Unknown. Final rule
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/register/2007/04/04/07-1636·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
--- schema: federal-register doc_type: fedreg source_file: FR-2007-04-04.xml --- 72 64 Wednesday, April 4, 2007 Contents Agency Agency for Healthcare Research and Quality NOTICES Committees; establishment, renewal, termination, etc.: U.S. Preventive Services Task Force, 16367-16368 07-1639 Agricultural Agricultural Marketing Service RULES Apricots grown in Washington, 16263-16265 E7-6224 Avocados grown in South Florida, 16261-16263 E7-6243 Cranberries not subject to cranberry marketing order; data collection, reporting, and recordkeeping requirements, 16265-16267 E7-6241 Potato research and promotion plan, 16267-16269 E7-6274 NOTICES Agency information collection activities; proposals, submissions, and approvals, 16325-16327 E7-6246 E7-6248 Agriculture Agriculture Department See Agricultural Marketing Service See Food Safety and Inspection Service Army Army Department NOTICES Environmental statements; availability, etc.:
Camp Shelby Joint Forces Training Center, MS; military training activities; special use permit renewal; correction, 16413 C7-1571 Environmental statements; notice of intent: U.S. Army training lands, AK; battle area complex and training facility, 16331-16332 07-1638 Centers Centers for Disease Control and Prevention NOTICES Agency information collection activities; proposals, submissions, and approvals, 16368-16370 E7-6275 E7-6276 Meetings: Disease, Disability, and Injury Prevention and Control Special Emphasis Panels, 16370 E7-6270 Coast Guard Coast Guard RULES Ports and waterways safety; regulated navigation areas, safety zones, security zones, etc.:
Siuslaw River, Portland, OR, 16275-16277 E7-6145 Commerce Commerce Department See Economics and Statistics Administration See National Oceanic and Atmospheric Administration Commodity Commodity Futures Trading Commission RULES Organization, functions and procedures and Commission records and information: Regional Office information; corrections, 16269-16270 E7-6190 Copyright Copyright Office, Library of Congress PROPOSED RULES Copyright Office and Procedures: Copyright claims, registration; renewals, 16306-16311 E7-6174 Defense Defense Department See Army Department Economics Economics and Statistics Administration NOTICES Meetings:
Bureau of Economic Analysis Advisory Committee, 16328 E7-6212 Education Education Department NOTICES Agency information collection activities; proposals, submissions, and approvals, 16332 E7-6279 Grants and cooperative agreements; availability, etc.: Elementary and secondary education— Advanced Placement Test Fee Program, 16332-16333 E7-6255 Postsecondary education— EU-U.S. Atlantis Program, 16333-16336 E7-6261 Employee Employee Benefits Security Administration NOTICES Employee benefit plans; individual exemptions:
Mellon Financial Corp. et al.; correction, 16385 E7-6216 Employment Employment and Training Administration NOTICES Adjustment assistance; applications, determinations, etc.: Dusenbery Worldwide et al., 16386-16387 E7-6184 Photronics, Inc., 16387 E7-6183 TDS/US Automotive, 16387 E7-6182 Energy Energy Department See Energy Efficiency and Renewable Energy Office See Energy Information Administration See Federal Energy Regulatory Commission See Southeastern Power Administration NOTICES Atomic energy agreements; subsequent arrangements, 16336-16337 E7-6280 07-1666 Energy Energy Efficiency and Renewable Energy Office NOTICES Meetings:
State Energy Advisory Board, 16337 E7-6232 Energy Energy Information Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 16337-16341 E7-6268 EPA Environmental Protection Agency RULES Pesticide programs: Plant-incorporated protectorants; procedures and requirements— Bacillus thuringiensis Vip3Aa20 protein and genetic material necessary for production in corn; tolerance exemption, 16277-16281 E7-6256 Pesticides; tolerances in food, animal feeds, and raw agricultural commodities:
Diphenylamine, 16281-16283 E7-5804 PROPOSED RULES Air pollutants, hazardous; national emission standards: Acrylic and modacrylic fibers production, carbon black production, lead acid battery manufacturing, wood preserving, etc., 16636-16676 E7-5790 Pesticide programs: Plant-incorporated protectants (formerly plant-pesticides), 16312-16315 E7-6151 NOTICES Air pollution control: Citizens suits; proposed settlements— Rocky Mountain Clean Air Action, et al. v. Johnson, 16347-16348 E7-6235 Meetings:
Scientific Counselors Board, 16349-16350 E7-6237 E7-6239 Pesticide, food, and feed additive petitions: Interregional Research Project No. 4 et al., 16352-16356 E7-6047 Pesticide registration, cancellation, etc.: Calcium thiosulfate, 16351-16352 E7-6059 Pesticides; emergency exemptions, etc.: Ethylene oxide, 16356-16357 E7-6249 Reports and guidance documents; availability, etc.: Pesticides— Atrazine; amphibian gonadal development, 16357-16359 E7-6253 Executive Executive Office of the President See Presidential Documents FAA Federal Aviation Administration PROPOSED RULES Airworthiness directives:
Bombardier, 16289-16291 E7-6267 McDonnell Douglas, 16287-16289 E7-6269 FCC Federal Communications Commission RULES Radio stations; table of assignments: Texas, 16283 E7-6225 Television broadcasting: Telecommunications Act of 1996; implementation— National broadcast television ownership rules, 16283-16284 E7-6162 PROPOSED RULES Radio stations; table of assignments: Virginia and Kentucky, 16315 E7-6258 NOTICES Agency information collection activities; proposals, submissions, and approvals, 16359-16362 E7-6154 E7-6156 E7-6157 Committees; establishment, renewal, termination, etc.:
Communications Security, Reliability and Interoperability Council, 16362-16363 E7-6254 Federal Energy Federal Energy Regulatory Commission RULES Electric utilities (Federal Power Act): Bulk-power system; mandatory reliability standards, 16416-16602 E7-5284 NOTICES Environmental statements; availability, etc.: Columbia Power & Water Systems, 16343-16344 E7-6206 Pacific Gas & Electric Co., 16344 E7-6207 Hydroelectric applications, 16344-16345 E7-6205 E7-6208 *Applications, hearings, determinations, etc.:* Columbia Gas Transmission Corp., E7-6204 16341-16342 E7-6210 E7-6211 Columbia Gulf Transmission Co., 16342 E7-6209 El Paso Natural Gas Co., 16343 E7-6203 Trans-Union Interstate Pipeline, L.P., 16343 E7-6202 FMC Federal Maritime Commission NOTICES Agreements filed, etc., 16363 E7-6250 Federal Reserve Federal Reserve System NOTICES Banks and bank holding companies:
Change in bank control, 16363 E7-6178 Formations, acquisitions, and mergers, 16364 E7-6219 FTC Federal Trade Commission NOTICES Premerger notification waiting periods; early terminations, 16364-16366 07-1646 Federal Transit Federal Transit Administration NOTICES Grants and cooperative agreements; availability, etc.: Tribal Transit Program, 16397-16407 E7-6192 E7-6199 Fish Fish and Wildlife Service RULES Endangered and threatened species: Green sturgeon, etc.; southern distinct population segment, 16284-16286 E7-6188 NOTICES Endangered and threatened species permit applications, 16383-16384 E7-6260 Environmental statements; notice of intent:
Buena Vista Lagoon Restoration Project, San Diego County, CA; correction, 16413 C7-1373 Papahanaumokuakea Marine National Monument, HI; management plan, 16328-16329 07-1652 Food Food and Drug Administration RULES Animal drugs, feeds, and related products: Melengestrol and lasalocid, 16270 E7-6180 Praziquantel and pyrantel, 16270 E7-6181 PROPOSED RULES Food for human consumption: Food labeling— Irradiation in the production, processing and handling of food, 16291-16306 07-1636 NOTICES Meetings:
Harmonisation International Conference— Rockville, MD; preparation and topics discussion, 16370-16371 07-1633 Food Food Safety and Inspection Service NOTICES Meetings: Risk-Based Inspection System, 16327-16328 07-1662 Health Health and Human Services Department See Agency for Healthcare Research and Quality See Centers for Disease Control and Prevention See Food and Drug Administration See Indian Health Service See Substance Abuse and Mental Health Services Administration NOTICES Meetings:
American Health Information Community, 16366 07-1645 Scientific misconduct findings; administrative actions: Uzelmeier, Rebecca, 16366-16367 07-1616 Homeland Homeland Security Department See Coast Guard NOTICES Meetings: State and Local Training Office Advisory Committee, 16381 07-1644 Housing Housing and Urban Development Department RULES HOME Investment Partnerships Programs: American Dream Downpayment Initiative; homeownership affordability requirements, 16678-16685 E7-5960 Mortgage and loan insurance programs:
Puerto Rico; presentation of condominium legal documents, 16688-16689 E7-6088 NOTICES Agency information collection activities; proposals, submissions, and approvals, 16381-16383 E7-6226 E7-6227 Indian Indian Health Service NOTICES Grant and cooperative agreement awards: Indian Health Scholarship Program; recipients list, 16371-16378 07-1634 Grants and cooperative agreements; availability, etc.: Loan Repayment Program, 16378-16380 07-1635 Interior Interior Department See Fish and Wildlife Service See Land Management Bureau IRS Internal Revenue Service NOTICES Privacy Act; computer matching programs, 16411-16412 E7-6238 International International Trade Commission NOTICES Import investigations:
Canned pineapple fruit from— Thailand, 16384-16385 E7-6278 Justice Justice Department See Prisons Bureau Labor Labor Department See Employee Benefits Security Administration See Employment and Training Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 16385 E7-6252 Land Land Management Bureau NOTICES Alaska Native claims selection: Bristol Bay Native Corp., 16384 E7-6264 Library Library of Congress See Copyright Office, Library of Congress NOAA National Oceanic and Atmospheric Administration PROPOSED RULES Fishery conservation and management:
Atlantic highly migratory species— Atlantic bluefin tuna, 16318-16324 E7-6259 NOTICES Environmental statements; notice of intent: Papahanaumokuakea Marine National Monument, HI; management plan, 16328-16329 07-1652 Meetings: West Coast canary rockfish, darkblotched rockfish and arrowtooth flounder; pre-assessment workshop, 16329-16330 E7-6201 Ocean and coastal resource management: Weeks Bay National Estuarine Research Reserve Management Plan; revisions, 16330 E7-6195 Postal Postal Service RULES International Mail Manual:
International product and pricing initiatives, 16604-16634 E7-6048 Presidential Presidential Documents EXECUTIVE ORDERS Puerto Rico; renaming the Caribbean National Forest as the El Yunque National Forest (EO 13428), 16691-16693 07-1704 Prisons Prisons Bureau RULES Inmate control, custody, care, etc.: National security; prevention of acts of violence and terrorism, 16270-16275 E7-6265 SEC Securities and Exchange Commission NOTICES Agency information collection activities; proposals, submissions, and approvals, 16387-16388 E7-6218 Self-regulatory organizations; proposed rule changes:
American Stock Exchange LLC, 16388-16389 E7-6200 NASDAQ Stock Market LLC, 16389-16392 E7-6179 E7-6335 New York Stock Exchange LLC, 16392-16395 E7-6189 SBA Small Business Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 16395 E7-6247 Disaster loan areas: Florida, 16395-16396 E7-6244 Interest rates; quarterly determinations, 16396 E7-6242 Meetings: Audit and Financial Management Advisory Committee, 16396 E7-6245 Southeastern Southeastern Power Administration NOTICES Power rates:
Georgia-Alabama-South Carolina System of Projects, 16345-16347 E7-6257 State State Department NOTICES Organization, functions, and authority delegations: Assistant Secretary of State for Educational and Cultural Affairs; correction, 16413 Z7-3011 Substance Substance Abuse and Mental Health Services Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 16380-16381 E7-6272 Surface Surface Transportation Board PROPOSED RULES Carrier rates and service terms:
Contract definition and interpretation, 16316-16318 E7-6215 NOTICES Railroad operation, acquisition, construction, etc.: Wilmington & Woburn Terminal Railway, 16408-16409 E7-6214 Railroad services abandonment: BNSF Railway Co., 16409 E7-5784 Transportation Transportation Department See Federal Aviation Administration See Federal Transit Administration See Surface Transportation Board NOTICES Aviation proceedings: Agreements filed; weekly receipts, 16396 E7-6266 Certificates of public convenience and necessity and foreign air carrier permits; weekly applications, 16396 E7-6271 Treasury Treasury Department See Internal Revenue Service NOTICES Foreign ownership of U.S. securities survey; reporting requirements, 16409-16410 E7-6196 Reports and guidance documents; availability, etc.:
Federal antidiscrimination, whistleblower protection, and retaliation laws; No FEAR Act notice, 16410-16411 E7-6223 Separate Parts In This Issue Part II Energy Department, Federal Energy Regulatory Commission, 16416-16602 E7-5284 Part III Postal Service, 16604-16634 E7-6048 Part IV Environmental Protection Agency, 16636-16676 E7-5790 Part V Housing and Urban Development Department, 16678-16685 E7-5960 Part VI Housing and Urban Development Department, 16688-16689 E7-6088 Part VII Executive Office of the President, Presidential Documents, 16691-16693 07-1704 Reader Aids Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions. 72 64 Wednesday, April 4, 2007 Rules and Regulations DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 915 [Docket No. AMS-FV-06-0170; FV07-915-1 FIR] Avocados Grown in South Florida; Suspension of Weekly Handler Reporting Requirements AGENCY:
Agricultural Marketing Service, USDA. ACTION: Final rule. SUMMARY: The Department of Agriculture
(USDA)is adopting, as a final rule, without change, an interim final rule changing the reporting requirements currently prescribed under the marketing order for avocados grown in South Florida (order). The order regulates the handling of avocados grown in South Florida and is administered locally by the Avocado Administrative Committee (Committee). This rule continues in effect the action that indefinitely suspended the weekly handler reporting requirements specified under the order. The information from the weekly reports is no longer being used by the industry or the Committee staff and the germane information is available from other sources. This action reduces the reporting burden on handlers, while aligning information collection requirements with the needs of the industry. DATES: *Effective Date:* May 4, 2007. FOR FURTHER INFORMATION CONTACT: William G. Pimental, Marketing Specialist, or Christian D. Nissen, Regional Manager, Southeast Marketing Field Office, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA; Telephone:
(863)324-3375, Fax:
(863)325-8793 or E-mail: *William.Pimental@usda.gov* or *Christian.Nissen@usda.gov* , respectively. Small businesses may request information on complying with this regulation by contacting Jay Guerber, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, 1400 Independence Avenue, SW., STOP 0237, Washington, DC 20250-0237; Telephone:
(202)720-2491, Fax:
(202)720-8938, or E-mail: *Jay.Guerber@usda.gov.* SUPPLEMENTARY INFORMATION: This rule is issued under Marketing Agreement No. 121 and Marketing Order No. 915, both as amended (7 CFR part 915), regulating the handling of avocados grown in South Florida, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” USDA is issuing this rule in conformance with Executive Order 12866. This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is not intended to have retroactive effect. This rule will not preempt any State or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule. The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling. This rule continues in effect the action that modified the reporting requirements prescribed under the order by indefinitely suspending the weekly handler reporting requirements. The information from the weekly report is no longer being used by the industry or the Committee staff and the germane information is available from other sources. This action reduces the reporting burden on handlers, while aligning information collection requirements with the needs of the industry. The Committee unanimously recommended this change at a meeting on April 19, 2006. Section 915.60 of the avocado marketing order provides authority for the Committee to require handlers to file reports and provide other information as may be necessary for the Committee to perform its duties. Section 915.150 of the order's rules and regulations specifies the requisite reporting requirements. This rule continues in effect the action that revised § 915.150 by indefinitely suspending paragraphs (a), (b), and
(c)which specify the weekly handler reporting requirements. Prior to this action, handlers were required to submit a weekly report to the Committee listing all avocados handled, the disposition of each lot of noncertified avocados removed from handler's premises, and each lot of noncertified avocados received from another district. The Committee provided a form to assist handlers with supplying the required information. This information was compiled into a report which was made available to the industry. The Committee also used this data for statistical reporting purposes, to assess handlers, and for program compliance. When instituted, the information from the weekly reports was adequate for industry and Committee needs. However, for the past several seasons, the industry has stopped requesting the reports compiled from the weekly data. The Committee believes timely data is necessary for the information to be valuable. The industry is still interested in the volume of avocados handled, but weekly reports are not timely enough to be beneficial when it comes to using such information to help growers and handlers make harvesting and packing decisions. In addition to the weekly reporting information, the Committee staff also receives daily shipment information for all avocado handlers from the Federal-State Inspection Service (FSIS). This information is collected from handlers at the time of inspection and includes information on the volume packed. The Committee staff uses this information to generate daily shipping reports. The reports generated from the FSIS information are more accurate and timely, and the industry finds this information to be more beneficial. As such, the Committee staff has stopped generating reports based on the weekly information. Further, the Committee has found reporting at the time of inspection to be an effective and efficient way of collecting information. Recently, the rules and regulations were amended to require handlers to report added information to the FSIS at the time of inspection (70 FR 59622, October 13, 2005). With that change, handlers are now required to provide information regarding the number of avocados pack per container, in addition to the previous requirement that handlers provide the number and sizes of containers packed. In comparison, handlers find weekly reporting to be time consuming and that it places an additional burden on their staff to ensure weekly reports are submitted. Also, with some of the information contained in the weekly report already being reported at the time of inspection, it represents a duplication of effort. At one time, the Committee staff used the information from the weekly handler reports for statistical reporting purposes, to assess handlers, and for program compliance. However, they too have found the information in the daily shipment reports to be more useful, and of more interest to the industry. Further, the Committee staff has not been using the weekly reports to support program operations or for compliance purposes for some time. The information needed for Committee operations, marketing policies, and compliance is available from the daily inspection information provided by FSIS and from other sources. In addition, damages sustained from hurricanes in 2004 and 2005 resulted in a substantial reduction in assessment income. This rule reduces the amount of time required by the Committee staff to monitor handler reports. Thus, this rule offers the potential for cost savings. This rule continues in effect the action that indefinitely suspended the provisions requiring the submission of the weekly handler report. The information collected under this requirement is no longer being utilized and is not necessary for the operations of the order. This action reduces the reporting burden on handlers and lessens the reporting oversight demands on the Committee staff. Therefore, the Committee voted unanimously to suspend § 915.150 paragraphs (a), (b), and (c). Section 8e of the Act provides that when certain domestically produced commodities, including avocados, are regulated under a Federal marketing order, imports of that commodity must meet the same or comparable grade, size, quality, and maturity requirements. As this rule changes the reporting requirements under the domestic handling regulations, no corresponding changes to the import regulations are required. Final Regulatory Flexibility Analysis Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA), the Agricultural Marketing Service
(AMS)has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis. The purpose of the RFA is to fit regulatory actions to the scale of business subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf. Thus, both statutes have small entity orientation and compatibility. There are approximately 300 producers of avocados in the production area and approximately 35 handlers subject to regulation under the order. Small agricultural producers are defined by the Small Business Administration
(SBA)as those having annual receipts of less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $6,500,000 (13 CFR 121.201). According to the National Agricultural Statistics Service and Committee data, the average price for Florida avocados during the 2005-06 season was around $46.75 per 55-pound bushel container, and total shipments were near 470,000 55-pound bushel equivalents. Using the average price and shipment information provided by the Committee, the majority of avocado handlers could be considered small businesses under the SBA definition. In addition, based on avocado production, grower prices, and the total number of Florida avocado growers, the average annual grower revenue is less than $750,000. Thus, the majority of Florida avocado producers may also be classified as small entities. This rule changes the reporting requirements currently prescribed under the order. This rule continues in effect the action that indefinitely suspended the weekly handler reporting requirements required under the order. The information from the weekly report is no longer being used by the industry or the Committee staff and the germane information is available from other sources. This action reduces the reporting burden on handlers, while aligning information collection requirements with the needs of the industry. This rule revises § 915.150, which specifies the requisite reporting requirements. Authority for this action is provided for in § 915.60 of the order. The Committee unanimously recommended this change at a meeting held on April 19, 2006. This rule is not expected to result in any additional costs for handlers. This rule continues in effect the action that reduced the reporting burden on handlers by indefinitely suspending the provisions requiring the submission of a weekly report. It also reduces the amount of time required by the Committee staff to monitor and review handler reports. Thus, this rule offers the potential for cost savings. The potential reduction in costs would benefit all handlers regardless of their size. Consequently, the benefits of this rule are expected to be equally available to all. The Committee discussed keeping the weekly reporting requirements in place as an alternative to this action. However, the Committee believes continuing to collect information that is no longer being utilized by the industry or the Committee staff is unnecessary. Therefore, this alternative was rejected. This rule will not impose any additional reporting or recordkeeping requirements on either small or large avocado handlers. The form, FV-215, “Avocado Handler's Weekly Report Form” is currently approved under OMB No. 0581-0189, Generic OMB Fruit Crops. The information collection for OMB No. 1581-0189 will be coming up for renewal, at which time the reduction in burden for this form will be addressed. The suspension of the reporting requirement reduces the overall burden for that collection by 54 hours. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies. In addition, USDA has not identified any relevant Federal rules that duplicate, overlap or conflict with this rule. The AMS is committed to complying with the E-Government Act, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes. Further, the Committee's meeting was widely publicized throughout the avocado industry and all interested persons were invited to attend the meeting and participate in Committee deliberations. Like all Committee meetings, the April 19, 2006, meeting was a public meeting and all entities, both large and small, were able to express their views on this issue. An interim final rule concerning this action was published in the **Federal Register** on December 22, 2006. Copies of the rule were mailed by the Committee's staff to all Committee members and avocado handlers. In addition, the rule was made available through the Internet by USDA and the Office of the Federal Register. That rule provided for a 60-day comment period which ended February 20, 2007. No comments were received. A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: *http://www.ams.usda.gov/fv/moab.html.* Any questions about the compliance guide should be sent to Jay Guerber at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section. After consideration of all relevant material presented, including the Committee's recommendation, and other information, it is found that finalizing the interim final rule, without change, as published in the **Federal Register** (71 FR 76897, December 22, 2006) will tend to effectuate the declared policy of the Act. List of Subjects in 7 CFR Part 915 Avocados, Marketing agreements, Reporting and recordkeeping requirements. PART 915—AVOCADOS GROWN IN SOUTH FLORIDA Accordingly, the interim final rule amending 7 CFR part 915 which was published at 71 FR 76897 on December 22, 2006, is adopted as a final rule without change. Dated: March 29, 2007. Lloyd C. Day, Administrator, Agricultural Marketing Service. [FR Doc. E7-6243 Filed 4-3-07; 8:45 am] BILLING CODE 3410-02-P DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 922 [Docket No. AMS-FV-07-0031; FV07-922-1 IFR] Apricots Grown in Designated Counties in Washington; Suspension of Container Regulations AGENCY: Agricultural Marketing Service, USDA. ACTION: Interim final rule with request for comments. SUMMARY: This rule suspends the container regulations prescribed under the Washington apricot marketing order by extending the temporary 2006 season suspension indefinitely. The marketing order regulates the handling of fresh apricots grown in designated counties in the State of Washington, and is administered locally by the Washington Apricot Marketing Committee (Committee). This indefinite suspension of the container regulations will continue to provide the apricot industry with increased marketing flexibility by allowing handlers to pack and ship apricots in any size, shape, or type of container. After evaluating the impact the temporary 2006 season container regulation suspension has had on the industry, the Committee determined that container regulations no longer contribute to the orderly marketing of the fresh apricot crop. DATES: Effective April 1, 2007. Comments received by June 4, 2007 will be considered prior to issuance of a final rule. ADDRESSES: Interested persons are invited to submit written comments concerning this rule. Comments must be sent to the Docket Clerk, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, 1400 Independence Avenue, SW., STOP 0237, Washington, DC 20250-0237; *Fax:*
(202)720-8938; or *Internet: http://www.regulations.gov.* All comments should reference the docket number and the date and page number of this issue of the **Federal Register** and will be made available for public inspection in the Office of the Docket Clerk during regular business hours or can be viewed at: *http://www.regulations.gov.* FOR FURTHER INFORMATION CONTACT: Robert J. Curry or Gary D. Olson, Northwest Marketing Field Office, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, 1220 SW., Third Avenue, Suite 385, Portland, Oregon 97204-2807; *Telephone:*
(503)326-2724; *Fax:*
(503)326-7440; or *E-mail: Robert.Curry@usda.gov* or *GaryD.Olson@usda.gov.* Small businesses may request information on complying with this regulation by contacting Jay Guerber, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, 1400 Independence Avenue, SW., STOP 0237, Washington, DC 20250-0237; *Telephone:*
(202)720-2491; Fax:
(202)720-8938; or *E-mail: Jay.Guerber@usda.gov.* SUPPLEMENTARY INFORMATION: This rule is issued under Marketing Agreement and Order No. 922 (7 CFR part 922) regulating the handling of apricots grown in designated counties in Washington, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” The Department of Agriculture
(USDA)is issuing this rule in conformance with Executive Order 12866. This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is not intended to have retroactive effect. This rule will not preempt any State of local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule. The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling. This rule indefinitely extends the temporary 2006 season container regulation suspension (§ 922.306), which ends on March 31, 2007. As it effectively did during the 2006 shipping season, this regulatory suspension will provide additional flexibility to the apricot industry by allowing handlers to pack apricots in any type, shape, or size container. The container regulations prescribed under § 922.306 will remain suspended for the 2007 and future seasons unless the Committee recommends, and USDA approves, action to reinstate the regulations. For the 2006 season, the Committee recommended a temporary suspension of the regulations rather than an open-ended suspension to help ensure that a thorough analysis of the 2006 shipping season would be completed prior to any potential future action regarding the issue of container regulation suspension. The Committee has reviewed the 2006 shipping season and determined that the industry can successfully market its fresh apricot crop without the container regulations in place. Consequently, the Committee has concluded that the Washington apricot industry is now best served by an open-ended suspension of § 922.306. To facilitate prompt reinstatement of the container regulations in the future should market conditions warrant such, the Committee recommended that the 2006 temporary regulation suspension be extended rather than replaced by a permanent removal of the regulations from the order. Section 922.52 of the order authorizes the issuance of regulations for grade, size, quality, maturity, pack, and container for any variety of apricots grown in the production area. Section 922.52(a)(3) specifically authorizes the establishment of the container regulations found in § 922.306. Section 922.53 authorizes the modification, suspension, or termination of regulations issued pursuant to § 922.52. Authority to regulate the size, weight, dimension and pack of containers used in the marketing of fresh apricots was included in the order when promulgated in 1957. Container regulatory authority was included in the order to provide container standardization, to enhance orderly marketing conditions, and to provide for increased producer returns. The Committee meets prior to each season to consider recommendations for modification, suspension, or termination of any regulatory requirements for Washington apricots that are issued on a continuing basis. Committee meetings are open to the public and interested persons may express their views at these meetings. The USDA reviews the Committee recommendations along with any supportive information submitted by the Committee, as well as information from other available resources, and determines whether modification, suspension, or termination of the regulatory requirements would tend to effectuate the declared policy of the Act. During such a review at its February 15, 2007, meeting, the Committee determined, and unanimously recommended, that the 2006 season container regulation suspension—effective from April 1, 2006, through March 31, 2007—be extended indefinitely. For a seamless extension of the suspension, the Committee recommended that this rule be effective by April 1, 2007. When effective, § 922.306 provides that apricots must be handled domestically in
(1)open containers or telescopic fiberboard cartons weighing 28 pounds or greater;
(2)closed containers with 14 pounds or more of apricots packed in a row-faced or tray-pack configuration;
(3)closed containers with 12 pounds (or more) of random sized, non row-faced apricots; or
(4)closed containers with 24 pounds or more of loose-packed apricots. In reaching a consensus to extend the 2006 regulatory suspension, Committee members found that arguments made in favor of the suspension at the meeting a year ago are still appropriate. They noted that container standardization had contributed to orderly marketing in the past, but buyers today are increasingly interested in non-traditional packaging options designed for better handling and greater consumer acceptance. Furthermore, handler members stated that they now enjoy a greater latitude in choosing the optimum container weight for a particular pack or customer. Committee members were unanimous in the opinion that this indefinite extension of the container regulation suspension will continue to provide the industry with the flexibility needed to meet the challenges of marketing fresh apricots. Initial Regulatory Flexibility Analysis Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA), the Agricultural Marketing Service
(AMS)has considered the economic impact of this rule on small entities. Accordingly, AMS has prepared this initial regulatory flexibility analysis. The purpose of the RFA is to fit regulatory actions to the scale of business subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf. Thus, both statutes have small entity orientation and compatibility. There are approximately 300 apricot producers within the regulated production area and approximately 22 regulated handlers. Small agricultural producers are defined by the Small Business Administration (SBA)(13 CFR 121.201) as those having annual receipts of less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $6,500,000. Data from the Washington Agricultural Statistics Service shows that the total 5,900 ton Washington apricot utilization sold for an average of $969 per ton in 2005 with a total value of $5,715,000. Based on the number of producers in the production area (300), the average annual producer revenue from the sale of apricots in 2005 can thus be estimated at approximately $19,050. In addition, based on information from the Committee and USDA's Market News Service, 2005 f.o.b. prices ranged from $15.00 to $20.00 per 24-pound loose-pack container, and from $14.00 to $24.00 for 2-layer tray pack containers. Assuming that equal quantities of the 2005 season fresh apricot pack-out of 4,471 tons went into loose-pack (24-pound) containers and tray-pack containers (weighing an average of about 20 pounds each), average gross receipts per handler from the sale of fresh apricots would have been approximately one half of the annual sales figure that the SBA uses to define the minimum size of a large agricultural service business ($750,000). Thus, the majority of producers and handlers of Washington apricots may be classified as small entities. At its February 15, 2007, meeting the Committee recommended that the temporary suspension of the order's container regulations (§ 922.306)—effective from April 1, 2006, through March 31, 2007—be indefinitely extended to cover the 2007 shipping season as well as all future seasons. Section 922.52(a)(3) of the order specifically authorizes the establishment of container regulations. Further, § 922.53 authorizes the modification, suspension, or termination of regulations issued pursuant to § 922.52. This indefinite extension of the container regulation suspension is expected to continue to provide the apricot industry with increased marketing flexibility by allowing handlers to pack and ship apricots in any size, shape, or type of container. Container regulations have been utilized in past seasons to provide a degree of standardization and thus have helped in providing the industry with orderly marketing conditions. However, changing market dynamics and the experience gained through the 2006 suspension have convinced the Committee that container standardization is no longer necessary to ensure orderly marketing. Last year, rather than seeking an indefinite suspension of the regulations, the Committee recommended a temporary suspension so that it could conduct a thorough evaluation of the impact the relaxation would have on the industry during the 2006 shipping season prior to taking any further action for subsequent seasons. In reviewing the 2006 season at the February 15, 2007, meeting, the Committee easily reached a consensus that an indefinite continuation of the container regulation suspension would best fit the industry's marketing needs. The Committee anticipates that this rule will not negatively impact small businesses. This rule extends the suspension of the container requirements found under § 922.306 of the order's rules and regulations and should continue to provide enhanced marketing opportunities. The Committee discussed—and subsequently rejected—alternatives to its recommendation to extend the container regulation suspension. These included allowing the reinstatement of the regulations (by not taking any action) and continuing with annual and temporary regulatory suspensions such as recommended for the 2006 season. With a successful season behind them, Committee members were unanimous in their decision to recommend to USDA an extension of the container regulations suspension for an indefinite period. This rule will not impose any additional reporting or recordkeeping requirements on either small or large apricot handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies. In addition, USDA has not identified any relevant Federal rules that duplicate, overlap or conflict with this rule. AMS is committed to complying with the E-Government Act, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes. The Committee's meeting was widely publicized throughout the Washington apricot industry and all interested persons were invited to attend the meeting and participate in Committee deliberations. Like all Committee meetings, the February 15, 2007, meeting was a public meeting and all entities, both large and small, were able to express their views on this issue. A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: *http://www.am.usda.gov/fv/moab.html.* Any questions about the compliance guide should be sent to Jay Guerber at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section. This rule invites comments on an indefinite extension of the suspension of the container regulations under the Washington apricot marketing order. Any comments received will be considered prior to finalization of this rule. After consideration of all relevant material presented, including the Committee's recommendation, and other information, it is found that the suspension of the order's container regulations should be indefinitely extended in order to effectuate the declared policy of the Act. Pursuant to 5 U.S.C. 553, it is also found and determined upon good cause that it is impracticable, unnecessary, and contrary to the public interest to give preliminary notice prior to putting this rule into effect and that good cause exists for not postponing the effective date of this rule until 30 days after publication in the **Federal Register** because:
(1)This rule extends the 2006 season container regulation suspension for Washington apricots to include the 2007 and future shipping seasons;
(2)the indefinite extension of the container regulation suspension was unanimously recommended by the Committee at a public meeting and all interested persons had an opportunity to express their views and provide input;
(3)Washington apricot handlers are aware of this recommendation, are currently operating under relaxed regulatory conditions, and need no additional time to comply with the continued relaxed requirements;
(4)this rule should be in effect by April 1, 2007, to ensure a seamless continuation of the current container regulation suspension; and
(5)this rule provides a 60-day comment period, and any comments received will be considered prior to finalization of this rule. List of Subjects in 7 CFR Part 922 Apricots, Marketing agreements, Reporting and recordkeeping requirements. For the reasons set forth in the preamble, 7 CFR part 922 is amended as follows: PART 922—APRICOTS GROWN IN DESIGNATED COUNTIES IN WASHINGTON 1. The authority citation for 7 CFR part 922 continues to read as follows: Authority: 7 U.S.C. 601-674. § 922.306 [Suspended] 2. In part 922, § 922.306 is suspended indefinitely. Dated: March 29, 2007. Lloyd C. Day, Administrator, Agricultural Marketing Service. [FR Doc. E7-6224 Filed 4-3-07; 8:45 am] BILLING CODE 3410-02-P DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 926 [Docket No. AMS-FV-06-0173; FV06-926-1 FIR] Data Collection, Reporting and Recordkeeping Requirements Applicable to Cranberries Not Subject to the Cranberry Marketing Order; Suspension of Provisions Under 7 CFR Part 926 AGENCY: Agricultural Marketing Service, USDA. ACTION: Final rule. SUMMARY: The U.S. Department of Agriculture
(USDA)is adopting, as a final rule, without change, an interim final rule suspending Part 926 in the Code of Federal Regulations, which requires persons engaged in the handling or importation of fresh cranberries or cranberry products, but not subject to the reporting requirements of the Federal cranberry marketing order (7 CFR part 929), to report sales, acquisition, and inventory information to the Cranberry Marketing Committee (Committee), and to maintain adequate records of such activities. The establishment of these requirements is authorized under section 8(d) of the Agricultural Marketing Agreement Act of 1937 (Act). The Committee, which administers marketing order 929, regulating the handling of cranberries grown in Massachusetts, Rhode Island, Connecticut, New Jersey, Wisconsin, Michigan, Minnesota, Oregon, Washington, and Long Island in the State of New York, has been delegated by USDA to collect such information authorized under Part 926. Based on information provided by the Committee, USDA has determined that the collection of information under Part 926 is of marginal benefit to the industry and should continue to be suspended. DATES: *Effective Date:* May 4, 2007. FOR FURTHER INFORMATION CONTACT: Patricia A. Petrella or Kenneth G. Johnson, DC Marketing Field Office, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, Unit 155, 4700 River Road, Riverdale, Maryland 20737; Telephone:
(301)734-5243, Fax:
(301)734-5275, or E-mail at *Patricia.Petrella@usda.gov* or *Kenneth.Johnson@usda.gov.* Small businesses may request information on complying with this regulation by contacting Jay Guerber, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, 1400 Independence Avenue, SW., STOP 0237, Washington, DC 20250-0237; Telephone:
(202)720-2491, Fax:
(202)720-8938, or E-mail: *Jay.Guerber@usda.gov.* SUPPLEMENTARY INFORMATION: This rule is issued pursuant to the Agricultural Marketing Agreement Act of 1937, as amended [7 U.S.C. 601-674], hereinafter referred to as the “Act”. USDA is issuing this rule in conformance with Executive Order 12866. This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is not intended to have retroactive effect. This rule will not preempt any State or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule. There are no administrative procedures which must be exhausted prior to any judicial challenge to the provisions of this rule. This rule continues in effect the action that suspended indefinitely Part 926 of the Code of Federal Regulations, which contains the reporting and recordkeeping requirements for entities engaged in the handling or importation of fresh cranberries or cranberry products but not subject to the cranberry marketing order (7 CFR part 929) (order). Under Part 926, such entities are required to provide to USDA or its delegate, certain information regarding the sales, acquisitions, and inventories of fresh cranberries or cranberry products. USDA delegated authority to the Committee to collect such information. The Committee, which is also responsible for administering the order, has used this information to analyze market conditions and make volume control recommendations to USDA. The Committee has determined that this data collection under Part 926 is not needed at this time, and advised USDA of its findings following its meeting on June 6, 2006. Section 608d(3) of the Act, as amended, authorizes the collection of cranberry and cranberry product inventory information from producer-handlers, second handlers, processors, brokers, and importers that are not regulated by the order. Pursuant to this statutory authority, USDA issued reporting and recordkeeping requirements for these entities under Part 926 on January 12, 2005 (70 FR 1995). Sections 926.16, 926.17, and 926.18 require these entities to file and maintain certain reports and other information that are also required of handlers regulated under the order. Part 926 was implemented to allow the Committee access to cranberry and cranberry product inventory information from throughout the industry, including segments outside the scope of the order, so that it could make more informed marketing decisions. For example, the Committee makes annual volume control recommendations to USDA that are based upon estimated cranberry production, acquisition, inventory, and sales for the total industry. Adding inventory data collected from entities outside the order to the data reported by handlers under the order was expected to provide a more accurate estimate of the total industry inventory, thus enabling the Committee to make more informed volume control recommendations. However, after more than a year's experience collecting the data pursuant to Part 926, the Committee has found that most inventories are maintained by handlers regulated under the order, and that the amount of cranberries and cranberry products held by entities outside the order is minimal and does not affect the Committee's marketing decisions. The Committee met on June 6, 2006, to evaluate the effectiveness of the data collection conducted under Part 926. Taking into account the marginal benefits of this data collection, the committee advised USDA that the reporting and recordkeeping provisions under Part 926 should be suspended. This action continues in effect, an interim final rule suspending the reporting and recordkeeping requirements of Part 926 indefinitely. Should changes occur in the cranberry industry that would warrant reimplementation of these requirements USDA may take appropriate action to reinstate these provisions under Part 926. Final Regulatory Flexibility Analysis Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA), the Agricultural Marketing Service
(AMS)has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis. The purpose of the RFA is to fit regulatory actions to the scale of business subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Small agricultural service firms are defined by the Small Business Administration
(SBA)[13 CFR 121.201] as those having annual receipts less than $6,500,000. Small agricultural producers are defined as those with annual receipts of less than $750,000. The Committee estimates that there are approximately 56 handlers, producer-handlers, processors, brokers, and importers subject to the data collection requirements under Part 926. The Committee further estimates that most of the entities required to file reports under Part 926 would be considered small under the SBA criteria. This final rule continues to suspend indefinitely the provisions of 7 CFR part 926, which require persons engaged in the handling of cranberries or cranberry products (including producer-handlers, second-handlers, processors, brokers, and importers) but not subject to the order to maintain adequate records and report sales, acquisitions, and inventory information to the Committee. Part 926 was established because the Committee needed inventory information from non-regulated entities as well as those subject to the order to better formulate its marketing decisions and recommendations. It continues to be suspended because the Committee has determined that, considering the size of the inventories held outside the scope of the order, collecting that data from the non-regulated entities is of marginal benefit to the industry. This action continues to suspend the reporting and recordkeeping requirements for these cranberry handlers and importers. It also reduces the Committee's costs associated with the collection and maintenance of that information. Alternatives to this action included continuing to collect information as currently provided in Part 926, raising the inventory threshold that triggers the need for a non-regulated entity to report its inventory so that only those entities holding the largest inventories would be required to file reports, or requesting that non-regulated entities provide inventory information voluntarily. However, the Committee advised USDA that most cranberries and cranberry products are currently held in the inventories of the regulated handlers until needed by processors, which greatly reduces the likelihood that large unreported inventories exist. Therefore, the collection of inventory information from entities under Part 926 no longer benefits the industry. In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the information collection requirements related to this rule were previously approved by the Office of Management and Budget
(OMB)and assigned OMB No. 0581-0222, Data Collection Requirements Applicable to Cranberries Not Subject to the Cranberry Marketing Order (7 CFR part 926). This information collection package expires August 31, 2007. We have submitted this information collection package (currently under OMB review) for renewal and requested OMB approval for a 1-hour burden placeholder for future reimplementation should changes occur in the cranberry industry that require reinstatement of these reporting and recordkeeping requirements under Part 926. The AMS is committed to complying with the E-Government Act, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes. In addition, USDA has not identified any relevant Federal rules that duplicate, overlap or conflict with this rule. An interim final rule concerning this action was published in the **Federal Register** on December 28, 2006 (7 FR 78044). Copies of the rule were made available through the Internet by the Office of the Federal Register and USDA. A 30-day comment period ending February 26, 2007, was provided to allow interested persons to respond to the interim final rule. No comments were received. A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: *http//www.ams.usda.gov/fv/moab/html.* Any questions about the compliance guide should be sent to Jay Guerber at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section. After consideration of all relevant material presented, it is found that Part 926, as suspended in this action, as hereinafter set forth, does not tend to effectuate the declared policy of the Act and that the interim final rule, as published in the **Federal Register** (71 FR 78044, December 28, 2006), is adopted, without change, in this final rule. List of Subjects in 7 CFR Part 926 Cranberries and cranberry products, Reporting and recordkeeping requirements. PART 926—DATA COLLECTION, REPORTING AND RECORDKEEPING REQUIREMENTS APPLICABLE TO CRANBERRIES NOT SUBJECT TO THE CRANBERRY MARKETING ORDER Accordingly, the interim final rule suspending 7 CFR part 926 which was published at 71 FR 78044 on December 28, 2006, is adopted as a final rule without change. Dated: March 29, 2007. Lloyd C. Day, Administrator, Agricultural Marketing Service. [FR Doc. E7-6241 Filed 4-3-07; 8:45 am] BILLING CODE 3410-02-P DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 1207 [Docket No. AMS-FV-06-0177; FV-06-703-FIR] Potato Research and Promotion Plan; Amendment of Administrative Committee Structure AGENCY: Agricultural Marketing Service, USDA. ACTION: Final rule. SUMMARY: The Department of Agriculture
(USDA)is adopting, as a final rule, without change, an interim final rule amending the structure of the Administrative Committee (Committee) of the National Potato Promotion Board (Board) as prescribed in the Potato Research and Promotion Plan. This rule continues in effect the action that increased the number of Vice-Chairperson positions on the Committee from six to seven. The change is intended to more closely correlate the Committee's representation with potato production in the Northwest district—a five state region which accounts for more than half of all U.S. potato production. DATES: *Effective Date:* May 4, 2007. FOR FURTHER INFORMATION CONTACT: Barry Broadbent, Marketing Specialist, or Gary Olson, Regional Manager, Northwest Marketing Field Office, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, 1220 SW., Third Avenue, Suite 385, Portland, OR 97204; Telephone:
(503)326-2724, Fax:
(503)326-7440, or e-mail: *Barry.Broadbent@usda.gov* or *GaryD.Olson@usda.gov.* Small businesses may request information on complying with this regulation by contacting Jay Guerber, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, 1400 Independence Avenue, SW., STOP 0237, Washington, DC 20250-0237; Telephone:
(202)720-2491, Fax:
(202)720-8938, or e-mail: *Jay.Guerber@usda.gov.* SUPPLEMENTARY INFORMATION: This rule is issued under the Potato Research and Promotion Plan [7 CFR Part 1207], hereinafter referred to as the “Plan.” The Plan is authorized by the Potato Research and Promotion Act, as amended [7 U.S.C. 2611-2627], hereinafter referred to as the “Act.” The Office of Management and Budget
(OMB)has waived the review process required by Executive Order 12866 for this action. This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is not intended to have retroactive effect. This rule will not preempt any State or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule. The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 311 of the Act, a person subject to a plan may file a petition with the U.S. Department of Agriculture
(USDA)stating that such plan, any provision of such plan, or any obligation imposed in connection with such plan is not in accordance with law and request a modification of such plan or to be exempted therefrom. Such person is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which such person is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided that a complaint is filed not later than 20 days after date of the entry of the ruling. This rule adopts the interim rule that modified the structure of the Board's Administrative Committee as prescribed in the Plan by increasing the number of Vice-Chairperson positions on the Committee from six to seven. This additional position is allocated, as provided in the Board's bylaws, to the Northwest district. This rule increased from 25 percent to 33 percent Board representation at the executive level for potato producers in Montana, Idaho, Oregon, Washington, and Alaska is. The change was recommended by a large majority of the Board, with only 3 of 84 members dissenting at the Board's meeting on March 18, 2006. Section 1207.327(b) of the Plan provides the authority to make rules and regulations, with USDA approval, to effectuate the terms and conditions of the Plan. Section 1207.328(a) of the Plan provides the authority to select from its members such officers as may be necessary and to adopt such rules for the conduct of its business as the Board may deem advisable. Section 1207.507(a) of the Plan's administrative rules delineates the structure of Board's Administrative Committee. The Committee is selected from among Board members and must be composed of producer members, one or more importer member(s), and the public member. The Board, through the adoption of their bylaws, may prescribe the manner of selection and the number of members; except that the regulations mandate that the Committee shall include a Chairperson and a fixed number of Vice-Chairpersons. The bylaws also designate the officers and the immediate past Chairperson as the Board's Executive Committee. Prior to this modification, the Plan provided for six Vice-Chairperson positions on the Committee. Vice-Chairperson positions are allocated in the Board's bylaws to represent production districts as determined by the Board. This rule adopts the interim rule that increased the number of Vice-Chairperson positions to seven. The additional Vice-Chairperson position is allocated to the Northwest district, which historically has been the district with the greatest production. At its meeting on March 18, 2006, the Board discussed the structure of its model of governance as it relates to adequate representation of their constituents. The Board had been studying this issue for a number of years. Representatives from the potato producing districts that have experienced increases over the last 30 years expressed a desire for greater Board representation. The Northwest district, which includes the States of Montana, Idaho, Oregon, Washington, and Alaska, has increased production such that the district now accounts for 49.5 percent of all potatoes produced by or imported into the U.S. Under the current Plan, the Northwest district accounts for 47.4 percent of the votes of the full Board, which the Board has determined to be equitable. In contrast, membership on the Executive Committee, the governing body of the Administrative Committee, is not representative of current production. The Northwest district has held only two of the eight executive positions, which represents only 25 percent of the Executive Committee vote, while production in the district has increased to nearly 50 percent. The members agreed to a compromise solution to increase the number of officer positions on the Administrative Committee by one and, through a change in the Board's bylaws, to allocate the additional Vice-Chairperson position to the Northwest district. Eighty-one Board members voted in favor of the proposal and three members were opposed. Those in opposition represented the Northeast district and were concerned, even after the compromise proposal, that too much influence on the Board would shift to the West. Final Regulatory Flexibility Analysis and Paperwork Reduction Act In accordance with the Regulatory Flexibility Act (RFA)[5 U.S.C. 601 *et seq.* ], the Agricultural Marketing Service has examined the impact of this rule on small entities. The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such action so that small businesses will not be disproportionately burdened. There are approximately 1,353 handlers, 5,223 producers, and 300 importers of potatoes and potato products who are subject to the provisions of the Plan. The Small Business Administration
(SBA)defines small agricultural service firms, which includes handlers and importers, as those having annual receipts of less than $6,500,000, and small agricultural producers are defined as those having annual receipts of less than $750,000. Most of the producers and handlers, and some of the importers would be classified as small businesses under the criteria established by the SBA (13 CFR 121.201). In addition, producers of less than 5 acres of potatoes are exempt from this program. This rule adopts the interim rule that modified the structure of the Administrative Committee of the Board, as delineated under § 1207.507 of the Plan, by increasing the number of Vice-Chairperson positions from six to seven. The Plan requires that the Committee be comprised of producer Board members, one or more importer Board member(s), and the public Board member. The exact number of members seated on the Committee is determined by the Board through the Board's bylaws. Additionally, the Plan regulations require that the Board elect a Committee Chairperson and a fixed number of Vice-Chairpersons. The Board, through their bylaws, allocates the Committee's officer positions according to production districts, so as to provide equitable representation at the executive level. The Northwest district, which has historically represented a large percentage of total potato production, has in the past been allocated two officer positions, while the other five districts have each been allocated one. Currently, producers within the Northwest district collectively produce over 50 percent of the total U.S. potato production. The additional Vice-Chairperson position created by this rule is allocated by the Board's revised bylaws to the Northwest district, thereby increasing representation for that district at the executive level from 25 percent to 33 percent. The authority for this action is provided in §§ 1207.327 and 1207.328 of the Plan. At their March 18, 2006, meeting, the Board discussed the factors leading up to this action and the potential impact on the industry after the change. However, there is no direct financial impact to producers, handlers, or importers as a result of this action. The Board discussed alternatives to this change, including reducing the number of districts, defining Committee representation as a ratio relative to Board members from each district, and reducing the size of the Board to the size of the existing Administrative Committee. None of the proposals garnered much support and were ultimately dropped from consideration because the changes were deemed to be too divisive to the industry. The AMS is committed to complying with the E-Government Act, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes. This rule will not impose any additional reporting or recordkeeping requirements on either small or large potato handlers or importers. As with all Federal research and promotion programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies. In addition, USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule. Further, the Board's meetings were widely publicized throughout the potato industry and all interested persons were invited to attend the meetings and participate in Board deliberations. Like all Board meetings, the March 18, 2006, meeting was a public meeting and all entities, both large and small, were able to express their views on this issue. Finally, interested persons were invited to submit information on the regulatory and informational impacts of this action on small businesses. An interim final rule concerning this action was published in the **Federal Register** on December 22, 2006. Copies of the rule were mailed by the Board's staff to all Board members and potato handlers. In addition, the rule was made available through the Internet by USDA and the Office of the Federal Register. The interim final rule provided for a 60-day comment period which ended February 20, 2007. Two comments were received, both of which were in support of the change. A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at the following Web site: *http://www.ams.usda.gov/fv/moab.html.* Any questions about the compliance guide should be sent to Jay Guerber at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section. After consideration of all relevant material presented, including the Board's recommendation, and other information, the interim final rule as published in the **Federal Register** (71 FR 76899, December 22, 2006), is adopted, as a final rule, without change. List of Subjects in 7 CFR Part 1207 Advertising, Agricultural research, Imports, Potatoes, Reporting and recordkeeping requirements. PART 1207—POTATO RESEARCH AND PROMOTION PLAN Accordingly, the interim final rule amending 7 CFR part 1207 which was published at 71 FR 76899 on December 22, 2006, is adopted as a final rule without change. Dated: March 29, 2007. Lloyd C. Day, Administrator, Agricultural Marketing Service. [FR Doc. E7-6274 Filed 4-3-07; 8:45 am] BILLING CODE 3410-02-P COMMODITY FUTURES TRADING COMMISSION 17 CFR Parts 140 and 145 Corrections to Regional Office Information AGENCY: Commodity Futures Trading Commission. ACTION: Final rule. SUMMARY: The Commodity Futures Trading Commission (“Commission”) is amending its regulations to delete references to the Minneapolis office, which was closed as of December 31, 2006, and to update the address of the Southwestern regional office. DATES: Effective April 4, 2007. FOR FURTHER INFORMATION CONTACT: Stacy Yochum, Deputy Executive Director, at
(202)418-5157, Office of the Executive Director, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st St., NW., Washington DC 20581; e-mail *syochum@cftc.gov.* SUPPLEMENTARY INFORMATION: Commission Rule 140.2 describes the organization and location of the Commission's regional offices in New York, Chicago, and Kansas City (the Eastern, Central, and Southwestern regional offices). As of December 31, 2006, the Commission closed the Minneapolis sub-office of the Southwestern regional office. In addition, the Kansas City office moved to a new location in September 2004. The Commission is therefore amending Rule 140.2 to delete the reference to the Minneapolis office and to reflect the new address of the Southwestern regional office. There is no change to the states covered by the Southwestern region. The Commission is also replacing the term “regional director” with “regional coordinator” to reflect the term used by the Commission to describe the head of each regional office. In addition, the Commission is amending the list of addresses provided in Rule 145.6, which instructs members of the public on where to direct requests for public records, to remove the reference to the Minneapolis office and to update the Kansas City address. List of Subjects 17 CFR Part 140 Authority delegations (Government agencies), Organization and functions (Government agencies). 17 CFR Part 145 Confidential business information, Freedom of Information. Accordingly, 17 CFR parts 140 and 145 are amended as follows: PART 140—ORGANIZATION, FUNCTIONS, AND PROCEDURES OF THE COMMISSION 1. The authority citation for part 140 continues to read as follows: Authority: 7 U.S.C. 2 and 12a. 2. Section 140.2 is amended by revising the section heading, the introductory text, and paragraph
(c)to read as follows: § 140.2 Regional Office-Regional Coordinators. Each of the Regional offices described herein functions as set forth in this section under the direction of a Regional Coordinator who, as a collateral duty, oversees the administration of the office and represents the Commission in negotiations with employee union officials and in interactions with external parties. Each regional office has delegated authority for the enforcement of the Act and administration of the programs of the Commission in the particular regions.
(c)The Southwestern Regional Office is located at Two Emanuel Cleaver II Blvd., Suite 300, Kansas City, Missouri 64112, and is responsible for enforcement of the Act and administration of the programs of the Commission in the States of Alaska, Arizona, Arkansas, California, Colorado, Hawaii, Idaho, Iowa, Kansas, Louisiana, Minnesota, Missouri, Montana, Nebraska, Nevada, New Mexico, North Dakota, Oklahoma, Oregon, South Dakota, Texas, Utah, Washington, and Wyoming. PART 145—COMMISSION RECORDS AND INFORMATION 3. The authority citation for part 145 continues to read as follows: Authority: Pub. L. 99-570, 100 Stat. 3207; Pub. L. 89-554, 80 Stat. 54; Pub. L. 98-502, 88 Stat. 1561-1564 (5 U.S.C. 552); Sec. 101(a), Pub. L. 93-463, 88 Stat. 1389 (5 U.S.C. 4a(j)); unless otherwise noted. 4. Section 145.6 is amended by revising paragraph
(a)to read as follows: § 145.6 Commission office to contact for assistance; registration records available.
(a)Whenever this part directs that a request be directed to the Assistant Secretary of the Commission for FOI, Privacy and Sunshine Acts Compliance, the request shall be made in writing and shall be addressed or otherwise directed to the Office of the Secretariat, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street, NW., Washington, DC 20581. Requests for public records directed to a regional office of the Commission pursuant to § 145.2 should be sent to: Commodity Futures Trading Commission, 140 Broadway, New York, New York 10005, Telephone:
(646)746-9700. Commodity Futures Trading Commission, 525 West Monroe Street, Suite 1100 North, Chicago, Illinois 60661, Telephone:
(312)596-0700. Commodity Futures Trading Commission, Two Emanuel Cleaver II Blvd., Suite 300, Kansas City, Missouri 64112, Telephone:
(816)960-7700. Dated: March 29, 2007. By the Commission. Eileen A. Donovan, Acting Secretary of the Commission. [FR Doc. E7-6190 Filed 4-3-07; 8:45 am] BILLING CODE 6351-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Praziquantel and Pyrantel AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration
(FDA)is amending the animal drug regulations to reflect approval of an original new animal drug application
(NADA)filed by Virbac AH, Inc. The NADA provides for use of chewable tablets containing praziquantel and pyrantel pamoate in dogs and puppies for the treatment and control of various internal parasites. DATES: This rule is effective April 4, 2007. FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7540, e-mail: *melanie.berson@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137, filed NADA 141-261 for WORMXPLUS (praziquantel and pyrantel pamoate) Flavored Chewables and VIRBANTEL (praziquantel and pyrantel pamoate) Flavored Chewables that provides for their use in dogs and puppies for the treatment and control of various internal parasites. The NADA is approved as of March 13, 2007, and 21 CFR 520.1871 is amended to reflect the approval. In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 3 years of marketing exclusivity beginning March 13, 2007. FDA has determined under 21 CFR 25.33(d)(1) 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. This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. List of Subjects in 21 CFR Part 520 Animal drugs. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is amended as follows: PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 520 continues to read as follows: Authority: 21 U.S.C. 360b. 2. Amend § 520.1871 as follows: a. Revise the section heading and paragraphs
(a)and (b); b. Redesignate paragraph
(c)as paragraph
(d)and add new paragraph (c); and c. Revise newly redesignated paragraphs (d)(1)(i), (d)(1)(iii), and (d)(2). The revisions, redesignation, and addition read as follows: § 520.1871 Praziquantel and pyrantel.
(a)*Specifications* —(1) Each tablet contains 18.2 milligrams
(mg)praziquantel and 72.6 mg pyrantel (as pyrantel pamoate).
(2)Each chewable tablet contains 30 mg praziquantel and 30 mg pyrantel pamoate or 114 mg praziquantel and 114 mg pyrantel pamoate.
(b)*Sponsors* . See sponsors in § 510.600(c) for use as in paragraph
(d)of this chapter.
(1)See No. 000859 for use of tablet described in paragraph (a)(1) of this section for use as in paragraph (d)(1) of this section.
(2)See No. 051311 for use of tablets described in paragraph (a)(2) of this section for use as in paragraph (d)(2) of this section.
(c)*Special considerations* . See § 500.25 of this chapter.
(d)* * *
(1)* * *
(i)*Dosage* . 1.5 to 1.9 pounds, 1/4 tablet; 2 to 3 pounds, 1/2 tablet; 4 to 8 pounds, 1 tablet; 9 to 12 pounds, 1 1/2 tablets; 13 to 16 pounds, 2 tablets. If reinfection occurs, treatment may be repeated.
(iii)*Limitations* . Not for use in kittens less than 1 month of age or weighing less than 1.5 pounds. May be given directly by mouth or in a small amount of food. Do not withhold food prior to or after treatment. Consult your veterinarian before giving to sick or pregnant animals.
(2)*Dogs* —(i) *Amount* . Administer a minimum dose of 5 mg praziquantel and 5 mg pyrantel pamoate per kilogram body weight (2.27 mg praziquantel and 2.27 mg pyrantel pamoate per pound body weight) according to the dosing tables on labeling.
(ii)*Indications for use* . For the treatment and control of roundworms ( *Toxocara canis* and *Toxascaris leonina* ), hookworms ( *Ancylostoma caninum* , *Ancylostoma braziliense* , and *Uncinaria stenocephala* ), and tapeworms ( *Dipylidium caninum* and *Taenia pisiformis* ) in dogs and puppies. Dated: March 26, 2007. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. E7-6181 Filed 4-3-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds; Melengestrol and Lasalocid AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration
(FDA)is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Div. of Ivy Animal Health, Inc. The ANADA provides for use of single-ingredient Type A medicated articles containing melengestrol and lasalocid to make two-way combination drug Type B or Type C medicated feeds for heifers fed in confinement for slaughter. DATES: This rule is effective April 4, 2007. FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: *john.harshman@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: Ivy Laboratories, Div. of Ivy Animal Health, Inc., 8857 Bond St., Overland Park, KS 66214, filed ANADA 200-451 for use of HEIFERMAX 500 (melengestrol acetate) Liquid Premix and BOVATEC (lasalocid sodium) single-ingredient Type A medicated articles to make dry and liquid, two-way combination drug Type B or Type C medicated feeds for heifers fed in confinement for slaughter. Ivy Laboratories' ANADA 200-451 is approved as a generic copy of NADA 140-288, sponsored by Pharmacia & Upjohn Co., a Division of Pfizer, Inc., for combination use of MGA 500 and BOVATEC. The application is approved as of March 12, 2007, and the regulations are amended in 21 CFR 558.342 to reflect the approval. In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. The agency has determined under 21 CFR 25.33(a)(2) 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. This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. List of Subjects in 21 CFR Part 558 Animal drugs, Animal feeds. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is amended as follows: PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 1. The authority citation for 21 CFR part 558 continues to read as follows: Authority: 21 U.S.C. 360b, 371. § 558.342 [Amended] 2. In § 558.342, amend the table in paragraph (e)(1)(iii) in the “Sponsor” column by adding in numerical sequence “021641”. Dated: March 26, 2007. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. E7-6180 Filed 4-3-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF JUSTICE Bureau of Prisons 28 CFR Parts 500 and 501 [BOP-1116; AG Order No. 2878-2007] RIN 1120-AB08 National Security; Prevention of Acts of Violence and Terrorism AGENCY: Bureau of Prisons, Department of Justice. ACTION: Final rule. SUMMARY: This rule finalizes the interim rules on Special Administrative Measures that were published on October 31, 2001 (66 FR 55062). The previously existing regulations authorized the Bureau of Prisons (Bureau), at the direction of the Attorney General, to impose special administrative measures with respect to specified inmates, based on information provided by senior intelligence or law enforcement officials, if determined necessary to prevent the dissemination of either classified information that could endanger the national security, or of other information that could lead to acts of violence and/or terrorism. The interim rule extended the period of time for which such special administrative measures may be imposed from 120 days to up to one year, and modified the standards for approving extensions of such special administrative measures. In addition, where the Attorney General has certified that reasonable suspicion exists to believe that an inmate may use communications with attorneys (or agents traditionally covered by the attorney-client privilege) to further or facilitate acts of violence and/or terrorism, the interim rule amended the previously existing regulations to provide that the Bureau must provide appropriate procedures to monitor or review such communications to deter such acts, subject to specific procedural safeguards, to the extent permitted under the Constitution and laws of the United States. The interim rule also requires the Director of the Bureau of Prisons to give written notice to the inmate and attorneys and/or agents before monitoring or reviewing any communications as described in this rule. The interim rule also provided that the head of each component of the Department of Justice that has custody of persons for whom special administrative measures are determined to be necessary may exercise the same authority to impose such measures as the Director of the Bureau of Prisons. DATES: *Effective date:* June 4, 2007. ADDRESSES: Rules Unit, Office of the General Counsel, Bureau of Prisons, 320 First Street, NW., Washington, DC 20534. FOR FURTHER INFORMATION CONTACT: Sarah Qureshi, Office of the General Counsel, Bureau of Prisons,
(202)307-2105. SUPPLEMENTARY INFORMATION: This rule finalizes interim rules on Special Administrative Measures that were published on October 31, 2001 (66 FR 55062). These rules are codified at 28 CFR 501.2 (national security) and 501.3 (violence and terrorism). We received approximately 5000 comments in opposition to the rule, which we discuss below. Section 501.2 Section 501.2 authorizes the Director of the Bureau, at the direction of the Attorney General, to impose special administrative measures with respect to a particular inmate that are reasonably necessary to prevent disclosure of classified information. These procedures may be implemented after written certification by the head of a United States intelligence agency that the unauthorized disclosure of such information would pose a threat to the national security and that there is a danger that the inmate will disclose such information. These special administrative measures ordinarily may include housing the inmate in special housing units and/or limiting certain privileges, including, but not limited to, correspondence, visiting, interviews with representatives of the news media, and use of the telephone, as is reasonably necessary to prevent the disclosure of classified information. The interim rule made no change in the substantive standards for the imposition of special administrative measures, but changed the initial period of time under § 501.2 from a fixed 120-day period to a period of time designated by the Director, up to one year. The rule also allows the Director to extend the period for the special administrative measures for additional one-year periods, based on subsequent certifications from the head of an intelligence agency that there is a danger that the inmate will disclose classified information and that the unauthorized disclosure of such information would pose a threat to national security. In addition, this rule provides that the subsequent certifications by the head of an intelligence agency may be based on the information available to the intelligence agency. Section 501.3 Section 501.3 also authorizes the Director of the Bureau, on direction of the Attorney General, to impose similar special administrative measures (with respect to a particular inmate) that are reasonably necessary to protect persons against the risk of death or serious bodily injury. These procedures may be implemented after written notification from the Attorney General or, at the Attorney General's discretion, from the head of a Federal law enforcement or intelligence agency, that there is a substantial risk that an inmate's communications or contacts with other persons could result in death or serious bodily injury to persons, or substantial damage to property that would entail the risk of death or serious bodily injury to persons. The interim rule made no change in the substantive standards for the implementation of special administrative measures under § 501.3(a). However, the interim rule allows the Director, with the approval of the Attorney General, to impose special administrative measures for a longer period of time, not to exceed one year, in cases involving acts of violence and/or terrorism. In addition, the rule provides authority for the Director to extend the period for the special administrative measures for additional periods, up to one year, after receipt of additional notification from the Attorney General or, at the Attorney General's discretion, from the head of a Federal law enforcement or intelligence agency. The interim rule also modified the standard for approving extensions of the special administrative measures. The rule provides that the subsequent notifications by the Attorney General, or the head of the Federal law enforcement or intelligence agency should focus on the key factual determination—that is, whether the special administrative measures continue to be reasonably necessary, at the time of each determination, because there is a substantial risk that an inmate's communications or contacts with persons could result in death or serious bodily injury to persons, or substantial damage to property that would entail the risk of death or serious bodily injury to persons. Where the Attorney General, or the head of a Federal law enforcement or intelligence agency, initially made such a determination, then the determination made at each subsequent review should not require a de novo review, but only a determination that there is a continuing need for the imposition of special administrative measures in light of the circumstances. In either case, the affected inmate may seek review of any special administrative measures imposed pursuant to §§ 501.2 or 501.3 in accordance with paragraph
(a)of this section through the Administrative Remedy Program, 28 CFR part 542. Justification for Special Administrative Measures Rules Although this rule does not alter the substantive standards for the initial imposition of special administrative measures under §§ 501.2 and 501.3, the Bureau's final rule implementing this section in 1997 devoted a substantial portion of the supplementary information accompanying the rule to a discussion of the relevant legal issues. 62 FR 33730-31. As the U.S. Supreme Court noted in *Pell* v. *Procunier* , 417 U.S. 817, 822-23 (1974), “a prison inmate retains those First Amendment rights that are not inconsistent with his status as an inmate or with the legitimate penological objectives of the corrections system. * * * An important function of the corrections system is the deterrence of crime. * * * Finally, central to all other corrections goals is the institutional consideration of internal security within the corrections facilities themselves.” (Emphasis added.) This regulation, with its concern for security and protection of the public, clearly meets this test. The changes made by this rule regarding the length of time and the standards for extension of periods of special administrative measures do not alter the fundamental basis of the rules that were adopted in 1997. Instead, they more clearly focus the provisions for extensions—both the duration of time and the standards—on the continuing need for restrictions on a particular inmate's ability to communicate with others within or outside the detention facility in order to avoid threats to national security or risks of terrorism and/or violence. In every case, the decisions made with respect to a particular inmate will reflect a consideration of the issues at the highest levels of the law enforcement and intelligence communities. Where the issue is protection of national security or prevention of acts of violence and/or terrorism, it is appropriate for government officials, at the highest level and acting on the basis of their available law enforcement and intelligence information, to impose restrictions on an inmate's public contacts that may cause or facilitate such acts. Comments We received approximately 5000 comments in opposition to the rule. All but 44 comments were variations of two form letters. We also received one comment in support of the rule. Other than the single supporting comment, all comments expressed identical and/or overlapping themes. We discuss the comments and our responses below. Monitoring of Attorney-Client Communications *Comment:* The provision allowing monitoring of attorney-client communications breaches attorney-client privilege and deprives inmates of the right to effective assistance of counsel under the Sixth Amendment. *Response:* We acknowledge that the Sixth Amendment limits the government's ability to monitor conversations between a detainee and his or her attorney. Nonetheless, as we noted in the preamble to the interim rule, the fact of monitoring by itself does not violate the Sixth Amendment right to effective assistance of counsel. *Weatherford* v. *Bursey* , 429 U.S. 545 (1977). Rather, the propriety of monitoring turns on a number of factors, including the purpose for which the government undertakes the monitoring, the protections afforded to privileged communications, and the extent to which, if at all, the monitoring results in information being communicated to prosecutors and used at trial against the detainee. In *Weatherford* , a government informant was present at two meetings between a defendant, Bursey, and his attorney during which Bursey and the attorney discussed preparations for Bursey's criminal trial. To preserve his usefulness as an undercover agent, the informant could not reveal that he was working for the government and thus sat through the meetings and heard discussions pertaining to Bursey's defense. Bursey later brought a suit under 42 U.S.C. 1983, claiming that his Sixth Amendment right had been violated. The court of appeals found for Bursey, holding that the informant's presence during the attorney-client meetings necessarily violated Bursey's Sixth Amendment right. The Supreme Court reversed, explaining that [t]he exact contours of the Court of Appeals' per se right-to-counsel rule are difficult to discern; but as the Court of Appeals applied the rule in this case, it would appear that if an undercover agent meets with a criminal defendant who is awaiting trial and with his attorney and if the forthcoming trial is discussed without the agent's revealing his identity, a violation of the defendant's constitutional rights has occurred, whatever was the purpose of the agent in attending the meeting, whether or not he reported on the meeting to his superiors, and whether or not any specific prejudice to the defendant's preparation for or conduct of the trial is demonstrated or otherwise threatened. *Weatherford* , 429 U.S. at 550. The Supreme Court expressly rejected such a *per se* rule and denied that having a government agent hear attorney-client communications results, without more, in an automatic violation of Sixth Amendment rights. Instead, the Court noted that it was significant that the government had acted not with the purpose of learning Bursey's defense strategy, but rather with the legitimate law enforcement purpose of protecting its informant's usefulness. *Id.* at 557. The Court further explained that “unless [the informant] communicated the substance of the Bursey-Wise conversations and thereby created at least a realistic possibility of injury to Bursey or benefit to the State, there can be no Sixth Amendment violation.” *Id.* at 557-58. Thus, the Court indicated that the Sixth Amendment analysis requires considering the government's purpose in overhearing attorney-client consultations and whether any information from overheard consultations was communicated to the prosecution in a manner that prejudiced the defendant. *Weatherford* supports the concept that when the government possesses a legitimate law enforcement interest in monitoring detainee-attorney conversations, no Sixth Amendment violation occurs so long as privileged communications are protected from disclosure and no information recovered through monitoring is used by the government in a way that deprives a defendant of a fair trial. This rule adheres to these standards by permitting monitoring only when the Attorney General certifies that reasonable suspicion exists to believe that a particular detainee may use communications with attorneys or their agents to further or facilitate acts of terrorism, and by establishing a strict firewall to ensure that attorney-client communications are not revealed to prosecutors. Of course, if the government detects communications intended to further acts of terrorism (or other illegal acts), those communications do not fall within the scope of the attorney-client privilege. That privilege affords no protection for communications that further ongoing or contemplated illegal acts, including acts of terrorism. *See, e.g., Clark* v. *United States* , 289 U.S. 1, 15
(1933)(such a client “will have no help from the law”). The crime-fraud exception applies even if the attorney is unaware that his professional services are being sought in furtherance of an illegal purpose, *see, e.g., United States* v. *Soudan* , 812 F.2d 920, 927 (5th Cir. 1986), and even if the attorney takes no action to assist the client, *see, e.g., In re Grand Jury Proceedings,* 87 F.3d 377, 382 (9th Cir. 1996). A detainee's efforts to use his or her lawyer to plan acts of terrorism simply are not protected by the attorney-client privilege. This rule carefully and conscientiously balances an inmate's right to effective assistance of counsel against the government's responsibility to thwart future acts of violence and/or terrorism perpetrated with the participation or direction of Federal inmates. In those cases where the government has substantial reason to believe that an inmate may use communications with attorneys or their agents to further or facilitate acts of violence and/or terrorism, the government has a responsibility to take reasonable and lawful precautions to safeguard the public from those acts. *Comment:* The monitoring provision of the rule violates the First Amendment right to petition the government, which includes the right to access courts. The commenter argued that the right to access courts involves consulting lawyers in confidence, which, according to the commenters, is infringed upon by this rule. Some commenters also argued that the provision likewise violates the Fifth Amendment by circumventing due process, which requires access to courts to “challenge unlawful convictions and to seek redress for violations” of constitutional rights. *Procunier* v. *Martinez* , 416 U.S. 396, 419 (1974). *Response:* For the reasons set forth above in our discussion of the monitoring provision and attorney-client privilege, we disagree that the rule infringes upon inmates' rights to consult lawyers in confidence. Inmates retain the same ability to access courts and consult lawyers as they had before the date of the Special Administrative Measures interim rule. We therefore do not change the rule based on these comments. Further, no due process rights are infringed. An inmate whose conversations with his/her attorney are monitored will enjoy strict procedural protections. First, the inmate and attorney will be notified that their communications are being monitored (§ 501.3(d)(2)). Second, a “privilege team” will conduct the monitoring and will be separated by a firewall from the personnel responsible for prosecuting the inmate (§ 501.3 (d)(3)). Third, the privilege team may disclose information only with the prior approval of a Federal judge or where acts of violence and/or terrorism are imminent (§ 501.3(d)(3)). The rule carefully balances inmates' need to communicate with their attorneys against the United States' need to prevent future acts of violence and/or terrorism. *Comment:* The monitoring provision in the rule violates the Fourth Amendment and Federal wiretapping statutes (18 U.S.C. 2510-2522). Commenters posited that before the government can intercept oral communications, it must demonstrate to a Federal judge probable cause to believe both that a particular individual is committing a crime, and that the individual will be communicating about that crime. 18 U.S.C. 2518(3). *Response:* Title 18, § 2518(7) of the United States Code allows an exception to the court order requirement upon the Attorney General's designee's determination that an emergency situation exists that involves immediate danger of death or serious physical injury to any person, or conspiratorial activities threatening the national security interest. Section 2518(7), (a)(i) and (a)(ii). Therefore, if the Attorney General so authorizes, and if, according to § 2518(7)(b), there are grounds upon which a court order could reasonably have been granted to allow interception of communications, privilege teams as authorized by the Attorney General may monitor attorney-client communications as provided for in this rule. We note that only persons held under SAM restrictions for acts of violence or terrorism, where lives are directly at risk, may potentially be subjected to monitoring of their attorney-client conversations. Even then, such attorney-client monitoring will be resorted to only after the Attorney General has made a specific determination that it is likely that attorney-client communications will be used to convey improper messages to or from the SAM restrictee. Since the effective date of the interim rule on October 30, 2001, this provision has been invoked only once, after the government obtained specific evidence revealing that the attorney had previously misused the attorney-client privilege in order to convey improper messages to and from her client. In other words, the Attorney General determined that the situation involved “immediate danger of death or serious physical injury to any person, or conspiratorial activities threatening the national security interest,” under 18 U.S.C. 2518(7). As has been recognized by the United States Supreme Court (see our response to the comment above, regarding the Sixth Amendment), the Sixth Amendment does not protect an attorney's communications with a client that are made to further the client's ongoing or contemplated criminal acts. Such communications do not assist in the preparation of a client's defense, and, therefore, are not legally privileged. Still, before such a SAM restriction may be imposed, the Attorney General must make a specific determination that attorney-client communications will be used to circumvent the purpose of the SAM, that is, to pass information that might reasonably lead to acts of violence or terrorism resulting in death or serious bodily injury, or cause property damage that would lead to the infliction of death or serious bodily injury. Even when attorney-client communications are to be monitored for the purposes of the SAM, these communications remain subject to the attorney-client privilege to the extent recognized under applicable law. *Comment:* The monitoring provision is too broad in that it applies unjustly to pretrial inmates, immigration violators, witnesses, and others in Federal (both Bureau of Prisons and non-Bureau) custody. *Response:* Before this rulemaking, §§ 501.2 and 501.3 covered only inmates in Bureau of Prisons custody. However, there are instances when a person is held in the custody of other officials of the Department of Justice (for example, the Director of the United States Marshals Service). To ensure consistent application of these provisions relating to special administrative measures in those circumstances where such restrictions are necessary, this rule clarifies that the appropriate officials of the Department of Justice having custody of persons for whom special administrative measures are required may exercise the same authorities as the Director of the Bureau of Prisons and the Warden. In such cases, the persons upon whom the special administrative measures are imposed must fall within the regulatory definition of “inmate” at § 500.1. Previously, the interim rule identified, as an example of an official of the Department of Justice who could exercise the same authorities as the Director of the Bureau of Prisons and the Warden, the Commissioner of the Immigration and Naturalization Service (INS). *See* 66 FR 55064 (Applicability to All Persons in Custody Under the Authority of the Attorney General). On March 1, 2003, however, the INS ceased to exist, and its functions were transferred to the Department of Homeland Security
(DHS)pursuant to the Homeland Security Act of 2002 (HSA), Pub. L. No. 107-296, 116 Stat. 2135. Section 441 of the HSA transferred to DHS all functions of the detention and removal program previously under the INS Commissioner. The Secretary of Homeland Security, via Delegation No. 7030, delegated all the authority vested in section 441 of the HSA to the Immigration and Customs Enforcement (ICE), a component of DHS. Accordingly, the detention authority previously exercised by the INS Commissioner now rests with ICE. Given that ICE detainees may be housed in Bureau facilities or Bureau contract facilities, this rule would apply to those inmates. Inmates convicted of Federal crimes, and many others in custody at Bureau facilities or Bureau contract facilities, such as pretrial inmates, witnesses, and immigration violators, have equal potential to attempt to perpetrate acts of violence and/or terrorism and/or acts that threaten national security. As discussed above and in the preamble to the interim rule (66 FR 55062), neither the special administrative measures previously authorized by this rule nor the monitoring provision currently authorized by this rule will be imposed arbitrarily. The Attorney General will carefully and systematically review each case and the potential threats before imposing special administrative measures or monitoring attorney-client communications. Regarding “Vagueness” of the Rule According to the commenters, the rule fails to 1. Detail the Administrative Remedies available if inmates oppose Special Administrative Measures (SAM). The Administrative Remedies available, which are the same for any issue an inmate wishes to pursue with the Bureau, are discussed in 28 CFR part 542. 2. Detail SAM conditions (how long confined to cell, program participation, exercise, recreation, training, association with other inmates). We do not detail SAM conditions in this rule because each case varies with the particular security needs of the inmate in question. 3. Define the “substantial standards” for imposing SAM. 4. Define what constitutes “reasonable suspicion” of terrorist activity which will prompt the Attorney General to monitor attorney-client communications. For items 3 and 4, as we note above, we do not detail “substantial standards” or what will prompt monitoring of attorney-client communications because each case varies with the particular security concerns raised by each situation. In general, however, the Attorney General will determine that SAMs are necessary in light of clear evidence that communication or contact with members of the public could result in death or serious bodily injury or damage to property, as stated in the rule. Generally, this will be shown through prior acts of violence or terrorism and evidence of a continuing threat due to contacts with members of the public who may contribute to or undertake acts of violence or terrorism. 5. Define “acts of violence or terrorism.” The United States Code, Title 18, 2332b, describes “[a]cts of terrorism transcending national boundaries.” In particular, the “Federal crime of terrorism” is defined at length in subsection (g)(5). As such, we need not reiterate that definition in the rule text. Regulatory Certifications The Department has determined that this rule is a significant regulatory action for the purpose of Executive Order 12866, and accordingly this rule has been reviewed by the Office of Management and Budget. The Department certifies, for the purpose of the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ), that this rule will not have a significant economic impact on a substantial number of small entities within the meaning of the Act. Because this rule pertains to the management of offenders committed to the custody of the Department of Justice, its economic impact is limited to the use of appropriated funds. This rule will not have substantial direct effects on the states, the relationship between the national government and the states, or the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. List of Subjects in 28 CFR Parts 500 and 501 Prisoners. Accordingly, under rulemaking authority vested in the Attorney General in 5 U.S.C. 552(a), we adopt as final the interim rule published on October 31, 2001, at 66 FR 55062, without change. Dated: March 29, 2007. Alberto R. Gonzales, Attorney General. [FR Doc. E7-6265 Filed 4-3-07; 8:45 am] BILLING CODE 4410-05-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [CGD13-07-012] RIN 1625-AA00 Safety Zone; Florence Rhodie Days Fireworks Display, Siuslaw River, Florence, OR AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a temporary safety zone on the waters of the Siuslaw River during a fireworks display. The Captain of the Port, Portland, Oregon is taking this action to safeguard watercraft and their occupants from safety hazards associated with this display. Entry into this safety zone is prohibited unless authorized by the Captain of the Port. DATES: This rule is effective on May 9, 2007 from 8:30 p.m. until 11:30 p.m. (PDT). ADDRESSES: Documents indicated in this preamble as being available in the docket are part of docket (CGD13-07-012) and are available for inspection or copying at U.S. Coast Guard Sector Portland, 6767 N. Basin Avenue, Portland, Oregon 97217 between 7 a.m. and 4 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: Petty Officer Lucia Mack, c/o Captain of the Port, Portland, 6767 N. Basin Avenue, Portland, Oregon 97217 (503-240-2590). SUPPLEMENTARY INFORMATION: Regulatory Information We did not publish a notice of proposed rulemaking
(NPRM)for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. If normal notice and comment procedures were followed, this rule would not become effective until after the date of the event. Publishing an NPRM would be contrary to the public interest because immediate action is necessary to ensure the safety of vessels and spectators gathering in the vicinity of the fireworks launching barge. Background and Purpose The Coast Guard is establishing a temporary safety zone to protect against the hazards associated with a fireworks display. This event occurs on the Siuslaw River in Florence, Oregon and is scheduled to start at 10 p.m. and end at approximately 10:15 p.m. on May 9, 2007. This event may result in a number of vessels congregating near the fireworks launching site. The safety zone is needed to protect watercraft and their occupants from safety hazards associated with fireworks displays. Discussion of Rule This rule establishes a safety zone to protect vessels and individuals from the hazards associated with a fireworks display. The safety zone will be located on the waters of the Siuslaw River in Florence, Oregon, encompassed by lines connecting the following points, beginning at 43°28′20″ N/124°04′46″ W, thence to 43°25′07″ N/124°04′40″ W, thence to 43°57′48″ N/124°05′54″ W, thence to 43°28′05″ N/124°05′54″ W, thence to the beginning point. This safety zone will commence prior to the launching of the fireworks in order to clear boaters out of the area for their own protection, and will last longer than the scheduled event time in case the fireworks display lasts longer than anticipated. Entry into this zone is prohibited unless authorized by the Captain of the Port, Portland, or his designated representative. The safety zone will be enforced by representatives of the Captain of the Port, Portland, who may be assisted by other Federal, State, and local agencies. Regulatory Evaluation This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. The rule is not significant because the safety zone will encompass a small portion of the river for a short duration when the vessel traffic is low. Small Entities Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule will affect the following entities, some of which may be small entities: The owners or operators of vessels intending to transit or anchor in the affected portion of the Siuslaw River from 8:30 p.m. to 11:30 p.m. on May 9, 2007. This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons. This rule will be in effect for only 3 hours late in the day when vessel traffic is low. Although the safety zone will apply to the entire width of the river, traffic will be allowed to pass through the zone with the permission of the Captain of the Port, or his designated representatives on scene, if it is safe to do so. Before the effective period, the Coast Guard will issue maritime advisories widely available to users of the river. Assistance for Small Entities Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process. If the rule will affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). Collection of Information This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Federalism A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism. Unfunded Mandates Reform Act The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble. Taking of Private Property This rule will not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights Civil Justice Reform This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden. Protection of Children We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children. Indian Tribal Governments This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Energy Effects We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211. Technical Standards The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies. This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards. Environment We have analyzed this rule under Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969
(NEPA)(42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction, from further environmental documentation because it establishes a safety zone. A final “Environmental Check List” and a final “Categorical Exclusion Determination” will be available in the docket where indicated under ADDRESSES . List of Subjects in 33 CFR Part 165 Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways. For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows: PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 1. The authority citation for part 165 continues to read as follows: Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50 U.S.C. 191, 195; 33 CFR 1.05-1(g), 6.04-1, 6.04-6 and 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1. 2. Add temporary § 165.T13-008 to read as follows: § 165.T13-008 Safety Zone; Florence Rhodie Days Fireworks Display, Siuslaw River, Florence, Oregon.
(a)*Location.* The following area is a safety zone: the waters of the Siuslaw River in Florence, Oregon, from surface to bottom, encompassed by the lines connecting the following points, beginning at 43°28′20″ N/124°04′46″ W, thence to 43°25′07″ N/124°04′40″ W, thence to 43°57′48″ N/124°05′54″ W, thence to 43°28′05″ N/124°05′54″ W, thence to the beginning point.
(b)*Regulations.*
(1)In accordance with the general regulations in Section 165.23 of this part, no person or vessel may enter or remain in this zone unless authorized by the Captain of the Port, Portland or his designated representatives.
(2)Designated representative means Coast Guard Patrol Commanders, including Coast Guard coxswains, petty officers or other officers operating Coast Guard vessels and Federal, State, and local officers designated by or assisting the Captain of the Port, Portland in the enforcement of the safety zone.
(c)*Enforcement Period.* This regulation will be enforced from 8:30 p.m. until 11:30 p.m.
(PDT)on May 9, 2007. Dated: March 21, 2007. Patrick G. Gerrity, Captain, U.S. Coast Guard, Captain of the Port. [FR Doc. E7-6145 Filed 4-3-07; 8:45 am] BILLING CODE 4910-15-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 174 [EPA-HQ-OPP-2006-0783; FRL-8120-5] Bacillus thuringiensis Vip3Aa20 Protein and the Genetic Material Necessary for its Production in Corn; Temporary Exemption From the Requirement of a Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes a temporary exemption from the requirement of a tolerance for residues of the *Bacillus thuringiensis* Vip3Aa20 protein and the genetic material necessary for its production in corn when applied or/used as a plant-incorporated protectant. Syngenta Seeds, Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), requesting the temporary tolerance exemption. This regulation eliminates the need to establish a maximum permissible level for residues of *Bacillus thuringiensis* Vip3Aa20 protein and the genetic material necessary for its production in corn when applied or/used as a plant-incorporated protectant on field corn, sweet corn, and popcorn. The temporary tolerance exemption expires on March 31, 2008. DATES: This regulation is effective April 4, 2007. Objections and requests for hearings must be received on or before June 4, 2007, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ). ADDRESSES: EPA has established a docket for this action under docket identification
(ID)number EPA-HQ-OPP-2006-0783. To access the electronic docket, go to *http://www.regulations.gov* , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov web site to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is
(703)305-5805. FOR FURTHER INFORMATION CONTACT: Alan Reynolds, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)605-0515; e-mail address: *reynolds.alan@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this “ **Federal Register** ” document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of 40 CFR part 174 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0783 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before June 4, 2007. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2006-0783, by one of the following methods. • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs
(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is
(703)305-5805. II. Background and Statutory Findings In the **Federal Register** of November 1, 2006 (71 FR 64269) (FRL-8095-4), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 6G7091) by Syngenta Seeds, Inc., P.O. Box 12257, Research Triangle Park, NC 27709. The petition requested that 40 CFR part 174 be amended by establishing a temporary exemption from the requirement of a tolerance for residues of the *Bacillus thuringiensis* Vip3Aa20 protein and the genetic material necessary for its production in corn when applied or used as a plant-incorporated protectant on field corn, sweet corn, and popcorn. This notice included a summary of the petition prepared by the petitioner, Syngenta Seeds, Inc. One comment was received in response to the notice of filing. The commenter objected to an exemption from the requirement of tolerance and expressed opposition to genetic alterations. The Agency understands the commenter's concerns and recognizes that some individuals believe that genetically modified crops and food should be completely banned. However, pursuant to its authority under the FFDCA, EPA conducted a comprehensive assessment of the Vip3Aa20 protein and the genetic material necessary for its production in corn, including a review of acute oral toxicity data and amino acid sequence comparisons to known toxins and allergens. In addition, data were reviewed that demonstrate that the Vip3Aa20 protein is rapidly degraded by gastric fluid *in vitro* , is not glycosylated, and is present in low levels in corn tissue. Based on these data, EPA concluded that there is a reasonable certainty that no harm will result from dietary exposure to this protein as expressed in genetically modified corn. Thus, under the standard in FFDCA section 408(c)(2), a tolerance exemption is appropriate. Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of the FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Pursuant to section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in section 408(b)(2)(C), which requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue * * *.” Additionally, section 408(b)(2)(D) of the FFDCA requires that the Agency consider “available information concerning the cumulative effects of a particular pesticide's residues” and “other substances that have a common mechanism of toxicity.” EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. III. Toxicological Profile Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability, and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Data have been submitted demonstrating a lack of mammalian toxicity at high levels of exposure to the pure (microbially-expressed) Vip3Aa20 protein. These data demonstrate the safety of Vip3Aa20 at levels well above maximum possible exposure levels that are reasonably anticipated in the crops. This is similar to the Agency position regarding toxicity and the requirement of residue data for the microbial *Bacillus thuringiensis* products from which this plant-incorporated protectant was derived (See 40 CFR 158.740(b)(2)(i)). For microbial products, the need for Tier II and III toxicity testing and residue data to verify the observed effects and clarify the source of these effects is triggered only by significant acute effects in studies such as the mouse oral toxicity study. In order to clarify the discussion that follows in the remainder of this Final Rule, it is necessary to distinguish the various Vip3A designations that are used. Vip3Aa20 is the designation applicable to Vip3A protein expressed in corn. Vip3Aa19 is the designation applicable to Vip3A protein expressed in cotton. Because the Agency has determined that both Vip3Aa19 and Vip3Aa20 are functionally equivalent, the Agency in establishing this temporary tolerance exemption for Vip3Aa20 expressed in corn has relied on data and analysis specifically developed for Vip3Aa20, as well as on data and analysis specifically developed for Vip3Aa19. A separate temporary exemption from the requirement of tolerance already has been established for Vip3Aa19 as expressed in cotton (71 FR 24582; 40 CFR 174.452).) An acute oral toxicity study was submitted for the Vip3Aa19 protein. Male and female mice (16 of each) were dosed with 3,675 milligrams/kilograms bodyweight (mg/kg bwt) of Vip3Aa19 protein. All mice survived the study, gained weight, had no test material-related clinical signs, and had no test material-related findings at necropsy. This acute oral toxicity data also supports the prediction that the Vip3Aa20 protein would be non-toxic to humans. When proteins are toxic, they are known to act via acute mechanisms and at very low dose levels (Sjoblad, Roy D., *et al* . 1992). Therefore, since no effects were shown to be caused by the plant- incorporated protectants, even at relatively high dose levels, the Vip3Aa20 protein is not considered toxic. Amino acid sequence comparisons showed no similarity between the Vip3Aa20 protein and known toxic proteins available in public protein data bases. According to the Codex Alimintarius guidelines, the assessment of potential toxicity also includes stability to heat (FAO/WHO Standards Programme, 2001). A heat lability study demonstrated that Vip3Aa19 is inactivated against Fall Armyworms (FAW), when heated to 55 °C for 30 minutes. Since Vip3Aa20 is a protein, allergenic sensitivities were considered. Currently, no definitive tests exist for determining the allergenic potential of novel proteins. Therefore, EPA uses a weight-of-the-evidence approach where the following factors are considered: Source of the trait; amino acid sequence similarity with known allergens; prevalence in food; and biochemical properties of the protein, including *in vitro* digestibility in simulated gastric fluid (SGF), and glycosylation. Current scientific knowledge suggests that common food allergens tend to be resistant to degradation acids and proteases; may be glycosylated; and present at high concentrations in the food. Data have been submitted that demonstrate that the Vip3A from recombinant maize (LPPACHA-0199) and *E. coli* (VIP3A-0100) proteins are rapidly degraded by gastric fluid *in vitro* . (VIP3A-0100 refers to a microbially-expressed Vip3A that has been shown to be the equivalent of the plant-expressed Vip3A protein.) In a solution of simulated gastric fluid (containing pepsin) and either 80 microliters (µL) of LPPACHA-0199 or 320 µL of VIP3A-0100 test protein, both were shown to be susceptible to pepsin degradation. These data support the conclusion that Vip3A proteins expressed in transgenic plants will be readily digested as a conventional dietary protein under typical mammalian gastric conditions. Further data demonstrate that Vip3Aa20 is not glycoslylated and a comparison of amino acid sequences of known allergens uncovered no evidence of any homology with Vip3Aa20, even at the level of 8 contiguous amino acid residues. Preliminary data of the quantification of Vip3Aa20 protein in various maize tissues were also submitted. This data demonstrated that mean Vip3Aa20 concentrations in corn kernels ranged from approximately 24.6 - 40.3 micrograms (µg) Vip3Aa20/dry weight, representing approximately 0.003% of the total protein in grain (assuming that corn grain contains 10% total protein by weight). Therefore, Vip3Aa20 is present in low levels in corn tissue and the protein expression is much lower than the amounts of allergen protein found in commonly allergenic foods. In those foods, the allergens can be 10 to 50% of the total protein found. Therefore, the potential for the Vip3Aa20 protein to be a food allergen is minimal. As noted above, toxic proteins typically act as acute toxins with low dose levels. Therefore, since no effects were shown to be caused by this plant-incorporated protectant, even at relatively high dose levels, the Vip3Aa20 protein is not considered toxic. IV. Aggregate Exposures In examining aggregate exposure, section 408 of the FFDCA directs EPA to consider available information concerning exposures from the pesticide residues in food and all other non-occupational exposures, including drinking water from ground water or surface water, and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses). The Agency has considered available information on the aggregate exposure levels of consumers (and major identifiable subgroups of consumers) to the pesticide chemical residue and to other related substances. These considerations include dietary exposure under the tolerance exemption and all other tolerances or exemptions in effect for the plant-incorporated protectant chemical residue, and exposure from non-occupational sources. Exposure via the skin or inhalation is not likely since the plant-incorporated protectant is contained within plant cells, which essentially eliminates these exposure routes or reduces these exposure routes to negligible. The amino acid homology assessment revealed no similarities to known aeroallergens, indicating that Vip3A has a low potential to be an inhalation allergen. It has been demonstrated that there is no evidence of occupationally related respiratory symptoms, based on a health survey on migrant workers after exposure to *Bt* pesticides (Berstein *et al* . 1999), which provides further evidence of the negligible respiratory risks of Bt plant-incorporated protectants. Exposure via residential or lawn use to infants and children is also not expected because the use sites for the Vip3Aa20 protein are all agricultural for control of insects. Oral exposure, at very low levels, may occur from ingestion of processed corn products and, theoretically, drinking water. However, oral toxicity testing done at a dose in excess of 3 gm/kg showed no adverse effects. Furthermore, the expected dietary exposure from both cotton and corn are several orders of magnitude lower than the amounts of Vip3Aa20 protein shown to have no toxicity. Therefore, even if negligible aggregate exposure should occur, the Agency concludes that such exposure would present no harm due to the lack of mammalian toxicity and the rapid digestibility demonstrated for the Vip3Aa20 proteins. V. Cumulative Effects Pursuant to FFDCA section 408(b)(2)(D)(v), EPA has considered available information on the cumulative effects of such residues and other substances that have a common mechanism of toxicity. These considerations include the cumulative effects on infants and children of such residues and other substances with a common mechanism of toxicity. Because there is no indication of mammalian toxicity, the Agency concludes that there are no cumulative effects arising from Vip3Aa20 protein residues in corn. VI. Determination of Safety for U.S. Population, Infants and Children A. Toxicity and Allergenicity Conclusions The data submitted and cited regarding potential health effects for the Vip3Aa20 protein include the characterization of the expressed Vip3Aa20 protein in corn, as well as the acute oral toxicity, heat stability, and *in vitro* digestibility of the proteins. The results of these studies were determined applicable to evaluate human risk, and the validity, completeness, and reliability of the available data from the studies were considered. Adequate information was submitted to show that the Vip3A protein test material derived from microbial cultures (designated VIP3A-0100) was biochemically and functionally similar to the Vip3Aa20 protein expressed in corn. Microbially produced protein was chosen in order to obtain sufficient material for testing. The acute oral toxicity data submitted supports the prediction that the Vip3Aa20 protein would be non-toxic to humans. As mentioned above, when proteins are toxic, they are known to act via acute mechanisms and at very low dose levels (Sjoblad, Roy D., *et al* . 1992). Since no effects were shown to be caused by Vip3Aa20 protein, even at relatively high dose levels (3,675 mg Vip3Aa19/kg bwt), the Vip3Aa20 protein is not considered toxic. This is similar to the Agency position regarding toxicity and the requirement of residue data for the microbial *Bacillus thuringiensis* products from which this plant-incorporated protectant was derived. (See 40 CFR 158.740(b)(2)(i)). Moreover, Vip3Aa20 showed no sequence similarity to any known toxin. Protein residue chemistry data for Vip3Aa20 were not required for a human health effects assessment of the subject plant-incorporated protectant ingredients because of the lack of mammalian toxicity. However, preliminary data (that were submitted with administrative materials for an Experimental Use Permit application for corn expressing the Vip3Aa20 protein) demonstrated low levels of Vip3Aa20 in corn tissues with less than 40 µg Vip3Aa20 protein/gram dry weight in kernels and less than 75 µg Vip3Aa20 protein/gram dry weight of whole corn plant. Since Vip3Aa20 is a protein, its potential allergenicity is also considered as part of the toxicity assessment. Information considered as part of the allergenicity assessment included data demonstrating that the Vip3Aa20 protein came from a *Bacillus thuringiensis* which is not a known allergenic source, showed no sequence similarity to known allergens, was readily degraded by pepsin, and was not glycosylated when expressed in the plant. Therefore, there is a reasonable certainty that the Vip3Aa20 protein will not be an allergen. Neither available information concerning the dietary consumption patterns of consumers (and major identifiable subgroups of consumers including infants and children), nor safety factors that are generally recognized as appropriate for the use of animal experimentation data were evaluated. The lack of mammalian toxicity at high levels of exposure to the Vip3Aa20 protein, as well as the minimal potential to be a food allergen, demonstrate the safety of Vip3Aa20 at levels well above possible maximum exposure levels anticipated in the crop. The genetic material necessary for the production of the plant-incorporated protectant active ingredients are the nucleic acids (DNA, RNA) which comprise genetic material encoding these proteins and their regulatory regions. The genetic material (DNA, RNA) necessary for the production of Vip3Aa20 protein already are exempted from the requirement of a tolerance under a blanket exemption for all nucleic acids (40 CFR 174.475). B. Infants and Children Risk Conclusions FFDCA section 408(b)(2)(C) provides that EPA shall assess the available information about consumption patterns among infants and children, special susceptibility of infants and children to pesticide chemical residues, and the cumulative effects on infants and children of the residues and other substances with a common mechanism of toxicity. In addition, FFDCA section 408(b)(2)(C) also provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base, unless EPA determines that a different margin of safety will be safe for infants and children. In this instance, based on all the available information, the Agency concludes that there is a finding of no toxicity for the Vip3Aa20 protein and the genetic material necessary for its production in corn. Because there are no threshold effects of concern, the Agency has determined that the additional tenfold margin of safety is not necessary to protect infants and children. Further, the provisions of consumption patterns, special susceptibility, and cumulative effects do not apply. C. Overall Safety Conclusion There is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of the Vip3Aa20 protein and the genetic material necessary for its production in corn, when it is applied or/used in accordance with good agricultural practices on field corn, sweet corn, and popcorn. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. The Agency has arrived at this conclusion because, as previously discussed, no toxicity to mammals has been observed, nor has there been any indication of allergenicity potential for this plant-incorporated protectant. VII. Other Considerations A. Endocrine Disruptors The pesticidal active ingredient is a protein, derived from sources that are not known to exert an influence on the endocrine system. Therefore, the Agency is not requiring information on the endocrine effects of the plant-incorporated protectant at this time. B. Analytical Method A method for extraction and enzyme linked immunosorbent assay (ELISA) analysis of Vip3Aa20 protein in corn has been submitted and is under review by the Agency. C. Codex Maximum Residue Level No Codex maximum residue levels exist for the plant-incorporated protectant *Bacillus thuringiensis* Vip3Aa20 protein and the genetic material necessary for its production in corn. VIII. Statutory and Executive Order Reviews This final rule establishes an exemption from the requirement of a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget
(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866, this rule is not subject to Executive Order 13211, *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq* ., nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act
(RFA)(5 U.S.C. 601 *et seq* .) do not apply. This final rule directly regulates growers, food processors, food handlers and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, This rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA)(Public Law 104-4). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). IX. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq* ., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the **Federal Register** . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 174 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: March 23, 2007. James Jones, Director, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 174—AMENDED 1. The authority citation for part 174 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 174.458 is added to subpart W to read as follows: § 174.458 Bacillus thuringiensis Vip3Aa20 protein and the genetic material necessary for its production in corn; temporary exemption from the requirement of a tolerance. Residues of *Bacillus thuringiensis* Vip3Aa20 protein in corn are temporarily exempt from the requirement of a tolerance when used as a plant-incorporated protectant in the food and feed commodities of corn; corn, field; corn, sweet; corn, pop. This temporary exemption from the requirement of tolerance will permit the use of the food commodities in this paragraph when treated in accordance with the provisions of the experimental use permit 67979-EUP-6, which is being issued in accordance with the provisions of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136). This temporary exemption from the requirement of a tolerance expires and is revoked March 31, 2008; however, if the experimental use permit is revoked, or if any experience with or scientific data on this pesticide indicate that the temporary tolerance exemption is not safe, this temporary exemption from the requirement of a tolerance may be revoked at any time. [FR Doc. E7-6256 Filed 4-3-07; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0731; FRL-8120-4] Diphenylamine; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes a tolerance for residues of diphenylamine in or on pear. Interregional Research Project Number 4 (IR-4) requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective April 4, 2007. Objections and requests for hearings must be received on or before June 4, 2007, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION) . ADDRESSES: EPA has established a docket for this action under docket identification
(ID)number EPA-HQ-OPP-2006-0731. To access the electronic docket, go to *http://www.regulations.gov* , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov web site to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at *http://www.regulations.gov* ,or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is
(703)305-5805. FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)308-3194; e-mail address: *brothers.shaja@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged in the following activities: • Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this “ **Federal Register** ” document through the electronic docket at *http://www.regulations.gov* , you may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0731 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before June 4, 2007. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA-HQ-OPP-2006-0731, by one of the following methods: • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs
(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is
(703)305-5805. II. Petition for Tolerance and Proposed Rule The Interregional Research Project Number 4 (IR-4) submitted a petition (PP# 0E6107) for a tolerance for the pesticide diphenylamine under section 408 of the FFDCA, 21 U.S.C. 346a. Specifically, the petition requested that 40 CFR 180.190 be amended by establishing a tolerance for residues of the plant growth regulator diphenylamine, in or on pear (post harvest) at 5.0 parts per million (ppm). However, neither IR-4 nor Atomchem North American Incorporated, the registrant, submitted all required elements of a petition in support of establishing a tolerance. Because the petition was incomplete, EPA did not publish a Notice of Filing for the petition. Instead, in the **Federal Register** of December 6, 2006 (71 FR 70703) (FRL-8104-1), EPA issued a proposed rule pursuant to section 408(e) of FFDCA, 21 U.S.C. 346a(e). The proposed rule included EPA's explanation of why the proposed diphenylamine tolerance regulation met the safety standard. The Northwest Horticulture Council submitted two comments in favor of the establishment of diphenylamine on pear. There was also a comment submitted by a private citizen who opposed the authorization to sell to any pesticide that leaves a residue on food. The Agency has previously responded to this commenter's claims regarding the validity of use animal testing to determine a pesticide's potential toxicity. Refer to **Federal Register** of (70 FR 1349, January 7, 2005). This commenter also claimed the Agency was “negligent” for only conducting 90-day testing on rats. The commenter is mistaken, however, because EPA examined other rat studies involving lifetime exposure and multiple generations of rats. (71 FR 70703) (FRL-7691-4), December 6, 2006). The final comment opposed the proposed regulation simply on the grounds that there are “too many bugs” and too many pesticide regulations. This comment supplied no rationale or supporting information and thus no response is warranted. III. Action on Tolerance Petition and Proposed Regulation Based on the rationale and findings set forth in the proposed rule, a tolerance is established for the residues of diphenylamine in or on pear at 5.0 ppm. IV. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget
(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866, this rule is not subject to Executive Order 13211, *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq* ., nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994). Pursuant to the Regulatory Flexibility Act
(RFA)(5 U.S.C. 601 *et seq.* ), the Agency hereby certifies that this proposed action will not have significant negative economic impact on a substantial number of small entities. Establishing a pesticide tolerance or an exemption from the requirement of a pesticide tolerance is, in effect, the removal of a regulatory restriction on pesticide residues in food and thus such an action will not have any negative economic impact on any entities, including small entities. This rule directly regulates growers, food processors, food handlers and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, This rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA)(Public Law 104-4). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). V. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq.* , generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the **Federal Register** . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: March 21, 2007. Donald R. Stubbs, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.190 is amended by alphabetically adding the following commodity to the table in paragraph
(a)to read as follows: § 180.190 Diphenylamine; tolerances for residues.
(a)* * * Commodity Parts per million * * * * * Pear (post harvest) 5.0 * * * * * [FR Doc. E7-5804 Filed 4-3-07; 8:45 am] BILLING CODE 6560-50-S FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 73 [DA 07-1349; MB Docket No. 02-177; RM-10489] Radio Broadcasting Services; Milano, TX AGENCY: Federal Communications Commission. ACTION: Final rule; dismissal of petition for reconsideration. SUMMARY: The staff approves the withdrawal of a petition for reconsideration in this FM allotment rulemaking proceeding and finds no reason for further consideration of the matters raised therein. *See* SUPPLEMENTARY INFORMATION . FOR FURTHER INFORMATION CONTACT: Andrew J. Rhodes, Media Bureau,
(202)418-2180. SUPPLEMENTARY INFORMATION: This is a synopsis of the Commission's *Memorandum Opinion and Order* , MB Docket No. 02-177, adopted March 16, 2007, and released March 20, 2007. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC Reference Information Center (Room CY-A257), 445 12th Street, SW., Washington, DC 20554. The complete text of this decision may also be purchased from the Commission's copy contractor, Best Copy and Printing, Inc., Portals II, 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone 1-800-378-3160 or *http://www.BCPIWEB.com.* The *Report and Order* in this proceeding dismissed a counterproposal in this rulemaking proceeding filed by Roy. E. Henderson, requesting the upgrade and reallotment of his Station KLTR(FM) from Channel 297A, Caldwell, Texas, to Channel 297C3 at Bedias, Texas. The counterproposal was dismissed because it was technically defective. The withdrawal of the petition for reconsideration complies with Section 1.420(j) of the Commission's rules because Henderson has documented that he has not and will not receive any consideration in exchange for the withdrawal of his petition. *See* 69 FR 34114 (June 18, 2004). This document is not subject to the Congressional Review Act. (The Commission, is, therefore, not required to submit a copy of this Memorandum Opinion and Order to GAO, pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A) because the petition for reconsideration was dismissed). Federal Communications Commission. John A. Karousos, Assistant Chief, Audio Division, Media Bureau. [FR Doc. E7-6225 Filed 4-3-07; 8:45 am] BILLING CODE 6712-01-P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 73 [FCC 06-117] National Broadcast Television Ownership Rules AGENCY: Federal Communications Commission. ACTION: Final rule. SUMMARY: In this document, the Commission conforms its rules to comply with the Consolidated Appropriations Act, 2004 (Appropriations Act). The Appropriations Act, among other things, directs the Commission to modify the national television ownership limit to specify 39 percent as the maximum aggregate national audience reach of any single television station owner. The Appropriations Act also adds a new section to the Telecommunications Act of 1996, which the Commission now implements. DATES: Effective May 4, 2007. FOR FURTHER INFORMATION CONTACT: Mania Baghdadi, Industry Analysis Division, Media Bureau, Federal Communications Commission,
(202)418-2330. Press inquiries should be directed to Clyde Ensslin,
(202)418-0506. SUPPLEMENTARY INFORMATION: Initial Paperwork Reduction Act of 1995 Analysis This document does not contain any information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, it does not contain any information collection burden “for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4). Synopsis of Order 1. On January 22, 2004, President Bush signed into law the Consolidated Appropriations Act, 2004, H.R. 2673 (“the Appropriations Act”). 1 Section 629(1) of the Appropriations Act amends section 202(c) of the Telecommunications Act of 1996 (“Telecommunications Act”) to direct the Commission to modify the national television ownership limit, contained in section 73.3555 of the Commission's rules, 2 to specify 39 percent as the maximum aggregate national audience reach of any single television station owner. 3 The Appropriations Act also adds to the Telecommunications Act a new section 202(c)(3), which states: 1 Consolidated Appropriations Act, 2004, Public Law 108-199, § 629, 118 Stat. 3 (2004). 2 47 CFR 73.3555. 3 47 U.S.C. 202(c)(1). Prior to passage of the Appropriations Act, Section 202(c)(1) of the Telecommunications Act established a national television ownership reach limit of 35 percent, which was incorporated in Section 73.3555(e) of the Commission's rules. In the 2002 biennial ownership proceeding, the Commission raised the national television ownership limit from 35 percent to 45 percent. *2002 Biennial Regulatory Review* , 68 FR 46286, August 5, 2003 (“2002 Biennial Report and Order”), *aff'd in part, remanded in part, Prometheus Radio Project* v. *FCC* , 373 F.3d 372 (3rd Cir. 2004) (“Prometheus Order”), *cert. denied* , 13 U.S.L.W. 3466 (June 13, 2005). The rule changes adopted in the biennial ownership proceeding were stayed, however, by the U.S. Court of Appeals for the Third Circuit and, except for a partial lifting of the stay with respect to the local radio ownership rules, remain stayed pending further judicial action. *Prometheus Radio Project,* *et al.* v. *FCC* , No. 03-3388 (Sept. 3, 2003) (order granting stay); *Prometheus Radio Project* v. *FCC* , No. 03-3388 (3rd Cir. Sept. 3, 2004) (order partially lifting stay).
(3)DIVESTITURE—A person or entity that exceeds the 39 percent national audience reach limitation for television stations in paragraph (1)(B) through grant, transfer, or assignment of an additional license for a commercial television broadcast station shall have not more than 2 years after exceeding such limitation to come into compliance with such limitation. This divestiture requirement shall not apply to persons or entities that exceed the 39 percent national audience reach limitation through population growth. 4 4 47 U.S.C. 202(c)(3). With this Order, the Commission conforms its rules to these provisions. Section 73.3555(d) will be redesignated as section 73.3555(e), section 73.3555(e)(1) is revised to reflect the changes directed by section 202(c)(1) of the Telecommunications Act, as amended by the Appropriations Act, and a new section 73.3555(e)(3) is added to reflect section 202(c)(3). 5 These changes are set forth in the rule changes section of this summary. 6 5 In 2003, the Commission's 2002 Biennial Report and Order eliminated the radio-television cross-ownership rule, formerly found at 47 CFR 73.3555(c). As a result, the national television ownership rule was renumbered from 47 CFR 73.3555(e)(1) to 47 CFR 73.3555(d)(1). However, the rules adopted in the 2002 Biennial Report and Order, and published in the CFR, were stayed by a court and did not go into effect. However, after the stay was applied, the new 39 percent cap was promulgated pursuant to the Appropriations Act. 6 The current broadcast attribution rules set forth in the notes to Section 73.3555 would continue to apply to the national television ownership rule as Congress did not indicate any intent that the Commission alter them in this proceeding. The statute directs the Commission to change the audience reach limit to 39 percent and add the new divestiture provision. Neither the statute nor the legislative history indicate that Congress intended that we make any other changes to the national television ownership rule in this proceeding. 2. The Commission is revising its rules without providing prior public notice and an opportunity for comment because the rule modifications are mandated by the applicable provisions of the Appropriations Act and Telecommunications Act. The Commission finds that notice and comment procedures are unnecessary, and that this action therefore falls within the “good cause” exception of the Administrative Procedure Act. 7 The rule changes adopted in this Order do not involve discretionary action on the part of the Commission. Rather, they simply implement provisions of the Appropriations Act, as it amends the Telecommunications Act, which directs the Commission to revise its rules according to specific terms set forth in those laws. 7 *See* 5 U.S.C. 553(b)(B) (notice requirements inapplicable “when the agency for good cause finds * * * that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest”); *Metzenbaum* v. *Federal Energy Regulatory Commission* , 675 F.2d 1282, 1291 (D.C. Cir. 1982) (agency orders that were nondiscretionary ministerial actions issued in conformity with statute were properly issued without notice and comment). Ordering Clauses 3. Accordingly, *it is ordered* that pursuant to section 629 of the Consolidated Appropriations Act, 2004, and section 202(c)(1) of the Telecommunications Act of 1996, as amended, and sections 4(i) and 303(r) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 303(r), Part 73 of the Commission's Rules, 47 CFR part 73, *is amended.* The rule change will become effective May 4, 2007. 8 8 *See* 5 U.S.C. 553(d). 4. The Commission will send a copy of this Order in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, *see* 5 U.S.C. 801(a)(1)(A). List of Subjects in 47 CFR Part 73 Television. Federal Communications Commission. Marlene H. Dortch, Secretary. Rule Changes Part 73 of Title 47 of the Code of Federal Regulations is amended to read as follows: PART 73—RADIO BROADCAST SERVICES 1. The authority citation for part 73 continues to read as follows: Authority: 47 U.S.C. 154, 303, 334, and 336. 2. Section 73.3555 is amended by redesignating paragraphs
(d)and
(e)as paragraphs
(e)and (f), add and reserve paragraph
(d)and revise paragraph (e)(1) and add paragraph (e)(3) to read as follows: § 73.3555 Multiple ownership.
(e)* * * *National television multiple ownership rule.*
(1)No license for a commercial television broadcast station shall be granted, transferred or assigned to any party (including all parties under common control) if the grant, transfer or assignment of such license would result in such party or any of its stockholders, partners, members, officers or directors having a cognizable interest in television stations which have an aggregate national audience reach exceeding thirty-nine
(39)percent.
(3)*Divestiture.* A person or entity that exceeds the thirty-nine
(39)percent national audience reach limitation for television stations in paragraph (e)(1) of this section through grant, transfer, or assignment of an additional license for a commercial television broadcast station shall have not more than 2 years after exceeding such limitation to come into compliance with such limitation. This divestiture requirement shall not apply to persons or entities that exceed the 39 percent national audience reach limitation through population growth. [FR Doc. E7-6162 Filed 4-3-07; 8:45 am] BILLING CODE 6712-01-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 17 RIN 1018-AV16 Endangered and Threatened Wildlife and Plants; Adding Four Marine Taxa to the List of Endangered and Threatened Wildlife AGENCY: Fish and Wildlife Service, Interior. ACTION: Final rule. SUMMARY: We, the U.S. Fish and Wildlife Service (Service), are adding four marine taxa to the List of Endangered and Threatened Wildlife
(List)in accordance with the Endangered Species Act of 1973, as amended. These amendments are based on previously published determinations by the National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration, Department of Commerce, which has jurisdiction for these species. These four taxa are the Southern Distinct Population Segment
(DPS)of green sturgeon ( *Acipenser medirostris* ), staghorn ( *Acropora cervicornis* ) and elkhorn ( *Acropora palmata* ) corals, and the Southern Resident killer whale DPS ( *Orcinus orca* ). DATES: This rule is effective April 4, 2007. *Applicability dates:* The Southern DPS of the North American green sturgeon ( *Acipenser medirostris* ) listing is applicable as of June 6, 2006. The elkhorn coral ( *Acropora palmata* ) and staghorn coral ( *Acropora cervicornis* ) listing is applicable as of June 8, 2006. The Southern Resident killer whale DPS ( *Orcinus orca* ) listing is applicable as of February 16, 2006. FOR FURTHER INFORMATION CONTACT: Branch of Listing, Endangered Species Program, U.S. Fish and Wildlife Service, 4401 N. Fairfax Drive, Mail Stop 420, Arlington, Virginia 22203 (703-358-2105). SUPPLEMENTARY INFORMATION: Background In accordance with the Act and the Reorganization Plan No. 4 of 1970, NMFS has jurisdiction over these taxa. Under section 4(a)(2) of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 *et seq.* ), NMFS must decide whether a species under its jurisdiction should be classified as endangered or threatened. The Service is responsible for the actual amendment of the List in 50 CFR 17.11(h). On April 6, 2005, NMFS published a proposed rule (70 FR 17386) to list the Southern DPS of the North American green sturgeon ( *Acipenser medirostris* ) as threatened. During the public comment period for that proposed rule, NMFS received 32 comments. On April 7, 2006, NMFS published a final rule to list the Southern DPS of the North American green sturgeon as threatened (71 FR 17757). The listing was effective as of June 6, 2006. In that final rule, NMFS addressed all public comments received in response to the proposed rule. On May 9, 2005, NMFS published a proposed rule (70 FR 24359) to list the elkhorn coral ( *Acropora palmata* ) and staghorn coral ( *Acropora cervicornis* ) as threatened. During the public comment period for that proposed rule, NMFS received 1,393 comments. On May 9, 2006, NMFS published a final rule to list the elkhorn and staghorn corals as threatened (71 FR 26852). The listing was effective as of June 8, 2006. In that final rule, NMFS addressed all public comments received in response to the proposed rule. On December 22, 2004, NMFS published a proposed rule (69 FR 76673) to list the Southern Resident killer whale DPS ( *Orcinus orca* ) as threatened. During the public comment period for that proposed rule, NMFS received 1,326 comments. On November 18, 2005, NMFS published a final rule to list the Southern Resident killer whale DPS as threatened (70 FR 69903). The listing was effective as of February 16, 2006. In that final rule, NMFS addressed all public comments received in response to the proposed rule. Because NMFS provided a public comment period on the proposed rules for these taxa, and because this action of the Service to amend the List in accordance with the determination by NMFS is nondiscretionary, the Service finds good cause that the notice and public comment procedures of 5 U.S.C. 553(b) are unnecessary for this action. We also find good cause under 5 U.S.C. 553(d)(3) to make this rule effective immediately. The NMFS rules extended protection under the Act to these species and listed them in 50 CFR part 224; this rule is an administrative action to add the species to the List of Endangered and Threatened Species in 50 CFR 17.11(h). The public would not be served by delaying the effective date of this rulemaking action. For more information concerning these two listing determinations, please consult the respective rules published in the **Federal Register** . Required Determinations National Environmental Policy Act The Service has determined that an Environmental Assessment, as defined under the authority of the National Environmental Policy Act of 1969, need not be prepared in connection with regulations adopted pursuant to section 4(a) of the Act. A notice outlining the Service's reasons for this determination was published in the **Federal Register** on October 25, 1983 (48 FR 49244). Paperwork Reduction Act The Service has examined this regulation under the Paperwork Reduction Act of 1995 and found it to contain no information collection requirements. We may not conduct or sponsor, and you are not required to respond to, a collection of information unless it displays a currently valid Office of Management and Budget
(OMB)control number. List of Subjects in 50 CFR Part 17 Endangered and threatened species, Exports, Imports, Reporting and recordkeeping requirements, Transportation. Regulation Promulgation Accordingly, part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, is amended as set forth below: PART 17—[AMENDED] 1. The authority citation for part 17 continues to read as follows: Authority: 16 U.S.C. 1361-1407; 16 U.S.C. 1531-1544; 16 U.S.C. 4201-4245; Pub. L. 99-625, 100 Stat. 3500, unless otherwise noted. 2. Amend § 17.11(h) by: a. Adding the subheading “CORALS” at the end of the table; and b. Adding the following entries, in alphabetical order under MAMMALS, FISHES, and CORALS, respectively, to the List of Endangered and Threatened Wildlife: § 17.11 Endangered and threatened wildlife.
(h)* * * Species Common name Scientific name Historic range Vertebrate population where endangered or threatened Status When listed Critical habitat Special rules MAMMALS * * * * * * * Whale, killer *Orcinus orca* Pacific Ocean Southern Resident DPS, which consists of whales from the J, K, and L pods, wherever they are found in the wild E 756 NA NA * * * * * * * FISHES * * * * * * * Sturgeon, North America green *Acipenser medirostris* U.S.A.
(CA)U.S.A.
(CA)Southern Distinct Population Segment, which includes all spawning populations south of the Eel River (exclusive), principally including the Sacramento River spawning population T 756 NA NA * * * * * * * CORALS Coral, elkhorn *Acropora palmata* U.S.A. (FL, PR, VI, Navassa); and wider Caribbean-Belize, Colombia, Costa Rica, Guatemala, Honduras, Mexico, Nicaragua, Panama, Venezuela, and all the islands of the West Indies N/A T 756 NA NA Coral, staghorn *Acropora cervicornis* U.S.A. (FL, PR, VI, Navassa); and wider Caribbean-Belize, Colombia, Costa Rica, Guatemala, Honduras, Mexico, Nicaragua, Panama, Venezuela, and all the islands of the West Indies N/A T 756 NA NA Dated: March 23, 2007. Kenneth Stansell, Acting Director, U.S. Fish and Wildlife Service. [FR Doc. E7-6188 Filed 4-3-07; 8:45 am] BILLING CODE 4310-55-P 72 64 Wednesday, April 4, 2007 Proposed Rules DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2007-27756; Directorate Identifier 2006-NM-255-AD] RIN 2120-AA64 Airworthiness Directives; McDonnell Douglas Model DC-8-62, DC-8-62F, DC-8-63, DC-8-63F, DC-8-72, DC-8-72F, and DC-8-73F Airplanes AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: The FAA proposes to adopt a new airworthiness directive
(AD)for all McDonnell Douglas Model DC-8-62, DC-8-62F, DC-8-63, DC-8-63F, DC-8-72, DC-8-72F, and DC-8-73F airplanes. This proposed AD would require deactivating certain components (the sump heater, scavenge valve, and scavenge pump) of the center wing fuel tank. This proposed AD results from fuel system reviews conducted by the manufacturer. We are proposing this AD to prevent certain conditions related to these components, which could lead to a possible ignition source in the fuel tank and a potential fire or explosion. DATES: We must receive comments on this proposed AD by May 21, 2007. ADDRESSES: Use one of the following addresses to submit comments on this proposed AD. • *DOT Docket Web site:* Go to *http://dms.dot.gov* and follow the instructions for sending your comments electronically. • *Government-wide rulemaking Web site:* Go to *http://www.regulations.gov* and follow the instructions for sending your comments electronically. • *Mail:* Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street, SW., Nassif Building, room PL-401, Washington, DC 20590. • *Fax:*
(202)493-2251. • *Hand Delivery:* Room PL-401 on the plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. Contact Boeing Commercial Airplanes, Long Beach Division, 3855 Lakewood Boulevard, Long Beach, California 90846, Attention: Data and Service Management, Dept. C1-L5A (D800-0024), for the service information identified in this proposed AD. FOR FURTHER INFORMATION CONTACT: Serj Harutunian, Aerospace Engineer, Propulsion Branch, ANM-140L, FAA, Los Angeles Aircraft Certification Office, 3960 Paramount Boulevard, Lakewood, California 90712-4137; telephone
(562)627-5254; fax
(562)627-5210. SUPPLEMENTARY INFORMATION: Comments Invited We invite you to submit any relevant written data, views, or arguments regarding this proposed AD. Send your comments to an address listed in the ADDRESSES section. Include the docket number “FAA-2007-27756; Directorate Identifier 2006-NM-255-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the proposed AD. We will consider all comments received by the closing date and may amend the proposed AD in light of those comments. We will post all comments we receive, without change, to *http://dms.dot.gov,* including any personal information you provide. We will also post a report summarizing each substantive verbal contact with FAA personnel concerning this proposed AD. Using the search function of that Web site, anyone can find and read the comments in any of our dockets, including the name of the individual who sent the comment (or signed the comment 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 (65 FR 19477-78), or you may visit *http://dms.dot.gov.* Examining the Docket You may examine the AD docket on the Internet at *http://dms.dot.gov,* or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone
(800)647-5227) is located on the plaza level of the Nassif Building at the DOT street address stated in the ADDRESSES section. Comments will be available in the AD docket shortly after the Docket Management System receives them. Discussion The FAA has examined the underlying safety issues involved in fuel tank explosions on several large transport airplanes, including the adequacy of existing regulations, the service history of airplanes subject to those regulations, and existing maintenance practices for fuel tank systems. As a result of those findings, we issued a regulation titled “Transport Airplane Fuel Tank System Design Review, Flammability Reduction and Maintenance and Inspection Requirements” (66 FR 23086, May 7, 2001). In addition to new airworthiness standards for transport airplanes and new maintenance requirements, this rule included Special Federal Aviation Regulation No. 88 (“SFAR 88,” Amendment 21-78, and subsequent Amendments 21-82 and 21-83). Among other actions, SFAR 88 requires certain type design (i.e., type certificate
(TC)and supplemental type certificate (STC)) holders to substantiate that their fuel tank systems can prevent ignition sources in the fuel tanks. This requirement applies to type design holders for large turbine-powered transport airplanes and for subsequent modifications to those airplanes. It requires them to perform design reviews and to develop design changes and maintenance procedures if their designs do not meet the new fuel tank safety standards. As explained in the preamble to the rule, we intended to adopt airworthiness directives to mandate any changes found necessary to address unsafe conditions identified as a result of these reviews. In evaluating these design reviews, we have established four criteria intended to define the unsafe conditions associated with fuel tank systems that require corrective actions. The percentage of operating time during which fuel tanks are exposed to flammable conditions is one of these criteria. The other three criteria address the failure types under evaluation: Single failures, single failures in combination with a latent condition(s), and in-service failure experience. For all four criteria, the evaluations included consideration of previous actions taken that may mitigate the need for further action. We have determined that the actions identified in this proposed AD are necessary to reduce the potential of ignition sources inside fuel tanks, which, in combination with flammable fuel vapors, could result in fuel tank explosions and consequent loss of the airplane. We have received a report of an overheated and damaged sump heater on a center wing fuel tank. Investigation revealed that several incidents of this kind had occurred in the past and that damage was caused by fatigue failure of the sump heater thermostat. Additionally, SFAR 88 analysis has identified certain lightning protection issues with the center wing crossfeed and scavenge valves, as well as frictional heating and sparking issues with the scavenge pump. Deactivating the sump heater, the scavenge valve and the scavenge pump will address all three issues. If not corrected, operation with a damaged sump heater thermostat or scavenge pump, or operation of the crossfeed and scavenge valves during lightning conditions could lead to a possible ignition source in the fuel tank and a potential fire or explosion. Relevant Service Information We have reviewed Boeing Alert Service Bulletin DC8-28A089, dated November 1, 2006. The service bulletin describes procedures for deactivating the sump heater, scavenge valve, and scavenge pump of the center wing fuel tank. Accomplishing the actions specified in the service information is intended to adequately address the unsafe condition. FAA's Determination and Requirements of the Proposed AD We have evaluated all pertinent information and identified an unsafe condition that is likely to exist or develop on other airplanes of this same type design. For this reason, we are proposing this AD, which would require accomplishing the actions specified in the service information described previously. Costs of Compliance There are about 119 airplanes of the affected design in the worldwide fleet. The following table provides the estimated costs for U.S. operators to comply with this proposed AD. Estimated Costs Work hours Average labor rate per hour Cost per airplane Number of U.S.-registered airplanes Fleet cost 6 $80 $480 84 $40,320 Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We have determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect 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. For the reasons discussed above, I certify that the proposed regulation: 1. Is not a “significant regulatory action” under Executive Order 12866; 2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and 3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Safety. The Proposed Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The Federal Aviation Administration
(FAA)amends § 39.13 by adding the following new airworthiness directive (AD): **McDonnell Douglas:** Docket No. FAA-2007-27756; Directorate Identifier 2006-NM-255-AD. Comments Due Date
(a)The FAA must receive comments on this AD action by May 21, 2007. Affected ADs
(b)None. Applicability
(c)This AD applies to all McDonnell Douglas Model DC-8-62, DC-8-62F, DC-8-63, DC-8-63F, DC-8-72, DC-8-72F, and DC-8-73F airplanes, certificated in any category. Unsafe Condition
(d)This AD results from fuel system reviews conducted by the manufacturer. We are issuing this AD to prevent certain conditions related to the sump heater, scavenge valve, and scavenge pump of the center wing fuel tank, which could lead to a possible ignition source in the fuel tank and a potential fire or explosion. Compliance
(e)You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done. Deactivation
(f)Within 24 months after the effective date of this AD, deactivate the sump heater, scavenge valve, and scavenge pump of the center wing fuel tank, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin DC8-28A089, dated November 1, 2006. Alternative Methods of Compliance (AMOCs) (g)(1) The Manager, Los Angeles Aircraft Certification Office, FAA, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19.
(2)Before using any AMOC approved in accordance with § 39.19 on any airplane to which the AMOC applies, notify the appropriate principal inspector in the FAA Flight Standards Certificate Holding District Office. Issued in Renton, Washington, on March 26, 2007. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E7-6269 Filed 4-3-07; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2007-27755; Directorate Identifier 2006-NM-289-AD] RIN 2120-AA64 Airworthiness Directives; Bombardier Model DHC-8-400 Series Airplanes AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: The FAA proposes to adopt a new airworthiness directive
(AD)for certain Bombardier Model DHC-8-400 series airplanes. This proposed AD would require revising the Limitations section of the airplane flight manual to include procedures for pulling the “HYD PWR XFER” circuit breaker in the event of the loss of all hydraulic fluid in the No. 1 or No. 2 hydraulic system. This proposed AD results from reports of fluid loss in the No. 2 hydraulic system, causing the power transfer unit to overspeed, increasing the fluid flow within the No. 1 hydraulic system. We are proposing this AD to prevent possible loss of both the No. 1 and No. 2 hydraulic systems, resulting in the potential loss of several functions essential for safe flight and landing of the airplane. DATES: We must receive comments on this proposed AD by May 4, 2007. ADDRESSES: Use one of the following addresses to submit comments on this proposed AD. • DOT Docket Web site: Go to *http://dms.dot.gov* and follow the instructions for sending your comments electronically. • *Government-wide rulemaking Web site:* Go to *http://www.regulations.gov* and follow the instructions for sending your comments electronically. • *Mail:* Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street, SW., Nassif Building, Room PL-401, Washington, DC 20590. • *Fax:*
(202)493-2251. • *Hand Delivery:* Room PL-401 on the plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. Contact Bombardier, Inc., Bombardier Regional Aircraft Division, 123 Garratt Boulevard, Downsview, Ontario M3K 1Y5, Canada, for service information identified in this proposed AD. FOR FURTHER INFORMATION CONTACT: Ezra Sasson, Aerospace Engineer, Systems and Flight Test Branch, ANE-172, FAA, New York Aircraft Certification Office, 1600 Stewart Avenue, Suite 410, Westbury, New York 11590; telephone
(516)228-7320; fax
(516)794-5531. SUPPLEMENTARY INFORMATION: Comments Invited We invite you to submit any relevant written data, views, or arguments regarding this proposed AD. Send your comments to an address listed in the ADDRESSES section. Include the docket number “FAA-2007-27755; Directorate Identifier 2006-NM-289-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the proposed AD. We will consider all comments received by the closing date and may amend the proposed AD in light of those comments. We will post all comments we receive, without change, to *http://dms.dot.gov,* including any personal information you provide. We will also post a report summarizing each substantive verbal contact with FAA personnel concerning this proposed AD. Using the search function of that web site, anyone can find and read the comments in any of our dockets, including the name of the individual who sent the comment (or signed the comment on behalf of an association, business, labor union, etc.). You may review the DOT's complete Privacy Act Statement in the **Federal Register** published on April 11, 2000 (65 FR 19477-78), or you may visit *http://dms.dot.gov.* Examining the Docket You may examine the AD docket on the Internet at *http://dms.dot.gov,* or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone
(800)647-5227) is located on the plaza level of the Nassif Building at the DOT street address stated in the ADDRESSES section. Comments will be available in the AD docket shortly after the Docket Management System receives them. Discussion Transport Canada Civil Aviation (TCCA), which is the airworthiness authority for Canada, notified us that an unsafe condition may exist on certain Bombardier Model DHC-8-400 series airplanes. TCCA advises that it has received several reports of fluid loss in the No. 2 hydraulic system, causing the power transfer unit
(PTU)to overspeed. This resulted in pressure fluctuations and increased fluid flow within the No. 1 hydraulic system. In one case, the hydraulic system control logic did not shut down the PTU, and the overspeed condition persisted, resulting in the illumination of the No. 1 “HYD FLUID HOT” caution light. This caution light indicated that the hydraulic fluid temperature had exceeded 225 degrees Fahrenheit. Had the temperature of the hydraulic fluid continued to increase to 275 degrees Fahrenheit, the No. 1 system hydraulic firewall shutoff would have closed, leaving only the standby power unit
(SPU)available. The SPU is not capable of meeting the increased flow demands of the PTU and other No. 1 hydraulic system services. Therefore, the No. 1 hydraulic system would have also been lost, leaving only the No. 3 hydraulic system available. Inoperative systems would include flaps, brakes and emergency brakes, nose wheel steering, and all primary flight controls other than elevator control and degraded aileron control. This condition, if not corrected, could result in the potential loss of several functions essential for safe flight and landing of the airplane. Relevant Service Information Bombardier has issued the following airplane flight manual
(AFM)temporary amendments: Table.—AFM Temporary Amendments For model— Bombardier temporary amendment— Issue— Dated— To Bombardier Dash 8 Q400 airplane flight manual— -400 airplanes 13 1 July 14, 2005 PSM 1-84-1A -401 airplanes 13 1 July 14, 2005 PSM 1-84-1A -402 airplanes 13 1 July 14, 2005 PSM 1-84-1A The temporary amendments describe procedures for pulling the “HYD PWR XFER” circuit breaker in the event of the loss of all hydraulic fluid in the No. 1 or No. 2 hydraulic system. TCCA mandated the service information and issued Canadian airworthiness directive CF-2006-08, dated April 26, 2006, to ensure the continued airworthiness of these airplanes in Canada. FAA's Determination and Requirements of the Proposed AD These airplanes are manufactured in Canada and are type certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. Pursuant to this bilateral airworthiness agreement, TCCA has kept the FAA informed of the situation described above. We have examined TCCA's findings, evaluated all pertinent information, and determined that we need to issue an AD for airplanes of this type design that are certificated for operation in the United States. Therefore, we are proposing this AD, which would require revising the Limitations section of the AFM to include procedures for pulling the “HYD PWR XFER” circuit breaker in the event of the loss of all hydraulic fluid in the No. 1 or No. 2 hydraulic system. Interim Action We consider this proposed AD interim action. The manufacturer is currently developing a modification that will address the unsafe condition identified in this proposed AD. Once this modification is developed, approved, and available, we might consider additional rulemaking. Costs of Compliance The following table provides the estimated costs for U.S. operators to comply with this proposed AD. Estimated Costs Action Work hours Average labor rate per hour Parts Cost per airplane Number of U.S.- registered airplanes Fleet cost AFM revision 1 $80 $0 $80 21 $1,680 Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We have determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect 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. For the reasons discussed above, I certify that the proposed regulation: 1. Is not a “significant regulatory action” under Executive Order 12866; 2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and 3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Safety. The Proposed Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The Federal Aviation Administration
(FAA)amends § 39.13 by adding the following new airworthiness directive (AD): **Bombardier, Inc. (Formerly de Havilland, Inc.):** Docket No. FAA-2007-27755; Directorate Identifier 2006-NM-289-AD. Comments Due Date
(a)The FAA must receive comments on this AD action by May 4, 2007. Affected ADs
(b)None. Applicability
(c)This AD applies to Bombardier Model DHC-8-400, DHC-8-401, and DHC-8-402 airplanes, certificated in any category; serial numbers 4001 and 4003 and subsequent. Unsafe Condition
(d)This AD results from reports of fluid loss in the No. 2 hydraulic system, causing the power transfer unit to overspeed, increasing the fluid flow within the No. 1 hydraulic system. We are issuing this AD to prevent possible loss of both the No. 1 and No. 2 hydraulic systems, resulting in the potential loss of several functions essential for safe flight and landing of the airplane. Compliance
(e)You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done. Airplane Flight Manual
(AFM)Revision
(f)Within 14 days after the effective date of this AD, revise the Limitations section of the applicable AFM to include the information in the applicable Bombardier temporary amendment specified in Table 1 of this AD, as specified in the temporary amendment. These temporary amendments introduce procedures for pulling the “HYD PWR XFER” circuit breaker in the event of the loss of all hydraulic fluid in the No. 1 or No. 2 hydraulic system. Operate the airplane according to the limitations and procedures in the applicable temporary amendment. Table 1.—AFM Temporary Amendments For Model— Use Bombardier Temporary Amendment— Issue— Dated— To Bombardier Dash 8 Q400 Airplane Flight Manual— -400 airplanes 13 1 July 14, 2005 PSM 1-84-1A. -401 airplanes 13 1 July 14, 2005 PSM 1-84-1A. -402 airplanes 13 1 July 14, 2005 PSM 1-84-1A. Note 1: This may be done by inserting a copy of the applicable temporary amendment into the applicable AFM. When the applicable temporary amendment has been included in general revisions of the AFM, the general revisions may be inserted into the AFM, provided the relevant information in the general revisions is identical to that in the temporary amendment. Alternative Methods of Compliance (AMOCs) (g)(1) The Manager, New York Aircraft Certification Office, FAA, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19.
(2)Before using any AMOC approved in accordance with § 39.19 on any airplane to which the AMOC applies, notify the appropriate principal inspector in the FAA Flight Standards Certificate Holding District Office. Related Information
(h)Canadian airworthiness directive CF-2006-08, dated April 26, 2006, also addresses the subject of this AD. Issued in Renton, Washington, on March 26, 2007. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E7-6267 Filed 4-3-07; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 179 [Docket No. 2005N-0272] RIN 0910-ZA29 Irradiation in the Production, Processing and Handling of Food AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration
(FDA)is proposing to revise its labeling regulations applicable to foods (including dietary supplements) for which irradiation has been approved by FDA. FDA is proposing that only those irradiated foods in which the irradiation causes a material change in the food, or a material change in the consequences that may result from the use of the food, bear the radura logo and the term “irradiated,” or a derivative thereof, in conjunction with explicit language describing the change in the food or its conditions of use. For purposes of this rulemaking, we are using the term “material change” to refer to a change in the organoleptic, nutritional, or functional properties of a food, caused by irradiation, that the consumer could not identify at the point of purchase in the absence of appropriate labeling. FDA is also proposing to allow a firm to petition FDA for use of an alternate term to “irradiation” (other than “pasteurized”). In addition, FDA is proposing to permit a firm to use the term “pasteurized” in lieu of “irradiated,” provided it notifies the agency that the irradiation process being used meets the criteria specified for use of the term “pasteurized” in the Federal Food, Drug, and Cosmetic Act (the act) and the agency does not object to the notification. This proposed action is in response to the Farm Security and Rural Investment Act of 2002 (FSRIA) and, if finalized, will provide consumers with more useful information than the current regulation. DATES: Submit written or electronic comments on the proposed rule by July 3, 2007. Submit comments regarding information collection by May 4, 2007 to OMB (see ADDRESSES ). ADDRESSES: You may submit comments, identified by Docket No. 2005N-0272 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 and Docket No. 2005N-0272 or Regulatory Information Number
(RIN)for this rulemaking. All comments received will be posted without change to *http://www.fda.gov/ohrms/dockets/default.htm* , including any personal information provided. For detailed instructions on submitting comments and additional information on the rulemaking process, see the “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. *Information Collection Provisions* : Submit written comments on the information collection provisions to the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB).To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974. FOR FURTHER INFORMATION CONTACT: Loretta A. Carey, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2371. SUPPLEMENTARY INFORMATION: I. Background A. Current Labeling Requirements for Irradiated Foods In the **Federal Register** of February 14, 1984 (49 FR 5714), FDA published a proposed rule (the 1984 proposal) to approve the use of ionizing radiation on several foods. The 1984 proposal did not include a requirement for labeling disclosing the use of ionizing radiation. FDA received over 5,000 comments on this proposal, including numerous comments on the issue of labeling irradiated foods. Based on the comments and information received in response to the 1984 proposal and on further analysis, FDA published a final rule in the **Federal Register** on April 18, 1986 (51 FR 13376) (the 1986 final rule). The 1986 final rule required that the label and labeling of retail packages and displays of irradiated food bear both the radura logo and a radiation disclosure statement (“Treated with radiation” or “Treated by irradiation”). FDA concluded that labeling indicating treatment of food with radiation was necessary to prevent misbranding of irradiated foods because irradiation may not visually change the food and in the absence of a label statement, the implied representation to consumers is that the food has not been processed. We stated in the preamble to the 1986 final rule that, in addition to the mandatory language, the manufacturer may also state on the wholesale or retail label the purpose of the treatment process or further describe the kind of treatment used (51 FR 13376 at 13387). That is, the manufacturer may include in the labeling any phrase such as “treated with radiation to control spoilage,” “treated with radiation to extend shelf life,” or “treated with radiation to inhibit maturation,” as long as the phrase truthfully describes the primary purpose of the treatment. Similarly, the manufacturer may choose to state more specifically the type of radiation used in the treatment, i.e., “treated with x-radiation,” “treated with ionizing radiation,” or “treated with gamma radiation,” if more specific description is applicable. B. The 1999 Advanced Notice of Proposed Rulemaking (ANPRM) on the Labeling of Irradiated Foods On November 21, 1997, the Food and Drug Administration Modernization Act (FDAMA) (Public Law 105-115) was enacted. Section 306 of FDAMA amended the act by adding section 403C (21 U.S.C. 343-3). Section 403C of the act addressed the disclosure of irradiation on the labeling of foods as follows: “(a) No provision of section 201(n), 403(a), or 409 shall be construed to require on the label or labeling of a food a separate radiation disclosure statement that is more prominent than the declaration of ingredients required by section 403(i)(2).
(b)In this section, the term “radiation disclosure statement” means a written statement that discloses that a food has been intentionally subject to radiation.” Although section 403C of the act addressed only the prominence of the radiation disclosure statements, the language in the FDAMA Joint Statement (H. Rep. 105-399, 105th Cong., 1st sess., at 98-99) stated that FDA should seek public comment on whether additional changes should be made to current regulations relating to the labeling of foods treated with ionizing radiation. Specifically, the Joint Statement stated that “the public comment process should be utilized by the Secretary to provide an opportunity to comment on whether the regulations should be amended to revise the prescribed nomenclature for the labeling of irradiated foods and on whether such labeling requirements should expire at a specified date in the future.” The FDAMA Joint Statement also indicated that “The conferees intend for any required irradiation disclosure to be of a type and character such that it would not be perceived to be a warning or give rise to inappropriate anxiety” (Ref. 1). In response to the conferees' report, FDA published an ANPRM in the **Federal Register** of February 17, 1999 (64 FR 7834) seeking public comment on the meaning of the current irradiation labeling statement and soliciting suggestions for possible revisions. The 1999 ANPRM described the intent of the conference report, cited several documents related to irradiation labeling, and asked for comment on how the current label is perceived by consumers. The 1999 ANPRM also described whether other labeling would more accurately convey that the food was irradiated without implying a warning or causing inappropriate consumer anxiety. FDA received over 5,550 comments in response to the 1999 ANPRM on the meaning of the current irradiation labeling statement and suggestions for possible revisions. The majority of comments urged FDA to retain the current labeling for irradiated foods. Some comments suggested alternate wording, such as “cold pasteurization,” or “electronic pasteurization,” while other comments contended that these terms serve only to obscure information and confuse consumers. A few comments stated that additional labeling, such as “irradiated to kill harmful bacteria,” was helpful. C. Consumer Research To better assist FDA in formulating specific revisions that would accomplish the objectives outlined in the FDAMA Joint Statement and also satisfy the requirements of the act, the agency, in addition to publishing the ANPRM, conducted focus group research in Maryland, Minnesota, and California, during June and July 2001. The primary focus of the research was to ascertain from focus group participants how they viewed the current irradiation disclosure statement. We were particularly interested in whether the focus group participants perceived the current irradiation disclosure statement as a warning. The focus group data indicated that the majority of participants were uncertain about the safety, effectiveness, and appropriateness of irradiated food products and greatly desired more information. Most of the participants viewed alternate terms, such as “cold pasteurization” and “electronic pasteurization,” as misleading, because such terms appeared to conceal rather than to disclose information. Participants did not see the current disclosure labeling as a warning, per se, because knowledgeable participants considered irradiation to be a positive safety attribute. Less knowledgeable participants, such as those who associated irradiation with things such as x-ray or radiation, wanted more information about the appropriateness of food irradiation. All participants agreed that irradiated foods should be labeled “honestly.” D. Farm Security and Rural Investment Act of 2002 (FSRIA) (Public Law 107-171) On May 13, 2002, the President signed into law the FSRIA. The law included two provisions that relate to irradiation labeling. One of these provisions, section 10808, as discussed in the following paragraph, includes new criteria for use of the term “pasteurization” in labeling. The other provision, section 10809, directed FDA to publish for public comment proposed changes to the current regulations relating to the labeling of foods that have been treated by irradiation using radioactive isotope, electronic beam, or x-ray to reduce pest infestation or pathogens. The provision further stated that “[p]ending promulgation of the final rule * * * any person may petition the Secretary [FDA] for approval of labeling, which is not false or misleading in any material respect, of a food which has been treated by irradiation using radioactive isotope, electronic beam, or x-ray.” Section 10809 also requires that, pending issuance of the final rule, “* * * [t]he Secretary [FDA] shall approve or deny such a petition within 180 days of receipt of the petition, or the petition shall be deemed denied, except to the extent additional agency review is mutually agreed upon by the Secretary [FDA] and the petitioner.” Section 10808 of the FSRIA, which includes new criteria for use of the term “pasteurized” in labeling, revised section 403(h) of the act to provide that a food may purport to be or be represented as pasteurized if the food has been subjected to a safe process or treatment that is prescribed as pasteurization for such food in a regulation issued under the act or the food has been subjected to a safe process or treatment that meet certain criteria. The criteria prescribed in section 10808 of the FSRIA are that the food has been subjected to a safe process that:
(1)Is reasonably certain to achieve destruction or elimination in the food of the most resistant micro-organisms of public health significance that are likely to occur in the food,
(2)is at least as protective of the public health as a process or treatment prescribed by regulation as pasteurization,
(3)is effective for a period that is at least as long as the shelf life of the food when stored under normal and moderate abuse conditions, and
(4)is the subject of a notification to the Secretary
(FDA)that includes effectiveness data regarding the process or treatment and at least 120 days have passed after receipt of such notification without the Secretary making a determination that the process or treatment involved has not been shown to meet the requirements. As part of FDA's implementation of section 10809 of the FSRIA, FDA issued a guidance document entitled “Guidance; Implementation of Section 10809 of the Farm Security and Rural Investment Act of 2002, Public Law No. 107-171, section 10809
(2002)Regarding the Petition Process to Request Approval of Labeling for Foods That Have Been Treated by Irradiation” (the 2002 Guidance). The 2002 Guidance was issued in accordance with FDA's Good Guidance Practices regulation in 21 CFR 10.115. The 2002 Guidance also advised how interested parties may petition the agency for the approval of labeling that may be used on irradiated food as an alternative to the currently required irradiation disclosure statement. FDA noted that this was an interim process and that it could be used until FDA published any final regulation on this issue. FDA published a notice in the **Federal Register** announcing the availability of the 2002 Guidance document on October 7, 2002 (67 FR 62487). To date, FDA has not received any petitions requesting the use of alternative labeling for irradiated foods. II. The Proposal A. Legal Authority/Statutory Directive FDA's authority to require labeling of all foods 1 , including irradiated foods, derives from sections 201(n) and 403(a)(1) of the act (21 U.S.C. 321(n) and 343(a)(1)). In addition, section 701(a) of the act (21 U.S.C. 371(a)) authorizes FDA to issue regulations for the efficient enforcement of the act. Under section 403(a)(1) of the act, a food is misbranded if “its labeling is false or misleading in any particular.” Section 201(n) of the act mandates that, in determining whether labeling is misleading, FDA take into account, among other things, whether the labeling fails to reveal facts that are material in the light of representations made or suggested or with respect to consequences that may result from the use of the product to which the labeling relates under the conditions of use prescribed in the labeling or under such conditions of use as are customary or usual. 1 Food refers to conventional foods as well as dietary supplements. Historically, the agency has generally interpreted the scope of the materiality concept to mean information about the characteristics of the food. FDA has required special labeling on the basis of it being “material” information in cases where the absence of such information leads the consumer to assume that a food, because of its similarity to another food, has nutritional 2 , organoleptic (e.g., taste, smell, or texture), or functional (e.g., storage) 3 properties of the food it resembles when in fact it does not. For example, the labeling of margarine that has been processed in a way that results in it no longer being suitable for frying must disclose this difference from regular margarine. 2 Currently, we are not aware of any changes to the nutritional properties of any food FDA has approved for irradiation. 3 The statutory phrase “the consequences that may result from the use of the food” (section 201(n) of the act) generally can also be described as changes in a food's functional properties. For brevity and clarity, we use the latter terminology in this document. Irradiation has various effects on foods that may cause changes in the characteristics of the food. Such changes may occur in the food's organoleptic, nutritional, or functional properties that would not be noticeable at the point of purchase but could be apparent when consumed or cooked. If these changes are not within the range of characteristics ordinarily found in such foods, they would be considered “material” under this proposal. In the absence of appropriate labeling disclosing these changes in the characteristics of the food, consumers would not have all of the necessary information needed to make a purchase decision or properly use the food. Thus, in the absence of information about these changes in the characteristics of the food, the labeling would be misleading under 201(n) of the act and the food would be misbranded. These changes are typically process specific and will vary with the food and the irradiation conditions. In addition, these changes and the degree of the changes may be measurable and of consequence to consumers. Thus, a blanket statement on when labeling would be required due to irradiation causing material changes cannot be made in advance for all products. Rather, the need for labeling must be determined on a case-by-case basis by appropriate testing of the food irradiated under specific conditions, e.g., time and dosage, because the effect of irradiation on the properties of concern depends on the particular food. Under the proposal, the fact that a food has been irradiated would not by itself require disclosure on the label. FDA is proposing to require that only those irradiated foods in which irradiation causes a material change in a food's characteristics (e.g., organoleptic, nutritional, or functional properties) under the conditions of use prescribed in the label and labeling or under customary or usual conditions of use bear the radura logo. Those irradiated foods must also bear the term “irradiated” or any derivative thereof (e.g., “irradiate,” “irradiation,” “radiation,” etc.) in conjunction with language describing the material change. Additionally, FDA will not object to the use of additional terms to indicate that a food has been subjected to the process of irradiation, e.g., “treated with radiation,” “treated by irradiation,” or “processed with radiation.” However, in the absence of a material change, under the proposal, the fact that the food has been irradiated is not considered a material fact and, therefore, no logo or label statement would be needed. For such foods, FDA would not object to manufacturers voluntarily labeling their products to indicate that the food is irradiated. FDA is also proposing to allow the use of alternate terms to “irradiated” or any of its derivatives if use of the term has been approved by FDA in response to a citizen petition submitted in accordance with § 10.30 (21 CFR 10.30). As discussed in more detail in section I of this document, the FSRIA amended section 403(h) of the act to include new criteria for the use of the term “pasteurized” in labeling. This section gives FDA authority to determine for labeling purposes whether alternate processes, e.g., irradiation, are equivalent to pasteurization in destroying pathogens. Therefore, FDA is also proposing to require that anyone seeking to label a food as “pasteurized” under this provision in lieu of referring to irradiation must notify FDA and provide supportive data. Provided the agency has not objected to the notification within 120 days after receipt of the notification, the notifier would be able to label a food as “pasteurized” in lieu of “irradiated.” Under section 409 of the act, no food may be irradiated without approval by FDA. Currently, FDA has approved irradiation for a number of foods, including spices, shell eggs and fruits and vegetables, although only a small fraction of these foods are actually irradiated. According to a report by the U.S. General Accounting Office 4 (2000), only 0.005 percent of fruits and vegetables consumed in the United States (about 1.5 million pounds), and 9.5 percent of all spices consumed in the United States (about 95 million pounds of spices and dry or dehydrated aromatic vegetable substances) are irradiated annually. See the following Web site for a listing of all foods that have been approved for irradiation: *http://a257.g.akamaitech.net/7/257/2422/10apr20061500/edocket.access.gpo.gov/cfr_2006/aprqtr/21cfr179.26.htm* . 4 Now the Government Accountability Office. B. Proposed Amendment As previously discussed in section II.A of this document, irradiation has various effects on foods that may change a food's characteristics. For example, as with other forms of processing, the effects of irradiation that kill or weaken insects and microorganisms may also cause some changes in the food itself. Many of these changes are of little significance, as the composition of the food will remain within normal variations of unirradiated foods. However, other changes to organoleptic, nutritional, and functional properties may occur. Changes to shelf life are likely to be among the most common of these changes. Bananas and spices are illustrative of irradiated foods that may have an extended shelf life and are discussed in the following paragraph. Bananas may be irradiated to delay ripening and extend shelf life. This is an example of a material change. Consumers have a general idea of the shelf life and ripening time of unirradiated bananas based upon their appearance and make purchase decisions based at least in part on the bananas' appearance (i.e., ripeness) and intended use. If irradiated bananas were not labeled to indicate the material change, e.g., delayed ripening, consumers would purchase the bananas expecting the faster ripening schedule of unirradiated bananas. A consumer who wanted to make a food that required very ripe bananas (e.g., banana bread) would not know, without labeling, that the irradiated bananas would not be ripe enough to make the banana bread when he wanted to do so. Thus, if the irradiated bananas are not labeled, the consumer might purchase the bananas and then discover later that they are unsuitable for the consumer's planned use. In contrast, there are instances where treatment with irradiation may extend a food's shelf life without changing any of its functional characteristics in a way that may require using the food differently than its unirradiated counterpart. For example, while spices that are irradiated to control microbial growth will likely have their shelf life extended, FDA tentatively believes that the extension in shelf life in this case does not have the potential to be detrimental to the consumer (e.g., to prevent the consumer's planned use of the food) because the irradiated spice can be used identically to an unirradiated spice. That is, in addition to possibly benefiting from the extended shelf life, a consumer buying the irradiated spice can use the irradiated spice the same as he would the unirradiated spice. Unlike the consumer of irradiated bananas described above, the spice consumer does not need additional information to prevent the potential for a detrimental consequence from using the irradiated food the same as its unirradiated counterpart. Thus, FDA tentatively believes that the extension of a spice's shelf life due to irradiation would not be material information that consumers need to know; therefore the producer would not be required to declare this information on the spice label. We request comment on the utility, for purposes of labeling, of distinguishing between those changes to a food's functional properties from irradiation that may make a food unsuitable for a particular use (e.g., delayed ripening) and those changes that still allow for the food to be used identically to one that is not irradiated (e.g., extension of shelf life alone). One of the goals of food science research on irradiation is to determine irradiation conditions that would minimize those unexpected effects that would be material to consumers. In a review article on the effects of irradiation on fresh-cut fruits and vegetables, Prakash and Foley (Ref. 1a) cite research illustrating how effects can vary depending on the food, irradiation conditions, and mitigating steps that can be taken. They report that in some cases low doses can cause significant loss in firmness; however, in other fruits and vegetables no such loss is observed, even at a higher dose. For example, firmness of diced Roma tomatoes irradiated at 0.5 kilogray
(kGy)decreased by 30 percent and firmness of cut romaine lettuce irradiated at 0.35 kGy decreased by 10 percent. However, no change in firmness was observed in shredded carrots or fresh-cut iceberg lettuce following irradiation at 1 and 2 kGy, or in celery irradiated at 1 kGy. In diced bell peppers, irradiation at 3.7 kGy reduced bell peppers' flavor and produced some off-flavors, while no effect on flavor or aroma was perceived in a control group of bell peppers that were not irradiated and in peppers irradiated at 1.32 kGy. Additionally, after storage for 9 days, off aroma was significantly higher in the control sample of bell peppers than in the two groups of irradiated peppers, coinciding with a slimy appearance attributed to microbial spoilage. Prakash and Foley also report that combining irradiation with other technologies, such as calcium treatment, warm water dips, and modified atmosphere packaging further mitigated measurable adverse effects on quality. Similarly, Kader (Ref. 1b) reported that fruits and vegetables such as papaya, strawberry, tomatoes, and dates have a high tolerance to irradiation at doses (below 1 kGy) used for insect control, while cucumber, green bean, grape, and lemon have a low tolerance at this same kilogray. Thus, whether effects occur that would change the food in a significant way will depend on the particular food that is irradiated and the dosage of irradiation used. In its decision approving the use of radiation on shell eggs, FDA cited to data in the petition showing an increased color loss in the irradiated egg yolk and a change in the egg's viscosity as the radiation dose was increased (65 FR 45280 at 45281; July 21, 2000). Such a change in the viscosity or other characteristics of the egg would affect its functionality, e.g., its cooking or binding properties. This change could be significant enough that consumers should be informed of the irradiation and its effect on the food. In sum, irradiation of food can cause effects in food that are material in light of representations made or on consequences of use. However, whether such effects are sufficient to meet the standard of section 201(n) of the act will vary based on several factors and cannot be determined without considering the particular food and irradiation processing applied. If the change in the irradiated food is within the range of characteristics ordinarily found in such foods, then the fact that the food is irradiated and the resulting change would not be material information and would not be required to be declared on the label. The use of irradiation is strictly voluntary and generally approved up to a maximum dose. We believe that manufacturers may adjust the dosage to get the most effective dose, while minimizing unexpected effects in the irradiated food. These food manufacturers or producers may choose to irradiate their food only if the irradiation does not alter in a significant way characteristics of the food that are material to the consumer. Thus, it is possible that many uses of irradiation will not result in a material change within the framework set out in this rule. FDA is interested in receiving information about the types of pre-market investigations, e.g., taste test panels or functional studies, done by food manufacturers to evaluate whether to irradiate and at what dose to irradiate in such a way that a material change does not result. Food is most commonly irradiated to control food-borne pathogens. FDA is not aware of data indicating that control of food-borne pathogens as a result of food irradiation would, by itself, result in a change in the food's characteristics that would not be apparent at the point of purchase of the food and, thus, would have to be disclosed in the labeling of the food to prevent the labeling from being misleading. Consumers expect food to be safe and of a certain quality, and therefore, FDA tentatively concludes that control of food-borne pathogens alone is not an unexpected change in the food. Thus, in instances where a food has been irradiated to enhance or maintain the safety of a food by controlling food-borne pathogens that may be present, and no other changes to the food have resulted, FDA tentatively concludes that information that the food has been irradiated is not necessary to prevent the labeling from being misleading. FDA is interested in receiving any information on whether the control of food-borne pathogens changes the characteristics of the food in an unexpected way, i.e., outside of the normal variation of the food, and would therefore require additional labeling to inform the consumer of such change. FDA also solicits comments on any specific changes that might be caused by irradiation that might constitute non-material changes. On the other hand, there may be situations in which irradiation to control food-borne pathogens has had other effects on foods, such as changes to organoleptic, nutritional, or functional properties which would not be readily apparent to the consumer. In such situations, information that there are changes in the characteristics of the food as a consequence of irradiation is the material information that is required in labeling in keeping with the act, to prevent the labeling from being misleading. Further, with regard specifically to shelf life, FDA recognizes that irradiation to control the growth of food-borne pathogens may have the unintended effect of extending shelf life. We specifically request comment on the effect of irradiation on shelf life and the extent of any relationship between control of food-borne pathogens and extension of shelf life. In the past, FDA policies on irradiation labeling have focused on the fact that the food has been processed. In the preamble to the 1986 final rule, we stated that “* * * irradiation may not change the food visually so that in the absence of a statement that a food has been irradiated, the implied representation to consumers is that the food has not been processed” (51 FR 13376 at 13388). FDA concluded that, to prevent deception, the fact that the irradiated food is processed is material information that is required to be disclosed on the label. Thus, FDA required in § 179.26(c) (21 CFR 179.26(c)) that, in addition to the radura logo, the label and labeling of irradiated foods bear the statement “Treated with radiation” or “Treated by irradiation.” In recent years, FDA policies on the labeling of foods have focused on the results of the processing of the food rather than the processing itself. As discussed earlier, although foods that have been irradiated have been processed, the irradiation does not always result in a material change in the food or in the consequences of use. Further, FDA consumer research indicates that information provided to consumers on the labels of foods is more meaningful if it describes the purpose of the irradiation (Ref. 2). FDA recognizes that labeling to inform the consumer that the product has been irradiated does not, in itself, inform the consumer if or how the product is materially changed. Thus, FDA tentatively believes that when the irradiation causes a material change in the characteristics of the food, the consumer needs to know about this change, and not just the fact that the food has been irradiated. FDA believes that this information should be provided in a disclosure statement on the label of the irradiated food. The disclosure statement would describe the material change in the properties of the food and give consumers additional information that would enable them to make better informed decisions about whether to purchase an irradiated food. Therefore, FDA is proposing to amend § 179.26(c)(1) and (c)(2) to require that only those foods that have been treated with radiation, and in which the irradiation caused a material change in the characteristics of the food must bear the radura logo and the term “irradiated,” or other derivatives as discussed previously in section II.A in conjunction with explicit language describing the change in the food or its conditions of use (e.g., “irradiated to inhibit sprouting”). In addition, as noted in the 1986 final rule (51 FR 13376 at 13391), FDA believes that the logo is still a necessary part of the label statement because it derives from the symbol that has been used internationally to convey the fact that the food has been irradiated. FDA tentatively concludes that this approach is appropriate because it would require that consumers be provided with more precise information about the material change in the characteristics of the food than what is currently required. As noted previously, such material changes may affect how products are stored and subsequently used by consumers, as well as whether or not the products are purchased in the first place. However, FDA requests comments on whether the term that describes the process, e.g., “irradiated” or an alternate term such as “pasteurized,” is a necessary part of the label statement to ensure that consumers completely understand the statement. As previously discussed in section I.D of this document, section 10809 of the FSRIA provides that anyone requesting approval of alternative labeling for a food that has been treated by irradiation, may petition FDA. As discussed in the 2002 Guidance, FDA believes that it is appropriate to use the citizen petition process provided in § 10.30. This regulation requires the petitioner to submit to the agency all relevant information regarding the petition. This relevant information includes both the information and views upon which the petitioner relies and the information known to the petitioner that is unfavorable to the petitioner's position. Thus for these purposes, relevant information would include any data known or relied upon by the petitioner (e.g., qualitative or quantitative consumer research), that show consumer understanding of the purpose and intent of the proposed alternative labeling. FDA believes that such information might include, but is not limited to, the following information:
(1)Data on consumers' prior assumptions about, and perceptions of, the product characteristics in light of the proposed labeling statements and
(2)data on consumer acceptance and comprehension of the proposed labeling statements in comparison to consumer acceptance and comprehension of the irradiation statement required by the current regulation (§ 179.26(c)(1)). Also, as noted in section I.D of this document, section 10808 of the FSRIA revised section 403(h) of the act to permit the use of the term “pasteurized” on labels of foods that have been subjected to a safe process as long as the process meets certain criteria. Therefore, we are proposing in § 179.26(c)(1) to permit the use of alternate terms to “irradiated” or any of its derivatives, on the labels and labeling of irradiated foods. We are proposing in § 179.26(c)(2) that the alternate term may be used on the labels and labeling of foods that have been treated by irradiation, that is, if use of the term has been approved by FDA in response to a citizen petition submitted in accordance with § 10.30. In the case that the alternative term is “pasteurized,” the irradiation process must meet the criteria of section 403(h)(3) of the act. Anyone seeking to label a food as “pasteurized” under this provision must notify FDA and provide effectiveness data regarding the process or treatment used. The agency intends to issue guidance to interested parties who wish to notify the agency to use the term “pasteurized” in accordance with section 403(h)(3) of the act. FDA and the Food Safety and Inspection Service (FSIS), U.S. Department of Agriculture, entered into a memorandum of understanding
(MOU)establishing procedures to jointly respond to petitions to use food ingredients and sources of irradiation in the production of meat and poultry products (see 64 FR 72168, December 23, 1999, at *http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/88-026F.pdf* ; for the MOU, see *http://www.fsis.usda.gov/Regulations_&_Policies/Labeling_FDA_MOU/index.asp* ). FSIS has separately issued regulations at 9 CFR 424.22(c) regarding the irradiation of meat and poultry products (see 64 FR 72150, December 23, 1999, at *http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/97-076F.pdf* ). III. Analysis of Economic Impacts A. Introduction FDA has examined the economic implications of this proposed rule as required by Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). 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). Executive Order 12866 classifies a rule as significant if it meets any one of a number of specified conditions, including: having an annual effect on the economy of $100 million or more or adversely affecting in a material way a sector of the economy, competition, jobs, the environment, public health, or safety, or State, local, or tribal governments or communities. A regulation also is considered a significant regulatory action if it raises novel legal or policy issues. We have determined that this rule is a significant regulatory action as defined by Executive Order 12866 because it raises novel policy issues. B. Preliminary Regulatory Impact Analysis 1. The Need for the Proposed Irradiation Labeling Rule Executive Order 12866 states, “Federal agencies should promulgate only such regulations as are required by law, are necessary to interpret the law, or are made necessary by compelling need, such as failures of private markets to protect or improve the health and safety of the public, the environment, or the well being of the American people.” As previously discussed in section I.D of this document, on May 13, 2002, the President signed into law the FSRIA, which contains a provision relating to irradiation labeling. Section 10809 directs FDA to publish a proposed rule and, with due consideration to public comment, a final rule to revise the current regulation governing the labeling of foods that have been treated by irradiation. This rule is proposed not to address any market failure, but to respond to section 10809 of FSRIA and because we tentatively believe that it may no longer be necessary to require that all irradiated food be labeled as such. 2. Regulatory Options We analyzed five options for the proposed irradiation regulation: • No new regulatory action (current state of the world, baseline). • Remove labeling requirements for irradiated foods. • Maintain the current labeling requirement (that is, all food that is irradiated must be labeled), but also require statements of purpose (e.g., “Irradiated to extend shelf life”). • Maintain the current labeling requirement, but also allow alternate terms to irradiation (e.g., “pasteurized”). • The proposed regulation—Only those foods treated with irradiation and for which the irradiation caused a material change in the food must bear the radura logo and the term “irradiated” or an alternate term such as “pasteurized” in conjunction with explicit language describing the change in the food or its conditions of use (e.g., “irradiated to inhibit sprouting”). A food undergoes a material change if irradiation changes the properties of the food in a way that is not readily apparent to the consumer at the point of purchase. Therefore, in the absence of a material change, the fact that the food was irradiated is not considered a material fact and, therefore, no radura logo or label statement would be needed. *Option 1: No New Regulatory Action (baseline).* Taking no new regulatory action on irradiation labeling is option 1 in our analysis. The FSRIA requires FDA to publish a proposed rule and, with due consideration to public comment, a final rule to revise the current irradiation labeling regulation. So this is not a viable option. We include it here because the Office of Management and Budget
(OMB)cost-benefit analysis guidelines recommend discussing statutory requirements that affect the selection of regulatory approaches. These guidelines also recommend analyzing the opportunity cost of legal constraints that prevent the selection of the regulatory action that best satisfies the philosophy and principles of Executive Order 12866. This option will serve as the baseline against which other options will be measured for assessing costs and benefits, and we assume the baseline has zero costs and benefits. The current regulation (§ 179.26) states that irradiated food must bear the radura logo and the phrase “Treated with radiation” or “Treated by irradiation” and does not explicitly address the inclusion of additional information that directs attention to shelf life or food safety. Currently, FDA has approved iradiation for a number of foods including spices, shell eggs, and fruits and vegetables; however, only limited amounts of irradiated foods are sold in the United States. According to a report by the General Accounting Office 5 (2000), it is estimated that 97 million pounds of food products are irradiated annually (including “meat food products” under the Federal Meat Inspection Act and “poultry” under the Poultry Products Inspection Act 6 , which are regulated by the United States Department of Agriculture), which is only a small fraction of the total amount of food consumed. For example, about 1.5 million pounds of fruits and vegetables are irradiated annually. This represents only 0.005 percent of the total amount of fruits and vegetables consumed. About 95 million pounds of spices and dry or dehydrated aromatic vegetable substances are irradiated annually, which represents 9.5 percent of all spices consumed. Because spices, shell eggs, fruits and vegetables account for virtually all the food irradiation done in the United States, we use only data about those foods in our economic analysis. 5 Now the Government Accountability Office. 6 It is our understanding that as of 2000 only a very small proportion of poultry (0.002 percent of annual consumption) and no meats were irradiated and available commercially (Ref. 10). *Option 2: Propose to remove labeling requirements for irradiated foods* This option also may not be viable because it could violate section 403(a) of the act, which provides that the labeling of all foods, including irradiated foods, must be truthful and not misleading. In addition, section 201(n) of the act mandates that, in determining whether particular labeling is misleading, FDA consider whether the labeling fails to reveal material facts in light of representations made, or with respect to, the consequences that may result from the use of the product. Having no labeling requirements might violate these provisions. If this option were chosen, costs and benefits would be generated if many firms ceased labeling their irradiated products. *Costs* : Since this option would not require labeling, search costs would increase for purchasers who do not want irradiated food. There will be an increase in search costs because these consumers would need to increase efforts to find information about irradiated foods other than on the labels or in the labeling, or obtain knowledge of producers who irradiate their food products. If firms decide to drop labeling, they would incur relabeling and label inventory costs but they would choose the least costly labeling option. *Benefits* : This option could be beneficial to those firms currently labeling irradiated food by allowing them to reclaim label space on the label for private purposes, such as marketing messages or label art. Without a labeling requirement, it is possible that irradiation would become more attractive to firms because of this benefit. Any increases in the numbers of irradiated foods could, in turn, result in increased food safety or shelf life. *Option 3* : Maintain the current labeling requirement (i.e., require that all irradiated food be labeled “Treated with radiation” or “Treated by irradiation,” along with the radura logo), but propose to also require statements of purpose (e.g., “Treated with irradiation to inhibit sprouting,” etc.). The current regulation (§ 179.26(c)) states that irradiated food must bear the radura logo and the phrase “Treated with radiation” or “Treated by irradiation.” The current regulation does not explicitly address the inclusion of additional information that directs attention to, for example, shelf life or food safety. This option would amend the current regulation to include explicit requirements on inclusion of additional information on irradiation benefits. While it is possible that some firms that irradiate food currently include statements of purpose, this option would formally require this inclusion. *Costs* : This option would generate costs because firms would be required to relabel their products in order to include statements of purpose. Tables 1 and 2 of this document outline estimated labeling costs for sectors of the food industry that may require relabeling. The food categories included in the table are currently approved for irradiation by FDA. Table 1 outlines low, medium, and high cost estimates based on a change in the principal display panel. Table 2 outlines low, medium, and high cost estimates based on a change in the information panel or assuming that the irradiation statement is similar in cost to a nutrient content claim or health claim. It is not certain which table most likely represents costs to firms because it is not certain what conditions would make the costs in table 1 more likely or what conditions would make table 2 more likely. Both tables show estimated costs under compliance periods of 12, 24, and 36 months. In both tables 1 and 2, compliance costs decrease as the length of compliance period increases for all product categories because firms can coordinate new changes in labels with already-scheduled changes in labels. In addition, the compliance period affects whether or not firms would incur additional labor costs, such as overtime, and the volume of labeling inventory that would have to be discarded as a result of a new rule. Cost estimates are shown in two proportions for each compliance period: If 1 percent of the industry irradiates and if 5 percent of the industry irradiates. As can be seen in the tables, industry costs decrease as the number of firms irradiating food decreases. Data on the actual number of firms that irradiate food or will want to irradiate food in the future are not currently available. The agency requests comments on the number of firms or products that would be affected by a new irradiation labeling rule. The cost model used in this analysis does not include costs for labeling fresh produce without packaging because fresh fruits and vegetables do not have Universal Product Codes that can be scanned. Nonetheless, it is still necessary to estimate costs associated with labeling fresh fruits and vegetables that have been irradiated. One way of labeling fresh fruits and vegetables is by placing stickers on the produce. While it is not known how many fruit and vegetable manufacturers irradiate or will want to irradiate as a result of this rule, according to the 2002 Census of Manufacturers (Ref. 8), there are 5,836 firms that process fresh fruits and vegetables. As with costs estimates for the other food categories, it is assumed that 1 percent of these firms, or 58, may want to irradiate, or 5 percent of these firms, or 292, may want to irradiate. Our 1 percent and 5 percent assumptions are based on the generally observed very low rate of adoption of irradiation technology in food processing to date. We do not have specific data to estimate the number of firms that will irradiate if this rule is finalized, and we request comment on this assumption. For firms, there are administrative costs involving the establishment of what the sticker will look like, as well as the costs of finding the printer to produce these stickers. Based on previous estimates of similar costs in the final rule on the Labeling of Juice Products (63 FR 24254; May 1, 1998), the agency estimates these administrative costs to be $100 per firm. In addition, printers levy one time charges for set-up in addition to the basic per unit cost of labels. The agency estimates these costs to be $250 per firm. Table 3A summarizes administrative costs associated with using stickers if 1 percent of the industry irradiates and if 5 percent of the industry irradiates. In addition to administrative costs, there are labor costs associated with affixing stickers to the fruits and vegetables. The agency estimates the labor cost of applying the labels by multiplying the average agricultural hourly wage ($10.75) (Ref. 8a) by the approximate number of hours needed to label the irradiated fruits and vegetables. Assuming it takes one worker 1 hour to label 240 pounds of fruits or vegetables (4 pounds per minute multiplied by 60 minutes) it would take approximately 6,250 hours to label 1.5 million pounds of fruits and vegetables, the approximate amount of fruits and vegetables irradiated annually in this country. The total labor costs associated with labels would then be $67,188. Table 3B summarizes total labor costs if one worker can label 240 pounds per hour, 360 pounds per hour or 480 pounds per hour. The agency requests comments on costs associated with labeling fresh fruits and vegetables that have been irradiated. *Benefits* : A statement regarding the purpose of irradiation would serve to provide more information to consumers than what is currently on the label. To the extent that the addition of the statement of purpose causes people to purchase irradiated products they may have previously avoided, and to the extent that these products have longer shelf life or lower risk of illness, then consumers will benefit. Consumers may look more favorably on irradiated food once they understand the purpose, which in turn, could result in more irradiated food in the market due to the increase in demand. Information may also be a benefit in itself even if purchases do not increase. Research indicates that providing a statement of purpose results in a more positive attitude by consumers toward the purchase of irradiated food (Ref. 3). Furthermore, research indicates that providing information about the benefits of irradiation may increase willingness of consumers to pay for irradiated food (Ref. 4). **Table 1.—Cost Estimates: Irradiation Relabeling, Principal Display Panel** Food Category Compliance Period Percentage of Firms Affected by Rule Cost Estimates Low Medium High Spices/Seasonings 12 months 1% $406,553 $581,000 $966,000 5% $2,032,033 $2,905,689 $4,831,841 24 months 1% $195,967 $279,944 $468,000 5% $981,269 $1,400,095 $2,335,798 36 months 1% $27,799 $39,650 $66,269 5% $138,995 $198,248 $331,343 Shell Eggs 12 months 1% $236,341 $314,692 $568,084 5% $1,181,032 $1,570,997 $2,844,160 24 months 1% $144,063 $191,041 $345,471 5% $718,210 $955,915 $1,728,457 36 months 1% $61,852 $82,324 $149,000 5% $309,262 $411,618 $744,275 Dried Vegetables 12 months 1% $164,604 $218,663 $394,000 5% $822,781 $1,094,153 $1,969,567 24 months 1% $92,292 $122,838 $222,307 5% $461,461 $614,191 $1,110,562 36 months 1% $32,092 $42,713 $77,233 5% $160,459 $213,566 $386,163 Totals 12 months 1% $807,498 $1,114,355 $1,928,084 5% $4,035,846 $5,570,839 $9,645,568 24 months 1% $432,322 $593,823 $1,035,778 5% $2,160,940 $2,970,201 $5,174,817 36 months 1% $121,743 $164,687 $292,502 5% $608,716 $823,432 $1,461,781 Note: Cost estimates include administrative, graphic design, prepress, engraving, analytical testing, market testing, and discarded inventory. Source: RTI International, “FDA Labeling Cost Model” RTI Project 06673.010, March 2003. **Table 2.—Cost Estimates: Irradiation Relabeling, Information Panel** Food Category Compliance Period Percentage of Firms Affected by Rule Cost Estimates Low Medium High Spices/Seasonings 12 months 1% $192,245 $285,335 $447,000 5% $959,479 $1,426,545 $2,233,436 24 months 1% $91,101 $134,964 $213,209 5% $455,504 $674,821 $1,065,921 36 months 1% $12,860 $19,042 $30,121 5% $64,298 $95,208 $150,605 Shell Eggs 12 months 1% $107,773 $151,940 $254,488 5% $538,863 $759,434 $1,273,169 24 months 1% $65,539 $92,365 $154,472 5% $327,694 $461,827 $774,240 36 months 1% $28,221 $39,773 $66,678 5% $141,105 $198,863 $333,388 Dried Vegetables 12 months 1% $76,347 $107,227 $178,332 5% $381,735 $536,134 $891,881 24 months 1% $42,110 $59,346 $99,492 5% $210,549 $296,732 $497,462 36 months 1% $14,642 $20,636 $34,595 5% $73,212 $103,179 $172,977 Totals 12 months 1% $376,365 $544,502 $879,820 5% $1,880,077 $2,722,113 $4,398,486 24 months 1% $198,750 $286,675 $467,173 5% $993,747 $1,433,380 $2,337,623 36 months 1% $55,723 $79,451 $131,394 5% $278,615 $397,250 $656,970 Note: Cost estimates include administrative, graphic design, prepress, engraving, analytical testing, market testing, and discarded inventory. Source: RTI International, “FDA Labeling Cost Model” RTI Project 06673.010, March 2003. **Table 3A.—Cost Estimates: Sticker Administrative Costs** Number of Firms Administrative Costs Printing Costs Total Administrative Costs 1%, or 57 $100 $250 $19,950 5%, or 283 $100 $250 $99,050 **Table 3B.—Cost Estimates: Sticker Labor Costs** Pounds Per Hour Hourly Wage Hours Needed Total Labor Cost 240 $10.75 6,250 $67,188 360 $10.75 4,167 $44,792 480 $10.75 3,125 $33,594 *Option 4: Maintain the current labeling requirement, but propose to also allow alternate terms to “Irradiation” (e.g., “Pasteurized”)* The current regulation (§ 179.26(c)) states that irradiated food must bear the radura logo and the phrase “Treated with radiation” or “Treated by irradiation.” Currently, no alternate terms to irradiation are allowed. This option would maintain the requirement that irradiated food must be labeled but allow the label to contain terms other than “irradiated,” such as “pasteurized.” But the term “pasteurized” may be used only if the process meets the definition as provided in section 403(h)(3) of the act. *Costs* : This option generates costs because some firms would opt to relabel their products, but it is uncertain how many firms would do this because this option would be voluntary. However, firms would only relabel if they thought doing so would increase profits. Tables 1 and 2 contain cost estimates for the main food categories that may be affected by this option. It is probable that firms would select a 24 to 36 month compliance period to keep costs down by coordinating the relabeling with regular labeling changes. In the short run, there may be increased consumption of irradiated food if those consumers who do not want irradiated food do not equate the alternative term with irradiation. Also, confusion could result from the use of alternative terms with uncertain meanings, causing some consumers to increase search costs. Research indicates that many consumers regard substitute terms for irradiation to be misleading (Refs. 2 and 5). In the long run (defined here as a time period long enough for consumers to adjust to and understand the meaning of the alternate terms), consumers' distaste for the term “irradiation” would extend to alternate terms used in labeling, especially if there is no additional statement of purpose. Once consumers understand that the alternate terms all mean “irradiation,” the result would likely be a return to the baseline number of irradiated products and labels. *Benefits* : It is possible that, in the short run, consumers will not understand that the alternate terms mean the same as “irradiation.” However, to the extent that the substitution of terms induces consumers to buy relabeled food that they may have previously avoided and to the extent that these products benefit them in terms of safety or longer shelf life, then consumers will benefit from the substitution of terms. In the short run, the quantity of irradiated food supplied may increase in response to increased demand. As previously mentioned, the long run outcome may be the same as the baseline because, over time, consumers will come to understand that any alternate terms have the same meaning as “irradiation.” Once consumers understand that the alternate terms have the same meaning as “irradiation” they may want to discontinue consumption of the food, resulting in the number of irradiated foods returning to the same number as before the change in terms. This is a result of producers responding to the change in demand by reducing the quantity of irradiated food supplied. *Option 5: The Proposed Regulation* Only those foods treated with irradiation, and in which the irradiation caused a material change in the food such that it would change the characteristics of the food in a way that is not readily apparent to the consumer at the point of purchase must bear:
(1)The radura logo and
(2)the term “irradiated” or a derivative thereof, or an alternate term such as “pasteurized,” in conjunction with explicit language describing the change in the food or its conditions of use (e.g., “irradiated to inhibit sprouting”). If a firm chooses to use an alternate term to “irradiation” other than “pasteurized,” it must submit a petition to the Secretary (FDA). If a firm wishes to use the term “pasteurized,” it must submit a notification including effectiveness data regarding the process or treatment to the Secretary (FDA). This option deviates from the current regulation (§ 179.26(c)) in two major ways. First, this option would require irradiation labeling only for food items treated with irradiation if irradiation causes a material change in the food or consequences that may result from use of the food. Secondly, this option requires explicit language describing the material change and allows use of alternate terms for irradiation, as long as a petition is approved by the agency or, in the case where “pasteurized” is used, a notification is sent to FDA to which the agency does not object. This option allows for more labeling flexibility and it is possible that the radura logo and label statements on some irradiated food, as long as the irradiation caused no material change, could be removed. The number of products that could be marketed without irradiation labeling is uncertain because labeling requirements cannot be made in advance for all products. Rather, the need for labeling must be determined on a case-by-case basis by appropriate testing of the food irradiated under specific conditions, i.e., time and dosage, because the effect of irradiation on the properties of concern depends on the particular food. It is more likely that this option would simply allow firms more flexibility in how they label irradiated food. *Costs* : This proposed rule generates costs because it requires firms to relabel some irradiated products. As with other options, Tables 1 and 2 contain cost estimates for relabeling in selected food categories. Note that cost estimates take into account all relabeling costs, including the costs of removing irradiation label statements. The requirement of a material change could reduce the number of products that would need to be labeled, so some firms would be able to remove current irradiation labeling. This rule would generate additional costs because, in order for a firm to be able to use an alternative to the term “irradiation,” a firm would have to submit a petition to the agency (as addressed in proposed § 179.26(c)(2)(i)). If it is the case that the desired alternate term is “pasteurized,” then, instead of submitting a petition, a firm must notify the agency and also submit effectiveness data on the method used in its process (as addressed in proposed § 179.26(c)(2)(ii)). Firms are not required to use an alternate term. It is assumed that a firm would choose to use an alternate term only if doing so would increase profits. Based on previous estimates of the cost to prepare a petition or notification, FDA is assuming the average cost to prepare a petition or notification is $84 per hour (Ref. 13). The agency estimates the total cost of a petition or notification as the time needed to prepare the notification or petition multiplied by $84, the approximate cost associated with the person for preparing the notification or petition. In the case where a firm wants to use the term “pasteurized,” the agency does not assume this rule generates any additional cost of gathering effectiveness data; that is, presumably the firm will already have data on the effectiveness of its method, or it would not undertake the cost of irradiation. As mentioned earlier, it is not known how many firms that currently irradiate or will irradiate in the future will be required to label a product as irradiated, and will desire to use an alternative to the term “irradiation.” Therefore, the cost estimates are based on an estimate of the number of firms manufacturing foods that are currently approved for irradiation choosing to submit a notification or petition. Table 4 of this document contains the initial cost estimates of preparing a notification or petition. The number of firms is based on the 2002 Census of Manufacturers (Refs. 6, 7, and 8). According to the Census of Manufacturers, there are 275 companies that manufacture spices and extracts, 311 companies that process poultry and shell eggs (the Census of Manufacturers groups poultry and shell egg processing together), and 5,836 firms that process fresh fruits and vegetables, for a total of 6,422 firms. It is possible that 1 percent of, or 64 firms in the industry will want to use an alternate term and it is possible that 5 percent of, or 321 firms in the industry will want to use an alternate term. The average of this range is 193 firms. Table 5 of this document presents cost estimates of the annual reporting burden for additional product notifications or petitions after the initial compliance period due to, for example, new firms entering into the industry. It is assumed that one petition to use an alternate term other than “pasteurized” will be submitted per year. The time estimates for both tables 4 and 5 are taken from section IV of this document. We estimate that the annual notifications would be about 10 percent of the initial number, that is, 10 percent of 193 (the estimate in table 4), or 19 firms. **Table 4.—Estimate of Total Cost of Submitting Notification or Petition** 21 CFR Section No. of Respondents Total Hours Cost Per Hour Total Cost 179.26(c)(2)(i) 1 150 $84 $12,600 179.26(c)(2)(ii) 193 28,950 $84 $2,431,800 Total $2,444,400 **Table 5.—Estimated Annual Cost of Submitting Notification or Petition** 21 CFR Section No. of Respondents Total Hours Cost Per Hour Total Cost 179.26(c)(2)(i) 1 150 $84 $12,600 179.26(c)(2)(ii) 19 2,850 $84 $239,400 Total $252,000 If irradiation causes no material change in the food, irradiation labeling would be removed under this option. Removing irradiation labeling could cause increases in search costs for consumers who desire to avoid purchasing irradiated goods and must find alternative sources to maintain knowledge of producers that irradiate their products. Some producers may alter their products' labels to use a term other than irradiated (e.g. “pasteurized”). However, it is uncertain how many producers would use alternate terms. Again, the use of alternative labels would generate potential costs because some consumers may wish to avoid irradiated products. As mentioned before, research indicates many consumers regard substitute terms for irradiation to be misleading (Refs. 2 and 5). These individuals would have to increase their search efforts in order to continue to be informed about approved alternate terms to irradiation. We request comment on the potential for this proposed rule if finalized to increase search costs, particularly for consumers and retailers who desire non-irradiated foods. *Benefits* : This proposed rule generates benefits because it could allow consumers to make more informed decisions about the food they purchase. If the addition of a statement of purpose causes people to buy relabeled irradiated products that they may have previously avoided and if these products have, for example, longer shelf life or lower risk of illness, then consumers will benefit. If, as a result of this proposed rule, consumers look more favorably on irradiated foods, the supply of such foods may increase. If retailers are more willing to carry relabeled irradiated products, then consumers benefit from the added opportunity to buy these products. As mentioned in the costs section of this option, if irradiation causes no material change, it is possible that some products would no longer have to bear the irradiation label statement or the radura logo, but it is uncertain how many products would fall into this category. For producers who voluntarily choose the no-label option, private benefits exceed private costs, since they no longer are required to continue with the existing labeling. That is, a firm would choose the no-label option if it believes doing so will increase profits. Reiterating the idea that the supply of irradiated food may increase as a result of this rule, it is possible that some manufacturers not currently using irradiation as a safety tool (because of the current labeling requirement) may opt to start using irradiation in order to enhance the safety of their products, if there is no material change in the product. Again, firms will only start using irradiation if they believe doing so will increase profits. As already pointed out, however, there are potential search costs for some customers. This analysis also applies to those firms who choose alternate terms for irradiation. Private benefits will exceed private costs for firms that voluntarily choose alternate terms for irradiation, because they will no longer be required to continue using existing labeling. These firms will only choose alternate terms to irradiation if they believe doing so will increase profits. Again, this use of alternate terms can result in the previously mentioned increase in search costs for consumers who desire to avoid irradiated goods. If the removal of explicit language indicating that a food has been irradiated causes people to buy irradiated products that they previously avoided, and if these products have lower prices or higher quality, then some consumers will benefit from the removal of information. Also, if retailers are more willing to carry unlabeled irradiated products at lower prices, then all consumers benefit from the lower prices. But it is uncertain that unlabeled irradiated products will be offered for lower prices than products that are not irradiated, because the irradiation process itself is not costless. If irradiation increases product quality but also increases the cost of production, then prices of irradiated products could be higher than the same non-irradiated products, with or without labels. C. Summary of Options Table 5A of this document summarizes the costs and benefits of each option analyzed. Costs are given based on the assumption that 1 percent of firms irradiate and relabel (at the medium cost level) using a 2-year compliance period if the option requires relabeling and a 3-year compliance period if relabeling is permitted voluntarily. For Option 5, it also assumes that 1 percent of firms prepare a notification to use the term “pasteurized” in the first year and 1 firm petitions to use another alternative term in the first year. The range of costs represents our uncertainty about the need for changes to the principal display panel or the information panel and the number of pounds of fresh fruits and vegetables that can be stickered per hour. For Option 5, the quantified costs are likely to be less than listed because some firms would be able to remove the irradiation labeling when it results in no material change when it is least costly for them to do so and will not need to submit notifications or petitions. **Table 5A.—Summary of Costs and Benefits of Options** Quantified Costs Unquantified Costs Unquantified Benefits Option 1 (baseline) 0 0 0 Option 2 0 Greatest increase in search costs Most additional labeling flexibility, potentially longer shelf-life Option 3 $341,000 - $681,000 0 Most additional information for consumers Option 4 $133,000 - $252,000 Increased search costs Additional labeling flexibility Option 5 (the proposed rule) Less than $2,785,400 - $3,125,400 Lowest non-zero increase in search costs Additional information for consumers, Least non-zero additional labeling flexibility We request comments on the estimates for these options and specifically on the following three issues: 1. The number of firms or products that would be affected by a new irradiation rule. 2. The number of firms that would begin irradiating products as a result of the various options described here. 3. Whether some industry sectors should be given more time to comply than others to reduce the economic impact on them. D. Small Entity Analysis FDA has examined the economic implications of this proposed rule as required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a rule has a significant economic impact on a substantial number of small entities, the Regulatory Flexibility Act requires agencies to analyze regulatory options that would lessen the economic effect of the rule on small entities. It is not known how many small firms currently irradiate food or will want to irradiate food. If small firms are using this technology, this proposed rule may have a significant economic impact on a substantial number of small entities. The agency requests comments on how this proposed rule will impact small firms. Under contract, Eastern Research Group developed a model framework for estimating regulatory impacts on small businesses. The model is designed to accommodate a variety of potential regulatory activities, ranging from Hazard Analysis Critical Control Point (HACCP) to product labeling. Using the 2002 Economic Census and other data, the model estimates the cash flows of representative establishments of varying class sizes of food manufacturers. Based on post-regulation cash flow and distribution of income for each model facility, the model generates the percentage of facilities in each model class that are vulnerable to closure. The model allows the agency to
(1)Predict the probability and frequency of small business failure as a result of FDA regulations and
(2)estimate the effects of various forms of regulatory relief on the survival of small businesses on a per-establishment basis. Cost estimates produced by the FDA Labeling Cost Model were used to help generate estimates of the average relabeling cost for firms in two of the four food categories examined here: spices/seasonings and dried vegetables. The middle estimated costs in each food category were divided by the estimated affected stockkeeping units
(SKUs)in each food category to arrive at average cost per SKU. Affected SKUs per category are then divided by total number of firms in each category to arrive at average number of affected SKUs per firm. The number of firms in each food category comes from the Ready-to-Eat Food Manufacturing Industry category in FDA's Small Business Impact Model (Ref. 9). We use these estimates to calculate cost per firm using the following formula: Cost/Firm = (Average SKUs per firm) x (Average Middle Relabeling Cost/SKU) This formula allows us to estimate the approximate average relabeling costs for firms in each food category. Keep in mind these are merely estimates and cost structures are treated identically across firms. That is, we assume that costs for small firms are similar to costs for large firms. The average relabeling costs for compliance periods of 12, 24, and 36 months were then entered into the Small Business Impact Model to estimate the number of firms at risk for negative cash flow, assuming all firms in each category must relabel. The results of these estimates are presented in tables 6 and 6A of this document. The table is divided into two sections, one for estimates if the information panel is affected and another for the principal display panel. **Table 6.—Estimates of Firms Affected By the Irradiation Rule—Changes in Information Panel** Food Category Compliance Period Firms with less than 20 Employees Affected Firms At-Risk Firms 1 Firms With 20 to 499 Employees Affected Firms At-Risk Firms 1 Firms With 500+ Employees Affected Firms At-Risk Firms 1 Spices/Seasonings 12 months 139 18 133 0 2 0 24 months 139 7 133 0 2 0 36 months 139 1 133 0 2 0 Dried Vegetables 12 months 23 8 25 0 1 0 24 months 23 3 25 0 1 0 36 months 23 2 25 0 1 0 1 Note: An “at-risk” firm is one that could potentially suffer from negative cash flow as a result of this proposed rule. **Table 6A.—Estimates of Firms Affected By the Irradiation Rule—Changes in Principal Display Panel** Food Category Compliance Period Firms with less than 20 Employees Affected Firms At-Risk Firms 1 Firms With 20 to 499 Employees Affected Firms At-Risk Firms 1 Firms With 500+ Employees Affected Firms At-Risk Firms 1 Spices/Seasonings 12 months 139 39 133 1 2 0 24 months 139 11 133 0 2 0 36 months 139 2 133 0 2 0 Dried Vegetables 12 months 23 8 25 0 1 0 24 months 23 8 25 0 1 0 36 months 23 3 25 0 1 0 1 Note: An “at-risk” firm is one that could potentially suffer from negative cash flow as a result of this proposed rule. The numbers of at-risk firms in the table are estimates generated by the model. These estimates are not based on specific data about the number of small firms affected, because there are no data available; however, they illustrate the idea that small firms, especially firms with fewer than 20 employees, could potentially be adversely affected by this proposed rule. For example, in the dried vegetable category, for a compliance period of 12 months, if as the model estimates, 23 firms would be affected, approximately 8 of these firms (or around 35 percent) would be at risk for negative cash flow as a result of this rule. However, for firms with less than 20 employees, the number of at risk firms decreases as the length of the compliance period increases. As illustrated in tables 1 and 2, when compliance periods increase, costs decrease because firms can coordinate new changes in food labels with already-scheduled changes in labels. By contrast, the model generates no at-risk firms among firms with 500+ employees, regardless of the compliance period. This result is important because the industry is characterized by a large number of small entities. The most effective regulatory relief for small firms would be extended compliance periods. As shown in tables 6 and 6A, as the compliance period increases from 12 to 36 months, the number of small firms at-risk virtually disappears. Firms producing shell eggs are not included in the Ready-to-Eat Application of the Small Business Impact Model because eggs are not considered ready to eat. Therefore, it is not possible to estimate the number of at-risk firms. Nonetheless, small firms producing shell eggs must still be addressed in this analysis. According to the 2002 Census of Manufacturers (Ref. 6), there are 311 companies that process poultry and shell eggs. Of this number, about 25 percent, or 79 firms have 20 employees or less. Again, it is not known how many processors irradiate or will want to irradiate as a result of this rule. Therefore, we will assume this rule could affect 1 percent, or approximately 1 firm. Firms processing fresh fruits and vegetables are also not included in the Small Business Impact Model. Again, it is not possible to estimate the number of at-risk firms. According to the 2002 Census of Manufacturers, there are 5,836 firms that process fresh fruit and vegetables. Because firm size for firms that process fresh fruits and vegetables is not yet available for the 2002 Census of Manufacturers, we use data from the 1997 Census of Manufacturers that 93 percent of these firms are single unit firms. Therefore, we estimate that there are 5,427 single unit firms that process fresh fruit and vegetables. As with the other food categories, it is not known how many of these firms irradiate or will want to irradiate as a result of this rule. Therefore, we will assume this rule could affect 1 percent, or approximately 54 firms. The agency requests comments on the number of small shell egg producers and fresh fruit and vegetable producers that could be affected by this rule. The effects on small businesses depend also on whether the labeling change is required or voluntary. If, for example, the labeling change is to allow an alternate term, or to remove the current label, the small business would do so only if it did not impose a burden. For required labeling changes, however, the labeling costs could indeed put additional firms at risk of going out of business. The length of the compliance period for labeling requirements is the most important variable affecting the burden. The other important factor is how much of the label needs redesigning. If the labeling change is similar to a change in the information panel, and if small businesses are given at least 36 months to comply, few will be at risk. The agency requests comments on the likely effect on small firms as a result of this proposed rule, and on the effects of longer compliance periods for these firms. E. Unfunded Mandates Reform Act of 1995 Section 202(a) of the Unfunded Mandates Reform Act of 1995 (Public Law 104-4) requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $122 million, using the most current
(2005)Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this proposed rule to result in any 1-year expenditure that would meet or exceed this amount. IV. Paperwork Reduction Act of 1995 This proposed rule contains information collection provisions that are subject to review by OMB under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). A description of these provisions is given below with an estimate of the reporting burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the information and data needed and completing and reviewing each collection of information. *Title* : Notice Concerning the Submission of Information to Use an Alternative to “Irradiation” *Description* : In this proposed rule, FDA is proposing to require the submission to the agency of data and information regarding the use of alternate terms to the word “irradiated” in foods that have been treated by irradiation using radioactive isotope, electronic beam, or x-ray. FDA is proposing that an alternate term may be used in lieu of “irradiated” if its use is approved in response to a petition that has been submitted to FDA. If the desired alternate term is “pasteurized,” a notification must be sent to the Secretary
(FDA)that includes effectiveness data to show that the process or treatment meets the requirements of section 403(h)(3) of the act. *Description of Respondents* : Manufacturers that irradiate food and desire to use an alternate term to “irradiation.” FDA estimates the burden of this collection of information as follows: **Table 7.—Estimated One-Time Reporting Burden** 1 21 CFR Section No. of Respondents Frequency of Response Total Responses Hours Per Response Total Hours 179.26(c)(2)(i) 1 1 1 150 150 179.26(c)(2)(ii) 193 1 193 150 28,950 Total 29,100 1 There are no capital costs or operating and maintenance costs associated with this collection of information. **Table 8.—Estimated Annual Reporting Burden** 1 21 CFR Section No. of Respondents Frequency of Response Total Responses Hours Per Response Total Hours 179.26(c)(2)(i) 1 1 1 150 150 179.26(c)(2)(ii) 19 1 19 150 2,850 Total 3,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Tables 7 and 8 of this document describe the reporting burden as a result of the provisions set forth in this proposed rule. Table 7 shows the estimated one time reporting burden after the regulation initially goes into effect. Table 8 shows the estimated annual reporting burden, perhaps due to firms entering into the industry and/or currently existing firms deciding to irradiate at a later date. The agency does not know how many firms will submit a notification or a petition to the agency to use an alternate to the term “irradiation.” It is also not known how many firms currently irradiate food they manufacture, although it is known that the amount of food irradiated each year is very small and there is only one facility that can irradiate food. However, it is assumed that most firms wishing to use an alternate term will choose to use “pasteurized” and submit a notification to FDA along with effectiveness data. It is also assumed that one firm per year will submit a petition to use an alternate term other than “pasteurized” as shown in the row corresponding to proposed § 179.26(c)(2)(i) in table 7. Proposed § 179.26(c)(2)(ii) addresses notifications. The number of firms is based on the 2002 Census of Manufacturers (Refs. 6, 7, and 8). According to the Census of Manufacturers, there are 275 companies that manufacture spices and extracts, 311 companies that process poultry and shell eggs (the Census of Manufacturers groups poultry and shell egg processing together), and 5,836 firms that process fresh fruits and vegetables, for a total of 6,422 firms. Table 7 shows the number of respondents presented as an average, based on percentages of total firms that process shell eggs, spices, and fruits and vegetables, the three categories of FDA-regulated foods that are currently approved for irradiation. It is possible that 1 percent of, or 64 firms in the industry will want to use an alternate term and it is possible that 5 percent of, or 321 firms in the industry will want to use an alternate term. The average of this range is 193 firms. Submission of the notification is voluntary because the proposed rule does not require all firms to submit notifications, only those firms that will be required to label a product as “irradiated” and desire use of an alternative to the term “irradiation”. Therefore, it is assumed that there will be no annual reporting burden for this rule for products that have already submitted notifications. Based on previous estimations of preparing notifications and preparing petitions, FDA is estimating that the time needed to prepare a notification is 150 hours. The agency already has a process for submitting citizen petitions, the burden of which is reported and approved under § 10.30. However, given some of the controversy surrounding irradiation and the use of alternative terms to irradiation, we expect more documentation and more hours spent on these petitions associated with irradiation labeling. Therefore, the agency is assuming submitting a petition will take a total of 190 hours. It is estimated that 40 of these hours are specific to the citizen petition process reported under § 10.30, with an additional 150 hours specific to the issues associated with irradiation labeling. It is this additional burden that is reported in table 7. The annual burden following the initial round of submissions would consist of submissions for additional products, perhaps as a result of market entry. This burden is shown in table 8. Again, we also assume that, each year, one firm will petition the agency to use an alternate term other than “pasteurized,” in response to proposed § 179.26(c)(2)(i). We do not know how many additional firms will submit notifications in response to proposed § 179.26(c)(2)(ii) each year, so table 8 assumes the number of additional firms will be 10 percent of the firms reported in table 7. We also assume that there will not be an additional recordkeeping burden associated with this rule, as it is assumed that firms already have the effectiveness data required by the agency for inclusion in the notification. In compliance with the PRA (44 U.S.C. 3507(d)), the agency has submitted the information collection provisions of this proposed rule to OMB for review. Interested persons are requested to submit comments regarding information collection to OMB (see ADDRESSES ). V. Analysis of Environmental Impact The agency has determined under 21 CFR 25.30(k) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environment assessment nor an environmental impact statement is required. VI. 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 does not contain policies that 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. Accordingly, the agency tentatively concludes that the proposed rule does not contain policies that have federalism implications as defined in the order and, consequently, a federalism summary impact statement is not required. VII. References The following references have been placed on display in the Division of Dockets Management (see ADDRESSES ) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the Web site address, but we are not responsible for subsequent changes to the Web site after this document is published in the **Federal Register** .) 1. Conference Report on S. 830, Food and Drug Administration Modernization Act of 1997, 143 Cong. Rec. H10452, 10477, (November 9, 1997). 1a. Prakash, Anuradha and Denise Foley, “Improving Safety and Extending Shelf Life of Fresh-Cut Fruits and Vegetables Using Irradiation in Irradiation of Food and Packaging; Recent Developments,” ACS Symposium Series 875, V. Komolprasert and K. Morehouse editors, American Chemical Society, Washington, DC 2004. 1b. Kader, Adel A., “Potential Applications of Ionizing Radiation in Postharvest Handling of Fresh Fruits and Vegetables,” *Food Technology* , 117-121, June 1986. 2. ORC Macro, “Consumers' Understanding of Food Irradiation Labeling,” Focus Group Report, December 2001. 3. Schutz, Howard G., Christine M. Bruhn and Katherine V. Diaz-Knauf, “Consumer Attitude Toward Irradiated Foods: Effects of Labeling and Benefits Information,” Food Technology 43, (October 1989): 80-86. 4. Fox, John A., Dermot J. Hayes, Jason F. Shogren, “Consumer Preferences for Food Irradiation: How Favorable and Unfavorable Descriptions Affect Preferences for Irradiated Pork in Experimental Auctions,” *The Journal of Risk and Uncertainty* , 24:1 (2002): 75-95. 5. Cates, Sheryl C., et al., “Consumer Research on Food Safety Labeling Features for the Development of Responsive Labeling Policy,” RTI, March 22, 2002. 6. “United States Census Bureau, Poultry Processing: 2002 Economic Census Manufacturing Industry Series,” available from *http://www.census.gov/prod/ec02/ec0231i311615.pdf* (accessed October 20, 2006). 7. “United States Census Bureau, Spice and Extract Manufacturing: 2002 Economic Census Manufacturing Industry Series,” available from *http://www.census.gov/prod/ec02/ec0231i311942t.pdf* (accessed October 20, 2006). 8. “United States Census Bureau, Comparative Statistics: 2002 Economic Census Manufacturing Industry Series,” p. 9, available from *http://0-www.census.gov.mill1.sjlibrary.org/prod/ec02/ec0200ccomp.pdf* (accessed October 20, 2006). 8a. *Private Industry by State and 6-Digit NAICS Industry: Establishments, Employment, and Wages, 2004 Annual Averages* , *http://www.bls.gov/cew/ew04sector11.pdf* , December 30, 2005. 9. Eastern Research Group, Inc., “Model for Estimating the Impacts of Regulatory Costs on The Survival of Small Businesses and its Application to Four FDA-Regulated Industries,” Contract No. 223-01-2461, June 7, 2002. 10. General Accounting Office, “Food Irradiation: Available Research Indicates That Benefits Outweigh Risks,” GAO/RCED-00-217, August, 2000. 11. RTI International, “FDA Labeling Cost Model,” RTI Project Number 06673.010, January 2003. 12. Office of Management and Budget, “GDP and Deflators Used in the U.S.,” Budget of the United States Government Fiscal Year 2004, Historical Table 10.1, 2003. 13. U.S. Food and Drug Administration, Substances Generally Recognized as Safe: Notification Procedure, OMB No. 0910-0342, Supporting Statement available from *http://www.fda.gov/OHRMS/DOCKETS/98fr/05n-0457-ss00001.pdf* . List of Subjects in 21 CFR Part 179 Food additives, Food labeling, Food packaging, Radiation protection, Reporting and recordkeeping requirements, Signs and symbols. 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 part 179 be amended as follows: PART 179—IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF FOOD 1. The authority citation for 21 CFR part 179 continues to read as follows: Authority: 21 U.S.C. 321, 342, 343, 348, 373, 374. 2. Section 179.26 is amended by revising paragraph (c)(1); by redesignating paragraphs (c)(2) and (c)(3) as paragraphs (c)(3) and (c)(4), respectively; by revising newly redesignated paragraph (c)(3); and by adding new paragraph (c)(2) to read as follows: § 179.26 Ionizing radiation for the treatment of food.
(c)*Labeling* .
(1)The label and labeling of a retail package of a food irradiated in conformance with paragraph
(b)of this section that has, as a result of the irradiation, undergone a material change in the characteristics of the food or in its consequences of use shall bear the following logo along with EP04AP07.000 the statement “irradiated,” or any derivatives of the term “irradiated” (e.g., “irradiation,” “irradiate,” “radiation,” etc.) or an alternate term as provided in paragraph (c)(2) of this section, in conjunction with language describing the material change in the characteristics of the food or its use. The logo shall be placed prominently and conspicuously in conjunction with the required statement. The radiation disclosure statement is not required to be more prominent than the declaration of ingredients required under § 101.4 of this chapter. As used in this provision, the term “radiation disclosure statement” means a written statement that discloses that a food has been intentionally subjected to irradiation and identifies the material change in the characteristics of the food or the consequences that may result from its use as a result of the irradiation.
(2)An alternate term may be used in lieu of “irradiated,” or any of its derivatives, if it meets the following provisions.
(i)A term that is not false or misleading in any material respect may be used in lieu of “irradiated,” or any of its derivatives, if its use is approved in response to a petition that has been submitted to FDA using the procedures under § 10.30 of this chapter for approval of the alternate term, or, if use of the term “pasteurized” is permissible under the requirements in paragraph (c)(2)(ii) of this section. The petition should include all relevant information and views on which the petitioner relies, including any data, e.g., qualitative or quantitative consumer research, that show consumer understanding of the purpose and intent of the alternative labeling.
(ii)The term “pasteurized” may be used in lieu of “irradiated” or any of its derivatives if the irradiation process is:
(A)Reasonably certain to achieve destruction or elimination in the food of the most resistant microorganism of public health significance that is likely to occur in the food;
(B)At least as protective of the public health as a process or treatment that is defined as pasteurization in this chapter;
(C)Effective for a period that is least as long as the shelf life of the food when stored under normal and moderate abuse conditions; and
(D)The subject of a notification to the Secretary of Health and Human Services (the Secretary) that includes effectiveness data regarding the process or treatment and the Secretary has not made a determination in 120 days after the receipt of the notification that the process or treatment involved has not been shown to meet the requirements provided in paragraph (c)(2)(ii)(A), (B), and
(C)of this section.
(3)For an irradiated food not in packaged form that has, as a result of the irradiation, undergone a material change in its characteristics or conditions of use, the required logo and the following disclosure statements, “irradiated,” or any of its derivatives, or an alternate term as provided in paragraph (c)(2) of this section in conjunction with language describing the material change in the characteristics of the food or conditions of use as a result of the irradiation, shall be displayed to the purchaser with either of the following:
(i)The labeling of the bulk container plainly in view or
(ii)A counter sign, card, or other appropriate device bearing the information that the product has been treated with radiation. As an alternative, each item of food may be individually labeled. In either case, the information must be prominently and conspicuously displayed to purchasers. The labeling requirement applies only to a food that has been irradiated, not to a food that merely contains an irradiated ingredient but that has not itself been irradiated. Dated: March 27, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 07-1636 Filed 4-3-07; 8:45 am]
Connectionstraces to 46
Traces to 46 documents
register
CFR
- What size standards has SBA identified by North American Industry Classification System codes?§ 121.201
- Praziquantel and pyrantel.§ 520.1871
- Confidentiality of data and information in a new animal drug application file.§ 514.11
- Animal drugs.§ 25.33
- Melengestrol.§ 558.342
- National security cases.§ 501.2
- Delegation of rulemaking authority.§ 1.05-1
- May I address the unsafe condition in a way other than that set out in the airworthiness directive?§ 39.19
- Issue of type certificate: import products.§ 21.29
- Good guidance practices.§ 10.115
- Citizen petition.§ 10.30
- Ionizing radiation for the treatment of food.§ 179.26
- General.§ 25.30
U.S. Code
- Rule making§ 553
- Definitions§ 601
- Jurisdiction of Commission; liability of principal for act of agent; Commodity Futures Trading Commission; transaction in interstate commerce§ 2
- Public information; agency rules, opinions, orders, records, and proceedings§ 552
- New animal drugs§ 360b
- EXPEDITED PROCESSING OF REQUESTS FOR JAPANESE IMPERIAL GOVERNMENT RECORDS.§ 804
- Civil action for deprivation of rights§ 1983
- Procedure for interception of wire, oral, or electronic communications§ 2518
- Avoidance of duplicative or unnecessary analyses§ 605
- Establishment, functions, and activities§ 272
- Transferred§ 1226
- Transferred§ 191
- Tolerances and exemptions for pesticide chemical residues§ 346a
- Purposes§ 3501
- SHORT TITLE.§ 801
- Definitions; generally§ 321
- Definitions§ 136
- Federal agency responsibilities§ 3506
- Discriminations and preferences§ 202
- Federal Communications Commission§ 154
- Congressional findings and declaration of purposes and policy§ 1531
- Federal Aviation Administration§ 106
- Disclosure§ 343–3
- Regulations and hearings§ 371
- Public information collection activities; submission to Director; approval and delegation§ 3507
72 references not yet in our index
- 7 CFR 915
- 7 USC 601-674
- 7 CFR 922
- 7 CFR 926
- 7 CFR 929
- 7 CFR 1207
- 7 USC 2611-2627
- 17 CFR 140
- 17 CFR 145
- Pub. L. 99-570
- 100 Stat. 3207
- Pub. L. 89-554
- 80 Stat. 54
- Pub. L. 98-502
- 88 Stat. 1561
- Pub. L. 93-463
- 5 USC 4a(j)
- 21 CFR 520
- 21 CFR 20
- 5 USC 801-808
- 21 CFR 558
- 28 CFR 542
- 417 U.S. 817
- 429 U.S. 545
- 289 U.S. 1
- 812 F.2d 920
- 87 F.3d 377
- 416 U.S. 396
- 18 USC 2510-2522
- Pub. L. 107-296
- 116 Stat. 2135
- 33 CFR 165
- 5 USC 601-612
- Pub. L. 104-121
- 44 USC 3501-3520
- 2 USC 1531-1538
- 42 USC 4321-4370f
- Pub. L. 107-295
- 40 CFR 174
- 40 CFR 178
+ 32 more
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