSPLIT). 60 It is important to note that while this modeling is not meant to quantify the particle concentration recorded in the Bakersfield area, it does support the State's demonstration that the winds on October 25, 2006 were of the appropriate intensity and direction to move a plume of dust from the central SJV to the Bakersfield area. 60 *Id.* at 27. c. Did the State demonstrate that the event is associated with measured concentrations in excess of normal historical fluctuations including background? For EPA to concur with a state's claim that an exceptional event caused an exceedance, one of the requirements that the state must meet is to show that the event is associated with concentrations that are beyond the normal historical fluctuations. See 40 CFR 50.14(c)(3)(iii)(C). The State provides data on PM-10 levels on the days before and after October 25, 2006. PM-10 concentrations before and after October 25, 2006 were significantly lower than the concentration recorded on October 25, 2006. An EPA review of continuous PM-10 data from Corcoran and Bakersfield-Golden State Highway showed that 24-hour average concentrations from October 1, when the TEOM continuous analyzers began reporting data, through October 24 did not exceed 100, and while there were a number of higher concentrations on the days after October 25, not counting the exceedances recorded on December 8, 2006, which are discussed further below in subsection d, the PM-10 concentrations at Corcoran and Bakersfield-Golden State Highway fell to mostly less than 100 again from October 28 through June 30, 2007. 61 61 “Continuous PM-10 Data Collected with TEOMs, Data Reported to EPA's AIRNOW Website,” July 30, 2007, Excel Spreadsheet, Bob Pallarino. Historically we can compare data from these continuous analyzers only with the separate manual FRM samplers operated at the sites. When we look at typical PM-10 concentrations recorded in the month of October from 2000 to 2006 the maximum value recorded at Bakersfield was 116 μg/m 3 measured on October 16, 2001 and the maximum non-exceedance value recorded at Corcoran was 150 μg/m 3 measured on October 31, 2006. 62 These concentrations indicate that the exceedances recorded on October 25, 2006 were unusual and not representative of typical high concentrations recorded at these monitoring locations. 62 Corcoran exceeded the 24-hour NAAQS on October 29, 2002 with a value of 168 μg/m 3 ; PM-10 Raw Data Reports, Corcoran 2000-2006 and Bakersfield-Golden 2000-2006. d. Did the State demonstrate that there would have been no exceedance “but for” the event? As discussed previously, to qualify as an exceptional event the State must also demonstrate that there would have been no exceedance “but for” the event. 40 CFR 50.14(c)(3)(iii)(D). To meet this “but for” requirement, the state must include analyses to demonstrate that an exceedance or violation would not have occurred but for the event. Such analyses do not require a precise estimate of the estimated air quality impact from the event. 72 FR at 13570. To meet this “but for” requirement the State first shows that there were no unusual activities occurring in the affected areas in the Valley that could have resulted in the exceedances. Specifically, based on information from District field staff and discussions with representatives of agricultural and industrial operations in the Valley, anthropogenic emissions were approximately constant in the Valley immediately before, during and after the event. The District staff observed no unusual emissions other than those associated with the wind event. The PM-10 generating activities were BACM-controlled sources that are usual for the area. 63 District staff conducted 90 inspections throughout the SJV on October 25 to ensure sources were in compliance with District air pollution rules. 64 63 NED for October 25, 2006 at 7 and 29. 64 *Id.* at 35. The State notes in the NED for October 25, 2006 that the PM-2.5 to PM-10 ratio on this day was very low, which indicates that mostly coarse PM was present on the filter, supporting its claim that the concentrations recorded on this day were affected by a blowing dust event. 65 65 *Id.* at 28. When we examine the typical make-up of PM-10 in the SJV during October we generally see particle concentrations that are mostly in the size fraction of PM-2.5, roughly 60-65%, with the remaining mass being particles in the PM-10-2.5 size fraction. 66 Typically, fugitive dust is the major constituent of the PM-10-2.5 size fraction and makes up about 25 to 35% of the total PM-10. When we look at a comparison of PM-2.5 and PM-10 concentrations recorded on October 25, 2006, we find that the PM-10-2.5 portion of the total PM-10 represents about 93% of the total PM-10 at Corcoran and 85 percent of total PM-10 at Bakersfield. This high percentage of PM-10-2.5, which is mostly fugitive dust, is atypical for this time of year and supports the State's demonstration that the PM-10 concentrations on this day consisted of mostly coarse geologic material. 66 Magliano Presentation. We can also look at the days immediately preceding and following the exceedance day to see if the concentrations on October 25 were unusual. The PM-10 concentrations recorded on October 25 at Corcoran and Bakersfield were over three times higher than they were on October 24. 67 PM-10 concentrations after the event decreased dramatically and by October 28, PM-10 concentrations at both sites were below 100. See also the discussion of the historical levels at these monitors set forth in subsection c. above, which further demonstrates that the concentrations recorded on October 25 were unusual. 67 NED for October 25, 2006 at 16, Table 3. Finally, as discussed above, there were reasonable and appropriate measures in place to control PM-10 in the SJV on October 25, 2006, Regulation VIII and Rule 4550. 68 Moreover, EPA has approved the District's BACM demonstration for all significant sources of PM-10 in the SJV as meeting CAA section 189(b)(1)(B). 69 Section 9.2 of the NED for October 25, 2006 indicates that the District staff performed 90 inspections on that date to ensure that regulated sources were complying with District fugitive dust rules. 70 The District's Natural Events Action Plan, discussed in section V.A.3. above, also addresses the reasonable and appropriate measures that the District has implemented to address high wind events in the SJV. 68 *Id.* at 29. 69 69 FR at 30035; 71 FR 7683. 70 NED for October 25, 2006 at 35. Based on the weight of evidence presented, EPA concludes that the State's documentation demonstrates that the exceedances at Corcoran and Bakersfield on October 24, 2006 would not have occurred but for the wind event on this day. 3. Mitigation Requirements See section V.A.3. above. Conclusion EPA believes that the high winds in the area of Lemoore on October 25, 2006, were an exceptional event as defined in 40 CFR 50.1(j). EPA also believes that the State has provided a sufficient weight of evidence demonstration to show that these high winds generated and transported PM-10 from the area of Lemoore to Corcoran, causing an exceedance of the 24-hour PM-10 NAAQS. Winds between Corcoran and the Bakersfield area were sufficient to transport the dust that originated in the Lemoore area such that they caused the monitor at Bakersfield-Golden State Highway to also exceed the NAAQS. The documentation submitted by the State demonstrates that but for the high winds in the area of Lemoore, the Corcoran and Bakersfield monitors would not have exceeded the 24-hour PM-10 NAAQS on October 25, 2006. Because EPA believes the State has satisfied the provisions of the Exceptional Events Rule, EPA proposes to concur with the State's request to flag these exceedances as being due to exceptional events and to exclude the data from consideration in determining whether the area has attained the PM-10 standard. C. December 8, 2006 Exceedances at Corcoran and Bakersfield The SJV recorded exceedances of the 24-hour PM-10 NAAQS on December 8, 2006 at two sites, Corcoran and Bakersfield-Golden State Highway, using continuous PM-10 analyzers designated as FEM monitors. The 24-hour average PM-10 concentrations recorded were 162 μg/m 3 at Corcoran and 213 μg/m 3 at Bakersfield-Golden State Highway. The State demonstrates that unusually high winds in the Bakersfield area eroded and entrained dust that impacted the continuous PM-10 analyzer at Bakersfield. Unlike September 22 and October 25, 2006, the winds in the SJV on this day were generally from the southwest, south and southeast, transporting dust northward and ultimately impacting the continuous PM-10 analyzer at Corcoran. Based on the evidence submitted, EPA agrees with the State's demonstration that high wind-entrained dust caused the exceedances at the two monitoring locations on December 8, 2006. 1. Procedural Requirements a. Data Are Flagged in EPA's AQS Database The December 8, 2006 exceedances were flagged in EPA's AQS database as of July 2007. b. Public had an opportunity to review and comment on the State's documentation In February 2007, the SJVAPCD notified the public in local newspapers and on its Web site of the availability of the document entitled “Natural Event Documentation, High Winds, Corcoran and Bakersfield, California, December 8, 2006,” SJV Unified Air Pollution Control District, February 2007 and requested public comments by March 5, 2007. The SJVACPD subsequently revised the February 2007 document and submitted to the California Air Resources Board

(CARB)the “Natural Event Documentation, Corcoran and Bakersfield, California, December 8, 2006,” SJV Unified Air Pollution Control District, May 23, 2007 and posted it on its Web site. SJVAPCD thereafter made revisions per CARB's request and submitted to CARB the “Natural Event Documentation, Corcoran and Bakersfield, California, December 8, 2006,” SJV Unified Air Pollution Control District, June 6, 2007 (NED for December 8, 2006) and posted it on its Web site. The District indicated that no public comments were received during the public process. c. The Documentation Was Submitted to EPA The NED for December 8, 2006 was subsequently submitted by the State to EPA on June 12, 2007 and is the document upon which EPA is basing its evaluation below. d. EPA Concurs With the State's Demonstration In this proposed rule, EPA is proposing to concur with the State's demonstration in the NED for December 8, 2006 that high wind-entrained dust caused the exceedances at the two monitoring locations on December 8, 2006. 2. Technical Criteria a. Did this event satisfy the criteria in section 50.1(j) of the Rule? As with the previous events discussed in this proposed rule, the State needs to show that this event, identified in the NED for December 8, 2006 as unusually high winds, affected air quality in the Corcoran and Bakersfield areas, was not reasonably controllable or preventable, was a natural event, and is determined by EPA to be an exceptional event. i. Affected Air Quality For an event to qualify as an exceptional event, the state must show that the event affected air quality. This criterion can be met by establishing that the event is associated with a measured exceedance in excess of normal historical fluctuations, including background and there is a causal connection between the event and the exceedance. This demonstration of a causal connection is necessary to establish that the event affected air quality and is also a separate statutory requirement as discussed above. In the NED for December 8, 2006, the State provides documentation that these measured exceedances were in excess of normal historical fluctuations. See subsection c. below. The State also establishes a causal connection between the high winds recorded in the Bakersfield and Southern SJV area and the high concentrations recorded at the Corcoran and Bakersfield monitors. The State's demonstration of the clear causal relationship between the event and the exceedances on this day is discussed in greater detail in subsection b. below. ii. Not Reasonably Controllable or Preventable Section 50.1(j) of the Exceptional Events Rule requires that for an event to qualify as an exceptional event, whether natural or anthropogenic, a state must show that the event was not reasonably preventable or controllable. Here this requirement is met by demonstrating that despite reasonable and appropriate measures in place, the December 8, 2006 wind event caused the exceedances. During this event, there were no other unusual dust-producing activities occurring in the SJV and anthropogenic emissions were approximately constant before, during and after the event. In addition, the State shows that reasonable and appropriate measures were in place, including Regulation VIII (the District's general fugitive dust rules) and Rule 4550 which limits fugitive dust emissions specifically from agricultural operations through Conservation Management Practices. 71 Moreover, EPA has approved the District's BACM demonstration for all significant sources of PM-10 in the SJV as meeting CAA section 189(b)(1)(B). 72 71 NED for December 8, 2006 at 25. 72 69 FR at 30035; 71 FR 7683. iii. Was a Natural Event In the preamble to the Exceptional Events Rule, EPA states that ambient particulate matter concentrations due to dust being raised by unusually high winds will be treated as due to uncontrollable natural events where

(1)the dust originated from nonanthropogenic sources, or

(SSI)Anderson sampler designated as a FRM by EPA. The monitoring site also measures ozone and meteorological parameters including wind speed and wind direction. The PM-10 sampler is located near the northeast corner on the roof of the pumping station. The current land cover around the pump station is paved parking. There are no obstructions of any kind and there is unrestricted airflow 360 degrees around the sampler inlet. 87 87 July 18, 2007 Memorandum, “On-Site Visit to Santa Rosa Rancheria,” from Bob Pallarino, EPA, to Sean Hogan, EPA (Site Visit Memorandum). To the east of the monitor is a paved parking lot, beginning about 25 feet east of the monitor location and extending approximately 50 feet to the east. Beyond the parking area are trailers and undeveloped land. To the north of the monitor is a larger parking lot, beginning about 100 feet north of the monitor location and extending north approximately 525 feet. Beyond the parking lot are a casino hotel, casino, and additional parking lots. To the immediate south (150 feet) and west (300 feet) are the remaining physical plant facilities (tanks, pumps, etc.) and the area is paved. Further south and west are agricultural fields (currently alfalfa). Agricultural fields also lie to the north beyond the casino and parking lot (approximately 0.5 mile). To the east is the SRR residential area. PM-10 is measured once-in-every-six days by the SRREPA according to the national sampling schedule. Sampling began on August 3, 2006 and continues to the present time. In 2006 there was a major construction project at the SRR, which involved construction of a casino hotel and associated parking lots. This construction activity, located near the monitor, was ongoing prior to the time the monitor began operation. The original intention of the SRREPA was to begin operation of the monitor and sampling only after completion of the parking lots and external portion of the hotel. Due to delays, however, the construction was not completed until November 2006. The monitor began operating as scheduled on August 3, 2006. The SRREPA's environmental technician informed EPA that he believes that many of the samples collected since PM-10 monitoring began on August 3, 2006, through mid-November 2006, were unduly influenced by the grading and paving of parking lots immediately adjacent to the monitoring site on the north and east sides of the pump station building where the PM-10 sampler monitor is located. 88 In addition to the exceedance days, much of the data between August 3 and November 25, 2006 submitted to the AQS database, has been flagged as affected by construction activity. 89 88 Site Visit Memorandum. 89 AQS Raw Data Report, Santa Rosa Rancheria PM-10 2006 to 2007. EPA believes there are two bases for excluding the September 14, September 20 and October 26, 2006 exceedances from consideration in determining whether the SJV has attained the PM-10 standard. First, as explained in more detail below, EPA believes that, during the time period the monitor was operating in such close proximity to the construction, the monitor should be considered to have been improperly sited under the principles established in 40 CFR part 58, appendix E. Second, EPA believes that, under its Exceptional Events Rule, the construction activity that occurred within such close proximity to the monitor constitutes an exceptional event that caused the exceedances. EPA believes that both of these rationales, separately or together, support EPA's proposal not to include the SRR monitor data recorded during the period of parking lot construction in our determination of whether the SJV has attained the PM-10 NAAQS. A. Evaluation Under Principles Established in 40 CFR Part 58, Appendix E 40 CFR part 58 establishes criteria and requirements for ambient air quality monitoring, and appendix E sets forth the probe and monitoring path siting criteria for ambient air quality monitoring. 71 FR 61236 (October 17, 2006). These include both binding requirements and goals. Section 1(b) of appendix E, the Introduction, provides that “[t]he probe and monitoring path siting criteria discussed in this appendix must be followed to the maximum extent possible.” Section 58.20 provides that Special Purpose Monitors, which may include monitors on tribal lands, must meet certain requirements of part 58, including appendix E, if the data they collect are to be used for purposes of comparison to the NAAQS. It is not clear whether the monitor in Santa Rosa Rancheria is intended to be designated a Special Purpose Monitor. It is clear, however, that EPA does not intend data from a monitor to be used for purposes of comparison to the NAAQS unless the data meet the criteria set forth in section 58.20, including appendix E. Under the principles established in part 58, appendix E, EPA believes that it is not a reasonable monitoring practice to locate a PM-10 monitor, intended for purposes of comparison to the NAAQS, so close to an obviously temporary dust source, as was the case at the SRR. Section 3(a) of appendix E, Spacing from Minor Sources, addresses the siting of monitors, including PM-10 monitors. It states that close spacing between a monitor and a minor source may be proper if the purpose of that monitoring site is to investigate emissions from that source and other local sources. However, if, as is the case with the SRR monitor here, the site is to be used to determine air quality over a larger area, such as a neighborhood or city, it should not be placed near local, minor sources, because the plume from the local minor source would inappropriately impact the air quality data collected at the site. It is plain that this occurred in the SRR situation, where the monitor, when it began operating, was only 25 feet from one parking lot construction zone and 100 feet from another. We believe that in general it is important to avoid placing a particulate monitor inordinately close to a location where active but temporary construction activity is generating dust emissions. As noted above, the SRREPA originally had not intended to start operating the monitor until after the conclusion of the construction activity. As a consequence of monitoring while this construction was still ongoing, the SRR Tribe was compelled to flag data for 12 of the 19 sampling days that occurred between August 3 and November 25, when the construction concluded. Thus more than 60% of the data collected during this time period was considered to be unusable for regulatory purposes. The dramatic contrast between concentrations monitored while construction was ongoing and post-construction concentrations also testifies to the impact that the improper siting had on the monitored data. After construction ceased, average monitored PM-10 concentrations declined 50%. See discussion below in section VI.B.2.d. below. EPA believes that after the construction concluded the monitor met the appropriate siting criteria. 90 90 Site Visit Memorandum. EPA has concluded that under the very unusual circumstances presented in the SRR, it was not appropriate, according to the principles established in part 58 appendix E, to deploy a new PM-10 monitor, for purposes of comparison to the NAAQS, so close to temporary construction activity, for the duration of that activity. EPA believes it would be unreasonable for the Agency to allow the data from such a monitor to determine the attainment status of the SJV. Conclusion EPA is proposing to conclude that the exceedances in the SJV at the SRR monitor that occurred on September 14, 2006, September 20, 2006 and October 26, 2006 should be excluded from consideration in determining whether the SJV has attained the PM-10 standard, because during this time period EPA deems that the monitor was not properly sited, under the principles established in part 58, appendix E. In proposing to find that, during the period of construction, the monitor was not properly sited for the purpose of comparison to the NAAQS, EPA is addressing only the particular facts and circumstances presented by the SRR monitoring operation. EPA notes that the construction activity at the SRR, which occurred in extremely close proximity to the monitor and on tribal land, predated the start of monitoring operations, and that monitoring was originally intended to begin only after the conclusion of construction activity. Under these circumstances, EPA believes that the September 14, September 20 and October 26, 2006 exceedances should be excluded from consideration in determining whether the SJV has attained the PM-10 standard. B. Evaluation Under the Exceptional Events Rule In addition to the rationale regarding the siting of the monitor, set forth above, EPA proposes to concur with the SRR Tribe's flagging of the exceedances at the SRR because EPA believes that the construction activity constitutes an exceptional event under EPA's Exceptional Events Rule. Our application of the requirements of the Rule to the SRR exceedances is set forth below. 1. Procedural Requirements a. Data Are Flagged in EPA's AQS Database The three exceedances were flagged by the SRR Tribe by the time the data were submitted to the AQS database in 2006. b. Public Had an Opportunity To Review and Comment on the Tribe's Documentation EPA is assisting the SRR Tribe by compiling and evaluating the documentation for the exceedances which have been flagged as being caused by exceptional events. The Exceptional Events Rule recognizes that tribes may not be in a position to address all of the requirements of the Rule and thus states that EPA will “* * * work with tribes on the implementation of this rule, which may include appropriate implementation by EPA of program elements ensuring that any exclusion * * * of data in Indian country with air quality affected by exceptional events comports with the procedures and requirements of this rule.” 72 FR at 13563. EPA, through this proposed rule, is providing the public with an opportunity to review and comment on the documentation of these exceptional events. c. The Documentation Was Submitted to EPA As discussed above, EPA is assisting the SRR Tribe by compiling and evaluating the documentation of the exceedances which they have flagged as being caused by exceptional events. d. EPA Concurs With the Tribe's Flagging and Demonstration EPA is proposing to concur with the SRR Tribe's flagging of these exceedances as affected by exceptional events. As discussed above, EPA is assisting the SRR Tribe by compiling and evaluating the documentation of the exceedances it has flagged as being caused by exceptional events, and by ensuring that the public has an opportunity, through this rulemaking, to review and comment upon it. 2. Technical Criteria a. Did this event satisfy the criteria in section 50.1(j) of the Rule? i. Affected Air Quality For an event to qualify as an exceptional event, the state or tribe must show that the event affected air quality. Here, EPA, on behalf of the SRR Tribe, needs to show that the event, identified as construction activity, affected air quality at the SRREPA PM-10 monitor. This criterion can be met by establishing that the event is associated with a measured exceedance in excess of normal historical fluctuations, including background, and there is a causal connection between the event and the exceedance. This demonstration of a causal connection is necessary to establish that the event affected air quality, and it is also a separate statutory requirement as discussed above. Because the SRREPA PM-10 monitor has been in operation only since August 2006, it is not possible to compare the data from exceedance days to historical levels. In this case, however, we can look at data that have been collected since the construction and parking lot paving was completed to determine representative concentrations of PM-10 in the absence of a large, earth-disturbing project such as the construction, grading and paving of parking lots. We discuss the range of data and its fluctuation in more detail in subsection c. below. We also need to show the causal connection between the exceptional event, in this case construction activity, and the exceedances recorded. In addition to other information provided during EPA's on-site visit, the SRREPA has provided EPA with wind speed and wind direction data collected at its site that show the wind was blowing in the appropriate direction and demonstrates that the PM-10 monitor was downwind of the construction activity on the exceedance days. We discuss the causal connection between the construction activity and the exceedances in more detail in subsection b. below. ii. Not Reasonably Controllable or Preventable Section 50.1(j) of the Exceptional Events Rule requires that for an event to qualify as an exceptional event, whether natural or anthropogenic, a state, tribe (or, in this case, EPA) must show that the event was not reasonably preventable or controllable. EPA believes that it would not have been reasonable to prevent the activity, i.e., paving of parking lots that were needed for the SRR Tribe's facilities. Paving a parking lot (which involves grading the ground, applying a base material such as gravel and applying asphalt) is a generally accepted form of control of PM-10. 91 To prevent the paving of a parking lot would not only be unreasonable, but illogical. With respect to whether the event was reasonably controllable, we note that the SRR Tribe does not have PM-10 control measures in place and is not subject to the fugitive dust control regulations adopted by the SJVAPCD. As discussed in the Exceptional Events Rule, “Tribes are not required to develop TIPs or otherwise implement relevant programs under the CAA. * * *” 92 “EPA recognizes Tribal Governments as sovereign entities with primary authority and responsibility for the reservation populace. Accordingly, EPA will work directly with Tribal Governments as the independent authority for reservation affairs, and not as political subdivisions of States or other governmental units.” 93 91 See, for example, SJV Rule 8051 Open Areas (Adopted November 15, 2001; Amended August 19, 2004) and Rule 8071 Unpaved Vehicle/Equipment Traffic Areas (Adopted November 15, 2001; Amended September 16, 2004). 92 63 FR 7254, 7265 (February 12, 1998); 72 FR at 13563. 93 59 FR 43956 (August 25, 1994). While paving itself is a control measure, EPA recognizes that other control measures may be reasonable during a paving process. For example, the SJVAPCD regulations require, among other things, that regulated construction sites apply as appropriate water or chemical/organic stabilizers or construct and maintain wind barriers. 94 In the circumstances of the SRR, however, even if these types of measures had been actively employed, we cannot be certain that they would have prevented exceedances at the PM-10 monitor. This is due in large part to the unusual circumstance presented here of the very close proximity of the construction activity to the monitor. As noted above, one of the parking lots was within 25 feet of the monitor, and the other was within 100 feet. 94 SJV Rule 8021 Construction, Demolition, Excavation, Extraction, and Other Earthmoving Activities (Adopted November 15, 2001; Amended August 19, 2004). EPA's evaluation of the parking lot construction activity's impact on the monitor, and whether it was reasonably controllable, during the activity, is informed by EPA's views on what constitutes acceptable monitor siting. As EPA has set forth in detail above, EPA believes that, for the duration of the construction activity, the monitor was not properly sited for the purposes of determining attainment of the SJV, and that as a result it was inordinately impacted by that activity. The provisions of 40 CFR part 58, appendix E regarding the siting of PM-10 monitors, are instructive with respect to EPA's analysis of the exceedances under the Exceptional Events Rule. We cannot conclude that the activity was reasonably controllable given that the exceedances were measured at a monitor that EPA's rule provides should not be operated at such a time and place, for the purposes of determining attainment. Thus, under the particular set of circumstances presented here, for the purposes of evaluating the “reasonably controllable” criterion of the Exceptional Events Rule, we deem this criterion to have been satisfied. iii. Was an Event Caused by Human Activity That is Unlikely to Recur at a Particular Location In this case, the event was paving of parking lots in the vicinity of the PM-10 monitor, and is a construction activity that is not expected to recur at that location. iv. Determined by EPA To Be an Exceptional Event Finally, EPA must determine through the process established in the Exceptional Events Rule whether an exceptional event occurred. The Exceptional Events Rule has both procedural requirements and technical criteria that we are assisting the SRREPA in meeting. We believe that by the initial flagging of the data, and through the vehicle of this proposed rulemaking we will demonstrate that the procedural requirements and technical criteria of the rule will have been met. b. Is there a clear causal connection between the exceedances and the claimed exceptional event? Under 40 CFR 50.14(c)(3)(iii)(B), a clear causal relationship must be established between the measured exceedance and the claimed exceptional event. The information compiled by EPA shows a clear causal connection between the exceedances and the construction activity at the nearby parking lots. The SRREPA environmental technician observed the conditions at the time the monitor was operating and noted on the sample tracking forms, which are completed with each sampling run, that there was construction nearby. Copies of these tracking forms are included in the documentation for this rulemaking. The SRREPA measures wind speed and wind direction at the SRR monitoring site. These meteorological data indicate that on the three days that exceeded the NAAQS, winds were predominantly from the northwest to northeast. This would indicate that any dust-producing activity north and northeast of the monitor would result in high concentrations of geologic dust being blown towards the monitor. The meteorological data lend support to the environmental technician's account of the events of that day. EPA also discussed these events with the SRR construction superintendent, who agreed with the environmental technician's account of the construction activity. A private consultant working for the SRREPA also stated that he had witnessed major earth-disturbing activities on these days. 95 95 Site Visit Memorandum. Based on the meteorological data, eyewitness accounts, and an on-site inspection of the monitoring site location and its proximity to the parking lots, we believe that there was a clear causal connection between the construction activity and the recorded PM-10 exceedances. c. Can it be demonstrated that the event is associated with a measured concentration in excess of normal historical fluctuations including background? For EPA to concur with the SRREPA's claim that an exceptional event caused an exceedance, one of requirements is to show that the event is associated with concentrations that are beyond the normal historical fluctuations. See 40 CFR 50.14(c)(3)(iii)(C). Of the 44 samples collected by the SRREPA, nearly 80% of the samples (35 days) were less than 100 μg/m 3 . After completion of the paving projects in mid-November, 2006, average PM-10 concentrations dropped by more than 50%, from an average of 97 μg/m 3 to an average of 45 μg/m 3 . 96 This would indicate that the construction activity had an obvious effect on the concentrations recorded by the SRR monitor and that the data collected during this construction period, including the exceedances recorded in September and October, 2006, were not representative of typical post-construction PM-10 concentrations at the location of the monitor. 96 Santa Rosa Rancheria PM-10 24 hour average concentrations, Excel spreadsheet, Bob Pallarino. d. Can it be demonstrated that there would have been no exceedance “but for” the event? To qualify as an exceptional event, there must be an analysis which demonstrates that there would have been no exceedance “but for” the event. 40 CFR 50.14(c)(3)(iii)(D). Such analyses do not require a precise estimate of the estimated air quality impact from the event. 72 FR at 13570. To meet this requirement, EPA believes the SRREPA environmental technician, consultant and the SRR construction superintendent have clearly indicated that the exceedances occurred on days where nearby construction was also occurring. As EPA has shown, the proximity of the monitor to the construction activity and the concomitant infeasibility of control measures to prevent the exceedances also demonstrate that there would have been no exceedances but for the construction activity. Given these factors and the fact that the average PM-10 concentrations dropped by more than 50% after the completion of the paving projects, we believe the weight of evidence shows that the exceedances would not have occurred but for the construction activity. 3. Mitigation Requirements Under 40 CFR 51.930, a state or tribe requesting to exclude air quality data due to exceptional events must take appropriate and reasonable actions, including public notification, public education and implementation of measures, to protect public health from exceedances or violations of the NAAQS. In the case of the SRR, EPA recognizes that tribes may implement only portions of air quality programs and not be in a position to address each of the procedures and requirements associated with excluding or discounting data. In the preamble to the Exceptional Events Rule, EPA cites an example of tribes that “* * * may operate a monitoring network for purposes of gathering and identifying appropriate data, but may not implement relevant programs for the purpose of mitigating the effects of exceptional events. * * *” 72 FR at 13563. That is the case with the SRR. Under these circumstances, as indicated in the preamble to the Exceptional Events Rule, EPA intends to work with the SRR on the implementation of the Rule. Conclusion EPA believes that the construction activities at the SRR on September 14, 2006, September 20, 2006 and October 26, 2006 were exceptional events as defined under 40 CFR 50.1(j). EPA believes that there is sufficient weight of evidence to conclude that the construction activities caused the exceedances on the exceedance days, and that the exceedances would not have occurred but for the construction activity. The proximity of the construction activities to the monitor and the wind direction recorded at the monitor support this conclusion. Because EPA believes that the provisions of the Exceptional Events Rule have been satisfied, EPA is proposing to concur with the SRR Tribe's flags indicating that these exceedances were due to exceptional events, and to exclude the data from consideration in determining whether the SJV has attained the PM-10 standard. In proposing to concur with the SRR Tribe's flags that construction activity at SRR constituted exceptional events, EPA is addressing only the particular facts and circumstances presented by the SRR monitoring operation. In general, fugitive dust control measures employed during construction activities are helpful in reducing ambient PM-10 concentrations and avoiding exceedances of the NAAQS. However, in the specific circumstances of the SRR during the days when exceedances were recorded, we are not able to conclude that the event was reasonably controllable due to the very close proximity of the monitor to the construction activity, and the other factors discussed above. Given this singular constellation of factors, EPA is proposing to concur with the Tribe's flagging of the exceedances on September 14, September 20 and October 26, 2006 as caused by exceptional events. VII. Summary of Exceedances From 2004 Through 2006 The table below provides a summary of exceedances relevant to today's proposed rule that were recorded at monitors located within the boundaries of the SJV. The table indicates, whether in determining attainment, EPA has excluded or proposes to exclude the exceedance, based on a finding that it was due to an exceptional event. The 24-hour standard is attained when the expected number of days per year with levels above 150 μg/m 3 (averaged over a three-year period) is less than or equal to one. 40 CFR part 50, appendix K. As shown in the table, all of the monitoring locations are meeting the PM-10 standard. Table Summarizing PM-10 24-Hour Exceedances in the SJV [From 2004 through 2006] Monitor Operating schedule Recorded (observed) exceedances 2004—2006 Date Conc Number of estimated exceedances Included in attn. deter. Reason for excluding exceedance Average number of annual exceedances 2004—2006 Corcoran Manual FRM 1 in 3 day 9/3/04 217 No Exceptional Event 0 9/22/06 215 No Exceptional Event Corcoran TEOM Continuous 9/22/06 261 No Exceptional Event 0 10/25/06 304 No Exceptional Event 12/8/06 162 No Exceptional Event Bakersfield Golden Manual FRM 1 in 6 day 9/22/06 157 No Exceptional Event 0 Bakersfield Golden BAM Continuous 11/22/05 156 Yes N/A 0.67 11/23/05 180 Yes N/A Bakersfield Golden TEOM Continuous 9/22/06 157 No Exceptional Event 0 10/25/06 193 No Exceptional Event 12/8/06 213 No Exceptional Event Tracy BAM Continuous 9/22/06 161 Yes N/A 0.33 Oildale Manual FRM 1 in 6 day 9/22/06 162 No Exceptional Event 0 Santa Rosa Rancheria Manual FRM 1 in 6 day 9/14/06 190 No Exceptional Event 0 9/20/06 158 No Exceptional Event 10/26/06 157 No Exceptional Event Sources: EPA Air Quality System Database. E-mail from Steven Shaw, SJVAPCD to Bob Pallarino, EPA Region 9, April 20, 2006. E-mail from Steve Shaw, SJVAPCD to Bob Pallarino, EPA Region 9, October 12, 2006. VIII. Petitions for Reconsideration and Withdrawal A. Winds and Wildfires on September 22 and October 25, 2006 Earthjustice filed its 2006 Petition for Reconsideration

(PFR)before the State provided its exceptional event documentation for the September 22, 2006 exceedances to the public or EPA. At that time CARB and the District had simply informed EPA that, based on preliminary analysis, they believed that these exceedances were due to high wind and wildfire natural events. Similarly, when Earthjustice filed its 2007 Petition for Withdrawal

(PFW)and the accompanying Jan Null declaration, the State had not yet submitted the complete documentation for the September and October 2006 exceedances on which EPA is basing this proposed rule. Therefore Earthjustice's conclusion in the petitions that the September 22, 2006 and October 25, 2006 exceedances do not qualify as natural events does not address the technical analysis of the winds and wildfires as ultimately submitted by the State and which EPA has evaluated in section V. above. To the extent that Earthjustice's assessments in the petitions of the nature and effect of the winds and wildfires are currently relevant, we believe our evaluation in section V. addresses the significant points raised in them. In addition, since EPA, as stated in section V. above, agrees with the petitioners that regional transport from north of the SJV and the northern SJV and wildfires were not the cause of the exceedances on September 22 and October 25, it is unnecessary for EPA to further address the arguments raised by petitioners with respect to these theories. B. Notice/Comment on September 22 and October 25, 2006 Exceedances The gravamen of the 2006 petition, which is reiterated in the Petition for Withdrawal, is Earthjustice's claim that EPA did not provide the public with an opportunity to comment on the September 22, 2006 exceedances and thus should not have finalized the attainment determination for the SJV. PFR at 2-4. Petitioners also complained that EPA did not require adequate documentation that these exceedances were caused by exceptional events. PFR at 3-4. Contrary to Earthjustice's assertions, EPA did not abuse its discretion in addressing the September 22, 2006 exceedances in its October 2006 determination of attainment. EPA noted at the time that the exceedances were based on preliminary data only: “Because these data, which were collected using manual reference method samplers, are preliminary and have not been quality assured, and because EPA believes that they may qualify as caused by natural events, and thus be excluded from consideration in an attainment determination, EPA is proceeding to finalize its determination that the area is in attainment.” 71 FR 63642. Thus the data had not been quality assured, and in addition EPA was on notice that CARB and the District intended to flag the data as due to exceptional events and to request EPA's concurrence on excluding the data from consideration in an attainment determination. EPA went on to note that “[i]f, after the data is quality assured, and after further evaluating CARB's request with respect to these data, EPA determines that the data do not qualify for exclusion under EPA's natural events policy, and EPA further believes that if included that they would establish that the area is in violation of the NAAQS, EPA will proceed with appropriate rulemaking action to withdraw its determination of attainment.” *Id.* It was thus clear that EPA's determination was subject to revision based on subsequent quality assurance and evaluation of the data, and EPA outlined its projected procedure for dealing with the data once they were quality assured and EPA had an opportunity to evaluate the documentation of the potential exceptional events. In this proposed rule, EPA is following through with this procedure, and is now providing for full notice and an opportunity for comment, in the context of a rulemaking, on whether those exceedances qualify as caused by exceptional events. EPA is also providing notice and opportunity for comment on additional claims that exceedances were caused by exceptional events on October 25, 2006, and December 8, 2006, and at the Santa Rosa Rancheria on September 14 and 20 and October 26, 2006. Contrary to Earthjustice's contention in its Petition for Reconsideration and Petition for Withdrawal, EPA did not reverse the burden of proof required to establish an exceptional event, or relieve the State from the obligation to document its claims. PFR at 4; PFW at 17. In the final determination, it is clear that EPA did not conclusively concur in excluding the data without requiring appropriate documentation and a showing from the State. Rather, EPA deferred its determination on the impact of the preliminary data until the data could be quality assured and the State would have an opportunity to meet its burden of showing that an exceedance qualified as caused by an exceptional event. Finally EPA notes that Earthjustice alleges in its 2007 petition that the Agency ignored in its final attainment determination the October 25, 2006 exceedances as well as the September 22, 2006 exceedances. PFW at 2. This is not the case. The exceedances in October occurred eight days after EPA promulgated its final determination of attainment, on October 17, 2006. (The notice was published on October 30, but the determination had been signed and disseminated to the public on October 17). Thus, EPA had no information on these exceedances at the time of its final action. C. Wind Conditions in the Valley With respect to the existence of high winds in the Valley generally, Earthjustice, in both petitions, characterizes statements in the 2003 PM-10 Plan for the area as concluding that wind erosion is not a significant contributing factor in dust emissions and as suggesting that winds with enough velocity to cause erosion disperse PM-10 concentrations and/or transport PM-10 out of the Valley. PFR at 4; PFW at 8. Earthjustice in its 2007 petition also cites a letter from the District to EPA which states that “there is no evidence of any significant linkage between high winds and PM-10 federal exceedance events [in the Valley].” *Id.* at 8-9. Earthjustice has taken the statements in the 2003 Plan to attain the PM-10 standard out of context. Chapter 2 of the Plan, quoted by Earthjustice, is a 12-page general overview of the San Joaquin Valley Air Basin, the purpose of which is to describe normal or typical meteorological conditions. It is not intended to nor does it address unusual winds such as those under consideration here that may occur in the Valley. Nevertheless, the District did determine that windblown dust is not a significant problem in the SJV for the purposes of attaining the PM-10 standard. For example, the Plan states that “[w]ind related PM-10 events are rare but possible when conditions are right” and that “PM-10 readings in the SJVAB are most severe during the fall and winter periods when wind speed and direction are not conducive to interregional transport.” 2003 PM-10 Plan, ES-10, 2-6. The District also states that “winds are effective in dispersing PM-10 concentrations and/or transporting PM-10 out of the Valley” in explaining why the spring and summer months, which are the windier months of the year in the SJV, do not yield higher PM-10 levels. However, the fact that PM-10 pollution from windblown dust is not generally a significant enough problem in the SJV that it needs to be controlled for the purposes of attaining the PM-10 standard, does not mean that windblown dust cannot cause an exceedance of the standard. In addition, even if windblown dust were a significant problem, there could be individual situations where particular conditions make it unreasonable to expect the District and State to be able to control sources in those circumstances. For such situations, EPA has issued the Exceptional Events Rule, and previously its policies, which as discussed above allows exceedances caused by exceptional events to be excluded from regulatory considerations as appropriate if certain conditions are met. Since there are many variables that can cause exceptional event exceedances, EPA believes the analyses for such events should be reviewed on a case by case basis. 72 FR 13560. For example, not all high wind days will lead to exceedances and not all exceedances monitored when high winds are recorded are necessarily due to those high winds. For the exceedances discussed in today's proposal, however, EPA believes the State has made an adequate demonstration that they were caused by exceptional events and have met all of the Exceptional Events Rule requirements, and thus the data for these particular events should be excluded from regulatory consideration. Earthjustice also cites a letter from the District to EPA responding to a letter from Charles Swanson to EPA commenting on the 2003 PM-10 Plan. April 15, 2004 letter from James Sweet, SJVAPCD, to Doris Lo, EPA (Sweet letter). Mr. Swanson disputes the following passage from Table G-15 in Appendix G entitled “BACM Comparative Analysis for `On-Field Activities”' concerning the BACM justification discussion associated with the “Other” category of the District's proposed Agricultural Conservation Management Practices: The SJV does not have a windblown dust problem to anywhere near the extent of the other nonattainment areas. The SJV has some of the lowest average wind speeds in the country. No wind related exceedances have been recorded in the basin during the last three years. Wind speeds are highest during the spring when PM-10 levels are at their lowest. The majority of the fugitive dust emissions are generated from earth disturbing activities. Certain soil types and crops are more prone to windblown dust problems. The “Other” category will give the farmers with the potential to experience wind blown dust emissions the flexibility to address this issue with a CMP. March 18, 2004 letter from Charles Swanson to Doris Lo, EPA (Swanson letter) at 1. In responding to Mr. Swanson, the District stated in its April 15, 2004 letter that “[t]he statements in the Plan provide a general characterization of the San Joaquin Valley

(SJV)and, as with all generalizations, are not without exception.” Sweet letter at 1. Furthermore, while, as Earthjustice points out, the District did also state that an analysis of all wind events since 1990 did not establish a linkage to PM-10 exceedances, the District also enumerated technical limitations that bear directly on this conclusion. For example, the data used did not report wind gusts and the 1 in 6 day sampling for PM-10 will not capture all wind events. Sweet letter at 7-8. Therefore, Earthjustice's attempts to characterize the statements in the Sweet letter regarding windblown dust as absolute is not warranted. Finally, the District also asserts that: Evaluation of past events indicates that often the area with the highest PM-10 levels is not where the wind is highest, but rather where the wind begins to slow. To understand the dynamics of this pattern we need only review the mechanisms for entrainment and deposition. When the wind slows, it can no longer keep the larger PM-10 particles aloft and they settle toward the surface. The settling of particulates aloft * * * results in an increased concentration in the deposition area. Sweet letter at 2. This scenario is precisely what occurred on September 22 and October 25, 2006 as discussed in section V. above. D. EPA's Natural Events Policy 1. BACM Implementation In both petitions Earthjustice asserts that EPA's 1996 Natural Events Policy requires that the State demonstrate that BACM were in place and that all sources were in compliance in order for EPA to concur on a high wind natural event request. PFR at 5; PFW at 9. Earthjustice contends that the State cannot demonstrate that agricultural sources were in compliance at the time of the wind event since it is not clear if any compliance inspections had been conducted. As discussed in sections IV. and V., EPA is evaluating the State's exceptional event documentation under EPA's Exceptional Event Rule and not under its pre-existing policies. The Rule does not require either a showing that BACM was in place at the time of the event or proof that sources were in compliance. Rather, in the preamble to the Rule EPA states that the State must take reasonable and appropriate measures under these circumstances. 72 FR at 13576-13577. That said, EPA has approved the District's BACM demonstration for all significant sources of PM-10 in the Valley, including agricultural sources, as meeting CAA section 189(b)(1)(B). 69 FR at 30035; 71 FR 7683. Moreover the State's documentation for the September 22 and October 25, 2006 events includes information on compliance inspections throughout the SJV. See section V. above. 2. District's Natural Events Action Plan In its 2007 petition Earthjustice claims that for the September 22, 2006 exceedances the District failed to meet the requirements of its Natural Events Action Plan for “[a]cceptable documentation for establishing an extraordinary natural event * * * .” Specifically, Earthjustice contends that acceptable documentation for establishing “an extraordinary natural event” includes issuance by the national Weather Service of a high wind or blowing dust advisory, the occurrence of strong winds aloft and surface wind maps showing potential for high winds to occur at the site. According to Earthjustice no adequate documentation of these factors was offered. PFW at 11. Earthjustice's statements regarding the requirements for documentation under the District's “Natural Events Action Plan for High Wind Events in the San Joaquin Valley Air Basin,” February 16, 2006

(NEAP)appear in the portion of its 2007 petition that addresses the causal relationship between high winds and the September 22, 2006 exceedances. *Id.* Section 3 of the NEAP concerns the documentation of high wind events and lists specific sources of documentation suggested by EPA: Filter analysis, meteorological data, modeling and receptor analysis, videos and/or photographs, maps, news accounts and BACM 97 requirements. Section 6 of the NEAP concerns meteorological forecasting criteria. This section states that if certain enumerated criteria are met, the District, in consultation with CARB, will declare a NEAP episode. The items that Earthjustice contends are required to document an exceptional event are among these criteria. Thus Earthjustice has confused forecasting an exceptional event with the documentation of it. EPA believes that the State has adequately documented the September 22, 2006 exceedances as being caused by all exceptional events as discussed above in section V.A. 97 As noted above, BACM implementation is not required under EPA's exceptional events rule. Finally we note again that EPA is proceeding in this rulemaking under its Exceptional Events Rule rather than the 1996 policy it replaces. In the preamble to the Rule, EPA explained that “following the promulgation of this rule, States will no longer be required to keep NEAPs in place that were not approved as a part of a SIP for an area.” 72 FR at 13576. E. Harvest Activities Earthjustice asserts in its 2006 petition that September is the peak harvest season for cotton and almonds and that EPA should investigate the contribution of these activities to the September 22 exceedances. PFR at 6. In the 2007 petition Earthjustice states that the end of October is generally when two of the dustiest crop harvests, cotton and almonds, take place and that these activities caused the October 25 exceedances. PRW at 13-14. EPA discusses the effect of anthropogenic sources on the 2006 exceedances in section V. above. F. Exceedances at Corcoran and Stockton in 2004, Bakersfield in 2005 and the Santa Rosa Rancheria in 2006 The 2007 petition raises issues regarding several exceedances that have already been addressed by the October 2006 attainment determination. These exceedances occurred on September 3, 2004 at Corcoran and Stockton and on November 22-23, 2005 at Bakersfield. EPA's position on these exceedances is found in the final rule at 71 FR at 63658-63661. Regarding the September 3, 2004 exceedance, Earthjustice states that EPA must now evaluate whether the Agency can concur on the State's request to flag the exceedance as a high wind event and cannot continue to rely on the argument that it is irrelevant because “even if EPA had not concurred with the exclusion of this data, the Corcoran site would still attain the 24-hour NAAQS * * *.” Earthjustice takes this position because it believes there are now other exceedances at Corcoran that cannot be excluded and that the September 3, 2004 exceedance will thus be important in determining the SJV's PM-10 attainment status. PFW at 9. EPA disagrees with Earthjustice's contention that there are now other exceedances that cannot be excluded. As discussed above, EPA believes the exceedances on September 22, October 25 and December 8, 2006 are all due to exceptional events and is proposing to concur with the State's request to flag these data as caused by high wind events. Thus our conclusion that the September 3, 2004 exceedance is not significant for the attainment determination is still valid. Regarding the November 2005 exceedances at Bakersfield, EPA stated in its determination of attainment that “[e]ven if the Bakersfield-Golden State Highway BAM and TEOM data are considered together (and even if they were quality-assured data not subject to natural events), the exceedances recorded at these monitors would not show that the area is in violation of the standard.” 71 FR at 63659. As discussed above, EPA believes that the exceedances at Bakersfield in 2006 were due to exceptional events and is proposing to concur with the State's request to flag these data. Thus we still believe that the 2005 Bakersfield-Golden exceedances, when considered for purposes of our 2006 attainment determination, would not contribute to or constitute a violation. In the 2007 petition Earthjustice also raises questions about exceedances recorded at the Santa Rosa Rancheria on September 14, 20 and October 26, 2006. PFW at 15-16. EPA addresses these exceedances in section VI. above. IX. Statutory and Executive Order Reviews Under Executive Order 12866 (58 FR 51735, October 4, 1993), this proposed action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely proposes a determination based on air quality data and does not impose any additional requirements. Accordingly, the Administrator certifies that this proposed rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because this proposed rule does not impose any additional enforceable duty, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Order 13175 (65 FR 67249, November 9, 2000) requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” Several Indian tribes have reservations located within the boundaries of the SJV. EPA is aware of only one tribe in the SJV that operates a PM-10 monitor, the Santa Rosa Rancheria. EPA has consulted with representatives of the Santa Rosa Rancheria Tribe on the data recorded by their monitor, and the flagging of the data, and will continue to work with the Tribe, as provided for in Executive Order 13175. Accordingly, EPA has addressed Executive Order 13175 to the extent that it applies to this action. This proposed action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This proposed action merely makes a determination based on air quality data and does not alter the relationship or the distribution of power and responsibilities established in the CAA. Executive Order 12898 establishes a Federal policy for incorporating environmental justice into Federal agency actions by directing agencies to identify and address, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority and low-income populations. Today's action involves proposed determinations based on air quality considerations and proposes to affirm that the San Joaquin area has attained the PM-10 NAAQS. It will not have disproportionately high and adverse effects on any communities in the area, including minority and low-income communities. This proposed rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant. The requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This proposed rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). List of Subjects 40 CFR Part 52 Environmental protection, Air pollution control, Incorporation by reference, Particulate matter, Reporting and recordkeeping requirements. 40 CFR Part 81 Environmental protection, Air pollution control, National parks, Wilderness areas. Dated: August 15, 2007. Wayne Nastri, Regional Administrator, Region 9. [FR Doc. E7-16693 Filed 8-24-07; 8:45 am] BILLING CODE 6560-50-P 72 165 Monday, August 27, 2007 Proposed Rules Part III Department of Health and Human Services Food and Drug Administration 21 CFR Parts 347 and 352 Sunscreen Drug Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph; Proposed Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 347 and 352 [Docket No. 1978N-0038] (formerly Docket No. 78N-0038) RIN 0910-AF43 Sunscreen Drug Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration

(FDA)is issuing a proposed rule that would amend the final monograph

(FM)for over-the-counter

(OTC)sunscreen drug products as part of FDA's ongoing review of OTC drug products. This amendment addresses formulation, labeling, and testing requirements for both ultraviolet B

(UVB)and ultraviolet A

(UVA)radiation protection. FDA is issuing this proposed rule after considering public comments and new data and information that have come to FDA's attention. This rule proposes to lift the stays of 21 CFR 347.20(d) and 21 CFR Part 352 when FDA publishes a final rule based on this proposed rule. DATES: Submit written or electronic comments by November 26, 2007. Submit written or electronic comments on FDA's economic impact determination by November 26, 2007. Please see section X of this document for the effective and compliance dates of any final rule that may publish based on this proposal. ADDRESSES: You may submit comments, identified by Docket No. 1978N-0038 and RIN number 0910-AF43, by any of the following methods: Electronic Submissions Submit electronic comments in the following ways: • Federal eRulemaking Portal: *http://www.regulations.gov* . Follow the instructions for submitting comments. • Agency Web site: *http://www.fda.gov/dockets/ecomments* . Follow the instructions for submitting comments on the agency Web site. Written Submissions Submit written submissions in the following ways: • FAX: 301-827-6870. • Mail/Hand delivery/Courier (for paper, disk, or CD-ROM submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. To ensure more timely processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail. FDA encourages you to continue to submit electronic comments by using the Federal eRulemaking Portal or the agency Web site, as described in the *Electronic Submissions* portion of this paragraph. *Instructions* : All submissions received must include the agency name, docket number and regulatory information number

(RIN)for this rulemaking. All comments received may be posted without change to *http://www.fda.gov/ohrms/dockets/default.htm* , including any personal information provided. For additional information on submitting comments, see the “Request for Comments” heading of the SUPPLEMENTARY INFORMATION section of this document. *Docket* : For access to the docket to read background documents or comments received, go to *http://www.fda.gov/ohrms/dockets/default.htm* and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Matthew R. Holman, Office of Nonprescription Products, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 5414, Silver Spring, MD 20993, 301-796-2090. SUPPLEMENTARY INFORMATION: Table of Contents I. Background II. Summary of Major Changes to the FM A. Ingredients B. UVB

(SPF)Labeling C. UVA Labeling D. Indications E. Warnings F. Directions G. UVB Testing H. UVA Testing III. FDA's Tentative Conclusions on the Comments A. General Comments on OTC Sunscreen Drug Products B. Comments on Tanning and Tanning Preparations C. Comments on Specific Sunscreen Active Ingredients D. General Comments on the Labeling of Sunscreen Drug Products E. Comments on the Labeling of Sunscreen Drug Products With UVA Protection F. Comments on the Labeling of Sunscreen Drug Products With High SPF Values G. Comments on Indications for Sunscreen Drug Products H. Comments on Directions for Sunscreen Drug Products I. General Comments on SPF Testing Procedure J. Comments on the Sunscreen Standard for SPF Testing Procedure K. Comments on Artificial Light Sources for SPF Testing Procedure L. Comments on the Design/Analysis of SPF Testing Procedure M. General Comments on UVA Testing Procedure N. Comments on UVA Testing Procedure Design and Testing Criteria O. Comments on the Photostability of Sunscreen Drug Products IV. FDA's Tentative Conclusions and Proposals V. Analysis of Impacts A. Background B. Number of Products Affected C. Cost to Relabel D. Cost to Test or Retest Products for UVA Protection E. Total Incremental Costs F. Small Business Impact G. Analysis of Alternatives VI. Paperwork Reduction Act of 1995 VII. Environmental Impact VIII. Federalism IX. Request for Comments X. Proposed Effective and Compliance Dates XI. References I. Background In the **Federal Register** of May 12, 1993 (58 FR 28194), FDA published a notice of proposed rulemaking in the form of a tentative final monograph

(TFM)for OTC sunscreen drug products. In the TFM, FDA proposed the conditions under which OTC sunscreen drug products would be considered generally recognized as safe and effective (GRASE), under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(p)), and not misbranded, under section 502 of the act (21 U.S.C. 352). In the **Federal Register** of April 5, 1994 (59 FR 16042), FDA reopened the administrative record until July 31, 1994, to allow additional submissions on UVA-related issues and announced a public meeting for May 12, 1994, to discuss UVA testing procedures. As explained in that **Federal Register** notice, the TFM included proposed UVB (i.e., 290-320 nm) testing and labeling. The sun protection factor

(SPF)test and corresponding labeling reflects the level of protection against sunburn, which is caused primarily by UVB radiation. The TFM also explained the importance of protection against UVA radiation (i.e., 320-400 nm), the other UV component of sunlight (58 FR 28194 at 28232 and 28233). The TFM referenced published UVA test methods but did not propose a method (58 FR 28194 at 28248 to 28250). Rather, the TFM stated that a product could be labeled as “broad spectrum” or a similar claim if it protected against UVA radiation. Thus, FDA held the 1994 public meeting to gather further information about an appropriate UVA test method and labeling. In the **Federal Register** of June 8, 1994 (59 FR 29706), FDA proposed to amend the TFM (and reopened the comment period until August 22, 1994) to remove five proposed sunscreen ingredients from the TFM because of lack of interest in establishing United States Pharmacopeia—National Formulary (USP-NF) monographs. FDA also reiterated that all sunscreen ingredients must have a USP-NF monograph before being included in the FM for OTC sunscreen drug products. In the **Federal Register** of August 15, 1996 (61 FR 42398), FDA reopened the administrative record until December 6, 1996, to allow additional submissions on zinc oxide and titanium dioxide as well as sunscreen photostability. FDA also announced a public meeting for September 19 and 20, 1996, to discuss the safety and efficacy of these two ingredients and photostability of sunscreens in general. In the **Federal Registers** of September 16, 1996 (61 FR 48645) and October 22, 1998 (63 FR 56584), FDA amended the TFM to add the UVA-absorbing sunscreen ingredients avobenzone and zinc oxide to the proposed list of monograph ingredients. FDA also proposed indications for these ingredients. As a result of this amendment to the TFM, in the **Federal Register** of April 30, 1997 (62 FR 23350), FDA announced an enforcement policy allowing interim marketing of OTC sunscreen drug products containing avobenzone. On November 21, 1997, Congress enacted the Food and Drug Administration Modernization Act of 1997 (FDAMA). Section 129 of FDAMA stated that “Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services shall issue regulations for over-the-counter sunscreen products for the prevention or treatment of sunburn.” FDA identified the UVB portions of the monograph (and related provisions on water resistant test methods and cosmetic labeling) as items that could be finalized within the timeframe set by FDAMA. Because of outstanding issues related to the development of testing standards and labeling for UVA radiation protection, FDA deferred final action on these items. Therefore, in the **Federal Register** of May 21, 1999 (64 FR 27666), FDA published the FM for OTC sunscreen drug products in part 352 (21 CFR part 352) with an effective date of May 21, 2001, but deferred UVA testing and labeling for future regulatory action. FDA stated that more time was required to review comments from interested parties on active ingredients, labeling, and test methods for products intended to provide UVA protection. This proposed amendment to the FM for OTC sunscreen drug products will complete the FM by addressing both UVB and UVA testing and labeling. In the **Federal Register** of June 8, 2000 (65 FR 36319), FDA reopened the administrative record of the rulemaking for OTC sunscreen drug products to allow for specific comment on high SPF and UVA radiation testing and labeling. FDA also extended the effective date for the FM to December 31, 2002. In the **Federal Register** of December 31, 2001 (66 FR 67485), FDA stayed the December 31, 2002, effective date of the FM for OTC sunscreen drug products in part 352 until we provided further notice in a future issue of the **Federal Register** . FDA took this action because we planned to amend part 352 to address formulation, labeling, and testing requirements for both UVB and UVA radiation protection. This document proposes such changes. This document also proposes an effective date related to publication of an amended FM (see section X of this document). The existing stay of the effective date for part 352 remains in effect at this time. In the **Federal Register** of June 20, 2002 (67 FR 41821), FDA published a technical amendment to change the names of four sunscreen active ingredients in § 352.10 of the monograph to be consistent with name changes that appeared in USP 24. The new names, which are simpler and more convenient, are meradimate for menthyl anthranilate, octinoxate for octyl methoxycinnamate, octisalate for octyl salicylate, and ensulizole for phenylbenzimidazole sulfonic acid. Because the names became official on March 1, 2001, manufacturers could begin using them at any time after that date. In the **Federal Register** of June 4, 2003 (68 FR 33362), FDA issued a final rule establishing conditions under which OTC skin protectant products are generally recognized as safe and effective and not misbranded. This final rule lifted the stay of 21 CFR part 352 to amend the final monograph for OTC sunscreen drug products to include sunscreen-skin protectant combination drug products. This final rule concluded by placing a stay on both part 352 and on § 347.20(d). The proposed rule that is the subject of this document provides UVA testing and labeling that is necessary on sunscreen and sunscreen-skin protectant combination drug products. This proposed rule, therefore, proposes that the stays of both part 352 and § 347.20(d) be lifted when this rule is finalized. These stays will be maintained until a final rule based on this proposed rule becomes effective. In the **Federal Register** of September 3, 2004 (69 FR 53801), FDA delayed the implementation date for OTC sunscreen drug products subject to the final rule that established standardized format and content requirements for the labeling of OTC drug products (i.e., Drug Facts rule). FDA explained that we postponed the Drug Facts implementation date because we did not expect to complete the final amendment of the sunscreen monograph to include UVA testing and labeling by the Drug Facts implementation date of May 16, 2005 (64 FR 13254 at 13273 and 13274, March 17, 1999). Thus, FDA delayed the implementation date of the Drug Facts rule with respect to OTC sunscreen drug products until further notice to avoid issuing successive relabeling requirements for sunscreen drug products at two closely related time intervals, as required by the Drug Facts rule and the final amendment to the sunscreen monograph. II. Summary of Major Changes to the FM In response to the TFM and FM, FDA received substantial data and information regarding UVA and UVB active ingredients, claims, and testing procedures, as well as on other issues addressed in this document. FDA summarizes these issues and proposed changes to the FM in this section. A. Ingredients FDA proposes to add combinations of avobenzone with zinc oxide and avobenzone with ensulizole as permitted combinations of active sunscreen ingredients in the FM (see section III.C, comment 7 of this document). B. UVB

(SPF)Labeling The FM allowed specific labeled SPF values up to, but not exceeding, 30. OTC sunscreen drug products with SPF values greater than 30 could be labeled with the collective term “30+.” In this amendment, FDA proposes to increase the specific labeled SPF value to 50 and revise the collective term to “50+.” FDA will consider higher specific labeled SPF values upon receipt of adequate, validated data (see section III.F, comment 15 of this document). In addition, FDA proposes to revise the following FM labeling: • The phrase “sun protection” to “sunburn protection” where used in §§ 352.3(b)(1), (b)(2), (b)(3), and

(d)and 352.52(e)(1)(i), (e)(1)(ii), and (e)(1)(iii) (see section III.D, comment 10 of this document); and • Section 352.50(a) to include the term “UVB” before the term “SPF” on the principal display panel (PDP), along with the product category designation

(PCD)(see section III.E, comment 14 of this document). FDA also proposes to revise the PCD SPF ranges in § 352.3(b)(1), (b)(2), and (b)(3) (proposed § 352.3(c)(1) through (c)(4)) to reflect the following: • The current standard public health message concerning use of sunscreens, • The proposed increase of the labeled SPF value to “50+,” and • The proposed addition of the term “UVB” before the word “sunburn.” Proposed § 352.3(c)(4) contains a new PCD of “highest UVB sunburn protection product” for products that provide an SPF value over 50. FDA further proposes to revise current § 352.3(b)(1) and (b)(2) to replace the current category descriptors of “minimal” and “moderate” with the terms “low” and “medium,” respectively. FDA considers the new terms to be simpler and uniform with the proposed UVB and UVA “Uses” statements. Proposed changes to PCDs and category descriptors also occur in proposed § 352.52(e)(1) (see section III.D, comment 13 and section III.G, comment 16 of this document). In addition, FDA proposes optional UVB radiation protection statements (see proposed § 352.52(e)(2) and (e)(3)). C. UVA Labeling FDA proposes new labeling to designate the level of UVA protection on the PDP of OTC sunscreen drug products. FDA proposes the use of symbols (“stars”) in conjunction with a descriptor (i.e., “low,” “medium,” “high,” or “highest”). FDA also proposes to add new § 352.50(b) specifying the required PDP labeling for OTC sunscreen products tested in accordance with the proposed UVA testing procedures in §§ 352.71 and 352.72 (see section III.E, comment 14 and section III.N, comment 45 of this document). D. Indications The FM allowed the following two UVB indications in § 352.52(b)(1): • “helps prevent sunburn” • “higher SPF gives more sunburn protection” In this amendment, FDA proposes to revise the first statement to read “low,” “medium,” “high,” or “highest” “UVB sunburn protection” in proposed § 352.52(b)(1)(i) through (b)(1)(iv). FDA is proposing to revise the additional indications in § 352.52(b)(2) to reflect the new PCD ranges in proposed § 352.3(c) (e.g., SPF of 2 to under 12 becomes SPF of 2 to under 15) and create the new PCD range over SPF 50. These proposed revisions are based upon the revised PCD categories in proposed § 352.3(c) (see section III.G, comment 16 of this document). FDA proposes that the second statement in current § 352.52(b)(1) (“higher SPF gives more sunburn protection”) no longer be required and proposes an additional indication regarding UVA protection (see proposed § 352.52(b)(2)(v)). In proposed § 352.52(b)(2)(v), FDA includes a new indication for UVA protection that involves selection of the appropriate descriptor (“low,” “medium,” “high,” or “highest”) to describe the level of protection. In proposed § 352.52(b)(2)(vi), FDA includes a modified version of the sunburn “Uses” statement required by proposed § 352.52(b)(1)(i) through (b)(1)(iv) when the additional statement in proposed § 352.52(b)(2)(v) is used and bears the same category descriptor as the SPF value (e.g., medium UVA/UVB protection from sunburn) (see section III.G, comment 17 of this document). E. Warnings FDA is proposing to shorten the warning in § 352.52(c)(1)(ii) (proposed § 352.52(c)(3)) under the subheading “Stop use and ask a doctor if” from “[bullet] rash or irritation develops and lasts” to “[bullet] skin rash occurs.” FDA proposes removing the optional “sun alert” product performance statement (current § 352.52(e)(2)) and requiring a revised “sun alert” statement in the “Warnings” section (proposed § 352.52(c)(1)). FDA proposes that this revised statement be required on all OTC sunscreen drug products except lip cosmetic-drug and lip protectant-sunscreen products subject to § 352.52(f), which are not required to include this statement under proposed § 352.52(f)(1)(v) and (f)(1)(vi) (see section III.G, comment 19 of this document). The statement in proposed § 352.52(c)(1) reads as follows: “UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen.” FDA proposes that the statement appear in bold type as the first statement in the “Warnings” section. F. Directions FDA proposes changes to the directions to reduce the likelihood that OTC sunscreen drug products are underapplied. Section 352.52(d)(1)(i) currently provides manufacturers the option to select one or more of the following terms: “liberally,” “generously,” “smoothly,” or “evenly.” FDA is proposing to allow the choice of one of two required terms (i.e., “liberally” or “generously”) and to include “evenly” as an additional optional term. FDA is proposing to eliminate the term “smoothly” because it is vague. FDA also proposes to add a new direction “apply and reapply as directed to avoid lowering protection” (proposed § 352.52(d)(1)(ii)). Because new information demonstrates the importance of sunscreen reapplication, FDA also proposes to make the optional directions in paragraph (d)(2) a requirement. As a result of this change, FDA is proposing to remove the current language in paragraph (d)(3) because it is no longer necessary. Instead, FDA is proposing, in paragraph (d)(3), required information for products that do not satisfy the water resistant testing procedures in § 352.76. FDA is also proposing a required reapplication statement in § 352.52(d)(1)(ii). The reapplication information in current § 352.52(d)(2) appears in proposed § 352.52(d)(2) and (d)(3) of this document (see section III.H, comment 22 of this document). G. UVB Testing FDA is proposing to revise the SPF

(UVB)testing procedure (see section III, paragraphs I through L of this document) and to move the SPF testing procedure currently in §§ 352.70 through 352.73 to proposed § 352.70. FDA proposes a padimate O/oxybenzone sunscreen standard in § 352.70 that will be required for testing sunscreen products with SPF values over 15. Manufacturers may use either this padimate O/oxybenzone standard or the homosalate standard to test products with SPF values of 2 to 15. FDA proposes a high pressure liquid chromatography

(HPLC)method to replace the spectrophotometric method used to assay the homosalate and padimate O/oxybenzone standards. FDA proposes the following modifications to the SPF testing procedure: • Specifications for the solar simulator in § 352.71 (proposed § 352.70(b)), • Instructions for the application of test materials and response criteria in § 352.72 (proposed § 352.70(c)), and • Doses and determination of minimal erythema dose

(MED)in § 352.73 (proposed § 352.70(d)). FDA proposes to continue requiring a finger cot to be used in the application of sunscreen standard and test product as specified in § 352.72(e) (proposed § 352.70(c)(5)). However, FDA now proposes that the finger cot be pretreated. These two proposed UVB testing changes also apply to UVA in vivo testing. H. UVA Testing FDA proposes a combination of spectrophotometric (in vitro) and clinical (in vivo) UVA test procedures in proposed §§ 352.71 and 352.72, respectively. To assure UVA protection for “water resistant” and “very water resistant” sunscreen products, FDA proposes that the in vivo UVA test be conducted after the appropriate water immersion period for OTC sunscreen drug products making a UVA claim. Therefore, FDA proposes modification of § 352.76 to state that the water resistance claim applies to the SPF and, if appropriate, UVA values determined after the appropriate water immersion period as described in proposed § 352.70 and, if appropriate, proposed § 352.72. III. FDA's Tentative Conclusions on the Comments A. General Comments on OTC Sunscreen Drug Products (Comment 1) Several comments asked that FDA provide more time to comply with requirements of the FM in order to avoid an adverse economic impact on the suncare industry and consumers. The comments described the seasonal dynamics of the suncare industry (i.e., products are sold in two marketing cycles over a period of 18 months) and stated that the industry would need more time to develop products that meet the FM requirements and allow for shipment of the previous year's returns. The comments mentioned times from 2 to 3 years after publication of the FM as appropriate or necessary for implementation. Several of these comments added that the date should be in the June/July time period because the shipping season is practically over at that time and manufacturing for the next season is just beginning. FDA understands the seasonal nature of the sunscreen industry and the time required for product testing and relabeling. FDA is also aware that more than 1 year may be needed for implementation. FDA is proposing an 18- to 24-month implementation date and will try to have it coincide with the June/July time period (see section XI of this document). (Comment 2) One comment requested that FDA and the Federal Trade Commission

(FTC)take steps to make sure that sunscreen manufacturers provide information to the American public to help them understand and use the Ultraviolet Index

(UVI)to determine their risk of sunburn. The National Weather Service, the Environmental Protection Agency (EPA), and the Centers for Disease Control and Prevention

(CDC)developed the UVI, which has been in use since 1995. This index is an indication of the amount of UV radiation reaching the surface of the earth as a function of ozone data, atmospheric pressure, temperature, and cloudiness and is generated for 58 cities around the United States. Usage information required by the OTC sunscreen drug product monograph applies regardless of the UVI value. Therefore, FDA believes that UVI information need not be required in the monograph for the safe and effective use of these products and should not be included in the “Drug Facts” labeling. However, manufacturers who wish to do so may voluntarily include such information in their labeling outside the “Drug Facts” box. (Comment 3) One comment requested that FDA make clear, through either the FM for skin protectant or sunscreen drug products, or both, that combination products containing sunscreen and skin protectant ingredients may be lawfully marketed. Section 347.20(d) of the skin protectant FM (21 CFR 347.20(d)), which published in the **Federal Register** of June 4, 2003 (68 FR 33362), provides for combinations of sunscreen ingredients and specific skin protectant ingredients. The final rule for OTC skin protectant drug products also included an amendment to the sunscreen FM, adding new § 352.20(b), which allows combinations of sunscreen and skin protectant active ingredients. Thus, both monographs now state the same conditions for lawfully marketing these combination products. The existing language in §§ 347.20(d) and 352.20(b) would include the two new combinations that FDA is proposing to add to the sunscreen monograph (see section II.A, comment 7 of this document). B. Comments on Tanning and Tanning Preparations (Comment 4) One comment requested that the effective date of § 740.19 (21 CFR 740.19) be extended to December 31, 2002, consistent with the delay of the effective date for § 310.545(a)(29) and (d)(31), part 352, and § 700.35 (65 FR 36319). The comment stated that singling out § 740.19 to become effective earlier might constitute an arbitrary and capricious decision by FDA. The May 21, 1999, final rule set a 2-year effective date (May 21, 2001) for § 310.545(a)(29) and (d)(31), part 352, and § 700.35. In the **Federal Register** of June 8, 2000 (65 FR 36319), FDA extended the effective date for compliance with § 310.545(a)(29) and (d)(31), part 352, and § 700.35 until December 31, 2002, to provide time for completion of a more comprehensive UVA/UVB FM for OTC sunscreen drug products. On December 31, 2001, FDA then stayed the effective date of part 352 (but not § 310.545(a)(29) and (d)(31), and § 700.35) until further notice (66 FR 67485). FDA took this action because we are amending part 352 to address formulation, labeling, and testing requirements for both UVA and UVB radiation protection. The May 21, 1999, final rule also set a 1-year effective date (May 22, 2000) for new § 740.19, which addresses a warning statement for cosmetic suntanning preparations that do not contain a sunscreen active ingredient. These products are not subject to the monograph for OTC sunscreen drug products in part 352. FDA considered this warning to be sufficiently important for safety reasons when we issued the final rule (64 FR 27666 at 27669) to require a 12-month effective date as opposed to the 24-month effective date for the other sections of the rule. Further, FDA's primary reason for extending the effective date of those other sections to December 31, 2002, and then staying part 352 to address formulation, labeling, and testing requirements for both UVA and UVB protection, was to allow FDA to develop a comprehensive UVB/UVA final monograph. This reason does not apply to § 740.19. Accordingly, FDA did not extend the effective date for § 740.19, and § 740.19 is in effect at this time. FDA concludes that this decision is not arbitrary and capricious, but is based on valid health concerns related to the products subject to the warning requirement in § 740.19. (Comment 5) One comment requested that FDA and FTC take steps to ensure sunscreen manufacturers inform consumers that their natural skin pigmentation provides protection from sunlight. The comment stated that these adaptive individuals might not require a daily application of a sunscreen. Another comment submitted a copy of a patent for an electronic sensor device to measure solar radiation. The comment stated that the personal device could alert consumers to their level of UV exposure so they could either come out of the sun or apply a sunscreen to avoid sunburn and skin cancer. FDA has no objection to sunscreen manufacturers informing consumers that their natural skin pigmentation provides protection from sunlight. However, FDA has no basis to require such information as part of the required labeling for OTC sunscreen drug products. Thus, manufacturers may include this information in labeling outside of the “Drug Facts” box, but are not required to include this information. FDA considers the comment regarding the UV measuring device to be outside the scope of this rulemaking, which evaluates the safety, effectiveness, and labeling of OTC drug products. C. Comments on Specific Sunscreen Active Ingredients (Comment 6) Several comments requested that dihydroxyacetone

(DHA)be added to the monograph as a single active ingredient for UVA protection. The comments claimed that DHA alone provides an SPF of 2 to 4. One comment claimed that a 15 percent topical solution of DHA provided a photoprotective factor of 10 in the UVA region. Other comments contended that the brown color produced by DHA, resembling melanin, should potentiate the action of sunscreens. Another comment stated that DHA alone is not a sunscreen, but forms a sunscreen when combined with lawsone. The comment cited unpublished observations by two independent investigators that the melanoidins of DHA-induced skin pigment resemble melanin in that they absorb UVB strongly, with decreasing absorbance through the UVA region and into visible light. The comment added that, because DHA alters the structure of the skin surface, it is, by definition, a drug. One comment provided information on the safety and UVA effectiveness of DHA alone (Ref. 1). Safety studies included the following: • Oral and dermal toxicity studies, • A chronic skin painting carcinogenicity study in mice, • Comedogenecity tests in rabbits, • Repeated insult patch test in humans, and • Photoallergy tests. Effectiveness studies consisted of published articles using either humans or photosensitized rats. Another comment discussed investigations with DHA on psoriasis patients sensitized with 8-methoxypsoralen (8-MOP). FDA is not proposing to include DHA in the monograph as a single active ingredient in OTC sunscreen products. Although there were no product submissions to the Advisory Review Panel on Topical Analgesic, Antirheumatic, Otic, Burn, and Sunburn Prevention and Treatment Drug Products (the Panel) using DHA as a sunscreen ingredient, the Panel discussed available scientific evidence for DHA as a single sunscreen ingredient. The Panel concluded that DHA is not a sunscreen but a cosmetic; it is a sunscreen only when used with lawsone (43 FR 38206 at 38215 to 38216, August 25, 1978). Although one comment stated that DHA alters the structure of the skin, it did not provide data to support this claim. Thus, at this time, FDA agrees with the Panel that DHA is a cosmetic. FDA acknowledges that DHA is the subject of an approved color additive petition and its safety as a color additive has been established. However, the submitted chronic (life-span) skin painting study in mice does not support the safe use of DHA as a sunscreen because no group of mice was included in the study to determine the possible photocarcinogenic effect of DHA. This effect needs to be studied because DHA is associated with carbonyl compounds known to react with pyrimidine bases in the presence of UV radiation, and it appears to be a potent inducer of thymine dimers, premutagenic deoxyribonucleic acid

(DNA)lesions. Therefore, its safety, in terms of the type, extent, and location of photo-induced DNA damage, is of concern and should be determined. Whether DHA contributes or promotes UV carcinogenesis is not known. The submitted studies on the effectiveness of DHA as a single UVA sunscreen ingredient add only qualitative information. Many of the studies utilized animal models; few included human subjects. One study involved only five subjects, three with erythropoietic protoporphyria and two with polymorphic light eruptions. Another study involved six subjects sensitized with 8-MOP. In both studies, too few subjects were enrolled, and the study subjects were not representative of the average sunscreen user. Well-controlled clinical trials with DHA alone are lacking. Although some investigations described by the comments suggest that DHA may help protect the normal skin of psoriasis patients, concerns remain about the usefulness of DHA products in the OTC market. For example, one comment stated that photoprotection provided by DHA depends upon the way the product polymerizes in the stratum corneum and that polymerization depends on the skin of each individual. Therefore, the photoprotection provided by DHA varies from person to person and has to be determined for each person by diffuse reflectance spectroscopy. Given these statements, it is not clear how appropriate OTC drug product labeling could be written to aid consumers in proper selection and use of a DHA sunscreen. FDA concludes that current information is inadequate to include DHA in the monograph as a single sunscreen ingredient. None of the comments provided information to establish the appropriate number of consecutive product applications and the timing of these applications (how far apart or how soon before sun exposure) that are necessary to achieve the desired protection using products containing various concentrations of DHA. In two submitted studies, a preparation containing 3 percent DHA was applied six times prior to sun exposure and a preparation containing 15 percent DHA preparation was applied one time 24 hours prior to sun exposure, respectively (Ref. 1). The comments did not include any information on appropriate regimens for various skin types, which is necessary because the level of photoprotection provided by DHA is dependent on skin type. Therefore, based upon this lack of information, it is not clear how to state appropriate label directions for consumer use. FDA needs additional information from clinical studies to determine the effective concentration of DHA in sunscreen product formulations and the frequency and timing of product application. (Comment 7) One comment submitted data to support the combination of avobenzone with ensulizole and avobenzone with zinc oxide (Ref. 2). The safety data included the following: • A repeat insult patch test, • A phototoxicity study, and • A photoallergy study. The effectiveness data involved a clinical study using the in vitro “critical wavelength”

(CW)method and the in vivo “protection factor A”

(PFA)method to support the UVA radiation protection potential of the combination products. The PFA test data were from a double blind clinical study using five sunscreen formulations. The safety studies demonstrated that the following combinations of active ingredients have a low potential for irritation, allergenic sensitization, and phototoxicity: • 3 percent or less avobenzone with 2 percent ensulizole • 3 percent or less avobenzone with 5 percent zinc oxide The data further suggested that the photoallergenic potential of avobenzone is not augmented by its combination with either ensulizole or zinc oxide. The clinical study using the PFA in vivo method demonstrated that the following combinations of active ingredients are significantly more effective than 1.5 percent ensulizole or 3 percent zinc oxide alone in protecting against UVA radiation: • 3 percent avobenzone with 1.5 percent ensulizole • 3 percent avobenzone with 4 percent zinc oxide FDA's detailed comments on the safety and effectiveness studies are on file in the Division of Dockets Management (Ref. 3). FDA considers the data submitted by the comment sufficient to support the safety and effectiveness of avobenzone with ensulizole and avobenzone with zinc oxide when used in the concentrations established for each ingredient in § 352.10 of the sunscreen monograph. Accordingly, FDA is proposing to amend § 352.20(a)(2) by adding ensulizole and zinc oxide. Marketing of products containing avobenzone with ensulizole and avobenzone with zinc oxide will not be permitted unless and until the following three actions occur: 1. The comment period specific to this proposal closes. 2. FDA has evaluated all comments on these combination products submitted in response to the proposal. 3. FDA publishes a **Federal Register** notice announcing our determination to permit the marketing of OTC sunscreen drug products containing these combinations. D. General Comments on the Labeling of Sunscreen Drug Products (Comment 8) One comment agreed that the labeling modifications allowed by the FM in § 352.52 for OTC sunscreen products marketed as a lipstick or labeled for use only on specific small areas of the face (e.g., lips, nose, ears, and/or around eyes) are appropriate for these products. Based on the labeling in § 352.52, the comment proposed eight additional modifications for all other OTC sunscreen products regardless of package size: 1. Delete “Drug Facts” title because it is inappropriate and unnecessary for sunscreens. 2. Omit “Purpose” because it is repetitive of the statement of identity on the PDP and “Uses” information. 3. Revise “higher SPF gives more sunburn protection” in “Uses” to read “higher SPF products give more sun protection, but are not intended to extend the time spent in the sun,” and require this statement only on products with an SPF value over 30. 4. Omit “For external use only” warning because it is self-evident for sunscreen products. 5. Revise “When using this product [bullet] keep out of eyes. Rinse with water to remove” to read “Keep out of eyes.” 6. Revise “Stop use and ask a doctor if [bullet] rash or irritation develops and lasts” to read “Stop use if skin rash occurs.” 7. Omit barlines, hairlines, and box enclosure. 8. Allow the option to list inactive ingredients in a different location on the label or in labeling accompanying the product. The comment stated that these modifications would allow reduced Drug Facts labeling for all OTC sunscreen drug products. The comment contended that sunscreen products meet all of FDA's criteria for reduced labeling (64 FR 13254 at 13270): • Packaged in small amounts, • High therapeutic index, • Extremely low risk in actual consumer use situations, • A favorable public health benefit, • No specified dosage limitation, and • Few specific warnings and no general warnings (e.g., pregnancy or overdose warnings). The comment added that OTC sunscreen products are a unique category substantially different from most other types of OTC drug products because they are recommended for use on a daily basis to prevent serious disease. The comment concluded that FDA's rationale for standardized labeling format and content requirements does not necessarily transfer to OTC sunscreen products and specifically not to drug-cosmetic products with a sunscreen. When FDA created the standardized labeling format and content requirements (i.e., “Drug Facts” labeling) for OTC drug products, we recognized that some product packages were too small to accommodate all of the required labeling. Therefore, under § 201.66(d)(10) (21 CFR 201.66(d)(10)), FDA allows labeling format modifications for all OTC drug products sold in small packages. In the final rule establishing “Drug Facts” labeling, FDA also stated that we may allow reduced labeling requirements beyond those specified under § 201.66(d)(10) for OTC drug products that meet the criteria listed in the preceding paragraph (see section III.D, comment 9 of this document). In the final rule for OTC sunscreen drug products (64 FR 27666 at 27681 to 27682), FDA recognized that some OTC sunscreen drug products meet these criteria for reduced labeling. Specifically, FDA identified OTC sunscreen drug products that qualify for the small package specifications in § 201.66(d)(10) and are labeled for use only on specific small areas of the face as meeting the criteria for reduced labeling. Therefore, FDA allows content and format modifications for these products under § 352.52(f). FDA allows further modifications for lip products containing sunscreen because these products for small areas of the face are sold in even smaller packages than the other sunscreen products marketed under § 352.52(f) (68 FR 33362 at 33371; 64 FR 13254 at 13270). FDA believes that sunscreen products labeled for use only on small areas of the face, including lip products containing sunscreen, serve an important public health need and FDA does not want to discourage manufacturers from marketing these products (64 FR 13254 at 13270). FDA does not find it appropriate to extend the labeling modifications for OTC sunscreen drug products marketed under § 352.52(f) to all OTC sunscreen drug products. FDA disagrees with the comment's argument that all sunscreen products meet the criteria for reduced Drug Facts labeling (64 FR 13254 at 13270), because most sunscreen products are not sold in small packages. Therefore, because sunscreen products do not generally meet all of the criteria for reduced Drug Facts labeling, FDA is not proposing reduced labeling for all OTC sunscreen products. FDA does not consider sunscreens as a unique category substantially different from other types of OTC drug products because they are recommended for use on a daily basis to prevent serious disease, as argued by the comment. Other OTC drug products are used on a daily basis, some to prevent serious disease and some for other reasons. For example, anticaries drug products are used daily to prevent dental caries. Antiperspirant drug products can be used daily to reduce underarm wetness. FDA has concluded that these various products should generally be labeled using the standardized content and format in § 201.66. The standardized labeling allows consumers to more easily recognize that these products are, in fact, drug products and to more easily read and understand the labeling information. The same principle applies when the product is a drug cosmetic product (e.g., sunscreen moisturizer or antiperspirant deodorant). Consumers need to be informed that the product has a drug effect, and the uniform Drug Facts labeling for all OTC drug and drug cosmetic products helps convey this message. FDA applied this rationale when it finalized the requirements in the final rule that established § 201.66. FDA agrees that some OTC sunscreen drug products meet the criteria for reduced information for safe and effective use (64 FR 13254 at 13270, 64 FR 27666 at 27681 to 27682). However, FDA disagrees with most of the modifications proposed by the comment for all package sizes of OTC sunscreen products. FDA disagrees with deletion of the “Drug Facts” title and the “Purpose” information because many sunscreen products do not meet the parameters for reduced Drug Facts labeling. FDA disagrees that the “Purpose” information is repetitive and, therefore, disagrees that it may be omitted where there is sufficient labeling space. The “Purpose” section is a standard part of Drug Facts labeling and is intended to inform consumers which ingredients are sunscreens in a product. This information is even more important when a sunscreen is marketed in a combination product. For example, in a sunscreen skin protectant drug product, the “Purpose” section informs consumers which ingredients are sunscreens and which are skin protectants. FDA has revised the “Uses” section and deleted the statement “higher SPF gives more sunburn protection” (see section III.G, comment 16 of this document). FDA disagrees with omitting the “For external use only” warning for all OTC sunscreen drug products. FDA finds no basis to exclude all OTC sunscreen products from this requirement. Likewise, FDA finds no reason to omit the two standard subheadings that accompany the warning statements, as proposed by the comment. Further, FDA disagrees with the comment's suggestion to omit the statement “Rinse with water to remove.” This is useful information if a sunscreen product gets into the eyes. FDA agrees with part of the proposed shortened warning for OTC sunscreen drug products to “Stop use if skin rash occurs” in place of “Stop use and ask a doctor [bullet] if rash or irritation develops and lasts.” Therefore, FDA is proposing to amend § 352.52(c)(1)(ii) (proposed § 352.52(c)(3)) to state: “Stop use and ask a doctor if [bullet] skin rash occurs.” FDA finds no reason to omit barlines, hairlines, or the box enclosure for all OTC sunscreen drug products regardless of package size. These labeling formats help consumers identify a product as a drug and help make labeling information easier to read and understand. Thus, they should be included when package size allows. The FM already allows horizontal barlines and hairlines and the box enclosure to be omitted if a small package meets the criteria in §§ 352.52(f) and 201.66(d)(10). Finally, FDA has no basis to provide an option for sunscreen products to list inactive ingredients in labeling that accompanies the products. FDA interprets section 502(e)(1)(A)(iii) of the act (21 U.S.C. 352(e)(1)(A)(iii)) as requiring the inactive ingredients to be listed on the outside container of a retail package or on the immediate container if there is no outside container or wrapper (§ 201.66(c)). Because this information, by law, must appear either on the outside container or immediate container of the product, FDA does not find a basis for allowing an option to list the inactive ingredients in a different location, such as other labeling accompanying the product. In accordance with § 201.66(c)(8), the inactive ingredients must be listed on the product label in the “Drug Facts” box. (Comment 9) Two comments supported extending the labeling in § 352.52(f) for products intended for use only on specific small areas of the face and sold in small packages to all OTC sunscreen products. The comments contended that all OTC sunscreen drug products meet most of FDA's criteria for products that require minimal information for safe and effective use (64 FR 13254 at 13270) (see section III.G, comment 8 of this document). The first comment added that FDA should permit the labeling modifications in § 352.52(f) for the following products: • Makeup products (as defined in 21 CFR 720.4(c)(7)) with sunscreen, and • Lotions and moisturizers for the hands or face with sunscreen in containers of 2 ounces

(oz)or less (by weight or liquid measure). The comment added that most facial makeup products are typically packaged in small containers. The comment stated that to meet any of FDA's concerns that lotions and moisturizers sold in larger packages may be used over the entire body despite labeling that restricts use to the face or hands, FDA could limit the flexible labeling to containers of 2 oz or less. Furthermore, the comment added that containers of 2 oz or less could not feasibly include the full OTC drug labeling. The second comment contended that the modified labeling in § 352.52(f) is particularly compelling for color cosmetic products for the face that contain sunscreens (i.e., “facial makeups with sunscreen”). The comment added that these products and OTC sunscreen drug products for use only on specific small areas of the face have the same overall safety profile, and, therefore, FDA should allow these products to be labeled similarly. A third comment strongly disagreed with a specific labeling exemption for makeup with sunscreen and moisturizer products for use on the face and hands. The comment contended that an exemption would not be in the best interest of consumers. The comment also argued that consumer confusion and subsequent misuse of sunscreen products, particularly failure to apply adequate amounts of sunscreen or to reapply a product after certain activities, will occur if FDA permits reduced labeling for these products. The comment added that many consumers use face and hand cosmetic products with sunscreen as their primary and only source of UV radiation protection for those areas of the body. Moreover, consumers are more likely to use these products properly if they contain full sunscreen drug labeling. The comment concluded that makeup foundations, tints, blushes, rouges, and moisturizers that are intended to be used on a daily or frequent basis to protect against the adverse health and skin aging effects of acute and chronic sun exposure must be labeled as drugs similar to other OTC sunscreen products. FDA is not proposing to extend the labeling modifications in § 352.52(f), which is specific for products used only on small areas of the face and sold in small packages, to all OTC sunscreen products. FDA has determined that most OTC sunscreen products should have full drug labeling information using the standardized content and format in § 201.66 to ensure the safe and effective use of these products. In establishing the labeling modifications in § 352.52(f), FDA determined how the labeling information for sunscreen drug products, including drug cosmetic products, could best be presented on products with limited labeling space and still provide consumers with adequate information to use these products safely and effectively. Although any sunscreen products sold in small packages that meet the criteria in § 201.66(d)(10) are allowed the format exemptions under that section, FDA is also proposing content exemptions for sunscreen products marketed under § 352.52(f). FDA is proposing these exemptions under § 352.52(f) because sunscreen products labeled for use only on small areas of the face and sold in small packages are generally sold in packages substantially smaller than other sunscreen products, even those sunscreen products labeled for other uses that meet the criteria in § 201.66(d)(10). FDA continues to believe that requiring full Drug Facts labeling on sunscreen products used only on specific small areas of the face and sold in small packages (i.e., § 352.52(f)) would discourage manufacturers from marketing some of these products for drug use. Many of these products, such as sunscreen-lip protectant products, are sold in extremely small packages that cannot accommodate the required labeling even with the format exemptions allowed under § 201.66(d)(10). As explained in a number of rulemakings (64 FR 27666 at 27681 to 27682; 68 FR 33362 at 33371; 64 FR 13254 at 13270), these products meet the criteria for additional reduced labeling. Removal of these products from the OTC market would have a negative impact on public health. FDA believes that the benefit of UV radiation protection provided by these products outweighs the need for manufacturers to include all sunscreen labeling information. In contrast, FDA believes manufacturers of sunscreen products that are not within the scope of § 352.52(f) will continue to market their products even though full Drug Facts labeling is required. Unlike sunscreen products that meet § 352.52(f), the package size of products that do not meet § 352.52(f) will accommodate full Drug Facts labeling. Although FDA is not extending the labeling modifications in § 352.52(f) to all OTC sunscreen products, as requested by the first and second comments, we are allowing these labeling modifications for certain makeup with sunscreen products. Specifically, these labeling modifications would apply to makeup with sunscreen products that are labeled for use only on specific small areas of the face and that meet the criteria in § 201.66(d)(10). However, FDA does not agree that these labeling modifications should apply to all makeup products identified in § 720.4(c) (21 CFR 720.4(c)) that contain sunscreen, because most are not sold in small packages and, therefore, do not meet all of the criteria for reduced labeling (64 FR 13254 at 13270). Thus, most of these products can accommodate full Drug Facts labeling, and FDA finds no reason to extend the labeling modifications in § 352.52(f) to all makeup with sunscreens products. As explained in the previous paragraph, the labeling modifications in § 352.52(f) apply to makeup with sunscreen products labeled for use only on specific small areas of the face and sold in small packages. FDA also believes that any sunscreen products that are used only on specific small areas of the face and sold in small packages meet FDA's reduced labeling criteria regardless of whether they are drug or drug-cosmetic products. Therefore, FDA is proposing to amend the heading of § 352.52(f) to read as follows: “Products, including cosmetic-drug products, containing any ingredient identified in § 352.10 labeled for use only on specific small areas of the face (e.g., lips, nose, ears, and/or around the eyes) and that meet the criteria established in § 201.66(d)(10) of this chapter.” In addition, FDA is proposing to extend the labeling exemptions, with some modifications, currently allowed for lipsticks in § 352.52(f)(1)(vi) to the following lip products with sunscreen, as defined in § 720.4(c): • Lipsticks, • Lip products to prolong wear of lipstick, • Lip gloss, and • Lip balm. FDA has identified lip products to prolong wear of lipstick as “makeup fixatives” under § 720.4(c)(7)(viii). Lip gloss and lip balm fall under “other makeup preparations” in § 720.4(c)(7)(ix). As long as these lip products with sunscreen are used only on specific small areas of the face and are sold in small packages (i.e., meet the criteria in § 201.66(d)(10)), they would meet FDA's reduced labeling criteria. As discussed earlier in this comment, FDA believes not allowing Drug Facts labeling exemptions for these products would discourage manufacturers from marketing some of these products for drug use. In proposed § 352.52(f)(1)(vi), FDA is proposing to extend the labeling modifications for lipsticks to other lip cosmetic products containing sunscreen and clarifying that the labeling modifications in § 352.52(f) apply to both sunscreen and makeup with sunscreen products. Furthermore, because lip products with sunscreen have substantially less labeling space than the nonlip products with sunscreen used only on specific small areas of the face and sold in small packages, proposed § 352.52(f)(1)(vi) allows more labeling exemptions for lip products with sunscreen than other products that are within the scope of § 352.52(f). (Comment 10) Several comments recommended changing the acronym “SPF” from “sun protection factor” to “sunburn protection factor” because the latter definition is more descriptive of the use of OTC sunscreen drug products and avoids giving consumers the impression of solar invincibility and a false sense of security. FDA agrees. In § 352.52(b) of the sunscreen FM, FDA included only indications for sunburn protection (e.g., “helps prevent sunburn”) (64 FR 27666 at 27691). In this document, FDA is proposing to change the word “sun” to “sunburn” in § 352.3(b)(1), (b)(2), (b)(3), and

(d)and § 352.52(e)(1)(i), (e)(1)(ii), and (e)(1)(iii). Manufacturers can continue to use existing labeling until the compliance dates of a final rule based on this proposal. However, FDA encourages manufacturers to revise any labeling that states “sun protection” attributed to sunscreen active ingredient(s) to the new term “sunburn protection” as early as possible. (Comment 11) Some comments questioned the constitutionality of the FM's labeling provisions. Specifically, the comments contended that the FM's prohibition on the labeling of SPF products over 30, its restrictions on skin aging claims, and its limitation of the indications for use for OTC sunscreen drug products all violate the first amendment to the U.S. Constitution. The comments asserted that these bans on allegedly truthful labeling in the FM go well beyond constitutionally permissible restrictions on commercial free speech. One comment contended that FDA had failed to meet its burden to demonstrate that the claims at issue are misleading or that the restrictions on speech directly advance any substantial governmental purpose. In addition, the comment claimed that any interest FDA has asserted in restricting the speech at issue is served equally well, if not better, by regulations that do not restrict speech to the same extent as FDA's regulations. FDA disagrees with the comments for the following reasons. OTC drug monographs establish conditions under which ingredients for certain OTC uses are generally recognized as safe and effective (GRASE) and are not misbranded. General recognition of safety and effectiveness in an OTC drug monograph means that experts qualified by scientific training and experience recognize the conditions as safe and effective for OTC marketing for the use recommended or suggested in the product's labeling. An OTC drug monograph establishes, among other things, specific indications that are appropriate for the safe and effective use of a drug. An OTC drug product with labeled indications different than those set forth in an applicable OTC drug monograph would not be considered GRASE. OTC drug monographs allow manufacturers to market those products satisfying the monograph standard without requiring the specific approval of the product by means of a new drug application

(NDA)under section 505 of the act. FDA has issued numerous OTC drug monographs for certain categories of OTC drug products. If an OTC drug product subject to a final monograph is labeled for indications that differ from those set forth in the monograph, then it would be a “new drug” under section 201(p) of the act. In order to be legally marketed and distributed in interstate commerce, the drug manufacturer would be required to obtain approval from FDA for that product, and those conditions varying from the monograph, in an NDA under section 505 of the act. All OTC drug monographs place limits on the conditions that have been found acceptable for inclusion in the monograph by an administrative rulemaking process based on scientific data. Here, FDA set certain limits on the labeling of sunscreen drug products in the final rule, such as the prohibition on specific SPF values over 30, certain skin aging claims, and other indications for use. FDA is maintaining similar labeling restrictions in this proposed rule with respect to skin aging claims and other indications proposed by the comments. Also, as described elsewhere in this document, the revised “sun alert” in the “Warnings” section does not include any skin aging claims (see section III.G, comment 19 of this document). However, FDA is proposing to increase the SPF labeling limit from 30 to 50, based on additional data that was submitted subsequent to the issuance of the FM. FDA is also proposing that the term “SPF 50+” can be used, rather than the term “SPF 30+” allowed in the FM. This increase in the SPF labeling limit addresses, in part, the comments' request that FDA allow specific labeled SPF values over 30. Elsewhere in this document, FDA explains the reasons for the specific labeling proposals, such as the required SPF labeling, revised “sun alert” in the “Warnings” section of the Drug Facts box, and indications for use (see section III.F, comment 15 and section III.G, comments 16, 17, and 19 of this document). FDA also explains our denial of specific labeling claims suggested by the comments, including the prohibition on specific SPF values over a certain threshold (SPF 50), skin aging claims, and additional indications for use (see section III.F, comments 15 and 17 of this document). As noted earlier in this comment, any variation from these labeling conditions in the monograph, if finalized, would cause an OTC sunscreen drug product to be a new drug requiring an approved NDA before it could be legally marketed in the United States. The labeling requirements in this proposed rule would not violate the first amendment. FDA's requirements for the disclosure of information in the labeling of OTC sunscreen drug products are constitutionally permissible because they are reasonably related to the Government's interest in promoting the health, safety, and welfare of consumers and because they are not an “unjustified or unduly burdensome” disclosure requirement that offends the first amendment (see *Zauderer* v. *Office of Disciplinary Counsel* , 471 U.S. 626, 651 (1985); see also *Ibanez* v. *Florida Dep't of Bus. and Prof'l Regulation* , 512 U.S. 136, 146 (1994)). The reasonable relationship between the required labeling disclosures proposed herein and the Government's interest is plain here. The proposed labeling disclosures addressed by the comments, such as the SPF value, indications for use, and revised “sun alert,” would contribute directly to the safe and effective use of OTC sunscreen drug products. The SPF value and indications for use are critical components of labeling that allow consumers to understand more clearly a sunscreen product's use in preventing sunburn and relative level of UVA/UVB protection. As explained elsewhere in this document, the revised “sun alert” we propose to require in the “Warnings” section would help consumers understand more clearly the role of sunscreens as part of a comprehensive sun protection program (see section III.F, comment 19 of this document). The greater consumer understanding resulting from all of these labeling conditions would promote directly the proper use of sunscreens, which, in turn, would better ensure the protection of public health. In addition, it would not be “unduly burdensome” to sunscreen manufacturers to require these labeling disclosures. Finally, it is important to note that a sunscreen manufacturer could pursue alternative labeling conditions for its product by filing an NDA with the appropriate evidence demonstrating the product's safety and effectiveness under the proposed conditions. In any event, FDA believes that the labeling requirements outlined in this proposed rule would pass muster when analyzed under the four-part test for restrictions on commercial speech set fourth by the Supreme Court in *Central Hudson Gas & Electric Corporation* v. *Public Service Commission* , 447 U.S. 557 (1980). Under the test, the first question is whether the commercial speech at issue is false, misleading, or concerns unlawful activity, because such speech is beyond the first amendment's protection and may be prohibited. If the speech is truthful, nonmisleading, and concerns lawful activity, the Government may nonetheless regulate it if the government interest asserted to justify the regulation is substantial, the regulation directly advances the asserted governmental interest, and the regulation is no more extensive than necessary to serve the government interest (Id. at 566). The Supreme Court has explained that the last element of the test is not a “least restrictive means” requirement but, rather, requires narrow tailoring (i.e., “a fit that is not necessarily perfect, but reasonable” between means and ends) ( *Board of Trustees of the State Univ. of N.Y.* v. *Fox* , 109 S.Ct. 3028, 3032-35 (1989)). In subsequent decisions, the Court has also clarified that “misleading” in the first element of the test refers to speech that is inherently or actually misleading. Thus, if the speech to be regulated concerns lawful activity and is not inherently or actually misleading, the remainder of the test applies (see *In re R.M.J.* , 455 U.S. 191, 203 (1982)). Based on the data currently available, FDA believes that the labeling statements proposed by the comments (i.e., specific SPF values above FDA's established threshold, skin aging claims, and certain other indications) would not be protected speech and may be prohibited under the first prong of the *Central Hudson* test. FDA has tentatively determined that these proposed labeling statements would be inherently misleading on OTC sunscreen products sold and, thus, misbrand the products under section 502(a) and 201(n) of the act. Because FDA believes these labeling statements are inherently misleading, they would not be subject to protection under the first prong of the Central Hudson test. With respect to the labeling limitations for SPF values, based on current data, FDA believes that the labeling of sunscreens with specific SPF values greater than 50 would be inherently misleading. As discussed elsewhere in this document, FDA is concerned with the accuracy and reproducibility of test results showing protection greater than SPF 50 due to the lack of adequate validation data (see section III.F, comment 15 of this document). FDA had the same concern with SPF values above 30 when we published the FM in 1999. At that time, FDA had only received data demonstrating that the SPF test produces accurate results for products with SPF values of 30 or less. Since publication of the FM, FDA has received additional SPF testing data for sunscreen products with SPF values between 30 and 50 (Ref. 13). However, FDA has not received any data for sunscreen products with SPF values greater than 50. The data submitted to FDA indicate that the SPF test is accurate and reproducible for sunscreen products with SPF values up to 50 (Ref. 13). However, these data cannot be extrapolated to SPF values above 50. Thus, FDA is proposing to allow specific labeled SPF values only up to 50. Increasing variability in test results is likely with increasing SPF values. If there is large variability in test results, then the SPF value determined from the test is not accurate (i.e., an SPF 60 product may not actually be an SPF 60 product). The submitted data demonstrated that variability is not an issue for sunscreen products with SPF values up to 50. However, FDA is concerned that variability will become an issue for sunscreen products with SPF values over 50. For those sunscreens with SPF values above 50, FDA is proposing that the labeling can denote such values by a “50+” designation. As discussed elsewhere in this document, FDA has sufficient assurance that a result over 50 from the required SPF test is, in fact, greater than 50 and can be labeled “50+” (see section III. F, comment 15 of this document). Thus, FDA believes that the term “50+” is truthful and nonmisleading on the label of OTC sunscreen drug products for which the SPF test in the monograph has indicated an SPF value greater than 50. However, without proper validation of specific SPF values above 50, there is no assurance that the specific values themselves are in fact truthful and not misleading. Thus, labeling of specific values above SPF 50 without appropriate validation (which FDA currently lacks) would be inherently misleading. As noted elsewhere, FDA invited any interested parties to submit such validation data for consideration by FDA and possible inclusion of specific values above SPF 50 in the FM. With respect to anti-aging, skin cancer, and sun damage claims proposed by the comments, as discussed elsewhere in this proposed rule, FDA is concerned that these statements would be false or misleading due to lack of sufficient data in support of these claims (see section III.F, comment 17 of this document). FDA has reviewed the submitted articles concerning UV-induced skin damage (i.e., premature aging and cancer) along with the articles obtained from a search of scientific literature (Refs. 26 through 34). As discussed elsewhere, although FDA has concluded that the studies support the conclusion that exposure to UV rays increase the risk of premature skin aging, the study data fails to show that sunscreen use alone helps prevent premature skin aging and skin cancer for several reasons (see section III. F., comment 17 of this document). First, with respect to premature skin aging, the studies have not completely defined the action spectrum for the majority of UV radiation-induced effects on human skin. Second, the inability to identify the exact UVB and UVA wavelengths that induce each histological change in skin derives from the study designs. Without knowing which UVB and UVA wavelengths induce each histological change in the skin, FDA is unable to determine which wavelengths are most important to causing skin aging and cannot determine the action spectrum for aging. Third, the studies did not examine the chronic, long-term consequences of UV radiation exposure in human skin. Fourth, although the studies that examined the ability of sunscreens to protect against UV radiation-induced histological changes in the skin provide useful data, it is difficult for FDA to conclude that sunscreen use alone helps prevent skin aging based on these studies. Likewise, FDA is not aware of data demonstrating that sunscreen use alone helps prevent skin cancer. Like skin aging, these are studies examining the effects of sunscreen drug products on short-term factors for skin cancer, such as sunburn and other cellular damage. However, it is difficult to extrapolate these short-term adverse effects of UV radiation to a long-term, chronic effect such as skin cancer. In addition, like skin aging, the complete action spectrum for skin cancer is not known at this time. For all these reasons, FDA has tentatively concluded that the available evidence fails to show that sunscreen use alone helps prevents skin cancer or premature skin aging. Thus, the anti-aging, skin cancer, and sun damage claims proposed by the comments would be false or misleading due to lack of sufficient data in support of these claims. For example, the statement proposed by one comment that sunscreen use “may help prevent sun-induced skin damage, such as premature skin aging” would be inherently misleading to consumers by suggesting that sunscreen use alone may help prevent premature skin aging. As explained in this response, the available data fail to show that sunscreen use alone helps prevent premature skin aging and skin cancer. As described elsewhere, FDA is proposing a revised “sun alert” so that the labeling of OTC sunscreen drug products include the most accurate information, based on the available scientific evidence, concerning the relationship of sunscreen use to the prevention of sunburn, skin cancer, and premature skin aging caused by UV exposure (see section III.F, comment 19 of this document). The revised “sun alert” also includes a statement about limiting sun exposure and wearing protective clothing because FDA has tentatively determined that it is critical for consumers to understand the role of sunscreen use in a comprehensive sun protection program. As FDA has explained, the available evidence strongly suggests that consumers rely more heavily on sunscreens alone without taking other protective measures against sunlight, particularly when the labeling of products indicates the potential for greater protection (see section III.F, comment 19 of this document). By indicating the potential for greater protection than is supported by the available evidence, the proposed anti-aging, skin cancer, and other related claims would mislead consumers into relying more heavily on sunscreens alone. Such excessive reliance would undermine consumers' protection from the sun and, thus, FDA's public health mission. FDA has also preliminarily determined that the proposed labeling statements would concern unlawful activity which are not protected speech under the first prong of the Central Hudson test. FDA is proposing specific conditions in the monograph under which OTC sunscreen drug products would be GRASE. Elsewhere, FDA explains how the labeling statements proposed by the comments would not be appropriate monograph indications for these sunscreen products (see section III.G, comment 17 of this document). Thus, the proposed labeling statements outside the proposed indications of the final monograph, as FDA proposes to revise it, would promote a sunscreen drug product for use as an unapproved new drug, which is illegal. In addition, any variation in the statements in a “Warnings” section of a final monograph, such as the revised “sun alert” statement in this proposed rule, would be outside the monograph conditions and, thus, would promote the product as an unapproved new drug. The marketing and distribution in interstate commerce of an OTC sunscreen drug product with such labeling variations would be prohibited under sections 301(d) and 505(a) of the act. Speech promoting such an illegal activity may be restricted without violating the first amendment ( *Central Hudson* , 447 U.S. at 563-564). If a manufacturer could circumvent the requirements and restrictions imposed by a final monograph by including nonmonograph labeling statements, or excluding required monograph statements, based on its own assertions of the alleged appropriateness and truthfulness of the statements, then such activity would significantly undermine the monograph system and FDA's assurance that OTC drugs are safe and effective for their labeled conditions. FDA has assessed the labeling statements proposed by the comments and preliminarily determined that they are not justified by the available scientific evidence as GRASE conditions for the monograph. Instead, in order to legally market a sunscreen drug product with such labeling statements, an interested manufacturer would have to submit an NDA to FDA with the appropriate evidence to show the safety and effectiveness of the drug under the proposed nonmonograph labeling conditions. Requiring premarket FDA review and authorization of such nonmonograph drug claims ensures that such claims will be evaluated by a public health agency that has scientific and medical expertise so that only products that are safe and effective will be permitted to be sold for therapeutic purposes. Although this preliminary-determination that the labeling statements at issue would be inherently misleading and would concern unlawful activity would obviate the need for FDA to address the other three prongs of the *Central Hudson* test, we believe that the labeling requirements proposed in this document would satisfy each of the parts of this test. With respect to the second prong, FDA's interest in the required labeling disclosures and prohibitions addressed by the comments would contribute directly to the safe and effective use of these OTC sunscreen drug products, which is critical for the protection of public health. FDA's interest in protecting the public health has been previously upheld as a substantial government interest under *Central Hudson* (see *Pearson* v. *Shalala* , 164 F.3d 650, 656 (D.C. Cir. 1999) (citing *Rubin* v. *Coors Brewing Co.* , 514 U.S. 476, 484-485 (1995)). The proposed labeling requirements would directly advance this interest, thereby satisfying the third prong of the *Central Hudson* test. By requiring labeling disclosure of the SPF value, the proposed revised “sun alert,” and indications for use, FDA can better assure that consumers understand more clearly the use of sunscreens in preventing sunburn, their relative UVA/UVB protection, and their role as part of a comprehensive sun protection program. The greater consumer understanding resulting from all of these labeling conditions would promote directly the proper use of sunscreens, which, in turn, would better ensure the protection of the public health. Likewise, this proposed rule's exclusion from the monograph of the labeling statements proposed by the comments also directly advances FDA's public health interest. FDA has preliminarily determined from the available evidence that these statements would not be appropriate conditions for OTC use under the monograph. Thus, the statements would directly undermine the protection of public health. In addition, it is important to note that the *Pearson* court, in assessing whether the specific dietary supplement regulations at issue directly advanced FDA's stated public health goals under the third prong of the *Central Hudson* test, explained that its findings under this prong did not apply to drugs, where “the potential harm is presumably much greater” than other products ( *Pearson* , 164 F. 3d at 656, n 13). Finally, under the fourth prong of the *Central Hudson* test, there are not numerous and obvious ( *Cincinnati* v. *Discovery Network* , 507 U.S. 410, 418 n. 13 (1993)) alternatives to the required labeling statements or labeling prohibitions proposed herein. Consumers are accustomed to using the label as their primary source of information about a drug product's contents and use. Neither a public education campaign, nor encouraging OTC drug product manufacturers to provide information, such as that in the proposed revised “sun alert,” to consumers by other means, would ensure that people have the information they need about sunscreen products at the point of sale or use. Likewise, with respect to the alternative labeling statements proposed by the comments, FDA's proposed indications and revised “sun alert” present the relevant public health information to consumers in the clearest and most direct manner. Thus, FDA's proposed indications and prohibition of other labeling statements are not more extensive than necessary. In this way, the required labeling disclosures and prohibitions proposed in this document would meet the fourth prong of the test. Furthermore, the proposed prohibition of claims in a final monograph does not prevent such claims from being approved in an NDA. As explained previously, a final monograph sets forth those conditions, including labeling, under which an OTC drug product would be considered GRASE and not misbranded. In issuing monographs, FDA considers whether the available scientific evidence demonstrates that OTC drug products within a therapeutic category are GRASE. A final monograph does not constitute an FDA decision regarding an NDA for an OTC drug proposing variations in these conditions. Thus, FDA's proposals in this document would not prohibit any interested manufacturer from filing an NDA, with the appropriate evidence, for any variations from the monograph labeling conditions. Because of this significant available option to manufacturers for proposing alternative labeling statements, FDA's proposed labeling requirements and prohibitions are not more extensive than necessary. In conclusion, FDA believes it has complied with its burdens under the first amendment to support the labeling requirements of this proposed rule. (Comment 12) One comment stated that voluntary professional labeling can be provided to physicians that will allow them to select or recommend sunscreen products for their patients' needs, based on more detailed information describing the quantity (protection factor) and the range of UV protection (e.g., UVB, UVA, or UVB/UVA protection). Another comment stated that FDA should not require professional labeling because complete and accurate product labeling should be available to all consumers, not just to their health care providers. FDA defines professional labeling in OTC drug monographs as labeling that is provided to health professionals but not to the general public (i.e., not directly to consumers) (for example, see § 331.80 (21 CFR 331.80)). In the final rule, FDA stated that it would consider professional labeling, such as protection against photosensitization reactions, if data were received (64 FR 22666 at 27674). FDA has not received any data to date. Therefore, FDA is not proposing any professional labeling in this document. FDA will consider professional labeling for OTC sunscreen drug products in the future if specific supportive data are provided. (Comment 13) Some comments objected to the ranges of SPF values that define the product category designations

(PCDs)in § 352.3(b). Stating that standard public health messages recommend use of a sunscreen with at least an SPF of 15, the comments contended that the “moderate” PCD (SPF values of 12 to under 30) may cause consumers to believe that SPF values of less than 15 provide adequate protection. One comment further stated that if the PCD range is from SPF 12 to 29, manufacturers will only produce the minimum SPF value as they can use less active ingredients and get the same PCD classification. As discussed in the final rule (64 FR 27666 at 27681), the PCD ranges in § 352.3(b) and § 352.52(e) reflect a modified, simpler, combined version of the previously proposed five PCDs and the “Recommended Product Guide.” However, FDA agrees with the comments that the current standard public health message from public health organizations generally recommends use of a sunscreen with an SPF value of at least 15 (see section III.G, comment 19 of this document). We also agree that allowing SPF values below 15 in any but the lowest PCD range may appear to contradict this message. Therefore, FDA is proposing to modify the PCD SPF value range in proposed § 352.3(c)(1) from “2 to under 12” to “2 to under 15” and in proposed § 352.3(c)(2) from “12 to under 30” to “15 to under 30.” FDA is also proposing to replace the PCD terms “minimal” and “moderate” with the simpler terms “low” and “medium,” respectively, and to use these simpler terms for the UVA radiation protection categories (see section III.E, comment 14 of this document). These labeling changes will provide consumers with familiar and consistent terms describing both UVA and UVB radiation protection. FDA disagrees with the comment contending that manufacturers will only produce the minimum SPF value in a given PCD range because they can use less active ingredients and get the same PCD classification. Section 352.50 of the current FM requires the SPF value to appear on a sunscreen product's PDP. This proposed rule would not change that requirement. Thus, while the PCD provides additional information about the SPF value, consumers seeking higher SPF values can readily identify such products by the SPF value stated on a sunscreen product's PDP. E. Comments on the Labeling of Sunscreen Drug Products With UVA Protection (Comment 14) Many comments discussed ways to categorize, phrase, and display UVA/UVB radiation protection on an OTC sunscreen drug product label. All of the comments stated that the SPF value should retain preeminence on the label's PDP and be the consumers' criteria for choosing an OTC sunscreen product. Some comments recommended that UVA radiation protection be stated on the PDP in descriptive words or simple phrases, rather than numbers or symbols, for the following reasons: • Simplicity, • Clarity, • To avoid confusion with SPF, and • To maximize consumer comprehension. Some comments referenced consumer research, discussed in subsequent paragraphs, to support this recommendation (Refs. 4 and 5). One comment suggested the following labeling statements: • “Protects against UVA rays” • “screens out UVA rays” • “shields from UVA rays” • “broad spectrum sunscreen” • “UVA/UVB protection” • “provides protection against both UVB and UVA rays” • other truthful and nonmisleading statements describing a quantification of the product's UVA radiation protection The comment stated that quantification of the UVA radiation protection should be allowed in labeling, but not required, so that consumers can have additional product performance information to help them select appropriate products. Another comment stated that UVA radiation protection should be labeled only as grades of effectiveness (multiple levels) for the following reasons: • UVA radiation irritation induces various skin reactions (e.g., erythema, pigment darkening, skin cancer, and photodermatitis), and • Some action spectra of damages have not been determined. This comment referred to The Japan Cosmetic Industry Association

(JCIA)Measurement Standards for UVA Protection Efficacy (Ref. 6), which recommend labeling UVA protection as three grades:

(1)PA+,

(2)PA++, or

(3)PA+++. Several comments recommended two categories of UV protection labeling based on the ratio of UVA radiation protection factor to SPF value: • “with UV protection” if ratio equals 0.20 • “with extra UV protection” if ratio equals 0.25 The proposed ratio is based on the UVA radiation protection factor as determined by the persistent pigment darkening

(PPD)test method (see section III.N, comment 46 of this document). These comments stated that, because the ratio of damage from solar UVB radiation to that of solar UVA radiation is 80:20 over a day, a sunscreen must protect against an 80:20 ratio of UVB to UVA radiation. The comments also recommended that products labeled “with UV protection” or “with extra UV protection” exhibit absorbance of 360 nanometers

(nm)and longer wavelengths. Another comment suggested two categories to state overall UV radiation protection: “regular” and “broad spectrum.” The comment proposed that the ratio of a sunscreen product's SPF value to its UVA protection factor be the single criterion for the “broad spectrum” designation, with the maximum ratio no greater than 4:1. For example, an SPF 16 product would need to provide a UVA protection factor of at least 4 to be designated “broad spectrum.” One comment disagreed with the previous comment, stating that there is no supportable scientific basis for the relevance of the 4:1 ratio. The comment argued that the ratio inappropriately combines, in the same equation, SPF values obtained with a solar simulator and solar irradiance values at low sun angles. Another comment suggested that sunscreen products with an SPF value of 2 or greater must have a UVA protection factor of at least 2 to be labeled “UVA/UVB” or “broad spectrum protection.” The comment stated that products with SPF values of at least 15 and UVA protection factors of at least 4 may be labeled “extra (or extended or enhanced) UVA protection.” The comment stated that these criteria are independent of test method and should apply to any of the proposed UVA radiation test methods. Another comment proposed establishing PCDs based on the UVA radiation protection value obtained by the PPD test method. The comment suggested four PCDs that would enable consumers to choose the desired levels of protection: • “moderate” • “high” • “very high” • “extra” Another comment recommended three PCDs: • “low UVA protection” • “moderate UVA protection” • “maximum UVA protection” Another comment suggested using the five PCDs proposed in the TFM (58 FR 28194 at 28295) and added a UVA protection factor number for each PCD based on the immediate pigment darkening

(IPD)test method. Two comments recommended a four-star rating system to describe UVA radiation protection. The comments stated that this system, based on the ratio of UVA to UVB radiation absorbance, would provide a simple method for consumers to determine the protective nature of an OTC sunscreen drug product. The absorbance ratio would range from 0 for products exhibiting no protection against UVA radiation to 1 for products exhibiting equal absorption at all wavelengths throughout the UVA/UVB radiation spectrum. Using this ratio, products would be classified in one of the following five categories: • 0 to < 0.2 = no UVA radiation protection claim • 0.2 to < 0.4 = Moderate (★) • 0.4 to < 0.6 = Good (★★) • 0.6 to < 0.8 = Superior (★★★) • 0.8 plus = Maximum (★★★★) Another comment recommended a five point rating system using the “critical wavelength”

(CW)(λ c ) test method. This system uses a scale analogous to the star rating system to assign products a “broad spectrum” rating as follows: • λ c < 325 = “0” • 325 < λ c < 335 = “1” • 335 < λ c < 350 = “2” • 350 < λ c < 370 = “3” • 370 < λ c = “4” Several comments supported a single claim, such as “provides broad spectrum protection against UVB and UVA radiation,” based on determining a sunscreen pass/fail CW (λ c ). Comments that supported this “broad spectrum protection” claim stated that, in combination with SPF, it provides simple and accurate labeling that is easily understood by consumers. The comments referred to a research study that suggested this approach to UVA radiation protection labeling was superior for consumer comprehension and ease of product selection (Ref. 7). Other comments provided consumer research data, discussed elsewhere in this comment, suggesting this approach was least preferred by consumers (Refs. 4 and 8). One comment stated that UVA radiation protection claims should be allowed for sunscreen products with SPF values of 4 and higher. The comment added that, for products claiming to protect against UVA and UVB radiation, a minimum UVA protection factor of 2 should be required if the SPF value is less than or equal to 12. Several comments stated that sunscreen drug products labeled as “full spectrum” or “broad spectrum” should protect consumers from substantially all of the harmful effects of the sun, including sunburn associated with UVA radiation. According to one comment, sunscreen drug products labeled “full spectrum” or “broad spectrum” that do not protect against nearly all UVB and UVA radiation wavelengths seriously risk misleading consumers into believing they are fully and completely protected from the dangers of the sun. One comment recommended using the claim “full spectrum” rather than “broad spectrum” to describe products that attenuate more than 90 percent of UVA radiation and are at least SPF 15. The comment suggested no UVA radiation protection claims be allowed if the product is below SPF 15. In support of their proposed UVA labeling, a number of comments provided results from consumer research studies that assessed consumer labeling preferences for stating UVA radiation protection. One comment described a 1996 survey (Ref. 4) in which 275 subjects compared two labeling systems: • 3-level descriptive (“light,” “intermediate,” or “extended” “UVA protection”) and • Grapho/numerical (a bar graph indicating a level, 0, 4, 8, or 12, with the corresponding number appearing alongside the graph). The comment stated that the survey data suggested that, while equally able to understand both types of labels, the panelists preferred the grapho/numerical system over the descriptive system. Another comment described two consumer research studies, conducted in 1994 and 1995 (Ref. 9), in which 235 subjects compared three potential UVA radiation labeling options: • Numerical (2, 3, or 5), • Symbolic (4 stars with 1, 2, 3, or 4 stars filled), and • 3-level descriptive (labeled blank if no UVA radiation protection provided or labeled “UVA and UVB Protection” or “UVB Plus Extended UVA Protection,” depending on the level of UVA radiation protection provided). The studies included focus group discussions and indepth interviews. The comment stated that the data suggested that a numeric designation for UVA radiation protection (in addition to the SPF value) created confusion for consumers and that symbols (i.e., stars) misled consumers into giving equal or greater importance to the UVA radiation rating compared to the SPF value. The comment concluded that a descriptive approach better conveyed to consumers the added benefit of UVA protection without detracting from the SPF value. Another comment described two consumer research studies conducted in 1999 (Ref. 7) in which 2,238 consumers assessed three sunscreen product labeling systems: • A pass/fail descriptive (labeled blank if no UVA protection provided (i.e., fails) or labeled “Broad Spectrum UVA and UVB Protection” if UVA radiation protection provided (i.e., passes)), • A 3-level descriptive (labeled blank if no UVA radiation protection provided or labeled “UVA and UVB Protection” or “UVB Plus Extended UVA Protection,” depending on the level of UVA radiation protection provided), and • A 3-level grapho/numerical (a bar graph indicating a level, 4, 8, or 12, with the corresponding number appearing alongside the graph). The comment stated that the data suggested the pass/fail descriptor, “broad spectrum,” was significantly superior to the other labels and recommended that FDA use this labeling to designate UVA radiation protection. Another comment described a consumer research study conducted in 2000 (Ref. 8) at 20 urban and suburban shopping malls in which 1,921 subjects ranked four labeling systems: • 4-level numerical, • 4-level symbolic, • 4-level descriptive, and • Pass/fail descriptive (“with/without broad spectrum UVA/UVB protection”). The numerical labeling system was shown as Arabic numerals “1, 2, 3, 4” with the number “2” highlighted. The descriptor labeling system was shown as the words “Minimum, Moderate, High, Maximum” with the word “Moderate” highlighted. The symbolic labeling system was shown as a picture of four stars with two stars highlighted. The comment concluded that the subjects had a significant preference for a labeling system based on descriptive words or numbers because of clarity, specificity, and ease of comprehension. Subjects least preferred the pass/fail system because they found it unclear, nonspecific, and lacking sufficient information to compare sunscreen products. This study also revealed that the numerical labeling system was one of the top two choices because numbers were “clearer, more specific, and easier to understand.” Age, gender, and educational or ethnic background were reported as not affecting the study results. In the TFM for OTC sunscreen drug products (58 FR 28194 at 28233), FDA proposed to allow claims relating to “broad spectrum protection” or “UVA radiation protection” for OTC sunscreen products that meet the following two criteria: 1. Contain sunscreen active ingredients with absorption spectra extending to 360 nm or above, and 2. Demonstrate meaningful UVA radiation protection using appropriate testing procedures to be developed. In the FM for OTC sunscreen drug products (64 FR 27666 at 27672), FDA stated that UVA radiation labeling of OTC sunscreen drug products could continue in accordance with the TFM and its amendments until addressed in a future issue of the **Federal Register** . Elsewhere in this document, FDA is proposing test methods for determining the UVA radiation protection potential of an OTC sunscreen drug product (see section III.N, comment 46). FDA believes that the existing data do not clearly define the relationship between UVA radiation and skin damage. The principal reason for not better understanding this relationship is that the action spectra for specific types of UVA radiation-induced skin damage (i.e., which wavelengths of UVA cause which types of skin damage) have not been established. However, most scientific data demonstrate that UVA radiation is harmful to the skin. Thus, until these action spectra are known, FDA believes that more protection against UVA radiation damage is better for consumers' health. Therefore, FDA believes it is important, as with the SPF value, to designate UVA radiation protection in a straightforward manner that consumers clearly understand. FDA proposes that the UVA radiation protection of an OTC sunscreen drug product determined from these UVA test methods be designated on the PDP using a combination of category descriptors (i.e., “low,” “medium,” “high,” or “highest”) and stars (i.e., symbols) similar to those described by some of the comments. The category descriptors and stars will designate relative levels of UVA radiation protection as measured by the UVA radiation test methods. The level of UVA radiation protection identified on the label reflects the following: • A numerical “UVA protection factor” (from the clinical test), and • A numerical ratio of UVA I (340 to 400 nm) radiation absorption to UVB/UVA (290 to 400 nm) radiation absorption (from the in vitro test). The test that indicates the lowest level of UVA radiation protection determines the level identified on the label. For example, if the clinical test indicates “low” protection and the in vitro test indicates “medium” protection for a product, the product is labeled as providing “low” UVA radiation protection. This system comprises four categories of UVA radiation protection as described in table 1 of this document. **Table 1.—Overall UVA Protection of a Sunscreen Drug Product** Star category Category descriptor ★✰✰✰ Low ★★✰✰ Medium ★★★✰ High ★★★★ Highest Some of the comments argued that the UVB radiation protection labeling is more important than UVA radiation protection and should be emphasized in the labeling over UVA radiation protection. FDA disagrees with the comments and proposes that the UVA radiation protection designation appear on the PDP along with the SPF value in an equally prominent manner that does not conflict with the SPF value. Because action spectra for UV-induced skin damage have not been clearly defined, FDA is unable to specify labeling for OTC sunscreen drug products that indicates what ranges of UV radiation are most harmful to consumers. In other words, FDA cannot conclude whether UVB or UVA radiation is more harmful to humans based on the scientific data collected to date. Therefore, FDA considers both UVB and UVA radiation protection equally important at this time because scientific data demonstrates that both have harmful effects on the skin. So that consumers consider UVB and UVA radiation protection equally in selecting an OTC sunscreen drug product, FDA is proposing a number of labeling requirements. Under this proposal, the font size of the stars and category descriptors for UVA radiation protection must be the same size as the SPF value and its descriptors. All four stars must appear and be preceded by the term “UVA” and followed by the appropriate category descriptor (e.g., UVA ★★★✰ High). All star borders and the color inside a solid star must be the same while the color of “empty” stars must be lighter and distinctively different than solid stars. The color inside a solid star must be distinctively different than the background color. The stars must be filled in starting with the first star on the left and must appear in a straight horizontal line. As requested by some comments, an OTC sunscreen drug product that does not provide the minimum UVA protection, as determined by the proposed UVA test methods, may only display an SPF value on the PDP. An OTC sunscreen drug product is not required to provide UVA protection and may bear only a sunburn (UVB/SPF) protection claim. However, FDA is proposing that a sunscreen product that does not provide at least a “low” level of UVA protection include the following statement on the PDP: “no UVA protection.” This statement must be the same font size as the SPF value and its descriptor. FDA is not proposing four empty stars because we are concerned that consumers may confuse products providing no UVA protection (i.e., four empty stars) with those providing the highest UVA protection (i.e., four filled stars). In developing this UVA radiation protection labeling, FDA has particularly considered the label comprehension studies (Refs. 4, 7, 8, and 9). These studies used multiple methodologies and report a diverse range of preferences for each labeling system: • Category descriptors, • Graphics, • Symbols, • Numerics, and • “Pass/fail” descriptors. The diverse results and varying methodology make it difficult to identify a clear preference for one labeling system. However, the studies indicate an overall preference for category descriptors. In agreement with the studies, FDA is proposing category descriptors to indicate the relative level of UVA radiation protection. As discussed in preceding paragraphs, FDA believes consumers should consider UVB and UVA radiation protection equally when selecting an OTC sunscreen drug product. For this reason, FDA is proposing that stars be used with category descriptors. FDA believes that the category descriptor and star labeling for UVA radiation protection will give it equal prominence with UVB radiation protection (i.e., category descriptor and SPF) on the PDP. FDA is not proposing grapho/numeric labeling because we are concerned that consumers may be confused by a second number on the PDP (i.e., in addition to the SPF value). FDA is also not proposing any of the simple two-category designations suggested by the comments: • With/without UVA protection, • With UVA protection/with extra UVA protection, or • Regular/broad spectrum protection. FDA agrees with one of the comments, which argued that these types of statements are misleading. FDA does not consider this labeling as providing consumers with enough information about the magnitude of UVA protection offered by an OTC sunscreen product. However, FDA does not object to the use of the following four statements for OTC sunscreen drug products that satisfy the requirements of proposed § 352.73 for a labeled UVA protection value: • “broad spectrum sunscreen”, • “provides [select one of the following: ‘UVB and UVA,’ or ‘broad spectrum’] protection”, • “protects from UVB and UVA [select one of the following: ‘rays’ or ‘radiation’]”, and • [select one of the following: “absorbs” or “protects”] “within the UVA spectrum”. These statements may appear elsewhere in product labeling outside the “Drug Facts” box or enclosure but not intermixed with the information required on the PDP under § 352.50. FDA agrees with some comments that these statements, by themselves, may be misleading by implying that a sunscreen protects against nearly all UVB and UVA radiation. However, FDA does not believe these optional statements will be misleading in the context of the entire label, because the relative level of UVB and UVA protection must be stated on sunscreen product labels (alongside these more general statements). Although none of the studies combined labeling systems as proposed in this document, FDA believes the studies support use of category descriptors and symbols together. One study suggested that symbols may imply importance over SPF values (Ref. 9). However, FDA believes consumers will not place greater importance on UVA protection because we are proposing a required statement to inform consumers about the importance of both UVB and UVA protection. We are proposing to require one of the following statements on the PDP of all OTC sunscreen drug products: • “UV rays from the sun are made of UVB and UVA. It is important to protect against both UVB & UVA rays.” • “UV rays from the sun are made of UVB and UVA. It is important to protect against both UVB & UVA rays to prevent sunburn and other skin damage.” FDA believes that the use of one of these statements, along with the proposed UVB and UVA radiation protection labeling, including the format requirements described in preceding paragraphs, will lead consumers to view UVB and UVA radiation protection as equally important. In addition, this statement will educate consumers about UVA radiation, which will be a new term and concept to many consumers. The proposed statement should help consumers better understand the new UVB and UVA labeling when it is initially introduced to the OTC market. Thus, FDA believes that the consumer label comprehension studies, along with the proposed educational statement about UVB and UVA radiation, support the stars and descriptor UVA radiation protection labeling proposed in this document. Moreover, a similar “star rating system” for UVA radiation protection (i.e., the Boots Star System) has been used to label sunscreen products throughout Europe for over 10 years. To prevent consumer confusion about UV radiation protection, FDA is proposing changes to UVB radiation protection labeling (i.e., the SPF value). SPF values indicate how effective a sunscreen product is in protecting against sunburn. By displaying the relative level of sunburn protection on the sunscreen drug product PDP in terms of an SPF value, consumers can choose their desired level of UVB radiation protection. To further improve consumers' understanding of the sunburn protection level provided by a certain sunscreen product, FDA is proposing to require descriptive terms of relative sunburn protection (i.e., “low,” “medium,” “high,” and “highest”) to accompany the SPF value on the PDP. FDA is further proposing that the SPF value must be preceded by the term “UVB” to further differentiate the SPF value from the UVA symbol/descriptor on the PDP. FDA believes that numerical labeling for UVB protection, symbolic labeling for UVA protection, and the same descriptive labeling for UVB and UVA protection will allow consumers to easily understand and choose from relative levels of UVB and UVA radiation protection. FDA is aware that consumers have used and become accustomed to choosing OTC sunscreen drug products based on the SPF value for many years. Likewise, FDA believes that, over a period of time, consumers will similarly become accustomed to the proposed labeling using symbols and descriptors to designate relative UVA radiation protection. Furthermore, FDA believes consumer familiarity with similar star rating systems (e.g., movies, hotels, and restaurants) used for many years in the United States provide a basis for consumers' understanding of this proposed labeling for OTC sunscreen drug products. FDA is providing a number of examples of how the UVA/UVB protection designations could appear on the PDP. EP27AU07.003 FDA believes that, as with SPF values, identifying the relative level of UVA radiation protection provides the most useful information for consumers. Consumers who desire more protection from the sun will be able to identify products with higher UVB

(SPF)and UVA radiation protection. FDA agrees with the comments that a product must provide at least some minimum level of UVA radiation protection (as with SPF values) to be labeled as providing UVA radiation protection. Therefore, FDA is proposing minimum criteria for the lowest UVA category in its proposed test procedures (see section III.N, comment 46 of this document). F. Comments on the Labeling of Sunscreen Drug Products With High SPF Values (Comment 15) Several comments objected to FDA limiting specific labeled SPF values “up to but not above 30.” The comments stated that data and information supplied to FDA since publication of the sunscreen FM demonstrate that SPF values over 30 can be safely tested with accuracy. The comments also argued that removing the limit will not lead to consumers spending more time in the sun when using high SPF sunscreens in comparison to low SPF sunscreens. To address that point, one comment proposed labeling to help reduce potential consumer misuse of sunscreens with SPF values over 30: “higher SPF products give more sun protection, but are not intended to extend the time spent in the sun.” Another comment noted that the SPF value, in addition to proper sunscreen application and reapplication, is only part of a comprehensive sun protection program. Other comments explained the need for high SPF sunscreen products. The comments contended that consumers and physicians are familiar with and want the many currently marketed sunscreens that are labeled as “SPF 45, SPF 50, etc.” Thus, the comments argued that U.S. consumers will be at a disadvantage within the international community, because products providing SPF values over 30 are available in other countries. In addition, the comments stated that many prominent medical authorities maintain the need for high SPF sunscreens for individuals at “high risk” based on medical and/or occupational concerns and individuals who desire increased protection from photoaging and lengthy/intensive sun exposure situations. The comments argued that the need for high SPF sunscreens is supported by findings that UV exposures in several cities are considerably higher than previously recognized and because high SPF products can reduce cumulative UV exposure. The comments stated that consumer desire for high SPF products is demonstrated by sales data showing that products with an SPF value of 45 are one of the fastest growing segments of the total sunscreen market. The remaining comments discussed the consequences of limiting the specific labeled SPF value. For example, one comment noted that if manufacturers cannot state the SPF level above 30, they will no longer have an incentive to fund research for better sunscreens. In addition, manufacturers may reformulate products to reduce active ingredients and, thus, reduce the level of UV protection. A comment argued that another adverse consequence results from most consumers failing to achieve the labeled SPF value because they do not apply enough sunscreen and/or reapply it too infrequently. Because high SPF products can help make up for such improper use, limiting the specific labeled SPF value to 30 has a negative impact on UV protection. A foreign industry organization suggested an upper limit for labeled SPF values of 50+ and provided three reasons: • Unreasonably high SPF values will lead consumers to expect “too much effectiveness” from sunscreen products. • Higher concentrations of sunscreen active ingredients are not “in the interest of safety.” • Higher SPF values will invite excessive, meaningless competition in the industry. The comment explained that competition would be meaningless because the amount of UV protection provided by products with SPF values above 50 is not significantly greater than products with an SPF of 50. Another comment from a sunscreen manufacturer agreed with FDA's concern about the possibility of increasing variability when testing high SPF sunscreens. The comment suggested a modified “binomial” test method and labeling requirements for SPF values over 20 that would allow for high SPF products. Another comment submitted a published survey of 208 sunbathers on Miami's South Beach during July 2001 with the goal of measuring UV radiation exposure and probable injury (Ref. 10). The “worst case” scenario identified by the survey was based on sunbathers with Type I skin (persons most sensitive to sunlight who burn easily and never tan) exposed to UV radiation near the longest day and highest sun angle of the year at the “southern-most major beach” in the United States. The survey was a followup to one conducted in 1993 with 62 sunbathers and evaluated by FDA in the FM (64 FR 27666 at 27674). The 2001 survey determined MEDs absorbed by the following three steps: 1. Measuring incident UV radiation (using three dosimeters), 2. Multiplying by an adjusting factor for skin type (using a 30 percent increase in sensitivity between skin types), and 3. Dividing by the SPF worn by the sunbather. The survey suggests that sunbathers with Type I skin might receive a cumulative dose of 49.5 MEDs with 8 hours of exposure. The comment concluded that, while SPF values up to, and including, 50 are warranted, values over 50 are unwarranted in any condition for sunburn protection. Two comments submitted testing data for sunscreens with SPF values between 30 and 50 using the test method in the FM. The comments concluded that the test method was valid for these high SPF values. In addition, one comment indicated that a very water resistant test for an SPF 45 to 50 sunscreen would take nearly 4.5 hours using the skin types of subjects in the SPF testing procedures in the FM (i.e., skin types I, II, and III) (Ref. 13). The comment concluded that it is beyond the practical endurance capabilities of many people in the test to spend more than 5 to 6 hours in front of a UV radiation lamp and that fatigue can lead to errors in test results. The comment also noted that the potential for intra and interlaboratory variability in test results increases as sunscreen SPF values increase. FDA concluded in the FM (64 FR 27666 at 27675) that test methods supported specific SPF label values up to 30. FDA invited interested persons to submit data in support of high SPF test methods and to consider proposed methods for communicating the level of protection in labeling. Data and information on high SPF testing and labeling were submitted to FDA at, and following, public meetings on July 22, 1999, and October 26, 1999, and after reopening of the administrative record (65 FR 36319) (see section III.I, comment 24 of this document) (Refs. 11 and 12). FDA continues to be aware that many OTC sunscreen products with specific labeled SPF values over 30 are currently marketed, both nationally and internationally, and are increasingly used by consumers and recommended by health professionals (64 FR 27666 at 27675). FDA agrees that these products should be available for those sun-sensitive consumers who require such products based upon personal knowledge, planned sun exposure, geographical location, or advice of a health professional. FDA previously noted the lack of any known safety problems for sunscreen products with SPF values greater than 30 (64 FR 27666 at 27675). The comment that argued higher concentrations of sunscreen active ingredients are not “in the interest of safety” did not supply any new data to support its contention. FDA will continue to monitor adverse drug experience reports for sunscreen drug products reported to its Medwatch program and in the medical literature. As noted by one comment, some researchers have raised the concern that sunscreen use may lead to increased sun exposure. The “compensation hypothesis” states that consumers who use high SPF sunscreens spend more time in the sun and/or use less protective clothing. The only double blind, randomized trial that addressed this issue showed a significant increase in sun exposure time when comparing use of SPF 30 to SPF 10 (Ref. 14). In addition, two retrospective survey studies showed that sun exposure time is longer when using sunscreen compared to not using sunscreen (Refs. 15 and 16). Other studies cited by the comment to support the premise that the “compensation hypothesis” is incorrect and either did not provide data about the length of sun exposure or the study method did not allow for data interpretation (Refs. 17 through 20). Based on all of this data, FDA believes that some consumers may increase total UV exposure through over-reliance on sunscreens. The apparent divergent results on the validity of the “compensation hypothesis” between studies may indicate that sun protection behaviors vary greatly for each person. More specifically, there is a spectrum of attitudes about the sun, from those individuals who seek dark suntans to those who seek to avoid the sun and consequent UV skin damage (Ref. 21). Such evidence underscores the need for adequate labeling so consumers can make informed decisions regarding their use of OTC sunscreen drug products. FDA agrees that the SPF value is one factor in a comprehensive sun protection program. However, the SPF is only a measure of protection from erythema (i.e., UVB radiation-induced sunburn) and does not measure protection from other UV skin damage, such as that induced by UVA radiation. While increased short wavelength UVA radiation protection generally increases with increasing SPF values, studies using in vivo or in vitro UVA radiation testing methods demonstrate that sunscreen products with the same SPF values can have markedly different levels of UVA protection, especially for long wavelength UVA radiation (Refs. 22 and 23). These studies also indicate that a specific high SPF product can provide much less UVA radiation protection than a product with a much lower SPF value. Elsewhere in this document, FDA is proposing UVA radiation testing methods and labeling that will categorize the relative levels of protection provided by the SPF and UVA values of the sunscreen product (see section III.E, comment 14 and section III.N, comment 45 of this document), allowing consumers to compare products and choose the levels of UVB and UVA radiation protection desired. An SPF 30 sunscreen product may provide adequate sunburn protection for many consumers. However, FDA believes that appropriately tested and labeled high SPF value sunscreen products should be available for consumers who desire or need high levels of UV protection, in particular, those who burn easily. Such products would do the following: • Help compensate for inadequate application and/or reapplication, • Provide additional sunburn protection during intense UV radiation conditions, • Help reduce cumulative UV radiation exposure (when used in conjunction with other measures to reduce overall sun exposure), and • Generally provide consumers incremental increases in sunburn protection. FDA agrees that SPF values should be supported by scientific evidence. In the FM, FDA limited the specific labeled SPF value to 30. At that time, FDA had only received data demonstrating that the SPF test produces accurate results for products with SPF values of 30 or less. Since publication of the FM, FDA has received additional SPF testing data for sunscreen products with SPF values between 30 and 50 (Ref. 13). However, FDA has not received any data for sunscreen products with SPF values greater than 50. The data submitted to FDA indicate that the SPF test is accurate and reproducible for sunscreen products with SPF values up to 50 (Ref. 13). However, these data cannot be extrapolated to SPF values above 50. Thus, FDA proposes to allow specific labeled SPF values up to 50. FDA agrees with the sunscreen manufacturer that increasing variability in test results is likely with increasing SPF values. If there is large variability in test results, then the SPF value determined from the test is not accurate (i.e., an SPF 50 product may not actually be an SPF 50 product). The submitted data demonstrate that variability is not an issue for sunscreen products with SPF values up to 50. However, FDA is concerned that variability will become an issue for sunscreen products with SPF values over 50. FDA recognizes that future data may demonstrate that variability may not be a problem for sunscreen products with SPF values over 50. Therefore, FDA will consider specific SPF values greater than 50 upon receipt of data demonstrating that accurate and reproducible results can be obtained from the SPF test for sunscreen products with SPF values over 50. Generally, such data should include results from multiple laboratories using the same sunscreen formulations and using the SPF test proposed in this document, along with a statistical analysis of the overall results. In addition, FDA believes that the modified “binomial” test method submitted by one comment has merit for high SPF sunscreens and is requesting others' views on this method during the comment period for this rulemaking (see section III.I, comment 24 of this document). In the FM (64 FR 27666 at 27675), FDA disagreed with the comment that manufacturers would have no incentive to fund research for better sunscreens and may reformulate to less protective products if there is an upper limit to specific labeled SPF values. Although FDA would not want to decrease research incentive, FDA is more concerned about valid scientific data demonstrating the ability of multiple laboratories to accurately and reproducibly determine SPF values. However, FDA does not believe it is necessary to arbitrarily limit specific labeled SPF values. To the contrary, both in the FM and in this proposal, FDA has specifically stated that high SPF sunscreens should be available for those individuals desiring such products. The maximum allowable specific labeled SPF value, both in the FM and in this proposal, is based upon the review of data and information submitted to FDA. FDA purposely did not limit labeled SPF values at 30 in the FM. Instead, FDA used the value of “30+,” pending the receipt of adequate data to support any higher specific label values. Similarly, in this document, FDA is proposing the collective value “50+.” FDA has sufficient assurance that a result over 50 from the required SPF test is, in fact, greater than 50 and can be labeled “50+.” Thus, FDA believes that the term “SPF 50+” is truthful and nonmisleading on the label of OTC sunscreen drug products for which the SPF test in the monograph has indicated an SPF value greater than 50. FDA believes that allowing manufacturers to label sunscreens as “SPF 50+” may encourage further research in human skin photobiology and the development of safe and effective sunscreen drug products with specific SPF values over 50. As explained earlier in this comment, FDA is not proposing that the specific value over 50 be stated in the labeling because there is no data, at this time, demonstrating the accuracy and reproducibility of the specific value over 50. Based upon the proposed labeling, improvements to SPF testing methods, and specific high SPF test data, FDA is proposing to modify the labeled SPF values in current § 352.50(a)(1) and (a)(2) by changing the SPF values from “30” to “50.” G. Comments on Indications for Sunscreen Drug Products (Comment 16) One comment requested that the “Uses” statement, “higher SPF gives more sunburn protection,” be omitted except for products with an SPF over 30. This and other comments suggested that FDA's labeling concerns regarding high SPF sunscreens could be alleviated if the following statement was required on sunscreens over SPF 30: “Higher SPF products give more sun protection, but are not intended to extend the time spent in the sun.” FDA is proposing to revise the sunscreen FM “Uses” statement “helps prevent sunburn” and delete the “Uses” statement “higher SPF gives more sunburn protection” in current § 352.52(b). The first indication, “helps prevent sunburn,” is being revised to one of the following, which would be required on all sunscreens: • “low UVB sunburn protection” • “medium UVB sunburn protection” • “high UVB sunburn protection” • “highest UVB sunburn protection” The relative level of sunburn protection is determined from the SPF value: • low = SPF 2 to under 15 • medium = SPF 15 to under 30 • high = SPF 30 to 50 • highest = SPF over 50 Thus, relative descriptors (low, medium, high, and highest) describe SPF values, which are relative and not absolute levels of sunburn protection intended to help consumers determine differences in sunburn protection offered by different sunscreen products (see section III.I, comment 23 of this document). FDA considers it important that consumers be made aware of the relative level of sunburn protection provided by a product in addition to its indication for sunburn protection. Individuals may select a low, medium, high, or highest sunburn protection product to meet their specific needs. The descriptor “UVB” is included to describe the predominant rays that are screened. The phrase “helps prevent” is being deleted because it is duplicative and no longer necessary. This phrase would only lengthen the “Uses” statement. Furthermore, consumers will now be able to equate a product's UVB radiation protection rating (i.e., SPF value) directly to the relative level of sunburn protection. The second indication “higher SPF gives more sunburn protection” is no longer needed because the relative level of sunburn protection is provided in the new “Uses” statements. In addition, without clarification, the statement may encourage consumers to spend more time in the sun. Clarification is necessary because, as discussed in comment 19 of this document, surveys reveal that consumers spend more time in the sun with increasingly higher SPF sunscreen products (Refs. 14, 15, and 16). Therefore, FDA is not allowing this statement in the “Uses” section. However, under proposed § 352.52(e)(2), FDA is proposing the following optional statement under “Other information” or anywhere outside of the “Drug Facts” box or enclosure: “higher SPF products give more sun protection, but are not intended to extend the time spent in the sun.” The phrase “but are not intended to extend the time spent in the sun” is additional information not included in the FM indication. FDA believes this revised indication statement will discourage consumers from spending more time in the sun when using a higher SPF product. FDA is proposing additional revisions in “Uses” in § 352.52(b)(1) to include UVA claims and other information (see section III.G, comments 17 and 18 of this document). The proposed revisions will help consumers to more fully understand the uses and expected results for individual sunscreen products. These changes are necessary because the PDP for a sunscreen product will now include two performance ratings (see section III.E, comment 14 of this document): • The well-accepted SPF value and new descriptor rating for UVB radiation protection, and • A new star/descriptor rating for UVA radiation protection. Consequently, FDA considers it important that the “Uses” statements in the “Drug Facts” box accurately reflect product claims related to specific indications, UVA and UVB radiation, and the level of anticipated protection (low, medium, high, or highest) determined by the UVA and UVB product ratings. As with the introduction of SPF labeling years ago, it will take the combined efforts of government, manufacturers, consumer organizations, and the health care community to educate consumers to fully understand these labeling initiatives to enhance their safe and effective use of sunscreen products. (Comment 17) One comment stated that FDA's “sun alert” statement in the FM recognized that sun-induced skin damage can contribute to photoaging and increase the risk of skin cancer. This statement reads: “Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.” The comment urged FDA to allow other truthful use statements, such as the following: • “helps protect against skin damage caused by the sun” • “helps protect against skin aging caused by the sun” • “regular use helps protect against certain forms of skin cancer caused by the sun” • “helps protect against fine lines and wrinkles caused by the sun” • “helps protect against pigmentary changes due to sun exposure” Another comment urged FDA to include the first three use statements suggested by the first comment, as well as “helps protect against the harmful effects of the sun” and “helps protect against (select one: ‘casual,’ ‘incidental,’ ‘intermittent,’ or ‘daily’) sun exposure.” The comment contended that, when used effectively as part of a sun protection program, sunscreens may prevent very serious disease conditions. Another comment provided citations from the medical literature to support its contention that claims of sunscreens preventing skin cancer induction may be false, deceptive, misleading, and unsubstantiated. The comment mentioned an article by Garland (Ref. 25) that states the following: “No epidemiological studies were identified that showed a protective effect of use of chemical sunscreen on risk of melanoma or other cutaneous malignancies in humans.” The comment also mentioned an article by Gasparro (Ref. 24) that states the following: “Although some have promoted daily use (of sunscreen) for the prevention of premature aging of the skin and the prevention of skin cancer, actual data are lacking to support these recommendations.” FDA has reviewed the submitted articles concerning UV-induced skin damage (i.e., premature aging and cancer) along with articles obtained from a search of the scientific literature (Refs. 26 through 34). Many of the articles involved preclinical data, which can be difficult to extrapolate to consumer (human) actual use conditions. FDA believes that the articles with clinical data provide more meaningful results, as they can be easily extrapolated to consumer actual use conditions. Therefore, FDA is focusing discussion in this document on the clinical studies. In agreement with Garland (Ref. 25) and Gasparro (Ref. 24), FDA does not believe, as a whole, that the studies demonstrate that sunscreens alone help prevent skin aging or skin cancer. Some of the clinical studies examined the role of UVB and UVA radiation in producing histological changes indicative of skin aging due to the sun. Lowe et al. demonstrated that high doses of UVA radiation (320 to 400 nm) increased melanization of human skin more than lower doses of UVA or solar simulating UV radiation at 290 to 400 nm (Ref. 26). Seite et al. demonstrated that melanization of human skin increased with exposure to UVB/UVA radiation at 290 to 400 nm (Ref. 32) and UVA radiation at 330 to 440 nm (Ref. 27). Seite et al. also showed that human skin hydration decreased after chronic exposure to UV radiation at the wavelengths studied. Five studies revealed stratum corneum thickening produced by both UVB and UVA radiation (Refs. 26 through 29 and 32). Stratum granulosum thickening was transiently induced after 6 weeks of exposure to UV radiation (UVB/UVA) at 290 to 400 nm (Ref. 32). The same effects were seen with solar simulated radiation and high and low doses of UVA radiation after 12 weeks of exposure (Ref. 26). Viable epidermal thickening was seen after 6 weeks of exposure to UV radiation at 290 to 400 nm in one study (Ref. 32) and after 9 days of exposure to UVA radiation at 335 to 345 nm in another study (Ref. 31). Inflammation and lysozyme deposition along the dermal elastic fibers were increased more in human skin exposed to UVA than UVB radiation (Refs. 26, 28, 29, and 31). Sunburn cell appearance, a typical response to UVB radiation, was also found to be present after exposure to different UVA radiation regimens in two studies (Refs. 28 and 31) but not found in a third study (Ref. 27). Thus, FDA concludes that these studies demonstrated that both UVB and UVA radiation induce histological changes associated with skin aging. Four of these studies focused on the histological changes within the skin induced by UVB and UVA radiation and explored the ability of sunscreens to protect human skin against these changes (Refs. 29, 30, 32, and 33). The first study suggested that an SPF 29 sunscreen prevented the development of solar elastosis, a condition in which skin loses its elasticity after chronic exposure to the sun (Ref. 33). However, these method and data analyses raise questions about the validity of the reported conclusion: • Discrepancies were noted concerning demographic characteristics of subjects, sunscreen application, and compliance rates. • Skin biopsy data at all three time points in the study were available from only 10 of the 35 subjects. • The only statistically significant difference between the sunscreen and placebo treatment groups was achieved in a computerized evaluation of solar elastosis at baseline and 24 months. The second study demonstrated significant contribution of a sunscreen in preventing UV radiation-induced skin damage (Ref. 32). The use of sunscreens with absorption spectra covering the 290 to 400 nm range prevented all of the effects of chronic exposure (6 weeks) to UV radiation evaluated in the study. The third study showed a photoprotective effect of an SPF 15 sunscreen product from damage induced by short term exposure to UVB radiation (Ref. 30). The fourth study showed that a UVB only sunscreen did not provide protection against chronic exposure to UVA radiation (Ref. 29). The studies provide evidence that both UVB and UVA radiation induce histological changes in the skin consistent with skin aging. Thus, the studies support the conclusion that exposure to UV rays increases the risk of premature skin aging. However, the study data fails to show that sunscreen use alone helps prevent premature skin aging for several reasons. First, the studies have not completely defined the action spectrum for the majority of UV radiation-induced effects on human skin. While studies demonstrate that a given histological change, such as thickening of the stratum corneum, is induced by certain wavelengths within the UVB and UVA region, studies have not examined the ability of the remaining UVB and UVA regions outside of these wavelengths to induce the same change. For example, studies may have shown that 290 nm to 310 nm and 360 nm to 400 nm radiation induce stratum corneum thickening, but it is not known whether 311 nm to 359 nm radiation induces the same histological change. Second, the inability to identify the exact UVB and UVA wavelengths that induce each histological change in the skin derives from the study designs. Each study differed in the following parameters: • UV radiation wavelengths, • UV exposure regimens, • Sunscreen doses, • Sunscreen application techniques, and • Endpoints. Therefore, FDA cannot combine all of the data from these studies to define a complete action spectrum for each histological change in the skin. Furthermore, the action spectrum for each histological change would need to be combined to define a single action spectrum for skin aging, which is a cumulation of these histological changes. Without knowing which UVB and UVA wavelengths induce each histological change in the skin, FDA is unable to determine which wavelengths are most important in causing skin aging and cannot determine the action spectrum for aging. Third, the studies did not examine the chronic, long-term consequences of UV radiation exposure in human skin. Thus, it is not possible for FDA to extrapolate the data to longer time points at which the short-term histological changes may cumulate to produce visible signs of skin aging. Fourth, although the studies that examined the ability of sunscreens to protect against UV radiation-induced histological changes in the skin provide useful data, it is difficult for FDA to conclude that sunscreens alone help prevent skin aging based on these studies. The number of participants in each study was relatively small, with only 10 to 35 subjects per study. Different sunscreen formulations, with differing absorption spectra, were used in each study. As explained previously, these studies do not identify exactly which UVB and UVA wavelengths contribute the most to skin aging (i.e., the studies do not define the skin aging action spectrum). For all of these reasons, the studies do not prove that sunscreens alone help prevent premature skin aging. Likewise, FDA is not aware of data demonstrating that sunscreens alone help prevent skin cancer. It has been known for many years that UV radiation increases the risk of skin cancer. It has also been known for many years that a higher incidence of sunburn earlier in life corresponds to a higher incidence of skin cancer later in life. However, FDA is not aware of any studies demonstrating that the use of sunscreens alone decreases the risk of skin cancer. Like skin aging, there are studies examining the effects of sunscreens on short-term factors for skin cancer, such as sunburn and other cellular damage. However, it is difficult to extrapolate these short-term adverse effects of UV radiation to a long-term, chronic effect such as skin cancer. In addition, like skin aging, the complete action spectrum for skin cancer is not known at this time. Unlike skin cancer and premature skin aging, FDA has evidence that sunscreens alone help prevent sunburn. The SPF test measures the effectiveness of sunscreens with sunburn (erythema) as the endpoint. Thus, the impact of sunscreens on sunburn can be measured directly. In contrast, it is difficult to measure directly the impact of sunscreens on skin cancer or premature skin aging because these are long-term, cumulative adverse effects of UV exposure. Thus, for all of the reasons discussed in this comment, FDA concludes that the available evidence fails to show that sunscreens alone help prevent skin cancer or premature skin aging. Based on this conclusion, FDA is not proposing the indication statements proposed by the first and second comments, because these claims are for protection from premature skin aging, skin cancer, and related factors (e.g., “helps protect against skin aging caused by the sun”). FDA also is not proposing claims that sunscreens protect against “casual, incidental, intermittent, or daily” sun exposure, as proposed by the second comment, because the studies do not support these claims. Furthermore, FDA considers these terms as lacking sufficient meaning to be useful to consumers. As described elsewhere in this document (see section III.G, comment 19), FDA is proposing to require a revised “sun alert” statement in the form of a new warning. The new warning statement is based on FDA's review of the available evidence concerning UV exposure and skin cancer, premature skin aging, and other skin damage. The new warning statement clarifies that UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. In addition, the new warning statement specifies that consumers should use complementary sun protection measures along with sunscreen (i.e., limit sun exposure and wear protective clothing). FDA has concluded from the available evidence that it is important to adopt a complete sun protection program (sunscreen, sun avoidance, and protective clothing) to decrease UV exposure. In fact, the second comment argued for new indication statements by considering the sunscreen use as part of such a sun protection program (i.e., in conjunction with limiting time in sun and wearing protective clothing). Thus, the second comment, along with the third comment, seemed to agree with FDA's conclusions in this proposed rule concerning the need for consumers to use sunscreens in conjunction with other sun protection measures. In addition, the reference in the new warning statement to sunscreen use combined with limiting sun exposure and wearing protective clothing is consistent with recommendations by other public health organizations. For example, the World Health Organization's International Agency for Research on Cancer

(IARC)(Ref. 21) makes the following assessments and recommendations: • There is inadequate evidence in humans for a cancer preventative effect of sunscreens against basal cell or malignant melanoma cancers. • There is only limited evidence for a preventive effect of sunscreens against squamous cell cancer. • Sunscreens should not be the first choice for skin cancer prevention or used as the sole agent for protection against UV radiation. Likewise, the CDC recommends that sunscreens be used as a complementary measure in an overall sun protection program (Ref. 35). FDA believes that additional information from controlled clinical studies is needed to better understand the role of sunscreens in preventing premature skin aging and skin cancer. Studies examining premature skin aging (using solar radiation or simulated solar radiation) are needed to determine the following in humans: • Measurable skin properties such as elasticity, collagen/elastin ratios and properties, wrinkling, pigmentation changes and visual grades, leading to accepted quantitative definitions of chronological and sun-induced skin aging; • The relationship between sunlight exposure and skin aging, stratified by skin type; • An action spectrum for photoaging of skin; • A dose response for UV radiation-induced skin aging; • Quantitative estimates of realistic “worst case,” long-term exposures to sunlight in relevant UVA and UVB radiation spectral ranges (i.e., the level of UVB and UVA protection needed); and • How UV radiation-induced processes that occur at a given wavelength affect UV radiation-induced processes that occur at other wavelengths. Similar information is needed for skin cancer, except that studies should examine the different types of skin cancer, rather than examining different skin properties. In addition, IARC has provided recommendations for research on skin cancer prevention and sunscreens. These recommendations can also be used as a guide in designing studies to examine the role of sunscreens in preventing premature skin aging due to the sun (Ref. 21). FDA encourages interested parties to submit study protocols to FDA for review to ensure that studies are as informative as possible. FDA also invites comments by interested parties on the feasibility and validity of surrogate endpoints for studies to determine whether the use of sunscreens alone help prevent skin cancer, premature skin aging, or other skin damage. (Comment 18) As discussed in section III.E of this document, FDA received several comments discussing ways to categorize, phrase, and display UVA/UVB radiation protection on an OTC sunscreen drug product label. In the amendment to include avobenzone in the monograph (61 FR 48645 at 48655), FDA proposed the following indications for UVB and UVA radiation protection by sunscreen drug products containing avobenzone: 1. “Broad spectrum sunscreen”; 2. “Provides” (select one of the following: “UVB and UVA,” or “broad spectrum”) “protection”; 3. “Protects from UVB and UVA” (select one of the following: “Rays” or “radiation”); 4. (Select one of the following: “Absorbs,” “Protects,” “Screens,” or “Shields”) “throughout the UVA spectrum”; and 5. “Provides protection from the UVA rays that may contribute to skin damage and premature aging of the skin”. Likewise, in the amendment to include zinc oxide in the monograph (63 FR 56584 at 56588), FDA proposed similar labeling for UVA and UVB radiation protection for products containing zinc oxide (substituting the word “within” for the word “throughout” in the fourth statement). FDA did not include these indications in the FM but has allowed their use until the UVA portion of the monograph is established. FDA has reconsidered these UVA protection indications. FDA is proposing to allow all of them except the fifth statement. In proposed § 352.52(e), the first four statements are optional statements allowed for products that demonstrate UVA protection according to the proposed testing (see section III.N, comment 45 of this document). The statements can only be included in labeling outside of the “Drug Facts” box. Within the “Drug Facts” box, FDA is proposing one of the following UVA indication statements, depending on the level of UVA protection provided by a product: • “low UVA protection” • “medium UVA protection” • “high UVA protection” • “highest UVA protection” The level of protection (i.e., low, medium, high, or highest) is determined from the UVA rating obtained from product testing (see section III.N, comment 45 of this document). Manufacturers who wish to combine the “Uses” statements about UVA protection and UVB sunburn protection may do so if the descriptors (i.e., levels of protection) are the same. For example, if the levels of UVA and UVB protection are medium, the “Use” may read: “medium UVA/UVB sunburn protection”. FDA is not including the fifth indication because FDA does not consider “skin aging” or “skin damage” claims adequately supported at this time. As discussed elsewhere in this document (see section III.G, comment 19), FDA is proposing a statement in the “Drug Facts” box that informs consumers that sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects from the sun when used in a regular program that relies upon limiting sun exposure and wearing protective clothing. Therefore, FDA believes the fifth indication statement would mislead consumers by not discussing sun exposure and protective clothing. (Comment 19) As discussed in section III.G of this document, FDA received several comments concerning the “sun” alert statement. In § 352.52(e)(2) of the FM, FDA included the optional statement: “Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.” This statement's emphasis of the need for a comprehensive sun protection program (64 FR 27666 at 27679) was based on the findings of numerous groups, including the following: • The American Academy of Dermatology (AAD), • The CDC, • The Australian Government; and • The New Zealand Government. These groups have recommended that sunscreens be considered an adjunct to other UV protection strategies, such as avoiding the sun near midday, seeking shade, and wearing protective clothing and hats. The FM provided that the “sun alert” appear under the heading “Other information” or anywhere outside of the “Drug Facts” box or enclosure. At that time, FDA encouraged manufacturers to voluntarily include this statement in labeling, make it available at the point of purchase, and/or make it available through consumer education programs. FDA is now proposing a revised “sun alert” statement be required in the “Warnings” section of the “Drug Facts” box. FDA is proposing the statement to read as follows: “UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen. FDA is proposing that the statement appear in bold type as the first statement in the “Warnings” section. FDA believes the statement is most appropriate in the “Warnings” section because it warns consumers that effective protection from the sun does not involve only the application of sunscreens, as many consumers believe. In addition, it warns consumers that UV radiation not only increases the risk of sunburn but also increases the risk of skin cancer and premature skin aging, which many consumers may not know. FDA believes the new warning will encourage consumers to use sunscreen, limit time in the sun, and wear protective clothing to reduce UV exposure. Because of the importance of warning statements and the need for consumers to receive a uniform message concerning such warnings, no variations in wording are allowed under § 330.1(c)(2). FDA acknowledges that the new warning statement differs from the wording of the voluntary “sun alert” in the FM. These differences are based on FDA's assessment of the additional evidence available since publication of the FM in 1999. As explained in comment 17 of this document, FDA does not believe that the available data support a claim concerning the use of sunscreen and a reduction in the risk of premature skin aging and skin cancer. The revised wording of the statement more accurately reflects the scientific conclusions that can be drawn from this evidence. FDA is proposing the warning because we continue to be concerned about adequate consumer understanding of a sun protection program that includes sun avoidance and wearing protective clothes along with sunscreen use. This proposed rule provides for even higher SPF values and a new rating system for UVA protection. Consumers may believe that sunscreens with higher SPF values (especially with UVA protection) provide complete UV radiation protection. Subsequently, consumers may prolong sun exposure because they think higher SPF values equate to longer times in the sun without burning. FDA is aware of a double-blind, randomized clinical study that showed a significant increase in sun exposure time of persons using high SPF sunscreens compared to persons using low SPF sunscreens (Ref. 14). In addition, two questionnaire-based surveys showed that sun exposure time is prolonged for persons using sunscreens compared to persons not using sunscreens (Refs. 15 and 16). By educating consumers about a sun protection program, we believe requiring this new proposed warning will decrease the likelihood of consumers spending more time in the sun when using a sunscreen. The new proposed warning also informs consumers that use of sunscreens alone is not the sole measure of protection from UV exposure, even with the use of high SPF products that provide UVA protection. Although it is well established that sunscreens protect against UV radiation, the following factors affect the level of protection provided by a sunscreen for each individual: • Variations between individuals, • UV radiation absorption, • Ability of sunscreens to adhere to and be absorbed by the skin, • Exposure conditions, and • Conditions of use (e.g., inadequate application amount or reapplication frequency). Therefore, FDA agrees with the numerous groups that promote sunscreen use as part of a total sun protection program. FDA reviewed the relationship between sunscreen use and skin cancer incidence in the scientific literature and did not find confirmatory evidence that sunscreens alone protect against the development of skin cancer. The incidence of skin cancer continues to rise in the United States. The incidence of the most serious form of skin cancer, malignant melanoma, grew 6.1 percent per year during the 1970s (Refs. 14 and 36). The rate is still rising an average 2.8 percent annually, with a rate of 14.3 percent per 100,000 persons in 1997. Melanoma is one of the top 10 cancers, by incidence, for persons with white skin. The American Cancer Society

(ACS)estimated the following statistics concerning skin cancer in 2007 (Ref. 37): • More than 1 million new cases of curable basal cell and squamous cell carcinomas would be detected, • Approximately 59,940 new cases of malignant melanoma would be diagnosed, and • An estimated 8,110 persons would die from melanoma and 2,000 persons would die from other skin cancers. Skin cancer affects roughly the same number of people as all other cancers combined. In view of the continuing increase in the incidence of all types of skin cancer and the lack of data demonstrating that sunscreens alone prevent skin cancer, FDA considers the new warning important for the protection of the public health. FDA is proposing that the new warning be required on all OTC sunscreen drug products except lip cosmetic-drug and lip protectant-sunscreen products subject to § 352.52(f). FDA continues to believe that all sunscreen products should have labeling to ensure that consumers are adequately protected against overexposure to UV radiation (64 FR 27666 at 27673). Thus, sunscreen products labeled for use only on specific small areas of the face and sold in small packages (i.e., sunscreen products subject to § 352.52(f)) must include the new warning. The only sunscreen products not required to include the new warning are those lip cosmetic-drug and lip protectant-sunscreen products subject to § 352.52(f), as proposed in § 352.52(f)(1)(ii). FDA is making this proposal because lip cosmetic and lip protectant products are often sold in packages that are substantially smaller than those of other products that fall under § 352.52(f). FDA believes requiring the new warning on lip cosmetic-sunscreen and lip protectant-sunscreen products may discourage manufacturers from marketing these products because it requires a significant amount of labeling space. FDA has limited labeling requirements as much as possible for sunscreen products subject to § 352.52(f). However, FDA believes consumers are at great risk for UV-induced skin damage, including cancer, on the face. Therefore, consumers who purchase products specifically for use on the face need to be informed about the information contained in the new warning. Although these products are marketed in small package sizes, FDA has determined that the products' labeling needs to include this important information in order to protect consumers. (Comment 20) One comment stated that consumers who use color cosmetics or facial moisturizers with sunscreens make the informed decision to purchase them as an additional benefit to their cosmetic use. The comment contended that a significant number of people with dark skin types, who do not burn easily, purchase sunscreens to provide protection from the sun damage that is not immediately recognizable. For these reasons, the comment requested claims such as the following: • “helps protect against casual or incidental or intermittent daily sun exposure” • “helps protect against the harmful effects of the sun” Another comment acknowledged that facial makeups with sunscreen provide protection from sunburn, but that is not the primary reason why consumers use these products. The comment contended that requiring the “sunburn” indication would be inappropriate and misleading labeling for most facial makeups with sunscreen. The comment, instead, requested a claim such as “protects against the harmful rays of the sun.” FDA notes that the second comment acknowledged that facial makeups with sunscreen provide protection from sunburn. Not every consumer who uses color cosmetics or facial makeups with sunscreen meets the following criteria: • Has a dark skin type, or • Uses these products solely to provide protection from sun damage that is not immediately recognizable. As noted in section III.D, comment 9 of this document, many consumers use facial products with sunscreen as their primary and only source of sunscreen protection for that area of the body. As discussed in section III.G, comment 16 of this document, sunscreen products will be required to bear a claim of low, medium, high, or highest UVB sunburn protection. FDA does not consider it inappropriate or misleading for color cosmetic or facial makeup products containing sunscreens to have this sunburn protection claim of low, medium, high, or highest. Sunscreen products that provide UVA radiation protection may also bear a claim about the level of protection. In addition, all OTC sunscreen products, except lip cosmetic-drug and lip protectant-sunscreen products subject to § 352.52(f), will be required to bear the revised “sun alert” statement, which is now included in the “Warnings” section of the “Drug Facts” box. FDA considers the information in this new “Warnings” statement much more beneficial to consumers than the statements proposed by the comments. FDA rejected the terms “casual, incidental, and intermittent,” as explained in section III.G, comment 17 of this document. H. Comments on Directions for Sunscreen Drug Products (Comment 21) Several comments requested alternative directions for makeup with sunscreen products. One comment requested “apply smoothly or evenly before sun exposure and/or as needed.” The comment added that “before sun exposure” may not always be appropriate as these makeup products are not exclusively or even primarily used for protection against sun exposure. A second comment requested “apply smoothly or evenly before sun exposure and reapply as needed.” A third comment did not suggest any specific language, but requested flexibility to recognize the product's primary use as a makeup, while providing adequate information about the sunscreen component. This comment added that the direction to consult a doctor for children under 6 months of age was clearly unnecessary for facial makeup with sunscreen because these products cannot reasonably be expected to be used on children that age. FDA agrees that flexibility is appropriate for the directions for makeup with sunscreen products. Elsewhere in this document, FDA is proposing to allow labeling modifications for makeup with sunscreen products used only on specific small areas of the face and sold in small packages (see section III.D, comment 9 of this document). Those modifications include modified directions for cosmetic lip products containing sunscreen that are within the scope of proposed § 352.52(f). FDA is not extending the proposed modifications to all makeup with sunscreen products. Makeup with sunscreen products not labeled only for specific small areas of the face may be applied to a large area of the face or other areas of the body. As explained later in this comment, FDA would have concerns with the modifications being applied to these products. Whether intentional or not, makeup with sunscreen products may be the primary sunscreen for many consumers. A recent study examined sunscreen use patterns (Ref. 48). Participants were instructed to apply sunscreen every day. Of those who used sunscreen infrequently, the majority spent some time outdoors with 11 percent spending the majority of their time outdoors. These same participants explained that they did not believe sunscreen was necessary because of their planned activities. The authors cited this finding in advocating educating consumers on the need for sunscreen for frequent incidental sun exposure in addition to intentional sun exposure, such as sunbathing. For these reasons, FDA considers it important that consumers using makeup with sunscreen products not labeled for use only on specific small areas of the face recognize that these products are sunscreens and use them appropriately to maximize UV protection. Therefore, FDA is not proposing modified directions for these makeup with sunscreen products. (Comment 22) One comment requested that FDA require sunscreen manufacturers to provide accurate and appropriate instructions about how much sunscreen should be applied to the body. The comment also suggested that a warning about the dangers of sunburn from applying suboptimal amounts be included in sunscreen product labeling. A second comment stated that it was not aware of any study indicating that consumers use adequate amounts of sunscreen. The comment supplied data and other information concerning the dependency of the SPF value on the total quantity of sunscreen applied (Ref. 49). Section 352.52(d)(1) currently provides manufacturers the option to select one or more of the following application terms for a sunscreen product: “liberally, generously, smoothly, or evenly.” Manufacturers may also include optional directions that state “[bullet] reapply as needed or after towel drying, swimming, or (select one of the following: ‘sweating’ or ‘perspiring’).” In the final rule, FDA had concluded that the directions in § 352.52(d)(1) to apply “liberally” or “generously” convey the appropriate message to ensure that consumers adequately apply the sunscreen (64 FR 27666 at 27679). Several studies suggest that, in practice, consumers may apply amounts of sunscreen below the density of 2 milligrams/square centimeter (mg/cm 2 ), which is the amount of product required for the SPF determination in § 352.72(e) (proposed § 352.71(e)). These data suggest that consumers may apply as little as 0.5 to 1.0 mg/cm 2 (Refs. 50 through 54). One comment reported that, to achieve the rated protection over the whole body, a typical adult with a surface area of 1.73 square meters (m 2 ) would need to apply 35 milliliters

(mL)of sunscreen, roughly one-third of a 4 oz bottle per application (Ref. 55). Studies indicate that SPF values determined at an application rate of 1 mg/cm 2 are approximately 50 percent of those determined at 2 mg/cm 2 , and when applied at 0.65 mg/cm 2 , the SPF values are 20 to 30 percent of those determined at 2 mg/cm 2 (Refs. 49, 50, and 51). Gasparro notes that statements such as “apply liberally and frequently” are too vague to be informative (Ref. 24). FDA is concerned that, in practice, consumers may be getting less protection than the labeled SPF value and believes that further information should be included in the labeling for sunscreen drug products to reduce the likelihood of underapplication. FDA believes that this information is better communicated as revised product directions rather than a warning. FDA is, therefore, proposing to revise § 352.52(d)(1). The directions will continue to state that OTC sunscreen drug products should be applied “liberally” or “generously” because it would be cumbersome to specify quantitative amounts for all possible body areas and the various uses on the label. However, FDA is proposing to make optional the directions in § 352.52(d)(1)(i) to apply “evenly.” FDA believes that this term, if used alone, may not convey the appropriate message to ensure that consumers apply sufficient sunscreen. In addition, FDA is proposing to remove the term “smoothly” from § 352.52(d)(1)(i) because FDA considers that term to be vague and it may have different meanings to different consumers. FDA also believes this term is more likely to result in product underapplication. In addition to labeling directing consumers to apply sufficient amounts of sunscreen, FDA is also proposing to revise the labeling requirements concerning reapplication of the sunscreen product. In § 352.52(d) of the FM, the general reapplication statement “and as needed” was the only required information. FDA made specific reapplication directions in § 352.52(d)(2) of the FM optional in an effort to equalize requirements between sunscreens with and without water resistant claims (64 FR 27666 at 27681). FDA now believes that more detailed reapplication directions must be included on all OTC sunscreen products, because sunscreens may be underapplied as suggested by the comments. FDA came to this conclusion after reviewing studies concerning sunscreen reapplication as well as recommendations of public health organizations. Wright, et al. suggests that inadvertent sunburn may be due to the failure to use and reapply sunscreen appropriately (Ref. 56). Study subjects who reapplied sunscreen every 1 to 2 hours and after swimming did not report sunburn. Rigel et al. reported that, even under intense solar conditions, those reapplying an SPF 15 sunscreen every 2 hours or sooner were five times less likely to sunburn compared to those who reapplied every 2.5 or more hours (Ref. 57). The AAD (Refs. 38, 58, and 59), the ACS (Ref. 60), and the EPA (Ref. 40) recommend reapplying sunscreens every 2 hours or sooner and also recommend application to all exposed areas of the body (Refs. 60, 61, and 62). Because the frequency of application appears to be critical for proper protection, FDA is proposing to add the statement “apply and reapply as directed to avoid lowering protection.” In addition, FDA is proposing to further revise the directions in § 352.52(d) to include the following reapplication statement: “reapply at least every 2 hours.” Likewise, for those products making a water resistant claim, FDA is proposing to include the number of minutes (i.e., 40 or 80) that the product maintains its water resistance before the “swimming/sweating” term. FDA believes these additional proposed directions will alert consumers about the hazards of using insufficient amounts of sunscreen product and encourage reapplication after the appropriate time. FDA considers these specific, informative reapplication statements, instead of “and as needed,” to be necessary on all OTC sunscreen products. FDA is also proposing the optional direction “apply to all skin exposed to the sun.” FDA is proposing that this direction be optional because we believe most consumers know to apply sunscreen to all exposed skin. However, if a sunscreen product can accommodate this direction, it will serve to remind consumers that all exposed skin is susceptible to UV damage. These proposed directions, as a whole, should serve to better protect consumers, particularly those who tend to underapply sunscreen, from overexposure to the sun. Accordingly, FDA is proposing to change § 352.52(d) to read as follows:

(d)*Directions* . * * *

(1)*For products containing any ingredient in § 352.10* .

(i)The labeling states “[bullet] apply [select one of the following: ‘liberally’ or ‘generously’] [and, as an option: ‘and evenly’] [insert appropriate time interval, if a waiting period is needed] before sun exposure”.

(ii)The labeling states “[bullet] apply and reapply as directed to avoid lowering protection”.

(iii)As an option, the labeling may state “[bullet] apply to all skin exposed to the sun”.

(iv)The labeling states “[bullet] children under 6 months of age: ask a doctor”.

(2)*For products that satisfy the water resistant or very water resistant testing procedures identified in § 352.76* . The labeling states “[bullet] reapply after [select one of the following: ‘40 minutes of’ or ‘80 minutes of’ for products that satisfy either the water resistant or very water resistant test procedures in § 352.76, respectively] swimming or [select one of the following: ‘sweating’ or ‘perspiring’] and after towel drying. Otherwise, reapply at least every 2 hours”.

(3)*For products that do not satisfy the water resistant or very water resistant testing procedures identified in § 352.76* . The labeling states “[bullet] reapply at least every 2 hours and after towel drying, swimming, or [select one of the following: ‘sweating’ or ‘perspiring’]”. As discussed in the FM (64 FR 27666 at 27679), manufacturers who have data to support different reapplication directions based on specific substantiation information may submit the information for approval of those directions via an NDA deviation as provided in § 330.11 (21 CFR 330.11). I. General Comments on SPF Testing Procedure (Comment 23) One comment suggested that the SPF test incorporate an amount of product that more closely reflects the amount applied by consumers. More specifically, the comment requested that FDA replace the 2 mg/cm 2 required in § 352.72(e) (proposed § 352.70(c)(5)) to a value between 0.5 and 1.0 mg/cm 2 . The comment argued that the protection afforded during actual usage may be only one-quarter to one-half the labeled SPF value (see section III.H, comment 22 of this document). The comment also suggested that SPF could be stated using descriptive terms, such as “light,” “moderate,” or “heavy” protection, instead of a numerical value. FDA is not proposing the suggested change in test method at this time. This issue was discussed in detail in the TFM (58 FR 28194 at 28264 to 28266). The majority of comments advocated continuing the use of an application density of 2 mg/cm 2 . The current comment did not provide data demonstrating the suitability of a smaller test amount. FDA is concerned that a uniform distribution of sunscreen over the test area might be difficult using a smaller amount of sunscreen. Further, the standard application density used worldwide in the SPF test is 2 mg/cm 2 (Ref. 63). FDA agrees that SPF values do not reflect exact levels of sunburn protection that consumers receive under actual use conditions. The required SPF test is a clinical test conducted with strict control over factors such as product application density. However, under actual use conditions, these factors are not controlled and vary greatly. The actual level of sunburn protection under consumer use conditions is affected by a number of factors. Some of the key factors are • Application density, • Reapplication frequency, • Skin type (e.g., burns easily versus never burns), • Time of day during sun exposure, and • Geographical location during sun exposure. Thus, SPF values reflect relative and not absolute levels of sunburn protection. Although SPF values do not convey actual levels of sunburn protection, when comparing multiple sunscreen products, SPF values enable consumers to determine which products provide the most sunburn protection. For example, FDA believes most consumers would correctly identify an SPF 20 product as providing more sunburn protection than an SPF 10 product. Thus, lowering the sunscreen application density would not be necessary to more accurately reflect the degree of relative sunburn protection. FDA agrees that, in addition to bringing SPF values closer to representing absolute levels of protection, lowering the sunscreen application density might also reduce some of the inaccuracies and limitations encountered when testing high SPF sunscreen products. Thus, FDA invites interested parties to submit data supporting a smaller application density for SPF testing of all sunscreen dosage forms in accordance with § 352.77. However, developing a single global method and labeling would require a coordinated effort between the regulatory agencies in many countries around the world. Because FDA does not have data to validate the SPF test using a lowering sunscreen density, FDA is proposing directions that we believe will encourage consumers to apply greater densities of sunscreen (i.e., closer to 2 mg/cm 2 ) (see section III.H, comment 22 of this document). FDA does not find that there are sufficient benefits for using descriptors instead of numerical values for SPF on the PDP. Consumers are familiar with numerical SPF values from over 20 years of usage. As described in section III.G, comment 16 of this document, FDA believes that the use of descriptors in combination with numerical values on the PDP may be beneficial to consumer understanding of the level of sunburn protection provided by a product. Thus, as explained in comment 16, FDA is proposing to include a descriptive term of relative sunburn protection (i.e., low, medium, high, or highest) with the proposed sunburn protection statement in the “Uses” section and on the PDP. The intent of this dual descriptive and numerical sunburn protection measure is to allow consumers to more easily differentiate the level of sunburn protection provided by different sunscreen products. In addition, this proposed labeling for sunburn protection is similar to the proposed UVA protection labeling (see section III.G, comment 14 of this document). FDA is also aware of sunscreen drug products marketed in dosage forms that may not be addressed by current SPF testing procedures. The SPF testing procedure described in § 352.72 (proposed § 352.70) references oils, lotions, creams, gels, butters, pastes, and ointments. FDA invites interested parties to submit SPF testing modifications for new dosage forms (e.g., mousses, foams, and towelettes) in accordance with § 352.77. (Comment 24) One comment recommended a pass/fail (binomial) test to determine SPF values (Ref. 49). The test would demonstrate that subjects have no reaction to a quantity of UV energy equivalent to an expected SPF value (for products passing the test). For example, subjects being tested with a product with an expected SPF value of 30 would be dosed only at the SPF 30 level, and the product would either pass or fail. A product passing this test would actually have an SPF value of 30 or over, whereas a product failing this test would have an SPF value below 30. The comment argued that while the monograph SPF test is probably adequate for products with low SPF values, it is not adequate for testing high SPF products because differences in solar simulators can provide as much as a 200 percent variation in results depending on the formulation. The comment further argued that an impossibly high number of subjects would be required for the current SPF method to obtain a 95 percent confidence level and that the test exposes subjects to a potentially dangerous condition, sunburn. According to the comment, the average MED for each skin type can be predicted from existing solar simulator calibration data. During the pass/fail test, each test subject is screened for skin type and then given a first day range of energy that does not exceed the expected MED. The comment proposed using a panel of five subjects. Using the MED information obtained on the first day, each subject is given four UV radiation exposures corresponding to the expected SPF value. Each subsite is then evaluated for erythema. If six or more of the 20 subsites show perceptible erythema, the product fails, as there would be less than a 95 percent probability the actual SPF value was higher than the expected SPF value. If less than six subsites show perceptible erythema, the product passes, as there would be greater than a 95 percent probability that the actual SPF value was more than the expected SPF value. The comment proposed the following: **Table 2.—Probability Table** No. of subjects Maximum no. of failures Probability 1 (n=4) 0 0.0625 1 2 (n=8) 2 0.0352 3 (n=12) 3 0.0200 4 (n=16) 5 0.0383 5 (n=20) 5 0.0207 1 n is not sufficient to make a 95 percent prediction The comment further proposed that if all eight subsites of the first two subjects pass, then the product passes and the remaining three subjects would not be evaluated. The probability of this happening would be 1/256 unless the product is over the expected SPF value. FDA agrees that, currently, there may not be enough experience and test data for products with SPF values of 30 and over on which to determine the sample size needed to obtain an acceptable 95 percent confidence interval. As discussed in section III.L, comment 37 of this document, to account for increased variability in SPF values for sunscreens with SPF values over 30, FDA proposes to increase the sample size to at least 25 subjects. Therefore, the comment may be correct in arguing that large numbers of subjects may be required for testing products with high SPF values. FDA believes that the pass/fail test has merit and could provide a reasonable substitute for the current SPF method for products with expected SPF value of 30 or higher. However, before the method can be accepted, method validation data are required that demonstrate the method can be performed satisfactorily by multiple laboratories using the same sunscreen formulation(s). FDA invites such data. If the pass/fail method is accepted, FDA may stipulate that the method be used only for products with SPF values of 30 and higher because of the large number of subjects that would be required for high SPF products under the current test method. A pass/fail method would require fewer test subjects. Low SPF products can be adequately tested under the current method without large numbers of subjects. In addition, FDA would likely require that all 20 subsites be evaluated even if the first 2 subjects pass. Further, using standard probability computer software, FDA calculates that the values for the maximum number of failures in table 2 of this document for subjects one through five should be 0, 1, 2, 4, and 5, respectively, rather than the values provided by the comment. FDA would also consider three modifications to the method described by the comment and invites comment. First, each subject may have test successes and failures due to multiple subsites on each subject. Statistically, these will not be independent observations, which is a condition needed for a binomial probability calculation. Therefore, FDA is considering that a test panel should consist of 20 to 25 subjects and that only one site be tested on each subject. A pass/fail determination would be made for each individual. Second, as an alternate, a double sampling plan based on Taylor's *Guide to Acceptance Sampling* may replace the five-layered plan proposed by the comment (Ref. 64). With the double sampling plan, two subjects are tested simultaneously with up to a maximum of four subjects, each having four subsites tested. If no more than one of the first eight subsites has perceptible erythema, the product passes. If three to eight subsites have perceptible erythema, the product fails. If exactly two of the eight subsites have perceptible erythema, then the second group of two subjects is tested. If two to four subsites from four subjects have perceptible erythema, the product passes. Otherwise, the product fails. According to this scheme, if probability p = 0.10 that the product tested would produce any recognizable erythema, then the probability = 0.95 that the product will pass. If probability p = 0.5 that the product tested would produce any recognizable erythema, then the probability = 0.05 that the product will pass. Third, an alternative to the probability calculation is a margin of error approach. With this method, a margin of error for the expected SPF value is defined before testing. The margin of error is used to determine the tolerability interval around the expected SPF value. The 90 percent confidence interval for the product's test result (one result per subject) must fall within the tolerability interval to be labeled with that SPF value. For example, if a 10 percent margin of error is claimed for a product with an expected SPF value of 40, then the tolerability interval would be 40 ± 4, or 36 to 44. If the related 90 percent confidence interval is from 37 to 43, an SPF value of 40 is assigned to the product. If the related 90 percent confidence interval is from 35 to 45, an SPF value of 40 could not be assigned to the product and the product may be retested at an expected SPF of 30. FDA invites discussion of these suggested modifications to the comment's pass/fail method for testing sunscreen drug products having an SPF value of 30 or higher. (Comment 25) One comment described an in vitro method it developed for simultaneously predicting SPF and assessing photostability. The method utilizes a 150 watt xenon arc lamp to irradiate sunscreen applied at a level of 1 to 2 mg/cm 2 to a flat collagen membrane substrate placed in the opening of an integrating sphere attached to a spectroradiometer. The spectral irradiance of the source and the spectral irradiance of the substrate alone are measured from 290 to 400 nm, at 1 nm intervals. The spectral irradiance transmitted by the sunscreen/substrate combination is measured at 1 minute intervals until the total erythemal-effective dose transmitted by the sunscreen exceeds 1 MED, where 1 MED equals 0.02 erythema-effective Joules (J)/cm 2 . Each 1 minute interval represents two to three MEDs. The time course of the sunscreen's SPF is then computed (Ref. 65). This information reveals the photostability of a sunscreen. If a sunscreen is photostable, it will not decompose when exposed to UV radiation, and the SPF will not change with increasing UV exposure. If a sunscreen is not photostable, it will decompose when exposed to UV radiation, and the SPF will decrease with increasing UV exposure. Another comment asked FDA to consider replacing the human SPF test with equivalent in vitro technology and chemical engineering, but did not suggest a suitable method. FDA does not agree that an in vitro method is adequate to replace the in vivo SPF test. In vitro tests are generally inadequate as the sole measure of SPF because substrates cannot mimic sweating, skin absorption, or certain interactions with skin that influence SPF. Some sunscreen ingredients do not behave similarly in vitro and in vivo. At this time, the comment's method has not been validated, and the chosen substrate has not been demonstrated to possess penetration characteristics and surface chemistry similar to human skin. The described in vitro method does have potential utility for measuring photostability of a sunscreen product. Measuring the erythemal-effective dose transmitted through the sunscreen in vitro over time seems like a reasonable approach. However, portions of the method require further exploration. Items such as the cut-off to define photostability need further explanation and validation. It should also be pointed out that the current SPF test method does not directly measure photostability, but it accounts for photostability. More specifically, the SPF value is determined after a sunscreen is exposed to UV radiation, so the SPF represents UVB protection provided by whatever fraction of the sunscreen has not decomposed. FDA agrees that in vitro tests are generally rapid and less expensive than in vivo tests and, for SPF measurements, would reduce exposure of human subjects to UV radiation. FDA is willing to consider alternate methods for SPF testing if they are adequately supported with data and are shown to be equivalent to established in vivo methods by collaborative studies. If the methods are equivalent, then the same SPF values should be determined for each sunscreen tested according to the SPF method and the alternate method. The comments have not provided data from such studies. Therefore, FDA is not proposing to include the described in vitro method in the monograph at this time. (Comment 26) Several comments urged FDA to revise § 352.72(h) and reinstate the requirement for determining MED at 16 to 24 hours after exposure, rather than 22 to 24 hours. The comments submitted data showing that, for an SPF 30 product and for the 8 percent homosalate standard, determining the MED at 16 or 24 hours does not result in any clinical or statistical difference in the SPF (Refs. 66 and 67). Comments argued that immediate pigmentation fades rapidly and does not interfere with MED readings. One comment further argued that the 16 to 24 hour time is universally accepted by the European Union, Australia, and Japan and FDA should adopt this time in the interest of international harmonization. The Panel recommended that the MED be evaluated 16 to 24 hours after exposure (43 FR 38206 at 38262). FDA proposed a post exposure time of 22 to 24 hours based upon information provided by comments to the Panel's report that immediate pigmentation may persist with higher doses of UV radiation up to 24 hours or, in some cases, for 36 to 48 hours after prolonged exposure (58 FR 28194 at 28268 to 28269). Comments had indicated that immediate pigmentation might interfere with an investigator's perception of minimally perceptible erythema. FDA agrees that these new data show no significant difference in MED readings at 16 and 24 hours. Thus, FDA is proposing to revise the MED determination time in §§ 352.72(h) and 352.73(c) (proposed §§ 352.70(c)(8) and 352.70(d)(3), respectively) from “22 to 24 hours” to “16 to 24 hours.” J. Comments on the Sunscreen Standard for SPF Testing Procedure (Comment 27) Several comments suggested that standard controls with SPF values of 15 or higher be developed to test high SPF sunscreen products. One comment stated that such standards would improve test accuracy and provide a consistent and adequate benchmark for compliance. One comment mentioned use of a control SPF 15 formula routinely in SPF evaluation and considered it a more valuable control than the 8-percent homosalate SPF 4 standard. Another comment supplied “round-robin,” collaborative SPF testing data from 7 laboratories on a total of 153 subjects with 2 potential SPF 15 sunscreen standard preparations, “Formulation A” on 147 subjects and “Formulation B” on 146 subjects (Refs. 13, 68, and 69). The comment concluded that differences between the two preparations were not significant (p=0.653) but “Formulation B” was preferred due to its less complex formula and slightly more consistent results. The comment added that the data showed that different laboratories can obtain valid, reproducible results when testing high SPF sunscreens. Another comment stated that it provided test results on 20 subjects using an SPF 25 product as the control (Ref. 70). Three comments suggested that the European Cosmetic, Toiletry, and Perfumery Association (COLIPA) “European low SPF Standard Code Number COL492/1 (formerly the DIN standard)” be included in the OTC sunscreen drug product monograph as a permissible standard sunscreen preparation, in addition to the 8-percent homosalate standard, and that either standard should be allowed in the SPF testing procedures. The comments contended that this approach will serve to permit international marketing and eliminate duplicative testing. Another comment asked FDA to adopt the JCIA SPF 15 “P3” standard, but did not provide supporting data. The comment concerning the SPF 25 control provided data from comparative tests on 20 subjects, using the 8-percent homosalate standard, an SPF 15 sunscreen drug product, and an SPF 25 sunscreen drug product (Ref. 70). FDA finds that this study is inadequate to support the comment's request because the study did not do the following: • Include sufficient numbers of subjects, • Address suitability of the standard across different laboratories, and • Document some properties required in a sunscreen standard to test high SPF sunscreen products. The following properties of a sunscreen standard were not addressed but need to be addressed: • Low level of interlaboratory variation, • Sensitivity to experimental error, and • Ease of preparation with a reasonable degree of accuracy. These data are also needed for the JCIA standard. Although comments provided data on 20 subjects in each of 4 laboratories using the COLIPA COL492/1 standard, FDA is not proposing to include this standard as an alternate to the 8-percent homosalate standard because we do not believe that using the COL492/1 standard will make the monograph method comparable to the European method, as other differences exist between the two methods. For example, the monograph method requires 20 evaluable subjects, while the European method requires only 10 evaluable subjects. Therefore, the COL492/1 standard is a valid standard under the European method but may not be a valid standard under the monograph method. Finally, FDA finds that the 8-percent homosalate standard is a suitable control for testing sunscreen drug products with SPF 15 or below (see section III.J, comment 28 of this document). FDA agrees with the comment that the submitted collaborative data from seven laboratories support “Formulation B” as an appropriate SPF 15 sunscreen standard. The mean SPF for “Formulation B” was 16.3 in 146 subjects tested, with 1.7 percent standard error of the mean, and laboratory means ranging from SPF 15.6 to 18.5. Therefore, FDA is proposing to include the “Formulation B” SPF 15 standard in the FM to be used for sunscreen drug products with an SPF value over 15 (optional for SPF values of 2 to 15). (Comment 28) One comment noted that there are two recognized standard control formulations: 1. An 8-percent homosalate preparation with an SPF value of 4 (§ 352.70(b) of the FM), and 2. Formulation B (padimate O/oxybenzone) with an SPF value of 15. The comment stated that the function of the standard formulation is quality assurance for method control and not as a calibration standard to bracket specific SPF ranges. The comment claimed that the 8-percent homosalate SPF 4 standard is appropriate to test products at any SPF level and that the choice of whether to use the SPF 4 or SPF 15 control formulation should rest with the manufacturer. Several other comments agreed with this comment. Another comment provided data using the 8-percent homosalate standard to test product formulations with estimated SPF values of 15, 30, and 45 on 20 subjects (Ref. 67). The comment concluded that the data showed testing procedures in the FM can differentiate high SPF sunscreens using the homosalate SPF 4 standard. The comment requested that the homosalate SPF 4 standard be allowed to be used for products with an SPF value over or below 15. FDA does not consider the data adequate to support the suggestion that the 8-percent homosalate standard currently used to evaluate sunscreen drug products with SPF values up to 15 is equally applicable to products with SPF values over 15 (Ref. 67). The study had the following deficiencies: • Did not include sufficient numbers of subjects, • Did not address suitability of the standard across different laboratories, and • Did not document certain properties required in a sunscreen standard to test high SPF sunscreen products. The following sunscreen standard properties were not addressed but need to be addressed: • Low level of interlaboratory variation, and • Sensitivity to experimental error. FDA agrees that the two standards are method controls rather than calibration tools. As such, the standard used should approximate the expected SPF of the product being tested to better verify that all aspects of the testing method are performing properly at the expected SPF level. Using the SPF 4 standard to measure SPF values over 15 is more likely to produce erroneous results than using a standard with an SPF of 15. In measuring SPF values over 15, much higher light energies (J/cm 2 ) are used in comparison to measuring SPF values below 15. Problems in the accurate quantitation of high light intensities may not be detected if the SPF 4 standard is used for SPF values over 15. While the SPF 4 standard may give acceptable results for products with SPF values over 15 in some studies, the extrapolation of these results to approximately 4 to 13 fold higher light energies used to test products with SPF values over 15 may be erroneous in other studies. Better assurance of an accurate SPF value is obtained by using a standard that is closer in SPF value to the sunscreen product being tested. The use of an SPF 15 standard would be reasonable to test products with SPF values below 15. SPF 15 is in the middle (geometrically) of the 4 to 50 range. The ratio of SPF 15 to SPF 4 is 3.75, and the ratio of SPF 50 to SPF 15 is 3.33. Thus, there would be equal coverage of all ranges. Therefore, FDA is proposing that Formulation B may be used to test sunscreen drug products with SPF 2 and over, and is required for testing sunscreen drug products with SPF over 15 (proposed § 352.70(a)(1)(ii)). The 8-percent homosalate standard may be used for testing sunscreen drug products with SPF of 2 to 15. (Comment 29) Several comments suggested that a modern, HPLC method is superior to the older spectrophotometric assay in § 352.70(c) of the FM. One comment provided technical information about the HPLC method and stated that it is now commonly used by analytical laboratories to assay sunscreen formulations (Ref. 71). Although this HPLC assay method was used in the study of two SPF 15 sunscreen standard preparations (see section III.J, comment 27 of this document), one comment noted that there are limited data on this method with the SPF 15 control formulation because FDA has not yet published this formula as an accepted standard. FDA agrees that an HPLC method is superior to the spectrophotometric method, which was originally published by FDA in 1978, in specificity and precision. Validation data provided by the comment documented the following: • Specificity, • Accuracy, • Limit of detection, • Linearity, • Precision, and • Reproducibility of the method. The validation data included chromatograms and demonstrated that the HPLC method is suitable for both the SPF 4 and SPF 15 standards. Further, FDA validated the method in its laboratories and concludes that the method is acceptable for quality control and regulatory purposes (Ref. 72). Finally, the spectrophotometric method has not been validated for the SPF 15 standard, and the HPLC method has been validated for both the SPF 4 and SPF 15 standards. Therefore, FDA is proposing to revise § 352.70 to replace the outdated spectrophotometric method with the HPLC method and to use the HPLC method to assay both the SPF 4 and SPF 15 standards. (Comment 30) Two comments disagreed with the requirement in § 352.70(a) for concomitant use of a standard sunscreen for each SPF test. One comment suggested that a standard could be run twice yearly. Another comment suggested that data to evaluate proper laboratory test procedures could be obtained from panels of a standard run as part of “the ongoing laboratory operation.” A third comment stated that a standard preparation should be run each time an SPF determination is made. FDA discussed this issue in comment 78 of the TFM (58 FR 28194 at 28253 to 28254). FDA disagreed with one comment that the standard could be run once or twice a year and reaffirmed the Panel's recommendation that concomitant testing is necessary in SPF determinations to ensure uniform evaluation of OTC sunscreen drug products and to serve as an internal indicator of experimental errors. The comments requesting a change did not provide any supporting data. In the absence of supporting data, FDA is not persuaded to change the concomitant use requirement in § 352.70(a). (Comment 31) One comment suggested that there is a need for a specific source to maintain and supply sunscreen standards. The comment contended that a few testing laboratories are reporting differences in the tested SPF of the 8-percent homosalate standard preparation depending on whether the standard is prepared by the laboratory or purchased from one company that manufactured this standard. The comment stated that either the testing procedures or the standard itself have changed since the original formula was published (earlier standard SPF values were 3.7/3.8 to 4.2/4.3 with an average of 4.1, while current values are 4.3 to 4.9/5.0). Data supporting the reliability and wide acceptance of the 8-percent homosalate standard preparation were previously discussed in the TFM (58 FR 28194 at 28250 through 28252). The comment did not provide any data to support its contention concerning discrepancies in the SPF of 8-percent homosalate standard preparations and FDA is not aware of any new data that support the need for a specific source to maintain and supply this standard. The standard is a control to validate the testing procedure, equipment, and facilities rather than a calibration tool for setting SPF values of sunscreen products. FDA considers the parameters established in § 352.70 of the FM adequate to assure a uniform standard and is not requiring that a specific source maintain and supply the sunscreen standard at this time. K. Comments on Artificial Light Sources for SPF Testing Procedure (Comment 32) Several comments suggested that FDA replace the specifications in § 352.71 that state “sun at a zenith angle of 10°” and “less than 1 percent of its total energy output contributed by nonsolar wavelengths shorter than 290 nm” with the COLIPA table of “percent erythemal contribution” as the spectral power distribution standard for the light source used in the SPF test procedures (Ref. 73). The comments suggested that the spectra of currently used solar simulators (especially around 290 nm and above 350 nm) could cause overestimation of SPF values for high SPF sunscreens. Because shorter wavelengths can make a very large contribution to erythema, the comments stated that small errors in the 290 nm region of solar simulator spectra could have considerable effects. The comments noted that spectral power deficiencies above 350 nm may give artificially high SPF values for sunscreen drug products that absorb poorly in the long wavelength UVA region. The comments added that there is general agreement in the industry that § 352.71 should be revised to permit compliance with the COLIPA standard for solar simulators. The comments further recommended one modification to the COLIPA standard: The energy for wavelengths below 290 nm should be limited to “less than 0.1 percent” rather than “less than 1.0 percent,” as stated in the COLIPA standard. The comments stated that a more restrictive specification of “0.01 percent,” as mentioned by FDA (65 FR 36319 at 36321), would result more in testing the limits of the measurement spectroradiometer rather than the true output of the solar simulator. One comment that supported the COLIPA standard subsequently suggested that the spectral limits be further narrowed to prevent excessive variability of SPF values for certain sunscreen products (Ref. 74). One comment discussed the calculations to obtain the source spectral specification according to COLIPA (Ref. 73). In the COLIPA table, the source spectral specification is described in terms of cumulative erythemal effectiveness by successive wavebands. The erythemal effectiveness of each waveband is expressed as a percentage of the total erythemal effectiveness from 250 nm to 400 nm, or as the Percentage Relative Cumulative Erythemal Effectiveness (%RCEE). According to the COLIPA specifications and consistent with § 352.71, wavelengths below 290 nm should be excluded from any source by appropriate filters. Likewise, wavelengths above 400 nm should be limited as much as possible and are not included in the calculation of %RCEE. Because RCEE values are calculated as relative percentages, measuring the spectral irradiance in absolute energy units is not necessary. Relative units are sufficient. The spectral irradiance of the source is multiplied by the Commission International de L'Eclairage

(1998)standard skin erythemal action spectrum to obtain the erythemal effectiveness of the source. The spectral erythemal effectiveness values of the source spectrum are then integrated from 250 nm to the various successive reference wavelength values shown in the COLIPA table in order to produce the cumulative erythemal effectiveness for each spectral waveband, and the total erythemal effectiveness is calculated up to 400 nm. Finally, the %RCEE is calculated at the reference waveband as the percentage ratio of the cumulative erythemal effectiveness in each of these wavebands to the total integrated value from 250 nm to 400 nm. Based on these calculations, the COLIPA table includes limits up to 400 nm. In contrast, when FDA requested comments on this issue, we included a modified COLIPA table that includes limits up to 350 nm (65 FR 36319 at 36321). However, the modified COLIPA table published by FDA was erroneous. FDA agrees with the comment (and COLIPA) that it is necessary to include all UV erythemal wavelengths (i.e., up to 400 nm) when standardizing solar simulator output. As argued by the comment, the erythemal contribution from long-wavelength UVA radiation (i.e., 350 nm to 400 nm) can become important when a high SPF product is tested. However, FDA believes that the limits for the 290 to 350 waveband should be changed from 93.5 to 99.0 percent to 93.5 to 98.5 percent. This modification will address some of the errors in SPF that are attributed to the lack of match between the solar simulator and actual solar spectra. FDA invites comments on these proposed changes. FDA does not agree, at this time, with the comment's suggestion to further narrow the COLIPA standard to the spectral limits that it proposed. The comment based its suggestion on a theoretical argument and did not supply the complete emission spectra of the four solar simulators used in its two referenced studies. There may be significant differences in the 290 to 350 nm range in these studies that can account for the reported differences in SPF test results. Further, FDA has concerns about the ability of currently used solar simulators to meet the comment's suggested spectral standard and invites comments on the changes suggested by the comment. FDA agrees with the comments that the COLIPA approach provides a more appropriate description for solar simulators. FDA's original proposal that solar simulators have a spectral power distribution “similar to sunlight at a zenith angle of 10°” is nonquantitative and may not be practical, considering the types of solar simulators that are generally available. Accordingly, FDA is proposing to revise the first part of § 352.71 (proposed § 352.70(b)) as follows:

(b)*Light source (solar simulator)* —(1) *Emission spectrum* . A solar simulator used for determining the SPF of a sunscreen drug product should be filtered so that it provides a continuous emission spectrum from 290 to 400 nanometers

(nm)with * * * the following percentage of erythema-effective radiation in each specified range of wavelengths: **Solar Simulator Emission Spectrum** Wavelength range

(nm)Percent erythemal contribution < 290 < 0.1 290-310 46.0-67.0 290-320 80.0-91.0 290-330 86.5-95.0 290-340 90.5-97.0 290-350 93.5-98.5 290-400 93.5-100.0 (Comment 33) Several comments suggested the following revisions to the light source (solar simulator) requirements in § 352.71: • Delete the “out of band” specification that not more than 5 percent of a solar simulator's total energy output can be contributed by wavelengths longer than 400 nm. • In place of this 5 percent “out of band” limitation, allow a limit such as 1,250 to 1,500 watts/square meter (W/m 2 ) on the total solar simulator irradiance delivered to the skin for all wavelengths. One comment provided data comparing solar simulators with and without a 50 percent neutral density filter to demonstrate that there is no measurable impact of heat load on the outcome of SPF testing (Ref. 13). The comment stated that thermal overload does not occur for COLIPA-compliant solar simulators operated at or below a total irradiance limit of 1,500 W/m 2 . The comments added that the “out of band” specification is not possible with existing solar simulators and new systems would need to be designed, tested, manufactured, and distributed to provide equipment capable of meeting this specification. The comments concluded that replacing the “out of band” specification with a limit would improve the testing of all products, including high SPF products. FDA believes that it is important to limit total energy delivered to the skin during the SPF test so that skin temperature does not reach a point that may compromise dose reciprocity. FDA concurs with the comments and is proposing to replace the “out of band” specification in § 352.71 (proposed § 352.70(b)) with a limit of 1,500 W/m 2 on total solar simulator irradiance between 250 and 1,400 nm. (Comment 34) Two comments recommended that FDA change the solar simulator specification in § 352.71 from “good beam uniformity (within 10 percent) in the exposure plane” to “the delivered dose to the UV exposure sites be within 10 percent of the prescribed dose with good beam uniformity” (without defining “good beam uniformity”). The comments contended that although “reasonable” or “good” beam uniformity is desirable, beam uniformity within 10 percent is virtually impossible to measure or achieve for the vast majority of solar simulators. FDA agrees that “dose” accuracy is a critical variable and the delivered dose to the UV exposure sites should be within 10 percent of the prescribed dose. Because FDA considers quantification of “good beam uniformity” to be an important issue, it is keeping a specification for this parameter. However, FDA believes that a specification of 20 percent is more achievable than the proposed 10 percent. Beam uniformity can be measured with broadband UV detectors that have been modified to provide a small input aperture to the detector. For example, for a single beam simulator with a subsite exposure area of approximately 1 cm 2 , an appropriate input aperture would be 0.25 cm 2 . Beam uniformity can then be checked by making a measurement in the center of each of the four quadrants of the exposure field. These readings should be within 20 percent of the peak reading. The same principle can be applied to larger exposure fields. Additionally, the average of these four readings should be within 10 percent of the prescribed dose for a given exposure site. In addition, FDA is proposing a requirement that places a quantifiable limit of 20 percent on time related fluctuations of the radiation emissions of the solar simulator. Accordingly, FDA is proposing to revise portions of § 352.71 (proposed § 352.70(b)(2)) to read as follows:

(2)*Operation* . A solar simulator should have no significant time related fluctuations (within 20 percent) in radiation emissions after an appropriate warmup time and good beam uniformity (within 20 percent) in the exposure plane. The average delivered dose to the UV exposure site must be within 10 percent of the prescribed dose. (Comment 35) Several comments recommended that the last sentence of § 352.71 be modified to include additional requirements for the periodic testing of solar simulators. The comments suggested that periodic measurements be made twice a year and that measurements be done after changes in the optical filtering components. FDA agrees with the comments and is proposing to revise the last part of § 352.71 (proposed § 352.70(b)(3)) to read as follows:

(3)*Periodic measurement* . To ensure that the solar simulator delivers the appropriate spectrum of UV radiation, the emission spectrum of the solar simulator must be measured every 6 months with an appropriate and accurately calibrated spectroradiometer system (results should be traceable to the National Institute for Standards and Technology). In addition, the solar simulator must be recalibrated if there is any change in the lamp bulb or the optical filtering components (i.e., filters, mirrors, lenses, collimating devices, or focusing devices). Daily solar simulator radiation intensity should be monitored with a broadband radiometric device that is sensitive primarily to UV radiation. The broadband radiometric device should be calibrated using side by side comparison with the spectroradiometer at the time of the semiannual spectroradiometric measurement of the solar simulator. If a lamp must be replaced due to failure or aging during a phototest, broadband device readings consistent with those obtained for the original calibrated lamp will suffice until measurements can be performed with the spectroradiometer at the earliest possible opportunity. L. Comments on the Design/Analysis of SPF Testing Procedure (Comment 36) Several comments contended that the series of seven exposure doses in § 352.73(c) should be modified to eliminate the two doses placed symmetrically around the middle exposure. One comment provided data comparing the seven-exposure series against the five-exposure series and concluded that the seven-exposure series did not increase the precision of the test (Ref. 66). Comments also argued that the seven-exposure series would require longer testing times, thus increasing exposure risk and discomfort to subjects, and that the five-exposure series is as accurate as the seven-exposure series even at high SPF values. FDA discussed its rationale for seven versus five exposure doses in the TFM (58 FR 28194 at 28269 to 28272). FDA sought an exposure format that would provide better accuracy and precision to SPF measurements, particularly at higher SPF values. FDA reasoned that the seven-exposure series in § 352.73(c), with two additional exposures symmetrically placed around the middle exposure of the geometric series, would increase precision and eliminate possible overestimation of the true SPF value of a product with a high SPF. FDA has evaluated the data and other information submitted by the comments and agrees they demonstrate that the additional two exposure doses do not make the test more precise. Therefore, FDA is proposing to modify § 352.73(c) (proposed § 352.70(d)(3)) as follows: * * * Administer a series of five UV radiation doses expressed as J/m 2 -eff (adjusted to the erythema action spectrum calculated according to paragraph (d)(1) of this section) to the subsites within each test site on a subject using an accurately calibrated solar simulator. The five UV doses will be a geometric series as described in paragraph (d)(2) of this section, where the middle exposure represents the expected SPF. For products with an expected SPF less than 8, use exposures that are the product of the initial unprotected MED times 0.64X, 0.80X, 1.00X, 1.25X, and 1.56X, where X equals the expected SPF of the test product. For products with an expected SPF between 8 and 15, use exposures that are the initial unprotected MED times 0.69X, 0.83X, 1.00X, 1.20X, and 1.44X, where X equals the expected SPF of the test product. For products with an expected SPF greater that 15, use exposures that are the initial unprotected MED times 0.76X, 0.87X, 1.00X, 1.15X, and 1.32X, where X equals the expected SPF of the test product. * * * (Comment 37) Several comments suggested changes to the number of subjects per test panel in § 352.72(g). One comment suggested deletion of the phrase “with the number fixed in advance by the investigator.” The comment reasoned that if the first 20 subjects provided data that can be evaluated, risk to human subjects could be curtailed by not impaneling another 5 subjects. Other comments recommended using 10 to 20 subjects, arguing that the criterion for accuracy should not be the number of subjects, but the relative deviation of individual SPF measurements. One comment used absorbance instead of the SPF value to calculate the number of subjects required for high SPF products and proposed a binomial test method to reduce the number of subjects (see section III.I, comment 24 of this document). Another comment stated that the 20 of 25 subject limitation may be an issue for products with high SPF values due to the high variability in the responses obtained and suggested that the number of subjects be increased when evaluating sunscreen products with high SPF values. As discussed in section III.I, comment 24 of this document, the binomial test method deserves further investigation and may prove to be a reasonable approach as additional data and experience become available. In addition, based on the current SPF test method, FDA agrees with the comment recommending deletion of the requirement to fix the number of subjects per panel in advance. This requirement is unnecessary because the panel is limited to a range of 20 to 25 subjects (under current § 352.72(g)). Thus, if 20 subjects produce valid data in accordance with proposed § 352.70(c)(9), then it would be unnecessary to test additional subjects. In addition, some subjects may not produce valid data in accordance with proposed § 352.70(c)(9) (e.g., no erythema produced), requiring testing of additional subjects (not exceeding 25 subjects). FDA agrees that the number of subjects should be based on error about the mean SPF, but disagrees that the minimum number of subjects can be lowered to 10. As described later in this comment, FDA has reevaluated the proposed minimum number of subjects based on error about the mean SPF. FDA agrees with one comment that more subjects are needed when testing products with high SPF values. FDA believes that a minimum sample size of 20 subjects is adequate for products with an expected SPF value of 30 or less. However, current data and experience with products having SPF values over 30 are not sufficient to determine an appropriate sample size. Therefore, to account for increased variability in SPF values for sunscreens with SPF values over 30, FDA proposes to increase the sample size to at least 25 subjects. FDA invites data demonstrating an appropriate panel size for sunscreens with SPF values over 30. At this time, FDA is proposing to revise § 352.72(g) (proposed § 352.70(c)(7)) as follows:

(7)*Number of subjects* —(i) *For products with an expected SPF value under 30* . A test panel shall consist of 20 to 25 subjects with at least 20 subjects who produce valid data for analysis. Data are valid unless rejected in accordance with paragraph (c)(9) of this section. If more than 5 subjects are rejected based on paragraph (c)(9) of this section, the panel is disqualified, and a new panel must be created.

(ii)*For products with an expected SPF of 30 or over* . A test panel shall consist of 25 to 30 subjects with at least 25 subjects who produce valid data for analysis. Data are valid unless rejected in accordance with paragraph (c)(9) of this section. If more than 5 subjects are rejected based on paragraph (c)(9) of this section, the panel is disqualified, and a new panel must be created. In the 1978 advance notice of proposed rulemaking (ANPRM), the Panel recommended that studies enroll at least 20 subjects, adding that “the standard error shall not exceed ± 5 percent of the mean” (43 FR 38206 at 38261). Following publication of the ANPRM, FDA held a public meeting on January 26, 1988 (52 FR 33598 at 33600 to 33601). During that meeting, attendees argued the following four points related to the number of subjects: 1. Test panels should consist of at least 20 subjects. 2. The size of the test panel should be fixed in advance. 3. The limitation that the standard error should be less than ± 5 percent should not apply. 4. The testing procedures should make it clear that the addition of subjects to the test panel to achieve the desired minimum is acceptable under specific conditions (58 FR 28194 at 28267). In the 1993 TFM, FDA based § 352.72(g) on these comments and the Panel's recommendation. The calculations of the sample size and confidence interval in § 352.72(g) are based on the assumption that there is a normal distribution about the mean (i.e., a bell curve). Based on this assumption, the t-test is used for statistical analysis. Based on the t-test, FDA calculated that a panel of 20 subjects should result in an acceptable error about the mean. However, in some cases, a panel of 10 subjects would probably result in an error about the mean that is unacceptably large. There is inherently higher variability in testing and, consequently, larger error about the mean for products with high SPF values. Therefore, FDA believes a greater number of subjects is necessary when testing products with high SPF values. FDA believes a panel of 25 to 30 subjects should result in an acceptable error about the mean for products with high SPF values. FDA invites additional data demonstrating adequate numbers of subjects, especially for products with high SPF values. (Comment 38) One comment stated that one factor affecting the SPF of a product is the erythemal threshold of the skin, or MED(US). The comment argued that SPF decreases with increasing erythemal threshold. The comment maintained that, because MED(US) varies only with skin type, the MED(US) of each subject in a test group should be within reasonably similar limits. The comment suggested that the MED(US) of each subject should be 50 to 150 percent of the median MED(US). The comment also suggested that subjects with an MED(US) that is twice the median should be excluded regardless of skin type. FDA is not proposing the revisions suggested by the comment. FDA based § 352.73(b), which describes determination of an MED(US), on the Panel recommendation in the ANPRM. The procedure for determining MED(US) requires irradiation of subjects with a geometric series of UV doses. When developing this procedure, the Panel explained that the geometric series provides the same relative level of uncertainty independent of the subject's sensitivity to UV light (i.e., independent of skin type) (43 FR 38206 at 38266). Thus, the Panel disagreed that skin type affects MED(US). The comment did not provide any data or other information demonstrating that skin type, in fact, affects MED(US). FDA is not aware of any data demonstrating this phenomenon. FDA will revise the proposed test criteria if we receive data or information demonstrating that the criteria are not appropriate or other criteria are more suitable. (Comment 39) Several comments urged FDA to reduce the minimum 1 cm 2 test subsite area in § 352.72(d)(2). One comment proposed the minimum test subsite area be decreased to 0.5 cm 2 . Two comments suggested that the test subsite area be defined by minimum diameters of 0.8 cm (circular area of 0.5 cm 2 ) and 0.15 cm (circular area of 0.017 cm 2 ), respectively. The comment supporting the 0.5 cm 2 test subsite area referenced a study published in 1987 (Ref. 75) that was mentioned in relation to artificial light sources in comment 86 of the TFM (58 FR 28258 to 28261). This study was designed to evaluate the FDA sequential technique of dosing using a single-port solar simulator (SPSS), a series sequential method using a multi-port xenon arc solar simulator (MPSS), and the Deutsches Institut für Normung

(DIN)simultaneous technique of dosing using an Osram Ultravitalux lamp. Five sunscreen formulations with SPF values from 4 to 15 were tested. The authors suggested that there was little systematic difference in estimates obtained using the SPSS and MPSS, but there was a large systematic deviation between the FDA and DIN methods. As this study was not designed specifically to compare irradiation areas, three different test subsite areas were used, and none was 0.5 cm 2 . FDA cannot determine the suitability of a 0.5 cm 2 test subsite area compared to a 1 cm 2 test subsite area based on this study. The comment advocating the 0.8 cm test subsite diameter argued that setting a lower area limit has the following four benefits: • Does not preclude the use of larger irradiation areas, • Will not affect the accuracy of resulting measurements, • Permits lower wattage lamps as well as liquid light guides that have apertures of 0.8 cm diameter, and • Provides more skin area for testing. The comment provided statistical analysis of a study comparing multi-port and single-port solar simulators (Ref. 66). SPF 15 or SPF 4 products were tested along with the homosalate standard sunscreen. Two subsite areas were exposed to the multi-port solar simulator, and two were exposed to the single-port solar simulator. The comment concluded that similar SPF values are determined using the two types of solar simulators. However, the study report did not include details such as subject selection, product application, or specifications for the solar simulators. More importantly, the study report did not specify the size of each subsite. Thus, FDA cannot draw any conclusions regarding appropriate test subsite area from the submitted study. The comment supporting the 0.15 cm test subsite diameter referenced two studies (Ref. 76). Significant discrepancies in the information submitted for the first study prevented evaluation of this study. The comment did not submit full details of the second study. Therefore, FDA could not reach any conclusions from the submitted studies. FDA agrees, in principle, with the advantages of a smaller test subsite area. The Panel stated that, depending on instrumental design, irradiation test subsite areas less than 1 cm 2 can be utilized and that test subsite diameters greater than 0.4 cm present no difficulty in determining skin erythema (43 FR 38206 at 38260). While FDA does not consider the information provided by the comments adequate to support the suggested test subsite areas, it recognizes that considerable advances have been made since the Panel met. However, FDA requires data demonstrating that the monograph test produces valid and reproducible results using a smaller test subsite area before amending the monograph test. FDA will consider a reduction in test subsite area if adequate supporting data are provided. The studies should do the following: • Compare the smaller subsite area to 1 cm 2 on the same subjects, • Utilize high SPF products as well as products with SPF values below 15, and • Demonstrate comparable results among several laboratories. (Comment 40) Several comments either agreed or disagreed with the blinding procedures for the application of test materials described in § 352.72(e). One comment stated that unblinded SPF testing is bad science, and that exposure sites within test areas should always be randomized no matter how many products are being tested. Another comment stated that the blinding procedure is an unnecessary complication and does not contribute to the accuracy of the test. One comment agreed that, in order to approximate true blinding, the individual who grades erythemal responses should not be the same clinician who applied the test materials. Another comment contended that it is not reasonable to randomly irradiate test sites with varying doses of UV radiation. One comment recommended making the use of finger cots optional because some product vehicles are incompatible with finger cot material. Another comment suggested that the amount of product remaining on the finger cot is a source of variability in the SPF test and suggested that the extent of this variability be fully evaluated. FDA agrees with the comments that favor blinding and randomization and is not proposing to remove the blinding and randomization requirements from § 352.72(e) (proposed § 352.70(c)(5)). According to § 352.72, blinding and randomization is required only when two or more sunscreen drug products are being evaluated at the same time. Because a test product is always tested in conjunction with the standard sunscreen, FDA proposes to delete the statement, “If only one sunscreen drug product is being tested, testing subsites should be exposed to varying doses of UV radiation in a randomized manner.” Section 352.72(h) (proposed § 352.70(c)(8)) specifies that the person who evaluates the MED responses must not be the same person who applied the sunscreen or administered the dose of UV radiation. The comments that disagreed did not provide evidence demonstrating that these requirements are unnecessary. With regard to the suggestion that the use of finger cots be made optional, the Panel's review of data found that numerous investigators have obtained more reproducible results by spreading a product using a finger cot than by spreading with a glass or plastic rod (43 FR 38206 at 38261). FDA agrees with the comment that some formulations may be chemically incompatible with latex finger cots, but there are finger cots composed of other materials that should be compatible with these sunscreens. Therefore, to increase reproducibility in sunscreen application, FDA is proposing to revise the application requirement in § 352.72(e) (proposed § 352.70(c)(5)) to read as follows: * * * Use a finger cot compatible with the sunscreen to spread the product as evenly as possible. Pretreat the finger cot by saturating with the sunscreen and then wiping off material before application. Pretreatment is meant to ensure that sunscreen is applied at the correct density of 2 mg/cm 2 . FDA urges manufacturers of sunscreen drug products to investigate the extent of variability in the SPF test that may be caused by various applicators. (Comment 41) One comment addressed illumination at the test site in § 352.72(h) and recommended that a level of at least 1,000 lux be used. The comment contended that 450 to 550 lux is too low to provide adequate illumination for reading erythema. As discussed in the TFM, the Panel recommended an incandescent or warm fluorescent illumination source but did not specify a required illumination level (58 FR 28194 at 28269). In the TFM, FDA agreed with the Panel about the illumination source. FDA also proposed that the illumination level be 450 to 550 lux. The comment did not provide any data to support its contention that 1,000 lux is the appropriate illumination level. Thus, FDA is not revising the lux range in § 352.72(h) (proposed § 352.70(c)(8)) at this time. FDA invites data and information on levels of illumination currently used to evaluate MED responses in SPF testing laboratories and will consider adequately supported alternatives. (Comment 42) One comment stated that the third sentence in § 352.73(b) should be modified to read: “* * * wherein each exposure dose is 25 percent greater than the previous exposure dose to maintain the same relative uncertainty * * *.” The comment explained that defining the exposure dose in terms of “time” is incorrect. FDA discussed the Panel's definition of dose in terms of time intervals in comment 84 of the TFM (58 FR 28194 at 28256 to 28257). FDA stated that it is more accurate to express dose as the “erythema-effective exposure,” in units that define the total amount of erythema-effective energy applied to the testing subsite (i.e., as J/m 2 ). FDA discussed replacing “exposure time interval” with “erythema-effective exposure (dose),” but inadvertently used “exposure time interval” instead of “dose” in § 352.73(b). FDA agrees that § 352.73(b) (proposed § 352.70(d)(2)) should be modified and is amending this section as the comment suggested. (Comment 43) Several comments suggested an alternative statistical procedure for calculating product SPF values and PCD in current § 352.73(d). The comments argued that the procedure described in the FM would result in significant lowering of SPF values. The comments advocated clinical equivalency testing (i.e., using a lower one-sided 95 percent confidence interval or a one-sided t test, with a delta of 5 percent). The comments noted that an upper and lower bound equivalency procedure with a delta of 20 percent would be an appropriate procedure. The comments added that SPF is not a precise value, but rather a valid estimate of product performance. Another comment suggested using the mean of the results to find the actual number and then round-off (either up or down) to the nearest whole number. FDA is not proposing to modify the calculation of product SPF values and PCD in § 352.73(d) (proposed § 352.70(d)(4)) at this time. The distinct advantage of the t-test is that it provides a simple computational procedure for a statistical test that makes inferences about the population. The SPF is determined to be the largest whole number that is excluded by a lower one-sided 95 percent confidence interval. Simply finding a mean value, as one comment suggested, is not adequate because such a value does not provide information about the validity of the test (e.g., standard deviation) that should be taken into consideration. FDA's evaluation of the equivalency testing approach for calculating SPF values indicates the method is less stringent than the FM method. The proposed equivalency test is essentially testing the following hypothesis: H 0 : μ ≤ 0.95L versus H a : μ > 0.95L where: H 0 = null hypothesis H a = alternative hypothesis μ = population mean L = confidence limit FDA acknowledges that the equivalency test may be a valid method for determining SPF. In many cases, the same SPF would be determined for a sunscreen using either the equivalency test or the FM method. However, in some cases, a higher SPF would be determined for a sunscreen using the equivalency test than would be determined using the FM method. By contrast, a higher SPF would never be determined for a sunscreen using the FM method than would be determined using the equivalency test. Thus, the FM method results in a more conservative SPF value than the equivalency test. FDA believes it is in the best interest of public health to label sunscreens with the more conservative SPF value. If FDA adopted the equivalency test after over 30 years of using the FM method, consumers may, in some cases, overestimate the protection provided by a sunscreen based on a higher SPF number resulting from the equivalency test. M. General Comments on UVA Testing Procedure (Comment 44) Many comments discussed UVA radiation action spectra and skin damage (erythema, photocarcinogenesis, DNA damage, photosensitivity reactions, photoaging, mutagenicity, and immunosuppression). Some comments described various types of solar-induced skin damage and the wavelengths contributing to the specific biological events. Some comments stated that UVA II radiation (320 to 340 nm) is much more damaging than UVA I radiation (340 to 400 nm). Other comments stated that there is presently no convincing evidence that the action spectra for damage from UV radiation have been clearly defined. One comment stated that until the separate dangers and risks of each portion of the UVB and UVA radiation action spectra are precisely and scientifically identified and quantified, FDA should consider the entire UVA radiation range as having significant biological risk. Another comment stated that protection against all UVA radiation wavelengths would seem to be both desirable and prudent considering the present state of our knowledge. FDA agrees that the action spectra for various harmful effects on human skin from chronic UVA radiation have not been clearly defined and that it may be misleading to associate damage with any specific action spectrum based upon current knowledge. Information provided by comments suggests a relatively greater role for UVA radiation than UVB radiation in long-term sun damage even though there is little consensus about the amount of UVA radiation protection required. Therefore, FDA is proposing UVA radiation test methods that assess protection throughout the UVA spectrum (see section III.N, comment 45 of this document). N. Comments on UVA Testing Procedure Design and Testing Criteria (Comment 45) FDA is proposing that both an in vitro and an in vivo test be conducted to determine UVA radiation protection. The proposed in vitro test is the ratio of long wavelength UVA absorbance (UVA I) to total UV absorbance (i.e., UVB + UVA). The proposed in vivo test is the PPD test, which is similar to the SPF test except the endpoint is pigment darkening rather than erythema. FDA is proposing that UVA labeling consist of a UVA rating reflecting both the in vitro and in vivo test results. The rating will be the lowest “high” protection, then the sunscreen would be labeled as providing “medium” UVA protection. FDA is proposing these UVA testing requirements based on many comments submitted in response to the TFM that contained data and information on possible test methods (and combinations or modifications of these methods). The comments discussed the following in vivo and in vitro test procedures: • IPD, • PPD, • PFA, • Photosensitivity methods, • UVA radiation protection percent, • Diffey/Robson method and modifications of that method, • Standards Association of Australia, • Diffuse reflectance method, • Skin 2 method, and • Psoralen photoadduct method. On May 12, 1994, FDA held a public meeting to discuss these UVA radiation testing procedures (Ref. 77). One comment suggested using either or both PPD and erythema skin responses to measure the UVA radiation protection effectiveness of OTC sunscreen drug products. The comment maintained that these two test methods have the following similarities: • Same UVA radiation source, • Same dose range, and • Similar post exposure time lags for observation. The only difference is in the skin types used, thus giving a variable balance in PPD and erythema responses. The comment added that such a combination of methods has the following advantages: • Reproducibility and stability, • Relevance, • Persistence of skin response through 1 to 24 hours, • Independence of source flux and accuracy, • Utilization for static as well as for water resistance photoprotective predictions, and • Practicability, convenience, and safety. Stating that there is currently no convincing evidence that the action spectrum for UVA radiation damage has been clearly defined, another comment suggested that protection from UV radiation be measured using two factors based on the degree of attenuation of UV radiation across the full spectrum. One factor, the SPF value, is erythemally weighted and gives an indication of the power of protection provided by the product. The second factor should take into account the shape of the transmittance curve measured by either in vivo or in vitro means. The comment stated that it is potentially dangerous to associate skin damage with any single action spectrum (e.g., IPD, PPD, or PFA). The comment argued that all of these indicators are wavelength-specific and protection from specific wavelengths does not mean protection from damage. The comment added that if only the erythema action spectrum is used, it virtually ignores the effects of wavelengths over 320 nm. The comment contended that using an SPF value augmented by the shape of the transmission curve would give consumers the information necessary to make an effective and safe judgment about the protection provided by a sunscreen drug product. For example, the comment noted that a product with a high SPF and a uniform high level of attenuation across the spectrum (i.e., equal attenuation at all UVB and UVA wavelengths) will provide the most protection. The comment added that, at a later date, if sufficient evidence becomes available to describe a credible UVA radiation damage spectrum, this combined system could be used by convoluting the attenuation curve with the action spectrum curve. One comment proposed a modification (“critical wavelength”) of the Diffey/Robson test method (Refs. 78 and 79). The comment noted that, when people are outdoors, they are not exposed to only UVB or UVA radiation but are exposed to solar UV radiation, which always contains both. In addition, biological effects against which people may wish to be protected are caused by all wavelengths in the solar UV radiation spectrum. The comment contended that investigators should not be exposing subjects to sources of radiation with spectra that have no practical application and using irrelevant biological effects as endpoints (e.g., IPD). The comment proposed to assess the UVA radiation protection potential of an OTC sunscreen drug product by first spectrophotometrically determining the absorption spectrum of the product throughout the UV radiation range. Then, one calculates the wavelength value λ c (the “critical wavelength”), where the area under the absorption spectrum from 290 nm to λ c is 90 percent of the integral of the absorption spectrum from 290 to 400 nm, and uses a five-point scale to classify products as follows: **Table 3.—Broad Spectrum Rating Based on Critical Wavelength** Critical Wavelength

(nm)Broad Spectrum Rating λ c < 325 0 325 ≤ λ c < 335 1 335 ≤ λ c < 350 2 350 ≤ λ c < 370 3 370 < λ c 4 The comment concluded that this test method makes no underlying assumptions about the form of action spectra for either acute or chronic photobiological damage. Because the efficiency of UV radiation to induce a given photobiological endpoint tends to decrease with increasing wavelength, the method utilizes wavelength intervals for classifying the “broad spectrum” rating, which increases in an approximately logarithmic manner. One comment submitted a protocol for the “critical wavelength”

(CW)modification of the Diffey/Robson method for classifying the relative degree of UVA radiation protection of sunscreen drug products (Ref. 80). The comment addressed product photostability by pre-irradiation of the sunscreen product with a UV radiation dose corresponding to one-third the labeled SPF value. The comment reported recommendations based on the results of a round-robin evaluation of the proposed CW method involving six laboratories using four test sunscreen formulations with various substrates. The comment concluded that the CW method is a convenient, reproducible in vitro method for measuring the uniformity of sunscreen absorbance spectra across the UV radiation spectrum to classify products into broad UVA radiation protection categories. In response to the June 8, 2000, reopening of the administrative record for the rulemaking for OTC sunscreen drug products (65 FR 36319), FDA received additional comments on UVA radiation testing methods. While all comments supported some type of testing to differentiate the UVA radiation protection potential of sunscreen products, they disagreed about the use of in vivo versus in vitro testing methods. Comments from a group of sunscreen product manufacturers contended that an in vivo test method, such as PPD or PFA, best describes the photoprotective characteristics of a sunscreen drug product. These comments stated that an in vivo method measures the actual effect of UVA radiation on the skin and estimates the expected product performance under actual use conditions. One comment presented test data that suggested PPD and PFA values are comparable (Ref. 6). The comment stated that an advantage of the PFA method is that it allows inclusion of skin type I, whereas the PPD test is conducted on darker skin types (II and III). However, the comment added that the PPD test has been accepted since 1996 by the JCIA for the assessment of UVA radiation protection efficacy of sunscreen products. One comment contended that the PPD test should be used for the following reasons: • It requires a relatively low dose of UV radiation. • The reaction is stabilized in 2 to 4 hours. • The test subject is left with no mark of irradiation and receives little or no injury. • The test can be conducted with high precision. Another comment stated that PPD values demonstrate the same correlative benefits that exist for SPF values and, therefore, do not give false impressions of magnitude. Another comment stated that products with the same SPF can have different levels of UVA radiation protection. Thus, PFA or PPD is not redundant with the SPF value. Comments from other sunscreen product manufacturers opposed an in vivo method to determine UVA radiation protection. One of these comments stated that in vivo tests expose human subjects to doses of UVA radiation with unknown human health consequences. The comment added that because exposure to UVA radiation alone is never encountered in nature, full spectrum light is most relevant for product evaluations. This comment contended that PFA values are redundant with SPF testing because of an overemphasis on short wavelength UVA radiation (UVA II), and PFA values give a false impression of the magnitude of absorption differences. For example, the comment stated that two products with PFA values of 5 and 10 may attenuate 80 and 90 percent of UVA radiation, respectively. Thus, the real difference is small. The comment further stated that the proposed in vivo methods modeled after the SPF test generate protection factors that are protocol dependent and of indeterminate clinical relevance, as none are surrogates for long term concerns like cancer and photoaging. Another comment added that the PPD and PFA tests do not adequately assess the breadth of UVA radiation protection and that the biologic effects of full spectrum UV radiation differ from the effects of isolated wavelengths. Several comments recommended using an in vitro method, and most considered the CW method as appropriate. One comment stated that CW allows for broad spectrum activity regardless of SPF so that, if consumers use a low SPF product, they will at least have the option of choosing one that provides a wide breadth of activity. Another comment stated that CW provides a simple, reproducible, and adaptable method that can account for sunscreen photostability and insure UVA radiation protection that is both commensurate with and independent from the SPF value. Another comment added that CW accounts for proportionality because, in order for a sunscreen to maintain a given CW, protection from both long and short UVA radiation wavelengths must increase as UVB radiation protection increases. Several comments stated that the CW threshold should be 370 nm for a “broad spectrum” claim on a sunscreen. Other comments recommended a threshold of 360 nm. One comment stated that if FDA were to arbitrarily select a standard higher than 360 nm, it would cause a major reformulation effort within the industry, higher prices to consumers, and a shortage of “broad spectrum” products in the OTC marketplace. The comments did not provide data to support the use of a specific threshold number in relation to the prevention of specific photobiological effects. Other comments opposed the CW method as not appropriate. One comment, which favored an in vivo method, stated that the CW method, based on an arbitrary, nonbiological criterion, fails to provide an accurate measure of the protection efficacy of a sunscreen product. This comment provided data to demonstrate that a significant failure of the CW method is its inherent inability to differentiate UVA radiation protection levels of sunscreen products relative to biological endpoints (e.g., premature skin aging) (Ref. 23). A second comment agreed with this assertion, while a third comment expressed concern that CW measurements may be misleading because two products can have the same CW with very different UVA radiation absorbance curves and, thus, provide different protection for consumers. Some comments stated that a combination of methods may be appropriate for assessing the complete UVA radiation protection potential of a sunscreen product. One comment suggested combining either the PPD or PFA method with an in vitro method for a meaningful and rigorous test of both the magnitude and breadth of the biological protection (i.e., the level of protection and the UVB and UVA wavelengths that are protected against) provided by a sunscreen product. Another comment stated that complete assessment of a sunscreen product's UVA radiation protection must include both of the following: • An in vitro measurement of the absorbance above 360 nm (i.e., demonstrate adequate breadth of absorbance), and • An in vivo measurement of the quantity of UV radiation protection (i.e., demonstrate adequate magnitude of absorbance). Other comments stated that a combination of the in vivo SPF method and the in vitro CW method provide a complete description of a product's inherent photoprotective characteristics with the SPF value describing the amplitude of protection and CW providing a reliable measure of the product's spectral absorption capability. One comment suggested a UVA/UVB radiation proportionality scheme. The comment referred to FDA's previous discussions about UVA/UVB radiation proportionality (Refs. 11 and 81) and a recommendation from the AAD that “an increase in SPF of a sunscreen must be accompanied by a proportional increase in the UVA protection value” (Ref. 82). The comment added that the proportional contribution to sunburn from solar UVB and UVA radiation is 80 to 20 (4 to 1), respectively, and that this relationship gives the minimum UVA radiation attenuation needed to provide proportional UVA/UVB radiation protection for any SPF value. The comment concluded that a minimum UVA protection value of 2 should be required even at low SPF levels with proportionately higher UVA protection values for higher SPF values. One comment suggested that the UVA protection value should be determined with an in vivo method while CW is appropriate to determine spectral broadness. Another comment stated that CW accounts for proportionality because both long and short UVA radiation protection must increase as UVB radiation protection increases in order for a sunscreen to maintain a given CW. Another comment provided data (Ref. 23) for two products with the same CW value but different SPF values and concluded that the product with the higher SPF value did not provide greater UVA protection. Other comments stated that there is no biological basis for establishing strict UVB/UVA radiation proportionality and that the establishment of this kind of ratio is arbitrary. The AAD (Ref. 83) referenced an international consensus conference on UVA radiation protection of sunscreens and recommended the following: 1. Both an in vitro and an in vivo testing method must be used to measure UVA radiation protection. 2. CW is the preferred method of in vitro testing for a broad spectrum claim (with a threshold for this claim at 370 nm). 3. CW must be combined with an in vivo method such as either PPD or PFA. 4. There must be a minimum four-fold increase in PPD or PFA value in the presence of a sunscreen (relative to the absence of sunscreen). In the **Federal Registers** of May 12, 1993 (58 FR 28194 at 28248 to 28250), September 16, 1996 (61 FR at 48645 at 48652), and October 22, 1998 (63 FR 56584 at 56587), FDA discussed photosensitivity and erythemal UVA radiation testing procedures for OTC sunscreen drug products. Criteria discussed for UVA radiation claims included the requirement for an absorption spectrum extending to 360 nm or above, plus the demonstration of meaningful UVA radiation protection via testing procedures. IPD/PPD, PFA, photosensitivity, and in vitro UVA radiation testing methodologies were also discussed at a public meeting on May 12, 1994 (Ref. 77). The selection of an appropriate UVA radiation testing procedure for OTC sunscreen drug products has been difficult for a number of reasons. The scientific community does not agree on which testing procedure is most appropriate. For example, Cole discusses the virtues and shortcomings of a variety of in vivo and in vitro test methods (Ref. 84). In addition, each test procedure has its own distinct advantages and disadvantages, as discussed in the following paragraphs. FDA believes the IPD test method provides an appropriate endpoint for determining UVA protection, because pigment darkening is caused primarily by UVA (and not UVB) radiation. This method is advantageous over other suggested test methods in that it uses low doses of radiation and, therefore, exposes subjects to less risk than other suggested test methods. On the other hand, the IPD response has not been shown to represent a direct or surrogate endpoint for biological damage. The IPD response is also extremely difficult to read. The PFA test method uses endpoints that reflect actual damage that can occur to normal skin as a result of UVA radiation exposure (i.e., erythema or tanning). The erythema action spectra may be similar to the action spectra of known chronic skin damage (e.g., solar elastosis) (Ref. 85). However, the PFA test method may not determine protection against skin melanoma or other skin damage thought to be caused by chronic exposure to UVA radiation (Refs. 29 and 86). The CW method can assess how broadly a sunscreen can absorb across the UV radiation spectrum, but provides no information concerning product performance after interaction with human skin. While in vivo methods to assess UVA radiation protection may have possible sources of variability similar to the SPF test (e.g., test product application, differences in light sources, etc.), in vitro methods also possess possible sources of inherent variability (e.g., test product evaporation time, substrate orientation, instrumentation, use with color change sunscreen formulations, etc.). In general, FDA would prefer the standard UVA radiation test method to have a clinically significant endpoint. After reviewing the data and information provided by the comments, FDA agrees that there is no convincing evidence that the action spectra for all possible types of UVA-induced damage have been clearly defined and that no one method is without disadvantages. At this time, FDA agrees with the recommendation provided by the AAD and other comments that an in vivo method is appropriate in combination with an in vitro testing method to assess the UVA radiation protection. Because the action spectrum for UVA-induced skin damage is not clearly known, FDA considers it necessary to measure both the magnitude and breadth of UVA protection. The magnitude of UVA absorbance is a measure of how well a product absorbs UVA radiation. The magnitude of UVA absorbance is best measured by an in vivo method. An in vivo method measures a biological response on the skin (e.g., pigment darkening) and, therefore, correlates to actual use conditions. The breadth of the UVA absorbance is a measure of how broadly a product absorbs UVA radiation across the entire UVA radiation spectrum. Breadth can best be determined by appropriate in vitro test methods. At this time, FDA believes a combination of existing in vivo and in vitro UVA radiation testing methods addresses the inadequacies of either method when used alone and provides a more complete UVA radiation attenuation profile for use in labeling OTC sunscreen drug products. Requiring the two test methods will ensure that both the magnitude and breadth of UVA protection is determined. As discussed later in this response, the proposed UVA labeling will reflect the results of both tests and, therefore, will reflect magnitude and breadth of UVA protection. FDA believes that the methods and labeling currently being proposed provide the best assurance for consumers to receive adequate protection across the entire UVA radiation spectrum. FDA is proposing the PPD method as the in vivo part of the test to determine UVA radiation protection of a sunscreen drug product. This test assesses UVA radiation attenuation by measuring UVA radiation-induced tanning, a direct effect induced by UVA exposure. The PPD test is relatively easy to perform and relies on a stable, biological endpoint that can describe the magnitude of UVA radiation protection of sunscreen products. It is similar to the SPF determination as it is a ratio of a minimum pigmenting dose

(MPD)on unprotected skin to that on protected skin. The endpoint is the PPD response, which is the stable, lasting residual part of the immediate pigment darkening or blue gray pigment that develops immediately during exposure to UVA radiation and quickly fades at the end of exposure. It provides consumers with a means to specifically compare the amount of UVA radiation protection between products and select an appropriate sunscreen product. The PPD test has been shown to produce reliable, reproducible data and to distinguish between varying levels of UVA radiation attenuation (Refs. 87 and 88). It has been shown to detect protection provided by “broad spectrum” sunscreens against both short and long wavelength UVA radiation. The endpoint is a stable skin response that is linearly dependent on the amount of UVA radiation that enters the viable epidermis. FDA also agrees with one comment that a UVA protection value of 2 should define the lowest end of acceptable PPD test results relative to the consideration of acceptable UVA radiation claims (see proposed § 352.72(d)(3)). FDA considers it desirable to incorporate measurable UVA radiation protection at all SPF levels for products that claim to protect against both UVB and UVA radiation. As one comment noted, the PPD test has been accepted and validated as the JCIA method since 1996 (Ref. 23) and is one of two in vivo methods suggested by the AAD (Ref. 83). Although data provided to FDA indicate that the PPD and PFA in vivo tests provide comparable results (Ref. 6), the PPD test provides the practical benefit of a shorter post exposure reading time. FDA agrees with the comments that PPD values are not redundant with SPF values as sunscreen drug products with the same SPF value can have very different levels of UVA radiation protection as measured by the PPD test. Accordingly, FDA is including the PPD method in proposed § 352.72 as part of the testing to determine the UVA radiation protection potential of an OTC sunscreen drug product. FDA agrees with the comments that suggested modifications to the PPD method (i.e., the JCIA standard). Therefore, FDA is proposing modifications to the PPD method. One group of sunscreen manufacturers suggested that the previously validated “high SPF” padimate O/oxybenzone standard sunscreen under consideration by FDA (see section III.J, comment 27 of this document) should also be used as the control formulation for in vivo UVA radiation testing (Ref. 6). Based upon data provided by the comment, FDA is proposing the referenced “high SPF” padimate O/oxybenzone standard sunscreen for use as the standard sunscreen in the in vivo UVA radiation test in proposed § 352.72. FDA invites comment on the suitability of this formulation as a UVA radiation test standard, on alternative standards, and on preparation/assay/validation data for any suggested alternatives. FDA also notes that the JCIA light source specification states that “UV rays shorter than 320 nm shall be excluded through the use of an appropriate filter.” FDA considers it important to set an exact limit for this specification and is proposing that optical radiation from the light source between 250 and 320 nm be less than 0.1 percent of the optical radiation between 320 and 400 nm. Also, the observation of pigment darkening in the JCIA standard is at 2 to 4 hours post irradiation. FDA notes that it appears the pigment darkening is most stable about 3 hours or more after post irradiation (Ref. 89), and is thus proposing that this observation occur at 3 to 24 hours post irradiation. This time range provides increased flexibility in the test method without sacrificing accuracy. As the current state of technology allows for an instrumental measurement/quantification of skin color via spectral reflectance, FDA also invites comments regarding colorimetry as a method of evaluating pigment darkening. By avoiding the subjectivity of detecting pigment change by the human eye, the reproducibility of the PPD method should increase. Colorimetry could likewise be used in SPF testing if submitted data demonstrated increased accuracy and reproducibility of colorimetry over visual inspection. As the PPD method is similar, overall, to the SPF method, FDA is also proposing that the directions for the PPD method be similar to those for the SPF test for determining MPDs on unprotected skin, individual UVA protection factors, test product UVA protection factors, and PCDs. Further, as discussed in section III.L, comment 37 of this document regarding the SPF test, FDA is proposing that a PPD test panel consist of 20 subjects who produce valid data, similar to the panel size for sunscreens having SPF values less than 30. FDA is concerned, however, that use of the PPD method alone could result in some products yielding high UVA radiation protection factors without having broad absorbance throughout the UVA radiation spectrum due to strong absorbance in the UVA II region. In other words, a sunscreen could absorb high levels of UVA II but very little UVA I and achieve a high UVA rating under the PPD method. Therefore, FDA is proposing that an in vitro method be used (to assess the breadth of absorbance across the UV radiation spectrum) in conjunction with the PPD method to more completely assess a product's UVA radiation protection. FDA disagrees with the comments that the CW method should be used as the in vitro testing method and proposes using a modification of the Boots adaptation of the Diffey/Robson method (Ref. 90). Both the CW and the in vitro test proposed by FDA measure the absorbance of a sunscreen product using in vitro spectrophotometry. However, FDA's proposed method calculates the ratio of long wavelength UVA absorbance (UVA I) to total UV absorbance to provide a measure of the relative UVA I radiation protection provided by a sunscreen drug product. FDA believes that this test, in combination with the PPD method, provides a better assessment of overall UVA radiation protection. The Boots adaptation of the Diffey/Robson test method assesses the absorbance of a sunscreen drug product over the UV radiation range from 290 to 400 nm by measuring the quantity of UV radiation transmitted through surgical tape (Transpore TM tape) before and after application of a sunscreen drug product. The test product (2 mg/cm 2 ) is applied to the textured surface of the Transpore TM tape. A xenon arc solar simulator is used as the UV radiation source. Transmitted UV energy is collected and measured at 5 nm intervals over the UVB and UVA radiation range, which provides a profile of UV radiation absorbance. Mathematical calculations are made separately of the areas under the UVB and UVA radiation parts of the curve. The ratio below the curve is determined as follows: EP27AU07.004 As the ratio increases, the degree of UVA radiation protection increases. FDA is concerned that this method, as described in previous paragraphs, determines the ratio of the entire UVA to UVB radiation spectra. Therefore, a sunscreen drug product that absorbs strongly in the UVA II radiation area, but does not absorb strongly in the UVA I radiation area, might still have an adequate ratio of UVA to UVB radiation protection to fulfill the test requirements, but would not provide adequate protection in the UVA radiation region where absorbance is lacking. FDA believes that this deficiency can be corrected by revising the calculations to take into account the ratio of UVA I and/or UVA II individually to UV radiation. Some comments were concerned that UVA II radiation may be the portion of the UVA spectrum most represented in the PPD test. FDA agrees that the UVA II spectrum is well represented by the PPD test. Therefore, to provide for a more balanced method, FDA is proposing that the in vitro component of the monograph UVA radiation method only need provide a measure of the relative UVA I radiation absorbance. FDA is proposing to measure UVA I radiation absorbance relative to UV radiation absorbance rather than relative to UVB radiation absorbance. If UVA I radiation protection is measured relative to UVB radiation, then the test does not account for UVA II radiation protection. FDA's proposed modification of the Boots adaptation of the Diffey/Robson method accounts for the entire UV radiation spectrum. Further, the ratio of UVA I radiation to UV radiation has a convenient finite range and allows for the use of defined values to categorize UVA radiation protection. FDA is proposing a modified Boots adaptation of the Diffey/Robson method instead of the CW method. The CW determination only reveals the shortest wavelength at which 90 percent of total UVB and UVA radiation is absorbed by a sunscreen. Thus, this method does not directly reveal the breadth of UV absorption, whereas the modified Boots adaptation of the Diffey/Robson method does. This point is demonstrated by data submitted by one comment (Ref. 23). The comment submitted the UV absorption spectra of two sunscreens having nearly identical SPF and CW values. The absorption spectra demonstrate that two sunscreens with similar CWs can have significantly different UVA absorption spectra. The ratios of UVA I/UV radiation absorbance for these formulations were markedly different: 0.85 and 0.52. Thus, FDA believes that the ratio method generally allows for better discrimination of products with these types of absorbance spectra. FDA is also concerned that the activity of the sunscreen ingredients in the product may be diminished by exposure to UV radiation, i.e., that the sunscreen ingredients in the product might not be photostable. Therefore, in order to account for changes in absorbance as a function of UV radiation exposure, FDA is proposing to revise the Boots modification of the Diffey/Robson method by incorporating pre-irradiation dose (PID), which is defined as follows (see section III.O, comment 46 of this document): PID (J/m 2 -eff) = SPF * 1 MED * 2/3, where 1 MED = 200 J/m 2 -eff FDA is also concerned about specifying the use of Transpore TM tape (used in the original Diffey/Robson method), an artificial substrate that mimics the surface topography of human stratum corneum. When sunscreen emulsions are applied to Transpore TM tape (Refs. 7 and 77), the emulsions may experience a micro environment that differs from human skin in several key aspects, including the following: • Lack of electrolyte effect, • Lack of moisturization/humectant plasticization of the substrate, • Differences in pH and wetting effects, and • Different degrees of sunscreen penetration and retention by the substrate. The fourth aspect, different degrees of penetration and retention, is especially significant for oil soluble sunscreen ingredients. One comment suggested that either roughened quartz plates or a synthetic collagen should be used as the substrate, noting that COLIPA has used quartz plates for its in vitro studies and that quartz plates are reusable and inert. Diffey et al. have also used quartz plates as the substrate for the CW method (Ref. 91). Accordingly, at this time, FDA is proposing that roughened quartz plates be specified as the substrate in the in vitro portion of its UVA test method. FDA requests comment regarding the suitability and availability of quartz plates and other possible substrates. FDA agrees with one comment that there is no biological basis for establishing a strict UVA to UVB ratio and that such a ratio would be arbitrary. FDA is proposing that data from the proposed in vitro and in vivo tests be integrated into a single labeled UVA rating. Similar to suggestions from some comments, FDA is proposing the categories of low, medium, high, and highest (corresponding to one, two, three, and four “stars,” respectively). Based on test data submitted by one comment (Ref. 6), FDA is proposing that test results for each in vitro or in vivo test be categorized as follows: **Table 4.—UVA Rating Categories** Category In vitro result In vivo result Low 0.2 to 0.39 2 to under 4 Medium 0.40 to 0.69 4 to under 8 High 0.70 to 0.95 8 to under 12 Highest greater than 0.95 12 or more FDA is aware of the difficulty for current sunscreen formulations to meet the “highest” category and believes that allowing such a category will foster additional research and development in this area. FDA is proposing that the overall UVA radiation category for use in product labeling be the lowest category determined by the in vitro and in vivo test results. For example, if the test results for a sunscreen indicate an in vitro category of “low” and an in vivo category of “high” (or the reverse), then the overall UVA classification on the sunscreen product label would be “low” (i.e., the lower of the two categories). FDA believes that using the lower of the two categories takes into account the following situations: • A product that has a high in vivo rating because of substantial UVA II absorbance, but a low in vitro rating because of poor UVA I absorbance, or • A product that has a low in vivo rating because of poor UVA II absorbance, but a high in vitro rating because of substantial UVA I absorbance. FDA is further proposing that each overall UVA radiation category correspond to and (on product labeling) be used with the following number of graphical representations in the form of solid “stars”: **Table 5.—Graphical UVA Rating Based on Category** Combined Category Rating Star Rating Low ★✰✰✰ Medium ★★✰✰ High ★★★✰ Highest ★★★★ FDA invites comment on these proposed test methods/criteria and encourages the continued development of biologically meaningful test procedures. O. Comments on the Photostability of Sunscreen Drug Products (Comment 46) Various comments discussed the photostability of OTC sunscreen formulations and active ingredients. One comment stated that photostability is important because many sunscreen ingredient combinations with avobenzone are not believed to be photostable. This comment stressed that a sunscreen drug product should maintain most of its UVA and UVB radiation protection throughout the expected consumer time in the sun. Another comment stated that the integrity of a sunscreen drug product depends on its degree of photostability and that a photostable product should maintain its protection over a wide range of UV radiation spectra. Some comments supported a standard method using pre-irradiation to account for photostability of sunscreen ingredients. One comment favoring the CW method for measuring UVA radiation protection submitted a formula to establish a pre-irradiation dose to assess photostability (Ref. 7). This comment stated that pre-irradiation provides a reasonable estimate of what a consumer might expect when using the product and stressed that the dose should be both full spectrum (290 to 400 nm) and sufficient to detect significant changes in CW as a function of UV radiation exposure. This comment considered its pre-irradiation dose of solar-simulated UV radiation to be equivalent to about 1 1/2 hours of noonday sun or 3 hours of sun exposure in the early morning or late afternoon. One comment noted that avobenzone-containing formulations can be photostabilized by the addition of suitable ingredients and supported a protocol developed by Sayre and Dowdy for measuring UVA radiation protection following a measured exposure of the test formulation to solar radiation (290 to 400 nm) (Ref. 92). Another comment stressed the importance of a standard pre-irradiation dose and included data suggesting that a “UVB-only” sunscreen product formulation, at high pre-irradiation doses, could qualify for UVA “broad spectrum” labeling by the CW method (Ref. 23). This comment concluded that pre-irradiation does not always account for photostability and appears to be very formulation specific. Another comment submitted an in vitro method for simultaneously predicting SPF and assessing photostability of sunscreen formulas (Ref. 65). The comment stated that pre-irradiation with measured UV radiation doses has permitted more accurate in vitro estimates of SPF. FDA agrees that it is important to address the photostability for sunscreen drug product formulations. Unstable product formulations present the problem of degradation of product effectiveness during actual use. The assessment of overall protection provided by such formulations is difficult due to product effectiveness being heavily dependent on the UV radiation exposure dose. Sayre and Dowdy demonstrated, through a series of in vitro studies, how the UV radiation transmission of an avobenzone containing formula changes with UV radiation exposure and that most of the loss of protection occurred in the UVA radiation spectrum (Ref. 92). FDA is proposing to address photostability by adding a pre-irradiation step to the in vitro test method for measuring UVA radiation protection (see section III.N, comment 45 of this document). As noted in the scientific literature, the choice of a pre irradiation dose is “somewhat arbitrary, yet critical to the outcome of the test” (Ref. 84). FDA received one comment with supporting data for a proposed pre-irradiation dose (Ref. 7). The comment suggested using a dose equivalent to the SPF times 2 J/cm 2 multiplied by a factor of 2/3. The comment stated that 2 J/cm 2 from a xenon arc solar simulator with 1 millimeter

(mm)WG-320 and 1 mm UG-5 filters was equivalent to one MED. Because all solar simulators used by the industry may not use this exact filter combination and the spectral transmittance of filters can vary from lot to lot, FDA is proposing to specify the pre-irradiation dose in terms of “erythemal effective dose.” The erythemal effective dose of a solar simulator can by calculated as described in proposed § 352.70(d) by weighting the output spectrum of the solar simulator with the reference action spectrum for erythema as defined by CIE. A typical weighted value (J/m 2 -eff) for an MED in a Skin Type II individual is 200 J/m 2 -eff (Ref. 93). Thus, FDA is proposing to use the following formula to determine the required pre-irradiation dose: PID (J/m 2 -eff) = SPF * 1 MED * 2/3 where 1 MED = 200 J/m 2 -eff In considering the selection of the appropriate pre-irradiation dose of solar-simulated UV radiation, FDA agrees that the maximum pre-irradiation exposure would be a dose of UV radiation that equaled the SPF of the product times the MED. However, FDA believes that this calculated dose is probably greater than the dose that a sunscreen product would incur during typical consumer usage. Thus, the dose was reduced by a factor of one-third to represent a more reasonable exposure condition. IV. FDA's Tentative Conclusions and Proposals FDA tentatively concludes that the FM for OTC sunscreen drug products should be amended to include the combinations of avobenzone with ensulizole and avobenzone with zinc oxide when used in the concentrations established for each ingredient in § 352.10 (see section III.C, comment 7 of this document). However, before marketing may begin, the comment period for this proposal must end and FDA must publish another **Federal Register** notice setting forth our determination concerning interim marketing before publication of the final rule for OTC sunscreen drug products. FDA followed this procedure previously for avobenzone as a single active ingredient and in combination with some GRASE active ingredients other than ensulizole or zinc oxide (62 FR 23350). FDA considers the UVA-related labeling in this proposal to supersede the labeling proposed in the TFM and its amendments of September 16, 1996, and October 22, 1998. While the prior proposed labeling can continue to be used until a FM is issued, FDA encourages manufacturers of OTC sunscreen drug products to voluntarily implement the UVA-related labeling changes as soon as possible after publication of this proposal, especially if product relabeling occurs in the normal course of business. We note, though, that any relabeling prior to issuance of the FM is subject to the possibility that FDA may change some of the labeling requirements as a result of comments filed in response to this proposal. Mandating warnings in an OTC drug monograph does not require a finding that any or all of the OTC drug products covered by the monograph actually caused an adverse event, and FDA does not so find. Nor does FDA's requirement of warnings repudiate the prior OTC drug monographs and monograph rulemakings under which the affected drug products have been lawfully marketed. Rather, as a consumer protection agency, FDA has determined that warnings are necessary to ensure that these OTC drug products continue to be safe and effective for their labeled indications under ordinary conditions of use as those terms are defined in the act. This judgment balances the benefits of these drug products against their potential risks (see 21 CFR 330.10(a)). FDA's decision to act in this instance need not meet the standard of proof required to prevail in a private tort action ( *Glastetter* v. *Novartis Pharmaceuticals Corp.* , 252 F.3d 986, 991 (8th Cir. 2001)). To mandate warnings, or take similar regulatory action, FDA need not show, nor do we allege, actual causation. For an expanded discussion of the case law supporting FDA's authority to require such warnings without evidence of actual causation, see Labeling of Diphenhydramine-Containing Drug Products for Over-the-Counter Human Use, final rule (67 FR 72555, December 6, 2002). V. Analysis of Impacts FDA has examined the impacts of this proposed rule under Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1501 *et seq.* ). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Under the Regulatory Flexibility Act, if a rule has a significant economic impact on a substantial number of small entities, an agency must analyze regulatory options that would minimize any significant impact of the rule on small entities. Section 202(a) of the Unfunded Mandates Reform Act requires that agencies prepare a written statement of anticipated costs and benefits before proposing any rule that may result in an expenditure in any one year by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million (adjusted annually for inflation). FDA believes that this proposed rule is consistent with the principles set out in the Executive Order 12866 and in these two statutes. The proposed rule is not a significant regulatory action as defined by the Executive order and, therefore, is not subject to review under the Executive order. Further, because this proposed rule is not expected to result in any 1-year expenditure that would exceed $100 million adjusted for inflation, FDA need not prepare additional analyses under the Unfunded Mandates Reform Act. Because the rule may have a significant economic impact on a substantial number of small entities, this section of the preamble constitutes FDA's regulatory flexibility analysis. An analysis of the costs and benefits of this regulation, conducted under Executive Order 12866, was discussed in the FM (64 FR 27666 at 27683 to 27686), which was later stayed (66 FR 67485). This analysis reflects the incremental costs of the revised or new requirements in this proposed amendment of the FM. A. Background The purpose of this document is to amend the conditions under which OTC sunscreen drug products are generally recognized as safe and effective (GRASE) and not misbranded. This amendment addresses formulation, labeling, and testing requirements for both UVB and UVA radiation protection. Manufacturers would not need to reformulate their sunscreen products to comply with the proposed requirements. Manufacturers also would not need to retest their sunscreen products for UVB protection (i.e., they would not need to retest for SPF). The labeled SPF value determined from the SPF test in the FM would not likely change if a sunscreen product was retested using the modifications to the SPF test proposed in this document. In addition, manufacturers who have tested and labeled their sunscreen products as “SPF 30+” can relabel their products with the specific SPF value above 30 (but no greater than 50) without retesting. However, all manufacturers would incur some relabeling costs due to proposed revisions to both the PDP and the Drug Facts section of the product label. If manufacturers wish to label their sunscreen products as providing UVA protection, then manufacturers of those sunscreen products would also incur UVA testing costs. Because UVA testing is not required, some manufacturers will choose not to test for UVA protection and the labeling for those sunscreens will state, “No UVA Protection.” B. Number of Products Affected Estimating the number of products affected is difficult because we lack data on the number of products currently marketed. Our Drug Listing System currently does not have accurate information on the number of marketed OTC sunscreen products, especially the drug-cosmetic combination products. Proprietary databases that track retail sales of OTC drugs and other products do not distinguish cosmetics containing sunscreens from other cosmetic products and their surveys do not include many of the outlets where sunscreen products are sold. Based on earlier estimates (64 FR 27666 at 27684) and our knowledge of the industry, we assume there are about 3,000 OTC sunscreen drug products (different formulations, not including products that differ only by color), including drug-cosmetic combinations, and about 12,000 individual stock keeping units

(SKUs)(individual products, packages, and sizes). All 12,000 SKUs will need to be relabeled, but manufacturers can choose whether to test their sunscreen products for UVA protection. We assume that about 75 percent (2,250) of the sunscreen products would be tested for UVA protection. We request comment on the accuracy of this assumption. C. Cost to Relabel The cost to relabel varies greatly depending on the printing method and number of colors used. The majority of sunscreen products are packaged in plastic bottles or tubes with the label printed directly on the container or applied as a decal or paper label during the packaging process. The proposed labeling requirements impact both the PDP and the Drug Facts section of the package and would be considered a major redesign. Frequent label redesigns are typical for OTC sunscreen products, with redesigns generally implemented every 1 to 2 years for a product. To the extent that a scheduled redesign coincides with the regulatory-mandated relabeling, the impact on the manufacturer will be negligible. We used a model developed for FDA by the consulting firm RTI to derive an estimate of the cost to relabel sunscreen products (Ref. 94). The model was developed to estimate the cost of food labels. However, we believe that the graphic and design estimates from that study are an appropriate proxy for the costs that would be incurred by OTC sunscreen manufacturers. RTI estimated that graphic design and prepress and engraving costs would range from $1,970 to $13,800 per SKU depending on the type of packaging and printing method used. There would also be administrative costs to account for contracting costs and obtaining final approvals for the new labels. RTI estimated administrative costs to range from $360 to $880 depending on the size of the firm. For this analysis, we are assuming an average design price of $7,000 per SKU and average administrative costs of $600 per SKU. 1 Therefore, the total relabeling cost per SKU would be $7,600 (i.e., $600 + $7,000). While all sunscreen SKUs would need to be relabeled to comply with the proposed rule, we estimate that the timing of the scheduled relabeling would coincide with the regulatory-mandated changes for 50 percent of the SKUs (i.e., 6,000 SKUs). We estimate the total labeling cost of the proposed labeling changes for the SKUs with the coinciding scheduled redesign would be 50 percent of the administrative cost (i.e., $300). Therefore, the total one-time cost to industry for relabeling would be about $47.5 million (i.e., (6,000 x $7,600) + (6,000 x $300)). 1 We did not select the midpoint of the ranges because of the large number of private label products that have lower design and administrative costs than branded goods. D. Cost to Test or Retest Products for UVA Protection This proposed rule will result in testing costs for products that make UVA protection claims. The approximate costs are $2,200 for in vivo UVA testing and $200 for in vitro UVA testing. Based on the number of sunscreen products currently labeled as providing UVA protection, we estimate that 75 percent (2,250) of the sunscreen products will be tested according to the proposed UVA tests. Therefore, FDA estimates a one-time UVA testing cost of approximately $5.4 million (i.e., 2,250 x $2,400). E. Total Incremental Costs The estimated total one-time incremental cost of this proposed rule is $53 million (i.e., $47.5 million + $5.4 million). The incremental cost for the UVA testing could be less should the rule become final because many manufacturers may voluntarily comply with the proposed rule when reformulating current products or marketing new products. Although the FM is not effective, manufacturers of sunscreen products comply with the UVB

(SPF)test in the FM for nearly all sunscreen products. Therefore, it is likely that manufacturers of sunscreen products will also voluntarily comply with the proposed UVA tests in this document. It should also be noted that sunscreen products that are already distributed by the effective date of the FM will not be required to be relabeled or retested in conformity with these FM conditions, unless these products are subsequently relabeled or repackaged after the effective date. Therefore, there is no one-time cost associated with disposing of sunscreens that are already on the market at the time of the rule's effective date. F. Small Business Impact In the FM (64 FR 27666 at 27685), FDA estimated that 78 percent of the 180 domestic companies that manufacture OTC sunscreen products would be considered a small business (defined as fewer than 750 employees). FDA cannot estimate with certainty the number of small firms that will need to test or retest their OTC sunscreen products to provide for UVA protection claims, but projects that approximately 75 percent of all products may need to be tested for UVA protection. Costs will vary by firm, depending on the number of products requiring testing. The firm-specific impact may vary inversely with the volume of product sales, because per unit costs will be lower for products with high volume sales. Thus, the relative economic impact of product retesting may be greater for small firms than for large firms. Because the OTC drug industry is highly regulated, all firms are expected to have access to the necessary professional skills on staff or to have contractual arrangements to comply with the testing requirements of this rule. G. Analysis of Alternatives FDA could have proposed only an in vivo or an in vitro test for UVA. FDA recognizes that requiring only the in vitro test would mean significantly less cost to manufacturers. However, the proposed in vivo test measures the magnitude of UVA protection. The proposed in vitro test measures the breadth of UVA protection. FDA believes it is important to conduct both tests to determine the magnitude and breadth of UVA protection. FDA plans to grant an extended compliance period when this proposed rule is finalized. Given the seasonal nature of these products, FDA is concerned that some manufacturers may not have sufficient time to incorporate labeling changes without disrupting their production schedules. By providing an additional 6 months to implement the changes, compliance costs to manufacturers will be reduced. In addition, FDA reduced compliance costs when we chose to stay the labeling requirements for the FM (64 FR 27666), sparing industry the cost of an additional regulatory-mandated label change. In the stay, FDA estimated a cost savings of $1.5 million to industry. It should be noted that labeling costs were significantly less in the FM than in this proposed rule primarily because we assumed in the FM that the majority of relabeling would coinside with scheduled voluntary label redesigns at no additional cost. Manufacturers were also able to avoid or postpone incurring an additional industry total of $5 million when FDA chose to stay the UVB testing requirements of the FM. FDA invites public comment regarding any substantial or significant economic impact that this proposed rule would have on manufacturers of OTC sunscreen drug products. Comments regarding the impact of this rulemaking on such manufacturers should be accompanied by appropriate documentation. FDA is providing a period of 90 days from the date of publication of this proposed rule in the **Federal Register** for comments to be developed and submitted. FDA will evaluate any comments and supporting data that are received and will reassess the economic impact of this rulemaking in the final rule. VI. Paperwork Reduction Act of 1995 FDA tentatively concludes that the labeling requirements in this document are not subject to review by the Office of Management and Budget because they do not constitute a “collection of information” under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ). Rather, the proposed labeling statements are a “public disclosure of information originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public” (5 CFR 1320.3(c)(2)). VII. Environmental Impact FDA has determined under 21 CFR 25.31(a) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. VIII. Federalism FDA has analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the proposed rule, if finalized as proposed, would have a preemptive effect on State law. Section 4(a) of the Executive order requires agencies to “construe * * * a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.” Section 751 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 379r) is an express preemption provision. Section 751(a) of the act (21 U.S.C. 379r(a)) provides that “no State or political subdivision of a State may establish or continue in effect any requirement—* * *

(1)that relates to the regulation of a drug that is not subject to the requirements of section 503(b)(1) or 503(f)(1)(A); and

(2)that is different from or in addition to, or that is otherwise not identical with, a requirement under this Act, the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 *et seq.* ), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 *et seq.* ).” Currently, this provision operates to preempt States from imposing requirements related to the regulation of nonprescription drug products. Section 751(b) through

(e)of the act outlines the scope of the express preemption provision, the exemption procedures, and the exceptions to the provision. This proposed rule, if finalized as proposed, would amend the labeling and include new UVA testing for OTC sunscreen drug products. Any final rule would have a preemptive effect in that it would preclude States from issuing requirements related to the labeling and testing of OTC sunscreen drug products that are different from or in addition to, or not otherwise identical with a requirement in the final rule. This preemptive effect is consistent with what Congress set forth in section 751 of the act. Section 751(a) of the act displaces both State legislative requirements and State common law duties. We also note that even where the express preemption provision in section 751(a) of the act is not applicable, implied preemption may arise (see *Geier* v. *American Honda Co.* , 529 US 861 (2000)). FDA believes that the preemptive effect of the proposed rule, if finalized as proposed, would be consistent with Executive Order 13132. Section 4(e) of the Executive order provides that “when an agency proposes to act through adjudication or rulemaking to preempt State law, the agency shall provide all affected State and local officials notice and an opportunity for appropriate participation in the proceedings.” FDA is providing an opportunity for State and local officials to comment on this rulemaking. IX. Request for Comments In the **Federal Register** of January 10, 2005 (70 FR 1721), FDA announced the availability of a final guidance for industry entitled “Labeling for Topically Applied Cosmetic Products Containing Alpha Hydroxy Acids as Ingredients.” The purpose of this guidance is twofold: • To educate consumers about the potential for increased skin sensitivity to the sun from the topical use of cosmetics containing alpha hydroxy acids

(AHAs)as ingredients. • To educate manufacturers to help ensure that their labeling for cosmetic products containing AHAs as ingredients is not false or misleading. As discussed in the guidance, AHAs may increase skin sensitivity to UV radiation. Therefore, FDA recommends that manufacturers of cosmetic products containing AHAs include the following warning: Sunburn Alert: This product contains an alpha hydroxy acid

(AHA)that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen and limit sun exposure while using this product and for a week afterwards. The guidance addresses only cosmetic products containing AHAs and does not address sunscreen drug products containing AHAs (i.e., drug-cosmetic products). FDA is considering an additional warning or direction for sunscreen drug products containing AHAs similar to the warning for the cosmetic products described in the guidance for industry. However, FDA invites interested parties to submit comments and data regarding such labeling. In particular, FDA would like the following questions addressed: 1. Does the body of existing evidence on AHAs and skin sensitivity warrant voluntary or mandatory labeling on OTC sunscreen drug products containing AHAs regarding possible risks of increased sun damage (e.g., sunburn)? 2. If additional labeling is warranted, what information should be conveyed in the labeling and why? Comments along with supporting data will help enable FDA to determine how and what information, if any, related to UV hypersensitivity due to AHAs in sunscreen-cosmetic products should be communicated to consumers. FDA will also be evaluating any comments or data submitted in response to the final guidance for cosmetic products containing AHAs. In addition to AHAs, FDA seeks comment on titanium dioxide and zinc oxide formulated in particle sizes as small as a few nanometers. FDA addressed issues concerning micronized sunscreen ingredients in the FM (64 FR 27666 at 27671 to 27672). The FM stated that FDA did not consider micronized titanium dioxide to be a new ingredient but rather a specific grade of the same active ingredient. The FM also stated that FDA was aware of concerns about potential risks associated with increased dermal penetration of such small particles. However, the FM explained that, based on the safety data submitted to FDA before publication of the FM, FDA was not aware of any evidence at that time demonstrating a safety concern from the use of micronized titanium dioxide in sunscreen products (64 FR 27666 at 27671 to 27672). FDA recognizes that more sunscreens containing small particle size titanium dioxide and zinc oxide ingredients enter the market each year. FDA is interested in receiving comments and data about these sunscreen ingredients and products that contain these ingredients, their safety and effectiveness, and how they should be regulated. FDA received a citizen petition shortly before publication of this document that, among other things, raises these issues. FDA is currently evaluating the citizen petition, which is filed as CP17 in Docket No. 1978N-0038. FDA encourages other parties to submit additional data or information on the safety and effectiveness of sunscreen ingredients formulated in particle sizes as small as a few nanometers. On April 14, 2006, FDA announced in the **Federal Register** that we were planning a public meeting on FDA-regulated products containing nanotechnology materials (71 FR 19523). As explained in the notice, the purpose of the meeting was to help FDA further its understanding of developments in nanotechnology materials that pertain to FDA-regulated products. The meeting was held on October 10, 2006, and FDA has received comments from interested members of the public which have been filed in the docket for this public meeting (Docket No. 2006N- 0107). Some of these comments concern sunscreen ingredients formulated with nanotechnology materials. FDA will file any comments concerning sunscreen ingredients formulated in nanometer particle sizes received in response to this proposed rule in the docket for this rulemaking and the citizen petition (Docket No. 1978N-0038) and the docket for the nanotechnology meeting. X. Proposed Effective and Compliance Dates FDA is proposing that any final rule that may issue based on this proposal become effective 18 months after its date of publication in the **Federal Register** . The compliance date for products with annual sales less than $25,000 would be 24 months after publication of the final rule in the **Federal Register** . XI. References The following references are on display in the Division of Dockets Management (see ADDRESSES ) under Docket No. 1978N-0038 and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. 1. Comment No. CP6. 2. Comment Nos. CP8, C548, SUP22, and C555. 3. Comment Nos. LET166 and LET169. 4. Comment No. C538. 5. Comment No. C576. 6. Comment No. C565. 7. Comment No. C581. 8. Comment No. C567. 9. Comment No. C515. 10. Comment No. C597. 11. Comment No. MM22. 12. Comment No. MM21. 13. Comment No. C573. 14. Autier, P. et al., “Sunscreen Use and Duration of Sun Exposure: a Double-blind, Randomized Trial,” *Journal of the National Cancer Institute* , 91(15):1304-1309, 1999. 15. Reynolds, K.D. et al., “Predictors of Sun Exposure in Adolescents in a Southeastern U.S. Population,” *Journal of Adolescent Health* , 19(6):409-415, 1996. 16. Robinson, J.K., D.S. Rigel, and R.A. Amonette, “Summertime Sun Protection Used by Adults for Their Children,” *Journal American Academy of Dermatology* , 42(5):746-753, 2000. 17. Gallagher, R.P. et al., “Broad-spectrum Sunscreen Use and the Development of New Nevi in White Children: A Randomized Controlled Trial,” *Journal of the American Medical Association* , 283(22):2955-2960, 2000. 18. Stender, I.M., J.L. Andersen, and H.C. Wulf, “Sun Exposure and Sunscreen Use among Sunbathers in Denmark,” *Acta Dermato-Venereologica* , 76:31-33, 1996. 19. Zitser, B.S. et al., “A Survey of Sunbathing Practices on Three Connecticut State Beaches,” *Connecticut Medicine* , 60(10):591-594, 1996. 20. Green, A. et al., “Daily Sunscreen Application and Betacarotene Supplementation in Prevention of Basal-cell and Squamous-cell Carcinomas of the Skin: a Randomized Controlled Trial,” *The Lancet* , 354:723-729, 1999. 21. *IARC Handbooks of Cancer Prevention Volume 5 Sunscreens* , H. Vainio, ed., International Agency for Research on Cancer, Lyon, France, p. 62, 2001. 22. Diffey, B.L. et al., “In Vitro Assessment of the Broad-spectrum Ultraviolet Protection of Sunscreen Products,” * Journal of the American Academy of Dermatology * , 43(6):1024-1035, 2000. 23. Comment No. C572. 24. Gasparro, F.P., “Sunscreens, Skin Photobiology, and Skin Cancer: the Need for UVA Protection and Evaluation of Efficacy,” *Environmental Health Perspectives* , 108 Suppl 1:71-78, 2000. 25. Garland, C.F., F.C. Garland, and E.D. Gorham, “Lack of Efficacy of Common Sunscreens in Melanoma Prevention” in *Epidemiology, Causes and Prevention of Skin Diseases* , Grob, J.J. et al. eds., Blackwell Science Ltd., Malden, MA, pp. 151-159, 1997. 26. Lowe, N.J. et al., “Low Doses of Repetitive Ultraviolet A Induce Morphologic Changes in Human Skin,” *Journal of Investigative Dermatology* , 105(6):739-743, 1995. 27. Seite, S. et al., “Effects of Repeated Suberythemal Doses of UVA in Human Skin,” *European Journal of Dermatology* , 7:204-209, 1997. 28. Lavker, R.M. et al., “Quantitative Assessment of Cumulative Damage from Repetitive Exposures to Suberythemogenic Doses of UVA in Human Skin,” *Photodermatology, Photoimmunology, and Photomedicine* , 62(2):348-352, 1995. 29. Lavker, R.M. et al., “Cumulative Effects from Repeated Exposures to Suberythemal Doses of UVB and UVA in Human Skin,” *Journal of the American Academy of Dermatology* , 32(1):53-62, 1995. 30. Elmets, C.A., A. Vargas, and C. Oresajo, “Photoprotective Effects of Sunscreens in Cosmetics on Sunburn and Langerhans Cell Photodamage,” *Photodermatology, Photoimmunology, and Photomedicine* , 9(3):113-120, 1992. 31. Lavker, R., and K. Kaidbey, “The Spectral Dependence for UVA-induced Cumulative Damage in Human Skin,” *Journal of Investigative Dermatology* , 108(1):17-21, 1997. 32. Seite, S. et al., “A Full-UV Spectrum Absorbing Daily Use Cream Protects Human Skin Against Biological Changes Occurring in Photoaging,” *Photodermatology, Photoimmunology, and Photomedicine* , 16(4):147-155, 2000. 33. Boyd, A.S. et al., “The Effects of Chronic Sunscreen Use on the Histologic Changes of Dermatoheliosis,” *Journal of the American Academy of Dermatology* , 33(6):941-946, 1995. 34. Comment No. CP15. 35. Center for Disease Control and Prevention, “Guidelines for School Programs To Prevent Skin Cancer” in *Morbidity and Mortality Weekly Report* , 1-18, 2002. 36. Ries, A.G. et al., “The Annual Report to the Nation on the Status of Cancer, 1973-1997, with a Special Section on Colorectal Cancer,” *Cancer* , 88(10):2398-2424, 2000. 37. Cancer Facts and Figures 2007, American Cancer Society, Inc., 2007. 38. Sun Safety Tips, The American Academy of Dermatology, 1999. 39. Skin Cancer: Preventing America's Most Common Cancer 2001 Choose Your Cover, Centers for Disease Control and Prevention, 2001. 40. The Sun, UV, and You: A Guide to SunWise Behavior, Environmental Protection Agency, 1999. 41. Sun Protection Facts to Help You Prevent Skin Cancer, American Cancer Society, 2000. 42. What You Need to Know About Skin Cancer, National Cancer Institute, 1998. 43. Committee on Environmental Health, American Academy of Pediatrics, “Ultraviolet Light: A Hazard to Children,” *Pediatrics* , 104:328-333, 1999. 44. Green, A. et al., “Site Distribution of Cutaneous Melanoma in Queensland,” *International Journal of Cancer* , 53:232-236, 1992. 45. Franceschi, S. et al., “Site Distribution of Different Types of Skin Cancer: New Aetiological Clues,” *International Journal of Cancer* , 67:24-28, 1996. 46. Raasch, B. et al., “Body Site Specific Incidence of Basal and Squamous Cell Carcinoma in an Exposed Population, Townsville, Australia,” *Mutation Research* , 422:101-106, 1998. 47. Osterlind, A., K. Hou-Jensen, and O.M. Jensen, “Incidence of Cutaneous Malignant Melanoma in Denmark 1978-1982. Anatomic Site Distribution, Histologic Types, and Comparison with Non-melanoma Skin Cancer,” *British Journal of Cancer* , 58:385-391, 1988. 48. Neale, R., G. Williams, and A. Green, “Application Patterns Among Participants Randomized to Daily Sunscreen Use in a Skin Cancer Prevention Trial,” *Archives of Dermatology* , 138:1319-1325, 2002. 49. Comment No. C584. 50. Steinberg, C., and O. Larko, “Sunscreen Application and its Importance for Sun Protection Factor,” *Archives of Dermatology* , 121:1400-1402, 1985. 51. Stokes, R., and B. Diffey, “How Well Are Sunscreen Users Protected?,” *Photodermatology, Photoimmunology, and Photomedicine* , 13:186-188, 1997. 52. Sayre, R.M. et al., “Product Application Technique Alters the Sun Protection Factor,” *Photodermatology, Photoimmunology, and Photomedicine* , 8:222-224, 1991. 53. Azurda, R.M. et al., “Sunscreen Application Technique in Photosensitive Patients: a Quantitative Assessment and the Effect of Education,” *Photodermatology, Photoimmunology and Photomedicine* , 16:53-66, 2000. 54. Bech-Thomsen, N., and H.C. Wulf, “Sunbather's Application of Sunscreen is Probably Inadequate to Obtain Sun Protection Factor Assigned to the Preparation,” *Photodermatology, Photoimmunolology and Photomedicine* , 9:242-244, 1992. 55. Diffey, B., “People Do Not Apply Enough Sunscreen for Protection,” *British Medical Journal* , 313:942, 1996. 56. Wright, M.W. et al., “Mechanisms of Sunscreen Failure,” *Journal of the American Academy of Dermatology* , 44:781-784, 2001. 57. Rigel, D. et al., “American Academy of Dermatology's Melanoma/Skin Cancer Detection and Prevention Month Press Release,” April 25, 2001. 58. The ABCs for Fun in the Sun Educational Pamphlet, The American Academy of Dermatology, 1999. 59. Ultraviolet Index—What You Need to Know, The American Academy of Dermatology, 1996. 60. Sun Basics-Skin Protection Made Simple for Everyone Under the Sun, American Cancer Society, Inc., 1999. 61. Skin Protection Guide for Everyone Under the Sun. A Parents Guide to Sun Protection, American Cancer Society, Inc., 1999. 62. Can Melanoma Be Prevented?, American Cancer Society, Inc., 2001. 63. Diffey, B., “Has the Sun Protection Factor Had Its Day?,” *British Medical Journal* , 320:176-177, 2000. 64. Taylor, W.A., “Double Sampling Plan” in *Guide to Acceptance Sampling* , R. R. Donnelly & Sons, U.S.A., pp. 117-142, 1992. 65. Comment No. C574. 66. Comment No. C405. 67. Comment No. C404. 68. Comment No. C111. 69. Comment No. RPT7. 70. Comment No. C442. 71. Comment No. SUP29. 72. Memorandum from W.H. DeCamp, FDA, to C. Ganley, FDA, July 7, 2000. 73. Comment No. CP12. 74. Comment No. SUP33. 75. Gabriel, K.L. et al., “Sun Protection Factor Testing: Comparison of FDA and DIN Methods,” *Journal of Toxicology-Cutaneous and Ocular Toxicology* , 6:357-370, 1987. 76. Comment No. C491. 77. Comment No. TR2. 78. Diffey, B.L., “A Method for Broad Spectrum Classification of Sunscreens,” *International Journal of Cosmetic Science* , 16:47-52, 1994. 79. Diffey, B.L., and J. Robson, “A New Substrate to Measure Sunscreen Protection Factors Throughout the Ultraviolet Spectrum,” *Journal of the Society of Cosmetic Chemists* , 40:127-133, 1989. 80. Comment No. RPT9. 81. Comment No. LET170. 82. Press Release: “The Future of Sunscreen Labeling: Recommendations of the Consensus Conference on UVA Protection of Sunscreens Convened by the American Academy of Dermatology,” New York, NY, April 26, 2000. 83. Lim, H.W. et al., “American Academy of Dermatology Consensus Conference on UVA Protection of Sunscreens: Summary and Recommendations,” *Journal of the American Academy of Dermatology* , 44:505-508, 2001. 84. Cole, C., “Sunscreen Protection in the Ultraviolet A Region: How to Measure Effectiveness,” *Photodermatology, Photoimmunology, and Photomedicine* , 17:2-10, 2001. 85. Comment No. C137. 86. Setlow, R.B., et al., “Wavelengths Effective in Induction of Malignant Melanoma,” *Proceedings of the American Academy of Science, U.S.A.* , 90:6666-6670, 1993. 87. Moyal, D. et al., “UVA Protection Efficacy of Sunscreens Can Be Determined by the Persistent Pigment Darkening

(PPD)Method (Part 2),” *Photodermatology, Photoimmunology, and Photomedicine* , 16:250-255, 2000. 88. Moyal, D. et al., “Determination of UVA Protection Factors Using the Persistent Pigment Darkening

(PPD)Method as the Endpoint (Part 1) Calibration of the Method,” *Photodermatology, Photoimmunology, and Photomedicine* , 16:245-249, 2000. 89. Chardon, A. et al., “Persistent Pigment-Darkening Response as a Method for Evaluation of Ultraviolet A Protection Assays” in *Sunscreens: Development, Evaluation, and Regulatory Aspects* , 2nd edition, Marcel Dekker, Inc., New York, NY, pp. 559-582, 1997. 90. Comment No. TS3. 91. Diffey, B.L. et al., “Suncare Product Photostability: a Key Parameter for a More Realistic In Vitro Efficacy Evaluation,” *European Journal of Dermatology* , 7:226-228, 1997. 92. Sayre, R.M., and J. Dowdy, “Photostability Testing of Avobenzone,” *Cosmetics and Toiletries* , 114:85-86, 88, 90-91, 1999. 93. Urbach, F., “Man and Ultraviolet Radiation” in *Human Exposure to Ultraviolet Radiation: Risks and Regulations* , Passchier, W.F. and Bosnjakovic, B.F.M. (eds.), Elsevier Science, New York, NY, pp. 3-6, 1987. 94. RTI International, “FDA Labeling Cost Model, Final Report,” prepared by Mary Muth, Erica Gledhill, and Shawn Karns, RTI. Prepared for Amber Jessup, FDA Center for Food Safety and Applied Nutrition, Revised January 2003. List of Subjects 21 CFR Part 347 Labeling, Over-the-counter drugs. 21 CFR Part 352 Labeling, Over-the-counter drugs, Incorporation by reference. Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR parts 347 and 352 be amended as follows: PART 347—SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE 1. The authority citation for 21 CFR part 347 continues to read as follows: Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371. 2. FDA is proposing to lift the stay of § 347.20(d) as published at 68 FR 33362, June 4, 2003. PART 352—SUNSCREEN DRUG PRODUCTS FOR OVER THE COUNTER HUMAN USE 3. The authority citation for 21 CFR part 352 continues to read as follows: Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371. 4. FDA is proposing to lift the stay of 21 CFR part 352 as published at 68 FR 33362, June 4, 2003. 5. Section 352.3 is amended by redesignating paragraphs

(b)through

(d)as

(c)through (e), respectively; revising newly redesignated paragraphs

(c)and (e); and adding new paragraph

(b)to read as follows: § 352.3 Definitions.

(b)*Minimal pigmenting dose (MPD)* . The quantity of erythema-effective energy (expressed as Joules per square meter) required to produce the first perceptible pigment darkening.

(c)*Product category designation (PCD)* . A labeling designation for sunscreen drug products to aid in selecting the type of product best suited to an individual's complexion (pigmentation) and desired response to ultraviolet

(UV)radiation.

(1)*Low UVB sunburn protection product* . A sunscreen product that provides a sunburn protection factor

(SPF)value of 2 to under 15.

(2)*Medium UVB sunburn protection product* . A sunscreen product that provides an SPF value of 15 to under 30.

(3)*High UVB sunburn protection product* . A sunscreen product that provides an SPF value of 30 to 50.

(4)*Highest UVB sunburn protection product* . A sunscreen product that provides an SPF value over 50.

(e)*Sunburn protection factor

(SPF)value* . The UV energy required to produce an MED on protected skin divided by the UV energy required to produce an MED on unprotected skin, which may also be defined by the following ratio: SPF value = MED (protected skin (PS))/MED (unprotected skin (US)), where MED(PS) is the minimal erythema dose for protected skin after application of 2 milligrams per square centimeter of the final formulation of the sunscreen product, and MED(US) is the minimal erythema dose for unprotected skin (i.e., skin to which no sunscreen product has been applied). In effect, the SPF value is the reciprocal of the effective transmission of the product viewed as a UV radiation filter. 6. Section 352.20 is amended by revising paragraph (a)(2) to read as follows: § 352.20 Permitted combinations of active ingredients.

(a)* * *

(2)Avobenzone in § 352.10(b) may be combined with one or more sunscreen active ingredients identified in § 352.10(c), (e), (f),

(i)through (l), (n), (o), (q), and

(r)in a single product when used in the concentrations established for each ingredient in § 352.10. The concentration of each active ingredient must be sufficient to contribute a minimum SPF of not less than 2 to the finished product. The finished product must have a minimum SPF of not less than the number of sunscreen active ingredients used in the combination multiplied by 2. 7. Section 352.50 is revised to read as follows: § 352.50 Principal display panel of all sunscreen drug products.

(a)*UVB sunburn protection designation* —(1) *For products with an SPF of 2 to under 15* . The labeling states “UVB SPF [insert tested SPF value of the product] low”.

(2)*For products with an SPF of 15 to under 30* . The labeling states “UVB SPF [insert tested SPF value of the product] medium”.

(3)*For products with an SPF of 30 to 50* . The labeling states “UVB SPF [insert tested SPF value of the product] high”.

(4)*For products with an SPF over 50* . The labeling states “UVB SPF 50 [select one of the following: ‘plus’ or ‘+’] highest”. Any statement accompanying the marketed product that states a specific SPF value over 50 or similar language indicating a person can stay in the sun more than 50 times longer than without sunscreen will cause the product to be misbranded under section 502 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 352).

(b)*UVA protection designation* —(1) *For products not providing UVA protection according to § 352.73* . The labeling states “no UVA protection”.

(i)The UVA protection designation shall appear on the principal display panel along with the UVB protection designation in an equally prominent manner that does not conflict with the UVB protection designation.

(ii)The font size of the UVA protection designation shall be the same size as the UVB protection designation.

(2)*For products providing UVA protection according to § 352.73* . The labeling states “UVA [select one of the following in accordance with § 352.73: ‘★✰✰✰ Low,’ ‘★★✰✰ Medium,’ ‘★★★✰ High,’ or ‘★★★★ Highest’]”.

(ii)The font size of the UVA protection designation shall be the same size as the UVB protection designation.

(iii)All star borders and the color inside a solid star shall be the same while the color of “empty” stars must be lighter and distinctly different than solid stars. The color inside a solid star should be distinctly different than the background color.

(iv)The stars are to be filled in starting with the first star on the left and are to appear in a straight horizontal line.

(c)Select one of the following: “UV rays from the sun are made of UVB and UVA. It is important to protect against both UVB & UVA rays.” or “UV rays from the sun are made of UVB and UVA. It is important to protect against both UVB & UVA rays to prevent sunburn and other skin damage.”

(d)*For products that satisfy the water resistant sunscreen product testing procedures in § 352.76* . The labeling states (select one of the following: “water,” “water/sweat,” or “water/perspiration”) “resistant.”

(e)*For products that satisfy the very water resistant sunscreen product testing procedures in § 352.76* . The labeling states “very” (select one of the following: “water,” “water/sweat,” or “water/perspiration”) “resistant.” 8. Section 352.52 is amended by revising paragraphs (b), (c), (d), (e), the heading of paragraph (f), paragraphs (f)(1)(ii) through (f)(1)(vi) to read as follows: § 352.52 Labeling of sunscreen drug products.

(b)*Indications* . The labeling of the product states, under the heading “Uses,” all of the phrases listed in paragraph (b)(1) of this section that are applicable to the product and may contain any of the additional phrases listed in paragraph (b)(2) of this section, as appropriate. Other truthful and nonmisleading statements, describing only the uses that have been established and listed in this paragraph (b), may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the act (21 U.S.C. 352) relating to misbranding and the prohibition in section 301(d) of the act (21 U.S.C. 331(d)) against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act (21 U.S.C. 355(a)).

(1)*For products containing any ingredient in § 352.10* .

(i)*For products with an SPF of 2 to under 15* . The labeling states “[bullet] 1 low UVB sunburn protection”. 1 See § 201.66(b)(4) of this chapter for definition of bullet symbol.

(ii)*For products with an SPF of 15 to under 30* . The labeling states “[bullet] medium UVB sunburn protection”.

(iii)*For products with an SPF of 30 to 50* . The labeling states “[bullet] high UVB sunburn protection”.

(iv)*For products with an SPF over 50* . The labeling states “[bullet] highest UVB sunburn protection”.

(v)*For products not providing UVA protection according to § 352.73* . The labeling states “[bullet] no UVA protection.”

(vi)*For products providing UVA protection according to § 352.73* . The labeling states “[bullet] [select one of the following in accordance with § 352.73: ‘Low,’ ‘medium,’ ‘high,’ or ‘highest’] UVA protection”.

(vii)*For products that satisfy the water resistant testing procedures identified in § 352.76* . The labeling states “[bullet] retains SPF after 40 minutes of [select one or more of the following: ‘activity in the water,’ ‘swimming,’ ‘sweating,’ ‘perspiring,’ ‘swimming/sweating,’ or ‘swimming/perspiring’]”.

(viii)*For products that satisfy the very water resistant testing procedures identified in § 352.76* . The labeling states “[bullet] retains SPF after 80 minutes of [select one or more of the following: ‘activity in the water,’ ‘swimming,’ ‘sweating,’ ‘perspiring,’ ‘swimming/sweating,’ or ‘swimming/perspiring’]”.

(2)*Additional indications* . In addition to the indications provided in paragraph (b)(1) of this section, the following may be used for products containing any ingredient in § 352.10:

(i)*For products with an SPF of 2 to under 15* . Select one or both of the following: “[Bullet] provides low protection against [select one of the following: ‘sunburn’ or ‘sunburn and tanning’]” or “[bullet] for skin that sunburns minimally”.

(ii)*For products with an SPF of 15 to under 30* . Select one or both of the following: “[Bullet] provides medium protection against [select one of the following: ‘sunburn’ or ‘sunburn and tanning’]” or “[bullet] for skin that sunburns moderately”.

(iii)*For products with an SPF of 30 to 50* . Select one or both of the following: “[Bullet] [select one of the following: ‘provides high’ or ‘high’] protection against [select one of the following: ‘sunburn’ or ‘sunburn and tanning’]” or “[bullet] for skin highly sensitive to sunburn”.

(iv)*For products with an SPF over 50* . Select one or both of the following: “[Bullet] [select one of the following: ‘provides highest’ or ‘highest’] protection against [select one of the following: ‘sunburn’ or ‘sunburn and tanning’]” or “[bullet] for skin extremely sensitive to sunburn”.

(v)If the UVA descriptor in § 352.52(b)(1)(vi) is the same as the SPF descriptor in § 352.52(b)(1)(i) through (b)(1)(iv), then the statement in § 352.52(b)(1)(i) through (b)(1)(iv) may be combined with the statement in § 352.52(b)(1)(vi) as follows: “[Bullet] [select one of the following descriptors in accordance with §§ 352.70 and 352.73: ‘low,’ ‘medium,’ ‘high,’ or ‘highest’] UVB sunburn/UVA protection”.

(c)*Warnings* . The labeling of the product contains the following warnings under the heading “Warnings:”

(1)The labeling states in bold type “UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen.”

(2)The labeling states “When using this product [bullet] keep out of eyes. Rinse with water to remove.”

(3)The labeling states “Stop use and ask a doctor if [bullet] skin rash occurs”.

(d)*Directions* . The labeling of the product contains the following statements, as appropriate, under the heading “Directions.” More detailed directions applicable to a particular product formulation (e.g., cream, gel, lotion, oil, spray, etc.) may also be included.

(1)*For products containing any ingredient in § 352.10* .

(ii)The labeling states “[bullet] apply and reapply as directed to avoid lowering protection”.

(iii)As an option, the labeling may state “[bullet] apply to all skin exposed to the sun”.

(iv)The labeling states “[bullet] children under 6 months of age: ask a doctor”.

(2)*For products that satisfy the water resistant or very water resistant testing procedures identified in § 352.76* . The labeling states “[bullet] reapply after [select one of the following: ‘40 minutes of’ or ‘80 minutes of’ for products that satisfy either the water resistant or very water resistant test procedures in § 352.76, respectively] swimming or [select one or more of the following: ‘sweating’ or ‘perspiring’] and after towel drying. Otherwise, reapply at least every 2 hours”.

(e)*Statement on product performance* —(1) * For products containing any ingredient identified in § 352.10 * . The following product category designation

(PCD)labeling claims may be used under the heading “Other information” or anywhere outside of the “Drug Facts” box or enclosure and shall not be intermixed with the information required under § 352.50(a).

(i)*For products with an SPF of 2 to under 15* . The labeling states “low sunburn protection product”.

(ii)*For products with an SPF of 15 to under 30* . The labeling states “medium sunburn protection product”.

(iii)*For products with an SPF of 30 to 50* . The labeling states “high sunburn protection product”.

(iv)*For products with an SPF over 50* . The labeling states “highest sunburn protection product”.

(2)*For products containing any ingredient identified in § 352.10* . The following labeling statement may be used under the heading “Other information” or anywhere outside of the “Drug Facts” box or enclosure and shall not be intermixed with the information required under § 352.50(a). The labeling states “higher SPF products give more sun protection, but are not intended to extend the time spent in the sun”.

(3)*For products containing any ingredient identified in § 352.10 and that satisfy the requirements in § 352.73 for a labeled UVA protection value* . The following labeling statements may be used anywhere outside of the “Drug Facts” box or enclosure and shall not be intermixed with the information required under § 352.50(a).

(i)The labeling states “broad spectrum sunscreen”.

(ii)The labeling states “provides [select one of the following: ‘UVA and UVB,’ or ‘broad spectrum’] protection”.

(iii)The labeling states “protects from UVA and UVB [select one of the following: ‘rays’ or ‘radiation’]”.

(iv)The labeling states “[select one of the following: ‘absorbs’ or ‘protects’] within the UVA spectrum”.

(f)*Products, including cosmetic-drug products, containing any ingredient identified in § 352.10 labeled for use only on specific small areas of the face (e.g., lips, nose, ears, and/or around the eyes) and that meet the criteria established in § 201.66(d)(10) of this chapter* . * * *

(1)* * *

(ii)The indication required by § 201.66(c)(4) of this chapter may be limited to the following: “Use [in bold type] helps prevent sunburn.”

(iii)The warnings required by § 201.66(c)(5)(i) through (c)(5)(ix) of this chapter may be limited to the following: “UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen. [in bold type]” “[bullet] keep out of eyes” “[bullet] stop use if skin rash occurs.”

(iv)The warning in § 201.66(c)(5)(x) of this chapter may be limited to the following: “Keep out of reach of children.”

(v)*For lip protectant products containing any ingredient identified in § 352.10* . The heading and the indication required by § 201.66(c)(4) of this chapter may be limited to “Use [in bold type] helps prevent sunburn and chapped lips”. The warnings required in paragraph (f)(1)(iii) of this section may be limited to the following: “Stop use if skin rash occurs.” The warning required in paragraph (f)(1)(iv) of this section may be omitted. The directions in paragraphs (d)(2) and (d)(3) of this section may be limited to the following: “apply liberally and reapply at least every 2 hours for sunburn protection”.

(vi)*For lipsticks, lip products to prolong wear of lipstick, lip gloss, and lip balm containing any ingredient identified in § 352.10 and identified in § 720.4(c)(7) of this chapter* . The labeling is identical to that in paragraph (f)(1)(v) of this section except the heading and the indication required by § 201.66(c)(4) of this chapter are limited to “Use [in bold type] helps prevent sunburn”. 9. Section 352.60 is amended by revising paragraphs

(c)and

(d)to read as follows: § 352.60 Labeling of permitted combinations of active ingredients.

(c)*Warnings* . The labeling of the product states, under the heading “Warnings,” the warning(s) for each ingredient in the combination, as established in the warnings section of the applicable OTC drug monographs, except that the warning for skin protectants in § 347.50(c)(3) of this chapter is not required for permitted combinations containing a sunscreen and a skin protectant identified in § 352.20(b). For products marketed as a lip protectant with sunscreen, § 352.52(f)(1)(vi) applies.

(d)*Directions* . The labeling of the product states, under the heading “Directions,” directions that conform to the directions established for each ingredient in the directions sections of the applicable OTC drug monographs, unless otherwise stated in this paragraph. When the time intervals or age limitations for administration of the individual ingredients differ, the directions for the combination product may not contain any dosage that exceeds those established for any individual ingredient in the applicable OTC drug monograph(s), and may not provide for use by any age group lower than the highest minimum age limit established for any individual ingredient. For permitted combinations containing a sunscreen and a skin protectant identified in § 352.20(b), the directions for sunscreens in § 352.52(d) must be used. For products marketed as a lip protectant with sunscreen, § 352.52(f)(1)(vi) applies. 10. Sections 352.70 through 352.73 are revised as follows: Subpart D—Testing Procedures Sec. 352.70 SPF testing procedure. 352.71 UVA in vitro testing procedure. 352.72 UVA in vivo testing procedure. 352.73 Determination of the labeled UVA protective value. § 352.70 SPF testing procedure.

(a)*Standard sunscreens* —(1) *Laboratory validation* . A standard sunscreen shall be used concomitantly in the testing procedures for determining the SPF value of a sunscreen drug product to ensure the uniform evaluation of sunscreen drug products.

(i)*For products with an SPF of 2 to 15* . The standard sunscreen shall be an 8-percent homosalate preparation with a mean SPF value of 4.47 (standard deviation = 1.28). In order for the SPF determination of a test product to be considered valid, the SPF of the standard sunscreen must fall within the standard deviation range of the expected SPF (i.e., 4.47 ± 1.28). Optionally, the standard sunscreen in paragraph (a)(1)(ii) of this section may be used.

(ii)*For products with an SPF over 15 (optional for SPF values of 2 to 15)* . The standard sunscreen shall be an SPF 15 formulation containing 7 percent padimate O and 3 percent oxybenzone with a mean SPF value of 16.3 (standard deviation = 3.43). In order for the SPF determination of a test product to be considered valid, the SPF of the standard sunscreen must fall within the standard deviation range of the expected SPF (i.e., 16.3 ± 3.43).

(2)*Standard homosalate sunscreen* —(i) *Preparation of the standard homosalate sunscreen* .

(A)The standard homosalate sunscreen is prepared from two different preparations (preparation A and preparation B) with the following compositions: **Composition of Preparation A and Preparation B of the Homosalate Standard Sunscreen** Ingredients Percent by weight Preparation A Lanolin 5.00 Homosalate 8.00 White petrolatum 2.50 Stearic acid 4.00 Propylparaben 0.05 Preparation B Methylparaben 0.10 Edetate disodium 0.05 Propylene glycol 5.00 Triethanolamine 1.00 Purified water USP 74.30

(B)Preparation A and preparation B are heated separately to 77 to 82 °C, with constant stirring, until the contents of each part are solubilized. Add preparation A slowly to preparation B while stirring. Continue stirring until the emulsion formed is cooled to room temperature (15 to 30 °C). Add sufficient purified water to obtain 100 grams of standard sunscreen preparation.

(ii)*High performance liquid chromatography

(HPLC)assay of the standard homosalate sunscreen* . Assay the standard homosalate sunscreen preparation by the following method to ensure proper concentration:

(A)*Reagents* . ( *1* ) Acetic acid, glacial, ACS grade. ( *2* ) Isopropanol, HPLC grade. ( *3* ) Methanol, HPLC grade. ( *4* ) Homosalate, USP reference standard.

(B)*Instrumentation* . Equilibrate a suitable liquid chromatograph to the following or equivalent conditions: Column Ultrasphere ODS 150 x 4.6 millimeters (5 microns), or Ultrasphere ODS 250 x 4.6 millimeters (5 microns) Mobile Phase 85:15:0.5 methanol:water:acetic acid Flow Rate 1.5 milliliters per minute Temperature Ambient Detector UV spectrophotometer at 308 nanometers Attenuation As needed Injection Amount 10 microliters

(C)*Standard preparation* . ( *1* ) Accurately weigh 0.50 gram of homosalate USP reference standard into a 250-milliliter volumetric flask. Dissolve and dilute to volume with isopropanol. Mix well. ( *2* ) Accurately pipet 20.0 milliliters of the homosalate solution (described in paragraph (a)(2)(ii)(C)( *1* ) of this section) into a 100-milliliter volumetric flask. Dilute to volume with isopropanol and mix well. This is the standard preparation.

(D)*Sample preparation* . ( *1* ) Accurately weigh 2.0 grams of sample into a 100-milliliter volumetric flask. ( *2* ) Add approximately 75 milliliters of isopropanol and heat with swirling until the sample is evenly dispersed. ( *3* ) Cool to room temperature (15 to 30 °C) and dilute to volume with isopropanol. Mix well. ( *4* ) Pipet 25.0 milliliters of this sample preparation into a 100-milliliter volumetric flask and dilute to volume with isopropanol. Mix well.

(E)*System suitability* . ( *1* ) Three replicate injections of the standard preparation (described in paragraph (a)(2)(ii)(C)( *2* ) of this section) will yield a relative standard deviation of not more than 2.0 percent calculated on peak areas for homosalate. ( *2* ) In case a system fails to meet this criterion, adjusting the mobile phase or replacing the column may be necessary to obtain suitable chromatography.

(F)*Analysis* . ( *1* ) Inject 10 microliters of the standard preparation (described in paragraph (a)(2)(ii)(C) of this section) in triplicate and collect data for about 15 minutes or until both homosalate (two isomers) peaks have completely eluted. ( *2* ) Similarly inject 10 microliters of each sample preparation. ( *3* ) The system suitability requirements must be met.

(G)*Calculation* . Sum the peak areas of the two homosalate isomers for each injection and calculate the percent (weight/weight) homosalate content in the sample preparation as follows: EP27AU07.005

(3)*Standard padimate O/oxybenzone sunscreen* —(i) *Preparation of the standard padimate O/oxybenzone sunscreen* . The standard sunscreen is prepared from four different parts (parts A, B, C, and D) with the following compositions: **Composition of the Padimate O/Oxybenzone Standard Sunscreen** Ingredients Percent by weight Part A Lanolin 4.50 Cocoa butter 2.00 Glyceryl monostearate 3.00 Stearic acid 2.00 Padimate O 7.00 Oxybenzone 3.00 Propylparaben 0.10 Part B Purified water USP 71.60 Sorbitol solution 5.00 Triethanolamine, 99 percent 1.00 Methylparaben 0.30 Part C Benzyl alcohol 0.50 Part D Purified water USP QS1 1 Quantity sufficient to make 100 grams

(A)*Step 1* . Add the ingredients of Part A into a suitable stainless steel kettle equipped with a propeller agitator. Mix at 77 to 82 °C until uniform.

(B)*Step 2* . Add the water of Part B into a suitable stainless steel kettle equipped with a propeller agitator and begin mixing and heating to 77 to 82 °C. Add the remaining ingredients of Part B and mix until uniform. Maintain temperature at 77 to 82 °C.

(C)*Step 3* . Add the batch of Step 1 at 77 to 82 °C to the batch of Step 2 at 77 to 82 °C, and mix until smooth and uniform. Slowly cool the batch to 49 to 54 °C.

(D)*Step 4* . Add the benzyl alcohol of Part C to the batch of Step 3 at 49 to 54 °C. Mix until uniform. Continue to cool batch to 35 to 41 °C.

(E)*Step 5* . Add sufficient water of Part D to the batch of Step 4 at 35 to 41 °C to obtain 100 grams of standard sunscreen preparation. Mix until uniform. Cool batch to 27 to 32 °C.

(ii)*HPLC assay of the standard padimate O/oxybenzone sunscreen* . To ensure that the standard sunscreen contains proper amounts of padimate O and oxybenzone, analyze it against USP reference standards for padimate O and oxybenzone in a high performance liquid chromatography procedure using the following parameters:

(A)*Reagents* . ( *1* ) Acetic acid, glacial, ACS grade. ( *2* ) Isopropanol, HPLC grade. ( *3* ) Methanol, HPLC grade. ( *4* ) Oxybenzone, USP reference standard. ( *5* ) Padimate O, USP reference standard.

(B)*Instrumentation* . Equilibrate a suitable liquid chromatograph to the following or equivalent conditions: Column Ultrasphere ODS 250 x 4.6 millimeters (5 microns), or Supelcosil LC-18 DB 250 x 4.6 millimeters (5 microns) Mobile Phase 85:15:0.5 methanol:water:acetic acid Flow Rate 1.5 milliliters per minute Temperature Ambient Detector UV spectrophotometer at 308 nanometers Attenuation As needed Injection Amount 10 microliters

(C)*Standard preparation* . ( *1* ) Weigh 0.50 gram of oxybenzone reference standard into a 250-milliliter volumetric flask. Dissolve and dilute to volume with isopropanol. Mix well. ( *2* ) Weigh 0.50 gram of padimate O reference standard into a 250-milliliter volumetric flask. Dissolve and dilute to volume with isopropanol. Mix well. ( *3* ) Pipet 3.0 milliliters of the oxybenzone solution and 7.0 milliliters of the padimate O solution into a 100-milliliter volumetric flask. Dilute to volume with isopropanol and mix well. This is the standard preparation.

(D)*Sample preparation* . ( *1* ) Weigh 1.0 gram of sample into a 50-milliliter volumetric flask. ( *2* ) Add approximately 30 milliliters of isopropanol and heat with swirling until the sample is evenly dispersed. ( *3* ) Cool to room temperature (15 to 30 °C) and dilute to volume with isopropanol. Mix well. ( *4* ) Pipet 5.0 milliliters of this sample preparation into a 50-milliliter volumetric flask and dilute to volume with isopropanol. Mix well.

(E)*System suitability* . ( *1* ) Three replicate injections of the standard preparation (described in paragraph (a)(3)(ii)(C) of this section) will yield a relative standard deviation of not more than 2.0 percent calculated on peak areas for oxybenzone and padimate O. ( *2* ) A calculated resolution between the oxybenzone and padimate O peaks will be not less than 3.0. ( *3* ) In case a system fails to meet this criterion, adjusting the mobile phase or replacing the column may be necessary to obtain suitable chromatography.

(F)*Analysis* . ( *1* ) Inject 10 microliters of the standard preparation (described in paragraph (a)(3)(ii)(C) of this section) in triplicate and collect data for about 15 minutes or until the padimate O peak has completely eluted. Elution order is oxybenzone, then padimate O. ( *2* ) Similarly inject 10 microliters of each sample preparation. ( *3* ) The system suitability requirements must be met.

(G)*Calculation* . Calculate the percent (weight/weight) of each sunscreen ingredient in the sample preparation as follows: ( *1* ) Oxybenzone (percent weight) EP27AU07.006 ( *2* ) Padimate O (percent weight) EP27AU07.007

(nm)with a limit of 1,500 watts per square meter (W/m 2 ) on total solar simulator irradiance for all wavelengths between 250 and 1400 nm and the following percentage of erythema-effective radiation in each specified range of wavelengths: **Solar Simulator Emission Spectrum** Wavelength range

(nm)Percent erythemal contribution < 290 < 0.1 290-310 46.0-67.0 290-320 80.0-91.0 290-330 86.5-95.0 290-340 90.5-97.0 290-350 93.5-98.5 290-400 93.5-100.0

(c)*General testing procedures* —(1) *Medical history* . Obtain a medical history from each subject with emphasis on the effects of sunlight on his/her skin. Determine that each subject is in good general health with skin type I, II, or III (as described in this paragraph). *Skin Type and Sunburn and Tanning History (Based on first 30 to 45 minutes of sun exposure after a winter season of no sun exposure).* I: Always burns easily; never tans (sensitive). II: Always burns easily; tans minimally (sensitive). III: Burns moderately; tans gradually (light brown) (normal). IV: Burns minimally; always tans well (moderate brown) (normal). V: Rarely burns; tans profusely (dark brown) (insensitive). VI: Never burns; deeply pigmented (insensitive). Determine that the subject is not taking topical or systemic medication that is known to alter responses to ultraviolet radiation and that the subject has no history of sensitivities to topical products and/or abnormal responses to sunlight, such as a phototoxic or photoallergic response.

(2)*Physical examination* . Conduct a physical examination to determine the presence of sunburn, suntan, scars, active dermal lesions, and uneven skin tones on the areas of the back to be tested. A suitable source of low power UVA, such as a Woods lamp, is helpful in this process. If any of these conditions are present, the subject is not qualified to participate in the study. The presence of nevi, blemishes, or moles will be acceptable if in the physician's judgment they will neither compromise the study, nor jeopardize subject safety. Subjects with dysplastic nevi should not be enrolled. Excess hair on the back is acceptable if the hair is clipped. Shaving is unacceptable because it may remove a significant portion of the stratum corneum and temporarily increase skin permeability to ultraviolet radiation.

(3)*Informed consent* . Obtain legally effective written informed consent from all subjects.

(4)*Test site delineation* —(i) *Test site* . A test site is the location on the back for determining the subject's initial and final minimal erythema dose

(MED)for unprotected skin and for determining SPF values after application of the sunscreen standard and the test sunscreen product(s). There typically are 4 to 6 test sites for each subject. Test sites should be located on the back between the beltline and the shoulder blades (scapulae) and lateral to the midline. Each test site shall be a minimum of 50 square centimeters, e.g., 5 x 10 centimeters. Outline the test sites to which the sunscreen standard and the test sunscreen product(s) will be applied with indelible ink. If the subject is to receive the doses of ultraviolet radiation in an upright (seated) position, draw the lines on the skin with the subject upright (seated). If the subject is to receive the doses of ultraviolet radiation while prone, draw the lines with the subject prone.

(ii)*Test subsite* . Test subsites are the locations to which ultraviolet radiation is administered within a test site. At least 5 test subsites will receive UV doses within each test site. Test subsites will be at least 1 square centimeter (cm 2 ) in area and will be separated from each other by at least 1 cm. Mark the location of each test subsite with indelible ink.

(5)*Application of test materials* . Apply the test sunscreen product and the standard sunscreen at 2 milligrams per square centimeter (mg/cm 2 ) to their respective test sites to establish standard films. Test sites will be randomly located on the back in a blinded manner. Use a finger cot compatible with the sunscreen to spread the product as evenly as possible. Pretreat the finger cot by saturating with the sunscreen and then wiping off material before application. Pretreatment is meant to ensure that sunscreen is applied at the correct density of 2 mg/cm 2 .

(6)*Waiting period* . Before exposing the test site areas after applying a product, wait at least 15 minutes.

(7)*Number of subjects* —(i) *For products with an expected SPF under 30* . A test panel shall consist of 20 to 25 subjects with at least 20 subjects who produce valid data for analysis. Data are valid unless rejected in accordance with paragraph (c)(9) of this section. If more than 5 subjects are rejected based on paragraph (c)(9) of this section, the panel is disqualified, and a new panel must be created.

(8)*Response criteria* . In order that the person who evaluates the MED responses is not biased, he/she must not be the same person who applied the sunscreen drug product to the test site or administered the doses of UV radiation. After UV radiation exposure from the solar simulator is completed, all immediate responses shall be recorded. These may include an immediate darkening or tanning, typically grayish or purplish in color, which fades in 30 to 60 minutes; an immediate reddening at the subsite, due to heating of the skin, which fades rapidly; and an immediate generalized heat response, spreading beyond the subsite, which fades in 30 to 60 minutes. After the immediate responses are noted, each subject shall shield the exposed area from further UV radiation until the MED response is evaluated. Determine the MED 16 to 24 hours after exposure. Evaluate the erythema responses of each test site using either tungsten or warm white fluorescent lighting that provides 450 to 550 lux of illumination at the test site. For the evaluation, the test subject should be in the same position used when the test site was irradiated. For each test site, determine the smallest UV dose that produced redness reaching the borders of the test subsite. The MED is the quantity of erythema-effective energy required to produce the first perceptible, redness reaction with clearly defined borders at 16 to 24 hours post-exposure. To determine the MED, there must be at least one subsite that received a smaller UV dose and does not produce redness as well as a subsite(s) with somewhat more intense redness. For subsites showing an erythema response, the maximal exposure should be no more than twice the total energy of the minimal exposure.

(9)*Rejection of test data* . Reject test data if the exposure series fails to elicit an MED response on either the treated or unprotected skin sites; or all subsites within a test site show more intense responses than the threshold erythema response; or the responses are inconsistent with the series of UV doses administered; or the subject was noncompliant, e.g., the subject withdraws from the test due to illness or work conflicts or does not shield the exposed testing sites from further UV radiation until the MED is read.

(d)*Determination of SPF* —(1) *Determination of erythema action spectrum* .

(i)Use the following erythema action spectrum as weighting factors to calculate the erythema-effective exposure produced by a solar simulator: V i (λ) = 1.0 (250 < λ < 298 nm) V i (λ) = 10 0.094 * (298 - λ ) (298 < λ < 328 nanometers) V i (λ) = 10 0.015 * (140 - λ ) (328 < λ < 400 nanometers)

(ii)Integrate the erythemally-effective spectral irradiance over wavelength and time to calculate the erythema-effective UV dose delivered by a solar simulator as follows: EP27AU07.008

(iii)The erythema action spectrum may be determined using a handheld radiometer with a response weighted to match the spectrum in “CIE S 007/E Erythemal Reference Action Spectrum and Standard Erythema Dose,” dated 1998, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from CIE Central Bureau, Kegelgasse 27, A-1030, Vienna, Austria, or may be examined at the Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 22, Silver Spring, MD, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. It is advisable to measure the solar simulator output before and after each phototest or, at a minimum, at the beginning and end of each test day. This radiometer should be calibrated using side by side comparison with the spectroradiometer (using the weighting factors determined according to paragraph (d)(1)(i) of this section) at the time of the semiannual spectroradiometric measurement of the solar simulator.

(2)*Determination of MED of unprotected skin* . Administer a series of five UV radiation doses expressed as J/m 2 -eff (adjusted to the erythema action spectrum calculated according to paragraph (d)(1) of this section) to the subsites within each test site on a subject using an accurately calibrated solar simulator. Use the series of five exposures to the unprotected test site to determine the initial unprotected MED. Select the doses that are a geometric series represented by (1.25 n ), wherein each exposure dose is 25 percent greater than the previous exposure dose to maintain the same relative uncertainty (expressed as a constant percentage), independent of the subject's sensitivity to UV radiation. Usually, the UV radiation for determining the initial unprotected MED is administered the day prior to applying the sunscreen product and standard sunscreen, and the responses then are evaluated immediately prior to applying the sunscreen product and sunscreen standard. Determine the final unprotected MED on the same day that UV radiation is administered to the sunscreen-protected test sites. Use the final unprotected MED (MED(US)) in calculating SPF.

(3)*Determination of individual SPF values* . Administer a series of five UV radiation doses expressed as J/m 2 -eff (adjusted to the erythema action spectrum calculated according to paragraph (d)(1) of this section) to the subsites within each test site on a subject using an accurately calibrated solar simulator. The five UV doses will be a geometric series as described in paragraph (d)(2) of this section, where the middle exposure represents the expected SPF. For products with an expected SPF less than 8, use exposures that are the product of the initial unprotected MED times 0.64X, 0.80X, 1.00X, 1.25X, and 1.56X, where X equals the expected SPF of the test product. For products with an expected SPF between 8 and 15, use exposures that are the initial unprotected MED times 0.69X, 0.83X, 1.00X, 1.20X, and 1.44X, where X equals the expected SPF of the test product. For products with an expected SPF greater that 15, use exposures that are the initial unprotected MED times 0.76X, 0.87X, 1.00X, 1.15X, and 1.32X, where X equals the expected SPF of the test product. The MED is the smallest erythemally-effective UV dose required to produce mild redness within the subsite border at 16 to 24 hours post-exposure. Calculate the SPF value of each sunscreen product and sunscreen standard using the MED of sunscreen-protected skin (MED(PS)) and the final unprotected skin MED (MED(US)) as follows: EP27AU07.009

(4)*Determination of the test product SPF and PCD* . Use data from at least 20 test subjects with n representing the number of subjects used. First, compute the SPF value for each subject as stated in paragraphs (d)(2) and (d)(3) of this section. Second, compute the mean SPF value, x , and the standard deviation, s, for these subjects. Third, obtain the upper 5-percent point from Student's t distribution table with n-1 degrees of freedom. Denote this value by t. Fourth, compute ts/√n. Denote this quantity by A (i.e., A = ts/√n). Fifth, calculate the SPF value to be used in labeling as follows: The label SPF equals the largest whole number less than x - A. Sixth and last, the sunscreen product is classified into a PCD as follows: If 50 + A < x , the PCD is Highest; if 30 + A ≤ x ≤ 50 + A, the PCD is High; if 15 + A ≤ x < 30 + A, the PCD is Medium; if 2 + A ≤ x < 15 + A, the PCD is Low; if x < 2 + A, the product shall not be labeled as an OTC sunscreen drug product and may not display an SPF value. § 352.71 UVA in vitro testing procedure.

(a)*Light source for transmittance/absorbance measurements* . The light source should satisfy the requirements for solar simulators described in § 352.70(b).

(b)*Substrate* . Use optical-grade quartz plate suitable for substrate spectrophotometry that has been roughened on one side.

(c)*Sample holder* . The sample holder should hold the substrate in a horizontal position to avoid flowing of the sunscreen drug product from one edge of the substrate to the other. It should be mounted as close as possible to the input optics of the spectroradiometer to maximize capture of forward scattered radiation. The sample holder should be a thin, flat plate with a suitable aperture through which UV radiation can pass. The substrate will be placed on the upper surface of the sample holder.

(d)*Spectroradiometer input optics* . Unless the spectroradiometer is equipped with an integrating sphere, an ultraviolet radiation diffuser should be placed between the sample and the input optics of the spectroradiometer. The diffuser will be constructed from any UV radiation transparent material (e.g., Teflon® or quartz). The diffuser ensures that the radiation received by the spectroradiometer is not collimated. The spectroradiometer input slits should be set to provide a bandwidth that is less than or equal to 5 nanometers.

(e)*Sunscreen drug product application to substrate* . The accuracy of the test depends upon the application of a precisely controlled amount of sunscreen product with a uniform distribution over the application area of the substrate. The product is applied at 2 milligrams per square centimeter to the substrate. To achieve uniform distribution over the substrate, the sunscreen product should be applied in a series of small dots over the application area of the substrate and then spread evenly using a gloved finger. A very light spreading action for a short period of time (approximately 10 seconds) should be used when distributing the product to ensure complete coverage without excessive buildup of product in the troughs of the substrate.

(f)*Pre-irradiation to account for differences in photostability* . To account for potentially varying degrees of photostability between sunscreen drug products, irradiate the sunscreen product on the substrate with a dose of UV radiation equal to the SPF of the sunscreen product multiplied by 200 J/m 2 -eff multiplied by 2/3. A UV radiation dose of 200 J/m 2 -eff is equivalent to one minimal erythema dose (MED). The UV dose to be delivered is determined by multiplying the light source spectral irradiance action spectrum for erythema in “CIE S 007/E Erythemal Reference Action Spectrum and Standard Erythema Dose,” at each wavelength, integrating over wavelength, and multiplying the integral by the exposure time. “CIE S 007/E Erythemal Reference Action Spectrum and Standard Erythema Dose,” dated 1998, is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from CIE Central Bureau, Kegelgasse 27, A-1030, Vienna, Austria, or may be examined at the Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 22, Silver Spring, MD 20993, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.

(g)*Calculation of the spectral transmittance at each wavelength interval* . The dynamic range of the measurement system and the intensity of the light source should be sufficiently high that signals measured at all UV wavelengths (290 to 400 nanometers) through a highly absorbing sunscreen product are above the noise level of the measurement system. Spectral irradiance will be measured at 5 nanometer intervals, from 290 to 400 nanometers. At least 12 measurements of spectral irradiance transmitted through the substrate without sunscreen drug product present will be obtained from different locations on the substrate surface (C(λ) 1 , C(λ) 2 , C(λ) 3 , . . . C(λ) 12 ). In addition, a minimum of 12 measurements of spectral irradiance transmitted through the substrate with the sunscreen drug product present will be similarly obtained after pre-irradiation of the sunscreen drug product (P(λ) 1 , P(λ) 2 , P(λ) 3 , . . . P(λ) 12 ). The mean transmittance for wavelength λ, T(λ) , is the ratio of the mean of the C(λ) values to the mean of the P(λ) values, as follows: EP27AU07.010 The standard deviation, s, associated with the spectral transmittance is evaluated using Taylor's approximation, as follows: EP27AU07.011 where C(λ) = mean of the measurements of C at wavelength λ. P(λ) = mean of the measurements of P at wavelength λ. s(C(λ)) = standard deviation of the measurements of C at wavelength λ. s(P(λ)) = standard deviation of the measurements of P at wavelength λ. s(C(λ)) is calculated as follows: EP27AU07.012 s(P(λ)) is calculated as follows: EP27AU07.013 This calculation gives 23 spectral transmittance values with associated standard deviations, one for each 5 nanometer wavelength increment from 290 to 400 nanometers. The standard deviation values will provide an indication of the uniformity of sunscreen drug product spreading during application to the substrate. The coefficient of variation, which is the standard deviation divided by the mean, and expressed as a percentage, should be less than 10 percent.

(h)*Calculation of the UVA I/UV ratio* .

(1)Spectral transmittance values, T(λ), are converted into absorbance values, A(λ), by taking the negative logarithm of the spectral transmittance value as follows: A(λ) = -log T(λ) The calculation yields 23 monochromatic absorbance values in 5 nanometer increments from 290 to 400 nanometers.

(2)The index of UVA I protection is calculated as the area (per unit wavelength) under the UVA I portions of a plot of wavelength versus A(λ), divided by the area (per unit wavelength) under the total curve, as follows: EP27AU07.014 UVA I area per unit λ is given as: EP27AU07.015 UV area per unit λ is given as: EP27AU07.016 where: A(λ) = effective absorbance given as -log T(λ) d(λ) = wavelength interval between measurements B(λ) = any biological action spectrum factor Because no appropriate biological action spectrum for UVA radiation damage has been universally accepted, no action spectrum is specified. The value of B(λ) is, therefore, equal to 1.0 for all wavelengths.

(3)The integrals in the formulae in paragraphs (h)(1) and (h)(2) of this section are evaluated using Simpson's Rule for irregular areas, which states: Area = h/3 x [Y 0 + Y 2m + 4(Y 1 + Y 3 . . . + Y 2m-1 ) + 2(Y 2 + Y 4 + . . . Y 2m-2 )] In this equation, Y 0 , Y 1 , Y 2 , . . . Y 2m are the lengths of 2m parallel lines drawn vertically to divide the area under the curve of a graph into 2m-1 segments of equal width, h. In practice, the values of Y 0 , Y 1 , Y 2 , . . . Y 2m are the A(λ) values determined and h is the wavelength interval at which the spectral transmittance is determined (i.e., 5 nanometers).

(4)UVA I area per unit wavelength (aUVA I/λ) is calculated as follows: aUVA I/λ = 5/3 x [A 340 + A 400 + 4(A 345 + ... + A 395 ) + 2(A 350 + A 360 + A 370 + ... + A 390 )]/60 UV area per unit wavelength (aUV/λ) is calculated as follows: aUV/λ = 5/3 x [A 290 + A 400 + 4(A 295 + A 305 + A 315 + ... + A 395 ) + 2(A 300 + A 310 + ... + A 390 )]/110 UVA I/UV ratio is calculated as follows: EP27AU07.017

(i)*Category determination of the UVA I/UV ratio* . Perform at least 5 separate determinations of the UVA I/UV ratio, from which the mean can be calculated. Using the mean, the sunscreen drug product is classified by in vitro UVA I/UV ratio as follows: UVA I /UV Ratio Category 0.20 to 0.39 Low 0.40 to 0.69 Medium 0.70 to 0.95 High greater than 0.95 Highest § 352.72 UVA in vivo testing procedure.

(a)*Standard sunscreen* . A standard sunscreen shall be tested concomitantly in the procedure for determining the UVA protection factor (UVA-PF) value by means of persistent pigment darkening to ensure the uniform evaluation of sunscreen drug products. The standard sunscreen shall be a preparation containing 7 percent padimate O and 3 percent oxybenzone as specified in § 352.70(a)(3). For the test to be valid, the measured mean UVA-PF value of the standard preparation shall be 3.2 with a standard deviation less than or equal to 0.5.

(b)*Light source* . The light source used for determining the UVA-PF value of a sunscreen drug product shall provide a continuous emission spectrum in the range of 320 to 400 nanometers. The ratio of UVA I (340 to 400 nanometers) to UVA II (320 to 340 nanometers) in the final beam shall be close to that of sunlight, i.e., emitted UVA II shall be 8 to 20 percent of the total UVA radiation. Optical radiation from 250 to 320 nanometers shall be less than 0.1 percent of the optical radiation between 320 to 400 nanometers. Exclude visible and infrared light to avoid the darkening effects of visible light and the effect of heat. Perform monitoring and maintenance of the light source as specified in § 352.70(b)(3).

(c)*General testing procedures* —(1) *Medical history* . Obtain a medical history from each subject with emphasis on the effects of sunlight on his/her skin. Determine that each subject is in good general health and has skin type II or III (as described in this paragraph). *Skin Type and Sunburn and Tanning History (Based on first 30 to 45 minutes of sun exposure after a winter season of no sun exposure).* I: Always burns easily; never tans (sensitive). II: Always burns easily; tans minimally (sensitive). III: Burns moderately; tans gradually (light brown) (normal). IV: Burns minimally; always tans well (moderate brown) (normal). V: Rarely burns; tans profusely (dark brown) (insensitive). VI: Never burns; deeply pigmented (insensitive). Determine that the subject is not taking topical or systemic medication that is known to alter responses to ultraviolet radiation and that the subject has no history of sensitivities to topical products and/or abnormal responses to sunlight, such as a phototoxic or photoallergic response.

(2)*Physical examination* . The physical examination shall be conducted as specified in § 352.70(c)(1).

(3)*Informed consent* . Obtain legally effective written informed consent from all subjects.

(4)*Test site delineation* —(i) *Test site* . A test site is the location on the back for determining the subject's initial and final minimal pigmenting dose

(MPD)for unprotected skin and for determining UVA-PF values after application of the sunscreen standard and the test sunscreen product(s). There typically are 4 to 6 test sites for each subject. Test sites should be located on the back between the beltline and the shoulder blades (scapulae) and lateral to the midline. Each test site shall be a minimum of 50 square centimeters (cm 2 ) (i.e., 5 x 10 centimeters). Outline the test sites to which the sunscreen standard and the test sunscreen product(s) will be applied with indelible ink. If the subject is to receive the doses of ultraviolet radiation in an upright (seated) position, draw the lines on the skin with the subject upright (seated). If the subject is to receive the doses of ultraviolet radiation while prone, draw the lines with the subject prone.

(ii)*Test subsite* . Test subsites are the locations to which ultraviolet radiation is administered within a test site. At least 5 test subsites will receive UV doses within each test site. Test subsites will be at least 1 cm 2 in area and will be separated from each other by at least 1 cm. Mark the location of each test subsite with indelible ink.

(5)*Application of test materials* . Apply the test sunscreen product and the standard sunscreen as specified in § 352.70(c)(5).

(6)*Waiting period* . Before exposing the test site areas after applying a product, wait at least 15 minutes.

(7)*Number of subjects* . A test panel shall consist of 20 to 25 subjects with at least 20 subject who produce valid data for analysis. Data is valid unless rejected in accordance with § 352.70(c)(9). If more than 5 subjects are rejected based on § 352.70(c)(9), the panel is disqualified, and a new panel must be created.

(8)*Response criteria* . In order that the person who evaluates the MPD responses is not biased, he/she must not be the same person who applied the sunscreen drug product to the test site or administered the doses of UV radiation. After UV radiation exposure from the solar simulator is completed, all immediate responses shall be recorded. These may include an immediate darkening or tanning, typically grayish or purplish in color, which fades in 30 to 60 minutes; an immediate reddening at the subsite, due to heating of the skin, which fades rapidly; and an immediate generalized heat response, spreading beyond the subsite, which fades in 30 to 60 minutes. After the immediate responses are noted, each subject shall shield the exposed area from further UV radiation until the MPD response is evaluated. Determine the MPD 3 to 24 hours after exposure. Evaluate the pigmentation responses of each test site using either tungsten or warm white fluorescent lighting that provides 450 to 550 lux of illumination at the test site. For the evaluation, the test subject should be in the same position used when the test site was irradiated. For each test site, determine the smallest UV dose that produced mild pigmentation reaching the borders of the test subsite. The MPD is the smallest UV dose required to produce the first perceptible pigment darkening at 3 to 24 hours post-exposure. To determine the MPD, there must be at least one subsite that received a smaller UV dose and does not produce pigmentation as well as a subsite(s) with somewhat more intense pigmentation. For subsites showing pigmentation, the maximal exposure should be no more than twice the total energy of the minimal exposure.

(9)*Rejection of test data* . Reject test data if the exposure series fails to elicit an MPD response on either the treated or unprotected skin sites, or all subsites within a test site show more intense responses than the threshold pigmentation response, or the responses are inconsistent with the series of UV doses administered, or the subject was noncompliant, e.g., the subject withdraws from the test due to illness or work conflicts or does not shield the exposed testing sites from further UV radiation until the MPD is read.

(d)*Determination of UVA-PF values* —(1) *Determination of MPD of unprotected skin* . Administer a series of five UV radiation doses expressed as Joules per square meter to the subsites within each test site on a subject using the light source described in paragraph

(b)of this section. Use the series of five exposures to the unprotected test site to determine the initial unprotected MPD. Select the doses that are a geometric series represented by (1.25 n ), wherein each exposure dose is 25 percent greater than the previous exposure dose to maintain the same relative uncertainty (expressed as a constant percentage), independent of the subject's sensitivity to UV radiation. Usually, the UV radiation for determining the initial unprotected MPD is administered the day prior to applying the sunscreen product and standard sunscreen, and the responses are then evaluated immediately prior to applying the sunscreen product and sunscreen standard. Determine the final unprotected MPD on the same day that UV radiation is administered to the sunscreen-protected test sites. Use the final unprotected MPD (MPD(US)) in calculating UVA-PF.

(2)*Determination of individual UVA-PF values* . Administer a series of five UV radiation doses expressed as Joules per square meter to the subsites within each test site on a subject using the light source described in paragraph

(b)of this section. The five UV doses will be a geometric series as described in paragraph (d)(1) of this section, where the middle exposure represents the expected UVA-PF. Use exposures that are the product of the initial unprotected MPD times 0.64X, 0.80X, 1.00X, 1.25X, and 1.56X, where X equals the expected UVA-PF of the test product. The MPD is the smallest UV dose required to produce pigmentation at 3 to 24 hours post-exposure. Calculate the UVA-PF value of each sunscreen product and sunscreen standard using MPD of sunscreen-protected skin (MPD(PS)) and the final unprotected MPD (MPD(US)) as follows: EP27AU07.018

(3)*Determination of test product UVA-PF and UVA product category designation (PCD)* . Use data from at least 20 test subjects with n representing the number of subjects used. First, compute the UVA-PF value for each subject as stated in paragraph (d)(2) of this section. Second, compute the mean UVA-PF value, x, and the standard deviation, s, for these subjects. Third, obtain the upper 5-percent point from Student's t distribution table with n-1 degrees of freedom. Denote this value by t. Fourth, compute ts/√n. Denote this quantity by A (i.e., A = ts/√n). Fifth, calculate the UVA-PF value to be used in labeling as follows: The label UVA-PF equals the largest whole number less than x - A. Sixth and last, the drug product is classified into a PCD as follows: If 12 + A ≤ x, the PCD is Highest; if 8 + A ≤ x < 12 + A, the PCD is High; if 4 + A < x < 8 + A, the PCD is Medium; if 2 + A ≤ x < 4 + A, the PCD is Low; if x < 2 + A, the product shall not display a UVA-PF value. § 352.73 Determination of the labeled UVA protection value. Test the sunscreen product in accordance with §§ 352.71 and 352.72. The UVA category on the principal display panel

(PDP)of the tested sunscreen product, as specified in § 352.50, shall be the lower of either the UVA I/UV ratio category determined in § 352.71(j) or the UVA-PF product category designation

(PCD)determined in § 352.72(d)(3). If the product does not attain at least a “low” category rating for both the UVA-PF and the UVA I/UV ratio, the product shall not display a UVA claim. State the final combined category rating (i.e., the lower of either the UVA I/UV ratio or UVA-PF PCD categories) on the PDP of the product along with the corresponding number of stars for that combined category rating as follows: Combined Category Rating Star Rating Low ★✰✰✰ Medium ★★✰✰ High ★★★✰ Highest ★★★★ 11. Section 352.76 is amended by revising the introductory paragraph and paragraphs

(a)introductory text, (a)(6),

(b)introductory text, and (b)(10) to read as follows: § 352.76 Determination if a product is water resistant or very water resistant. The general testing procedures in § 352.70(c) shall be used as part of the following tests, except where modified in this section. An indoor fresh water pool, whirlpool, and/or jacuzzi maintained at 23 to 32 °C shall be used in these testing procedures. Fresh water is clean drinking water that meets the standards in 40 CFR part 141. The pool and air temperature and the relative humidity shall be recorded.

(a)*Procedure for testing the water resistance of a sunscreen product* . For sunscreen products making the claim of “water resistant,” the label SPF and, if appropriate, UVA values shall be the label SPF and UVA values determined after 40 minutes of water immersion using the following procedure for the water resistance test:

(6)Begin light source exposure to test site areas as described in § 352.70(b) and, if appropriate, § 352.72(b).

(b)*Procedure for testing a very water resistant sunscreen product* . For sunscreen products making the claim of “very water resistant,” the label SPF and, if appropriate, UVA values shall be the label SPF and UVA values determined after 80 minutes of water immersion using the following procedure for the water resistance test:

(10)Begin light source exposure to test site areas as described in § 352.70(b) and, if appropriate, § 352.72(b). Dated: August 10, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 07-4131 Filed 8-23-07; 8:45 am]

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