I. Background and Discussion of Interim Final Rule II. Regulatory Review III. Approval of the Office of Secretary I. Background and Discussion of Interim Final Rule

Section 1605(b) of the Energy Policy Act of 1992 directed DOE to issue guidelines establishing a voluntary greenhouse gas reporting program (42 U.S.C. 13385(b)). On February 14, 2002, the President directed DOE, together with other involved Federal agencies, to recommend reforms to enhance the Voluntary Reporting of Greenhouse Gases Program established by DOE in 1994. On April 21, 2006, following a lengthy public review process, DOE published revised final General Guidelines for Voluntary Greenhouse Gas Reporting (71 FR 20784). Those guidelines incorporated by reference detailed Technical Guidelines, dated March 2006, that are needed to fully implement the revised Voluntary Reporting of Greenhouse Gases Program.

Subsequent to the April 21, 2006 publication of the revised final General Guidelines and during preparation of new forms and instructions for reporting, DOE identified a number of errors and inconsistencies in the Technical Guidelines that warrant correction or clarification. To ensure that any revision of the March 2006 Technical Guidelines addressed as many of these problems as possible, on August 3, 2006, DOE sent a message by electronic mail to all persons who had previously expressed an interest in the guidelines and requested that they identify any needed technical corrections, clarifications, interpretations or other changes to the guidelines. Subsequently, DOE received communications that recommended additional corrections and other changes for consideration.

Following a careful review of the recommended corrections and other suggested changes, DOE made those modifications to the Technical Guidelines that it believed were necessary to correct all the identified errors and inconsistencies or other ambiguities, while adhering to the essential language and intent of the March 2006 version of the Technical Guidelines. The updated version of the Technical Guidelines is dated January 2007.

The regulations of the Administrative Committee of the Federal Register provide that an agency that seeks to change a document approved for incorporation by reference in a regulation must: (1) Publish notice of the change in the Federal Register and amend the Code of Federal Regulations; (2) ensure that a copy of the amendment or revision is on file at the Office of the Federal Register; and (3) notify the Director of the Federal Register in writing that the changes are being made. 1 CFR 51.11(a). Accordingly, DOE sent the January 2007 update of the Technical Guidelines to the Director of the Federal Register and obtained his approval of the incorporation by reference of the January 2007 Technical Guidelines in the regulations for the section 1605(b) program that are published in the Federal Register and the Code of Federal Regulations. By today's interim final rule, DOE changes the date of the Technical Guidelines from March 2006 to January 2007 in 10 CFR 300.13.

DOE believes that all of the modifications in the January 2007 version of the Technical Guidelines are fully consistent with the section 1605(b) program's General Guidelines and DOE's original intent regarding the methods and other guidance provided in the Technical Guidelines. Before these changes are made final, however, DOE is providing an opportunity for public review and comment on the specific changes that DOE has made. DOE is specifically soliciting public comment on whether any of the changes DOE has made are inconsistent with the General Guidelines. The revised January 2007 Technical Guidelines are available on the web at: http://www.pi.energy.gov/enhancingGHGregistry/ . DOE is making two versions of the updated Technical Guidelines available on the Web site. One version shows all of the changes made since the March 2006 Technical Guidelines were issued, with the new text underscored and the deleted text marked as deleted. The second version includes all the changes, but does not highlight them.

The changes and clarifications included in the updated Technical Guidelines fall into the following categories:

Corrections of factual and drafting errors. The updated Technical Guidelines correct a number of clerical or typographical errors that appeared in the March 2006 Technical Guidelines. The errors include inaccurate physical values, repeated text, misplaced definitions, and incorrect citations or Web site links.

Elimination of inconsistencies. There were instances where language in the March 2006 Technical Guidelines was not entirely consistent with the General Guidelines or with language in other parts of the Technical Guidelines. DOE has revised the Technical Guidelines to eliminate this inconsistency. In cases where the Technical Guidelines were internally inconsistent, DOE endeavored to remove this inconsistency by retaining the language it determined was most consistent with DOE's original intent, as explained in the preambles to the interim final General Guidelines published on March 24, 2005 (70 FR 15171-81) and the final General Guidelines published on April 21, 2006 (71 FR 20785-803).

Updated references. In some cases, the March 2006 Technical Guidelines do not refer to the most current versions of documents referenced in the guidelines, even though some of those documents were in the public domain before the issuance of the final guidelines. The updated Technical Guidelines include a number of updates to referenced documents. During the development of the updated Technical Guidelines, consideration was given to referencing the 2006 emission inventory guidelines of the Intergovernmental Panel on Climate Change (IPCC). While these guidelines are generally viewed as the best available inventory guidelines, they have yet to be officially adopted by the UN Framework Convention on Climate Change. Since DOE's Energy Information Administration has authority under the Technical Guidelines to update the factors and methodologies based on the IPCC guidelines as soon as it is appropriate to do so, no change to the Technical Guidelines is necessary at this time.

Clarifications of intent. In some instances the language used in the March 2006 Technical Guidelines was confusing or vague. In the updated version, DOE added clarifying words or text where a modification was likely to significantly enhance reader comprehension.

Modification or elimination of inappropriate calculation methods. In a few cases, commenters or DOE identified certain calculation methods as inappropriate for the purposes stated in the Technical Guidelines. For example, DOE eliminated the action-specific method for calculating the reductions associated with the recovery of methane from anaerobic digesters of animal waste because DOE concluded that this method is not needed to calculate reductions associated with these sources of emissions and is inconsistent with other guidance in both the General Guidelines and other parts of the Technical Guidelines. In other cases, formulas or factors were modified to ensure the applicability of the methods to the sources identified.

DOE did not adopt in the January 2007 Technical Guidelines some clarifications or other changes recommended by stakeholders. In some cases, the stakeholders sought modifications that would be inconsistent with the General Guidelines or outside the scope of the guidelines under section 1605(b). DOE may consider additional changes to the Technical Guidelines when it conducts the periodic reviews provided for in 10 CFR 300.1(f).

Today's regulatory action has been determined to not be a “significant regulatory action” under Executive Order 12866, “Regulatory Planning and Review,” 58 FR 51735 (October 4, 1993), as amended by Executive Order 13258, 67 FR 9385 (February 26, 2002). Accordingly, this action was not subject to review under that Executive Order by the Office of Information and Regulatory Affairs of the Office of Management and Budget (OMB).

The Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et seq. ) requires that an agency prepare an initial regulatory flexibility analysis for any regulation when a general notice of proposed rulemaking is required, unless the agency certifies that the rule, if promulgated, will not have a significant economic impact on a substantial number of small entities (5 U.S.C. 605(b)). This rule makes corrections, updates and clarifying changes to Technical Guidelines for the Voluntary Reporting of Greenhouse Gases Program incorporated by reference in General Guidelines published on April 21, 2006. These changes do not affect the burden on the entities that report emissions under the section 1605(b) program. Moreover, as stated in the April 2006 notice of final guidelines, the reporting program is voluntary and DOE anticipates that small entities will weigh the benefits and costs when deciding to participate. On the basis of the foregoing, DOE certifies that these amendments to the Technical Guidelines will not have a significant economic impact on a substantial number of small entities. Accordingly, DOE has not prepared a regulatory flexibility analysis for this rulemaking. DOE will provide this certification and supporting statement of factual basis to the Chief Counsel for Advocacy of the Small Business Administration pursuant to 5 U.S.C. 605(b).

The Energy Information Administration (EIA) on November 9, 2006 (71 FR 65786) submitted the new forms and associated instructions for reporting under the April 2006 revised guidelines to OMB for review and approval in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). The changes to the Technical Guidelines made by today's interim final rule do not include any additional information collection requirements.

DOE has concluded that promulgation of this rule falls into the class of actions that does not individually or cumulatively have a significant impact on the human environment as set forth in DOE's regulations implementing the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq. ). Specifically, the interim final rule is covered under the categorical exclusion in paragraph A5 of Appendix A to subpart D, 10 CFR part 1021, which applies to rulemaking interpreting or amending an existing rule or regulation that does not change the environmental effect of the rule or regulation being amended. Accordingly, neither an environmental assessment nor an environmental impact statement is required.

Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires each Federal agency to prepare a written assessment of the effects of any Federal mandate in a proposed or final agency regulation that may result in the expenditure by states, tribal, or local governments, on the aggregate, or by the private sector, of $100 million in any one year. The Act also requires a Federal agency to develop an effective process to permit timely input by elected officials of state, tribal, or local governments on a proposed “significant intergovernmental mandate,” and requires an agency plan for giving notice and opportunity to provide timely input to potentially affected small governments before establishing any requirements that might significantly or uniquely affect small governments. DOE has determined that the rule published today does not contain any Federal mandates affecting states, tribal, or local governments, so these requirements do not apply.

With respect to the review of existing regulations and the promulgation of new regulations, section 3(a) of Executive Order 12988, “Civil Justice Reform,” 61 FR 4779 (February 7, 1996) imposes on Federal agencies the general duty to adhere to the following requirements: Eliminate drafting errors and needless ambiguity, write regulations to minimize litigation, provide a clear legal standard for affected conduct rather than a general standard, and promote simplification and burden reduction. Section 3(b) requires Federal agencies to make every reasonable effort to ensure that a regulation, among other things: Clearly specifies the preemptive effect, if any, adequately defines key terms, and addresses other important issues affecting the clarity and general draftsmanship under guidelines issued by the Attorney General. Section 3(c) of Executive Order 12988 requires Executive agencies to review regulations in light of applicable standards in section 3(a) and section 3(b) to determine whether they are met or it is unreasonable to meet one or more of them. DOE has completed the required review and determined that, to the extent permitted by law, this interim final rule meets the relevant standards of Executive Order 12988.

Executive Order 13132, “Federalism,” 64 FR 43255 (August 10, 1999) imposes certain requirements on agencies formulating and implementing policies or regulations that preempt State law or that have federalism implications. Agencies are required to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the States and carefully assess the necessity for such actions. DOE has examined this interim final rule and has determined that it would not preempt State law and would 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 responsibility among the various levels of government. No further action is required by the Executive Order.

Section 654 of the Treasury and General Government Appropriations Act, 1999 (Pub. L. 105-277) requires Federal agencies to issue a “Family Policymaking Assessment” for any rule that may affect family well-being. This rule has no impact on the autonomy or integrity of the family as an institution. Accordingly, DOE has concluded that it is not necessary to prepare a Family Policymaking Assessment.

Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy, Supply, Distribution, or Use,” 66 FR 28355 (May 22, 2001) requires preparation and submission to OMB of a Statement of Energy Effects for significant regulatory actions under Executive Order 12866 that are likely to have a significant adverse effect on the supply, distribution, or use of energy. DOE has determined that the rule published today is not a significant regulatory action and will not have a significant adverse effect on the supply, distribution, or use of energy and, thus, the requirement to prepare a Statement of Energy Effects does not apply.

The Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516 note) provides for agencies to review most dissemination of information to the public under guidelines established by each agency pursuant to general guidelines issued by OMB. OMB's guidelines were published at 67 FR 8452 (February 22, 2002), and DOE's guidelines were published at 67 FR 62446 (October 7, 2002). DOE has reviewed today's interim final rule under the OMB and DOE guidelines, and concluded that it is consistent with applicable policies in those guidelines.

As required by 5 U.S.C. 801, DOE will submit to Congress a report regarding the issuance of today's interim final rule prior to the effective date set forth at the outset of this rulemaking. The report will state that it has been determined that the rule is not a “major rule” as defined by 5 U.S.C. 801(2).

The Secretary of Energy has approved the publication of this interim final rule.

In revising § 620.5(i)(2)(i), we inadvertently omitted the last two paragraphs in the final rule as published at 71 FR 5740, February 2, 2006.

The FAA is implementing a new process for streamlining the issuance of ADs related to MCAI. This streamlined process will allow us to adopt MCAI safety requirements in a more efficient manner and will reduce safety risks to the public. This process continues to follow all FAA AD issuance processes to meet legal, economic, Administrative Procedure Act, and Federal Register requirements. We also continue to meet our technical decision-making responsibilities to identify and correct unsafe conditions on U.S.-certificated products.

This AD references the MCAI and related service information that we considered in forming the engineering basis to correct the unsafe condition. The AD contains text copied from the MCAI and for this reason might not follow our plain language principles.

The Civil Aviation Authority of Israel (CAAI), which is the aviation authority for Israel, has issued Israeli Airworthiness Directive 52-06-11-08, dated November 28, 2006 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The unsafe condition is incomplete closure of the main entry door, which may result in the door opening in flight, causing damage to wing, fuselage, engine, and/or tail, and possible damage to the airplane. The MCAI requires amending the airplane flight manuals to include additional procedures for verifying complete closure and locking of the main entry door. You may obtain further information by examining the MCAI in the AD docket.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, they have notified us of the unsafe condition described in the MCAI and service information referenced above. We are issuing this AD because we evaluated all the information provided by the State of Design Authority and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have required different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are described in a separate paragraph of the AD. These requirements take precedence over the actions copied from the MCAI.

An unsafe condition exists that requires the immediate adoption of this AD. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because there have been two incidents of main entry doors opening in flight, both at relatively low altitude and airspeeds. Since it cannot be shown the airplane can continue safe operation and return to the nearest airport after such an event in any phase of flight, we have determined that loss of an airplane is possible unless immediate actions are taken. Therefore, we determined that notice and opportunity for public comment before issuing this AD are impracticable and that good cause exists for making this amendment effective in fewer than 30 days.

This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2007-27077; Directorate Identifier 2006-NM-286-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD because of those comments.

We will post all comments we receive, without change, to http://dms.dot.gov , including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this AD.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, part A, subpart III, section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We determined that this AD would not have federalism implications under Executive Order 13132. This AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify this regulation:

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and

3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

The FAA is implementing a new process for streamlining the issuance of ADs related to MCAI. This streamlined process will allow us to adopt MCAI safety requirements in a more efficient manner and will reduce safety risks to the public. This process continues to follow all FAA AD issuance processes to meet legal, economic, Administrative Procedure Act, and Federal Register requirements. We also continue to meet our technical decision-making responsibilities to identify and correct unsafe conditions on U.S.-certificated products.

This AD references the MCAI and related service information that we considered in forming the engineering basis to correct the unsafe condition. The AD contains text copied from the MCAI and for this reason might not follow our plain language principles.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA Emergency Airworthiness Directive 2006-0364-E, dated December 6, 2006 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states that during MLG lubrication, a crack has been found visually in the MLG rib 6 aft bearing forward lug on one A330 in-service aircraft. The crack has extended through the entire thickness of the forward lug at approximately the 4 o'clock position (when looking forward). (Similar cracks have been found on MLGs with similar configurations on other Airbus airplane models). The investigations are ongoing to determine the root causes of this event and to define the appropriate corrective actions. This situation, if not corrected, could affect the structural integrity of the MLG attachment, which constitutes an unsafe condition. The aim of the MCAI is to mandate repetitive detailed visual inspections of the LH (left-hand) and RH (right-hand) wing MLG rib 6 aft bearing lugs as the first step before finalization of the investigations, and replacement of MLG rib 6 if a crack is detected. You may obtain further information by examining the MCAI in the AD docket.

Airbus has issued Service Bulletins A330-57A3096, A340-57A4104, and A340-57A5009, all dated December 5, 2006. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, they have notified us of the unsafe condition described in the MCAI and service information referenced above. We are issuing this AD because we evaluated all the information provided by the State of Design Authority and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have required different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are described in a separate paragraph of the AD. These requirements take precedence over the actions copied from the MCAI.

An unsafe condition exists that requires the immediate adoption of this AD. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because during a MLG maintenance task for lubrication, a crack was visually detected in the wing MLG rib 6 aft bearing forward lug on one in-service A330 aircraft. The crack had extended through the entire thickness of the forward lug at the 4 o'clock position. Failure of this attachment could result in gear collapse upon landing. Therefore, we determined that notice and opportunity for public comment before issuing this AD are impracticable and that good cause exists for making this amendment effective in fewer than 30 days.

This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2007-27064; Directorate Identifier 2006-NM-274-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD because of those comments.

We will post all comments we receive, without change, to http://dms.dot.gov , including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this AD.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We determined that this AD would not have federalism implications under Executive Order 13132. This AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify this regulation:

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and

3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

You may examine the airworthiness directive (AD) docket on the Internet at http://dms.dot.gov or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone (800) 647-5227) is located on the plaza level of the Nassif Building at the street address stated in the ADDRESSES section.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to certain Boeing Model 737-100, -200, -200C, -300, -400, and -500 series airplanes. That NPRM was published in the Federal Register on April 18, 2006 (71 FR 19835). That NPRM proposed to require repetitive inspections to detect cracks in the vertical beam webs of the body station (BS) 178 bulkhead, and corrective actions if necessary. That NPRM also proposed to require a terminating modification for the repetitive inspections.

We provided the public the opportunity to participate in the development of this AD. We have considered the comments received.

Continental Airlines (Continental) requests that the threshold for the compliance times specified in Table 1 of the NPRM be aligned with the compliance times specified in ADs 2000-05-29, amendment 39-11639 (65 FR 14834, March 20, 2000), and 2001-02-01, amendment 39-12085 (66 FR 7576, January 24, 2001). Continental states that this will reduce the economic impact on operators from doing early inspections and will encourage operators to terminate those ADs at 20,000 total flight cycles as opposed to doing repetitive inspections.

We do not agree. Continental provided no technical justification for revising the inspection threshold. In developing an appropriate compliance time for this action, we considered the safety implications and normal maintenance schedules for the timely accomplishment of the inspections. In consideration of these items, as well as the reports of numerous cracks in the vertical beam webs in service, we have determined that the compliance times specified in Table 1 of this AD will ensure an acceptable level of safety and allow the inspections to be done during scheduled maintenance intervals for most affected operators. However, according to the provisions of paragraph (m) of the AD, we may approve requests to adjust the compliance time if the request includes data that substantiate that the new compliance time would provide an acceptable level of safety.

The Air Transport Association (ATA), on behalf of one of its members, United Airlines (United), requests that the compliance time specified in paragraph (f)(2) of the NPRM be revised to reflect the intention of Boeing Service Bulletin 737-53A1225, Revision 1, dated April 14, 2005 (referred to in the NPRM as the appropriate source of service information for accomplishing the repetitive inspections and terminating preventative modification). United proposes that all airplanes should have a minimum of 4,500 flight cycles after the effective date of the AD to do the initial inspection required by paragraph (f) of the NPRM. United also states that Boeing Service Bulletin 737-53A1225, dated October 19, 2000, specifies an interval of 12,000 flight cycles for the repetitive high frequency eddy current (HFEC) inspections. Without a grace period, United points out that operators doing those inspections would be grounded as of the effective date of the AD.

We agree and have revised paragraph (f)(2) of this AD to provide a grace period of 4,500 flight cycles after the effective date of this AD.

Boeing requests that we revise Table 1, “Compliance Times,” of the NPRM to address airplanes inspected in accordance with Boeing Service Bulletin 737-53A1225, Revision 1.

We do not agree. Operators are given credit for actions previously done by means of the phrase in paragraph (e) of this AD that states, “unless the actions have already been done.” Therefore, in the case of this AD, if the required inspection specified in Boeing Service Bulletin 737-53A1225, Revision 1, has been done before the effective date of this AD, this AD does not require that it be repeated. In addition, if the required inspection specified in Boeing Service Bulletin 737-53A1225, Revision 1, has not been done before the effective date of this AD, this AD requires that inspection to be done at the applicable time specified in Table 1. We have made no change to the final rule in this regard.

KLM Engineering & Maintenance (KLM), Southwest Airlines (Southwest), and United request that the procedures specified in Boeing BOECOM M-7200-01-00546, dated March 1, 2001 (referred to in paragraph (j) of the NPRM) be allowed to be used after the effective date of the AD as an acceptable method of compliance with the preventative modification specified in paragraph (i) of the NPRM. Southwest states that BOECOM M-7200-01-00546 describes procedures for fabricating replacement parts, which would result in a significant cost savings to operators. United states that it has modified the majority of its fleet using instructions equivalent to those contained BOECOM M-7200-01-00546. KLM states that it has modified a majority of its fleet using Boeing Service Bulletin 737-53A1173, Revision 4, dated September 19, 2002 (Revision 3 of Boeing Service Bulletin 737-53A1173 is referred to in paragraph (k) of the NPRM as the appropriate source of service information for accomplishing the preventative modification), together with the instructions specified in BOECOM M-7200-01-00546. United and KLM would like to continue modifying their fleets using the same instructions. In addition, Boeing requests that the description of acceptable actions in paragraph (j) of the NPRM be revised to include procedures done in accordance with Boeing BOECOM M-7200-01-00546 and approved by Boeing and the FAA after March 1, 2001.

We partially agree. We agree that doing the replacement or modification specified in Boeing BOECOM M-7200-01-00546, dated March 1, 2001, may be an acceptable means of compliance with the requirements of paragraph (j) of this AD. However, it is not likely that replacement or modification in accordance with BOECOM M-7200-01-00546 can be done without deviations that require further FAA approval. It has been our experience that work done in accordance with BOECOM M-7200-01-00546 has nearly always required deviations. As noted in BOECOM M-7200-01-00546, to obtain approval for using the BOECOM, the operator must provide an Authorized Representative (AR) for the Boeing Commercial Airplanes Delegation Option Authorization Organization with the airplane identification, the details of the proposed replacement, and any deviations. Therefore, we have determined that operators who use the BOECOM procedures after the effective date of this AD must get them approved as an alternative method of compliance (AMOC) in accordance with the procedures specified in paragraph (m) of this AD. We have made no change to the final rule in this regard.

Boeing requests that the word “repair” in paragraph (i) of the NPRM and in the “Relevant Service Information” section of the NPRM be deleted. Boeing did not provide a justification.

We agree. We have re-reviewed Boeing Service Bulletin 737-53A1225, Revision 1. In several places in Parts II through IV of the Accomplishment Instructions, the service bulletin states, “Repair or change the vertical beam * * * Refer to Figure 25 * * *.” Figure 25 refers to “replacement” procedures; however, it does not refer to a repair procedure. Therefore, we have deleted “repair or” in paragraph (i) of this AD. We have made no change to the AD in regard to the “Relevant Service Information” section, because that section of the NPRM does not reappear in the final rule.

Southwest requests that paragraph (j) of the NPRM be revised to allow certain repair plans approved by an AR for the Boeing Commercial Airplanes Delegation Option Authorization Organization or a Boeing Designated Engineering Representative (DER) before the release of Boeing BOECOM M-7200-01-00546, dated March 1, 2001, as an acceptable method of compliance with the preventative modification specified in paragraph (i) of the NPRM. Southwest states that it has installed thicker vertical beam webs with such approval on some of its airplanes before the issuance of Boeing BOECOM M-7200-01-00546, dated March 1, 2001.

We do not agree with Southwest to revise paragraph (j) of this AD. Southwest did not provide sufficient data for us to determine if these earlier repairs are equivalent to those specified in Boeing BOECOM M-7200-01-00546, dated March 1, 2001. It is possible that the review and approval of earlier repairs may not have taken into account the latest information that was used to develop the BOECOM. However, if a particular repair is shown to be equivalent to that specified in the BOECOM, paragraph (m) of the AD provides operators the opportunity to apply for an AMOC to address this type of repair.

Southwest requests that paragraph (j) of the NPRM be revised to clarify that it is not necessary to replace certain stiffeners per step 4 of Boeing BOECOM M-7200-01-00546, if the existing holes can be oversized and a new identical fastener can be installed with an acceptable edge distance. Step 4 indicates that certain stiffeners must be replaced because they are offset by the thickness of the new webs. Southwest believes that the intent of that step is to eliminate detrimental fastener over-sizing and short edge distances that can result from the offset.

We do not agree with Southwest to revise paragraph (j) of this AD. Southwest did not provide any specific limits nor define any acceptable combinations of maximum over-sizing of fasteners and/or minimum fastener edge distance. Therefore, we are unable to provide approval at this time. However, under the provisions of paragraph (m) of this AD, we may consider requests for approval of an AMOC if sufficient data are submitted to substantiate that such a design change would provide an acceptable level of safety.

Delta Air Lines (Delta) requests that the concurrent requirements of paragraphs (k) and (l) of the NPRM be deleted, and to continue to allow the requirements specified in paragraph (c) of ADs 2000-05-29 and 2001-02-01 to be done separately. Delta notes that the “Effect of Accomplishing Concurrent Requirements” section in the preamble of the NPRM states, “We realize that the concurrent requirements of this proposed AD will force some operators to do the preventative modifications required by AD 2001-02-01 early and to do the optional preventative modification specified in AD 2000-05-29. However, accomplishing the applicable preventative modifications together is necessary to avoid repeated disassembly and re-assembly of common parts, which increases the likelihood of additional assembly errors.” Delta states that the timing of doing the preventative modification is an economic and operational decision, which is properly at the discretion of the operators, not a subject for an AD.

We partially agree. We do not agree with Delta that the concurrent requirements be deleted. We determined that mandating the previous optional preventative modification specified in AD 2000-05-29 in this AD will better ensure long-term continued operational safety of the affected airplanes by removing the source of the problem, rather than by repetitive inspections. Long-term inspections may not provide the degree of safety necessary for the affected airplanes. This, coupled with our understanding of the human factor errors associated with numerous repetitive inspections, has led us to consider placing less emphasis on special procedures and more emphasis on design improvements. The preventative modification required by paragraph (l) of this AD is consistent with these considerations. Additionally, accomplishing the modifications concurrently provides the most effective installation of these modifications and will avoid repeated disassembly and re-assembly of common parts of critical structure, which increases the likelihood of additional assembly errors. Boeing also has provided us with data supporting our determination.

We somewhat agree with Delta to allow the requirements specified in paragraph (c) of ADs 2000-05-29 and 2001-02-01 to be done separately. It is acceptable to do the preventative modifications required by AD 2001-02-01 before the requirements of paragraph (i) of this AD. However, paragraphs (k) and (l) of the NPRM state, “Concurrently with the requirements of paragraph (i) of this AD * * *.” Therefore, we have revised those paragraphs to clarify that the concurrent requirements must be done “before or concurrently with the requirements of paragraph (i) of this AD.” For clarification purposes, we also removed the phrase “unless already done before the effective date of this AD” from paragraph (k) of this AD.

The ATA, on behalf of one of its members, Delta, requests that AD 2000-05-29 be superseded or revised to avoid conflicting requirements. Delta states that this should be done if its request in the “Request To Delete Concurrent Requirements” section of this AD is not feasible.

We do not agree. Paragraph (k) of this AD mandates the previously optional preventative modification specified in paragraph (c) of AD 2000-05-29. A mandatory requirement takes precedence over an optional action. Therefore, we find that no conflict exists between the requirements of this AD and AD 2000-05-29.

In addition, we considered superseding ADs 2000-05-29 and AD 2001-02-01 when developing the NPRM. We determined that doing so would have made this AD more complex and would have increased the consequent workload associated with revising maintenance record entries, because this AD does not affect all requirements of those ADs. This AD only affects paragraph (c) of those ADs. Therefore, we determined that a less burdensome approach for operators was not to supersede those existing ADs.

If the concurrent requirements of the NPRM are kept, Delta further requests that Boeing be tasked to address airplanes on which the replacement of the forward pressure bulkhead web has been done and on which the modification of the vertical beam has not been done.

We do not agree. We have determined that the procedures specified in the Accomplishment Instructions of Boeing Service Bulletin 737-53A1225, Revision 1, dated April 14, 2005, adequately address all affected airplanes. Although the information mentioned by Delta may be helpful, the procedures specified in the service bulletin are adequate. Therefore, we find it inappropriate to task Boeing to revise the service bulletin and to delay the issuance of this AD. However, if additional data are presented that would justify additional actions, we may consider further rulemaking on this issue.

Southwest requests that paragraphs (k) and (l) of the NPRM be revised to allow AMOCs approved previously in accordance with ADs 2000-05-29 and 2001-02-01, respectively. Southwest wants to avoid any issues as to whether or not those AMOCs must be resubmitted to us for approval.

Continental requests that paragraph (k) of the NPRM be revised to refer to Boeing Service Bulletin 737-53A1173, Revision 4, dated September 19, 2002. Continental states that Revision 4 included several corrections and work flow improvements.

We partially agree with both Southwest and Continental. We agree that approved AMOCs to paragraph (c) of ADs 2000-05-29 and 2001-02-01 that are done before or concurrently with the requirements of paragraph (i) of this AD are acceptable as AMOCs for the corresponding provisions of paragraphs (k) and (l) of this AD, respectively. Boeing Service Bulletin 737-53A1173, Revision 4, is one of those AMOCs. We do not agree with the commenters that the paragraphs (k) and (l) should be revised in regard to AMOCs. The appropriate paragraph to revise is paragraph (m) of this AD, which is the AMOC paragraph. Therefore, we have revised paragraph (m) accordingly.

Boeing requests that paragraph (m)(3) of the NPRM be changed to allow AR approval of modifications as well as repairs.

We agree and have revised paragraph (m)(3) of this AD accordingly.

The ATA, on behalf of two of its members, U.S. Airways and United, requests that the Costs of Compliance section in the preamble of the NPRM account for the work required to gain access, reassemble, complete post-modification checkouts, close access, etc. associated with the proposed inspection and preventative modification. U.S. Airways states that these actions represent an increase of almost 40 percent above and beyond the 240 work hours specified in the NPRM. United states that the proposed inspection and preventative modification are not normally accessed at any routine maintenance visit.

We do not agree. The Costs of Compliance section describes only the direct costs of the specific actions required by this AD. Based on the best data available, the manufacturer provided the number of work hours (240 for preventative modification; 4 for each inspection) necessary to do the required actions. This number represents the time necessary to perform only the actions actually required by this AD. We recognize that, in doing the actions required by an AD, operators may incur incidental costs in addition to the direct costs. The cost analysis in AD rulemaking actions, however, typically does not include incidental costs such as the time required to gain access and close up, time necessary for planning, or time necessitated by other administrative actions. Those incidental costs, which may vary significantly among operators, are almost impossible to calculate. Therefore, we have made no change to this AD in this regard.

Boeing requests that a typographical error be fixed in paragraph (h) of the NPRM. The reference to “paragraph (1) of this AD” should be changed to “paragraph (m) of this AD.”

We agree and have changed paragraph (h) of this AD accordingly.

We have carefully reviewed the available data, including the comments received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We have determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD.

There are about 3,132 airplanes of the affected design in the worldwide fleet. The following table provides the estimated costs for U.S. operators to comply with this AD.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in subtitle VII, part A, subpart III, section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866;

(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation.

Section 801 of the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 381 referred to herein as section 381), and the regulations promulgated under that statute, provide the basic legal framework governing the importation of food, drugs, devices, and cosmetics into the United States. Under 21 U.S.C. 381(a), the Secretary of the Treasury shall deliver to the Secretary of Health and Human Services, upon request, samples of food, drugs, devices, and cosmetics which are being imported or offered for import. The Secretary of Health and Human Services is authorized under section 381(a) to refuse admission of, among other things, any article that appears from the examination or otherwise to be adulterated or misbranded or to have been manufactured, processed, or packed under insanitary conditions. In addition, the Secretary of the Treasury is required by section 381(a) to cause the destruction of any article refused admission unless the article is exported, under regulations prescribed by the Secretary of the Treasury, within 90 days of the date of notice of the refusal or within such additional time as may be permitted pursuant to those regulations.

Under 21 U.S.C. 381(b), pending decision (by FDA) as to the admission of an article being imported or offered for import, the Secretary of the Treasury may authorize delivery of that article to the owner or consignee upon the execution by him of a good and sufficient bond providing for the payment of liquidated damages in the event of default, as may be required pursuant to regulation. In addition, section 381(b) allows the owner or consignee in certain circumstances to take action to bring an imported article into compliance for admission purposes under such bonding requirements as the Secretary of the Treasury may prescribe by regulation.

On November 25, 2002, the President signed into law the Homeland Security Act of 2002, Public Law 107-296, 116 Stat. 2135 (referred to in this document as “the HS Act”), which involved, among other things, the creation of a new cabinet-level department, the Department of Homeland Security (DHS), and the transfer or reorganization of a number of executive branch agencies and offices within existing cabinet-level departments. This legislation and subsequent reorganization plans affected the organization and operation of the Customs Service.

Section 402 of the HS Act provides that the Secretary of Homeland Security shall be responsible for administering the customs laws of the United States. With regard to the Customs Service, section 403(1) of the HS Act transferred the functions, personnel, assets, and liabilities of the Customs Service, including the functions of the Secretary of the Treasury relating to the Customs Service, to the Secretary of Homeland Security. However, notwithstanding the transfer of the Customs Service to DHS, section 412 of the HS Act provides that the legal authority vested in the Secretary of the Treasury over customs revenue functions is to be retained by the Secretary of the Treasury. Section 412 also authorizes the Secretary of the Treasury to delegate any of the retained legal authorities over the customs revenue functions to the Secretary of Homeland Security.

By Treasury Order 100-16, dated May 15, 2003, the Secretary of the Treasury, by virtue of authority vested in him/her by 31 U.S.C. 321(b) and section 412 of the Homeland Security Act of 2002, delegated to the Secretary of Homeland Security authority for customs revenue functions with certain exceptions, including that contained in paragraph (1)(a)(i) of the Order by which the Secretary of the Treasury retains the sole authority to approve regulations concerning import quotas or trade bans, user fees, marking, labeling, copyright and trademark enforcement, and the completion of entry or substance of entry summary including duty assessment and collection, classification, valuation, application of the U.S. Harmonized Tariff Schedules, eligibility or requirements for preferential trade programs, and establishment of related recordkeeping requirements. As this final rule concerns activities involving both the completion of entry and the substance of the entry summary focusing on bond obligations and consequences that might arise as a result of post-entry and post-summary determinations of admissibility of merchandise, its subject matter is excepted from the delegation of authority to the Secretary of Homeland Security. Thus, the responsibility for this regulation rests with the Secretary of the Treasury.

Based upon the above Federal Food, Drug, and Cosmetic Act statutory provisions, imported foods, drugs, devices, and cosmetics are conditionally released under bond while determinations as to admissibility are made; see 19 CFR 12.3. Under current 19 CFR 141.113(c), CBP may demand the return to CBP custody of most types of merchandise that fail to comply with the laws or regulations governing their admission into the United States (also referred to as the redelivery procedure).

The condition of the basic importation and entry bond contained in 19 CFR 113.62(d) sets forth the obligation of the importer of record to timely redeliver released merchandise to CBP on demand and provides that a demand for redelivery will be made no later than 30 days after the date of release of the merchandise or 30 days after the end of the conditional release period, whichever is later. Under current procedures, when imported merchandise is refused admission by the Food and Drug Administration (FDA), CBP issues a notice of redelivery in order to establish a claim for liquidated damages if the importer of record fails to export, destroy, or redeliver the refused merchandise in the time period prescribed in that notice of redelivery.

CBP has taken the position in C.S.D. 86-21 that the term “end of the conditional release period” in 19 CFR 113.62(d) has reference to a set time limitation that is either established by regulation ( see , for example, 19 CFR 141.113(b) which prescribes a 180-day conditional release period for purposes of determining the correct country of origin of imported textiles and textile products) or by express notification to the importer of record. The end of the conditional release period does not refer to the liquidation of the entry covering the imported merchandise.

On June 7, 2002, a Notice of Proposed Rulemaking was published in the Federal Register (67 FR 39322; the NPRM) that proposed to amend the regulations to provide for a specific conditional release period for merchandise for which the FDA is authorized to determine admissibility. The changes proposed were intended to clarify importers' responsibilities under the bond, provide a defined period of time to allow the FDA to perform its enforcement functions, and provide finality to the process.

The NPRM proposed to make the following specific changes to what were then referred to as the Customs regulations (now the CBP regulations):

1. To redesignate some paragraphs in 19 CFR 141.113 due to the addition of a new paragraph (c), which provided for a specific conditional release period of 180 days for any food, drug, device, or cosmetic. The FDA would have this time period to make its determination of admissibility. Similar to the case of textiles and textile products mentioned above, the proposed amendment specified a 180-day conditional release period but also provided for a shorter period if FDA made a determination of inadmissibility before the expiration of that 180-day period. It is noted that under the proposed regulatory text, a demand for redelivery under 19 CFR 113.62(d) could be made up to 210 days (that is, 180 days plus 30 days) after the date of release of the merchandise. (The standard CBP bond condition states that redelivery may be demanded within 30 days after release or 30 days after the end of any applicable conditional release period, whichever is later.) The proposed regulation also made clear that the failure to redeliver merchandise would result in the assessment of liquidated damages equal to three times the value of the merchandise or equal to the domestic value of the merchandise in those instances where the port director has required a bond equal to the domestic value as permitted by current 19 CFR 12.3.

2. To amend 19 CFR 151.11 to authorize a representative of the FDA to obtain samples of food, drugs, devices, and cosmetic products covered by the Federal Food, Drug, and Cosmetic Act.

One hundred and forty (140) comments were received from importers, brokers, sureties, freight forwarders, express consignment operators, and trade associations. All commenters were opposed to the length of time of the proposed conditional release period. An analysis of those comments follows.

The vast majority of commenters stated that, as importers of food and health and beauty aid products, having a conditional release period of 180 days would effectively put them out of business. The costs involved in warehousing the goods would make their businesses unmanageable. Additionally, the long waiting period could cause products to fall out of specification, lose effectiveness, or become obsolete or unusable. These comments assume that any FDA-regulated merchandise must be held intact for 180 days after entry. Other commenters who stated that the 180-day period is too long recognize that the intent of the regulation was not to require that all this merchandise be held during the pendency of the conditional release period, but rather that it only apply to merchandise for which an admissibility decision by FDA is not made. Many of these commenters specifically recommended that the conditional release period end upon issuance of a notice from FDA providing that the goods may proceed (a may proceed notice) or issuance of a notice of refusal if those acts occur before the end of the 180-day conditional release period. Various other commenters noted that under FDA's own Regulatory Procedures Manual, articles which have been released by FDA are no longer considered to be in import status by that agency.

After review of all the comments, CBP concurs that the 180-day conditional release period is too long. Thus, the regulatory text of this final rule is amended to provide that the conditional release period ends upon the soonest occurring of the following events: issuance by the FDA that the merchandise may proceed, issuance of a notice of refusal of admission, or expiration of the 30-day period after release of the goods.

It was not the intention of the proposed regulation to require that all goods regulated by the FDA be warehoused for 6 months while the conditional release period runs its course. When FDA issues a notice that the merchandise may proceed (which is the case on the vast majority of entries that come under FDA scrutiny), that act will serve to end the conditional release period. Accordingly, we concur with the commenter who recommended amendment of the proposed rule to indicate that the conditional release period ends upon issuance of the notice by FDA that the merchandise may proceed. In addition, the issuance of a notice of refusal of admission would end the conditional release period.

There may be some situations where FDA will need additional time to determine admissibility. Accordingly, the final rule also includes regulatory language that would permit FDA to extend the general 30-day conditional release period through express notification to the importer identifying the necessary testing requiring this extension.

Many commenters opposed the 180-day conditional release period for the reason that it extends the current conditional release period of 30 days.

Under the conditions of the basic importation bond, in order to establish a valid claim for liquidated damages for failure to redeliver merchandise into CBP custody, CBP must issue a notice of redelivery within 30 days of CBP release of merchandise or within 30 days after the end of the conditional release period, whichever is later. As stated in the notice of proposed rulemaking, there currently exists no conditional release period created by regulation for merchandise the admissibility of which is determined by the FDA. Therefore, neither the proposed rulemaking nor this final rule extends the conditional release period from 30 to 180 days because no express conditional release period for FDA contexts has ever been created by regulation. The commenters were apparently confusing the conditional release period with the 30-day period, after the conditional release period, during which CBP may still demand redelivery.

One commenter suggested that the proposed sampling procedures would result in the compromising of its packaging between manufacturing sites and customers' facilities. The commenter proposed a process whereby it and other manufacturers could provide dedicated samples of present and proposed imported products, and CBP could maintain a data bank of importers and known imported products covered by these regulations.

The commenter's suggestion is outside the scope of the regulation because it proposes an examination procedure that is not done on a shipment-by-shipment basis. Under the provisions of 21 U.S.C. 381, CBP delivers to the Secretary of Health and Human Services such samples of food, drugs, devices, and cosmetics that are being imported or offered for import into the United States. Through these regulations, this sampling authority is delegated to the FDA in recognition of the practicalities of merchandise inspection. This will clarify that FDA inspectors may, under section 381(a), pull samples of imports of food, drugs, devices, and cosmetics.

One commenter asked whether CBP contemplates changing line release (otherwise known as Border Release Advanced Screening and Selectivity (BRASS)) procedures to accommodate the exchange of information necessary for providing notices of sampling.

Contemplated changes to line release (otherwise known as BRASS release) systems are operational in nature and are, thus, outside the scope of this rulemaking.

One commenter suggested that the rule must be rescinded in order to comply with Executive Order (E.O.) 12866. The commenter stated that given the huge volume of imports involved, the storage costs alone would almost certainly exceed the $100 million threshold or would, at the very least, adversely affect in a material way the economy, a sector of the economy, productivity, competition, or jobs.

The commenter did not provide detail or justification for these comments, but CBP does not believe that storage costs of this magnitude would be incurred as a result of the rule now being promulgated. As noted above, CBP does believe that the 180-day conditional release period originally proposed is too long and realizes that this time period could negatively affect importers. To that end, CBP has modified the conditional release period from 180 days to 30 days in the final rule to reduce potential negative impacts to imports and corresponding storage costs.

Various commenters state that CBP has failed to comply with the Regulatory Flexibility Act, disagreeing with the statement in the proposed rulemaking that the proposed amendments, if adopted, will not have a significant impact on a substantial number of small entities. The commenters claim that, contrary to the assertion in the notice of proposed rulemaking, assessment of liquidated damages of three times the value of imported merchandise could have a devastating impact upon the many thousands of small companies engaged in the importation of FDA-regulated products. It is also stated that the proposed rulemaking represents a radical departure from current CBP policy with regard to redelivery of FDA-regulated products.

CBP does not agree because the rule is not a radical departure from current CBP policy. Additionally, in response to the comments to the proposed rule, the final rule reduces the conditional release period time from 180 days to 30 days, and potential costs that could be incurred should now be substantially less. The rule should not affect small entities that are compliant with redelivery requirements, and the rule does not impose further entry requirements or additional paperwork burden.

Various commenters suggested that CBP rescind or place a stay on consideration of the proposed rulemaking until the implications of recently passed legislation governing port security can be considered in relation to FDA's inspection protocol and CBP's release procedures. The commenters indicated that the new law requires that importers provide CBP and FDA with advance notice of their intent to import food products—a procedure that should enhance FDA's ability to promptly identify shipments that pose a safety concern. Those commenters also stated that the proposed rule should be rescinded in order to allow CBP and FDA to examine and discuss standardization of FDA notifications to importers and to take into account the commercial needs of the importing community.

CBP disagrees. We are unaware of legislation governing port security that impinges upon or supplants FDA's authority to refuse merchandise pursuant to the provisions of 21 U.S.C. 381(a). That provision allows for the release of merchandise under bond while the determination as to admissibility is made. This rulemaking simply provides for the creation of a conditional release period for FDA contexts that is more clearly defined than the practice that currently exists. Furthermore, the Bioterrorism Act creates a new section 21 U.S.C. 381(m), which specifically indicates that FDA-regulated food and food products for which prior notice of arrival is not received shall not be released under a bond authorized by section 381(b). As set out in implementing regulations issued by FDA and CBP (see 68 FR 58974), decisions regarding compliance with new prior notice requirements are different from, and may precede, determinations of admissibility under other sections of the Federal Food, Drug, and Cosmetic Act or other laws. ( See 21 CFR 1.283(g).) While CBP believes that the Bioterrorism Act will affect the importation of FDA-regulated products, it does not serve to overrule regulations concerning longstanding FDA and CBP authorities. Effect must be given to all of the substantive provisions of 21 U.S.C. 381, not part of them. Further, since the FDA-regulated food or food products for which prior notice of arrival is not received will not be released under a bond authorized by section 381(b), any issues arising concerning a conditional release period for merchandise released under bond are moot.

One commenter suggested that the time period to comment on the proposed rule be extended because of the complex underlying issues involved.

CBP disagrees that the comment period needed to be extended. CBP received 140 comments to the proposed rule, and a wide variety of issues were presented in these comments. The primary concern, which was raised by all commenters to the proposed rule, was the length of the conditional release period. In response to this concern CBP has reduced the conditional release period from 180 to 30 days.

Many commenters conceded that it may be appropriate to clearly define a conditional release period, but they also suggested that 30 days would be a reasonable conditional release period for these products. Those same commenters also stated that CBP must further clarify and limit the scope of the proposed rule. Clarification is needed that clearly exempts from the conditional release period shipments that have been issued a may proceed notice. The commenters also suggested that FDA should notify importers when an entry is deemed conditional. As proposed, the commenters claimed that the rule represents a radical departure from current practices when the release of imported product is only rendered conditional through FDA's timely notification of its intent to examine or sample the product.

CBP agrees that the rule should make clear that a conditional release period ends when FDA provides a may proceed notice. The final rule has been amended accordingly. CBP also agrees that a conditional release period shorter than 180 days is appropriate and has amended the rule to provide for a conditional release period of 30 days after the release of the merchandise unless FDA issues a may proceed notice or a notice of refusal which would immediately end the conditional period as provided for in the final rule. However, shipments that have been issued a may proceed notice are still subject to demands for redelivery for 30 days from the issuance of the may proceed notice. The regulation confirms that all FDA-regulated products under the Federal Food, Drug, and Cosmetic Act are conditionally released pending FDA's determination of admissibility. In the vast majority of cases the conditional release period will end when the may proceed notice is provided before the end of the time provided in the regulation.

Various commenters contended that CBP seeks to modify its regulations in order to reverse the result of the court decision in United States v. So's USA Company, Inc., 23 CIT 605 (1999). These commenters stated that the So's court indicated that an importer must have affirmative notice that goods are released conditionally in order to extend the redelivery period beyond the 30 days from the date of release. Another stated that under the proposed regulation, FDA would no longer be required to advise an importer why its product is on hold, or even that it is on hold, within the first 30 days of entry.

CBP disagrees. The final rule is entirely consistent with the So's opinion and it does not conflict with that opinion in any respect. Further, this regulation does not affect any notice that FDA provides to an importer under its authorities.

One commenter stated that the proposal is arbitrary because the Government has not explained the need for a 180-day period to render a decision on admissibility. The statement in the proposed rule that the 180-day period is a reasonable period of time to allow the FDA to perform its enforcement functions is not supported by any explanation.

Again, CBP agrees that the 180-day period is too long a time period to have this merchandise conditionally released by regulation. Accordingly, the conditional release period has been reduced to 30 days in the final regulation. The 30-day release period can be shortened by the earlier issuance of a may proceed notice or a notice of refusal of admission. It also can be extended by an express notification from FDA to the importer.

One commenter suggested that FDA import inspectors issue a notice of review with regard to any shipment for which a may proceed notice is not provided. The commenter stated that the conditional release period could be established from the issuance date of the notice of review. That same commenter stated that for perishable products, the conditional release period should not exceed 5 days. For non-perishable products, the conditional release period should not exceed 30 days.

Issuance of a new FDA form of notice that a shipment is under review is beyond the scope of this regulation. CBP disagrees that a conditional release period should be for as little as 5 days. The taking of samples and testing of merchandise could exceed that 5-day time period.

Some commenters stated that the 180-day conditional release period is not consistent with the Customs-Trade Partnership Against Terrorism (C-TPAT) in that homeland security efforts are focused on increased review of imports at the time of admission. The proposed 180-day period would provide no potential homeland security benefits since the materials would already be conditionally released to importers.

CBP acknowledges that the proposed 180-day conditional release period is too long and has revised the regulation accordingly. Review of cargo for terrorism concerns preferably is performed earlier than the time of admission of merchandise. In fact, review for terrorism concerns is performed in the information transmission or presentation process, which is in advance of arrival. For example, the FDA's prior notice regulations (21 CFR 1.276 et seq. ) require notice of food being imported or offered for import into the United States in advance of the foods' arrival, and CBP's advance electronic cargo information regulations (set forth in 68 FR 68140) require information concerning cargo before the cargo is brought into the United States by any mode of transportation, so that CBP can pre-screen all cargo based on advance data transmission. CBP's enforcement of these requirements is consistent with C-TPAT. The conditional release period is meant to address the longstanding application of the provisions of the Federal Food, Drug, and Cosmetic Act, which allow for the release of merchandise under good and sufficient bond pending an admissibility determination and therefore is in addition to the prior notice and advance cargo information requirements that implement border security measures.

Many commenters stated that a 180 day conditional release period is contrary to public policy in that merchandise which causes a public health or safety issue should be identified and refused by FDA as quickly as possible. A 180-day period raises an unreasonable risk.

CBP has revised the regulation to provide for a 30-day conditional release period in order to address this concern.

Many commenters indicated that if the redelivery period was shorter than the 180-days prescribed, companies would hold merchandise pending such a period and there would be more chance for a successful recall for safety concerns, since there is less chance that the goods would have been used or consumed.

CBP agrees and has revised the final rule to provide for a 30-day conditional release period in order to address this concern.

One commenter suggested that CBP should strive to allow unconditional release of FDA-regulated merchandise with the filing of the CF-3461 (CBP entry document) as long as the entry summary and carrier manifest data are consistent with information contained within the FDA approved product listings.

CBP disagrees because this would have CBP making decisions as to admissibility under the Federal Food, Drug, and Cosmetic Act when this decision-making authority clearly resides with the Secretary of Health and Human Services.

Many commenters stated that the proposed amendment to 19 CFR 151.10 of the CBP regulations regarding the collection of samples is not necessary. The commenters noted that the provisions of section 702(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 372) already allow for the taking of samples by representatives of FDA.

Under the provisions of 21 U.S.C. 381(a), CBP delivers samples of food, drugs, devices, and cosmetics that are being imported or offered for import into the United States, to the Secretary of Health and Human Services upon his request. The proposed amendment simply clarifies that such delivery authority is delegated to representatives of FDA and is not intended to intrude on any other authority that the Secretary of Health and Human Services may already have.

A group of commenters suggested the adoption of regulatory language that would preclude the issuance of fines or penalties against an importer who distributes articles after having received an FDA may proceed notice.

CBP disagrees with this proposed language. CBP cannot by regulatory amendment exempt an importer from incurring fines or penalties that may otherwise be imposed for violation of a statute.

Various commenters stated that imposition of a 180-day conditional release period is violative of U.S. international obligations under the GATT 1994, and one commenter indicated that the proposed rule is violative of the Agreement on the Application of Sanitary and Phytosanitary Measures. While conceding that some additional controls at the border are acceptable, these commenters asserted that extending CBP control over imports for a seven-month period after importation would not stand scrutiny. Additionally, it was noted that sanitary and phytosanitary procedures must be undertaken and completed without undue delay (commenter's emphasis) and in no less favorable a manner for imported products than for like domestic products. Imposition of a conditional release period of 180 days is claimed to be violative of this “undue delay” proscription.

Again, CBP has reduced the conditional release period from 180 to 30 days in the final rule.

Some commenters indicated that continuation of a conditional release period after FDA admits goods into commerce is inconsistent with the provisions of the Federal Food, Drug, and Cosmetic Act. The commenters stated that conditional delivery of the merchandise to the owner is made pending a decision as to admission generally, and not solely a decision to deny admission. It is argued that conditional release also ends upon admission of the article and, as such, CBP's proposal to extend the conditional release period to 180 days without concern as to whether the merchandise has been admitted defeats the statutory intent of the Act. In contrast, another commenter stated that once a positive determination as to admissibility is made, the importer should not have to be subjected to the possibility of a redelivery demand for sampling or testing of the product. The latter commenter further contended that even after receiving a may proceed notice, an importer is left in the dark as to the status of goods that are apparently admitted into the commerce.

CBP agrees that issuance of a notice from FDA that the merchandise may proceed would usually make it unnecessary to issue a redelivery notice in order to establish liability under the bond. For purposes of clarity, CBP is amending the language in the final rule to indicate that one of three acts occurring first in time—issuance of a notice of refusal, issuance of a may proceed notice or passage of 30 days from the date of conditional release—will end the conditional release period. However, it should be understood that issuance of a may proceed notice does not mean that CBP is precluded from issuing a subsequent demand to redeliver within 30 days from the end of that conditional release period.

Two commenters suggested that sureties be given the earliest possible notice (preferably in electronic form) that goods they have secured are subject to detention, refusal, and/or redelivery in order that immediate action can be taken with regard to pending and future importations. Also, mitigation guidelines should be adopted that provide extraordinary mitigation to sureties for efforts to locate, redeliver, and/or rehabilitate goods which are subject to liquidated damages for failure to redeliver into CBP custody.

Mitigation guidelines for claims for liquidated damages are outside the scope of this rulemaking. Issuance of notices of detention and refusal are governed by FDA statute and regulation and any changes to issuance of those documents are also outside the scope of this regulation. Notices of redelivery may include private or confidential business information that would not be releasable to a surety unless a demand for payment was made against its bond.

One commenter proposed that the regulation require that all demands for redelivery be made contemporaneously with the notice of refusal issued by FDA. The commenter contended that this change would promote cooperation between FDA and CBP and encourage compliance through the more efficient issuance of required notices.

CBP does not agree because, for operational reasons, it may not always be possible for notices to be issued contemporaneously.

In accordance with the foregoing analysis of the comments and further consideration of the matter, CBP has determined that the amendments of the proposed rule should be adopted as final with the sole major change being a reduction in the conditional release period from 180 days to 30 days, as set forth in the regulatory text further below. In addition, cross-references to the section of the regulations involving conditional release periods are being added to the relevant portion of the section on basic importer and entry bond conditions in 19 CFR 113.62.

This rule is not considered to be a significant regulatory action under Executive Order 12866. Accordingly, a regulatory assessment is not required.

It is certified, pursuant to the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), that the regulatory amendments set forth in this final rule will not have a significant economic impact on a substantial number of small entities. The rule should not affect small entities that are compliant with redelivery requirements, and the rule does not impose further entry requirements or additional paperwork burdens.

A review of data for FY2004 indicates actual CBP liquidated damage collections for FDA jurisdiction goods are comparatively rare and of modest amounts. The total amount of liquidated damages collected in FY2004 for these goods was approximately $4 million. The total revenue (including those liquidated damages) collected for all imports was $27 billion. This amount reflects 6,000 liquidated damage cases, compared to 28.1 million entries of all goods worth $1.41 trillion. Pertinent cases and liquidated damage amounts are a tiny fraction (less than 1 percent) of overall revenue collected and import value. The value of liquidated damages collected changes minimally from year to year based on the number of importers, the number of bonds, and the number of violations. CBP does not expect this amount to change as a result of this rule.

Additionally, the conditional release period should help importers, regardless of size, by clarifying that CBP must issue a redelivery notice within 30 days if it wishes to collect liquidated damages. As noted previously, there is currently no set date to issue a redelivery notice. The rule will compel CBP to act more quickly to provide notice to importers that violate the conditions of their bond. If CBP cannot act within the 30 days, it then foregoes collecting any liquidated damages.

The Saint Lawrence Seaway Development Corporation (SLSDC) and the St. Lawrence Seaway Management Corporation (SLSMC) of Canada, under international agreement, jointly publish and presently administer the St. Lawrence Seaway Tariff of Tolls (Schedule of Fees and Charges in Canada) in their respective jurisdictions.

The Tariff sets forth the level of tolls assessed on all commodities and vessels transiting the facilities operated by the SLSDC and the SLSMC. The SLSDC is revising 33 CFR 402.8, “Schedule of tolls”, to reflect the fees and charges levied by the SLSMC in Canada beginning in the 2007 navigation season. With one exception, the changes affect the tolls for commercial vessels and are applicable only in Canada. The collection of tolls by the SLSDC on commercial vessels transiting the U.S. locks is waived by law (33 U.S.C. 988a(a)). Accordingly, no notice or comment was necessary on these amendments.

The SLSDC is amending 33 CFR 402.8, “Schedule of tolls”, to increase the minimum charge per vessel per lock for full or partial transit of the Seaway from $20.40 to $25.00. This charge is for vessels that are not pleasure craft or subject in Canada to the tolls under items 1 and 2 of the Tariff. This increase is due to higher operating costs at the locks.

The SLSDC is modifying its practice regarding the collection of pleasure craft tolls by allowing pleasure craft operators to pay the toll for transiting the U.S. locks, Eisenhower and Snell, in either $30 U.S. or $30 Canadian. Currently the toll is payable in $25 U.S. or $30 Canadian; however, this has resulted in confusion to pleasure craft operators when transiting both Canadian and U.S. locks. With almost eighty (80) percent of the tolls for pleasure crafts being paid in Canadian dollars and little disparity between the U.S. and Canadian exchange rates, the SLSDC is streamlining the pleasure craft toll collection process by allowing for payment in either $30 U.S. or $30 Canadian. Additionally, the SLSDC is making several minor editorial changes to 33 CFR402.3 and 33 CFR 402.5. Interested parties have been afforded an opportunity to comment; however no comments were received.

Regulatory Notices: Privacy Act: Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit http://dms.dot.gov.

This regulation involves a foreign affairs function of the United States and therefore Executive Order 12866 does not apply and evaluation under the Department of Transportation's Regulatory Policies and Procedures is not required.

I certify this regulation will not have a significant economic impact on a substantial number of small entities. The St. Lawrence Seaway Tariff of Tolls primarily relate to commercial users of the Seaway, the vast majority of whom are foreign vessel operators. Therefore, any resulting costs will be borne mostly by foreign vessels.

This regulation does not require an environmental impact statement under the National Environmental Policy Act (49 U.S.C. 4321, et reg.) because it is not a major federal action significantly affecting the quality of the human environment.

The Corporation has analyzed this rule under the principles and criteria in Executive Order 13132, dated August 4, 1999, and has determined that this proposal does not have sufficient federalism implications to warrant a Federalism Assessment.

The Corporation has analyzed this rule under Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, 109 Stat. 48) and determined that it does not impose unfunded mandates on State, local, and tribal governments and the private sector requiring a written statement of economic and regulatory alternatives.

This regulation has been analyzed under the Paperwork Reduction Act of 1995 and does not contain new or modified information collection requirements subject to the Office of Management and Budget review.

In addition to revising 36 CFR Part 1280 provisions on the inspection of personal property, the final rule identified those properties that had come under the control of the Archivist since the last revision of the regulation. Although the final rule incorrectly used “ The National Archives Southwest Region ” as the heading to 36 CFR 1280.2(d), the rule did correctly identify the physical location of the property as the National Archives Southeast Region in Morrow, Georgia, as specified in 36 CFR 1253.7(e).

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This supplementary information section is arranged as follows:

On June 15, 2004, the EPA designated eight counties in Southeast Michigan as nonattainment for the 8-hour ozone standard (Detroit-Ann Arbor CMSA—Lenawee, Livingston, Macomb, Monroe, Oakland, St. Clair, Washtenaw, and Wayne Counties). These counties were initially classified under the CAA as Moderate, but EPA later reclassified them as Marginal on September 22, 2004. See 69 FR 56697 (September 22, 2004) for further details. As part of this reclassification, the Michigan Department of Environmental Quality (MDEQ) and the Southeast Michigan Council of Governments (SEMCOG) committed to a schedule to identify and implement controls that will help the area attain by the Marginal attainment date of June 15, 2007.

To bring this area into attainment, the State is adopting and implementing a broad range of ozone control measures including control of emissions from cement manufacturing, control of emissions from the use of consumer/commercial products, and the implementation of a 7.0 psi low-RVP fuels program.

The State of Michigan submitted a SIP revision on May 26, 2006, and July 14, 2006, which included legislation establishing a lower RVP fuel requirement for gasoline distributed in the 8-hour ozone nonattainment area portions of Southeast Michigan. In addition, Michigan submitted additional technical support for the SIP revision, including materials supporting the State's request to waive the CAA preemption of State fuel controls pursuant to section 211(c)(4) of the CAA. On August 15, 2006, EPA proposed approval of the State's SIP revision to establish a 7.0 psi low-RVP fuel program in the Southeast Michigan area which includes Lenawee, Livingston, Macomb, Monroe, Oakland, St. Clair, Washtenaw, and Wayne Counties. (See 71 FR 46879.) As detailed in the proposed approval, EPA found the State's demonstration sufficient to satisfy the necessity requirement of Section 211(c)(4)(C) of the CAA. In addition, EPA also proposed approval of the State's SIP revision as consistent with the provisions of the Energy Policy Act (EPAct), based on our interpretation of the EPAct provisions discussed at 71 FR 32532 (June 6, 2006).

During the comment period we received two comment letters on the August 15, 2006, proposal. The first, from the Grand Rapids Area Chamber of Commerce, supported the proposed SIP approval and recommended that it be implemented as quickly as possible. The second, from the National Petrochemical and Refiners Association (NPRA), raised concerns regarding whether the August 15, 2006, proposal addressed all the pertinent requirements under EPAct needed to approve Michigan's fuel waiver request. NPRA's comments are addressed below.

Comment: The NPRA expressed support for EPA's fuel controls preemption review process, but commented that EPA could not approve Michigan's request for a waiver from preemption of state fuel controls, prior to finding, after public review and comment, that the proposed new fuel would not cause either supply or distribution disruptions or have an adverse impact on fuel producibility in the affected or contiguous areas. The NPRA also stated that EPA should consult with the Secretary of Energy and publish findings in the Federal Register that the proposed new fuel will not cause supply or distribution disruptions and will not have an adverse impact on fuel producibility in the affected area or in contiguous areas.

Response: In our proposed approval of Michigan's waiver of preemption to adopt a 7.0 psi RVP fuel program, we explained that the EPAct amended CAA section 211(c)(4)(C) by requiring EPA, in consultation with the Department of Energy (DOE), to determine the total number of fuels approved into all SIPs as of September 1, 2004, under section 211(c)(4)(C), and publish for public review and comment a list of such fuels, including the state and Petroleum Administration for Defense District (PADD) in which they are used. We explained that the EPAct also placed three additional restrictions on our authority to waive preemption by approving a state fuel into the SIP. Under one restriction, where our approval of a new fuel would not increase the total number of fuels approved into SIPs as of September 1, 2004, because the total number of fuels at that point is below the number of fuels approved into SIPs as of September 1, 2004, we make a finding, after consultation with the DOE, that the new fuel will not cause supply or distribution interruptions or have a significant adverse impact on fuel producibility in the affected or contiguous areas.

We further explained that, on June 6, 2006, we had discussed an interpretation of the EPAct that required EPA to identify and publish a list of the total number of fuels approved into all SIPs as of September 1, 2004, and imposed three restrictions on our ability to approve future state fuel programs into SIPs.

We also explained that, based on our June 6, 2006, interpretation of the EPAct amendments, Michigan's 7.0 psi RVP requirement for Southeast Michigan would not increase the total number of fuels approved into all SIPs, as of September 1, 2004, and was not a “new fuel type,” because 7.0 psi RVP is on the published draft list of fuels. We further explained that we did not need to make a finding, after consultation with DOE, on the effect of a 7.0 psi RVP fuel requirement in Southeast Michigan on fuel supply and distribution in either Southeast Michigan or the contiguous areas because the fuel was not a new fuel, and the total number of fuels approved into SIPs as of our consideration of Michigan's 7.0 psi RVP fuel was not below the number of fuels approved into SIPs as of September 1, 2004, or, in other words, below the total number of fuels on the published draft list. 71 FR 46879, 46882-46883 (August 15, 2006).

At proposal, we also referenced that an April 2005 American Petroleum Institute study titled “Potential Effects of the 8-Hour Ozone Standard on Gasoline Supply, Demand and Production Costs,” which had concluded that the petroleum industry was capable of supplying 7.0 psi RVP fuel without any fuel supply or distribution disruptions. 71 FR 46879, 46882-46883.

We have now finalized the interpretation of the EPAct amendments, and published our final list of fuels, subject to a few revisions. See the final Federal Register notice entitled “Boutique Fuels List” under Section 1541(b) of the Energy Policy Act.” 71 FR 78192 (December 28, 2006). Under this final interpretation, because the 7.0 psi RVP is not a new fuel; and the total number of fuels approved into all SIPs at this time is not below the number of fuels on the final list of fuels, we are not required to make a finding, after consultation with DOE, on the effect of Michigan's 7.0 psi RVP fuel requirement in Southeast Michigan on fuel supply and distribution in either Southeast Michigan or the contiguous areas.

Comment: The commenter emphasized that the fuel supply analysis and public comment duties outlined in the EPAct apply to this approval process because currently there are no other summer maximum 7.0 psi RVP conventional gasoline areas within hundreds of miles of Detroit and Ann Arbor.

Response: As earlier explained, under the fuel type interpretation that we have adopted, where there is a new fuel type and there is “room” on the fuels list, we may approve a state fuel program, after consultation with the DOE, and a finding that the state fuel will not cause either supply or distribution interruptions; or have a significant adverse impact on fuel producibility in either the affected or contiguous areas. This fuel is not a new fuel and the total number of fuels approved into all SIPs at this time is not below the number of fuels on the final list of fuels (See 71 FR 78192), therefore we do not believe that we are required to make a finding on the effect of a 7.0 psi RVP fuel requirement in Southeast Michigan on fuel supply and distribution in either Southeast Michigan or the contiguous areas. In addition, EPA consulted with DOE and they have concurred with our determination that the 7.0 psi Michigan fuel does not constitute a new boutique fuel and hence a supply study is not required.

In a Federal Register notice published on June 6, 2006 (71 FR 32532), we discussed an interpretation of the EPAct provisions which was based on a fuel type interpretation. We also identified and published a draft list of the total number of fuels approved into all SIPs as of September 1, 2004, pursuant to section 211(c)(4)(C)(i). On August 15, 2006, we proposed approval of Michigan's SIP revision as consistent with our June 6, 2006, interpretation of the EPAct provisions. On December 21, 2006, EPA Administrator Stephen L. Johnson signed a Federal Register notice containing EPA's final interpretation of the EPAct provisions. The final notice was published in the Federal Register on December 28, 2006. (See 71 FR 78192.) Our approval of Michigan's 7.0 psi RVP program is consistent with EPA's final promulgated interpretation of the EPAct.

EPA is approving a SIP revision submitted by the State of Michigan on May 26, 2006, and July 14, 2006, establishing a 7.0 psi RVP fuel requirement for gasoline distributed in Southeast Michigan which includes Lenawee, Livingston, Macomb, Monroe, Oakland, St. Clair, Washtenaw, and Wayne Counties. EPA is approving Michigan's fuel requirements into the SIP because EPA has found that the requirements are necessary for Southeast Michigan to achieve the 8-hour NAAQS for ozone. EPA's approval is consistent with the boutique fuel provisions of section 211(c)(4)(C) enacted in EPAct.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and, therefore, is not subject to review by the Office of Management and Budget.

Because it is not a “significant regulatory action” under Executive Order 12866 or a “significant regulatory action,” this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001).

This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ).

Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).

This rule also does not have tribal implications because it will 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, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

This action also does not have Federalism implications because it does not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act.

This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the state to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply.

This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under Section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by April 2, 2007. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. ( See Section 307(b)(2).)

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

In addition to accessing an electronic copy of this Federal Register document through the electronic docket at http://www.regulations.gov , you may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr. You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr.

Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0962 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before April 2, 2007.

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2006-0962 by one of the following methods:

•  Federal eRulemaking Portal : http://www.regulations.gov. Follow the on-line instructions for submitting comments.

•  Mail : Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

•  Delivery : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Building), 2777 S.Crystal Drive, Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is (703) 305-5805.

EPA, on its own initiative, in accordance with sections 408(e) and 408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is establishing time-limited tolerances for residues of the fungicide thiabendazole in or on Brussels sprout, cabbage, and cauliflower at 0.05 parts per million (ppm). These tolerances expire and are revoked on December 31, 2009. EPA will publish a document in the Federal Register to remove the revoked tolerances from the Code of Federal Regulations (CFR).

Section 408(l)(6) of the FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on section 18 related tolerances to set binding precedents for the application of section 408 of the FFDCA and the new safety standard to other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party.

Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of the FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

Section 18 of the FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” This provision was not amended by the Food Quality Protection Act of 1996 (FQPA). EPA has established regulations governing such emergency exemptions in 40 CFR part 166.

The fungus Phoma lingam is the cause of a destructive disease (black leg disease) on crucifer crops and has caused periodic epidemics in the United States. The applicants from California and Washington state that an emergency situation has existed since the registration for the pesticide product that had been the industry standard was cancelled in 2002. The applicants asserted that without the requested use of thiabendazole to control this disease, significant economic losses would occur. EPA has authorized under FIFRA section 18 the use of thiabendazole on Brussels sprout, cabbage, and cauliflower seeds for control of black leg disease caused by Phoma lingam in California and Washington State. After having reviewed the submission, EPA concurs that emergency conditions exist for these States.

As part of its assessment of these emergency exemptions, EPA assessed the potential risks presented by residues of thiabendazole in or on Brussels sprout, cabbage, and cauliflower. In doing so, EPA considered the safety standard in section 408(b)(2) of the FFDCA, and EPA decided that the necessary tolerances under section 408(l)(6) of the FFDCA would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemptions in order to address the urgent non-routine situations and to ensure that the resulting food is safe and lawful, EPA is issuing these tolerances without notice and opportunity for public comment as provided in section 408(l)(6) of the FFDCA. Although these tolerances expire and are revoked on December 31, 2009, under section 408(l)(5) of the FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerances remaining in or on Brussels sprout, cabbage, and cauliflower after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by these tolerances at the time of that application. EPA will take action to revoke these tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

Because these tolerances are being approved under emergency conditions, EPA has not made any decisions about whether thiabendazole meets EPA's registration requirements for use on Brussels sprout, cabbage, and cauliflower seeds or whether permanent tolerances for these uses would be appropriate. Under these circumstances, EPA does not believe that these time-limited tolerances serve as a basis for registration of thiabendazole by a State for special local needs under FIFRA section 24(c). Nor do these time-limited tolerances serve as the basis for any States other than California and Washington to use this pesticide on these crop seeds under section 18 of FIFRA without following all provisions of EPA's regulations implementing FIFRA section 18 as identified in 40 CFR part 166. For additional information regarding the emergency exemption for thiabendazole, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT .

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.

Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of thiabendazole and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for time-limited tolerances for residues of thiabendazole in or on Brussels sprout, cabbage, and cauliflower seeds at 0.05 ppm. EPA's assessment of the dietary exposures and risks associated with establishing these tolerances follows.

The dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological endpoint. However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences.

For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA SF.

For non-dietary risk assessments (other than cancer) the UF is used to determine the level of concern (LOC). For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x 10 6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a “point of departure” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOE cancer = point of departure/exposures) is calculated. A summary of the toxicological endpoints used for human risk assessment is discussed in Table 1 on page 8 of the human health risk assessment dated November 20, 2006: Section 18 Exemptions for the Use of Thiabendazole on Brussels sprout, Cabbage, and Cauliflower as a Seed Treatment , available in the docket for this action.

1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.242) for the residues of thiabendazole in or on a variety of raw agricultural commodities. Tolerances have also been established for thiabendazole and its metabolite 5-hydroxythiabendazole at 0.4 ppm in milk, 0.1 ppm in eggs, and 0.1 ppm in meat, fat, and meat byproducts of livestock and poultry. Risk assessments were conducted by EPA to assess dietary exposures from thiabendazole in food as follows:

i. Acute exposure. Since there are no toxic effects noted in the database that are likely the result of a single exposure to thiabendazole, no acute dietary endpoints have been selected.

ii. Chronic exposure. In conducting this chronic dietary risk assessment the Dietary Exposure Evaluation Model (DEEM TM ) analysis evaluated the individual food consumption as reported by respondents in the USDA 1994-1996 and 1998 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: The chronic dietary exposure analysis for thiabendazole is partially refined. For the use of thiabendazole as a seed treatment, the Agency used the analytical method limit of quantitation (LOQ) of 0.05 ppm as the appropriate residue value for Brussels sprout, cabbage, and cauliflower and assumed 100% crop treated as inputs into the DEEM chronic dietary analysis. Inputs into the DEEM analysis for all existing uses incorporated PDP data for many commodities, experimental processing factors, anticipated residues for animal commodities and percent crop treated information. Further, estimated thiabendazole residues in drinking water were incorporated directly into the dietary assessment using the highest chronic estimated environmental concentration (EEC) value for surface water.

iii. Cancer. Thiabendazole has been classified as “not likely to be carcinogenic to humans at doses that do not alter rat thyroid hormone homeostasis.” Chronic dietary risk is currently being regulated with a chronic RfD that reflects a dose level below the dose levels at which thyroid hormone balance is impacted. Since chronic dietary risk is below the Agency's level of concern, there is no concern for dietary cancer risk arising from existing uses as well as the use of thiabendazole as a seed treatment on Brussels sprout, cabbage, and cauliflower.

2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for thiabendazole in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of thiabendazole. Further, information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.

The treatment of seeds for purposes of the section 18 request is expected to be an indoor activity with no potential concern for leaching to ground water or run off to surface water. However, there is some potential for transfer of residues of thiabendazole to the environment with the planting of treated seed in the field. Drinking water was incorporated directly into the dietary assessment by extrapolation of the drinking water concentrations generated as a result of planting treated seed. Based on the GENEEC and SCI-GROW models, the estimated environmental concentrations (EECs) of for acute exposures are estimated to be 2.4 parts per billion (ppb) for surface water and 0.01 ppb for ground water. The EECs for chronic exposures are estimated to be 0.52 ppb for surface water and 0.01 ppb for ground water.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). The Agency has concluded that there is low potential for residential exposure based on thiabendazole's use profile, and the proposed section 18 uses of thiabendazole on Brussels sprout, cabbage, and cauliflower seeds do not result in new residential exposure scenarios. Currently, there are no thiabendazole products registered for use by residential users. However, thiabendazole is incorporated in low concentrations into paints, adhesives, paper, and carpet. This incorporation greatly reduces the potential for exposure. The Agency has calculated worst case scenarios for thiabendazole exposure to thiabendazole treated carpet and paint. A summary of the residential exposure and risk estimates for thiabendazole are summarized in Table 6 on page 16 of the human health risk assessment dated November 20, 2006: Section 18 Exemptions for the Use of Thiabendazole on Brussels sprout, Cabbage, and Cauliflower as a Seed Treatment , available in the docket for this action.

4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to thiabendazole and any other substances and thiabendazole does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that thiabendazole has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.

1. In general. Section 408 of the FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans.

2. Developmental toxicity studies. The toxicity database for thiabendazole includes an acceptable prenatal developmental toxicity study in rats and rabbits, which shows no increased sensitivity to fetuses. A neurotoxicity study is not required since there is no evidence in the database that supports a requirement for a developmental neurotoxicity study.

3. Reproductive toxicity study. Based on data submitted to the Agency as well as data from the open literature, there was no evidence of reproductive toxicity in the prenatal developmental toxicity studies in rats, rabbits, and mice or in the two-generation reproduction study in rats.

4. Prenatal and postnatal sensitivity. There is no evidence of increased susceptibility in rats, rabbits, or mice to in utero or early postnatal exposure to thiabendazole based on the prenatal developmental toxicity study rats, rabbits, and mice and in the two-generations reproduction study in rats. The developmental effects in the fetuses occurred at or above doses that caused maternal or paternal toxicity.

5. Conclusion. There is a complete toxicity database for thiabendazole and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. In terms of hazard, there are low concerns and no residual uncertainties regarding prenatal and/or postnatal toxicity.

The Agency currently has two ways to estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses. First, a screening assessment can be used, in which the Agency calculates drinking water levels of comparison (DWLOCs), which are used as a point of comparison against estimated drinking water concentrations (EDWCs). The DWLOC values are not regulatory standards for drinking water, but are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. More information on the use of DWLOCs in dietary aggregate risk assessments can be found at http:/www.epa.gov/oppfead1/trac/science/screeningsop.pdf. More recently, the Agency has used another approach to estimate aggregate exposure through food, residential and drinking water pathways. In this approach, modeled surface water and ground water EDWCs are directly incorporated into the dietary exposure analysis, along with food. This approach provides a more realistic estimate of exposure because actual body weights and water exposures are then added to estimated and water consumption form the CSFII are used. The combined food and water exposures are then added to estimated exposure from residential sources to calculate aggregate risks. The resulting exposure and risk estimates are still considered to be high end, due to the assumptions used in developing drinking water modeling inputs. The risk assessment for thiabendazole used in this tolerance document uses this approach of incorporating water exposure directly into the dietary exposure analysis.

EPA conducted partially refined chronic dietary assessments, which included the use of thiabendazole used as a seed treatment in/on Brussels sprout, cabbage, cauliflower seeds in addition to the existing use for thiabendazole that results in a chronic dietary exposure (food and water) for the U.S. population equivalent to 1.4% of the cPAD. The most highly exposed population subgroup is children 1 to 2 years of age with a chronic dietary exposure (food and water) which is equivalent to 4.2% of the cPAD. Since chronic dietary (food and water) estimates of risk for the U.S. population and all subgroups are below 100% of the cPAD, the Agency has no concern for chronic dietary risk from the use of thiabendazole as a seed treatment for use on Brussels sprout, cabbage, and cauliflower seeds.

1. Acute risk. EPA did not assess acute dietary risk for thiabendazole because no acute dietary endpoint of concern was identified for the general population or any subpopulation.

2. Chronic risk. EPA concluded that chronic aggregate exposure to thiabendazole from food and water will utilize 4.2% of the cPAD for the most highly exposed population subgroup, which is children 1 to 2 years of age. This chronic aggregate risk estimate is based on dietary risk from food and water. Since the estimated thiabendazole chronic aggregate dietary exposure from food and water for the general population and all subpopulations results in an estimated risk value less than 100% of the cPAD, EPA has no concern for chronic aggregate risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to from food will utilize 1.4% of the cPAD for the U.S. population, 4.2% of the cPAD for the most highly exposed subpopulation (children 1-2 years of age) and 1.2 % of the cPAD for females 13 to 49 years of age.

3. Short and Intermediate-term risk. Short-and intermediate-term aggregate exposure takes into account non-dietary, non-occupational exposure plus chronic exposure to food and water (considered to be a background exposure level). EPA does not expect short-and intermediate-term aggregate exposure to exceed the Agency's level of concern. The Agency has concluded that there is low potential for residential exposure based on thiabendazole's use profile. There are currently no thiabendazole products registered for use by residential users. However, thiabendazole is incorporated in low concentrations into paints, adhesives, paper, and carpet. This incorporation greatly reduces the potential for exposure. To assess short-and intermediate-term aggregate exposure likely to result from the use of thiabendazole on Brussels sprout, cabbage, and cauliflower as a seed treatment, as well as existing uses, the Agency combined average food and water exposure values with estimates of residential exposure. For adult populations, the Agency assumed that both painting with thiabendazole treated paint and contact with thiabendazole treated carpet could occur simultaneously and combined those exposures for the purpose of calculating the aggregate risk estimates. For infant and child populations, the Agency assumed that residential exposure was a result of contact with treated carpet only.

More detailed information on the short-and intermediate-term exposure and risk estimates for thiabendazole are summarized and can be found in the document entitled Section 18 Exemptions for the Use of Thiabendazole on Brussels sprout, Cabbage, and Cauliflower as a Seed Treatment , dated November 20, 2006 in Table 7 on page 17 of the human health risk assessment, by going to http:www.regulations.gov , and searching for docket ID number EPA-HQ-OPP-2006-0962. Double - click on the document to view the referenced information.

4. Aggregate cancer risk for U.S. population. Thiabendazole has been classified as “not likely to be carcinogenic to humans at doses that do not alter rat thyroid hormone homeostasis.” Since the chronic aggregate exposure is below the level that would alter rat thyroid hormone homeostasis, there is no concern for aggregate cancer risk arising from existing uses or the use of thiabendazole use as a seed treatment in/on Brussels sprout, cabbage, and cauliflower seeds.

5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population and to infants and children from aggregate exposure to thiabendazole residues.

Adequate enforcement methodology (example—gas chromatography) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov .

No specific CODEX, Canadian or Mexican maximum residue limits (MRLs) or tolerances have been established for thiabendazole in or on Brussels sprout, cabbage, or cauliflower. Therefore, international harmonization is not an issue at this time.

Therefore, time-limited tolerances are established for residues of thiabendazole in or on Brussels sprout, cabbage, or cauliflower at 0.05 ppm. These tolerances expire and are revoked on December 31, 2009.

This final rule establishes time-limited tolerances under section 408 of the FFDCA. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, 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). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq ., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a FIFRA section 18 exemption under section 408 of the FFDCA, such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on 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, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 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 final rule directly regulates growers, food processors, food handlers, and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, 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 rule 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. Thus, Executive Order 13175 does not apply to this rule.

The Congressional Review Act, 5 U.S.C. 801 et seq ., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

This is a synopsis of the Commission's Report and Order, MB Docket No. 05-114, adopted January 10, 2007, and released January 12, 2007. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC Reference Information Center (Room CY-A257), 445 12th Street, SW., Washington, DC 20554. The complete text of this decision may also be purchased from the Commission's copy contractor, Best Copy and Printing, Inc., Portals II, 445 12th Street, SW., Room CY-B402, Washington, DC 20054, telephone 1-800-378-3160 or http://www.BCPIWEB.com .

The reference coordinates for Channel 236C1 at Hale Center, TX, are 34-13-00 NL and 101-34-00 WL. See 70 FR 17384, April 6, 2005.

The Commission will send a copy of the Report and Order in this proceeding in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

This is a synopsis of the Commission's Report and Order , MB Docket No. 05-238, adopted January 10, 2007, and released January 12, 2007. The Notice of Proposed Rule Making proposed the allotment of Channel 228A at Columbus, Indiana and its reservation for NCE use. See 70 FR 48357, published August 17, 2005. The full text of this Commission decision is available for inspection and copying during regular business hours at the FCC's Reference Information Center, Portals II, 445 Twelfth Street, SW., Room CY-A257, Washington, DC 20554. The complete text of this decision may also be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC, 20554, telephone 1-800-378-3160 or http://www.BCPIWEB.com . The Commission will send a copy of the Report and Order in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

This is a synopsis of the Commission's Report and Order , MB Docket No. 05-79, adopted January 10, 2007, and released January 12, 2007. The full text of this Commission decision is available for inspection and copying during regular business hours at the FCC's Reference Information Center, Portals II, 445 Twelfth Street, SW., Room CY-A257, Washington, DC 20554. The complete text of this decision may also be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20054, telephone 1-800-378-3160 or http://www.BCPIWEB.com . The Commission will send a copy of the Report and Order in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

The National Transportation Safety Board (NTSB) determined that one of the probable causes of the May 11, 1996 crash of ValuJet Airlines flight No. 596 was a fire in the airplane's cargo compartment initiated and enhanced by the actuation of one or more chemical oxygen generators carried as cargo in violation of requirements in the Hazardous Materials Regulations (HMR; 49 CFR Parts 171 through 180). Recommendations issued by the NTSB following this tragedy, in which 110 lives were lost, addressed both the initiation of the fire by the improperly packaged generators (which produce external heat when activated) and the possible enhancement of an aircraft cargo compartment fire (of any origin) by the oxygen produced by the generators or other cargo, such as gaseous oxygen in cylinders and other oxidizing agents. In response to the NTSB recommendations, the Department of Transportation has:

In the August 19, 1999 final rule, “Hazardous Materials: Chemical Oxidizers and Compressed Oxygen Aboard Aircraft,” (Docket No. HM-224A), we amended the HMR to: (1) Allow a limited number of cylinders containing medical-use oxygen to be carried in the cabin of a passenger-carrying aircraft; (2) limit the number of oxygen cylinders that may be carried as cargo in compartments lacking a fire suppression system and require cylinders to be stowed horizontally on the floor or as close as practicable to the floor of the cargo compartment or unit load device; and (3) require each cylinder of compressed oxygen transported in the passenger cabin or a cargo compartment to be placed in an overpack or outer packaging that meets the performance criteria of Air Transport Association Specification 300 for Type I (ATA 300) shipping containers. In the HM-224A rulemaking, we received more than 55 written comments, and 14 persons made oral statements at a public meeting on January 14, 1998. Based on the comments submitted in that proceeding and our assessment of alternatives, we did not adopt the proposal in Docket No. HM-224A to prohibit all transportation of all oxidizers, including compressed oxygen, on passenger-carrying aircraft.

In the preamble to the August 19, 1999 final rule, we explained that testing conducted by FAA indicated the ATA 300 container provides an “incremental” level of thermal protection for oxygen cylinders by increasing the time before a cylinder exposed to a fire would release its contents. However, FAA's testing also indicated the risk posed by a compressed oxygen cylinder in a cargo compartment can be further reduced, or even eliminated, if the cylinder is placed in an overpack or outer packaging providing more thermal protection and flame resistance than the ATA 300 containers currently in use. Accordingly, we announced we were “considering a requirement that an oxygen cylinder may be carried in an inaccessible cargo compartment on an aircraft only when the cylinder is placed in an outer packaging or overpack meeting certain flame penetration resistance, thermal protection, and integrity standards.” (64 FR 45393). In our earlier June 5, 1997 final rule (also in Docket No. HM-224A), we also indicated we were considering additional packaging requirements for chemical oxygen generators (62 FR at 30769).

On May 6, 2004, we published a notice of proposed rulemaking under Docket HM-224B (69 FR 25469). In the NPRM, we proposed to amend the HMR to: (1) Require cylinders of compressed oxygen and packages of chemical oxygen generators to be placed in an outer packaging that meets certain flame penetration and thermal resistance requirements when transported aboard an aircraft; (2) revise the PRD setting limit on cylinders of compressed oxygen transported aboard aircraft; (3) limit the types of cylinders authorized to transport compressed oxygen aboard aircraft; (4) prohibit the transportation of all oxidizing gases, other than compressed oxygen aboard cargo-only or passenger aircraft; and (5) incorporate most of the provisions of an oxygen generator approval into the HMR.

When installed on an aircraft or provided during flight for the use of passengers or crew members, compressed oxygen in cylinders and oxygen generators are subject to requirements in FAA's regulations in Title 14 of the Code of Federal Regulations, and are not subject to the HMR. When transported as cargo, cylinders of compressed oxygen and oxygen generators are subject to requirements in the HMR. Air carriers routinely transport their own oxygen cylinders and oxygen generators as replacement items for use on other aircraft. Some also transport cylinders for their passengers or other customers. Commenters to Docket HM-224A identified a continuing need for the transportation of oxygen cylinders as cargo on both passenger and cargo-only aircraft.

As determined through testing conducted by FAA in 1999, cylinders of compressed oxygen release their contents at temperatures well below those that aircraft cargo compartment liners and structures are designed to withstand. When the surface temperature of a cylinder of compressed oxygen reaches approximately 300 °F, the increase in internal pressure causes the cylinder's pressure relief device to open and release oxygen. In addition to the ValuJet tragedy, three accidents and ten incidents involving airplane cargo compartment fires have occurred between 1986 and 2002. While some of these events involved hazardous materials, in some instances the fire was caused by a malfunction of the aircraft's electrical system. The origin of other fires could not be determined. Regardless of the cause of the fire, the presence of an oxygen generator or a cylinder containing oxygen or another oxidizing gas creates the potential for oxygen or another oxidizing gas to be released and to vent directly into a fire, which significantly increases the risks posed by the fire.

FAA also found that use of an outer packaging may significantly lengthen the time a cylinder will retain its contents when exposed to fire or heat. Some outer packagings meeting the ATA specification 300 Category I extended the time by up to 60 minutes or more. However, the ATA 300 standard does not specifically address thermal protection or flame penetration. An outer packaging designed to provide both thermal protection and flame penetration could provide even more protection. A copy of the test report is available for review in the public docket.

In additional tests conducted in 2002, FAA determined that a sodium chlorate oxygen generator will initiate and release oxygen at a minimum temperature of 600 °F. However, due to uncertainties with other designs and the physical properties of sodium chlorate, the FAA has recommended that oxygen generators not be exposed to temperatures above 400 °F. A copy of this test report is also available in the public docket. This test report shows that an unprotected oxygen cylinder or oxygen generator can quickly and violently release its contents when exposed to temperatures that can be expected from an aircraft cargo compartment fire.

Because of safety concerns associated with the air transportation of compressed oxygen cylinders and oxygen generators, we are amending the HMR to require cylinders of compressed oxygen and chemical oxygen generators to be transported in an outer packaging that: (1) Meets the same flame penetration resistance standards as required for cargo compartment sidewalls and ceiling panels in transport category airplanes; and (2) provides certain thermal protection capabilities so as to retain its contents during an otherwise controllable cargo compartment fire. The outer packaging standard that is being adopted addresses two safety concerns: (1) Protecting a cylinder and an oxygen generator that could be exposed directly to flames from a fire; and (2) protecting a cylinder and an oxygen generator that could be exposed indirectly to heat from a fire. These performance requirements must remain in effect for the entire service life of the outer packaging.

Under this final rule, an outer packaging for a cylinder containing compressed oxygen or another oxidizing gas and a package containing an oxygen generator must meet the standards in Part III of Appendix F to 14 CFR Part 25, Test Method to Determine Flame Penetration Resistance of Cargo Compartment Liners. An outer packaging's materials of construction must prevent penetration by a flame of 1,700 °F for five minutes, in accordance with Part III of Appendix F, paragraphs (a)(3) and (f)(5) of 14 CFR Part 25.

In addition, a cylinder of compressed oxygen or another oxidizing gas must remain below the temperature at which its pressure relief device would activate and an oxygen generator must not actuate when exposed to a temperature of at least 400 °F for three hours. The 400 °F temperature is the estimated mean temperature of a cargo compartment during a halon-suppressed fire. 1 Three hours and 27 minutes is the maximum estimated diversion time world-wide; based on an aircraft flying a southern route over the Pacific Ocean. Data collected during the FAA tests indicate that, on average, a 3AA oxygen cylinder with a pressure relief device set at cylinder test pressure will open when the cylinder reaches a temperature of approximately 300 °F. This result is consistent with calculations performed by PHMSA. In analyzing PRD function, PHMSA calculated that a 3HT cylinder with a PRD set at 90% of cylinder test pressure will vent at temperatures greater than 220 °F. In order to assure an adequate safety margin for all authorized cylinders, including 3HT cylinders, we are amending the HMR to require cylinders of compressed oxygen and other oxidizing gases, which are contained in the specified outer packaging, to maintain an external temperature below 93 °C (199 °F) when exposed to a 400 °F temperature for three hours.

PHMSA received comments from 24 entities in response to proposals and specific questions in the NPRM concerning outer packaging, PRDs, authorized cylinders, oxidizing gases aboard aircraft, and chemical oxygen generator approvals. These comments were submitted by representatives of trade organizations, hazardous materials shippers, carriers, and packaging manufacturers, including Airbus, Air Line Pilots Association (ALPA), Air Products and Chemicals, Air Transport Association (ATA), Alaska Airlines, Aviation Excellence, Aviation Mobility, Aviosupport, BE Aerospace, Carleton Technologies, Continental Airlines, Draeger Aerospace, Federal Express (FedEx), International Federation of Air Line Pilots Association (IFALPA), Intertechnique, National Transportation Safety Board (NTSB), Northwest Airlines (NWA), Satair, Scott Aviation (Scott), SR Technics Switzerland, United Parcel Service (UPS), Viking Packing Specialist (Viking), and two individuals.

Commenters generally noted our continued efforts to enhance the safe transportation of hazardous materials by air. For example, ALPA applauds our efforts to address the potential hazards associated with oxidizing chemicals, oxygen generators, and gaseous oxygen. Relevant portions of these comments are discussed in the following sections of the preamble.

In the NPRM, we proposed to require an outer packaging for an oxygen cylinder and a package containing an oxygen generator to meet the standards in Part III of Appendix F to 14 CFR Part 25, Test Method to Determine Flame Penetration of Cargo Compartment Liners. We proposed to require the outer packaging to conform to these performance requirements with no deterioration for its entire service life. We also proposed to prohibit cylinders of compressed oxygen contained in an outer packaging from reaching an external temperature of 93 °C (199 °F)—which is below the temperature at which its PRD would actuate—when exposed to a 205 °C (400 °F) temperature for three hours. We proposed to add a thermal resistance test for packagings for oxygen cylinders and oxygen generators in appendix D to Part 178. We further proposed to remove the limits in § 175.85(i) on the number of oxygen cylinders that may be transported in cargo compartments not equipped with sufficient fire suppression systems. We proposed to allow outer packaging to be built either to the ATA Specification 300 standard or to a UN standard at the Packing Group II performance level. We proposed to authorize only rigid outer packagings for compressed oxygen cylinders. In addition, we proposed one year after publication of the final rule as the mandatory date to comply with the thermal resistance and flame penetration standards for outer packagings for oxygen cylinders and oxygen generators transported on board aircraft.

FedEx and NWA ask PHMSA to reconsider its approach to this rulemaking and begin a more comprehensive assessment with other Federal agencies (including FAA and NTSB), equipment manufacturers, and the air carrier industry. NWA states the requirements on compressed oxygen cylinders proposed in the NPRM are not adequately justified. It differentiates oxygen cylinders from oxygen generators because the latter provide their own heat source and, once initiated, release an uncontrolled flow of oxygen. FedEx suggests the origins and results of cargo compartment fires should be examined in a more comprehensive manner before this rulemaking is implemented. Continental states PHMSA should seek input from both the International Air Transport Association (IATA) and International Civil Aviation Organization (ICAO) regarding the potential impact of the proposed packaging requirement on international regulations and international carriers serving the United States.

ATA states thermal protection of oxygen cylinders and oxygen generators does not increase the level of safety under the extreme conditions assumed in test protocols. ATA also states passenger carriers no longer transporting oxygen generators on passenger aircraft due to post-1996 regulations must transport oxygen generators by ground, and ground transportation of oxygen generators in compliance with post-1996 regulations has not resulted in any incidents involving oxygen generators. ATA recommends PHMSA thoroughly review all incidents pertaining to burned aircraft in order to investigate the condition of any oxygen cylinders or oxygen generators that were on board.

Aviation Excellence, an aircraft parts distributor holding a Competent Authority Approval to ship oxygen generators (UN3356) questions why the transportation of oxygen generators has become a critical concern, and, along with other commenters, cites ValuJet as the only accident of note involving oxygen generators. This commenter asserts the ValuJet incident was likely due to improper marking and loading, not improper packaging standards, and that thick smoke was the likely cause of the ValuJet incident. Aviation Excellence suggests PHMSA should address the reasons a fire occurred in the cargo bay, rather than what effect the fire had on oxygen, and notes non-hazardous materials, such as rubber and plastic, generate deadly gases and smoke when exposed to fire.

Scott notes chemical oxygen generators are currently transported by air as either components or as larger assemblies. When transported as components, the commenter states chemical oxygen generators are cylinders ranging from 2 1/2 to 4 inches in diameter and 5 to 11 inches in overall length. The commenter states the size of chemical oxygen generator outer packaging would depend on whether the shipping requirement is for individual generators or a group of generators.

Intertechnique also suggests the exception in § 175.501(c) of the HMR allowing a limited number of oxygen cylinders to be transported in the aircraft cabin should recognize that oxygen cylinders used for carrying supplemental oxygen on board frequently have a large capacity, up to 213 cubic feet. Intertechnique states these cylinders must be transported from their respective manufacturing sites to the aircraft manufacturing facility, as well as to and from maintenance facilities, and restrictions on air transportation would increase turnaround times and operational costs when surface transportation is required. Intertechnique also notes that equipment containing an oxygen cylinder must be considered an oxygen cylinder, even when the cylinder is not apparent as in the case of the large number of protective breathing equipment units used on aircraft.

We disagree with the commenters' assertions that PHMSA did not conduct a comprehensive assessment before initiating this rulemaking and that the requirements proposed in the NPRM were not effectively justified. The safe transportation of hazardous materials by air is an ongoing area of significant concern for the Department. We regularly assess methods to increase the safe transportation of hazardous materials, and incorporate input from other Federal agencies (including NTSB), equipment manufacturers, and the regulated community as we develop new or revised regulatory requirements. This process was applied to this current rulemaking as well.

The FAA and PHMSA have taken a number of steps to reduce the likelihood of a fire on board an aircraft. These include limiting the transport of known flammable materials; imposing restrictions on aircraft systems likely to increase the risk of a fire, requiring increased inspection and maintenance of wiring systems; and incorporating designs to prevent the spread of fire from highly flammable zones. Despite all these measures, it is not possible to totally eliminate fires aboard aircraft. In addition to the risks presented by hazardous materials (whether shipped in violation or conformance with the HMR), structural failures, improper maintenance, and the ignition of non-hazardous materials remain possibilities. For these reasons, we cannot accept claims that PHMSA and the FAA did not conduct a sufficient assessment before initiating this rulemaking.

We also disagree with the commenter that suggested we only addressed the reasons a fire occurs in a cargo bay, rather than what effect a fire has on oxygen. A fire in cargo compartments aboard an aircraft can result from several causes, some of which cannot be controlled through regulations, including illegal shipments of oxidizing agents, heat- or fire-producing chemical interaction between certain goods damaged during shipment, or human error. FAA concluded that the use of an outer packaging may significantly lengthen the time an oxygen cylinder or chemical oxygen generator will retain its contents when exposed to fire or heat. The provisions of this final rule will reduce the risk that a fire on board an aircraft will be significantly worsened by the presence of compressed oxygen cylinders or chemical oxygen generators.

Because the possibility of fire in a cargo compartment cannot be completely eliminated, the FAA has adopted requirements to mitigate risk and increase the likelihood that a fire can be suppressed and contained long enough to land the aircraft. The FAA has upgraded fire safety standards to require inaccessible cargo compartments on passenger aircraft to have a fire detection and three-hour suppression system, by minimizing the available oxygen (e.g., 14 CFR 25.857(c), 25.858, 121.314(c)). In addition, flame penetration and fire resistance requirements apply to cargo compartments on both passenger and cargo-only aircraft (e.g., 14 CFR 25.855, 121.314(a)). However, these requirements do not, and cannot, address those situations where a fire is actually fed by oxygen provided by other cargo, such as cylinders of compressed oxygen or other oxidizing gases or oxygen generators.

Accordingly, as discussed in the “Background” section above, we have prohibited the transportation of chemical oxygen generators on board passenger-carrying aircraft and the transportation of spent chemical oxygen generators on both passenger-carrying and cargo-only aircraft, and we issued standards governing the transportation of chemical oxygen generators on cargo-only aircraft, including the requirement for an approval issued by PHMSA. We have also imposed additional requirements on the transportation of compressed oxygen cylinders by aircraft; and prohibited the carriage of chemical oxidizers in inaccessible aircraft cargo compartments that do not have a fire or smoke detection and fire suppression system. The amendments adopted in this final rule are a continuation of our ongoing objective to reduce the risk of another catastrophic event like the ValuJet crash.

Because fires on aircraft cannot be totally eliminated, and the consequences of fire in air transportation are far greater than those in highway transportation, an absence of incidents involving ground transportation of oxidizing gases and oxygen generators does not justify postponing these actions. The fact that an oxygen cylinder or generator did not release oxygen during a particular aircraft fire does not diminish the potential for enhancement of a cargo compartment fire by the release of oxygen and the likely consequences. For these reasons, we disagree with the comment that PHMSA should only address the reasons a fire occurs in a cargo bay, rather than what effect a fire has on oxygen.

We accept the suggestion that international carriers and international regulations should be considered when undertaking any rulemaking potentially affecting international commerce. The escalating quantity of hazardous materials transported in international commerce necessitates the harmonization of domestic and international requirements to the greatest extent possible. However, we cannot wait for an international agreement when it is necessary to address a known safety hazard. Therefore, we intend to submit a paper to the ICAO Dangerous Goods Panel proposing that the ICAO Technical Instructions be amended consistent with this final rule.

We also considered this proposal based on its overall impact on transportation safety and the economic implications associated with its adoption into the HMR. Our goal in this rulemaking is to increase the level of safety for the transportation of oxygen cylinders and oxygen generators currently in the HMR in the most cost-effective manner possible. We believe the adoption of this final rule contributes to meeting that goal.

Larger cylinders used as part of an aircraft's supplemental oxygen system (up to 213 cubic feet) makes it impractical for them to be transported (as cargo) in the aircraft cabin under the exception in § 175.501(c). As noted above, when these cylinders are installed on the aircraft, they are not subject to the HMR, nor are Protective Breathing Equipment (PBEs) that are part of the required equipment on board the aircraft—but alternate packagings may be used for these cylinders and PBEs when carried or shipped as replacement items (or company material), “provided such packagings provide at least an equivalent level of protection to those that would be required by this” final rule. 49 CFR 175.8(a)(3) (as adopted at 71 FR 14605 [March 22, 2006]).

We disagree with the commenter's opinion that thick smoke was the likely cause of the ValuJet incident. First, that view has little support in the NTSB's findings (at p. 134 of the accident report) that “[o]nly a small amount of smoke entered the cockpit before the last recorded flightcrew verbalization * * * including the period when the cockpit door was open,” and the “loss of control was most likely the result of flight control failure from the extreme heat and structural collapse,” although “the Safety Board cannot rule out the possibility that the flightcrew was incapacitated by smoke or heat in the cockpit during the last 7 seconds of the flight.” Moreover, even if the commenter were correct, that circumstance would support the measures we are adopting to prevent the enhancement of a cargo compartment fire (and the associated smoke) caused by the release of oxygen from a cylinder or an oxygen generator.

BP Aerospace and Intertechnique recommend an exception from the proposed packaging requirements for cylinders that are nominally empty, with only a small amount of residual pressure, on the ground that the hazards of these “empty” cylinders are negligible. BP Aerospace states it is a common practice to transport such cylinders in order to avoid possible contamination of the cylinder from inward leakage. Intertechnique notes many cylinders are shipped before filling (new or repaired cylinders) or after being emptied (for maintenance).

Oxygen is a Division 2.2 gas and, as such, is only subject to the regulations when the pressure in the container (cylinder) equals or exceeds 280 kPa (40.6 psia) at 20 °C (68 °F) (see § 173.115(b)(1)). Therefore, oxygen cylinders where the pressure has been reduced to less than 280 kPa (40.6 psia) are not subject to the regulations and are considered to have been purged to the extent necessary for the purposes of § 173.29(b)(2)(ii). In addition, a completely empty cylinder (either new and never filled or purged of all its contents) is not subject to the packaging requirements adopted in this final rule (or to other transportation requirements in the HMR).

Several commenters also addressed our proposal to prohibit the transportation of all oxidizing gases (other than compressed oxygen) aboard both passenger and cargo-only aircraft. In the NPRM, we discussed our concern that cylinders containing these materials, if exposed to a fire, could intensify the fire to the extent that it would overcome the compartment's halon fire suppression system, penetrate the cargo compartment sidewalls, and cause severe damage or destruction of the aircraft. We stated we had no information to support the need for the following materials to be transported aboard aircraft: “Air, refrigerated liquid, (cryogenic liquid),” “Carbon dioxide and oxygen mixtures, compressed,” “Nitrous oxide,” “Nitrogen trifluoride, compressed,” “Compressed gas, oxidizing, n.o.s.,” and “Liquefied gas, oxidizing, n.o.s.”

Air Products expressed agreement with the Department on the need to increase the level of safety in the transportation of oxidizing gases by aircraft, and it states the list should not be limited to oxygen. Air Products suggests materials in Division 2.2 with a subsidiary risk of 5.1 can be transported safely by aircraft and pose no great risk to the aircraft unless the oxidizing material is exposed to abnormally high temperatures over an extended period of time. This commenter suggested packaging performance requirements can be met by limiting the fill density pressure of the oxidizing material and configuring the cylinder so that oxidizing material cannot escape at temperatures up to and including 205 °C (400 °F). Air Products submitted alternative wording for a new section under § 173.302a that would pertain to nitrogen trifluoride and nitrous oxide.

Alaska Airlines opposes the proposal to ban Division 2.2 gases with a 5.1 subsidiary risk for transportation by air, stating it is not aware of any experience indicating a safety problem. According to the Alaska Airlines' comments, consumers in Alaska use some of these gases, and in many cases, could not obtain them if not via air transportation. One Anchorage vendor of gas products estimates 20,000 to 50,000 pounds of cylinders of compressed oxygen and nitrous oxide are transported by air every month to medical facilities around the State, with empty cylinders constantly being returned for refilling and return to the hospitals. Alaska Airlines states DOT needs to consider the impact of this proposed rule on the health and welfare of Alaskans, not to mention the subsequent increased cost of medical care. This commenter also notes international regulations identify two additional materials classified as Division 2.2 materials with a 5.1 subsidiary hazard that are permitted on passenger aircraft: “UN2037, Receptacles, small, containing gas (oxidizing) without a release device, non-spillable,” and “UN2037, Gas cartridges (oxidizing) without a release device, non-spillable.” The commenter concludes that if PHMSA does ban oxidizing gases, it will create additional variances between United States and United Nations dangerous goods regulations DOT has been working to harmonize.

The comments summarized above indicate a continuing need for air transportation of most of the oxidizing gases we had proposed to prohibit on aircraft, including Compressed gas, oxidizing, n.o.s.; Nitrogen trifluoride, compressed; and Nitrous oxide. Based on those comments, we conclude we should not prohibit air transportation of these oxidizing gases; however, the same outer packaging standards adopted for cylinders of compressed oxygen and oxygen generators should also be required for these other oxidizing gases. The only exception is that Air, refrigerated liquid (cryogenic liquid), which is already prohibited on passenger aircraft, will also be prohibited on cargo-only aircraft.

In the NPRM, we proposed to require a cylinder of compressed oxygen to remain below the temperature at which its PRD would activate, and an oxygen generator not actuate, when exposed to a temperature of at least 205 °C (400 °F) for three hours. ALPA recommends the design standards be raised to 260 °C (500 °F), instead of 205 °C (400 °F), and to 3.5 hours, instead of three hours, in cargo compartments required to have an active fire suppression system, and maintain the knock-down fire status to allow for a safety margin for temperature in excess of the expected mean of 205 °C (400 °F). In addition, Aviation Mobility states there is no aircraft that would survive the extreme conditions for the three-hour duration which the rule would require the cylinder to survive without the actuation of the PRD.

We disagree. We continue to believe that these requirements for outer packagings are the most appropriate means to prevent the release of oxidizing gases from a cylinder or chemical generator, which could feed an aircraft compartment fire. The U.S. DOT/FAA Report titled “Evaluation of Oxygen Cylinder Overpacks Exposed to Elevated Temperature” (included in the docket of this rulemaking), found that: “In a Class C compartment, the fire would be detected and agent discharged to extinguish the fire. In the event of a suppressed but not fully extinguished fire, which would be the case if the origin were a deep-seated fire, the temperatures in the compartment could reach 205 °C (400 °F).” For a deep-seated fire in a Class C cargo compartment, a temperature of 205 °C (400 °F) is the estimated mean temperature of a cargo compartment during a halon-suppressed fire.

The FAA test results support our conclusion that a temperature of at least 205 °C (400 °F) is sufficient for the flame resistant penetration test method. In addition, the conditions noted in the NPRM are a worst-case scenario, and were based on a deep-seated fire in a Class C cargo compartment, the duration of which would be the maximum estimated diversion flight time for an aircraft flying a southern route over the Pacific Ocean. However, limiting the requirement for overpacks capable of meeting the three-hour suppression performance standard to overseas flights would be impractical, since this rulemaking anticipates in most instances the overpacks will be provided with the containers, rather than purchased and maintained by an air carrier. Since the initial shipper may not know the final destination of its product, it would also be unable to reliably determine when to use a three-hour overpack as opposed to a one-hour overpack. In any case, applying a lesser fire penetration and thermal protection standard to overpacks because of the shorter flight times to diversion airports in geographic areas other than the South Pacific would undermine the existing rationale behind our requirements that Class C cargo compartments on airplanes be equipped to meet the three-hour fire suppression standard. Therefore, we are amending the HMR to require each cylinder of compressed oxygen remain below the temperature at which its PRD would activate, and that an oxygen generator not actuate, when exposed to a temperature of at least 205 °C (400 °F) for three hours.

We also received comments on the proposal to require an outer packaging to be built either to the ATA Specification 300 standard or to a UN standard at the Packing Group II performance level. One commenter (Aviation Mobility) states it encloses oxygen cylinders in a manner that provides safe delivery to the gate and use of the cylinder in the passenger compartment without altering the outer packaging. The commenter notes that, under Special Provision A52 of the HMR, an oxygen cylinder may be carried in the passenger compartment or an inaccessible cargo compartment on a passenger aircraft if it is in “an overpack or outer packaging that conforms to the performance criteria of Air Transport Association (ATA) Specification 300 for Category I shipping containers.” The same commenter states its specific outer packaging meets the ATA 300 definition of a “rigid pack” and questions whether PHMSA intended any difference in its use of the term “rigid” in the NPRM.

For clarification, we proposed requiring an outer packaging to be built either to the ATA Specification 300 standard or to a UN standard at the Packing Group II performance level to provide greater flexibility in the design of outer packaging for oxygen cylinders. In the NPRM, we proposed to authorize only rigid outer packagings in order to clarify our original intent to ensure outer packaging provides an adequate level of safety. In addition to meeting the flame penetration and thermal resistance protection requirement, we will continue to require the outer packaging for compressed oxygen cylinders to meet certain performance criteria. Therefore, we are amending the HMR to allow the outer packaging be built either to the ATA Specification 300 standard or to a UN standard at the Packing Group II performance level. In addition, we are amending the HMR to authorize only rigid outer packaging for compressed oxygen cylinders.

Commenters expressed concern about the availability and cost of the proposed outer packaging, and the number of different types of outer packagings meeting the proposed thermal resistance and flame penetration requirements. For example, Continental states because this packaging is not yet available, any cost estimate is subject to significant error. Continental estimates the initial cost to provide outer packagings meeting the required flame and temperature penetration standards will exceed $850,000. The same commenter estimates costs of at least $500,000 to modify its medical oxygen service.

Scott states it would need a minimum of nine (9) different-sized ATA 300 specification containers to accommodate all of the high-pressure oxygen cylinders it currently supplies, and additional size packages may be required to adequately accommodate high pressure oxygen cylinders supplied by other entities or to accommodate cylinder configurations for new aircraft development programs. This commenter estimates the average cost of currently used outer packagings would range from $300 to $500 per container. Scott recommends PHMSA conduct additional analyses to determine the number of different outer containers that would be required to accommodate chemical oxygen generators.

Scott also disputes our statement in the NPRM that only a few small aviation entities will require flame and heat protective reusable packaging and suggests PHMSA did not consider the major potential impact of this rule on small entities. According to Scott, “many small aircraft operators do not provide their own oxygen system maintenance or have extensive spare part inventories but, rather, rely on the shipping of these components to specialized oxygen repair stations, by air, in order to maintain their aircraft in a timely manner.” Scott states these companies would be required to obtain outer packages meeting the requirements of this proposed rule in order to ship oxygen cylinders and valve and regulator assemblies to oxygen service shops for maintenance. These outer packages “would then be used to return these items to the operator in the same manner that the present rule has required the operators to purchase ATA 300 specification containers for that purpose.”

ATA contends the requirement for carriers to comply with the proposed outer packaging requirements would be costly and prohibitive to air carriers of oxygen generators, forcing carriers to refuse passengers or cancel flights because of the lack of generators supplying emergency oxygen to aircraft passenger seats. It states it conferred with vendors and found neither existing packaging, nor a design amenable to the proposed requirements in the developmental stage of manufacturing. ATA estimates replacement packaging costs of approximately $2,200,000 to $3,350,000 for its members, without any substantial improvement in safety. This commenter states this cost could effectively double as existing ATA Specification 300 packaging, acquired in response to the final rule in HM-224A, could not be converted for other uses.

NWA states it uses seven cylinder types and estimates four separate sized boxes will be required for its seven cylinder types to meet the proposed packaging requirement. NWA foresees the replacement of 1,400 boxes at twice the cost necessary to replace the boxes that were required by HM-224A. In addition, the commenter says it would be forced to scrap the boxes purchased in compliance with HM-224A before the exhaustion of their useful life. FedEx notes the proposed outer packaging is neither currently available for purchase, nor does it know when it will be available, or at what cost. It estimates the required packaging will range between $600 and $900 per unit, for an estimated cost imposed on its operations of between $360,000 and $540,000.

Intertechnique states the introduction of the packaging proposed in the NPRM will lead to added costs for shipping cylinders from the cylinder manufacturer to aircraft manufacturers and airlines, and to and from airline maintenance sites. Intertechnique asserts there are approximately 500 new cylinders per year requiring outer packagings and those packagings delivered to aircraft manufacturers may be sent back for future shipment (with an estimated loss of 20% per year). It says the outer packagings of cylinders shipped to airlines will be retained by the airlines for their own shipment or repair, and new packagings will have to be bought for each shipment. Intertechnique estimates a replacement rate of 10% per year, with a best estimate need of 300 new outer packagings per year, leading to an average cost increase of the oxygen cylinders and repairs of 10 to 15% depending on the final cost of packaging not yet available on the market.

Satair states it is currently spending approximately $50,000.00 on packaging and other materials to facilitate the shipping of chemical oxygen generators. It estimates a ten-fold increase in packaging and other material costs needed to implement the requirements in the NPRM, for a total of approximately $500,000.00. This commenter considers this to be a significant impact on its business and would have to bill and recover this expense from its customers, the airlines. Aviation Excellence states the additional cost for packaging and return shipments will impose a prohibitive financial burden.

Many of the commenters indicate they do not provide medical oxygen service to persons with disabilities, and, therefore, do not address whether the proposals would increase the cost to transport medical oxygen. However, Continental and ATA state they offer this service and this requirement would have to be evaluated for the cost impacts and feasibility of this service. Aviation Mobility states it is not aware of any outer packaging in existence that would meet the fire resistance criteria proposed in the NPRM. The commenter states the cost of this service would become too expensive to pass along to customers, or for carriers to absorb. This same commenter asserts that, as a result of the costs to acquire the outer packaging specified in this rulemaking and the added weight of such a packaging, most carriers transporting medical oxygen to passenger air carriers will discontinue this service. Further, this commenter states all cost speculations with regard to such a packaging are merely theoretical. ATA recommends PHMSA reconsider this rulemaking action to consider possible disadvantages to disabled passengers requiring medical oxygen.

We considered possible cost increases and the availability of outer packaging for oxygen generators and cylinders containing compressed oxygen and other oxidizing gases. At least one packaging manufacturer (Viking) appears to have addressed the flame penetration and thermal penetration standard and states it is able to produce the required packaging. That manufacturer provided estimates of costs for the existing ATA specification 300 packagings and the new outer packagings, and those estimates were used in our complete analysis of the associated costs to implement this final rule in the regulatory evaluation (available for review in the public docket for this rulemaking).

In that regulatory evaluation, we specifically discussed cost figures provided by other commenters and the basis on which we estimated a total cost of $10.8 million ($7.6 million discounted to present value) over 15 years, for the transport of oxygen cylinders; and $27.0 million ($16.9 million discounted to present value) over 15 years, for the costs associated with the transport of chemical oxygen generators. While some of the cost figures provided by other commenters are higher, those figures are reasonably close to the estimates used in the regulatory evaluation; moreover, the estimates used in the regulatory evaluation do not reflect the likelihood that, when this requirement becomes effective, additional manufacturers will produce the required packaging, thereby reducing purchase prices. With competitive packaging pricing available in the marketplace, air carriers will be in a better position to make cost-effective business decisions to continue providing medical oxygen service to the disabled community and will continue to do so. Even if we were to assume the industry commenters were correct, and the cost of this rule was to double, the benefits would still outweigh the higher costs. Thus, the agency has carefully weighed these comments in deciding to proceed with this rulemaking initiative.

We also estimated benefits of this rule over the next 15 years range from $30 million, if a single cargo aircraft accident is averted, to $357 million, if a single passenger aircraft accident is averted. This indicates a significant potential to improve the level of safety associated with the continued transportation aboard aircraft of packages of chemical oxygen generators and cylinders containing compressed oxygen and other oxidizing gases.

PHMSA continues to believe that only a few small entities will be affected by this rulemaking. For example, we learned from container manufacturers that only ten small air carriers transport cylinders of compressed oxygen. Outside of Alaska, air shipments of other oxidizing gases are very infrequent, according to the comment of Air Products, and most small entities will be able to utilize ground transportation or local companies for shipping cylinders of compressed oxygen or other oxidizing gases.

Therefore, we are amending the HMR to require an outer packaging for an oxygen cylinder and a package containing an oxygen generator to meet the standards in Part III of Appendix F to 14 CFR Part 25, Test Method to Determine Flame Penetration of Cargo Compartment Liners. We are also amending the HMR to require cylinders of compressed oxygen and chemical oxygen generators to be transported in an outer packaging meeting certain flame penetration and thermal resistance requirements when transported aboard an aircraft. In addition, we are amending the HMR to require that the outer packaging be capable of meeting the requirements throughout its service life.

PHMSA received several comments regarding the proposed effective date of one year after publication of the final rule as the mandatory date to comply with this final rule. Many commenters state one year does not provide adequate time to resolve concerns regarding a lack of packaging development and availability, manufacturing lead times, inventory, logistics, and documentation. For instance, Scott states the currently proposed rule, with a proposed compliance date of one year after promulgation, provides neither the time necessary for an orderly process of ensuring compliance, nor a mechanism by which compliance can be readily determined. The commenter also states the demand for reusable flame and heat-resistant packagings required by the proposed rule may be much higher than PHMSA currently envisions. Another commenter (ATA) states a one-year effective date would impose additional costs on carriers by forcing the removal of aircraft from service to replace the outer packaging proposed in the NPRM. In response to our inquiries in the NPRM regarding the effective date, we received recommendations ranging from one to three years for implementation of the effective date of this final rule.

It appears compliance with the additional overpack requirements of one year following the publication of the final rule as proposed in the NPRM may result in insufficient time or undue hardship on the affected parties to come into compliance with the new requirements. A compliance date that allows flexibility for the affected parties and sufficient time for various manufacturers to develop and market the necessary equipment would better serve the overall objectives of this rulemaking. Therefore, we are amending the HMR to establish a mandatory compliance date of two years following the effective date of the final rule.

In the NPRM, we proposed amendments to the HMR pertaining to limits on PRD settings and cylinders authorized for the transportation of oxygen aboard aircraft. Compressed Gas Association (CGA) Pamphlet S-1.1, which has been incorporated by reference in the HMR, specifies the rated burst pressure of a rupture disk must be no greater than the cylinder minimum test pressure. However, CGA Pamphlet S-1.1 does not set a lower burst limit on the disks, increasing the risk of oxygen releases at elevated temperatures. To better prevent a cylinder from releasing its contents when exposed to a fire, we proposed to require an oxygen cylinder to be equipped with a PRD that has a rated burst pressure equal to the cylinder test pressure with allowable tolerances of −10 to plus zero percent.

We also proposed to limit cylinders authorized for the transportation of compressed oxygen aboard aircraft to DOT specifications 3A, 3AA, 3AL, and 3HT in order to minimize numerous PRD setting requirements for oxygen cylinders aboard aircraft. Although numerous specifications are authorized for oxygen and other oxidizing gases (49 CFR 173.201, 173.202a, 173.204, 173.204a), we understand these four specifications account for the vast majority of the cylinders used to transport these materials aboard aircraft—in addition to cylinders made of composite materials and authorized under special permit. (Specification 3HT cylinders are only authorized for aircraft use, and specification 3A and 3AA cylinders represent approximately 70% of the cylinders in all service.) This proposed limitation was not intended to restrict the use of composite cylinders that are currently, or may in the future be, authorized for transporting oxygen and other oxidizing gases under special permits.

Several commenters, including ATA, noted the proposed PRD setting for a DOT specification 3HT was incorrect. The NPRM should have stated the rated burst pressure of a rupture disk on a 3HT cylinder must be 90% of the cylinder test pressure. In this final rule, we have corrected this error.

ATA also asks about the proposal for replacement of PRDs specifically on 3HT cylinders, and whether this standard will be applied to other types of cylinders. Aviation Mobility expresses concern that raising the discharge pressure of PRDs on any gas cylinder will increase the potential for catastrophic failure. Continental Airlines states the limit on PRD settings proposed in the NPRM does not significantly increase the level of safety beyond current hazardous materials regulations. It questions the need to raise the PRD standards based on the lack of incidents related to compressed oxygen that meet existing temperature and pressure relief standards. It argues the level of protection of the aircraft transporting the oxygen cylinders is not increased even if the level of protection to the oxygen cylinders is increased.

Continental also raises cost concerns and estimates the costs for its company to meet the new PRD settings could exceed $2,500,000, of which $500,000 would be required to modify its medical oxygen service. According to this commenter, these costs will result in additional expense to disabled customers via increased oxygen service fees, and may force airlines to consider discontinuing this service. Scott suggests the requirement for PRDs apply after the next requalification.

NWA expresses concern about the cost to replace approximately 2,800 PRDs in its current supply of cylinders. The commenter states its cylinder maintenance is performed by a vendor and this rulemaking will force cylinders out of service for an extended period of time. NWA also recommends PHMSA perform an analysis to determine the effects a slow venting cylinder will have on the concentration of oxygen in cargo holds.

For cost reasons and ease of maintenance, according to Intertechnique, most PRDs are standard items, and changing the PRDs to match the new requirements will increase costs and delays. Intertechnique recommends that the reliability of PRDs with a smaller tolerance should be considered. In addition, Intertechnique states increasing the PRD setting does not drastically change the safety level. The leaking of the cylinder will be delayed until the temperature is higher (as will be the pressure), but the energy released at the moment of bursting the device will be higher, thus propelling oxygen with a higher flow and a larger velocity to a larger area. Intertechnique also states proof pressure varies from steel to composite cylinders, and the same PRD can be used for both types. It says changing the tolerance will lead to duplicating the PRD part numbers and cost increases, resulting in confusion within workshops that could lead to errors in installing PRDs. In addition, Intertechnique states the packaging should include a pressure balancing device (PBD) to prevent packaging burst due to pressure change within the cargo compartment during ascents and descents.

PHMSA continues to believe increasing the discharge pressure of PRDs on cylinders used to transport oxygen and other oxidizing gases will significantly increase the level of safety without increasing the potential for catastrophic failure of the packaging. One objective of this rulemaking is to prevent the actuation of the cylinder PRD so as to retain the cylinder's contents during an otherwise controllable cargo compartment fire. The outer packaging requirement proposed in the NPRM is designed to protect a cylinder and oxygen generator that could be exposed directly to flames from a fire, or indirectly, to heat from a fire. A new limit on the PRD settings on cylinders containing compressed oxygen or other oxidizing gases transported aboard aircraft will help ensure the contents of the cylinder are not released into an aircraft cargo compartment in the event of a fire. The design safety margin on the cylinder is high enough that the risk of catastrophic failure of the cylinder is not a serious concern.

Therefore, we are amending the HMR to require a new limit on the PRD settings on cylinders containing compressed oxygen or other oxidizing gases when transported aboard aircraft to ensure the cylinder contents are not released into an aircraft cargo compartment in the event of a fire. In order to accomplish this, we are amending the HMR to limit the PRD to a setting that will prevent it from releasing at temperatures the cylinder will experience while protected by the outer packaging. We are also amending the HMR to require cylinders containing oxidizing gases, including oxygen, to be equipped with PRDs that have a set pressure equal to the cylinder test pressure with allowable tolerances of −10 to plus zero percent.

In order to eliminate a significant portion of the costs associated with this requirement, we are adopting the commenter's suggestion to apply this requirement to cylinders beginning with each individual cylinder's next requalification date. Although not required, many cylinder owners replace the PRD during the five-year requalification as recommended by CGA Pamphlet S-1.1. Because relatively few cylinders are shipped by air, any additional costs associated with replacing the PRD at the next requalification date will be negligible.

Several commenters (Airbus, ATA, Carleton, Draeger, Intertechnique, Satair, Scott Aviation, and UPS) ask PHMSA to reconsider the requirement to limit the transportation of compressed oxygen aboard aircraft to DOT specifications 3A, 3AA, 3AL, and 3HT cylinders. Airbus states this proposed restriction is based on the assumption that these cylinders are the most commonly used for the transportation of compressed oxygen aboard aircraft, and on an apparent intention by PHMSA to limit the number of PRD settings. BE Aerospace contends the large volume of these cylinders is primarily because they have been in existence for many years. Scott confirms that the majority of oxygen cylinders currently in aviation service are DOT specification 3AA and 3HT cylinders.

Several commenters appear to believe we were proposing to exclude composite cylinders on board aircraft, despite the fact that a significant portion of compressed oxygen cylinders are currently made of composite material. For example, Airbus states composite cylinders combine weight-saving potential with significant cost reductions; perform as well as steel/aluminum cylinders; are subject to the same qualification tests as steel/aluminum cylinders; and are likely to be used increasingly in the future, especially the storage of oxygen as part of a gaseous oxygen system and portable oxygen cylinders for first aid. Airbus and others suggest that, if composite oxygen cylinders are not allowed aboard aircraft, many airlines will experience difficulty and increased costs regarding the maintenance and servicing of these composite oxygen cylinders. Carleton recommends that 49 CFR 173.302a(c)(1) be amended to include “DOT Exemption Cylinders manufactured to the requirements of DOT FRP-1 or DOT-CFFC,” and that § 173.302a(e)(2) define the PRD requirements for compressed oxygen cylinders and be amended to include “DOT Exemption Cylinders must be equipped with a PRD as required by the appropriate Specification.” Carleton also recommends PHMSA amend paragraph (e)(2) to read “90% of cylinder test pressure” and change “−10 to zero percent of cylinder test pressure” to “−10 to plus zero percent of cylinder test pressure.”

Composite cylinders are lightweight, possess weight- and fuel-saving potential, and may lead to an overall reduction in the associated costs for air transportation of compressed oxygen. PHMSA recognizes the prevalence of composite cylinders in air transportation, the increased use of these cylinders by industry for the transportation of compressed oxygen, and that these trends are likely to continue in the future. We acknowledge that composite cylinders are currently authorized for the transportation of compressed oxygen aboard aircraft under special permit. No change in the HMR is required to permit composite cylinders to be used in oxygen service. The limitation of cylinders authorized for the transportation of compressed oxygen and other oxidizing gases aboard aircraft to DOT specifications 3A, 3AA, 3AL, and 3HT does not exclude composite cylinders from being utilized for the transport of compressed oxygen by air transportation under the terms of a special permit, which is issued only upon a finding that the use of a composite cylinder achieves a level of safety that is at least equal to that required by this rulemaking. The PRD requirements for composite cylinders will be updated to match the new requirements of this final rule. Consistent with our past practice of adopting special permits into the HMR, we will review these special permits to determine if they are suitable for inclusion into the HMR.

Therefore, we are amending the HMR to require cylinders authorized for the transportation of compressed oxygen aboard aircraft to be limited to DOT specifications 3A, 3AA, 3AL, and 3HT.

In HM-224A, we adopted a limitation on the number of cylinders of compressed oxygen allowed to be carried on aircraft: (1) Up to six cylinders belonging to the aircraft carrier plus one cylinder per passenger needing oxygen at destination could be transported in the passenger cabin, and (2) no more than a combined total of six cylinders of compressed oxygen may be carried in inaccessible aircraft cargo compartments that lack a fire or smoke detection system and a fire suppression system. See former 49 CFR 175.10(b), 175.85(i), recodified at 175.501(b) & (c) (71 FR 14586). In the NPRM in this rulemaking, we proposed to remove the limits on the number of oxygen cylinders that may be transported in cargo compartments not equipped with sufficient fire suppression systems.

NTSB did not support the proposal to remove the current limit on the number of compressed oxygen cylinders that may be transported aboard aircraft until sufficient data on the performance and durability of the proposed overpacks has been collected. ALPA notes that, in justifying the proposal to require cylinders of compressed oxygen contained in an outer packaging not reach a temperature of 93 °C (199 °F) when exposed to a 205 °C (400 °F) temperature for three hours, PHMSA outlines conditions expected to be encountered within a cargo compartment during a suppressed cargo fire. The commenter states these conditions are then used as a basis for the requirement that an oxygen cylinder withstand a 1,700 °F flame for 5 minutes, followed by a temperature of 205 °C (400 °F) for 3 hours.

ALPA questions why PHMSA would propose to allow these oxygen cylinders in cargo compartments without any fire or smoke detection or an active fire suppression system. The commenter states if there were to be a fire in a cargo compartment without an active fire suppression system, the temperatures in the compartment would far exceed 205 °C (400 °F). According to ALPA, the only method available to limit the severity of such a fire is to limit the oxygen present within the compartment, either through an airtight under-floor design or by depressurizing the aircraft in the case of the main deck (Class E compartment) of an all-cargo aircraft. By introducing an oxygen cylinder unable to withstand the high temperatures of an unsuppressed fire, the commenter states either method would be negated. The commenter recommends oxygen cylinders be prohibited from transport in compartments without a fire or smoke detection system and an active fire suppression system.

Further, ALPA stresses any fire suppression system required by the rulemaking should be an active fire suppression system, with a knock-down agent (e.g., Halon). While a cargo compartment that limits the flow of oxygen may be considered to have a suppression system, the commenter contends this is clearly not the intent of the rulemaking, and asks that the word “active” be included in any discussion of suppression systems. The commenter also requests specific criteria to determine what constitutes passing or failing a visual inspection of oxygen generators by accepting personnel, and suggests a requirement for this person to provide a signature indicating the cylinder has passed a visual inspection. Finally, this commenter expresses concern with the proposal to allow oxygen generators aboard cargo-only aircraft in cargo compartments without an active fire suppression system, as the compartment design criteria are insufficient to withstand the conditions encountered in an unsuppressed fire. The objections by this commenter to this scenario are the same as for oxygen cylinders; specifically, the compartment design criteria are insufficient to withstand the conditions that would be encountered in an unsuppressed fire. The commenter concludes by recommending that oxygen generators be prohibited from transport on both passenger and cargo-only aircraft due to the additional hazard potential even in the presence of fire suppression systems.

Other commenters suggest alternatives to this rulemaking. Intertechnique recommends PHMSA conduct further investigation into this area before incorporating this proposal into the HMR. The commenter notes one procedure to control or suppress fire involves depressurizing the aircraft and suggests tests should include a rapid pressure change of the test chamber to simulate rapid decompression followed by a rapid descent of the burning aircraft. The commenter argues this decompression should not lead to bursting the packaging, and the ingestion of hot gas into the packaging during descent may lead to a rapid increase of the internal temperature that should be evaluated before the introduction of this regulatory change.

We acknowledge the commenters' concerns regarding the transportation of oxygen cylinders in cargo compartments without an active fire suppression system, and have reconsidered this proposed regulatory change. Based on these comments and consistent with current requirements, we are revising § 175.501 to require that, except for Oxygen, compressed, no person may load or transport a hazardous material for which an OXIDIZER label is required in an inaccessible cargo compartment that does not have a fire or smoke detection system and a fire suppression system. We are also revising this section to simplify the stowage requirements of cylinders of compressed oxygen previously located in § 175.85(i)(2) and (3), and to retain the limit of a combined total of six cylinders of compressed oxygen that may be stowed on an aircraft in the inaccessible aircraft cargo compartment(s) that do not have fire or smoke detection systems and fire suppression systems.

In the NPRM, we proposed to add a new § 173.168 that would: (1) Specify the means to be incorporated into an oxygen generator to prevent inadvertent actuation; (2) require the oxygen generator to be capable of withstanding a 1.8 meter drop with no loss of contents or actuation; and (3) specify packaging, shipping paper, and marking requirements for those oxygen generators that are installed in a piece of equipment sealed or otherwise packaged so it is difficult to determine if an oxygen generator is present.

SR Technics supports the additional marking requirement contained in the newly proposed § 173.168. This commenter states it is currently undergoing an evaluation involving the inadvertent transportation of chemical oxygen generators assembled in sealed components. In this situation, personnel handling this material did not realize the generators were installed in the component (passenger service units). In addition, this same commenter suggests chemical oxygen generators are not properly identified on Material Safety Data Sheets (MSDS). The commenter recommends we coordinate efforts with the Occupational Safety and Health Administration (OSHA) so critical safety transportation information is included on a MSDS for chemical oxygen generators.

Scott argues the proposed rule would reword paragraph 173.168(d) to require “a chemical oxygen generator installed in equipment, (e.g., a PBE) [to] be placed in a rigid packaging * * * that conforms to the requirements capable of meeting the flame penetration and thermal resistance requirements of this proposed rule for shipment by air.” PBEs, manufactured by Scott, are all one size and shape and, therefore, one size outer packing may suffice for Scott. This commenter states other manufacturers offering PBEs will most likely need a different outer packing. The commenter says PBEs are not the only aviation “equipment” in which oxygen generators are installed. For instance, Scott states that, in certain aircraft, it may be practical to replace just the chemical oxygen generator when maintenance is required. However, in other aircraft, it may be safer and more convenient to replace what is termed the “dropout box,” or passenger service unit (PSU), rather than just the oxygen generator. According to Scott, the dropout box is an assembly containing one or more oxygen masks, a chemical oxygen generator, and the related equipment needed to cause the box to open and the masks to deploy during a depressurization event.

The same commenter further states chemical oxygen generators are often contained in PSUs, which are segments of the cabin interior ceiling containing a chemical oxygen generator, several passenger oxygen masks, the reading lights, ventilation ducting, attendant call button, and other associated appliances. The commenter suggests the great variety of sizes and shapes of these assemblies means a large number of different sized packages may be required, or that these items may have to be disassembled, their chemical oxygen generators removed for shipment in a separate package, and the items reassembled at destination. The commenter says disassembly for shipment and subsequent reassembly increases cost and the possibility of mis-assembly and the subsequent failure of the oxygen equipment to function properly in an emergency.

Other commenters also express concern about the elimination of approvals for any person except manufacturers of chemical oxygen generators. Aviosupport recommends the proposal to eliminate distributors from being able to handle or repackage chemical oxygen generators to the airline industry be removed from this rulemaking, altogether. Satair states this proposal would not allow it to handle, repack and offer for transportation chemical oxygen generators and PBEs on any mode of transportation, including air. The commenter states such a limitation would create a significant loss of support in the commercial aerospace supply chain and would negatively impact its company. The same commenter further states the Competent Authority approval is a proven tool to ensure safe storage, handling and transportation of chemical oxygen generators and PBEs.

The approval requirement for a chemical oxygen generator is still necessary and will be retained. However, the approval process will apply only to manufacturers of the chemical oxygen generator. This will eliminate the need for other persons to obtain shipment approvals, because we are incorporating into the HMR those aspects of the approvals specifically focused on safety controls, packaging, and marking. Accordingly, in this final rule, we are amending the HMR by adding a new § 173.168 to: (1) Specify means to be incorporated into an oxygen generator design to prevent actuation; (2) require an oxygen generator to be capable of withstanding a 1.8 meter drop with no loss of contents or actuation; and (3) establish packaging, shipping paper, and marking requirements for those oxygen generators that are installed in sealed equipment (or equipment in which it otherwise is difficult to determine if an oxygen generator is present). In addition, we have reconsidered the proposal to amend the shipping paper requirements and are not adopting this provision at this time. The recommendation that we coordinate efforts with OSHA to ensure that critical safety transportation information is included on a MSDS is beyond the scope of this rulemaking, but may be considered in the future.

We also proposed to specify in the HMR that a chemical oxygen generator that has passed the manufacturer's expiration date is forbidden for transportation by aircraft. Through the approval process, PHMSA had not allowed the transportation of expired oxygen generators aboard aircraft. With the elimination of the approval for other than oxygen generator manufacturers, we believe it is now necessary to specify this restriction in the HMR. We did not receive any adverse comments to this specific proposal. Therefore, we are amending the HMR to specify that a chemical oxygen generator that has passed the manufacturer's expiration date is forbidden for transportation by aircraft.

Under separate PHMSA and FAA requirements [49 CFR 175.8(b)(1), and 14 CFR 121.574, 125.219, and 135.91, respectively], which this rulemaking would not amend, passengers may not carry their own oxygen dispensing systems aboard aircraft for use during flight. Air carriers are permitted to provide oxygen for passenger use in accordance with specified requirements in the aforementioned rules, although some air carriers may choose not to provide this service for their passengers. In the NPRM, PHMSA requested comments on whether the new proposed provisions placed on carriage of air carriers' own oxygen cylinders will significantly interfere with carriers' ability to provide this service, or increase the costs of this service, to passengers. This topic is covered above under “Outer Packaging for Compressed Oxygen Cylinders and Oxygen Generators.”

The Office of the Secretary, PHMSA and FAA have initiated projects separate from this rulemaking action to explore whether safe alternatives exist for accommodating passenger needs in regard to use of medical oxygen. These projects may result in proposals to amend the relevant portions of the HMR and FAA regulations, as well as those of the Office of the Secretary implementing the Air Carrier Access Act of 1986 (49 U.S.C. 41705), which prohibits discrimination in regard to air traveler access on the basis of disability.

This final rule is published under the authority of Federal hazardous materials transportation law (Federal hazmat law; 49 U.S.C. 5101 et seq. ) and 49 U.S.C. 44701. Section 5103(b) of Federal hazmat law authorizes the Secretary of Transportation to prescribe regulations for the safe transportation, including security, of hazardous material in intrastate, interstate, and foreign commerce. Section 1.53 of 49 CFR delegates the authority to issue regulations in accordance with 49 U.S.C. 5103(b) to the Administrator of the Pipeline and Hazardous Materials Safety Administration. United States Code § 44701 authorizes the Administrator of the Federal Aviation Administration to promote safe flight of civil aircraft in air commerce by prescribing regulations and minimum standards for practices, methods, and procedure the Administrator finds necessary for safety in air commerce and national security. Under 49 U.S.C. 40113, the Secretary of Transportation has the same authority to regulate the transportation of hazardous material by air, in carrying out § 44701, that he has under 49 U.S.C. 5103.

This final rule is considered a significant regulatory action under section 3(f) of Executive Order 12866 and, therefore, was reviewed by the Office of Management and Budget (OMB). This rule is significant under the Regulatory Policies and Procedures of the Department of Transportation (44 FR 11034). The costs associated with the transport of oxygen cylinders are estimated to be $10.8 million over 15 years ($7.6 million discounted; the majority of which is believed to be associated with the transport of oxygen cylinders aboard passenger-carrying aircraft). The costs associated with the transport of chemical oxygen generators is estimated to be $27.0 million over 15 years ($16.9 million discounted). All costs have been discounted to present value at 7% and are expressed in 2004 dollars). The benefits of this rulemaking range from $30 million, if a single cargo aircraft accident is averted to $357 million, if a passenger aircraft accident is averted. Therefore, we conclude this final rule will be cost beneficial. A copy of the regulatory evaluation is available for review in the public docket.

This final 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. The changes to the HMR in this final rule will not have a retroactive effect. Under PHMSA's procedural rules, there is a right to administratively appeal this final rule to PHMSA's Administrator (49 CFR 106.100 et seq. ), but such an administrative appeal is not a prerequisite to seeking judicial review in accordance with 49 U.S.C. 5127.

This final rule has been analyzed in accordance with the principles and criteria contained in Executive Order 13132 (“Federalism”). This final rule preempts State, local and Indian tribe requirements, but does not amend any regulation that has direct effects on the States, the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government. Therefore, the consultation and funding requirements of Executive Order 13132 do not apply.

The Federal hazardous materials transportation law, 49 U.S.C. 5101-5127, contains an express preemption provision (49 U.S.C. 5125(b)) that preempts State, local, and Indian tribe requirements on the following subjects:

(1) The designation, description, and classification of hazardous material;

(2) The packing, repacking, handling, labeling, marking, and placarding of hazardous material;

(3) The preparation, execution, and use of shipping documents related to hazardous material and requirements related to the number, contents, and placement of those documents;

(4) The written notification, recording, and reporting of the unintentional release in transportation of hazardous material; and

(5) The design, manufacture, fabrication, marking, maintenance, recondition, repair, or testing of a packaging or container represented, marked, certified, or sold as qualified for use in transporting hazardous material.

This final rule addresses items 2 and 5 above and would preempt any State, local, or Indian tribe requirements not meeting the “substantially the same” standard.

Federal hazardous materials transportation law provides at § 5125(b)(2) that, if DOT issues a regulation concerning any of the covered subjects, DOT must determine and publish in the Federal Register the effective date of Federal preemption. The effective date may not be earlier than the 90th day following the date of issuance of the final rule and not later than two years after the date of issuance. This effective date of preemption is 90 days after the publication of this final rule in the Federal Register .

This final rule has been analyzed in accordance with the principles and criteria contained in Executive order 13175 (“Consultation and Coordination with Indian Tribal Governments”). Because this final rule will not have tribal implications and does not impose substantial direct compliance costs on Indian tribal governments, the funding and consultation requirements of Executive Order 13175 do not apply, and a tribal summary impact statement is not required.

The Regulatory Flexibility Act of 1980 establishes “as a principle of regulatory issuance that agencies shall endeavor, consistent with the objective of the rule and of applicable statutes, to fit regulatory and informational requirements to the scale of the business, organizations, and governmental jurisdictions subject to regulation.” To achieve that principle, the Act requires agencies to solicit and consider flexible regulatory proposals and to explain the rational for their actions. The Act covers a wide-range of small entities, including small businesses, not-for-profit organizations and small governmental jurisdictions.

Agencies must perform a review to determine whether a proposed or final rule will have a significant economic impact on a substantial number of small entities. If the determination is that it will, the agency must prepare a regulatory flexibility analysis (RFA) as described in the Act.

However, if an agency determines that a proposed or final rule is not expected to have a significant economic impact on a substantial number of small entities, 5 U.S.C. 605(b) provides that the head of the agency may so certify and an RFA is not required. The certification must include a statement providing the factual basis for this determination, and the reasoning should be clear.

The Small Business Administration recommends that “small” represent the impacted entities with 1,500 or fewer employees. For this final rule, small entities are part 121 and part 135 air carriers with 1,500 or fewer employees that are approved to carry hazardous materials. DOT identified 729 air carriers that meet this definition. DOT contacted several of these entities to estimate the number of containers that each small air carrier uses to transport oxygen cylinders aboard aircraft in other than the passenger cabin. All the entities that were contacted maintained that although they are approved to carry hazardous materials, they transport no oxygen cylinders in cargo compartments. From conversations with container manufacturers, DOT learned that approximately ten small air carriers transport compressed oxygen cylinders. DOT believes that each of the ten small air carriers would need approximately 5 compressed oxygen containers to comply with the final rule. DOT also estimates that each of ten small carriers will need approximately 5 oxygen generator containers to comply with the final rule.

After calculating the prorated annualized costs per entity using the same assumptions that were used in the cost section (all costs have been discounted to present value at 7% and are expressed in 2004 dollars), DOT has determined that the incremental cost impact per small entity would be $451 (See Table 3 of the regulatory evaluation in the public docket), which PHMSA considers “de minimus” for a small business (See Appendix C) . The baseline costs per small entity shown in Table 3 are generated from Appendix C by adding the baseline discounted costs of oxygen cylinders and chemical oxygen generator overpacks. Similarly, the costs in Table 3 are generated by adding discounted costs of the rule for oxygen cylinder and chemical oxygen generator overpacks. Annualized costs are calculated by applying a capital recovery factor to total incremental costs and measuring the annual impact of the regulation.

Thus, DOT has determined that this final rule will not have a significant impact on a substantial number of small entities. Accordingly, pursuant to the Regulatory Flexibility Act, 5 U.S.C. 605(b), DOT certifies that this rule will not have a significant economic impact on a substantial number of small entities.

The Trade Agreements Act of 1979 prohibits Federal agencies from establishing any standards or engaging in related activities that create unnecessary obstacles to the foreign commerce of the United States. Legitimate domestic objectives, such as safety, are not considered unnecessary obstacles. The statute also requires consideration of international standards and, where appropriate, that they be the basis for U.S. standards. The FAA has assessed the potential affect of this final rule and has determined that it will have only a domestic impact and therefore it will not affect any trade-sensitive activity.

The Unfunded Mandates Reform Act of 1995 (the Act) is intended, among other things, to curb the practice of imposing unfunded Federal mandates on State, local, and tribal governments. Title II of the Act requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed or final agency rule that may result in an expenditure of $100 million or more (adjusted annually for inflation) in any one year by State, local, and tribal governments, in the aggregate, or by the private sector; such a mandate is deemed to be a “significant regulatory action.” The FAA currently uses an inflation-adjusted value of $120.7 million in lieu of $100 million.

This final rule does not contain such a mandate. The requirements of Title II do not apply.

This final rule results in an information collection and recordkeeping burden increase under OMB Control Number 2137-0572, due to changes in package design and testing requirements for compressed oxygen and oxygen generators. There is an editorial change with no change in burden under OMB Control Number 2137-0557, due to changes in section designations regarding approval requirements for oxygen generators. PHMSA currently has approved information collections under OMB Control Number 2137-0572, “Testing Requirements for Non-Bulk Packaging” with 32,500 burden hours, and an expiration date of July 31, 2007, and OMB Control Number 2137-0557, “Approvals for Hazardous Materials” with 25,605 burden hours, and an expiration date of March 31, 2008. Under the Paperwork Reduction Act of 1995, no person is required to respond to an information collection unless it displays a valid OMB control number.

PHMSA estimates this rulemaking will result in approximately 10 additional respondents, 500 additional responses, 2,500 additional burden hours, and $750,000 additional burden costs. The new total information collection and recordkeeping burden for OMB Control Number 2137-0572 would be as follows:

Total Annual Number of Respondents : 5,010.

Total Annual Responses: 15,500.

Total Annual Burden Hours: 32,500.

Total Annual Burden Cost: $812,500.00.

Requests for a copy of this information collection should be directed to Deborah Boothe or T. Glenn Foster, Office of Hazardous Materials Standards (PHH-11), Pipeline and Hazardous Materials Safety Administration, Room 8430, 400 Seventh Street, SW., Washington, DC 20590-0001, Telephone (202) 366-8553.

The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321-4347) requires Federal agencies to consider the consequences of major Federal actions and prepare a detailed statement on actions significantly affecting the quality of the human environment. We developed an environmental assessment (EA) to consider the effects of these revisions on the environment and determine whether a more comprehensive environmental impact statement may be required. We have concluded that there are no significant environmental impacts associated with this final rule. An environmental assessment prepared for this final rule has been placed in the public docket for this rulemaking.

A regulation identifier number (RIN) is assigned to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. The RIN number contained in the heading of this document can be used to cross-reference this action with the Unified Agenda.

Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit http://dms.dot.gov.

The Atlantic bluefish fishery is cooperatively managed by the Mid-Atlantic Fishery Management Council (Council) and the Atlantic States Marine Fisheries Commission (Commission). The management unit for bluefish ( Pomatomus saltatrix ) is the U.S. waters of the western Atlantic Ocean.

The FMP requires that the Council recommend, on an annual basis, total allowable landings (TAL) for the fishery, consisting of a commercial quota and recreational harvest limit (RHL). A research set aside (RSA) quota is deducted from the bluefish TAL (after any applicable transfer) in an amount proportional to the percentage of the overall TAL as allocated to the commercial and recreational sectors. The annual review process for bluefish requires that the Council's Bluefish Monitoring Committee (Monitoring Committee) review and make recommendations based on the best available data including, but not limited to, commercial and recreational catch/landing statistics, current estimates of fishing mortality, stock abundance, discards for the recreational fishery, and juvenile recruitment. Based on the recommendations of the Monitoring Committee, the Council makes a recommendation to the Northeast Regional Administrator (RA). Because the Bluefish FMP is a joint plan with the Atlantic States Marine Fisheries Commission (Commission), the Commission meets during the annual specification process to adopt complimentary measures.

In July 2006, the Monitoring Committee met to discuss the updated estimates of bluefish stock biomass and project fishery yields for 2007. In August 2006, the Council approved the Monitoring Committee's recommendations and the Commission's Bluefish Board (Board) adopted complementary management measures. Detailed background information regarding the status of the bluefish stock and the development of the 2007 specifications for this fishery was provided in the proposed specifications (71 FR 68524, November 27, 2006). That information is not repeated here.

A request for proposals was published on December 23, 2005, to solicit research proposals to utilize RSA in 2007 based on research priorities identified by the Council (70 FR 76253). One research project that would utilize 363,677 lb (164,961 kg) of bluefish RSA has been conditionally approved by NMFS and is currently awaiting notice of award. Therefore, this final rule implements a 363,677-lb (164,961-kg) RSA quota for the 2007 bluefish fishery. If this project is not approved by the NOAA Grants Office, the research quota associated with the disapproved proposal will be restored to the bluefish TAL through publication in the Federal Register .

The FMP specifies that the bluefish stock is to be rebuilt to B MSY over a 9-year period and requires the Council to recommend, on an annual basis, a level of total allowable catch (TAC) consistent with the rebuilding program in the FMP. An estimate of annual discards is deducted from the TAC to calculate the TAL that can be made during the year by the commercial and recreational fishing sectors combined. The FMP rebuilding program requires the TAC for any given year to be set based either on the target F resulting from the stock rebuilding schedule specified in the FMP (0.31 for 2007), or the F estimated in the most recent fishing year (F 2005 = 0.15), whichever is lower. An overall TAC of 32.033 million lb (14,530 mt) is recommended as the coastwide TAC by the Council at its August 2006 meeting to achieve the target fishing mortality rate (F = 0.15) in 2007, consistent with the rebuilding schedule specified in Amendment 1.

The TAL for 2007 is derived by subtracting an estimate of discards of 4.271 million lb (1,937 mt), the average discard level from 2001-2005, from the TAC. After subtracting estimated discards, the 2007 TAL is approximately 12 percent greater than the 2006 TAL, or 27.762 million lb (12,593 mt). Based strictly on the percentages specified in the FMP (17 percent commercial, 83 percent recreational), the commercial quota for 2007 would be 4.720 million lb (2,141 mt), and the RHL would be 23.043 million lb (10,452 mt) in 2007. In addition, up to 3 percent of the TAL may be allocated as RSA quota. The discussion below describes the allocation of TAL between the commercial and recreational sectors that is being implemented in this final rule, and its proportional adjustment downward to account for the bluefish RSA quota.

As described in the proposed rule, based on the best information available at the time, the Council recommended that 4.780 million lb (2,168 mt) be transferred from the initial recreational allocation of 23.043 million lb (10,452 mt) resulting in a 2007 commercial quota of 9.500 million lb (4,309 mt) and a RHL of 18.262 million lb (8,284 mt). These allocations were also recommended by the Commission to be implemented by the states for fisheries within state waters.

Although the Council recommendation was based on the best information available at the time, more recent information not available at the time of the Council's recommendation or at the time of publication of the proposed rule was used to develop a new landings projection for the 2007 fishing year. This new projection indicates that the initial transfer amount would exceed the amount allowable under the regulations. Based on data provided by the Marine Recreational Fisheries Statistic Survey (MRFSS) program, projected recreational landings in 2006 equal 18,823,384 lb (8,538 mt). Using this amount as the most reasonable proxy for expected landings in 2007, this final rule will reduce the amount of the transfer from the recreational to the commercial sector by 810,780 lb (367,764 kg) from 4,780,000 lb (2,168 mt) to 3,969,220 lb (1,800 mt), commensurate with the increase in projected recreational landings. Therefore, the initial recreational allocation of 18,262,270 lb (8,284 mt) will be reduced by 3,969,220 lb (1,800 mt) resulting in a post-transfer commercial quota of 8,688,760 lb (3,941 mt) and a recreational harvest limit of 19,073,240 lb (8,651 mt). After adjusting for the RSA quota, the resulting 2007 specifications will include a commercial quota of 8,574,939 lb (3,890 mt) and a recreational harvest limit of 18,823,384 lb (8,538 mt). The RSA quota will remain unchanged at 363,677 lb (164,961 kg).

In accordance with the regulations found at 50 CFR 648.160(f)(4), NMFS published an in-season adjustment to New York's commercial bluefish quota on May 15, 2006 (71 FR 27977), as the result of an overage of 51,397 lb (23,313 kg) that occurred during FY 2005. Since the publication of that in-season adjustment, updated landings information for FY 2005 indicates an additional bluefish quota overage for New York in the amount of 6,238 lb (2,829 kg), resulting in a total 2005 bluefish quota overage of 57,635 lb (26,143 kg) for the state. This final rule adjusts the 2007 bluefish quota for New York downward by 6,238 lb (2,829 kg) to account for this additional 2005 overage, from 890,516 lb (403,931 kg) to 884,278 lb (401,106 kg).

The 2007 commercial quota is allocated by state as shown in Table 1 below, according to the percentages specified in the FMP. Table 1 shows the allocations both before and after the deductions made to reflect the RSA quota allocation, and also accounts for the carryover quota overage for New York from FY 2005.

In this final rule, NMFS approves the Council's recommendation to maintain the current recreational possession limit of up to 15 fish per person to achieve the RHL.

The public comment period on the proposed rule ended on December 27, 2006, with only one comment received.

Comment 1: The commenter expressed general support for environmental reforms and conservation of bluefish for future generations. The commenter suggested that the TAC be reduced by 50 percent initially, and by 10 percent in each subsequent year.

Response: NMFS acknowledges the importance of the issues raised by the commenter, but those of a general nature are outside the scope of this rulemaking. The commenter gave no specific rationale for why the quotas should be reduced in the manner suggested, and there is no known scientific basis for the commenter's suggestions. The reasons presented by the Council and NMFS for recommending the final 2007 bluefish specifications are discussed in the preambles to both the proposed and final rules, and sufficient analysis is contained within the supporting documents.

This final rule is exempt from review under Executive Order 12866.

Included in this final rule is the FRFA prepared pursuant to 5 U.S.C. 604(a). The FRFA incorporates the IRFA, a summary of the significant issues raised by the public comments in response to the IRFA, and NMFS' responses to those comments, and a summary of the analyses completed to support the action. A copy of the EA/RIR/IRFA is available from the Council (see ADDRESSES ).

The preamble to the proposed rule included a detailed summary of the analyses contained in the IRFA, and that discussion is not repeated here.

A description of the reasons why this action is being taken, and the objectives of and legal basis for these specifications are explained in the preambles to the proposed rule and this final rule and are not repeated here.

One comment was submitted on the proposed rule, but it was not specific to the IRFA or the economic effects of the rule. NMFS has responded to the comment in the Comments and Responses section of the preamble to this final rule. No changes were made to the final rule as a result of the comment received.

The Small Business Administration (SBA) defines small businesses in the commercial fishing and recreational fishing sectors as firms with receipts (gross revenues) of up to $4.0 million and $6.5 million, respectively. This rule could affect any vessels that fish for bluefish in Federal or state waters. The final measures regarding the 2007 quotas could affect any vessels holding an active Federal permit for bluefish as well as vessels that fish for this species in state waters.

An active participant in the commercial sector was defined as being any vessel that reported having landed one or more pounds of bluefish the dealer data during calendar year 2005. Of the active vessels reported in 2005, 745 known vessels landed bluefish from Maine through North Carolina. The Northeast Region dealer data do not cover vessel activity in the South Atlantic. The Northeast Region dealer data indicate that 148 federally permitted vessels landed bluefish in North Carolina in 2005. However, the North Carolina landings data for bluefish may be incomplete is this data system. South Atlantic Trip Ticket Report data indicate that 882 vessels landed bluefish in North Carolina in 2005. Some of these vessels may be included among the 148 vessels identified as landing bluefish in the Northeast Region dealer data. As such, double counting is possible. In addition, up to 620 vessels may have landed bluefish in Florida's east coast in 2005. Bluefish landings in South Carolina and Georgia were less than a thousand pounds combined in FY 2005, representing a negligible proportion of the total bluefish landings along the Atlantic coast in 2005. Therefore, for the purpose of this analysis, it is assumed that no vessels landed bluefish from South Carolina and Georgia.

In addition, it was estimated that in recent years approximately 2,063 party/charter vessels may have been active and/or caught bluefish. All of these vessels are considered small entities under the RFA, having gross receipts of less than $5 million annually. Since the recreational possession limits will remain at 15 fish per person, there should be no impact on demand for party/charter vessel fishing, and, therefore, no impact on revenues earned by party/charter vessels.

No additional reporting, recordkeeping, or other compliance requirements are included in this final rule.

Specification of commercial quota, recreational harvest levels, and possession limits is constrained by the conservation objectives of the FMP, under the authority of the Magnuson-Stevens Act. The commercial quota and RHL contained in this final rule are 8.5 percent lower and 4.4 percent higher, respectively, than the Council's preferred alternative contained in the proposed rule. Although the commercial quota under this new alternative is lower than the commercial quota recommended by the Council, it is 7.7 percent higher than the final 2006 commercial quota (71 FR 9471; February 24, 2006). As a result, all affected states will receive an increase in their individual commercial quota allocation in comparison to their respective 2006 individual state allocations. However, the magnitude of that increase varies depending on the state's respective percent share in the total commercial quota, as specified in the FMP, and depending on if the state had any additional overages from FY 2005 that needed to be adjusted for in this final rule (e.g., New York). NMFS considered a TAL that would have allowed a higher allocation of quota to the commercial sector, but this alternative, proposed by the Council, would have been inconsistent with the goals and objectives of the FMP and the Magnuson-Stevens Act. The new alternative, which will transfer less quota from the recreational sector to the commercial sector than the alternative contained in the proposed rule (see Table 2), is being implemented consistent with recent recreational landings trends and should ensure that the 2007 RHL is not exceeded. Furthermore, the RHL being implemented in this final rule is 14.3 percent higher than the RHL specified in FY 2006. In conclusion, because both the 2007 commercial quota and RHL being implemented in this final rule represent increases over the 2006 specifications, and because the revised 2007 RHL is consistent with recent trends in recreational landings, no negative economic impacts are expected relative to the status quo and the Council's preferred alternative.

The impacts on revenues of the proposed RSA were analyzed. The social and economic impacts of this proposed RSA are expected to be minimal. Assuming the full RSA is allocated for bluefish, the set-aside amount could be worth as much as $120,013 dockside, based on an average 2005 ex-vessel price of $0.33 per pound for bluefish. Assuming an equal reduction among all 745 active dealer reported vessels, this could mean a reduction of about $161 per individual vessel. Changes in the recreational harvest limit would be insignificant (less than a 2- percent decrease), if 1.3 percent of the TAL is used for research. There are no anticipated adverse impacts associated with the RSA. In general, RSAs are expected to yield important long-term benefits associated with improved data upon which to base management decisions.

Table 2. Comparison of New Alternative to Council Preferred and 2006 Specifications

Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 states that, for each rule or group of related rules for which an agency is required to prepare a FRFA, the agency shall publish one or more guides to assist small entities in complying with the rule, and shall designate such publications as “small entity compliance guides.” The agency shall explain the actions a small entity is required to take to comply with a rule or group of rules. As part of this rulemaking process, a small entity compliance guide will be sent to all holders of Federal permits issued for the bluefish fishery. In addition, copies of this final rule and guide (i.e., permit holder letter) are available from NMFS (see ADDRESSES ) and at the following website: http://www.nero.noaa.gov/nero/nr/index.html .

The CPS FMP, which was implemented by publication of a final rule in the Federal Register on December 15, 1999 (64 FR 69888), divides management unit species into two categories: actively managed and monitored. Harvest guidelines for actively managed species (Pacific sardine and Pacific mackerel) are based on formulas applied to current biomass estimates. Biomass estimates are not calculated for species that are only monitored (jack mackerel, northern anchovy, and market squid).

At a public meeting each year, the biomass for each actively managed species is reviewed by the Pacific Fishery Management Council's (Council) CPS Management Team (Team). The biomass, harvest guideline, and status of the fisheries are then reviewed at a public meeting of the Council's CPS Advisory Subpanel (Subpanel). This information is also reviewed by the Council's Scientific and Statistical Committee (SSC). The Council reviews the reports from the Team, Subpanel, and SSC, provides opportunity for public comment, and then makes its recommendation to NMFS. The annual harvest guideline and season structure are then written and published by NMFS in the Federal Register . The Pacific mackerel season begins on July 1 and ends on June 30 of each year.

Public meetings of the Team and Subpanel, as well as a subcommittee of the SSC, were held at NMFS Southwest Fisheries Science Center (SWFSC), in La Jolla, CA on May 16, 17, and 18, 2006 (April 28, 2006; 71 FR 25152). During these meetings the current stock assessment update for Pacific mackerel, which included a preliminary biomass estimate and harvest guideline, were reviewed in accordance with the procedures of the FMP. These meetings are designed to allow a review of the biomass and harvest guideline, and are required by the FMP.

The formula in the FMP uses the following factors to determine the harvest guideline:

1. The biomass of Pacific mackerel. For 2006, this estimate is 112,700 metric tons (mt).

2. The cutoff. This is the biomass level below which no commercial fishery is allowed. The FMP established the cutoff level at 18,200 mt. The cutoff is subtracted from the biomass, leaving 94,500 mt.

3. The portion of the Pacific mackerel biomass that is in U.S. waters. This estimate is 70 percent, based on the historical average of larval distribution obtained from scientific cruises and the distribution of the resource obtained from logbooks of fish-spotters. Therefore, the harvestable biomass in U.S. waters is 70 percent of 94,500 mt, or 66,150 mt.

4. The harvest fraction. This is the percentage of the biomass above 18,200 mt that may be harvested. The FMP established the harvest fraction at 30 percent. The harvest fraction is multiplied by the harvestable biomass in U.S. waters (66,150 mt), which results in 19,845 mt.

The Team supported the conclusions from the Pacific mackerel stock assessment and recommended to the Council at its June 2006 Council meeting that the Council adopt a harvest guideline (HG) for the 2006/2007 management season (i.e., July 1, 2006, through June 30, 2007) of 19,845 mt. The Council adopted this HG, as well as the Subpanel's recommendation on the management of the fishery by dividing the harvest guideline into a directed fishery with a guideline of 13,845 mt and set-aside of 6,000 mt to accommodate incidental landings of Pacific mackerel in other CPS fisheries. The set-aside is intended to prevent a reoccurrence of the 2000/ 2001 Pacific mackerel season where early attainment of the entire harvest guideline in the directed fishery curtailed the Pacific sardine fishery which incidentally lands mackerel.

The incidental fishery would be constrained to a 40-percent incidental catch rate when Pacific mackerel are landed with other CPS, except that up to one metric ton of Pacific mackerel can be landed without landing any other CPS. The Council recommended a review of the Pacific mackerel fishery at the March 2007 Council meeting with the understanding that NMFS will consider releasing some or all of the incidental fishery set-aside if a sufficient amount of the guideline remains available for harvest.

Based on the estimated biomass of 112,700 mt and the formula in the FMP, a harvest guideline of 19,845 mt will be in effect for the fishery which began on July 1, 2006. This harvest guideline applies to Pacific mackerel harvested in the U.S. EEZ off the Pacific coast from 12:01 a.m. on July 1, 2006, through 11:59 pm on June 30, 2007, unless the harvest guideline is attained and the fishery is closed before June 30, 2007. All landings made after July 1, 2006, will be counted toward the 2006-2007 harvest guideline of 19,845 mt. There shall be a directed fishery of 13,845 mt, followed by an incidental fishery of 6,000 mt. An incidental allowance of 40 percent of Pacific mackerel in landings of any CPS will become effective after the date when 13,845 mt of Pacific mackerel is estimated to have been harvested. A landing of 1 mt of Pacific mackerel per trip will be permitted during the incidental fishery for trips in which no other CPS is landed.

This final rule is exempt from review under Executive Order 12866.

The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this action would not have a significant economic impact on a substantial number of small entities. The factual basis for the certification was published in the proposed rule (October 20,2006; 71 FR 61944) and is not repeated here.

No comments were received regarding this certification or the economic impact of this rule. As a result, a regulatory flexibility analysis was not required and none was prepared.