Proposed Rules. Proposed rule

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BILLING CODE 6717-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 888 [Docket No. 2006N-0019] Orthopedic Devices; Reclassification of the Intervertebral Body Fusion Device AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration

(FDA)is proposing to reclassify intervertebral body fusion devices that contain bone grafting material, from class III (premarket approval) into class II (special controls), and retain those that contain any therapeutic biologic (e.g., bone morphogenic protein) in class III. Elsewhere in this issue of the **Federal Register** , FDA is announcing the availability of a draft guidance document that would serve as the special control if FDA reclassifies this device. The agency is proposing this reclassification based on the recommendation of the Orthopaedic and Rehabilitation Devices Panel (the Panel). DATES: Submit written or electronic comments by May 10, 2006. See section X of this document for the proposed effective date of a final rule based on this proposed rule. ADDRESSES: You may submit comments, identified by Docket No. 2006N-0019, 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 followings 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 number for this rulemaking. All comments received may be posted without change to *http://www.fda.gov/ohrms/dockets/default.htm* , including any personal information provided. For additional information on submitting comments, see the “Comments” heading of the SUPPLEMENTARY INFORMATION section of this document. *Docket* : For access to the docket to read background documents or comments received, go to *http://www.fda.gov/ohrms/dockets/default.htm* and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Jodi N. Anderson, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2036, ext. 186. SUPPLEMENTARY INFORMATION: I. Background (Regulatory Authorities) The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301 *et seq.* ), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Public Law 94-295), the Safe Medical Devices Act of 1990 (Public Law 101-629), the Food and Drug Administration Modernization Act of 1997 (Public Law 105-115), and the Medical Device User Fee and Modernization Act of 2002 (Public Law 107-250), established a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the act (21 U.S.C. 360c) established three categories (classes) of devices, depending on the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval). Under section 513 of the act, devices that were in commercial distribution before May 28, 1976 (the date of enactment of the 1976 amendments), generally referred to as preamendments devices, are classified after FDA has done the following:

(1)Received a recommendation from a device classification panel (an FDA advisory committee);

(2)published the panel's recommendation for comment, along with a proposed regulation classifying the device; and

(3)published a final regulation classifying the device. FDA has classified most preamendments devices under these procedures. Devices that were not in commercial distribution prior to May 28, 1976, generally referred to as postamendments devices, are classified automatically by statute (section 513(f) of the act) into class III without any FDA rulemaking process. Those devices remain in class III and require premarket approval, unless and until the device is reclassified into class I or II or FDA issues an order finding the device to be substantially equivalent, under section 513(i) of the act, to a predicate device that does not require premarket approval. The agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations. A preamendments device that has been classified into class III may be marketed, by means of premarket notification procedures, without submission of a premarket approval application

(PMA)until FDA issues a final regulation under section 515(b) of the act (21 U.S.C. 360e(b)) requiring premarket approval. Reclassification of classified postamendments devices is governed by section 513(f ) of the act. This section provides that FDA may initiate the reclassification of a device classified into class III under section 513(f)(1) of the act, or the manufacturer or importer of a device may petition the Secretary of Health and Human Services (the Secretary) for the issuance of an order classifying the device in class I or class II. FDA's regulations in 21 CFR 860.134 set forth the procedures for the filing and review of a petition for reclassification of such class III devices. In order to change the classification of the device, it is necessary that the proposed new class have sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. Under section 513(f)(3)(B)(i) of the act, the Secretary may, for good cause shown, refer a proposed reclassification to a device classification panel. The Panel shall make a recommendation to the Secretary respecting approval or denial of the proposed reclassification. Under section 513(f)(3)(B)(i), any such recommendation must contain the following:

(1)A summary of the reasons for the recommendation,

(2)a summary of the data upon which the recommendation is based, and

(3)an identification of the risks to health (if any) presented by the device with respect to which the proposed reclassification was initiated. II. Regulatory History of the Device The intervertebral body fusion device is a postamendments device classified into class III under section 513(f)(1) of the act. It is intended for intervertebral body fusion. The intervertebral body fusion device cannot be placed in commercial distribution for implantation unless it is reclassified under section 513(f)(3), or subject to an approved PMA under section 515 of the act. Based on information discussed at a December 11, 2003, Panel meeting (see section IV of this document) regarding the intervertebral body fusion device, the FDA believes potential risks associated with the intervertebral body fusion device, except those that contain any therapeutic biologic, can be addressed by special controls in the form of a guidance document. Thus, FDA is proposing to reclassify intervertebral body fusion devices that contain bone grafting material from class III into class II. Consistent with the act and the regulation, FDA referred the proposal to the Panel for its recommendation on the requested changes in classification. Intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein) will remain in class III. FDA believes that there is insufficient information to determine that general and special controls would provide a reasonable assurance of their safety and effectiveness. III. Device Description The following device description is based on the Panel's recommendation and the agency's review: An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion. IV. Recommendation of the Panel At a public meeting on December 11, 2003, the Panel recommended unanimously that the intervertebral body fusion device, except those that contain any therapeutic biologic, be reclassified from class III into class II (Ref. 1). The Panel believed that class II with special controls, in addition to the general controls, would provide reasonable assurance of the safety and effectiveness of the device. The Panel also recommended that the proposed special controls for the device be mechanical, animal, and clinical testing, labeling, sterilization, and biocompatibility as suggested by FDA staff. V. Risks to Health After considering the information in the Panel's recommendation, as well as other information, including Medical Device Reports (MDRs), FDA has evaluated the risks to health associated with use of the intervertebral body fusion device that contains bone grafting material and determined that the following risks to health are associated with its use: A. Infection Infection of the soft tissue, bony tissue, and the disc space is a potential risk to health associated with all surgical procedures and implanted spinal devices. Material composition or impurities, wear debris, operative time, and operative environment may compromise the vascular supply to the area or affect the immune system, which could increase the risk of infection. Improper sterilization or packaging may also increase the risk of infection. B. Adverse Tissue Reaction Adverse tissue reaction is a potential risk to health associated with all implanted devices. The implantation of the intervertebral body fusion device will elicit a mild inflammatory reaction typical of a normal foreign body response. Incompatible materials or impurities in the materials and wear debris may increase the severity of a local tissue reaction or cause a systemic tissue reaction. If the materials used in the manufacture of intervertebral body fusion device are not biocompatible, the patient could have an adverse tissue reaction. C. Pain and Loss of Function Pain and loss of function are risks to health associated with any implanted spinal device. Some device-related complications that may cause pain and loss of function include device fracture, deformation, loosening, extrusion, or migration due to inappropriate patient or device selection. The wear of materials, which may cause osteolysis (dissolution of bone), and component disassembly, fracture, or failure may also result in pain and loss of function. D. Soft Tissue Injury Soft tissue injury is a risk to health associated with all spinal surgery. This includes injury to major blood vessels, viscera, nerve roots, spinal cord, and cauda equina. E. Vertebral Endplate Injury Vertebral endplate injury is a risk to health associated with the insertion of an intervertebral body fusion device. Surgically inserting a device with a different geometry and modulus of elasticity than bone may lead to vertebral fracture, sinking of the device into the vertebral endplate (subsidence), collapse of the local blood supply, and collapse of the vertebral end plate. F. Reoperation Reoperation is a risk to health associated with any surgery. The need for reoperation could result from a failed intervertebral body device or component of the device, from nerve root decompression or adjacent level disease, or from reasons related to any surgery, e.g., infection or bleeding. G. Pseudarthrosis (i.e., non-union) Pseudarthrosis (i.e., non-union) is a risk associated with all spinal fusion surgeries. It signifies failure of the bony fusion mass and results in persistent instability. VI. Summary of the Reasons for the Reclassification FDA believes that the intervertebral body fusion device that contains bone grafting material should be reclassified into class II because special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device. In addition, there is sufficient information to establish special controls to provide such assurance. VII. Summary of the Data Upon Which the Reclassification is Based As discussed previously in this document, FDA is proposing this reclassification based on the Panel's recommendation. In addition FDA has reviewed MDRs related to this device. After evaluating this information, FDA believes that the potential risks to health associated with use of the intervertebral body fusion device described in section V of this document can be addressed by special controls. In addition, there is reasonable knowledge of the benefits of the device, including the provision of mechanical support, which aids in fusion procedures of the anterior spinal column. VIII. Special Controls FDA believes that the draft guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device” (the class II special controls guidance document), in addition to providing general controls, can address the risks to health associated with the use of the device and described in section V of this document. FDA believes further that the class II special controls guidance document, which incorporates voluntary consensus standards and labeling recommendations, addresses the Panel's concerns regarding the content of a special controls guidance document. Elsewhere in this issue of the **Federal Register** , FDA is publishing a notice of availability of the draft guidance document that the agency intends to use as the special control for this device. The class II special controls guidance document contains specific recommendations with regard to device performance testing and other information FDA believes should be included in premarket notification submissions (510(k)s) for the intervertebral body fusion device that contains bone grafting material. Sections of the draft special controls guidance document address the following topics: Material characterization, mechanical testing, animal testing, clinical testing, sterility, biocompatibility, and labeling. FDA has identified the risks to health associated with the use of the device in the first column of table 1 of this document and the recommended mitigation measures identified in the class II special controls guidance document in the second column. **Table 1.** Identified Risk Recommended Mitigation Measures Infection Sterility Adverse Tissue Reaction Biocompatibility Pain and Loss of Function Mechanical Testing Animal Data Clinical Data Labeling Soft Tissue Injury Labeling Vertebral Endplate Injury Material Characterization Mechanical Testing Biocompatibility Labeling Reoperation Labeling Psuedoarthrosis (i.e., non-union) Labeling Following the effective date of a final rule based on this proposal, any firm submitting a 510(k) premarket notification for an intervertebral body fusion device will need to address the issues covered in the special controls guidance. However, the firm need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurance of safety and effectiveness. IX. FDA's Findings FDA believes the intervertebral body fusion device that contains bone grafting material should be reclassified into class II because special controls, in addition to general controls, can provide reasonable assurance of the safety and effectiveness of the device. In addition, there is sufficient information to establish special controls to provide such assurance. FDA, therefore, is proposing to reclassify the intervertebral body fusion device that contains bone grafting material into class II and establish the class II special controls guidance document as the special control for that device, and to retain in class III those devices that contain any therapeutic biologic. X. Effective Date FDA proposes that any final rule that may issue based on this proposal become effective 30 days after its date of publication in the **Federal Register** . XI. Environmental Impact The agency has determined under 21 CFR 25.34(b) that this proposed reclassification 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. XII. Analysis of Impacts FDA has examined the impacts of the proposed rule under 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). The agency believes that this proposed rule is not a significant regulatory action as defined by the Executive order. The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Reclassification of this device from class III to class II will relieve all manufacturers of the device of the costs of complying with the premarket approval requirements in section 515 of the act. Because reclassification will reduce regulatory costs with respect to this device, the agency certifies that the proposed rule will not have a significant economic impact on a substantial number of small entities. Section 202(a) of the Unfunded Mandates Reform Act of 1995 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 $115 million, using the most current

(2003)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. XIII. Federalism FDA has analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the proposed rule, if finalized, would not contain policies that would 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 Executive order and, consequently, a federalism summary impact statement has not been prepared. XIV. Paperwork Reduction Act of 1995 FDA tentatively concludes that this proposed rule contains no collections of information. Therefore, clearance by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520) is not required. FDA also tentatively concludes that the special controls guidance document does not contain new information collection provisions that are subject to review and clearance by OMB under the PRA. Elsewhere in this issue of the **Federal Register** , FDA is publishing a notice announcing the availability of the draft guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device;” the notice contains an analysis of the paperwork burden for the draft guidance. XV. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this proposal. Submit a single copy of electronic comments or two paper copies of mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. XVI. References The following reference has 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. 1. Orthopedic and Rehabilitation Devices Panel Meeting Transcript, pp. 1-141, December 11, 2003. List of Subjects in 21 CFR Part 888 Medical devices. 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 888 be amended as follows: PART 888—ORTHOPEDIC DEVICES 1. The authority citation for 21 CFR part 888 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371. 2. Section 888.3080 is added to subpart D to read as follows: § 888.3080 Intervertebral body fusion device.

(a)*Identification* . An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

(b)*Classification* .

(1)Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.

(2)Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.

(c)*Date premarket approval application

(PMA)or notice of product development protocol

(PDP)is required* . Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution. Dated: February 1, 2006. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E6-1736 Filed 2-8-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [CGD05-06-006] RIN 1625-AA08 Special Local Regulations for Marine Events; Maryland Swim for Life, Chester River, Chestertown, MD AGENCY: Coast Guard, DHS. ACTION: Notice of proposed rulemaking. SUMMARY: The Coast Guard proposes to amend the special local regulations at 33 CFR 100.533, established for the “Maryland Swim for Life” held annually on the waters of the Chester River, near Chestertown, Maryland by changing the event date to the third Saturday in June. This proposed rule is intended to restrict vessel traffic in portions of the Chester River and is necessary to provide for the safety of life on navigable waters during the event. DATES: Comments and related material must reach the Coast Guard on or before April 10, 2006. ADDRESSES: You may mail comments and related material to Commander (oax), Fifth Coast Guard District, 431 Crawford Street, Portsmouth, Virginia 23704-5004, hand-deliver them to Room 119 at the same address between 9 a.m. and 2 p.m., Monday through Friday, except Federal holidays, or fax them to

(757)398-6203. The Auxiliary and Recreational Boating Safety Branch, Fifth Coast Guard District, maintains the public docket for this rulemaking. Comments and material received from the public, as well as documents indicated in this preamble as being available in the docket, will become part of this docket and will be available for inspection or copying at the above address between 9 a.m. and 2 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: Dennis M. Sens, Project Manager, Auxiliary and Recreational Boating Safety Branch, at

(d)of Section 100.533 establishes the enforcement date for the Maryland Swim for Life. This regulation proposes to change the enforcement date from the second Saturday in July to the third Saturday in June each year. Notice of exact time, date and location will be published in the **Federal Register** prior to the event. The Maryland Swim for Life Association who is the sponsor for this event intends to hold it annually. To provide for the safety of participants and support vessels, the Coast Guard will temporarily restrict vessel traffic in the event area during the swim. Discussion of Proposed Rule The Coast Guard proposes to amend the regulations at 33 CFR 100.533 by revising the date of enforcement in paragraph

(d)to reflect the event will be conducted annually on the third Saturday in June. This proposed change is needed to accommodate attendance by a wide range of participants at the event. The special local regulations will be enforced from 6:30 a.m. to 1:30 p.m. on June 17, 2006, and will restrict general navigation in the regulated area during the swimming event. Except for persons or vessels authorized by the Coast Guard Patrol Commander, no person or vessel may enter or remain in the regulated area during the effective period. The regulated area is needed to control vessel traffic during the event to enhance the safety of participants and transiting vessels. Regulatory Evaluation This proposed 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. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS). We expect the economic impact of this proposed rule to be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary. The effect of this proposed action merely establishes the dates on which the existing regulations would be in effect and modifies the boundaries of the regulated area and would not impose any new restrictions on vessel traffic. Small Entities Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this proposed 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 proposed rule would not have a significant economic impact on a substantial number of small entities. This proposed rule would effect the following entities, some of which might be small entities: The owners or operators of vessels intending to transit or anchor in a portion of the Chester River during the event. This proposed rule would not have a significant economic impact on a substantial number of small entities for the following reasons. This proposed rule would merely establish the dates on which the existing regulations would be in effect of the regulated area and would not impose any new restrictions on vessel traffic. If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES ) explaining why you think it qualifies and how and to what degree this rule would economically affect it. 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 this proposed rule so that they can better evaluate its effects on them and participate in the rulemaking. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the address listed under ADDRESSES . The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard. Collection of Information This proposed rule would call 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 proposed 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 proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble. Taking of Private Property This proposed rule would 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 proposed 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 proposed rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Safety Risks. This rule is not an economically significant rule and would not create an environmental risk to health or risk to safety that might disproportionately affect children. Indian Tribal Governments This proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would 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 proposed 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 proposed rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards. Environment We have analyzed this proposed 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)(h), of the Instruction, from further environmental documentation. Special local regulations issued in conjunction with a regatta or marine event permit are specifically excluded from further analysis and documentation under that section. Under figure 2-1, paragraph (34)(h), of the Instruction, an “Environmental Analysis Check List” and a “Categorical Exclusion Determination” are not required for this rule. Comments on this section will be considered before we make the final decision on whether to categorically exclude this rule from further environmental review. List of Subjects in 33 CFR Part 100 Marine safety, Navigation (water), Reporting and recordkeeping requirements, Waterways. For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 100 as follows: PART 100—SAFETY OF LIFE ON NAVIGABLE WATERS 1. The authority citation for part 100 continues to read as follows: Authority: 33 U.S.C. 1233; Department of Homeland Security Delegation No. 0170.1. 2. In § 100.533, revise paragraph (d), to read as follows: § 100.533 Maryland Swim for Life, Chester River, Chestertown, Maryland.

(d)*Enforcement period* .

(1)This section will be enforced annually on the third Saturday in June. A notice of enforcement of this section will be published annually in the **Federal Register** and disseminated through the Fifth Coast Guard District Local Notice to Mariners announcing the specific event dates and times. Notice will also be made via marine Safety Radio Broadcast on VHF-FM marine band radio channel 22 (157.1 MHz).

(2)For 2006, this section will be enforced from 6:30 a.m. to 1:30 p.m. on June 17, 2006. Dated: January 23, 2006. Larry L. Hereth, Rear Admiral, U.S. Coast Guard, Commander, Fifth Coast Guard District. [FR Doc. E6-1740 Filed 2-8-06; 8:45 am] BILLING CODE 4910-15-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [CGD05-06-007] RIN 1625-AA08 Special Local Regulations for Marine Events; Severn River, College Creek, Weems Creek and Carr Creek, Annapolis, MD AGENCY: Coast Guard, DHS. ACTION: Notice of proposed rulemaking. SUMMARY: The Coast Guard proposes to suspend the special local regulations at 33 CFR 100.518 and establish a temporary rule that will be effective during the suspension period. This rulemaking is intended to accommodate a change in event dates for the year 2006 and modify the boundaries of the regulated area. The marine events included in this proposed rule include the Safety at Sea Seminar, U.S. Naval Academy Crew Races and the Blue Angels Air Show. This proposed rule is intended to restrict vessel traffic in portions of the Severn River during the period of these marine events and is necessary to provide for the safety of life on navigable waters during the event. DATES: Comments and related material must reach the Coast Guard on or before March 13, 2006. ADDRESSES: You may mail comments and related material to Commander (oax), Fifth Coast Guard District, 431 Crawford Street, Portsmouth, Virginia 23704-5004, hand-deliver them to Room 119 at the same address between 9 a.m. and 2 p.m., Monday through Friday, except Federal holidays, or fax them to

(757)398-6204. SUPPLEMENTARY INFORMATION: Request for Comments We encourage you to participate in this rulemaking by submitting comments and related material. If you do so, please include your name and address, identify the docket number for this rulemaking (CGD05-06-007), indicate the specific section of this document to which each comment applies, and give the reason for each comment. Please submit all comments and related material in an unbound format, no larger than 8 1/2 by 11 inches, suitable for copying. If you would like to know they reached us, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received during the comment period. We may change this proposed rule in view of them. Public Meeting We do not now plan to hold a public meeting. But you may submit a request for a meeting by writing to the address listed under ADDRESSES explaining why one would be beneficial. If we determine that one would aid this rulemaking, we will hold one at a time and place announced by a later notice in the **Federal Register** . Background and Purpose For 2006, we propose to suspend 33 CFR 100.518 and issue a temporary rule to accommodate changes to the enforcement period for U.S. Naval Academy sponsored marine events. The dates for the marine events for 2006 will be; the Safety at Sea Seminar on April 1, 2006, the U.S. Naval Academy crew races on March 25, April 15, April 22, April 23, May 12 and May 28, 2006; and the Blue Angels air show on May 23 and May 24, 2006. The events will be enforced from 5 a.m. to 6 p.m. on those days and if the event's daily activities should conclude prior to 6 p.m., enforcement of this proposed regulation may be terminated for that day at the discretion of the Patrol Commander. The U.S. Naval Academy who is the sponsor for all of these events intends to hold them annually on the dates provided in 33 CFR 100.518, however, in 2006, this is not possible. To accommodate the availability of the various marine event participants new dates were necessary to support the conduct of the events. The Coast Guard proposes to suspend 33 CFR 100.518 only from March 1, 2006 through June 1, 2006, which would also be the effective period of our proposed temporary rule. 33 CFR 100.518 would also be amended to reflect changes in the regulated area. The proposed northwest boundary of the regulated area is bounded by a line approximately 1300 yards north and parallel with the U.S. 50 Severn River Bridge. The proposed southeast boundary of the regulated area is extended approximately 1100 yards to the south to a point 700 yards east of Chinks Point, MD. These adjustments to the regulated area have been made to accommodate the aerobatic maneuvering area for the Blue Angels Air Show and encompass the rowing course for Naval Academy Crew Races. The proposed temporary rule also reflects these new regulated area boundaries. Discussion of Proposed Rule The Coast Guard proposes to suspend the regulations at 33 CFR 100.518 from March 1, 2006 through June 1, 2006 and establish a temporary rule that will be in effect during the time of the suspension. The suspension and creation of a new temporary rule is necessary to reflect new enforcement dates. The Coast Guard also proposes to adjust the boundaries of the regulated area for these events in both 33 CFR 100.518 and the temporary rule. These proposed changes are needed to control vessel traffic during the events to enhance the safety of participants, spectators and transiting vessels. Regulatory Evaluation This proposed 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. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS). We expect the economic impact of this proposed rule to be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary. The effect of this proposed action merely establishes the dates on which the existing regulations would be enforced and modifies the boundaries of the regulated area. It would not impose any additional restrictions on vessel traffic. Small Entities Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this proposed 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 proposed rule would not have a significant economic impact on a substantial number of small entities. This proposed rule would affect the following entities, some of which might be small entities: The owners or operators of vessels intending to transit or anchor in a portion of the Severn River during the event. This proposed rule would not have a significant economic impact on a substantial number of small entities for the following reasons. This proposed rule would merely establish the dates on which the existing regulations would be enforced and modify the boundaries of the regulated area. It would not impose any additional restrictions on vessel traffic. If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES ) explaining why you think it qualifies and how and to what degree this rule would economically affect it. 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 this proposed rule so that they can better evaluate its effects on them and participate in the rulemaking. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the address listed under ADDRESSES . The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard. Collection of Information This proposed rule would call 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 proposed 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 proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble. Taking of Private Property This proposed rule would 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 proposed 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 proposed rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and would not create an environmental risk to health or risk to safety that might disproportionately affect children. Indian Tribal Governments This proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would 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 proposed 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 proposed rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards. Environment We have analyzed this proposed 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)(h), of the Instruction, from further environmental documentation. Special local regulations issued in conjunction with a regatta or marine event permit are specifically excluded from further analysis and documentation under that section. Under figure 2-1, paragraph (34)(h), of the Instruction, an “Environmental Analysis Check List” and a “Categorical Exclusion Determination” are not required for this rule. Comments on this section will be considered before we make the final decision on whether to categorically exclude this rule from further environmental review. List of Subjects in 33 CFR Part 100 Marine safety, Navigation (water), Reporting and recordkeeping requirements, Waterways. For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 100 as follows: PART 100—SAFETY OF LIFE ON NAVIGABLE WATERS 1. The authority citation for part 100 continues to read as follows: Authority: 33 U.S.C. 1233; Department of Homeland Security Delegation No. 0170.1. 2. Revise § 100.518, paragraphs (a)(1) and (c)(1) to read as follows: § 100.518 Severn River, College Creek, Weems Creek and Carr Creek, Annapolis, Maryland.

(a)*Regulated area.*

(1)The regulated area is established for the waters of the Severn River from shoreline to shoreline, bounded to the northwest by a line drawn from the south shoreline at latitude 39°00′38.9″ N, longitude 076°31′05.2″ W thence to the north shoreline at latitude 39°00′54.7″ N, longitude 076°30′44.8″ W, this line is approximately 1300 yards northwest of the U.S. 50 fixed highway bridge. The regulated area is bounded to the southeast by a line drawn from the Naval Academy Light at latitude 38°58′39.5″ N, longitude 076°28′49″ W thence southeast to a point 700 yards east of Chinks Point, MD at latitude 38°58′1.9″ N, longitude 076°28′1.7″ W thence northeast to Greenbury Point at latitude 38°58′29″ N, longitude 076°27′16″ W. All coordinates reference Datum NAD 1983.

(c)*Enforcement period.*

(1)This section will be enforced during, and 30 minutes before each of the following annual events: § 100.518 [Suspended] 3. From March 1, 2006 through June 1, 2006, suspend § 100.518. 4. From March 1, 2006 through June 1, 2006, add temporary § 100.35-T06-007 to read as follows: § 100.35-T06-007, Severn River, College Creek, Weems Creek and Carr Creek, Annapolis, Maryland.

(a)*Regulated area.*

(b)*Definitions.*

(1)*Coast Guard Patrol Commander* means a commissioned, warrant, or petty officer of the Coast Guard who has been designated by the Commander, Coast Guard Sector Hampton Roads.

(2)*Official Patrol* means any vessel assigned or approved by Commander, Coast Guard Sector Hampton Roads with a commissioned, warrant, or petty officer on board and displaying a Coast Guard ensign.

(c)*Special local regulations.*

(1)Except for persons or vessels authorized by the Coast Guard Patrol Commander, no person or vessel may enter or remain in the regulated area.

(2)The operator of any vessel in the immediate vicinity of the regulated area shall:

(i)Stop the vessel immediately when directed to do so by any Official Patrol and then proceed only as directed.

(ii)All persons and vessels shall comply with the instructions of the Official Patrol.

(3)Any spectator vessel may anchor outside of the regulated area specified in paragraph (a)(1) of this section but may not block a navigable channel.

(d)*Enforcement period.*

(1)This section will be enforced from 5 a.m. to 6 p.m. on those days and if the event's daily activities should conclude prior to 6 p.m., enforcement of this proposed regulation may be terminated for that day at the discretion of the Patrol Commander. Enforcement will be during, and 30 minutes before each of the following annual events:

(i)Safety at Sea Seminar, April 1, 2006;

(ii)Naval Academy Crew Races, March 25, April 15, April 22, April 23, May 12 and May 28, 2006;

(iii)Blue Angels Air Show, May 23 and May 24, 2006.

(2)The Commander, Fifth Coast Guard District will publish a notice in the Fifth Coast Guard District Local Notice to Mariners announcing the specific event times.

(e)*Effective period.* This section is effective from March 1, 2006 through June 1, 2006. Dated: January 23, 2006. Larry L. Hereth, Rear Admiral, U.S. Coast Guard, Commander, Fifth Coast Guard District. [FR Doc. E6-1738 Filed 2-8-06; 8:45 am] BILLING CODE 4910-15-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 51 [EPA-HQ-OAR-2005-0175; FRL-8030-6] Transition to New or Revised Particulate Matter (PM); National Ambient Air Quality Standards (NAAQS) AGENCY: Environmental Protection Agency (EPA). ACTION: Advance Notice of Proposed Rulemaking (ANPR). SUMMARY: The EPA recently issued a notice of proposed revisions to the national ambient air quality standards (NAAQS) for particulate matter (PM). EPA will take final action on the proposal by September 27, 2006. This notice provides advance notice of key issues for consideration in the development of potentially new or revised policies and/or regulations to implement revisions to the NAAQS for PM recognizing that no final decision has been made concerning whether or how to revise the PM NAAQS. The EPA is posing a number of questions related to the transition from the current to potentially revised PM 2.5 standards, as well as the transition from the current PM 10 standards to potentially new PM 10-2.5 standards. In this ANPR, EPA is soliciting comment on the Agency's preferred approaches to revocation of the 1997 PM 2.5 standards once any new 2006 PM 2.5 standards would be in place, and also approaches to revocation of the 24-hour PM 10 standard in areas where it would remain after promulgation of any new PM 10-2.5 standards. The EPA is also highlighting and providing preliminary thinking on how to address some of the key New Source Review

(NSR)issues related to the new PM 10-2.5 standards, and the transition from PM 10 standards to PM 10-2.5 standards. Finally, EPA is requesting comment on potential timeframes for designations, attainment demonstrations and State Implementation Plan

(SIP)submittals and attainment dates for both any new PM 2.5 and PM 10-2.5 standards. DATES: Comments must be received on or before April 10, 2006. ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2005-0175, by one of the following methods: • *http://www.regulations.gov* : Follow the on-line instructions for submitting comments. • E-mail: *A-and-R-Docket@epa.gov* , Attention Docket ID No. EPA-HQ-OAR-2005-0175. • Fax: Fax your comments to

(202)566-1741, Attention Docket ID. No. EPA-HQ-OAR-2005-0175. • Mail: Docket EPA-HQ-OAR-2005-0175 Environmental Protection Agency, Mail Code: 6102T, 1200 Pennsylvania Ave., NW., Washington, DC, 20460. Please include a total of two copies. • Hand Delivery: Deliver your comments to: Air Docket, Environmental Protection Agency, 1301 Constitution Avenue, NW., Room B102, Washington, DC 20004, Attention Docket ID No. EPA-HQ-OAR-2005-0175. Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information. *Instructions:* Direct your comments to Docket ID No. EPA-HQ-OAR-2005-0175. The EPA's policy is that all comments received will be included in the public docket without change and may be made available online at *http://www.regulations.gov* , including any personal information provided, unless the comment includes information claimed to be Confidential Business Information

(CBI)or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through *http://www.regulations.gov* or e-mail. The *http://www.regulations.gov* Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through *http://www.regulations.gov* , your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For further information about EPA's public docket visit the EPA Docket Center homepage at *http://www.epa.gov/epahome/dockets.htm.* For additional instruction on submitting a comment, go to “What Should I Consider as I Prepare My Comments for the EPA?” of the SUPPLEMENTARY INFORMATION section of this document. *Docket:* All documents in the docket are listed in the *http://www.regulations.gov* index. Although listed in the index, some information is not publicly available, *e.g.* , CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in *http://www.regulations.gov* or in hard copy at the EPA Docket Center, EPA/DC, EPA West, Room B102, 1301 Constitution Avenue, NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. A reasonable fee may be charged for copying. The telephone number for the Public Reading Room is

(202)566-1744, and the telephone number for the Air Docket is

(202)566-1742. FOR FURTHER INFORMATION CONTACT: For questions regarding PM implementation issues, contact Ms. Barbara Driscoll, U.S. Environmental Protection Agency, Office of Air Quality Planning and Standards, Mail Code C504-02, Research Triangle Park, NC 27711, phone number

(919)541-1051 or by e-mail at: *driscoll.barbara@epa.gov.* Regarding NSR issues, contact Raj Rao, U.S. Environmental Protection Agency, Office of Air Quality Planning and Standards, Mail Code C339-03, Research Triangle Park, NC 27711, phone number

(919)541-5344 or by e-mail at *rao.raj@epa.gov.* SUPPLEMENTARY INFORMATION: How Should I Submit CBI to the Agency? Do not submit information that you consider to be CBI through *http://www.regulations.gov* or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. Send or deliver information identified as CBI only to the following address: Roberto Morales, U.S. EPA, Office of Air Quality Planning and Standards, Mail Code C404-02, Research Triangle Park, NC 27711, telephone

(919)541-0880, e-mail at *morales.roberto@epa.gov* , Attention Docket ID No. EPA-HQ-OAR-2005-0175. What Should I Consider as I Prepare My Comments for EPA? You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide any technical information and/or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at your estimate. 5. Provide specific examples to illustrate your concerns. 6. Offer alternatives. 7. Make sure to submit your comments by the comment period deadline identified. 8. To ensure proper receipt by EPA, identify the appropriate docket identification number in the subject line on the first page of your response. It would also be helpful if you provided the name, date, and **Federal Register** citation related to your comments. Table of Contents I. What Actions Related to the PM NAAQS Have Recently Been Proposed or Will Soon Be Proposed Which Relate to This Notice? A. National Ambient Air Quality Standards for Particulate Matter B. Revisions to Ambient Air Monitoring Regulations C. Treatment of Data Influenced by Exceptional Events II. What Is EPA'S Strategy for Addressing PM? A. The State Implementation Plan

(SIP)System B. National Rules III. How Should EPA Implement the Transition From the 1997 PM 2.5 NAAQS to Any New 2006 PM 2.5 NAAQS? A. What Is the Status of Areas Designated Under the 1997 PM 2.5 NAAQS? B. How Might EPA Implement the Transition from the 1997 PM 2.5 NAAQS to Any New 2006 PM 2.5 NAAQS? 1. PM 2.5 NAAQS Option 1 2. PM 2.5 NAAQS Option 2 IV. What Are the Potential Timelines for Implementation of Any New 2006 PM 2.5 NAAQS? A. How Would the Implementation Schedules of the 1997 PM 2.5 NAAQS and Any New 2006 PM 2.5 NAAQS Fit Together if the Revised PM 2.5 Standards Are More Stringent Than the Current Standards? B. What Is EPA's Preferred Schedule for Any New 2006 PM 2.5 Designation Process? C. What Would the Schedule Be for Attainment Demonstrations and SIP Submittals for Any New 2006 PM 2.5 Standards? D. What Are Attainment Dates for Any New 2006 PM 2.5 Standards? V. What Are the Potential Timelines for Implementation of Any New PM 10-2.5 NAAQS? A. What Is a Potential Schedule for Any New PM 10-2.5 Designation Process? B. What Is EPA's Preferred Schedule for Designations for any New PM 10-2.5 Standards? C. What Is EPA's Preferred Schedule for Attainment Demonstrations and SIP Submittals for Any New PM 10-2.5 Standards? D. What Is EPA's Preferred Schedule for Attaining Any New PM 10-2.5 Standards? VI. How Should EPA Implement the Transition From the PM 10 Standards to Any New PM 10-2.5 Standards? A. What Is EPA's Proposal for Revoking the PM 10 Standards? B. What Should the Timing Be for Revoking the 24-Hour PM 10 Standard for Those Areas Where the 24-Hour PM 10 Standard Is Retained? C. What Transition Issues Are Created by Revoking the 24-Hour PM 10 Standard in Areas Where It is Currently Proposed to be Retained and How Might They be Addressed? 1. Control Measures 2. Transportation Conformity 3. General Conformity 4. New Source Review Program VII. What Emissions Inventory Requirements Should Apply Under Any New PM 2.5 and PM 10-2.5 NAAQS? VIII. Statutory and Executive Order Reviews I. What Actions Related to the PM NAAQS Have Recently Been Proposed or Will Soon Be Proposed Which Relate to This Notice? This ANPR is intended to solicit input into key issues related to the transition to any new or revised NAAQS for PM. The EPA has proposed two rulemakings, the NAAQS for Particulate Matter; Proposed Rule (71 FR 2620, January 17, 2006) and the Revisions to Ambient Air Monitoring Regulations (71 FR 2710, January 17, 2006), and will be proposing another rulemaking, Treatment of Data Influenced by Exceptional Events (anticipated to be published by March 2006). These proposals are summarized here to provide background for the issues and questions raised in this document. The EPA is not taking comment on these actions here. Rather, if you have comments, you should submit them to the docket for the proposed rulemaking to which they are applicable, following the procedures described in each proposal. A. National Ambient Air Quality Standards for Particulate Matter On December 20, 2005, the Administrator signed a notice proposing revisions to the primary and secondary NAAQS for PM, which was published on January 17, 2006 (71 FR 2620). The proposal can be found at: *http://www.epa.gov/oar/particlepollution/actions.html.* For the primary standards for fine particles (particles generally less than or equal to 2.5 micrometers (μm) in diameter, or PM 2.5 ), EPA proposed to revise the level of the 24-hour PM 2.5 standard from 65 micrograms per cubic meter (μmg/m 3 ) to 35 μg/m 3 , providing increased protection against health effects associated with short-term exposure (including premature mortality and increased hospital admissions and emergency room visits) and to retain the level of the annual PM 2.5 standard at 15 μg/m 3 , continuing protection against health effects associated with long-term exposure (including premature mortality and development of chronic respiratory disease). The EPA is also taking comment on alternative NAAQS levels. Additionally, EPA proposed to revise the criteria for spatial averaging of monitors for purposes of the annual PM 2.5 standard. In addition, for the primary standards for coarse particles generally less than or equal to 10μm in diameter (PM 10 ), EPA proposed to revise the 24-hour PM 10 standard in part by establishing a new indicator for thoracic coarse particles (particles generally between 2.5 and 10μm in diameter, PM 10-2.5 ), qualified so as to include any ambient mix of PM 10-2.5 that is dominated by resuspended dust from high-density traffic on paved roads and PM generated by industrial sources and construction sources, and exclude any ambient mix of PM 10-2.5 that is dominated by rural windblown dust and soils and PM generated by agricultural and mining sources. The EPA also proposed that agricultural sources, mining sources and other similar sources of crustal material shall not be subject to control in meeting the proposed standard. The EPA proposed to set the new PM 10-2.5 standard at a level of 70 μg/m 3 , continuing to provide a generally equivalent level of protection against health effects associated with short-term exposure (including hospital admissions for cardiopulmonary diseases, increased respiratory symptoms and possibly premature mortality). In addition, EPA proposed to revoke the annual PM 10 standard everywhere, and the 24-hour PM 10 standard everywhere except in areas where there is at least one monitor that is located in an urbanized area 1 with a minimum population of 100,000 people and that violates the 24-hour PM 10 standard based on the most recent 3 years of data. This revocation of the PM 10 standards would become effective upon promulgation of the PM 10-2.5 NAAQS (expected to be December 2006). In the January 17, 2006, notice, the Agency provided a specific list of areas where the 24-hour PM 10 standard would not be revoked under the proposal based on the most recent 3 years of data. EPA proposed to revoke the 24-hour PM 10 standard in all other areas. In addition, EPA requested comment on whether the 24-hour PM 10 standard should be retained in additional areas that are either urbanized areas with populations less than 100,000 people or non-urbanized areas (i.e., populations less than 50,000) but where the majority of the ambient mix of PM 10-2.5 is generated by high density traffic on paved roads, industrial sources, and construction sources, and which have at least one monitor that violated the 24-hour PM 10 standard based on the most recent 3 years of data. 1 As defined by the U.S. Bureau of the Census, an urbanized area has “a minimum residential population of at least 50,000 people” and generally includes “core census block groups or blocks that have a population density of at least 1,000 people per square mile and surrounding census blocks that have an overall density of at least 500 people per square mile.” The Census Bureau notes that “under certain conditions, less densely settled territory may be part of each UA.” See *http://www.census.gov/geo/www/ua/ua_2k.html.* For the secondary PM standards, EPA proposed to revise the current standards by making them identical to the suite of proposed primary standards for fine and coarse particles. B. Revisions to Ambient Air Monitoring Regulations At the same time EPA proposed revisions to the PM NAAQS, EPA also proposed Revisions to the Ambient Air Monitoring Regulations (71 FR 2710, January 17, 2006) for criteria pollutants to support the proposed revisions to the NAAQS. The proposal can be found at: *http://www.epa.gov/oar /particlepollution/actions.html.* Included among the proposed PM-related changes are new provisions to be added to 40 CFR parts 53 and 58 which address approval of monitoring methods and PM 10-2.5 monitoring requirements. The added provisions in part 53 would address approval of PM 10-2.5 filter-based Federal Reference Method

(FRM)samplers and both filter-based and continuous Federal Equivalent Method

(FEM)monitors. Provisions in part 58 would provide the monitoring requirements for a PM 10-2.5 network, including the minimum number of monitors a State must deploy. In addition, the proposal adds provisions for the conditions under which a PM 10-2.5 monitor may be compared to the PM 10-2.5 NAAQS. The proposal also amends a number of existing provisions for PM 2.5 monitoring, including changing the criteria for FEM equivalency determinations for continuous PM 2.5 monitors. This should allow States to operate continuous monitors at more required monitoring sites, thereby providing more robust data for the PM 2.5 air quality program. C. Treatment of Data Influenced by Exceptional Events The EPA will soon propose a rule to govern the review and handling of air quality monitoring data influenced by exceptional events. Section 319 of the Clean Air Act

(CAA)defines an event as an exceptional event if the event affects air quality; is not reasonably controllable or preventable; is a natural event, or an event caused by human activity that is unlikely to recur at a particular location; and is determined by the Administrator to be an exceptional event. The EPA will be proposing procedures and criteria related to the identification, evaluation, interpretation and use of air quality monitoring data related to the NAAQS where State air quality agencies petition EPA to exclude, in whole or in part, air quality data that are directly affected by exceptional events. Section 319 of the CAA, as amended by section 6013 of the Safe Accountable Flexible Efficient-Transportation Equity Act (SAFE-TEA) of 2005, requires EPA to publish a proposed rule in the **Federal Register** , no later than March 1, 2006. II. What Is EPA's Strategy for Addressing PM? Our overall strategy for achieving the PM primary and secondary standards is based on the structure outlined in the CAA. The CAA outlines important roles for State and Tribal governments and for EPA in implementing NAAQS. States have primary responsibility for developing and implementing SIPs that contain local and in-State measures needed to achieve the air quality standards in each area. We assist States and Tribes by providing technical tools, assistance and guidance, including information on potential control measures. The EPA recently issued a Proposed rule to Implement the Fine Particle NAAQS (70 FR 65984) to support implementation of the 1997 PM 2.5 NAAQS. In addition, we set national emissions standards/limits for some sources, such as new motor vehicles, certain categories of major new sources, and existing stationary sources of toxic air pollutants, all of which may obtain reductions in PM. Where upwind sources (such as coal-fired power plants) significantly contribute to downwind problems in other States or tribal areas, we can issue Federal regulations to ensure that the upwind States address these contributing emissions (such as the Clean Air Interstate Rule), or we can put in place Federal regulations in situations where the upwind States fail to address these sources. A. The State Implementation Plan

(SIP)System A SIP is the compilation of regulations and programs that a State uses to carry out its responsibilities under the CAA, including the attainment, maintenance, and enforcement of the NAAQS. States use the SIP process to identify the emissions sources that contribute to the nonattainment problem in a particular area, and to select the emissions reductions measures most appropriate for that area, considering technical and economic feasibility, and a variety of local factors such as population exposure, enforceability, and economic impact. Under the CAA, SIPs must ensure that areas reach attainment as expeditiously as practicable. These plans take into consideration emissions reductions resulting from national programs (such as mobile source regulations, the acid rain program, or maximum achievable control technology

(MACT)standards for air toxics), as well as from State or local programs not directly mandated under the CAA. B. National Rules As described in a recent EPA report, *The Particle Pollution Report: Current Understanding of Air Quality and Emissions through 2003,* 2 State and Federal programs have made substantial progress in reducing ambient concentrations of PM 10 and PM 2.5. For example, PM 10 concentrations have decreased 31 percent nationally since 1988. Regionally, PM 10 concentrations decreased most in areas with historically higher concentrations—the Northwest (39 percent decline), the Southwest (33 percent decline), and southern California (35 percent decline). Direct emissions of PM 10 have decreased approximately 25 percent nationally since 1988. 2 Environmental Protection Agency (2004). The Particle Pollution Report: Current Understanding of Air Quality and Emissions through 2003. Office of Air Quality Planning and Standards; Emissions, Monitoring, and Analysis Division, Research Triangle Park, NC 27711; report no. EPA-454-R-04-002. December 2004. Programs aimed at reducing direct emissions of particles have played an important role in reducing PM 10 concentrations, particularly in western areas. Some examples of PM 10 controls include paving unpaved roads and using best management practices for agricultural sources of resuspended soil. Of the 87 areas that were designated nonattainment for PM 10 in the early 1990's, 64 now meet those standards. In cities that have not attained the PM 10 standards, the number of times the standard is exceeded is down significantly. National programs that affect regional emissions have contributed to lower sulfate concentrations and, consequently, to lower PM 2.5 concentrations, particularly in the Industrial Midwest and Southeast. National ozone-reduction programs designed to reduce emissions of volatile organic compounds

(VOCs)and nitrogen oxides (NO X ) also have helped reduce carbon and nitrate particles, both of which are components of PM 2.5. Power plant emissions of sulfur dioxide dropped 33% from 1990 to 2003, largely as a result of EPA's Acid Rain Program. Nationally, SO 2 emissions have declined 9 percent, NO X emissions have declined 9 percent, and VOC emissions have declined by 12 percent from 1999 to 2003. In eastern States affected by the Acid Rain Program, sulfates decreased 7 percent over the same period. Over the next 10 to 20 years, national and regional regulations will make major reductions in ambient PM 2.5 levels. The Clean Air Interstate Rule

(CAIR)and the NO X SIP Call will reduce SO 2 and NO X emissions from electric generating units and industrial boilers across the eastern half of the U.S., regulations to implement the current ambient air quality standards for PM 2.5 will likely result in direct PM 2.5 and PM 2.5 precursor controls in nonattainment areas, and new national mobile source regulations affecting off-highway diesel engines, highway gasoline and diesel vehicles, and other mobile sources will reduce emissions of NO X , direct PM 2.5, SO 2 , and VOCs. The EPA estimates that these Federal regulations for stationary and mobile sources will cut SO 2 emissions by 6 million tons annually in 2015 from 2001 levels. Emissions of NO X will be cut by 9 million tons annually in 2015 from 2001 levels. Emissions of VOCs will drop by 3 million tons, and direct PM 2.5 emissions will be cut by 200,000 tons in 2015, compared to 2001 levels. III. How Should EPA Implement the Transition From the 1997 PM 2.5 NAAQS to Any New 2006 PM 2.5 NAAQS? A. What Is the Status of Areas Designated Under the 1997 PM 2.5 NAAQS? On April 5, 2005, nonattainment designations became final for 39 nonattainment areas. These areas were designated based on air quality data from 2001-2003 and 2002-2004. Nationally, PM 2.5 concentrations have declined by 10 percent from 1999 to 2003. Generally, PM 2.5 concentrations have also declined the most in regions with the highest concentrations—the Southeast (20 percent decline), southern California (16 percent decline), and the Midwest (9 percent decline)—with the exception of the Northeast, where PM 2.5 concentrations increased by 1%. Direct emissions of PM 2.5 have decreased by 5 percent nationally over the past 5 years. Modeling done by EPA indicates that by 2010, 18 of the 39 areas currently not attaining the 1997 PM 2.5 standards should come into attainment of those standards just based on regulatory programs already in place, including CAIR, the Clean Diesel Rules, and other Federal measures. Four more PM 2.5 areas are projected to attain the standards by 2015 based on the implementation of these programs. All areas in the eastern U.S. will have lower PM 2.5 concentrations in 2015 relative to present-day conditions. In most cases, the predicted improvement in PM 2.5 ranges from 10 percent to 20 percent. B. How Might EPA Implement the Transition From the 1997 PM 2.5 NAAQS to Any New 2006 PM 2.5 NAAQS? The EPA has evaluated several options for the transition from the 1997 PM 2.5 standards to any new 2006 PM 2.5 standards, and is elaborating on two potential options. Should the Agency decide to revise the current PM 2.5 standards, then either of the following two options would continue the momentum and continuity of the existing implementation program as areas look to reduce ambient PM 2.5 concentrations to meet the current and revised PM 2.5 NAAQS. Any suggested alternatives to these approaches should demonstrate how it will continue the momentum and continuity of the implementation program. 1. PM 2.5 NAAQS Option 1 Option 1 recognizes that the only proposed change to the 1997 annual PM 2.5 standard is a change in the application of spatial averaging (71 FR 2620). Because the EPA believes that the proposed change, if adopted, would not be significant enough to require new designations under section 107(d), we are soliciting comment on whether it would be appropriate to view this revision as minor, thus not requiring a designation process. Even though section 107(d) calls for EPA to commence the designation process for “any new or revised NAAQS,” exceptions could be made for revisions to a NAAQS of a *de minimis* or insignificant nature such that they should not lead to the initiation of the designation process and consequent establishment of new SIP submission and attainment deadlines. Option 1 would be considered only if EPA finalized a revision to the annual PM 2.5 standard that was of such a minor nature as the proposed revision. It would not be available if EPA revised the standard more substantially. Following this path, EPA would propose not to revoke the 1997 annual PM 2.5 standard, and would propose to revoke the 1997 24-hour PM 2.5 standard 1 year after designations are finalized under any new 2006 PM 2.5 standard. With the exception of 2 areas in California (South Coast Air Quality District and San Joaquin Valley) all areas designated as nonattainment for PM 2.5 were only violating the annual standard. Under this path, new nonattainment designations would only be made for the areas which do not meet any new 2006 24-hour PM 2.5 standard. Therefore, areas which are designated nonattainment for the 1997 annual PM 2.5 standard would continue to develop and implement their SIPs based on a final implementation rule for the PM 2.5 NAAQS (proposed on November 1, 2005 at 70 FR 65984). Areas which are newly designated nonattainment under any new 24-hour PM 2.5 standard would submit a SIP by April 2013 following the proposed schedule in part IV.C below. This approach would maintain the momentum in the PM 2.5 SIP development and implementation program. It would also not require the development and implementation of an anti-backsliding rule to maintain progress in the program, as no areas are in nonattainment based solely on the 24-hour PM 2.5 standard. Therefore control measures would still be in place under the approved PM 2.5 SIPs. 2. PM 2.5 NAAQS Option 2 Option 2 varies from Option 1 in that EPA would revoke the 1997 annual and 24-hour PM 2.5 standards 1 year after designations under any new 2006 PM 2.5 standards. This approach is similar to that promulgated under the ozone program (69 FR 23951, April 30, 2004) for the revocation of the 1-hour ozone standard one year after designations under the 8-hour ozone standard. Following this path, EPA would develop and implement an “anti-backsliding” rule to ensure that SIP control measures developed and adopted under the 1997 PM 2.5 NAAQS remained in place until SIPs could be submitted and approved to meet any new 2006 PM 2.5 standards. In the anti-backsliding rule, EPA would address issues similar to those addressed in the anti-backsliding rule adopted as part of the transition from implementation of the 1-hour ozone standard to the 8-hour ozone standard including:

(1)Which planning and control requirements should remain in effect;

(2)effect of the revised standards on the New Source Review

(NSR)program; and

(3)how the transition would affect general and transportation conformity programs. In addressing some of these issues, EPA is inclined to follow the precedent set by the ozone program which required areas in nonattainment with both the 1-hour and 8-hour ozone NAAQS to maintain mandatory control measures already in place, and allowed such areas to revise or remove discretionary control measures following a section 110(l) demonstration. In addition, such areas would implement transportation conformity and NSR based on their designations for the revised standard only, for the reasons explained in the ozone anti-backsliding rule (69 FR 23954, April 30, 2004). The EPA invites comment on these two options, and solicits comments on any additional options which would ensure a smooth transition and continued improvement in air quality. IV. What Are the Potential Timelines for Implementation of Any New 2006 PM 2.5 NAAQS? A. How Would the Implementation Schedules of the 1997 PM 2.5 NAAQS and Any New 2006 PM 2.5 NAAQS Fit Together if the Revised PM 2.5 Standards Are More Stringent Than the Current Standards? Section 109(d)(1) of the CAA requires a thorough review of the NAAQS, and revisions if appropriate, at 5-year intervals. Current requirements of the CAA thus anticipate an overlap in review and implementation of standards. The EPA believes that for planning purposes, when EPA revises a standard as it has proposed to do, it is beneficial for States to understand control strategies that may be useful in attaining any new 2006 PM 2.5 standards when developing control strategies for the 1997 PM 2.5 standards. B. What Is EPA's Preferred Schedule for the Any New 2006 PM 2.5 Designation Process? Under the terms of the consent decree governing the review of the 1997 PM NAAQS, EPA agreed that no later than September 27, 2006, it would sign for publication a notice of final rulemaking concerning its review of the PM NAAQS. The EPA expects that any new 2006 PM 2.5 standards would be published in the **Federal Register** within 4 weeks, and become effective 60 days later probably in December 2006. Timeframes below are outlined based on this assumption. Section 107(d)(1) lays out a schedule allowing States up to 1 year in which to make recommendations to EPA for areas that might be designated as nonattainment for any new PM 2.5 standards. State designation recommendations would then be due by December 2007. Tribes would also be encouraged, but not required, to submit designation recommendations to EPA for their reservations or other areas under their jurisdiction by December 2007. These recommendations would be based on 3 years of the most recent monitoring data ( *e.g.* , 2004-2006). The EPA(s evaluation of the existing PM 2.5 monitoring network indicates that it is adequate for designations under both the proposed revised annual and proposed revised 24-hour standards. Depending on which revocation process is selected for the 1997 PM 2.5 NAAQS, designations may be for the revised 24-hour standard alone or both the annual and 24-hour standards. Following submittal of designation recommendations by the States, EPA would evaluate the recommendations and make possible modifications. Consistent with section 107, States would be notified of these changes, and would be allowed to make additional comments on the proposed designations. The EPA would issue final PM 2.5 designations under any new PM 2.5 NAAQS no later than December 2009. These designations would be effective by April 2010. The CAA provides EPA with up to 3 years to designate nonattainment areas following promulgation of a new or revised NAAQS. The EPA anticipates that this full time period may be necessary for a variety of reasons as it has been in the past, including evaluating more recent data in order to determine appropriate designation boundaries. This timeline would allow States to look at 2006-2008 monitoring data and update their recommendations to EPA if they choose to do so based on the more recent data. In addition, as was done for the 1997 PM 2.5 NAAQS designations, we would anticipate allowing a further update based on 2007-2009 monitoring data, and make designations effective in April 2010. Table 1 at the end of part IV(D) provides a timeline showing the dates that would result from such a designation process. The EPA would appreciate comments on this timeline and other potential approaches. C. What Would the Schedule Be for Attainment Demonstrations and SIP Submittals for Any New 2006 PM 2.5 Standards? Part D of title I of the CAA sets forth the requirements for SIPs needed to attain the NAAQS. Part D includes a general subpart 1 which applies to all NAAQS for which a specific subpart does not exist. These provisions apply to the PM 2.5 standards and would apply to any revised PM 2.5 standards. The EPA has currently proposed implementation rules for PM 2.5 (70 FR 65984) which, when finalized, will govern any revised standards. Section 172(b) of the CAA requires that at the time the Agency promulgates nonattainment area designations, EPA must also establish a schedule for States to submit SIPs meeting the applicable requirements of section 172(c) and section 110(a)(2) of the CAA. Section 172(b) requires that such schedule allow a State to submit its attainment demonstration and SIP revision within no more than 3 years of nonattainment designation. Following the above timeline (outlined in IV.B), if nonattainment area designations become effective in April 2010, and EPA allows the maximum time for SIP submissions, then attainment demonstrations and SIP revisions would be due by April 2013. D. What Are Attainment Dates for Any New 2006 PM 2.5 Standards? Section 172(a)(2)(A) states that the attainment date for a nonattainment area must be “as expeditiously as practicable, but no later than 5 years from the date of designation for the area.” If any new 2006 PM 2.5 designations are made in December 2009 and have an effective date of April 2010, the initial attainment date for any new PM 2.5 standard would be no later than April 2015. As an aside, this attainment date would correspond with the latest date an area designated in April 2005 could come into attainment with the 1997 PM 2.5 NAAQS. For an area with a maximum 5-year attainment date, EPA would determine whether it had attained the standard by evaluating air quality data from the three previous calendar years (2012-2014). Section 172 also states that if EPA deems it appropriate, the Agency may extend the attainment date for an area for a period not greater than 10 years from the date of designation as nonattainment, taking into account the severity of the nonattainment problem in the area, and the availability and feasibility of pollution control measures. For any area that is granted the full 5-year attainment date extension, the attainment date would be as expeditiously as practicable, but no later than April 2020. For such areas, EPA would determine whether the area attained the standard by evaluating air quality data from 2017, 2018, and 2019. Table 1 is an overview of the proposed timeline for implementing any new 2006 PM 2.5 standards. Table 1.—Proposed Timeline for Any New 2006 PM 2.5 Standards Effective date of standard December 2006 Monitoring data used for State recommendations 2005-2007. State recommendations to EPA December 2007. Final designations signature December 2009. Effective date of designations April 2010. SIPs due April 2013. Attainment date Up to April 2015 (based on 2012-2014 data). Attainment date with a 5-year extension Up to April 2020 (based on 2017-2019 data). The EPA is soliciting comments on which relevant factors should influence EPA's decision on any potential timeline. V. What Are the Potential Timelines for Implementation of Any New PM 10-2.5 NAAQS? A. What Is a Potential Schedule for Any New PM 10-2.5 Designation Process? Section 107(d)(1)(B) gives the Agency the authority to promulgate designations for all areas as expeditiously as practicable, but no later than 3 years from the date of promulgation of the new or revised NAAQS. Currently, a PM 10-2.5 monitoring network does not exist. The EPA's proposed monitoring regulations for PM 10-2.5 (71 FR 2710) call for monitors to be deployed by January 2009. If this schedule is adopted, the first period when 3 years of data would be available for State designation recommendations would be mid-2012 based on air quality data for 2009-2011. As noted above, following the statutory timeline, designations for PM 10-2.5 would be required to occur no later than late 2009. Three years of PM 10-2.5 monitoring data will not be available at that time. For EPA to meet its statutory obligation, EPA would need to designate all areas as unclassifiable under section 107(d)(1)(A)(iii), on the basis that no information is available to determine whether an area is meeting any new NAAQS for PM 10-2.5 . From a historical perspective this was the situation in 1997 when we established the PM 2.5 NAAQS. Subsequent, to the establishment of the PM 2.5 NAAQS in 1997, Congress passed legislation which modified the CAA for the purposes of PM 2.5 designations. EPA is potentially confronting this issue again with respect to any new PM 10-2.5 NAAQS. As a policy, EPA does not think that designating all areas of the country as unclassifiable provides useful information to the public about their area meeting new air quality standards. EPA would prefer to not make designations until three years of monitoring data is available. EPA is soliciting comments on the best way to address this issue. B. What Is EPA's Preferred Schedule for Designations for Any New PM 10-2.5 Standards? The first available 3 years of data from a monitoring network for PM 10-2.5 will be 2009-2011. If EPA had not previously designated areas unclassifiable, EPA could then request recommendations from States for areas that might be designated nonattainment for PM 10-2.5 by July 2012. This is approximately 6 months after a full 3 years of data would be available for some areas. EPA believes this is adequate time for evaluating and quality assuring data to make recommendations on designations. On the other hand, States have until May 1 to certify that their monitoring data is correct, and may need additional time for designation recommendations. Another option would be to allow the States until October 2012 to make recommendations. The EPA would like to take comment on this option. Following submittal of designation recommendations by the States, EPA will evaluate the recommendations and make modifications by December 2012. States will be notified of these changes, and given another opportunity to comment on the proposed modifications to designations. The EPA would then issue final modified PM 10-2.5 designations by May 2013 which would be effective approximately July 2013. If EPA had previously designated areas unclassifiable, then, once EPA had sufficient monitoring data available, EPA would move forward in accordance with the provisions of section 107(d)(3)(A) to notify States that it believed designations for areas should be revised. States would then have the opportunity to respond in accordance with section 107(d)(3)(B), and EPA would take action regarding any revisions of the designations in accordance with section 107(d)(3)(C). Since classifications under Title I are done at the same time as designations, EPA is considering the role a classification system could play in facilitating the implementation of any new PM 2.5 NAAQS. The EPA prefers not to develop a classification system to use in determining the amount of time permitted for attainment, for reasons similar to those outlined in the Proposed Rule to Implement the Fine Particle National Ambient Air Quality Standards; Proposed Rule (70 FR page 66000, November 1, 2005). Developing a classification system is only an option, not a requirement under section 172(a)(1), and for the reasons noted EPA does not believe it would be preferable to implement a classification scheme. The EPA would like comments on this potential designation timeline, and on its intentions to not develop a classification system. C. What Is EPA's Preferred Schedule for Attainment Demonstrations and SIP Submittals for Any New PM 10-2.5 Standards? Section 172(b) of the CAA requires EPA to establish a schedule for a State to submit its attainment demonstration and SIP revision within 3 years of nonattainment designation. Following the schedule outlined in part V(B) above, if nonattainment designations for any new PM 10-2.5 standards were effective in July 2013, then attainment demonstrations and SIP revisions would be due by July 2016. The EPA would like comments on this proposed timeline. D. What Is EPA's Preferred Schedule for Attaining Any New PM 10-2.5 Standards? Section 172(a)(2)(A) states that the attainment date for a nonattainment area must be “as expeditiously as practicable, but no later than 5 years from the date of designation for the area.” If new PM 10-2.5 designations are made in May 2013 and are effective in July 2013, the initial attainment date for PM 10-2.5 would be as expeditiously as practicable but no later than July 2018. For an area with an attainment date of July 2018, EPA would determine whether it had attained the PM 10-2.5 standards by evaluating air quality data from the 3 previous calendar years ( *i.e.* , 2015, 2016 and 2017). Section 172 also states that if EPA deems it appropriate, the Agency may extend the attainment date for an area for a period not greater than 10 years from the date of designation, taking into account the severity of the nonattainment problem in the area, and the availability and feasibility of pollution control measures. For any area that is granted the full 5-year attainment date extension, the attainment date would be no later than July 2023. For such areas, EPA would determine whether they have attained the standard by evaluating air quality data from 2020, 2021 and 2022. Table 2 is an overview of this proposed timeline for designation, SIP submittal and attainment dates under this proposed schedule. Table 2.—Proposed Timeline for a Possible 2006 PM 10-2.5 Standards Effective date of standard December 2006 Monitoring data used for State recommendations 2009-2011. State recommendations to EPA July 2012. Final designations signature May 2013. Effective date of designations July 2013. SIPs due July 2016. Attainment date Up to July 2018 (based on 2015-2017 data). Attainment date with extension Up to July 2023 (based on 2020-2022 data). The EPA requests comment on this potential timeline for attaining any new PM 10-2.5 standards. VI. How Should EPA Implement the Transition From the PM 10 Standards to Any New PM 10-2.5 Standards? A. What Is EPA's Proposal for Revoking the PM 10 Standards? Before areas are designated under any new PM 10-2.5 standards, we intend to address how to transition from implementation of the PM 10 standards to any new PM 10-2.5 standards. As part of the NAAQS proposal (71 FR 2620), EPA proposed to revoke the annual PM 10 standard everywhere, and the 24-hour PM 10 standard everywhere except in areas where there is at least one monitor that is located in an urbanized area with a minimum population of 100,000 people and that violates the 24-hour PM 10 standard based on the most recent 3 years of data. This revocation would be effective upon promulgation of the PM NAAQS in December 2006. The EPA also provided a list of places where the 24-hour PM 10 standard would not be revoked under the proposal. In addition, EPA requested comment on whether the 24-hour PM 10 standard should be retained in areas that are either urbanized areas with populations less than 100,000 people or non-urbanized areas ( *i.e.* , population less than 50,000) but where the majority of the ambient mix of PM 10-2.5 is generated by high density traffic on paved roads, industrial sources, and construction sources, and which have at least one monitor that violated the 24-hour PM 10 standard. Comments on this revocation plan should be submitted under that notice (71 FR 2620). This raises a number of issues for those areas where the 24-hour PM 10 standard would still apply including: When and how should the 24-hour PM 10 standard be revoked for these areas; should anti-backsliding provisions apply; how to address NSR and maintenance issues; and other implementation issues. Our principal objective for the transition is to ensure that air quality will not degrade in areas where the potential new PM 10-2.5 NAAQS would apply, and that areas continue to make progress toward attainment of the PM standards. Subject to requirements under the CAA for revising SIPs, EPA expects States would take the opportunity to revise their SIPs to reflect the revocation of the PM 10 standards. B. What Should the Timing Be for Revoking the 24-Hour PM 10 Standard for Those Areas Where the 24-Hour PM 10 Standard Is Retained? The EPA contemplates that the 24-hour PM 10 standard would be revoked one year after attainment/nonattainment designations are effective for a 24-hour PM 10-2.5 standard. Because attainment/nonattainment designations would not occur until July 2013, it is reasonable to expect that some areas where the 24-hour PM 10 standard has not been revoked would come into attainment with the PM 10 standard prior to July 2013. We invite comment on how these areas should be treated. C. What Transition Issues Are Created by Revoking the 24-Hour PM 10 Standard in Areas Where It Is Currently Proposed To Be Retained and How Might They Be Addressed? 1. Control Measures EPA wants to ensure that air quality is not degraded if we move from one version of the NAAQS to another. What protections should remain in place to ensure that air quality will not degrade once the 24-hour PM 10 standard is revoked, and that progress will continue as areas transition from implementing the 24-hour PM 10 standard to implementing the 24-hour PM 10-2.5 standard? *a. What requirements based on an area's classification for the PM* 10 *standard should continue to apply?* The EPA believes an approach similar to what was done under the ozone transition from the 1-hour to the 8-hour standard (69 FR 23951 page 23969) would be appropriate here in that control measures which remain in place were determined by the area's classification. Such an approach would mean that moderate PM 10 nonattainment areas should continue to require reasonably available control measures

(RACM)(as described in section 189(a)(1)(C) of the CAA). Serious PM 10 nonattainment areas should also continue to require best available control measures

(BACM)(section 189(b)(1)(B) of the CAA). All nonattainment areas should have an EPA-approved part D SIP in place, and continue to implement the nonattainment requirements and control measures identified in the SIP. Any effort to change SIP-approved measures would be subject to a section 110(l) demonstration of no interference with applicable requirements. The EPA also believes that those areas where the 24-hour PM 10 standard is being violated and has not been revoked should continue to implement the requirements of the CAA until nonattainment and attainment designations for PM 10-2.5 are completed. However, this could represent a significant period of time (from 2006-2013). Consequently, EPA is interested in alternative views regarding the appropriate implementation pathway for the PM 10 standard in these areas. *b. How should EPA address maintenance?* Those PM 10 nonattainment areas where the 24-hour PM 10 standard has not been revoked which come into attainment with the 24-hour PM 10 NAAQS prior to designations under the 24-hour PM 10-2.5 standard, may request to be redesignated as attainment for PM 10 under section 107(d). As such they would need to submit a maintenance plan under section 175A. Maintenance areas do not have any outstanding obligation to adopt further mandatory control obligations. We would anticipate an approach to maintenance requirements similar to what was provided in the ozone rule where maintenance areas retain the discretion to modify any discretionary control measures upon a demonstration under section 110(l) (69 FR 23951 page 23955). The EPA requests comments on how to address maintenance areas. 2. Transportation Conformity Transportation conformity is required under section 176(c) of the CAA (42 U.S.C. 7506(c)) to ensure that federally supported highway and transit project activities are consistent with (conform to) the purpose of a SIP. Conformity to the purpose of a SIP means that transportation activities will not cause new air quality violations, worsen existing violations, or delay timely attainment of the NAAQS. Transportation conformity applies in nonattainment areas and maintenance areas. The EPA's transportation conformity rule, 40 CFR part 93, establishes the criteria and procedures for determining whether transportation activities conform to the State air quality plan. It also establishes criteria and procedures for determining whether transportation activities conform in areas where no SIP containing motor vehicle emissions budgets yet exists. Transportation conformity rulemakings, as well as other relevant conformity materials such as guidance documents, policy memoranda, the complete text of the conformity rule, and conformity research can be found at EPA's transportation conformity Web site, at *http://www.epa.gov/otaq/transp.htm* (once at the site, click on “Transportation Conformity.” Until areas are designated nonattainment, transportation conformity will not apply for any new PM 10-2.5 standard. Based on the timeline outlined above, designations for any new PM 10-2.5 NAAQS could be effective in July 2013, and for all nonattainment areas transportation conformity would then apply 1 year later. Prior to the designation date, EPA would propose to update the transportation conformity rule to address any new PM 10-2.5 standard. The EPA will solicit public comment on these and other issues associated with determining transportation conformity in any new PM 10-2.5 nonattainment areas when it proposes to revise the conformity rule to address the new standard. Once we revoke the PM 10 standard and the associated designations, transportation conformity will no longer apply under the terms of the statute for that standard. 3. General Conformity Section 176(c) of the CAA requires that before a Federal entity takes an action, it must make a determination that the proposed action will not interfere with the SIP or the State's ability to attain and maintain the NAAQS. In November 1993, EPA promulgated two sets of regulations to implement section 176(c). One set, known as the general conformity regulations, deals with all other Federal activities besides funding of highway and mass transit projects. These activities include funding and approval of airport projects, expansion of military bases, and permitting of projects to deepen waterways. Federal agencies take thousands of actions every day and requiring determinations on every action would not be possible. Therefore, EPA established a number of exemptions to the rule requirements including a de minimis emission level generally based upon the size of a major stationary source in the nonattainment or maintenance area. Following are a series of questions related to implementation of general conformity on which EPA is soliciting input: • What de minimis levels should EPA establish for direct and precursor emissions for any new PM 10-2.5 standards? The EPA currently does not have speciated monitoring data for PM 10-2.5 . Consequently, we do not know if the mass of PM 10-2.5 contains a significant amount of particulate matter formed by atmospheric chemical reactions. • In transitioning to a new standard, how should EPA treat previous conformity evaluations and determinations based on the PM 10 standard? • Are there any categories of actions that should be exempt from the conformity requirements for any new PM 10-2.5 standards? If so, how could such exemptions be devised? 4. New Source Review Program The NSR program is a preconstruction permitting program that applies when a new source is constructed or an existing one is modified. The major NSR program applies to major stationary sources and is comprised of the Prevention of Significant Deterioration

(PSD)program that applies in attainment areas and a nonattainment NSR program that applies to pollutants for which an area is designated nonattainment. There are many major NSR program implementation issues that EPA will address for a new PM 10-2.5 NAAQS, including revocation of the existing PM 10 NAAQS. In this ANPR, EPA is highlighting some of the key issues and providing EPA's preliminary thinking on approaches for addressing them. We recognize that there may be other implementation issues not identified here, and we invite you to identify them. When submitting comments, please support your comments with adequate data and/or practical scenarios or illustrations. a. Does PM 10 continue to be a regulated NSR pollutant for PSD in areas where the 24-hour PM 10 NAAQS would be revoked? The PSD program applies when a major stationary source of any “regulated NSR pollutant”, that is located in an area designated as attainment or unclassifiable for any criteria pollutant, is constructed or undergoes a major modification (40 CFR 52.21(a)(2); 40 CFR 51.166(a)(7)). EPA defines a “regulated NSR pollutant” to include

(1)any pollutant for which a NAAQS has been promulgated (otherwise known as a “criteria” pollutant);

(2)any pollutant subject to a New Source Performance Standard promulgated under section 111 of the CAA; and

(3)any pollutant that is otherwise regulated under the Act, except for hazardous air pollutants regulated under section 112 of the Act 3 (40 CFR 52.21(b)(50); 40 CFR 51.166(b)(49)). Thus, in addition to applying to criteria pollutants for which EPA has promulgated a NAAQS, the PSD program also applies to any non-criteria pollutant that is covered by the additional prongs of the definition of a “regulated NSR pollutant” described above. However, not all of the PSD program requirements outlined below are applicable to non-criteria pollutants that are subject to the PSD program. 3 This definition also covers any pollutant that is subject to any standard promulgated under or established by Title VI of the Act, but this is not relevant to particulate matter. The PSD requirements include but are not limited to: • Installation of Best Available Control Technology (BACT), • Air quality monitoring and modeling analyses to ensure that a project's emissions will not cause or contribute to a violation of any NAAQS or maximum allowable pollutant increase (PSD increment), • Notification of Federal Land Manager when a proposed source or modification may affect nearby Class I areas, and • Public comment on the permit. For any criteria pollutant subject to PSD, all PSD requirements including the PSD increments analyses apply. However, since there are no NAAQS for non-criteria pollutants, only some requirements, including BACT, apply to these pollutants (See 42 U.S.C. 7475(a)(4); 40 CFR 52.21(j)); 40 CFR 52.166(j)). The proposed revocation of the 24-hour PM 10 NAAQS in certain areas raises issues about whether existing PSD regulations would continue to apply to PM 10 in any respect after the revocation of the NAAQS in these areas. The extent to which all or some of the PSD requirements apply depends on whether PM 10 continues to be a regulated NSR pollutant in these areas, either as a criteria or a non-criteria pollutant, under EPA's regulations and the CAA. We seek comment on the following options to address these issues: *Option 1.* Since the 24-hour PM 10 standard would remain in effect at least in some areas, we could conclude that PM 10 continues to be a regulated NSR pollutant for the PSD program. Thus, even in those areas in which the 24-hour PM 10 NAAQS is revoked (24-hour revoked areas), PM 10 would be regarded as a regulated NSR pollutant only by virtue of being otherwise subject to regulation under the CAA (40 CFR 52.21(b)(50)(iv)) because a 24-hour PM 10 NAAQS continues to apply in other areas. Under this approach, PSD for PM 10 would continue to apply in all areas. However, as stated earlier, only a few PSD requirements, including BACT, would apply in 24-hour revoked areas since PM 10 would be regarded as a non-criteria pollutant in those areas. In those areas where the 24-hour PM 10 NAAQS is not revoked, all PSD program elements would continue to apply for PM 10 because it remains a criteria pollutant in these areas. *Option 2.* Alternatively, we could interpret all prongs of the “regulated NSR pollutant” definition to be area-specific. Thus, in 24-hour revoked areas, PM 10 would no longer be a criteria pollutant, and none of the other prongs of the definition of “regulated NSR pollutant” would apply to PM 10 in these areas. Therefore, none of the PSD requirements would apply to PM 10 in such areas. We request comment on whether there is any other basis for retaining PM 10 as a regulated NSR pollutant, even if it is no longer a criteria pollutant. b. Does the CAA require continued obligation for some form of PM increment? Section 163 of the CAA states that each SIP should contain measures assuring that maximum allowable increases over baseline concentration (increments) for PM shall not be exceeded in attainment areas. Section 163 contains specific numerical increments (expressed as μg/m 3 ) for PM, which EPA initially implemented using the total suspended particulate indicator. After EPA transitioned to PM 10 as the indicator for PM in 1987, the Agency substituted PM 10 increments for the PM increments in section 163 based on the authority of section 166(f) of the Act (58 FR 31622, June 3, 1993). Section 166(f), which was enacted in the 1990 amendments to the CAA, authorized EPA to substitute PM 10 increments “of equal stringency in effect” as the section 163 PM increments, but also required that the PM increments remain in effect until the new PM 10 increments were promulgated. For pollutants other than PM and sulfur dioxide, 4 Section 166(a) of the CAA directs the Administrator to conduct a study and promulgate regulations, which may include increments, to prevent significant deterioration of air quality. EPA promulgated increments for nitrogen oxides under this authority (70 FR 59582, Oct. 12, 2005, and 53 FR 40656, Oct. 17, 1988). Section 166(a) also directs the Administrator to promulgate pollutant-specific PSD regulations for pollutants for which NAAQS are promulgated after 1977. The proposed revocation of the PM 10 NAAQS raises two issues with respect to EPA's PSD regulations for PM. The first is whether EPA has a continuing obligation under section 163 or 166(f) of the CAA to implement some form of a PM increment. The second question concerns the methodology that EPA should use to establish PSD regulations for PM 2.5 and PM 10-2.5 to replace the increments for PM 10 . We seek comment on the following options to address these issues: 4 Section 163 also contains increments for sulfur dioxide. 42 U.S.C. 7473. *Option 1.* Once the PM 10 NAAQS is revoked, one approach would be to conclude that section 166(f), requiring equivalent PM 10 increments, is no longer applicable in the absence of a PM 10 NAAQS. Furthermore, since section 166(f) effectively superseded section 163, we would not construe the latter provision to require that EPA maintain a PM increment after the revocation of the PM 10 NAAQS. Thus, we could conclude that neither the section 163 increment requirement for PM nor the section 166(f) increment requirement for PM 10 remains effective after revocation of the PM 10 standard. Accordingly, we would need to develop new increments 5 for PM 2.5 and PM 10-2.5 . In the interest of simplicity and ease of implementation, we could develop new increments for PM 2.5 and PM 10-2.5 pursuant to section 166 of the CAA. This approach would include among other things, establishing new baseline dates and trigger dates for PM 2.5 and PM 10-2.5 on the theory that these are separate, new pollutants, at least for NSR purposes. Otherwise the alternative approach, described below, of trying to continue the implementation of the section 163 increments for PM (using the new indicators) would involve retroactively estimating PM 2.5 and PM 10-2.5 emissions in 1978 (based on the original PSD requirements for PM), and would be extremely difficult in most cases. 5 Alternatively, if we promulgate such regulations under section 166, EPA could develop equivalent PSD regulations for PM 2.5 and PM 10-2.5 that include other measures instead of increments. *Option 2.* Another approach would be to interpret sections 163 and 166(f) to require some form of PM increments on a continuous basis. However, we would recognize the Congressional intent reflected in section 166(f) that EPA update the PM increments as it modifies the NAAQS for PM. Under this option, we could substitute PM 10 increments with two new increments (PM 2.5 and PM 10-2.5 ) “of equal stringency in effect” based on section 166(f) of the CAA by using the methodology reflected in our 1993 PM 10 increments regulation. This approach would provide continuity with the existing PM 10 increments system and would most likely involve retaining the existing baseline areas and dates. c. How should permitting authorities implement the PM 2.5 program upon revocation of the PM 10 NAAQS? When EPA first promulgated the NAAQS for PM 2.5 in 1997, we encountered a number of technical difficulties with implementing the PSD program for PM 2.5 upon the effective date of the NAAQS for PM 2.5 . To address these difficulties, EPA established a policy that enabled permitting authorities to use the implementation of the PSD program for PM 10 as a surrogate for a PM 2.5 PSD program until the necessary tools were in place to measure PM 2.5 and implement PSD permitting programs for PM 2.5 . See Memorandum from John S. Seitz, Director, Office of Air Quality Planning and Standards, to Regional Air Directors, Interim Implementation of New Source Review for PM 2.5 (October 23, 1997) at: *http://www.epa.gov/Region7/programs/artd/air/nsr/nsrmemos/pm25.pdf* . The EPA extended this PM 10 surrogate policy to implementation of the NSR program in nonattainment areas, once PM 2.5 nonattainment designations became effective on April 5, 2005. See Memorandum from Stephen D. Page, Director, Office of Air Quality Planning and Standards, to Regional Air Directors, Interim Implementation of New Source Review for PM 2.5 in Nonattainment Areas (April 5, 2005) at: *http://www.epa.gov/Region7/programs/artd/air/nsr/nsrmemos/pm25guid.pdf* ). These policies remain in effect today pending the promulgation of EPA's PM 2.5 implementation rules for NSR and approval of SIPs containing PSD programs for PM 2.5 . Because of the proposed revocation of the PM 10 NAAQS, there may not be a PM 10 PSD program remaining in 24-hour revoked areas to rely upon as a surrogate for implementation of a PSD program for PM 2.5 . This raises the issue of how States may continue to satisfy the PSD program requirements for PM 2.5 in the interim period. We seek comment on the following options to address this issue: *Option 1.* One approach that we might use would be to continue using an analysis of PM 10 air quality as a surrogate for the air quality analysis under the PM 2.5 program with a change. Permitting authorities may continue to analyze PM 10 emissions and concentrations, but they would have to compare these concentrations with the PM 2.5 NAAQS to show that the predicted PM 10 concentrations would not exceed the PM 2.5 NAAQS. This approach would overpredict actual PM 2.5 concentrations in most cases, but it would represent a conservative screening mechanism that could demonstrate that a new source or major modification would not cause or contribute to a violation of the PM 2.5 NAAQS. We believe that this would be a suitable interim approach until all the necessary implementation elements for carrying out an independent PM 2.5 program have been finalized. *Option 2.* An alternative approach would be to continue to apply the existing surrogate policy for implementing the PM 2.5 program, even after the PM 10 standard has been revoked. In other words, the impacts of the PM 10 emissions would continue to be compared with the former PM 10 NAAQS. Again this would serve as an interim policy, until all the PM 2.5 implementation elements for carrying out an independent PM 2.5 program have been finalized. d. How should EPA implement the PSD program for PM 10-2.5 upon the effective date of the promulgation of the PM 10-2.5 NAAQS? The EPA has interpreted various provisions in title I, part C of the CAA to require immediate implementation of the PSD program in all areas for each pollutant upon the effective date of a NAAQS for that pollutant. See Seitz Memorandum (October 27, 1997). As noted earlier, EPA's PSD regulations define a regulated NSR pollutant to include, among other things, any pollutant for which a NAAQS is promulgated (40 CFR 51.166(b)(49); 52.21(b)(50)). In contrast, under part D of the CAA, the nonattainment NSR program is not required to be implemented for a particular pollutant subject to a NAAQS until nonattainment areas are designated pursuant to section 107 of the CAA, and are in effect for that pollutant. As described in detail in the earlier PM 2.5 implementation discussion, EPA established a policy that enabled permitting authorities to use the implementation of a PSD program for PM 10 as a surrogate for implementation of the PSD program for PM 2.5 until the necessary tools were in place to measure PM 2.5 and implement permitting programs for PM 2.5 . The EPA anticipates that it will encounter similar difficulties with implementing a PSD program for PM 10-2.5 upon the effective date of a NAAQS for PM 10-2.5 . However, as discussed above in the context of PM 2.5 , the revocation of the PM 10 NAAQS may leave EPA without a PM 10 program to rely upon as a surrogate for implementation of a PSD program for PM 10-2.5 . Thus, we are exploring other approaches that EPA might use to fulfill the PSD requirements in title I, part C of the CAA upon the effective date of a NAAQS for PM 10-2.5 . We request comment on the following approaches and welcome suggestions for additional approaches we might use for a temporary, interim period to prevent significant deterioration of air quality from new and modified sources of PM 10-2.5 : *Option 1.* One approach that we might use would be to continue using an analysis of PM 10 air quality as a surrogate for the air quality analysis under a PM 10-2.5 program. Permitting authorities may continue to analyze PM 10 emissions and concentrations and compare that with the PM 10-2.5 NAAQS to show that the predicted PM 10 concentrations would not exceed the PM 10-2.5 NAAQS. This approach would overpredict actual PM 10-2.5 concentrations in most cases, but it would represent a conservative screening mechanism that could demonstrate that a new source or major modification would not cause or contribute to a violation of the PM 10-2.5 NAAQS. *Option 2.* Another approach might be to compare the PM 10 analysis to the former PM 10 NAAQS and thus use compliance with the former PM 10 NAAQS as a surrogate for compliance with the new PM 10-2.5 NAAQS for a temporary period. This latter approach might be used independently or as a secondary step in a tiered analysis if the first approach discussed above was found to be overly conservative. *Option 3.* Another approach might be to use compliance with BACT for PM 10-2.5 as a surrogate for the PM 10-2.5 NAAQS compliance demonstration. In this approach, we might make a determination for an interim period that the first major sources that trigger PSD requirements for PM 10-2.5 are not likely to cause or contribute to noncompliance with the PM 10-2.5 NAAQS if they meet BACT for PM 10-2.5 . Thus, we might consider compliance with BACT to represent a surrogate for the PM 10-2.5 NAAQS compliance demonstration for a limited period until we have the tools in place to assess PM 10-2.5 concentrations. e. How should ambient PM 10-2.5 dominated by rural windblown dust and soils, and generated by agricultural and mining sources be treated in the NSR program for the proposed PM 10-2.5 standard? The proposed PM 10-2.5 indicator is qualified so as to include any ambient mix of PM 10-2.5 that is dominated by resuspended dust from high density traffic on paved roads and PM generated by industrial sources and construction sources, and excludes any ambient mix of PM 10-2.5 that is dominated by rural windblown dust and soils and PM generated by agricultural and mining sources. This suggests that the NSR applicability test would exclude these sources from consideration. We request comment on how we would implement the NSR program if we promulgate a NAAQS with these characteristics. VII. What Emission Inventory Requirements Should Apply Under Any New PM 2.5 and PM 10-2.5 NAAQS? Emission inventories are critical for the efforts of State, local, tribal and Federal agencies to attain and maintain the NAAQS that EPA has established for criteria pollutants including PM 2.5 and any new PM 10-2.5 standards. Pursuant to its authority under section 110 of Title I of the CAA, EPA has long required States to submit emission inventories containing information regarding the emissions of criteria pollutants and their precursors. The EPA codified these requirements in 40 CFR part 51, subpart Q in 1979 and amended them in 1987. In June 2002, EPA promulgated the Consolidated Emissions Reporting Rule (CERR)(67 FR 39602, June 10, 2002). The CERR consolidates the various emissions reporting requirements into one place in the CFR. In January 2006, EPA proposed the Air Emissions Reporting Requirements

(AERR)(71 FR 69, January 3, 2006) which proposes to modify some of the reporting requirements established by CERR. In addition, EPA has developed guidance “Emissions Inventory Guidance for Implementation of Ozone and Particulate Matter National Ambient Air Quality Standards (NAAQS) and Regional Haze Regulations, EPA-454/R-99-006 available at: *http://www.epa.gov/ttn/chief/eidocs/eiguid/index.html* . The EPA developed this guidance document to complement the CERR and proposed AERR and to provide specific guidance to State and local agencies and Tribes on how to develop emissions inventories for 8-hour ozone, PM 2.5 , and regional haze SIPs. The CERR and AERR set forth national requirements for emission data elements for all States, regardless of NAAQS attainment status. EPA guidance complements these requirements and indicates how the data should be prepared for SIP submissions. The SIP inventory, which may be derived from the CERR inventory, applies only to nonattainment areas. The SIP inventory also must be approved by EPA as a SIP element and is therefore subject to public hearing requirements, and is thus regulatory in nature. The inventory required by the CERR is not. Because of the regulatory significance of the SIP inventory, EPA will need more documentation on how the SIP inventory was developed by the State as opposed to the documentation required for the CERR inventory. Therefore, the basis for EPA's emission inventory program is specified in the CERR, the AERR notice of proposed rulemaking

(NPRM)and the related guidance document. The EPA is interested in receiving comments on whether or not additional emission inventory requirements or guidance are needed to implement any new PM 2.5 standards and any new PM 10-2.5 NAAQS. Following are a set of questions on which we would like input: a. Are the data elements specified within the CERR and AERR sufficient to develop adequate SIPs for PM 2.5 and PM 10-2.5 ? For example, should EPA expand the listing of reportable compounds to include elemental and organic carbon? b. Fugitive emissions are a significant contributor to ambient levels of PM 10-2.5 . Should EPA require and/or develop more precise methods for estimating fugitive particulate emissions, perhaps including wind blown dust? c. The EPA believes that daily emissions will be important under both PM 2.5 and PM 10-2.5 . Should EPA require any additional emission inventory data elements or temporal allocation techniques to estimate more accurately daily emissions and their variability? d. Are there other inventory issues that EPA should define through either regulation or guidance? VIII. Statutory and Executive Order Reviews Under Executive Order 12866, Regulatory Planning and Review (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and is, therefore, not subject to review by the Office of Management and Budget. List of Subjects in 40 CFR Part 51 Environmental protection, Particulate matter. Dated: February 3, 2006. Stephen L. Johnson, Administrator. [FR Doc. E6-1798 Filed 2-8-06; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 51 [OAR-2005-0124; FRL-8030-1] RIN 2060-AN34 Air Quality: Revision to Definition of Volatile Organic Compounds—Exclusion of HFE-7300 AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: This action proposes to revise EPA's definition of volatile organic compounds

(VOC)for purposes of preparing State implementation plans

(202)566-1741. • Mail: Environmental Protection Agency, Mailcode: 6102T, 1200 Pennsylvania Ave., NW., Washington, DC 20460. Attn: Docket No. OAR-2005-0124, “Air Quality: Revision to Definition of Volatile Organic Compounds—Exclusion of HFE-7300.” Please include a total of two copies. • Hand Delivery: EPA Docket Center, U.S. Environmental Protection Agency, EPA West Building, Room B102, 1301 Constitution Avenue, NW., Washington, DC. Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information. *Instructions:* Direct your comments to Docket ID No. OAR-2005-0124. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at *http://www.epa.gov/edocket* , including any personal information provided, unless the comment includes information claimed to be Confidential Business Information

(CBI)or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through EDOCKET, regulations.gov, or e-mail. The EPA EDOCKET and the Federal regulations.gov Web sites are “anonymous access” systems, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through EDOCKET or regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. *Docket:* All documents in the docket are listed in the EDOCKET index at *http://www.epa.gov/edocket.* Although listed in the index, some information is not publicly available, i.e., 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 either electronically in EDOCKET or in hard copy at the EPA Docket Center, EPA/DC, EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is

(202)566-1744, and the telephone number for the Air Docket is

(202)566-1742. *Public Hearing:* If anyone contacts EPA requesting a public hearing, it will be held at Research Triangle Park, NC. Persons wishing to request a public hearing, wanting to attend the hearing or wishing to present oral testimony should notify Mr. David Sanders, Air Quality Strategies and Standards Division (C539-02), U.S. Environmental Protection Agency, Research Triangle Park, NC 27711, telephone

(919)541-3356. EPA will publish notice of a hearing, if requested, in the **Federal Register** . Any hearing will be strictly limited to the subject matter of the proposal, the scope of which is discussed below. Interested persons may call Mr. Sanders to see if a hearing will be held and the date and location of any hearing. FOR FURTHER INFORMATION CONTACT: David Sanders, Office of Air Quality Planning and Standards, Air Quality Strategies and Standards Division (C539-02), Research Triangle Park, NC 27711, phone

(919)541-3356, or by e-mail at *sanders.dave@epa.gov.* SUPPLEMENTARY INFORMATION: This compound has potential for use as a heat-transfer fluid. As a hydrofluoroether (HFE), this compound may be used as an alternative to ozone-depleting substances. Under the Significant New Alternatives Policy

(SNAP)program (CAA 612; 40 CFR part 82 subpart G), EPA may identify substitutes for ozone-depleting compounds, evaluate the acceptability of these substitutes, determine as acceptable for use those substitutes believed to present lower overall risks to human health and the environment (relative to the class I and class II compounds being replaced, as well as to other substitutes for the same end-use), and prohibit the use of those substitutes found, based on the same comparisons, to increase overall risks. Because they do not contain chlorine or bromine, they do not deplete the ozone layer. All HFEs have an ozone depletion potential

(ODP)of 0 although some HFEs have high global warming potential (GWP). According to a U.S. patent application submitted by 3M Innovative Properties Company, the organic compound 1,1,1,2,2,3,4,5,5,5-decafluoro-3-methoxy-4-trifluoromethyl pentane [C 2 F 5 CF(OCH 3 )CF(CH 3 ) 2 ] that is the subject of this notice possesses the capacity to form myriad azeotrope mixtures with other organic compounds such as 1-bromopropane, hexamethyldisilazane, isobutyl acetate, methylisobutyl ketone, trans-1,2-dichloroethylene, and trifluoromethylbenzene which may not be exempt from VOC regulation. This patent application lists a broad range of processes and applications where these azeotropes can be used. Some of these azeotrope uses include:

(1)Coating deposition applications, where the azeotrope functions as a carrier for a coating material,

(2)heat-transfer fluids in heat-transfer processes,

(3)to clean organic and/or inorganic substrates, and

(4)to formulate working fluids or lubricants for machinery operations and manufacturing processes. The patent application indicated that the azeotrope mixtures can be formulated at compositions of 1,1,1,2,2,3,4,5,5,5-decafluoro-3-methoxy-4-trifluoromethyl pentane [C 2 F 5 CF(OCH 3 )CF(CH 3 ) 2 ] ranging from 1 to 100 percent, depending on the organic co-solvent and the desired properties of the azeotrope. I. Background Tropospheric ozone, commonly known as smog, occurs when VOC and nitrogen oxides (NO X ) react in the atmosphere. Because of the harmful health effects of ozone, EPA and State governments limit the amount of VOC and NO X that can be released into the atmosphere. Volatile organic compounds are those compounds of carbon (excluding carbon monoxide, carbon dioxide, carbonic acid, metallic carbides or carbonates, and ammonium carbonate) which form ozone through atmospheric photochemical reactions. Compounds of carbon (also known as organic compounds) have different levels of reactivity—that is, they do not react at the same speed or do not form ozone to the same extent. It has been EPA's policy that organic compounds with a negligible level of reactivity need not be regulated to reduce ozone. EPA determines whether a given organic compound has “negligible” reactivity by comparing the compound's reactivity to the reactivity of ethane. EPA lists these compounds in its regulations [at 40 CFR 51.100(s)] and excludes them from the definition of VOC. The chemicals on this list are often called “negligibly reactive” organic compounds. On July 8, 1977, EPA published the “Recommended Policy on Control of Volatile Organic Compounds” (42 FR 35314) which established the basic policy that EPA has used regarding organic chemical photochemical reactivity since that time. In that statement, EPA identified the following four compounds as being of negligible photochemical reactivity and said these should be exempt from regulation under SIPs: Methane; ethane; 1,1,1-trichloroethane (methyl chloroform); and 1,1,2-trichloro-1,2,2-trifluoroethane (CFC-113). That policy statement said that as new information becomes available, EPA may periodically revise the list of negligibly reactive compounds to add compounds to or delete them from the list. EPA's decision to exempt certain compounds in its 1977 policy was heavily influenced by experimental smog chamber work done earlier in the 1970's. In this experimental work, various compounds were injected into a smog chamber at a molar concentration that was typical of the total molar concentration of VOC in Los Angeles ambient air (4 ppmv). As the compound was allowed to react with NO X at concentrations of 0.2 ppm, the maximum ozone formed in the chamber was measured. If the compound in the smog chamber did not result in ozone formation of 0.08 ppm (0.08 ppm was the NAAQS for oxidants at that time), it was assumed that emissions of the compound would not cause the oxidant standard to be exceeded. The compound could then be considered to be negligibly reactive. Ethane was the most reactive compound tested that did not cause the 0.08 ppm ozone level in the smog chamber to be met or exceeded. Based on those findings and judgments, EPA designated ethane as negligibly reactive, and ethane became the benchmark VOC species separating reactive from negligibly reactive compounds. Since 1977, the primary method for comparing the reactivity of a specific compound to that of ethane has been to compare the k OH values for ethane and the specific compound of interest. The k OH value represents the molar rate constant for reactions between the subject compound (e.g., ethane) and the hydroxyl radical (i.e., •OH). This reaction is very important since it is the primary pathway by which most organic compounds initially participate in atmospheric photochemical reaction processes. At this time, EPA has exempted 53 compounds or classes of compounds with 4 of these based on a new comparison using Maximum Incremental Reactivity

(MIR)values and the remainder based on a comparison of k OH values. On August 30, 2004, the Performance Chemicals and Fluid Division of the 3M Company submitted to EPA a petition requesting that the compound 1,1,1,2,2,3,4,5,5,5-decafluoro-3-methoxy-4-trifluoromethyl-pentane be added to the list of compounds which are considered to be negligibly reactive in the definition of VOC at 40 CFR 51.100(s). This compound would be used as a heat transfer liquid and for other heat transfer applications. In its petition, 3M points out that it has suggested HFE-7300 be used to reduce greenhouse gases resulting from emissions of compounds such as hydroflurocarbons, perfluorocarbons, and perfluoropolyethers in certain applications and, therefore, help reduce global warming potential. In support of 1,1,1,2,2,3,4,5,5,5-decafluoro-3-methoxy-4-trifluoromethyl-pentane, 3M Company supplied information on its photochemical reactivity. The 3M Company stated that, as a hydrofluoroether, this compound is very similar in structure, toxicity, and atmospheric properties to other compounds such as C 4 F 9 OCH 3 , (CH 3 ) 2 CFCF 2 OCH 3 , C 4 F 9 OC 2 H 5 , (CH 3 ) 2 CFCF 2 OC 2 H 5 , n-C 3 F 7 OCH 3 , and C 3 F 7 CF(OC 2 H 5 )CF(CF 3 ) 2 which are exempt from the VOC definition. Other information submitted by 3M Company consists mainly of a peer-reviewed article entitled “Atmospheric Chemistry of Some Fluoroethers,” Guschin, Molina, Molina: Massachusetts Institute of Technology, May 1998,which has been submitted to the docket. This article discusses a study in which the rate constant for the reaction of the subject compound with the hydroxyl

(OH)radical is shown to be less than that for ethane and slightly more than that for methane. This rate constant (k OH value) is commonly used as one measure of the photochemical reactivity of compounds. The petitioner compared the subject compound rate constant with that of ethane, which has already been listed as photochemically negligibly reactive. The compound under consideration has the reported k OH rate constant as listed in Table 1 which is lower that that of ethane at 2.4 × 10 −13 . The scientific information which the petitioner has submitted in support of the petition has been added to the docket for this rulemaking. This information includes references for the journal articles where the rate constant values are published. EPA has included the 3M Company Material Safety Data Sheet for HFE-7300 indicating the compound as having very low toxicity. This information has been placed in the docket. Table 1.—Reaction Rate and Toxicity Compound OH Radical at 25 °C (cm 3 /molecule/sec) MIR mole gram Toxicity HFE-7300 1.5 × 10 −14 Not available Very low. II. EPA Response to the Petition For the petition submitted by the 3M Company, the data submitted by the petitioners support the contention that the reactivity of the compound submitted, with respect to reaction with the OH radical in the atmosphere, is lower than that of ethane. This notice to exempt 1,1,1,2,2,3,4,5,5,5-decafluoro-3-methoxy-4-trifluoromethyl pentane [C 2 F 5 CF(OCH 3 )CF(CH 3 ) 2 ] as negligibly reactive from the VOC definition applies to this compound only in its pure state and does not apply to any of its azeotrope mixtures or organic blends in which any of the other constituents are not VOC exempt compounds. The term “pure state” is taken to mean at a composition purity level of at least 99.96 percent by weight (cited in the patent application 10/739,231 published on June 23, 2005 titled “Azeotrope-like Compositions and Their Use,” Publication Number: US 2005/0137113 A1) of 1,1,1,2,2, 3,4,5,5,5-decafluoro-3-methoxy-4-trifluoromethyl pentane [C 2 F 5 CF(OCH 3 )CF(CH 3 ) 2 ]. For those azeotrope mixtures and organic blends which contain both VOC exempt and non-exempt compounds, the amount of credit that can be apportioned as VOC exempt credit is limited to the total molar fraction of all the VOC exempt constituents contained in the mixture or blend. EPA is responding to the petition by proposing in this action to add 1,1, 1,2,2,3,4,5,5,5-decafluoro-3-methoxy-4-trifluoromethyl-pentane (also known as HFE-7300) to the list of compounds appearing in 40 CFR 51.100(s). III. Proposed Action Today's proposed action is based on EPA's review of the material in Docket No. OAR-2005-0124. EPA hereby proposes to amend its definition of VOC at 40 CFR 51.100(s) to exclude HFE-7300 as VOC for ozone SIP and ozone control purposes. States are not obligated to exclude from control as a VOC those compounds that EPA has found to be negligibly reactive. However, if this action is made final, States may not take credit for controlling this compound in their ozone control strategy. IV. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review Under Executive Order 12866 (58 FR 51735, October 4, 1993), the Agency must determine whether a regulatory action is “significant” and therefore subject to Office of Management and Budget

(OMB)review and the requirements of this Executive Order. The Order defines “significant regulatory action” as one that is likely to result in a rule that may:

(1)Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or Tribal governments or communities;

(2)Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;

(3)Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligation of recipients thereof; or

(4)Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. Pursuant to the terms of Executive Order 12866, it has been determined that this rule is not “significant” because none of the listed criteria apply to this action. Consequently, this action is not submitted to OMB for review under Executive Order 12866. B. Paperwork Reduction Act This action does not contain any information collection requirements subject to OMB review under the Paperwork Reduction Act, 44 U.S.C. 3501 *et seq.* It does not contain any recordkeeping or reporting requirement. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply, with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An Agency does not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The control numbers for EPA(s regulations are listed in 40 CFR part 9 and 48 CFR chapter 15. C. Regulatory Flexibility Act The Regulatory Flexibility Act

(RFA)generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the proposed rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions. For purposes of assessing the impacts of today's rule on small entities, small entity is defined as:

(1)A small business as defined by the Small Business Administration's

(SBA)regulations at 13 CFR 121.201;

(2)a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and

(3)a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field. After considering the economic impacts of today's proposed rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. In determining whether a rule has a significant economic impact on a substantial number of small entities, the impact of concern is any significant adverse economic impact on small entities, since the primary purpose of the regulatory flexibility analyses is to identify and address regulatory alternatives “which minimize any significant economic impact of the rule on small entities.” 5 U.S.C. 603 and 604. Thus, an agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, or otherwise has a positive economic effect on all of the small entities subject to the rule. Today's proposed rule proposes to revise EPA's definition of volatile organic compounds

(VOC)for purposes of preparing State implementation plans

(SIPs)to attain the national ambient air quality standards (NAAQS) for ozone under title I of the Clean Air Act (CAA). This proposed revision would add 1,1,1,2,2,3,4,5,5,5-decafluoro-3-methoxy-4-trifluoromethyl-pentane [also known as HFE-7300 or L-14787 or [C 2 F 5 CF(OCH 3 )CF(CF 3 ) 2 ] to the list of compounds excluded from the definition of VOC on the basis that this compound makes a negligible contribution to tropospheric ozone formation. We continue to be interested in the potential impacts of the proposed rule on small entities and welcome comments on issues related to such impacts. D. Unfunded Mandates Reform Act Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and Tribal governments and the private sector. Under section 202 of the UMRA, EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to State, local, and Tribal governments, in the aggregate, or to the private sector, of $100 million or more in any 1 year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost-effective or least burdensome alternative if the Administrator publishes with the final rule an explanation why that alternative was not adopted. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including Tribal governments, it must have developed under section 203 of the UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements. EPA has determined that this rule does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and Tribal governments, in the aggregate, or the private sector in any 1 year. Since this proposed rule is deregulatory in nature and does not impose a mandate upon any source, this rule is not estimated to result in the expenditure by State, local and Tribal governments or the private sector of $100 million in any 1 year. Therefore, the Agency has not prepared a budgetary impact statement or specifically addressed the selection of the least costly, most cost-effective, or least burdensome alternative. Because small governments will not be significantly or uniquely affected by this rule, the Agency is not required to develop a plan with regard to small governments. Thus, today's rule is not subject to the requirements of sections 202 and 205 of the UMRA. E. Executive Order 13132: Federalism Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations 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.” This proposed action addressing the exemption of a chemical compound from the VOC definition does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. This action does not impose any new mandates on State or local governments. Thus, Executive Order 13132 does not apply to this rule. In the spirit of Executive Order 13132, and consistent with EPA policy to promote communications between EPA and State and local governments, EPA specifically solicits comment on this proposed rule from State and local officials. F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 6, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.” This proposed rule does not have Tribal implications. It will not have substantial direct effects on Tribal governments, 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, as specified in Executive Order 13175. Today's action does not have any direct effects on Indian Tribes. Thus, Executive Order 13175 does not apply to this rule. In the spirit of Executive Order 13175, and consistent with EPA policy to promote communications between EPA and Tribal governments, EPA specifically solicits additional comment on this proposed rule from Tribal officials. G. Executive Order 13045: Protection of Children From Environmental Health and Safety Risks Executive Order 13045: “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997) applies to any rule that:

(1)Is determined to be “economically significant” as defined under Executive Order 12866, and

(2)concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency. While this proposed rule is not subject to the Executive Order because it is not economically significant as defined in Executive Order 12866, EPA has reason to believe that ozone has a disproportionate effect on active children who play outdoors (62 FR 38856; 38859, July 18, 1997). EPA has not identified any specific studies on whether or to what extent the chemical compound may affect children's health. EPA has placed the available data regarding the health effects of this chemical compound in Docket No. OAR-2005-0124. EPA invites the public to submit or identify peer-reviewed studies and data, of which EPA may not be aware, that assess results of early life exposure to the chemical compound HFE-7300. H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use 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) because it is not a significant regulatory action under Executive Order 12866. I. National Technology Transfer Advancement Act Section 12(d) of the National Technology Transfer Advancement Act of 1995 (“NTTAA”), Public Law 104-113, section 12(d), (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( *e.g.* , materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, with explanations when the Agency decides not to use available and applicable voluntary consensus standards. This proposed rulemaking does not involve technical standards. Therefore, EPA is not considering the use of any voluntary consensus standards. List of Subjects in 40 CFR Part 51 Environmental protection, Administrative practice and procedure, Air pollution control, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds. Dated: February 3, 2006. Stephen L. Johnson, Administrator. For reasons set forth in the preamble, part 51 of chapter I of title 40 of the Code of Federal Regulations is proposed to be amended as follows: PART 51—REQUIREMENTS FOR PREPARATION, ADOPTION, AND SUBMITTAL OF IMPLEMENTATION PLANS. 1. The authority citation for part 51 continues to read as follows: Authority: 23 U.S.C. 101; 42 U.S.C. 7401-7641q. § 51.100 [Amended] 2. Section 51.100 is amended at the end of paragraph (s)(1) introductory text by removing the words “and methyl formate (HCOOCH3), and perfluorocarbon compounds which fall into these classes:” and adding in their place the words; “methyl formate (HCOOCH 3 ), 1,1,1,2,2,3,4,5,5,5-decafluoro-3-methoxy-4-trifluoromethyl-pentane (HFE-7300) and perfluorocarbon compounds which fall into these classes:”. [FR Doc. E6-1800 Filed 2-8-06; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 707 and 799 [EPA-HQ-OPPT-2005-0058; FRL-7752-2] RIN 2070-AJ01 Export Notification; Proposed Change to Reporting Requirements AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: EPA is proposing amendments to the Toxic Substances Control Act

(TSCA)section 12(b) export notification regulations at subpart D of 40 CFR part 707. One amendment would change the current annual notification requirement to a one-time requirement for exporters of chemical substances or mixtures (hereinafter referred to as “chemicals”) for which certain actions have been taken under TSCA. Relatedly, for the same TSCA actions, EPA is proposing to change the current requirement that the Agency notify foreign governments annually after the Agency's receipt of export notifications from exporters to a requirement that the Agency notify foreign governments once after it receives the first export notification from an exporter. EPA is also proposing de minimis concentration levels below which notification would not be required for the export of any chemical for which export notification under TSCA section 12(b) is otherwise required, proposing other minor amendments (to update the EPA addresses to which export notifications must be sent, to indicate that a single export notification may refer to more than one section of TSCA where the exported chemical is the subject of multiple TSCA actions, and to correct an error), and clarifying exporters' and EPA's obligations where an export notification-triggering action is taken with respect to a chemical previously or currently subject to export notification due to the existence of a previous triggering action. DATES: Comments must be received on or before April 10, 2006. ADDRESSES: Submit your comments, identified by docket identification

(ID)number EPA-HQ-OPPT-2005-0058, by one of the following methods: • * http://www.regulations.gov* : Follow the on-line instructions for submitting comments. • *Agency Website* : EDOCKET, EPA's electronic public docket and comment system, was replaced on November 25, 2005, by an enhanced Federal-wide electronic docket management and comment system located at *http://www.regulations.gov* . Follow the on-line instructions. • *E-mail* : *oppt.ncic@epa.gov* . • *Mail* : Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Hand Delivery* : OPPT Document Control Office (DCO), EPA East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID number EPA-HQ-OPPT-2005-0058. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is

(202)564-8930. Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information. *Instructions* : Direct your comments to docket ID number EPA-HQ-OPPT-2005-0058. EPA's policy is that all comments received will be included in the public docket without change and may be made available on-line at *www.regulations.gov* , including any personal information provided, unless the comment includes information claimed to be Confidential Business Information

(CBI)or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through *www.regulations.gov* or e-mail. The *www.regulations.gov* website is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through *www.regulations.gov* , your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA's public docket, visit the EPA Docket Center homepage at *http://www.epa.gov/epahome/dockets.htm/* . *Docket* : All documents in the docket are listed in the *www.regulations.gov* index. Although listed in the index, some information is not publicly available, i.e., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy form. Publicly available docket materials are available either electronically in *www.regulations.gov* or in hard copy at the OPPT Docket (EPA/DC), EPA West, Rm. B102, 1301 Constitution Ave., NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is

(202)566-1744, and the telephone number for the OPPT Docket is

(202)566-0280. FOR FURTHER INFORMATION CONTACT: *For general information contact* : Colby Lintner, Regulatory Coordinator, Environmental Assistance Division (7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:

(202)554-1404; e-mail address: *TSCA-Hotline@epa.gov* . *For technical information contact* : Kenneth Moss, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:

(202)564-9232; e-mail address: *moss.kenneth@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you export or intend to export any chemical substance or mixture for which any of the following actions have been taken under TSCA with respect to that chemical substance or mixture: Data are required under TSCA section 4 or 5(b), an order has been issued under TSCA section 5, a rule has been proposed or promulgated under TSCA section 5 or 6, or an action is pending, or relief has been granted under TSCA section 5 or 7. Potentially affected entities may include, but are not limited to: • Exporters of chemical substances or mixtures (NAICS codes 325 and 324110; e.g., chemical manufacturing and processing and petroleum refineries). 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. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions at 40 CFR 707.60 for TSCA section 12(b)-related obligations. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document and Other Related Information? In addition to using the electronic docket, you may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr/* . A frequently updated electronic version of both 40 CFR parts 707 and 799 are available on E-CFR Beta Site Two at *http://www.gpoaccess.gov/ecfr/* . C. What Should I Consider as I Prepare My Comments for EPA? 1. *Submitting CBI* . Do not submit this information to EPA through * http:// www.regulations.gov * or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 2. *Tips for preparing your comments* . When submitting comments, remember to: i. Identify the rulemaking by docket ID number and other identifying information (subject heading, **Federal Register** date and page number). ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations

(CFR)part or section number. iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes. iv. Describe any assumptions and provide any technical information and/or data that you used. v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced. vi. Provide specific examples to illustrate your concerns, and suggest alternatives. vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats. viii. Make sure to submit your comments by the comment period deadline identified. II. Background A. What Action is the Agency Taking? EPA is proposing amendments to TSCA section 12(b) export notification regulations at subpart D of 40 CFR part 707. The first amendment would change the current annual notification requirement for exporters of chemicals for which certain actions have been taken under TSCA. Currently, the TSCA section 12(b) regulations require exporters of chemicals to notify EPA of the first export or intended export to a particular country in a calendar year when data are required under TSCA section 5(b), an order has been issued under TSCA section 5, a rule has been proposed or promulgated under TSCA section 5 or 6, or an action is pending, or relief has been granted under TSCA section 5 or 7. For chemicals subject to a final TSCA section 4 action, exporters are currently required to submit an export notification only for the first export or intended export to a particular country. This proposed rule would change the current annual export notification requirement to a one-time requirement for each of the following TSCA section 12(b)-triggering actions per each destination country for each exporter of a chemical: An order issued, an action pending, or an action granting relief under TSCA section 5(e), a proposed or promulgated rule under TSCA section 5(a)(2), or an action requiring the submission of data under TSCA section 5(b). For exports of chemicals that are the subjects of TSCA section 12(b)-triggering actions under TSCA section 5(f), 6, or 7, however, each exporter would continue to be required to submit annual export notifications to EPA. Relatedly, EPA is proposing a change in the frequency for which the Agency must notify foreign governments after the Agency's receipt of export notifications from exporters. Consistent with the current requirement that EPA notify foreign governments one time regarding the export of chemicals subject to final TSCA section 4 actions, EPA is proposing that the Agency provide a one-time (rather than the current annual) notice to each foreign government to which exported chemicals that are the subjects of any of the following actions are sent: An order issued, an action pending, or an action granting relief under TSCA section 5(e), a rule proposed or promulgated under TSCA section 5(a)(2), or an action requiring the submission of data under TSCA section 5(b). EPA would continue to notify each foreign government on an annual basis regarding the export of chemicals that are the subject of TSCA section 5(f), 6, or 7 actions. EPA is also proposing de minimis concentration levels below which notification would not be required for the export of any chemical for which export notification under TSCA section 12(b) is otherwise required. Specifically, EPA is proposing that export notification would not be required for such chemicals if the chemical is being exported at a concentration of less than 1% (by weight or volume), unless that chemical is: 1. Listed as a “known to be human carcinogen” or “reasonably anticipated to be human carcinogen” in the Report on Carcinogens issued by the U.S. Department of Health and Human Services National Toxicology Program

(NTP)(Ref. 1), 2. Classified as a Group 1, Group 2A, or Group 2B carcinogen by the World Health Organization International Agency for Research on Cancer

(IARC)in the list of IARC Monographs on the Evaluation of Carcinogenic Risks to Humans and their Supplements (Ref. 2), or 3. Characterized as a carcinogen or potential carcinogen in the Occupational Safety and Health Administration's (OSHA's) regulations related to toxic and hazardous substances (29 CFR part 1910, subpart Z). For paragraphs 1-3 of this unit, a de minimis concentration level of less than 0.1% (by weight or volume) would apply. For exports of polychlorinated biphenyls (PCBs), notification would not be required if such chemicals are being exported at a concentration of less than or equal to 50 parts per million

(ppm)(by weight or volume). EPA believes this proposed rule is needed to further focus importing governments' resources and attention on chemicals for which EPA has proposed to make or has made a finding under TSCA that a chemical substance or mixture “presents or will present” an unreasonable risk, and to reduce overall burden on exporters and the Agency. EPA requests comments on these proposed amendments, and is particularly interested in receiving comments discussing whether the proposed changes would continue to provide adequate notice and information to foreign governments about chemicals imported from the United States. EPA is also interested in receiving specific, well supported, information regarding how the proposed changes would affect exporters. In this **Federal Register** document, EPA is also updating the instructions for the submission of export notifications to the Agency (40 CFR 707.65(c)), clarifying exporters' and EPA's obligations when subsequent TSCA section 12(b)-triggering actions are taken with respect to a chemical previously or currently subject to export notification due to a separate triggering action, indicating in 40 CFR 707.67 that a single export notification may refer to more than one section of TSCA where the exported chemical is the subject of multiple TSCA actions, and correcting 40 CFR 799.19 to make it clear that final multi-chemical TSCA section 4 rules also trigger export notification (see Unit IV.). B. What is the Agency's Authority for Taking this Action? EPA is proposing these amendments pursuant to TSCA section 12(b), 15 U.S.C. 2611(b). Section 12(b) of TSCA requires that any person who exports or intends to export to a foreign country a chemical for which the submission of data is required under TSCA section 4 or 5(b), an order has been issued under TSCA section 5, a rule has been proposed or promulgated under TSCA section 5 or 6, or with respect to which an action is pending or relief has been granted under TSCA section 5 or 7 must notify the Administrator of EPA of such exportation or intent to export. Upon receipt of such notification, EPA must furnish the government of the importing country with: 1. Notice of the availability of data received pursuant to an action under TSCA section 4 or 5(b) or 2. Notice of such rule, order, action, or relief under TSCA section 5, 6, or 7. C. History In the **Federal Register** of December 16, 1980, EPA promulgated rules at 40 CFR part 707, subpart D, implementing TSCA section 12(b) (Ref. 3). Under these rules, exporters were required to submit a written notification to EPA for the first export or intended export to a particular country in a calendar year for any chemical that was the subject of a TSCA section 12(b)-triggering action. Upon receipt of such notification from an exporter, the implementing rules required (and still require) that EPA provide the importing country with, among other things, a summary of the action taken or an indication of the availability of data received pursuant to action under TSCA section 4 or 5(b) (see 40 CFR 707.70(b)). To facilitate foreign governments' consideration of export notices for chemicals exported from the United States and to reduce the burden on EPA and exporters, EPA promulgated a rule in the **Federal Register** of July 27, 1993, that amended the regulations in 40 CFR part 707, subpart D (Ref. 4). The amendment limited the notification requirement for each exporter of chemicals subject to a final TSCA section 4 action to a one-time notification to EPA for the export of each such chemical to each particular country, instead of requiring annual notification to EPA for shipments of the chemical to that country. The amended rule also limited EPA's notice to foreign governments to one time for the export of each chemical subject to a final TSCA section 4 action. The 1993 amendment did not change the export notification requirements for chemicals that are the subject of an action under TSCA section 5, 6, or 7; that is, exporters are currently required to provide annual notification of the export of each chemical that is the subject of an action under TSCA section 5, 6, or 7. The 1993 amendment also did not change the frequency of EPA's notice to foreign governments for chemicals subject to TSCA section 5, 6, or 7; EPA notice is provided upon receipt of the first annual export notification for each such chemical to each country. In support of the 1993 amendment, EPA indicated that an increase in the number of TSCA section 12(b) export notifications during the 1980s made import monitoring more difficult for many foreign countries, and imposed an increasing burden upon foreign governments, industry, and EPA resources. EPA had determined that much of the increase in notifications was associated with the export or intended export of chemicals subject to final TSCA section 4 actions. At the time, EPA believed that the increasing volume of notices made it difficult for foreign countries which receive a large number of notices to generally distinguish between those chemicals for which, for example, EPA had taken an action to restrict use and those chemicals for which EPA has required the generation of data but has not taken an action to restrict use. By decreasing the volume of notices importing countries receive on chemicals subject to final TSCA section 4 actions, EPA believed that the 1993 amendment could increase the relative effectiveness of notices by allowing foreign governments to better focus their efforts on notices for chemicals that are the subject of actions under TSCA section 5, 6, or 7. To further reduce the information collection burden for TSCA section 12(b) export notification, EPA developed and periodically updates a website that provides a list of chemicals subject to TSCA section 12(b) export notification requirements (see “Current List of Chemical Substances Subject to TSCA Section 12(b) Export Notification Requirements” at *http://www.epa.gov/opptintr/chemtest/main12b.htm* ). In addition, exporters' obligation to submit a one-time export notification to EPA for the export of a chemical subject to a final TSCA section 4 action terminates once the reimbursement period for that particular action expires. OPPT has made available a comprehensive listing of these “sunset” dates for all such chemicals (see “Sunset Date/Status of TSCA Section 4 Testing, Reimbursement, and Reporting Requirements and TSCA Section 4-Triggered TSCA Section 12(b) Export Notification Requirements” at *http://www.epa.gov/opptintr/chemtest/sunset.htm* ). The regulated community has indicated that these lists serve as useful tools to assist exporters in complying with TSCA and EPA believes that they have resulted in an overall reduction of the information collection burden associated with TSCA section 12(b) export notification requirements. D. Rotterdam Convention EPA notes as further background the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade (Rotterdam Convention) (Ref. 5), a multi-lateral environmental agreement that the United States signed in September of 1998 but has not yet ratified (and thus is not a Party to). This Rotterdam Convention, which went into force in February of 2004, includes the following major obligations: 1. *Notification of control action and imposition of export notification requirement on exporters* . The Rotterdam Convention requires exporting parties to: Determine whether a pesticide or industrial chemical is “banned” or “severely restricted” (BSR); notify the Secretariat of that determination; and notify importing parties of the export of those chemicals from their country prior to their export after making the BSR determination and thereafter for the first export of every calendar year. 2. *Impose export restrictions consistent with importing parties response* . Once a BSR chemical (and its use category, i.e., use as a pesticide or industrial chemical) is, by consensus of the Parties, added to Annex III of the Rotterdam Convention, the Rotterdam Convention requires importing parties to identify any conditions/restrictions on the import of these substances and exporting parties to make sure exports occur consistent with conditions/restrictions identified by importing countries. Annex III of the Rotterdam Convention contains a list of chemicals that are subject to the Prior Informed Consent Procedures described by the Rotterdam Convention (Ref. 5). 3. *Label exported products* . For countries' domestic BSR chemicals and the Rotterdam Convention's Annex III chemicals, the Rotterdam Convention requires labeling to “ensure adequate availability of information with regard to risks and/or hazards to human health or the environment.” For the Rotterdam Convention's Annex III chemicals, labels must also include a Harmonized System Code if available (Ref. 6). For an exporting country's BSR chemicals and the Rotterdam Convention's Annex III chemicals that are to be used in an occupational setting, each exporting Party must send the most up-to-date safety data sheet for the chemical to each importer. EPA believes the export notification mechanism in the Rotterdam Convention broadly reflects importing governments' interests and that this proposal to amend the TSCA section 12(b) export notification rule is not inconsistent with the export notification provisions of the Rotterdam Convention. EPA wishes to note that the Administration is committed to the United States becoming a Party to the Rotterdam Convention, as well as two other chemicals-related multi-lateral environmental agreements: the Stockholm Convention on Persistent Organic Pollutants

(POPs)(Stockholm Convention) (Ref. 7) and the POPs Protocol to the United Nations Economic Commission for Europe Convention on Long Range Transboundary Air Pollution (LRTAP) (Ref. 8). The Administration has been and intends to continue working with Congress to facilitate the development of legislation that would provide the authority needed for the United States to fully implement and become a Party to those agreements. If and when such legislation is enacted, and depending on the nature of the legislation, it may be appropriate or necessary to further amend the TSCA section 12(b) regulations. III. Rationale for This Proposed Rule EPA believes this proposed rule is a reasonable supplement to the 1993 amendments to EPA's export notification regulations because it would further reduce overall burden on exporters and the Agency and would further focus importing governments' resources and attention on chemicals for which EPA has proposed to make or has made a definitive finding that a chemical “presents or will present” an unreasonable risk to human health or the environment. In the 1993 amendments, it was EPA's view that TSCA section 5(a)(2) and 5(e) actions, which are based on exposure or risk concerns for identified use scenarios, “restrict” in a limited sense, regulated uses. The 1993 amendments further stated that the Agency has authority to take follow-up action under TSCA section 5(a)(2) via TSCA section 5(e) and because there is no similar provision under TSCA section 4 (with the exception of a separate proceeding under TSCA section 6 or 7), there was a reasonable basis for treating the export notification requirement for chemicals regulated under TSCA sections 4 and 5 differently (Ref. 4, p. 40240). This proposed rule, however, would treat actions under TSCA sections 5(a)(2) and 5(e) similarly to final actions under TSCA section 4 for purposes of export notification, such that a one-time notice would be required. Although TSCA sections 5(a)(2) and 5(e) restrict use in some sense, the statutory finding for such actions is based on consideration of “factors” relating to a “significant new use” determination under TSCA section 5(a)(2) or, for TSCA section 5(e), the same “may present an reasonable risk” or “substantial production/significant/substantial exposure” findings required under TSCA section 4 rulemakings. EPA believes foreign governments will want to focus greater attention on chemicals for which the Agency has made a finding that a chemical “presents or will present” an unreasonable risk to human health or the environment (TSCA sections 5(f)(1), 6(a), and 7). This finding represents a definitive determination and thus is different from a finding that a chemical “may present” an unreasonable risk (TSCA sections 4(a)(1)(A)(i) and 5(e)(1)(A)(ii)(I)), substantial production and substantial or significant exposure/release findings (“exposure-based” findings; TSCA sections 4(a)(1)(B)(i), 5(b)(4)(A)(i), and 5(e)(1)(A)(ii)(II)), or factors determining a significant new use (TSCA section 5(a)(2)). Because “presents or will present” an unreasonable risk to human health or the environment is a definitive risk determination, EPA believes that it is reasonable to require more frequent notification for those chemicals that are the subject of each export notification-triggering action under TSCA sections 5(f), 6, and 7. Therefore, EPA would continue to require annual export notification by exporters of chemicals that are the subject of each action under TSCA section 5(f), 6, or 7, and EPA is similarly amending the regulatory provision regarding EPA's notice to foreign governments to limit annual notices to chemicals that are the subject of each TSCA section 5(f), 6, or 7 action. EPA is also proposing de minimis concentration levels below which notification would not be required for the export of any chemical that is the subject of an action under TSCA section 4, 5, 6, or 7. In 1993, EPA considered but did not adopt a de minimis concentration exemption from its TSCA section 12(b) regulations, although the Agency expected to re-examine that option if further experience indicated that such an exemption would be warranted. Accordingly, this proposed rule provides background on the use of de minimis concentration levels under an international chemical classification and labeling scheme as a basis for incorporation of a de minimis concentration level under TSCA section 12(b). The 1992 United Nations Conference on Environment and Development (Ref. 9), provided the international mandate for development of the Globally Harmonized System of Classification and Labelling of Chemicals

(GHS)(Ref. 10). The GHS was adopted by the United Nations Economic and Social Council in July 2003 and is an internationally agreed upon tool for chemical hazard communication that incorporates a harmonized approach to hazard classification and provisions for standardized labels and safety data sheets. The GHS labeling is intended to provide a foundation for national programs to promote safer use, transport and disposal of chemicals, and to facilitate international trade in chemicals whose hazards have been properly assessed and identified based on internationally agreed upon criteria. As with TSCA section 12(b), one of the primary purposes of the GHS labeling scheme is to communicate information on chemicals to foreign governments. Accordingly, EPA believes it is appropriate to look to GHS for guidance on establishing a de minimis concentration exemption under TSCA section 12(b). Classification of chemical mixtures under the GHS for several health and environmental hazard classes is triggered when generic cut-off values or concentration limits are exceeded, for example, ≥1.0% for target organ systemic toxicity, ≥0.1% for known or presumed human carcinogens, etc. (See Ref. 10, chapter 1.5. The cut-off levels for each hazard class are provided in chapters 3.1-3.10 and chapter 4.1 of Ref. 10.) When a chemical is present below these cut-off levels, the GHS does not require that the chemical appear on labeling or other information sources. The GHS represents international consensus on appropriate de minimis concentrations below which governments do not find information useful for hazard communication on chemicals in international (or domestic) commerce. The focus of GHS is relevant to that of TSCA section 12(b), which is primarily intended to alert and inform foreign governments, in a general manner, of hazards that may be associated with a chemical substance or mixture. As a result, EPA believes it is logical to refer to GHS as a guide to implementation of TSCA section 12(b). EPA believes the inclusion of de minimis concentration thresholds in GHS is indicative of foreign governments' likely preference not to be notified by the United States about its export of chemicals present in low concentrations. In order to implement an exemption from export notification requirements for chemicals exported in de minimis concentrations EPA is proposing de minimis concentration levels below which notification would not be required for the export of any chemical for which export notification under TSCA section 12(b) is otherwise required. Specifically, EPA is proposing that export notification would not be required for such chemicals if the chemical is being exported at a concentration of less than 1% (by weight or volume), with two exceptions. The first exception would be made for chemicals treated for export notification purposes as carcinogens or potential carcinogens. These chemicals would be identified in the regulation based on the three sources referred to in OSHA's regulations related to hazard communication (29 CFR 1910.1200(d)(4)), i.e.,: 1. Listed as a “known to be human carcinogen” or “reasonably anticipated to be human carcinogen” in the Report on Carcinogens issued by the U.S. Department of Health and Human Services National Toxicology Program

(NTP)(Ref. 1), 2. Classified as a Group 1, Group 2A, or Group 2B carcinogen by the World Health Organization International Agency for Research on Cancer

(IARC)in the list of IARC Monographs on the Evaluation of Carcinogenic Risks to Humans and their Supplements (Ref. 2), or 3. Characterized as a carcinogen or potential carcinogen in OSHA's regulations related to toxic and hazardous substances (29 CFR part 1910, subpart Z). For paragraphs 1-3 of this unit, a de minimis concentration level of less than 0.1% (by weight or volume) would apply. The NTP Report on Carcinogens is mandated by section 301(b)(4) of the Public Health Service Act, as amended (42 U.S.C. 201 *et seq* .), which stipulates that the Secretary of the Department of Health and Human Services shall publish an annual report which contains a list of all substances: • Which either are known to be carcinogens in humans or may reasonably be anticipated to be human carcinogens. • To which a significant number of persons residing in the United States are exposed. In 1993, Public Law 95-622 was amended to change the frequency of publication of the NTP Report on Carcinogens from an annual to a biennial report. The IARC Monographs on the Evaluation of Carcinogenic Risks to Humans are independent assessments prepared by international working groups of experts of the evidence on the carcinogenicity of a wide range of agents, mixtures, and exposures. The evaluations of IARC Working Groups are scientific, qualitative judgments on the evidence for or against carcinogenicity provided by the available data. The Monographs are used by national and international authorities to make risk assessments, formulate decisions concerning preventive measures, provide effective cancer control programs, and decide among alternative options for public health decisions. Copies of the NTP and IARC lists referenced in this proposed rule have been placed in the public version of the official record for this rulemaking. In the final rule, EPA intends to seek approval from the Director of the Office of the Federal Register for the incorporation by reference of the NTP and IARC lists used in the final rule in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The third source of carcinogens or potential carcinogens which is referred to in OSHA's regulations related to hazard communication (29 CFR 1910.1200(d)(4)) is the group of carcinogens or potential carcinogens in OSHA's toxic and hazardous substances regulations (29 CFR part 1910, subpart Z). In lieu of referencing OSHA's regulations directly in the regulatory text of this proposed rule, this proposed rule republishes the two chemicals characterized by OSHA as carcinogens or potential carcinogens that are not already included on either the NTP or IARC lists referenced in this proposed rule. The rest of the chemicals characterized by OSHA as carcinogens or potential carcinogens are included on either or both the NTP and/or IARC lists. EPA would update the lists of chemicals identified in its export notification regulation as carcinogens or potential carcinogens, as appropriate, in order to reflect changes made to the sources referred to in OSHA's hazard communication regulations at 29 CFR 1910.1200(d)(4). Concentration threshold levels like those used in the GHS context are also generally accepted or recognized in other United States Federal regulatory contexts. OSHA has established 1.0% and 0.1% concentration thresholds as a basis for requiring the development of Material Safety Data Sheets (MSDSs) and workplace labeling under the OSHA's Hazard Communication (HAZCOM) Standard (29 CFR 1910.1200 and Ref. 11). The Emergency Planning and Community Right-to-Know Act, section 313 (Toxic Release Inventory (TRI)) regulations use the OSHA HAZCOM Standard for purposes of establishing a chemical's de minimis concentration as either 1.0% or 0.1% for chemical substances when present in a mixture (40 CFR 372.38(a)). EPA's TSCA New Chemicals Program also uses concentration limits of 1.0% and 0.1% in TSCA section 5(e) consent orders as thresholds for hazard communication and personal protective equipment requirements (Ref. 12). EPA believes that in the context of TSCA section 12(b) export notification, foreign governments would have little interest in notices regarding exports of chemicals present in de minimis concentrations, and that notices for such exports may divert attention from notices for exports of chemicals in higher concentrations that potentially may warrant more serious consideration. Thus, EPA believes that de minimis concentration thresholds are justified in the context of its TSCA section 12(b) regulations and is proposing that the export of chemicals present at a concentration below the specified de minimis concentration levels be exempt from notification requirements. As EPA has noted in the past, some chemicals retain their toxic properties at levels less than the general thresholds proposed, so the de minimis concentration thresholds proposed in this TSCA section 12(b) context are not an indication that EPA has determined that chemicals are generally not toxic at lesser concentrations. The de minimis concentration exemption in this proposal is only a reflection of the circumstances under which EPA believes foreign governments want to receive information regarding chemicals imported into their countries. In this proposed rule, the second exception to the proposed generally applicable de minimis concentration levels would be made for PCBs, which, when exported in a concentration of greater than 50 ppm, would require the submission of an export notification. EPA believes it is appropriate to include a different de minimis concentration level for PCBs in its TSCA section 12(b) regulations (i.e., levels less than or equal to 50 ppm versus the proposed general 1%/0.1% for carcinogens levels) after considering the coverage of PCBs under certain international treaties and/or guidance materials developed thereunder, including the Stockholm Convention and the Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal (Basel Convention) (Ref. 13). Note that the manufacture and distribution in commerce of PCBs for use within the United States or for export from the United States are generally prohibited, with certain exceptions (see, for example, 40 CFR 761.20(b) and (c)). The Stockholm Convention, which entered into force on May 17, 2004, and for which there were 113 Parties and 151 Signatories as of November 2005 (the United States is a Signatory but not yet a Party), includes, among other things, provisions that require Parties to reduce and/or eliminate the production and use of listed intentionally produced chemicals or pesticides. Annex A of the Stockholm Convention lists chemicals subject to elimination, including PCBs which are listed with a specific exemption for “articles in use in accordance with the provisions of Part II of this Annex.” Part II of Annex A of the Stockholm Convention states, in part: “Each Party shall:

(a)With regard to the elimination of the use of polychlorinated biphenyls in equipment (e.g., transformers, capacitors or other receptacles containing liquid stocks) by 2025, subject to review by the Conference of the Parties, take action in accordance with the following priorities . . .

(iii)Endeavour to identify and remove from use equipment containing greater than 0.005 percent [50 ppm] polychlorinated biphenyls and volumes greater than 0.05 litres . . .

(d)Except for maintenance and servicing operations, not allow recovery for the purpose of reuse in other equipment of liquids with polychlorinated biphenyls content above 0.005 per cent;

(e)Make determined efforts designed to lead to environmentally sound waste management of liquids containing polychlorinated biphenyls and equipment contaminated with polychlorinated biphenyls having a polychlorinated biphenyls content above 0.005 per cent, in accordance with paragraph 1 of Article 6, as soon as possible but no later than 2028, subject to review by the Conference of the Parties;

(f)In lieu of note

(ii)in Part I of this Annex, endeavour to identify other articles containing more than 0.005 per cent polychlorinated biphenyls (e.g., cable-sheaths, cured caulk and painted objects) and manage them in accordance with paragraph 1 of Article 6;” Annex A of the Stockholm Convention thus focuses attention on PCBs in equipment or articles where the PCBs are at a concentration of more than 50 ppm. In addition, the Basel Convention, which entered into force on May 5, 1992, and for which there were 166 governments that were Parties as of November 2005 (the United States is a Signatory but not yet a Party), stipulates that any trans-boundary movement of wastes (export, import, or transit) is permitted only when the movement itself and the disposal of the concerned hazardous or other wastes are environmentally sound. The Stockholm Convention directs close cooperation with the Basel Convention to define a “low POPs content” for purposes of safe disposal of wastes contaminated with POPs. Under the Basel Convention, “General Technical Guidelines for the Environmentally Sound Management of Wastes Consisting of, Containing or Contaminated with Persistent Organic Pollutants” (Basel POPs Guidelines) have been developed that provisionally identify the level of 50 milligrams/kilograms (mg/kg) (50 ppm) as “low POPs content” for PCBs (Ref. 14). Because the 50 ppm level is used in the Stockholm Convention as a cut-off level for purposes of obligations associated with PCB-containing equipment and has been further supported by the Basel POPs Guidelines as a low level not warranting the attention and control required for higher PCB levels, EPA believes it reasonable to propose using it as the basis of a de minimis concentration level for PCBs under TSCA section 12(b). Thus, at this time, EPA believes importing governments would not desire export notices from the United States for PCBs at levels of 50 ppm or less. EPA specifically seeks comment on whether 50 ppm is a reasonable level for the purposes of TSCA section 12(b), and if not, what other, if any, level may be appropriate and why (see Unit VI.). EPA believes that the most practical means of maintaining the quality of notification, of improving the scrutiny importing countries give to notices, and of reducing burden on both exporters and EPA, is to amend the TSCA section 12(b) regulations under 40 CFR part 707 to reduce the frequency of certain export notifications submitted by exporters to EPA as well as EPA notices sent to foreign governments. EPA's responsibility is both to alert and to make information and data available to the importing government. EPA believes that although the frequency of EPA's notices to foreign governments may be reduced by this rule, if finalized as proposed, the quality of the information provided to them would not be substantially affected. IV. Additional Proposed Amendments and Clarifications In addition to the proposed amendments to the TSCA section 12(b) regulations regarding the scope of exporters' and EPA's responsibilities, the Agency is proposing minor amendments to update the EPA addresses to which export notifications must be sent (40 CFR 707.65(c)), to indicate that a single export notification may refer to more than one section of TSCA where the exported chemical is the subject of multiple TSCA actions(40 CFR 707.67), and to correct an error in 40 CFR 799.19, which currently omits mentioning multi-chemical test rules as being among those final TSCA section 4 actions that trigger export notification. EPA is also clarifying exporters' and EPA's obligations where a TSCA section 12(b)-triggering action is taken with respect to a chemical previously or currently subject to export notification due to the existence of a previous triggering action. EPA's intention is that exporters notify EPA with respect to each TSCA section 12(b)-triggering action to which the chemical becomes subject (as long as the exporter in fact still exports or intends to export the chemical to that country) even if they have previously notified EPA about the export of that chemical to that country as a result of an earlier TSCA section 12(b)-triggering action. Note that an export notification may indicate more than one triggering action, i.e., separate export notifications need not be submitted where the need for export notification as a result of more than one triggering action at the same time exists with respect to a given chemical. Similarly, EPA would notify a foreign government with respect to each TSCA section 12(b)-triggering action to which the chemical becomes subject (as long as the Agency continues to receive an export notification from any exporter for the export of the chemical to that country) even if it has previously notified that government about the export of the chemical as a result of an earlier TSCA section 12(b)-triggering action. In this proposed rule, EPA is amending 40 CFR 707.65 and 707.70 in order to make these obligations clear. V. Economic Impact EPA has evaluated the potential costs of these proposed amendments. The Agency anticipates that these proposed amendments would reduce the number of export notifications sent to EPA by exporters of chemicals that are the subject of actions under TSCA section 5(e), 5(a)(2), or 5(b), and that they would also eliminate the submission of export notifications from exporters of chemicals otherwise subject to TSCA section 12(b) where they are present at a concentration below the relevant de minimis concentration threshold. The amendments would also potentially reduce the number of export notices sent by EPA to foreign governments. These reductions would save both exporter and EPA resources. For the period 1996-2004, EPA received an average of approximately 8,600 export notifications from exporters annually. On average, each year nearly 60% of those export notifications were for chemicals subject to final TSCA section 4 actions, 25% for chemicals that were the subject of actions under TSCA section 5, and the remainder were primarily for chemicals that were the subject of actions under TSCA section 6 and a very few for chemicals subject to actions under TSCA section 7. At this time, EPA is unable to predict with certainty the reduction in export notifications received by EPA from exporters due to the de minimis concentration exemption of this proposed rule, but based on personal communication with the American Chemistry Council

(ACC)(Ref. 15), EPA is estimating a 5% across-the-board reduction in TSCA section 12(b) notification burden to exporters due to the de minimis concentration exemption. Based on historical reporting, EPA is able to estimate, after the first year, a 50% reduction in export notifications triggered by TSCA section 5(e), 5(a)(2), or 5(b) actions as a result of the one-time-only provision, if these amendments are finalized as proposed. Thus, EPA expects to receive roughly 8,170 export notifications in the first year, and 7,125 in all subsequent years. These reductions are expected to save the regulated community over $12,000 in the first year of the proposed rule (3%), and over $41,000 in subsequent years (12%). Over 20 years, if finalized as proposed, these proposed amendments would save the regulated community approximately $440,000 at a 7% discount rate, and over $600,000 at a 3% discount rate. See the Economic Analysis of the Proposed Change to TSCA Section 12(b) Export Notification Requirements (Ref. 16) for details on all cost and burden calculations. The costs to EPA would also likely be reduced based on these proposed amendments, as EPA incurs costs for processing export notifications received, and for sending export notices to foreign governments. While EPA has been sending roughly 1,600 notices to foreign governments annually, that number is expected to drop as a result of these proposed amendments, if finalized as proposed, to an estimated 1,520 notice during the first year in which the rule is effective, and an estimated 980 notices sent in all subsequent years. These reductions are expected to save the Federal Government over $7,500 during the first year in which the rule is effective (4% of current costs), and over $43,000 in subsequent years (24% of current costs). Over 20 years, these proposed amendments, if finalized as proposed, would save the Federal Government approximately $450,000 at a 7% discount rate, and roughly $630,000 at a 3% discount rate. VI. Request for Comment The following is a list of issues on which the Agency is specifically requesting public comment. EPA encourages all interested persons to submit comments on these issues, and to identify any other relevant issues as well. This input will assist the Agency in developing a rule that successfully addresses information needs while minimizing potential reporting burdens associated with the rule. EPA requests that commenters making specific recommendations include supporting documentation where appropriate. 1. Based on certain international efforts, specifically GHS and the Stockholm Convention (and the Basel POPs Guidelines), EPA believes foreign governments would have little interest in TSCA section 12(b) notices regarding exports of chemicals present in low concentrations (i.e., 1%, 0.1%, or, for PCBs, 50 ppm or less). EPA specifically seeks comment on whether the proposed thresholds are set at a reasonable level for the purposes of TSCA section 12(b), and if not, what other, if any, level(s) may be appropriate and why. 2. This proposal makes the point that GHS represents international consensus on appropriate de minimis concentrations below which foreign governments do not find information useful for hazard communication on chemicals in international commerce. As with TSCA section 12(b), one of the primary purposes of the GHS labeling scheme is to communicate information on chemicals to foreign governments. Accordingly, EPA believes it is appropriate to look to GHS for guidance on establishing a de minimis concentration exemption under TSCA section 12(b). EPA is specifically seeking comment on the appropriateness of using GHS. 3. The proposal uses the Stockholm Convention as a basis for selecting a 50 ppm threshold for PCBs. Is this appropriate? 4. EPA estimates that the proposed de minimis concentration exemption would reduce the burden of TSCA section 12(b) reporting by 5%. However, since EPA does not currently require exporters to consider the concentration of chemicals they are exporting, the potential burden reduction is difficult to estimate. EPA is seeking information that might further inform the Agency's burden estimate. VII. References The official record for this proposed rule has been established under docket ID number EPA-HQ-OPPT-2005-0058, and the public version of the official record is available for inspection as specified under ADDRESSES . These references have been placed in the public docket. 1. Report on Carcinogens, Eleventh Edition; United States Department of Health and Human Services, Public Health Service, National Toxicology Program. Available online at *http://ntp.niehs.nih.gov/index.cfm?objectid=32BA9724-F1F6-975E-7FCE50709CB4C932* . 2. International Agency for Research on Cancer Monographs on the Evaluation of Carcinogenic Risks to Humans and their Supplements. Available online at *http://www-cie.iarc.fr/monoeval/allmonos.html* . 3. EPA. 1980. Chemical Imports and Exports; Notification of Export. Final Rule. **Federal Register** (45 FR 82844, December 16, 1980). Available on-line at *http://www.heinonline.org/HOL/Index?index=fedreg/fedreg&collection=fedreg* . 4. EPA. 1993. Export Notification Requirement; Change to Reporting Requirements. Final Rule. **Federal Register** (58 FR 40238, July 27, 1993). Available on-line at *http://www.heinonline.org/HOL/Index?index=fedreg/fedreg&collection=fedreg* . 5. Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade. September, 1998 (amended September 2004). Available on-line at *http://www.pic.int/en/viewpage.asp?id_cat=0* . Annex III: Chemicals Subject to the Prior Informed Consent Procedure. Available on-line at *http://www.pic.int/en/ViewPage.asp?id=104#III%20Annex* . 6. Harmonized System Convention, World Customs Organization (WCO). Available on-line at *http://www.wcoomd.org/ie/En/Topics_Issues/topics_issues.html* . June 14, 1983. The Harmonized Commodity Description and Coding System, generally referred to as “Harmonized System” or simply “HS,” is a multi-purpose international product nomenclature developed by the WCO. 7. Stockholm Convention on Persistent Organic Pollutants (POPs). May 22, 2001. Available on-line at *http://www.pops.int* . 8. United Nations Economic Commission for Europe Convention on Long Range Transboundary Air Pollution (LRTAP) Protocol on Persistent Organic Pollutants (POPs), June 24, 1998. Available on-line at *http://www.unece.org/env/lrtap/pops_h1.htm* . 9. United Nations Conference on Environment and Development (Earth Summit) Agenda 21; Chapter 19: Environmentally Sound Management of Toxic Chemicals, Including Prevention of Illegal International Traffic in Toxic and Dangerous Products. Rio de Janeiro, June 1992. Available on-line at *http://www.un.org/esa/sustdev/documents/agenda21/english/agenda21chapter19.htm* . 10. GHS. Available on-line at *http://www.unece.org/trans/danger/publi/ghs/ghs_welcome_e.html* . United Nations, 2003. GHS Chapter 1.5: Hazard Communication: Safety Data Sheets Table 1.5.1: Cut-off values/concentration limits for each health and environmental hazard class. See *http://www.unece.org/trans/danger/publi/ghs/ghs_rev01/English/01e_part1.pdf* .GHS Chapter 1.3: Classification of Hazardous Substances and Mixtures Subparagraph 1.3.3.2: Use of cut-off values/concentration limits. See *http://www.unece.org/trans/danger/publi/ghs/ghs_rev00/English/GHS-PART-3e.pdf* . 11. OSHA. Hazard Communication, Final Rule. **Federal Register** (48 FR 53280-53348, November 25, 1983). For discussion of 1% and 0.1% concentration thresholds, see pages 53290-53293. 12. New Chemicals Program Boilerplate TSCA Section 5(e) Consent Orders. Available on-line at *http://www.epa.gov/opptintr/newchems/boilerpl.htm* . 13. Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal Adopted by the Conference of the Plenipotentiaries March 22 1989. Entry into force May 1992. 14. Basel Convention General Technical Guidelines for Environmentally Sound Management of wastes consisting of, containing or contaminated with Persistent Organic Pollutants (POPs). April 2005. See *http://www.basel.int/techmatters/techguid/frsetmain.php* . 15. Personal Communication. James Miller, EPA Economist, and members of the American Chemistry Council's TSCA Action Group. November 15, 2005. 16. Economic and Policy Analysis Branch, Office of Pollution Prevention and Toxics, EPA. November 2005. Economic Analysis of the Proposed Change to TSCA Section 12(b) Export Notification Requirements. VIII. Statutory and Executive Order Reviews A. Executive Order 12866 Under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993), the Office of Management and Budget

(OMB)has determined that this proposed rule is not a “significant regulatory action” under section 3(f) of the Executive Order. In addition, EPA has prepared an economic assessment of the potential costs and benefits associated with this proposed action, which is contained in a document entitled *Economic Analysis of the Proposed Change to TSCA Section 12(b) Export Notification Requirements* (Ref. 16). This document is available in the docket, and is briefly summarized in Unit V. B. Paperwork Reduction Act This action does not impose any new information collection burden that would require additional approval by OMB under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq* . This rule is expected to reduce the existing burden that is approved under OMB Control No. 2070-0030 (EPA ICR No. 0795), which covers the information collection activities contained in the existing regulations at 40 CFR part 707, related to export notification under TSCA section 12(b). The annual respondent burden for the collection of information currently approved by OMB is estimated to be about 1 hour per response. A copy of the OMB approved Information Collection Request

(ICR)has been placed in the docket for this rulemaking, and the Agency's estimated burden reduction is presented in the *Economic Analysis* (Ref. 16) that has been prepared for this rule. Under the PRA, “burden” means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information that is subject to approval under the PRA, unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the **Federal Register** when approved, are listed in 40 CFR part 9, are displayed either by publication in the **Federal Register** or by other appropriate means, such as on the related collection instrument or form, if applicable. The display of OMB control numbers in certain EPA regulations is consolidated in 40 CFR part 9. Submit any comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, along with your comments on the proposed rule. The Agency will consider any comments related to the information collection requirements contained in this proposal as it develops a final rule. Any changes to the burden estimate for the ICR will be effectuated with the final rule. C. Regulatory Flexibility Act Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA), 5 U.S.C. 601 *et seq* ., due to the burden-reducing nature of this rule, the Agency hereby certifies that this proposed rule will not have a significant adverse economic impact on a substantial number of small entities. The factual basis for the Agency's determination is presented in the small entity impact analysis prepared as part of the *Economic Analysis* for this proposed rule (Ref. 16), which is summarized in Unit V., and a copy of which is available in the docket for this rulemaking. The following is a brief summary of the factual basis for this certification. For purposes of assessing the impacts of this proposed rule on small entities, small entity is defined as: 1. A small business as defined by the Small Business Administration's

(SBA)regulations at 13 CFR 121.201 based on the applicable NAICS code for the business sector impacted. 2. A small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000. 3. A small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field. Available information indicates that small governmental jurisdictions and small not-for-profit organizations would not generally engage in the activities regulated. As such, the Agency assessed the impacts on small exporters of chemical substances or mixtures within NAICS codes 325 (chemical manufactures and processors) and 324110 (petroleum refineries). As discussed in Unit V., this proposed rule, if finalized as proposed, will amend an existing requirement and result in a reduction of burden and costs for exporters, regardless of the size of the firm. As such, these amendments will not have a significant adverse economic impact on a substantial number of small entities. D. Unfunded Mandates Reform Act Pursuant to Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, EPA has determined that this proposed rule, which would result in a burden reduction upon being finalized, does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or the private sector in any 1 year. It is estimated that the total cost reduction of the rule, which is summarized in Unit V. and presented in the *Economic Analysis* (Ref. 16), over 20 years, would be $440,000 to $600,000 to the regulated community and $450,000 to $630,000 to the Federal Government. In addition, based on EPA's experience with the TSCA 12(b) reporting, State, local, and tribal governments have not been affected by this reporting requirement, and EPA does not have any reason to believe that any State, local, or tribal government will be affected by these proposed amendments. As such, EPA has determined that this regulatory action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any affect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205. E. Executive Order 13132 Pursuant to Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999), EPA has determined that this proposed rule does not have “federalism implications,” because it will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in the Order. As indicated previously, EPA does not have any reason to believe that any State or local government will be affected by these proposed amendments. Thus, Executive Order 13132 does not apply to this proposed rule. F. Executive Order 13175 As required by Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000), EPA has determined that this proposed rule does not have tribal implications because it will not have any affect on tribal governments, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in the Order. As indicated previously, EPA does not have any reason to believe that any tribal governments will be affected by these proposed amendments. Thus, Executive Order 13175 does not apply to this proposed rule. G. Executive Order 13045 This proposed rule does not require special consideration pursuant to the terms of Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997), because this proposed rule is not designated as an “economically significant” regulatory action as defined by Executive Order 12866, nor does it establish an environmental standard, or otherwise have a disproportionate effect on children. H. Executive Order 13211 This proposed rule is not subject to Executive Order 13211, entitled *Actions concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001) because it is not designated as an “economically significant” regulatory action as defined by Executive Order 12866, nor is it likely to have any significant adverse effect on the supply, distribution, or use of energy. I. National Technology Transfer and Advancement Act Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, 12(d) (15 U.S.C. 272 note), directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards. This proposed rule does not impose any technical standards that would require EPA to consider any voluntary consensus standards. J. Executive Order 12898 This proposed rule does not have an adverse impact on the environmental and health conditions in low-income and minority communities. Therefore, under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994), the Agency does not need to consider environmental justice-related issues. List of Subjects in 40 CFR Parts 707 and 799 Environmental protection, Chemicals, Exports, Hazardous substances, Imports, Reporting and recordkeeping requirements. Dated: January 31, 2006. Susan B. Hazen, Acting Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances. Therefore, it is proposed that 40 CFR chapter I be amended as follows: PART 707—[AMENDED] 1. The authority citation for part 707 continues to read as follows: Authority: 15 U.S.C 2611(b) and 2612. 2. By redesignating paragraphs

(c)through

(e)of § 707.60 as paragraphs

(d)through

(f)of § 707.60. 3. By adding a new paragraph

(c)to § 707.60 and revising newly redesignated paragraph

(d)of § 707.60 to read as follows: § 707.60 Applicability and compliance.

(c)No notice of export is required for the export of a chemical substance or mixture for which export notification is otherwise required, where such chemical substance or mixture is present in a concentration of less than 1% (by weight or volume), except that:

(1)No notice of export is required for the export of the following chemical substances or mixtures where such chemical substance or mixture is present in a concentration of less than 0.1% (by weight or volume) (The listed chemicals and mixtures are treated by EPA in paragraph (c)(1) of this section as carcinogens or potential carcinogens for the limited purpose of application of the 0.1% concentration export notification threshold.):

(i)A chemical substance or mixture listed as a “known to be human carcinogen” or “reasonably anticipated to be human carcinogen” in the Report on Carcinogens, Eleventh Edition issued by the U.S. Department of Health and Human Services National Toxicology Program,

(ii)A chemical substance or mixture classified as a Group 1, Group 2A, or Group 2B carcinogen by the World Health Organization International Agency for Research on Cancer

(IARC)in the list of IARC Monographs on the Evaluation of Carcinogenic Risks to Humans and their Supplements, or

(iii)Alpha-naphthylamine (Chemical Abstract Service Registry Number (CAS No.) 134-32-7) or 4-nitrobiphenyl (CAS No. 92-93-3).

(2)No notice of export is required for the export of polychlorinated biphenyl chemicals

(PCBs)(see definition in 40 CFR 761.3), where such chemical substances are present in a concentration of less than or equal to 50 ppm (by weight or volume).

(d)Any person who exports or intends to export PCBs or PCB articles (see definition in 40 CFR 761.3), for any purpose other than disposal, shall notify EPA of such intent or exportation under TSCA section 12(b), except as specified in § 707.60(c)(2). 4. By revising pragraph

(a)introductory text, (a)(2), and

(c)of § 707.65 to read as follows: § 707.65 Submission to agency.

(a)For each action under TSCA triggering export notification, exporters must notify EPA of their export or intended export of each subject chemical substance or mixture for which export notice is required under § 707.60 in accordance with the following:

(i)The notice must be for the first export or intended export by an exporter to a particular country in a calendar year when the chemical substance or mixture is the subject of an order issued, an action that is pending, or relief that has been granted under TSCA section 5(f), a rule that has been proposed or promulgated under TSCA section 6, or an action that is pending or relief that has been granted under TSCA section 7.

(ii)The notice must be for only the first export or intended export by an exporter to a particular country when the chemical substance or mixture is the subject of an order issued, an action that is pending, or relief that has been granted under TSCA section 5(e), a rule that has been proposed or promulgated under TSCA section 5(a)(2), or when the submission of data is required under TSCA section 4 or 5(b).

(c)*Notices shall be marked “TSCA Section 12(b) Notice” and sent to EPA by mail or delivered by hand or courier* . Send notices by mail to: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 (Attention: TSCA Section 12(b) Notice). Hand delivery of TSCA section 12(b) notices should be made to: OPPT Document Control Office (DCO), EPA East Bldg., Rm. 6428, Environmental Protection Agency, 1201 Constitution Ave., NW., Washington, DC (Attention: TSCA Section 12(b) Notice). The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is

(202)564-8930. Such deliveries are only accepted during the DCO's normal hours of operation. 5. By adding an “and/” in front of the “or” in the first sentence of paragraph

(a)and paragraph

(e)of § 707.67. 6. By revising paragraph

(a)of § 707.70 to read as follows: § 707.70 EPA notice to foreign governments. (a)(1) Notice by EPA to the importing country shall be sent no later than 5 working days after receipt by the TSCA Document Processing Center of the first annual notification from any exporter for each chemical substance or mixture that is the subject of an order issued, an action that is pending, or relief that has been granted under TSCA section 5(f), a rule that has been proposed or promulgated under TSCA section 6, or an action that is pending or relief that has been granted under TSCA section 7.

(2)Notice by EPA to the importing country shall be sent no later than 5 working days after receipt by the TSCA Document Processing Center of the first notification from any exporter for each chemical substance or mixture that is the subject of an order issued, an action that is pending, or relief that has been granted under TSCA section 5(e), a rule that has been proposed or promulgated under TSCA section 5(a)(2), or for which the submission of data is required under TSCA section 4 or 5(b). PART 799—[AMENDED] 7. The authority citation for part 799 continues to read as follows: Authority: 15 U.S.C 2603, 2611, 2625. 8. By revising § 799.19 to read as follows: § 799.19 Chemical imports and exports. Persons who export or who intend to export chemical substances or mixtures listed in subpart B, subpart C, or subpart D of this part are subject to the requirements of part 707 of this title. [FR Doc. E6-1797 Filed 2-8-06; 8:45am] BILLING CODE 6560-50-S DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration 49 CFR Part 571 [Docket No. NHTSA-2005-22895] RIN 2127-AI53 Federal Motor Vehicle Safety Standards No. 111 Rearview Mirrors AGENCY: National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT). ACTION: Denial of petition for rulemaking. SUMMARY: This document denies the petition for rulemaking submitted by Mr. Bernard Cox, requesting that NHTSA amend the Federal Motor Vehicle Safety Standard for rearview mirrors to require manufacturers to install a mirror of unit magnification (a flat mirror) on the passenger's side of multipurpose passenger vehicles

(MPVs)and trucks with a gross vehicle weight rating

(GVWR)of 4,536 kg (10,000 pounds) or less when such vehicles are equipped with a tow hitch package. Accordingly, manufacturers of MPVs, trucks, and buses (other than school buses) with a GVWR of 4,536 kg (10,000 pounds) or less continue to have the option of installing either a flat mirror or a convex mirror on the passenger's side of the vehicle provided that either mirror meets the applicable requirements of the standard. FOR FURTHER INFORMATION CONTACT: *For non-legal issues:* Mr. John Lee, Office of Crash Avoidance Standards, NVS-123, National Highway Traffic Safety Administration, 400 Seventh Street, SW., Washington, DC 20590. Telephone number:

(202)366-2720. Fax:

(202)366-7002. *For legal issues:* Mr. Eric Stas, Office of the Chief Counsel, NCC-112, National Highway Traffic Safety Administration, 400 Seventh Street, SW., Washington, DC 20590. Telephone number:

(202)366-2992. Fax:

(202)366-3820. SUPPLEMENTARY INFORMATION: Background On June 5, 2004, Mr. Bernard Cox submitted a petition for rulemaking 1 requesting that NHTSA amend Federal Motor Vehicle Safety Standard (FMVSS) No. 111, *Rearview Mirrors* , to require original equipment manufacturers

(OEMs)to install a mirror of unit magnification (called a “flat” mirror) on the passenger's side of MPVs and trucks with a GVWR of 4,536 kg (10,000 pounds) or less when such vehicles are equipped with a tow hitch package, thereby eliminating the current option for vehicle manufacturers to install either a flat mirror or a convex mirror in that location. The petitioner expressed his belief that when the vehicle's interior flat rearview mirror is obstructed by an object in tow, it is unsafe to make a lane change relying solely on an exterior passenger-side convex rearview mirror. Mr. Cox stated that he attempted to replace the outside passenger side convex mirror with a flat mirror and was told by his local automobile dealership that a flat mirror was unavailable for that application. The petitioner did not provide any data in support of his recommended amendments to Standard No. 111. 1 Docket No. NHTSA-2004-16856-61. Agency Analysis Under paragraph S6, *Requirements for multipurpose passenger vehicles, trucks, and buses, other than school buses, with GVWR of 4,536 kg or less,* FMVSS No. 111 currently requires such vehicles to be equipped with either with:

(1)Mirrors that conform to the requirements of S5, or

(2)outside mirrors of unit magnification, each with not less than 126 cm 2 of reflective surface, installed with stable supports on both sides of the vehicle, located so as to provide the driver a view to the rear along both sides of the vehicle, and adjustable in both the horizontal and vertical directions to view the rearward scene ( *see* S6.1 of FMVSS No. 111). *S5.3, Outside rearview mirror passenger's side,* permits either a mirror of unit magnification or a convex mirror to be installed in that location. Thus, Standard No. 111 provides a choice to vehicle manufacturers in terms of the type of passenger-side mirror that they install on MPVs, trucks, and buses (other than school buses) within the above-referenced weight class, which is the subject of the present petition. That portion of the vehicle fleet currently covered by S6 of the standard reflects a mix of convex mirrors and mirrors of unit magnification on the passenger's side of the vehicle. Each type of mirror has its advantages. Convex mirrors have the advantage of providing a wider field of view than a mirror of unit magnification of the same size. However, convex mirrors tend to provide an image that causes objects to appear further away and to be moving more slowly than they actually are. In contrast, mirrors of unit magnification generally provide a realistic rendering of approaching vehicles, although a narrower field of view and a larger “blind spot.” Consumer preferences also vary in terms of the type of rearview mirror installed on the passenger's side of vehicles. The agency has received complaints from some vehicle owners who find convex mirrors annoying when trying to back up and maneuver trailers. However, others have asked the agency to allow convex mirrors in situations in locations where only a mirror of unit magnification is permitted ( *e.g.* , driver-side outside rearview mirrors). The critical question posed by Mr. Cox's petition is whether there is evidence that use of a convex mirror at the passenger's side location on the vehicles in question has a negative impact on vehicle safety. To examine this issue, we reviewed the available research, including a relevant, agency-sponsored fleet study whose results were reported in a DOT research report titled, “Field Test Evaluation of Rearview Mirror Systems for Commercial Vehicles.” 2 This study involved a two-year field examination of fleets of telephone company repair vans, some using passenger-side mirrors of unit magnification and others using passenger-side convex mirrors. In that study, the convex mirrors had a 40-inch radius of curvature, similar to the OEM supplied passenger-side mirrors that the petitioner is seeking to have changed. Although those vans were not pulling trailers, such cargo vans generally have poor direct rear visibility, so the situations are generally analogous. The study reported that vans equipped with passenger-side convex mirrors had a lower crash rate than vans equipped with passenger-side mirrors of unit magnification. Thus, the available safety data do not demonstrate adverse safety consequences associated with the use of passenger-side convex mirrors. As noted previously, the petitioner did not provide any data, to demonstrate a safety problem that would be remedied by his requested amendments to the standard. 2 DOT HS 806 948 (Sept. 1985). Furthermore, consumers who experience difficulty adjusting to the field of view provided by a passenger-side convex mirror, including on vehicles towing a trailer, have a readily available alternative. There are currently many mirrors available in the aftermarket specifically designed to improve the visibility for drivers towing trailers, the majority of which are inexpensive and do not require significant vehicle modification. In summary, the petitioner has not demonstrated and the agency's own research has not revealed the existence of a safety problem, as would justify amending FMVSS No. 111. People's attitudes regarding side-mounted rearview mirrors may vary based upon physiological differences or personal preference. For those consumers who desire a passenger-side mirror of unit magnification, aftermarket equipment is available to effectuate such a change. Accordingly, we do not see any reason to diminish the range of choice which FMVSS No. 111 currently provides to manufacturers to equip the vehicles in question with either a passenger-side convex mirror or mirror of unit magnification which meets the requirements of the safety standard. Decision To Deny the Petition In accordance with 49 CFR part 552, this completes the agency's review of the petition for rulemaking. In light of the considerations discussed above, the agency has concluded that agency resources should be spent addressing higher priority safety issues. Therefore, the petition for rulemaking is denied. Authority: 49 U.S.C. 332, 30111, 30115, 30117; and 30166; delegation of authority at 49 CFR 1.50. Issued on: February 3, 2006. Stephen R. Kratzke, Associate Administrator for Rulemaking. [FR Doc. E6-1739 Filed 2-8-06; 8:45 am] BILLING CODE 4910-59-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 17 Endangered and Threatened Wildlife and Plants; Petition To List the Polar Bear as Threatened AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of 90-day petition finding and initiation of status review. SUMMARY: We, the U.S. Fish and Wildlife Service (Service), announce a 90-day finding on a petition to list the polar bear ( *Ursus maritimus* ) as threatened under the Endangered Species Act of 1973, as amended (Act). We find that the petition presents substantial scientific or commercial information indicating that the petitioned action of listing the polar bear may be warranted. We, therefore, are initiating a status review of the polar bear to determine if listing under the Act is warranted. To ensure that the status review is comprehensive, we are soliciting scientific and commercial information regarding this species. DATES: We must receive your comments on or before April 10, 2006. ADDRESSES: If you wish to comment, you may submit your comments and/or information concerning this species and the status review by any one of the following methods: 1. You may submit written comments and information to the Supervisor, U.S. Fish and Wildlife Service, Marine Mammals Management Office, 1011 East Tudor Road, Anchorage, Alaska 99503. 2. You may hand-deliver written comments to our office at the address given above. 3. You may send your comments by electronic mail (e-mail) directly to the Service at *AK_Polarbear@fws.gov,* or to the Federal eRulemaking Portal at *http://www.regulations.gov.* Your submission must include “Attn: Polar Bear” in the beginning of your message, and you must not use special characters or any form of encryption. Electronic attachments in standard formats (such as .pdf or .doc) are acceptable, but please name the software necessary to open any attachments in formats other than those given above. Also, please include your name and return address in your e-mail message. If you do not receive a confirmation from the system that we have received your e-mail message, please submit your comments in writing using one of the alternate methods described above. In the event that our Internet connection is not functional, please submit your comments by one of the alternate methods mentioned above. FOR FURTHER INFORMATION CONTACT: Scott Schliebe (see ADDRESSES ), telephone, 907-786-3800; facsimile, 907-786-3816. SUPPLEMENTARY INFORMATION: Public Comments Solicited We intend that any final action resulting from this status review will be as accurate and as effective as possible. Therefore, we solicit comments or suggestions from the public, concerned governmental agencies, the scientific community, industry, or any other interested party. We are opening a 60-day public comment period to allow all interested parties an opportunity to provide information on the status of the polar bear throughout its range, including:

(1)Information on taxonomy, distribution, habitat selection (especially denning habitat), food habits, population density and trends, habitat trends, and effects of management on polar bears;

(2)Information on the effects of climate change and sea ice change on the distribution and abundance of polar bears and their principal prey over the short- and long-term;

(3)Information on the effects of other potential threat factors, including oil and gas development, contaminants, hunting, poaching, and changes of the distribution and abundance of polar bears and their principal prey over the short and long term;

(4)Information on management programs for polar bear conservation, including mitigation measures related to oil and gas exploration and development, hunting conservation programs, anti-poaching programs, and any other private, tribal, or governmental conservation programs which benefit polar bears, and

(5)Information relevant to whether any populations of the species may qualify as distinct population segments. We will base our finding on a review of the best scientific and commercial information available, including all information received during the public comment period. Our practice is to make comments, including names and home addresses of respondents, available for public review during regular business hours. Individual respondents may request that we withhold their home addresses from the record, which we will honor to the extent allowable by law. There also may be circumstances in which we would withhold from the record a respondent's identity, as allowable by law. If you wish us to withhold your name and/or address, you must state this prominently at the beginning of your comment. However, we will not consider anonymous comments. We will make all submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, available for public inspection in their entirety. All comments and materials received will be available for public inspection, by appointment, during normal business hours at our Anchorage, Marine Mammals Management Office (see ADDRESSES ). Background We received a petition from the Center for Biological Diversity dated February 16, 2005, to list the polar bear as threatened throughout its range with critical habitat in the United States. The petition, which was clearly identified as such, contained detailed information on the natural history and biology of the polar bear, and the current status and distribution of the species. It also contained information on what they reported as potential threats to the species from climate change, oil and gas development, contaminants, hunting, and poaching. The petition also discussed existing regulatory mechanisms and their perceived inadequacy. In a letter dated July 5, 2005, the petitioners informed us that two additional parties were joining as petitioners: The Natural Resources Defense Council and Greenpeace, Inc. In the same letter, the petitioners informed us of two new scientific articles, Henson *et al.* 2005, and Stroeve *et al.* 2005, that they wanted us to take into consideration when conducting our evaluation on the petition to list the polar bear. The petitioner further submitted new information in a letter received on December 27, 2005, to be considered, along with the information in the initial petition, in making our 90-day finding. Subsequent to the filing of the initial petition with the Service, a petitioner may submit additional information relevant to the petitioned action. If the petitioner requests that the Service consider the information in making the 90-day finding on the petition, the Service will treat the new information, together with the information in the initial petition, as a new petition filed on the date that the new information is received. In such case, the Service will consider the initial petition to be withdrawn by the petitioner. This has the effect of “resetting the clock” for the purpose of calculating the statutory deadlines under section 4(b)(3) of the Act. Applying this reasoning to the Center for Biological Diversity's petition regarding the polar bear, we consider the petition to have been received on December 27, 2005. On the basis of information provided in the petition we have determined that the petition presents substantial scientific or commercial information that listing the polar bear as threatened may be warranted. Therefore, we are initiating a status review to determine if listing the species is warranted. To ensure that the status review is comprehensive, we are soliciting scientific and commercial information regarding this species. Under section 4(b)(3)(B) of the Act, we are required to make a finding as to whether listing the polar bear is warranted by December 27, 2006. The petitioners also requested that critical habitat be designated for this species. We always consider the need for critical habitat designation when listing species. If we determine in our 12-month finding that listing the polar bear is warranted, we will address the designation of critical habitat in a subsequent proposed rule. Author The primary author of this document is Scott Schliebe, Polar Bear Project Leader, Marine Mammals Management Office, U.S. Fish and Wildlife Service, Anchorage, Alaska. Authority: The authority for this action is the Endangered Species Act of 1973 as amended (16 U.S.C. 1531 *et seq.* ). Dated: February 3, 2006. H. Dale Hall, Director, U.S. Fish and Wildlife Service. [FR Doc. 06-1226 Filed 2-8-06; 8:45 am]

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