Notices. Final rule
51,934 words·~236 min read·
/register/2007/01/31/07-407A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 9111-14-P DEPARTMENT OF TRANSPORTATION Saint Lawrence Seaway Development Corporation 33 CFR Part 402 [Docket No. SLSDC 2006-26584] RIN 2135-AA25 Tariff of Tolls AGENCY: Saint Lawrence Seaway Development Corporation, DOT. ACTION: Final rule. SUMMARY: 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 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 its regulations to reflect the fees and charges levied by the SLSMC in Canada starting in the 2007 navigation season, which are effective only in Canada. An amendment to increase the minimum charge per lock for those vessels that are not pleasure craft or subject in Canada to tolls under items 1 and 2 of the Tariff for full or partial transit of the Seaway will apply in the U.S.
Also, the SLSDC is changing the toll charged per pleasure craft using the U.S. locks from $25 U.S. or $30 Canadian to $30 U.S. or $30 Canadian. Several minor editorial corrections are being made in § 402.3, “Interpretation.” and § 402.6, “Description and weight of cargo.” (See Supplementary Information .) DATES: This rule is effective March 2, 2007. FOR FURTHER INFORMATION CONTACT: Craig H. Middlebrook, Acting Chief Counsel, Saint Lawrence Seaway Development Corporation, 400 Seventh Street, SW., Washington, DC 20590,
(202)366-0091. SUPPLEMENTARY INFORMATION: 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.* Regulatory Evaluation 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. Regulatory Flexibility Act Determination 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. Environmental Impact 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. Federalism 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. Unfunded Mandates 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. Paperwork Reduction Act 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. List of Subjects in 33 CFR Part 402 Vessels, Waterways. Accordingly, the Saint Lawrence Seaway Development Corporation is amending 33 CFR part 402, Tariff of Tolls, as follows: PART 402—TARIFF OF TOLLS 1. The authority citation for Part 402 continues to read as follows: Authority: 33 U.S.C. 983(a), 984(a)(4) and 988, as amended; 49 CFR 1.52. 2. Section 402.3 is amended by revising paragraph (a)(5), (b)(1) and
(f)to read as follows § 402.3 Interpretation.
(a)* * *
(5)Ores and minerals (crude, screened, sized or concentrated, but not otherwise processed) loose or in sacks, including alumina, bauxite, gravel, phosphate rock, sand, stone and sulphur;
(b)* * *
(1)Empty containers or the tare weight of loaded containers;
(f)*General cargo* means goods other than bulk cargo, grain, government aid cargo, steel slabs and coal. 3. Section 402.5 is amended by revising paragraph
(b)to read as follows: § 402.5 Description and weight of cargo.
(b)The cargo tonnage shall be rounded to the nearest 1,000 kilograms (2,204.62 pounds.) 4. Section 402.8 is revised to read as follows: § 402.8 Schedule of tolls. Column 1 Item—description of charges Column 2 Rate ($) Montreal to or from Lake Ontario (5 locks) Column 3 Rate ($) Welland Canal—Lake Ontario to or from Lake Erie (8 locks) 1. Subject to item 3, for complete transit of the Seaway, a composite toll, comprising:
(1)a charge per gross registered ton of the ship, applicable whether the ship is wholly or partially laden, or is in ballast, and the gross registered tonnage being calculated according to prescribed rules for measurement or under the International Convention on Tonnage Measurement of Ships, 1969, as amended from time to time 0.0966 0.1568
(2)a charge per metric ton of cargo as certified on the ship's manifest or other document, as follows: ( *a* ) bulk cargo 1.0012 0.6634 ( *b* ) general cargo 2.4124 1.0616 ( *c* ) steel slab 2.1833 0.7600 ( *d* ) containerized cargo 1.0012 0.6634 ( *e* ) government aid cargo n/a n/a ( *f* ) grain 0.6151 0.6634 ( *g* ) coal 0.5911 0.6634
(3)a charge per passenger per lock 1.4233 1.4233
(4)a charge per lock for transit of the Welland Canal in either direction by cargo ships: ( *a* ) loaded n/a 529.79 ( *b* ) in ballast n/a 391.43 2. Subject to item 3, for partial transit of the Seaway 20 percent per lock of the applicable charge under items 1(1) and
(2)plus the applicable charge under items 1(3) and
(4)13 percent per lock of the applicable charge under items 1(1) and
(2)plus the applicable charge under items 1(3) and (4). 3. Minimum charge per ship per lock transited for full or partial transit of the Seaway 25.00 25.00 4. A rebate applicable to the rates of item 1 to 3 n/a n/a 5. A charge per pleasure craft per lock transited for full or partial transit of the Seaway, including applicable federal taxes 1 25.00 25.00 6. Subject to item 3, in lieu of item 1(4), for vessel carrying new cargo on the Welland Canal or returning ballast after carrying new cargo on the Welland Canal, a charge per gross registered ton of the ship, the gross registered tonnage being calculated according to item 1(1):
(a)loaded n/a 0.1561
(b)in ballast n/a 0.1144 7. Subject to item 3, in lieu of item 1(1), for vessel carrying new cargo on the MLO section or returning ballast after carrying new cargo on the MLO Section, a charge per gross registered ton of the ship, the gross registered tonnage being calculated according to item 1(1): 0.0000 n/a Issued at Washington, DC on January 22, 2007. Saint Lawrence Seaway Development Corporation. Collister Johnson, Jr., Administrator. [FR Doc. E7-1535 Filed 1-30-07; 8:45 am] BILLING CODE 4910-61-P NATIONAL ARCHIVES AND RECORDS ADMINISTRATION 36 CFR Part 1280 [NARA-06-0005] RIN 3095-AB55 Use of NARA Facilities; Correction AGENCY: National Archives and Records Administration (NARA). ACTION: Correcting amendment. SUMMARY: The National Archives and Records Administration
(NARA)published a final rule in the **Federal Register** on December 20, 2006 (71 FR 76166), revising NARA's rules relating to use of NARA property. In the heading to a paragraph within a section, the rule misidentified the National Archives Southeast Region as the National Archives Southwest Region. This document corrects the identification error. 1 The applicable charge at the Saint Lawrence Seaway Development Corporation's locks (Eisenhower, Snell) for pleasure craft is $30 U.S. or $30 Canadian per lock. The applicable charge under item 3 at the Saint Lawrence Seaway Development Corporation's locks (Eisenhower, Snell) will be collected in U.S. dollars. The other amounts are in Canadian dollars and are for the Canadian Share of tolls. The collection of the U.S. portion of tolls for commercial vessels is waived by law (33 U.S.C. 988a(a)). EFFECTIVE DATE: Effective on January 31, 2007. FOR FURTHER INFORMATION CONTACT: Laura McCarthy at 301-837-3023 or fax number 301-837-0319. SUPPLEMENTARY INFORMATION: 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). List of Subjects in 36 CFR Part 1280 Archives and records. For the reason stated in the preamble, 36 CFR part 1280 is corrected by making the following correcting amendment: PART 1280—USE OF NARA FACILITIES 1. The authority citation for part 1280 continues to read as follows: Authority: 44 U.S.C. 2104(a). 2. Revise § 1280.2
(d)to read as follows: § 1280.2 What property is under the control of the Archivist of the United States?
(d)*The National Archives Southeast Region.* The National Archives Southeast Region in Morrow, Georgia, as specified in 36 CFR 1253.7(e). Dated: January 23, 2007. Allen Weinstein, Archivist of the United States. [FR Doc. E7-1498 Filed 1-30-07; 8:45 am] BILLING CODE 7515-01-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R05-OAR-2006-0547; FRL-8274-4] Approval and Promulgation of Air Quality Implementation Plans; Michigan; Control of Gasoline Volatility AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: EPA is approving a State Implementation Plan
(SIP)revision submitted by the State of Michigan on May 26, 2006, and July 14, 2006, establishing a lower Reid Vapor Pressure
(RVP)fuel requirement for gasoline distributed in the Southeast Michigan area which includes Lenawee, Livingston, Macomb, Monroe, Oakland, St. Clair, Washtenaw, and Wayne Counties. Michigan has developed these fuel requirements to reduce emissions of volatile organic compounds
(VOC)in accordance with the requirements of the Clean Air Act (CAA). EPA is approving Michigan's fuel requirements into the Michigan SIP because EPA has found that the requirements are necessary for Southeast Michigan to achieve the 8-hour ozone National Ambient Air Quality Standard (NAAQS). On August 15, 2006, the EPA published a Notice of Proposed Rulemaking
(NPRM)proposing to approve the SIP revision. During the comment period EPA received adverse comments from one commenter. This document summarizes the comments received, EPA's responses, and finalizes the approval of Michigan's SIP revision to establish a RVP limit of 7.0 pounds per square inch
(psi)for gasoline sold in Southeast Michigan. DATES: This final rule is effective on March 2, 2007. ADDRESSES: EPA has established a docket for this action under Docket ID No. EPA-R05-OAR-2006-0547. All documents in the docket are listed on the *www.regulations.gov* Web site. Although listed in the index, some information is not publicly available, *i.e.* , Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically through *www.regulations.gov* or in hard copy at the Environmental Protection Agency, Region 5, Air and Radiation Division, 77 West Jackson Boulevard, Chicago, Illinois 60604. This facility is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays. We recommend that you telephone Francisco J. Acevedo, Environmental Protection Specialist, at
(312)886-6061 before visiting the Region 5 office. FOR FURTHER INFORMATION CONTACT: Francisco J. Acevedo, Environmental Protection Specialist, Criteria Pollutant Section, Air Programs Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604,
(312)886-6061, *acevedo.francisco@epa.gov.* SUPPLEMENTARY INFORMATION: Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This supplementary information section is arranged as follows: I. What is the background for this action? II. What is our response to comments received on the notice of proposed rulemaking? III. Is this action consistent with provisions of the Energy Policy Act (EPAct)? IV. What action is EPA taking today? V. Statutory and Executive Order Reviews. I. What is the background for this action? 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). II. What is our response to comments received on the notice of proposed rulemaking? 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. III. Is this action consistent with provisions of the Energy Policy Act (EPAct)? 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. IV. What action is EPA taking today? 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. V. Statutory and Executive Order Reviews Executive Order 12866: Regulatory Planning and Review 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. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use 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). Regulatory Flexibility Act 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.* ). Unfunded Mandates Reform Act 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). Executive Order 13175: Consultation and Coordination With Indian Tribal Governments 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). Executive Order 13132: Federalism 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. Executive Order 13045: Protection of Children From Environmental Health and Safety Risks 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. National Technology Transfer Advancement Act 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. Paperwork Reduction Act 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.* ). Congressional Review Act 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).) List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Ozone, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds. Dated: January 18, 2007. Mary A. Gade, Regional Administrator, Region 5. 40 CFR part 52 is amended as follows: PART 52—[AMENDED] 1. The authority citation for part 52 continues to read as follows: Authority: 42 U.S.C. 7401 *et seq.* Subpart X—Michigan 2. The table in § 52.1170(c) entitled, “EPA Approved Michigan Regulations” is amended by adding a new entry in the “State Statutes” section after “House Bill 5016” titled “House Bill 5508” to read as follows: § 52.1170 Identification of plan.
(c)* * * EPA—Approved Michigan Regulations Michigan citation Title State effective date EPA approval date Comments * * * * * * * State Statutes * * * * * * * House Bill 5508 Amendment to Motor Fuels Quality Act, Act 44 of 1984 4/06/06 3/2/07, [Insert page number where the document begins] * * * * * * * [FR Doc. E7-1421 Filed 1-30-07; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0962 FRL-8111-1] Thiabendazole; Pesticide Tolerances for Emergency Exemptions AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes time-limited tolerances for residues of thiabendazole in or on Brussels sprout, cabbage, and cauliflower. This action is in response to EPA's granting of an emergency exemption under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide on Brussels sprout, cabbage, and cauliflower. This regulation establishes a maximum permissible level for residues of thiabendazole in these food commodities. The tolerances expire and are revoked on December 31, 2009. DATES: This regulation is effective January 31, 2007. Objections and requests for hearings must be received on or before April 2, 2007, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION . ADDRESSES: EPA has established a docket for this action under docket identification
(ID)number EPA-HQ-OPP-2006-0962. All documents in the docket are listed on the regulations.gov website. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the Office of Pesticide Programs
(OPP)Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is
(703)305-5805. FOR FURTHER INFORMATION CONTACT: Stacey Groce, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)305-2505; e-mail address: *groce.stacey@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr.* You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr.* C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, 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. II. Background and Statutory Findings 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. III. Emergency Exemption for Thiabendazole on Brussels sprout, cabbage, nd cauliflower and FFDCA Tolerances 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 . IV. Aggregate Risk Assessment and Determination of Safety 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. A. Toxicological Endpoints 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 <sup>cancer</sup> = 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. B. Exposure Assessment 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/.* C. Safety Factor for Infants and Children 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. D. Aggregate Risks and Determination of Safety 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. V. Other Considerations A. Analytical Enforcement Methodology 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* . B. International Residue Limits 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. VI. Conclusion 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. VII. Statutory and Executive Order Reviews 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. VIII. Congressional Review Act 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). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: January 18, 2007. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. Section 180.242 is amended by alphabetically adding the following commodites to paragraph
(b)to read as follows: § 180.242 Thiabendazole; tolerances for residues.
(b)* * * Commodity Parts per million Expiration/revocation date Brussels sprout 0.05 12/31/09 Cabbage 0.05 12/31/09 Cauliflower 0.05 12/31/09 * * * * * [FR Doc. E7-1234 Filed 1-30-07; 8:45 am] BILLING CODE 6560-50-S FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 73 [DA 07-52; MB Docket No. 05-114; RM-11190] Radio Broadcasting Services; Hale Center, TX AGENCY: Federal Communications Commission. ACTION: Final rule. SUMMARY: The staff grants a rulemaking petition filed by Charles Crawford to allot Channel 236C1 to Hale Center, Texas, as a first local aural service. With this action, the proceeding is terminated. See SUPPLEMENTARY INFORMATION . DATES: Effective February 26, 2007. ADDRESSES: Federal Communications Commision, 445 12th Street, SW., Washington, DC 20554. FOR FURTHER INFORMATION CONTACT: Andrew J. Rhodes, Media Bureau,
(202)418-2180. SUPPLEMENTARY INFORMATION: 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). List of Subjects in 47 CFR Part 73 Radio, Radio broadcasting. As stated in the preamble, the Federal Communications Commission amends 47 CFR part 73 as follows: PART 73—RADIO BROADCAST SERVICES 1. The authority for part 73 continues to read as follows: Authority: 47 U.S.C. 154, 303, 334, 336. § 73.202 [Amended] 2. Section 73.202(b), the Table of FM Allotments under Texas, is amended by adding Hale Center, Channel 236C1. Federal Communications Commission. John A. Karousos, Assistant Chief, Audio Division, Media Bureau. [FR Doc. E7-1522 Filed 1-30-07; 8:45 am] BILLING CODE 6712-01-P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 73 [DA 07-37; MB Docket No. 05-238; RM-11260] Radio Broadcasting Services; Columbus, IN AGENCY: Federal Communications Commission. ACTION: Final rule. SUMMARY: The Audio Division grants a Petition for Rule Making filed by Columbus Community Radio Corporation, licensee of Station WHUM-LP, Channel 253L1, Columbus, Indiana, requesting the allotment of Channel 228A at Columbus, Indiana, as its reservation for noncommercial educational NCE use. The reference coordinates for Channel *228A at Columbus, Indiana are 39-09-06 NL and 85-52-09 WL. This allotment requires a site restriction of 7.9 kilometers (4.9 miles) southeast of Columbus. DATES: Effective February 26, 2007. ADDRESSES: Federal Communications Commission, 445 Twelfth Street, SW., Washington, DC 20554. FOR FURTHER INFORMATION CONTACT: Rolanda F. Smith, Media Bureau,
(202)418-2180. SUPPLEMENTARY INFORMATION: 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). List of Subjects in 47 CFR Part 73 Radio, Radio broadcasting. As stated in the preamble, the Federal Communications Commission amends 47 CFR part 73 as follows: PART 73—RADIO BROADCAST SERVICES 1. The authority citation for part 73 continues to read as follows: Authority: 47 U.S.C. 154, 303, 334, 336. § 73.202 [Amended] 2. Section 73.202(b), the Table of FM Allotments under Indiana, is amended by adding Channel *228A at Columbus. Federal Communications Commission. John A. Karousos, Assistant Chief, Audio Division, Media Bureau. [FR Doc. E7-1524 Filed 1-30-07; 8:45 am] BILLING CODE 6712-01-P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 73 [DA 07-42; MB Docket No. 05-79; RM-10983, RM-11247] Radio Broadcasting Services; Opelika and Waverly, AL AGENCY: Federal Communications Commission. ACTION: Final rule. SUMMARY: The Audio Division grants a counterproposal filed by Waverly Radio Broadcasters by allotting Channel 232A at Waverly, Alabama, as the community's first local aural transmission service. The reference coordinates for Channel 232A at Waverly, Alabama are 32-42-28 NL and 85-29-27 WL. This allotment requires a site restriction of 8.7 kilometers (5.4 miles) east of Waverly. To accommodate the allotment, Station WSTR(FM) Channel 231C at Smyrna, Georgia, was downgraded to Channel 231C0 at its existing transmitter site. Additionally, the petition filed by Opelika Broadcasting Company, requesting the allotment of Channel 232A at Opelika, Alabama, as its second local FM transmission service was denied. DATES: Effective February 26, 2007. ADDRESSES: Federal Communications Commission, 445 Twelfth Street, SW., Washington, DC 20554. FOR FURTHER INFORMATION CONTACT: Sharon P. McDonald, Media Bureau,
(202)418-2180. SUPPLEMENTARY INFORMATION: 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). List of Subjects in 47 CFR Part 73 Radio, Radio broadcasting. As stated in the preamble, the Federal Communications Commission amends 47 CFR part 73 as follows: PART 73—RADIO BROADCAST SERVICES 1. The authority citation for part 73 continues to read as follows: Authority: 47 U.S.C. 154, 303, 334, 336. § 73.202 [Amended] 2. Section 73.202(b), the Table of FM Allotments under Alabama, is amended by adding Waverly, Channel 232A. Federal Communications Commission. John A. Karousos, Assistant Chief, Audio Division, Media Bureau. [FR Doc. E7-1523 Filed 1-30-07; 8:45 am] BILLING CODE 6712-01-P DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Parts 171, 172, 173, 175 and 178 [Docket No. RSPA-04-17664 (HM-224B)] RIN 2137-AD33 Hazardous Materials Regulations: Transportation of Compressed Oxygen, Other Oxidizing Gases and Chemical Oxygen Generators on Aircraft AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT. ACTION: Final rule. SUMMARY: PHMSA (also, “we” or “us”) is amending the Hazardous Materials Regulations
(HMR)to: require cylinders of compressed oxygen and other oxidizing gases 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; revise the pressure relief device
(PRD)setting limit on cylinders of compressed oxygen and other oxidizing gases transported aboard aircraft; limit the types of cylinders authorized for transporting compressed oxygen aboard aircraft; and convert most of the provisions of an oxygen generator approval into requirements in the HMR. PHMSA is issuing this final rule in cooperation with the Federal Aviation Administration
(FAA)to increase the level of safety associated with transportation of these materials aboard aircraft. DATES: *Effective Date:* The effective date of these amendments is October 1, 2007. *Voluntary Compliance:* Voluntary compliance with all these amendments, including those with a delayed mandatory compliance date, is authorized as of March 2, 2007. FOR FURTHER INFORMATION CONTACT: John A. Gale or T. Glenn Foster, Office of Hazardous Materials Standards, telephone
(202)366-8553, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, 400 Seventh Street, SW., Washington, DC 20590-0001, or David Catey, Office of Flight Standards Service, telephone
(202)267-3732, Federal Aviation Administration, U.S. Department of Transportation, 800 Independence Avenue, SW., Washington, DC 20591. SUPPLEMENTARY INFORMATION: List of Topics I. Background II. Safety Issues Associated with the Air Transportation of Compressed Oxygen Cylinders and Oxygen Generators III. Summary of the Final Rule IV. Comments and Regulatory Changes A. General B. Outer Packagings for Compressed Oxygen Cylinders, Other Oxidizing Gases, and Chemical Oxygen Generators 1. Scope of Rulemaking 2. Other Oxidizing Gases Aboard Aircraft 3. Packaging Design Standards 4. Packaging Availability and Costs 5. Compliance Date C. Pressure Relief Device Settings and Authorized Cylinders for Compressed Oxygen and Other Oxidizing Gases D. Limits on Number of Oxygen Cylinders Transported on Aircraft E. Chemical Oxygen Generator Approval V. Effects on Individuals with Disabilities VI. Regulatory Analyses and Notices A. Statutory/Legal Authority for Rulemaking B. Executive Order 12866 and DOT Regulatory Policies and Procedures C. Executive Order 12988 D. Executive Order 13132 E. Executive Order 13175 F. Regulatory Flexibility Act, Executive Order 13272, and DOT Procedures and Policies G. International Trade Impact Assessment H. Unfunded Mandates Reform Act of 1995 I. Paperwork Reduction Act J. Environmental Assessment K. Regulation Identifier Number
(RIN)L. Privacy Act I. Background 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: —Prohibited the transportation of chemical oxygen generators (including personal-use chemical oxygen generators) on board passenger-carrying aircraft and the transportation of spent chemical oxygen generators on both passenger-carrying and cargo-only aircraft [61 FR 26418 (May 24, 1996), 61 FR 68952 (Dec. 30, 1996), 64 FR 45388 (Aug. 19, 1999)]; —Issued standards governing the transportation of chemical oxygen generators on cargo-only aircraft (and by motor vehicle, rail car and vessel), including the requirement for an approval issued by PHMSA [62 FR 30767 (June 5, 1997), 62 FR 34667 (June 27, 1997)]; —Upgraded fire safety standards for cargo compartments on aircraft to require a smoke or fire detection system and a means of suppressing a fire or minimizing the available oxygen, on certain transport-category aircraft [63 FR 8033 (Feb. 17, 1998)]; and —Imposed additional requirements on the transportation of cylinders of compressed oxygen 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 [64 FR 45388 (Aug. 19, 1999)]. 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. II. Safety Issues Associated With the Air Transportation of Compressed Oxygen Cylinders and Oxygen Generators 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. III. Summary of Final Rule 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. 1 The FAA is currently evaluating other non-ozone-depleting suppression agents that could eventually be used in cargo compartments. Some of these agents can maintain an adequate level of safety in the compartment, but the mean temperature may be slightly higher than 400 °F, which is the level found during typical halon-suppressed fires. If an alternate agent is used, the oven soak temperature level may need to be adjusted accordingly. IV. Comments and Regulatory Changes A. General 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. B. Outer Packaging for Compressed Oxygen Cylinders, Other Oxidizing Gases, and Chemical Oxygen Generators 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. 1. Scope of Rulemaking 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). 2. Other Oxidizing Gases Aboard Aircraft 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. 3. Packaging Design Standards 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. 4. Packaging Availability and Cost 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. 5. Compliance Date 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. C. Pressure Relief Device Settings and Authorized Cylinders for Compressed Oxygen and Other Oxidizing Gases 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. D. Limits on Number of Oxygen Cylinders Transported on Aircraft 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. E. Chemical Oxygen Generator Approval 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. V. Effects on Individuals With Disabilities 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. VI. Regulatory Analyses and Notices A. Statutory/Legal Authority for Rulemaking 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. B. Executive Order 12866 and DOT Regulatory Policies and Procedures 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. C. Executive Order 12988 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. D. Executive Order 13132 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** . E. Executive Order 13175 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. F. Regulatory Flexibility Act, Executive Order 13272, and DOT Procedures and Policies 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. G. International Trade Impact Assessment 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. H. Unfunded Mandates Reform Act of 1995 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. I. Paperwork Reduction Act 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: “Testing Requirements for Non-Bulk Packaging” OMB Number 2137-0572: *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. J. Environmental Assessment 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. K. Regulation Identifier Number
(RIN)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. L. 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.* List of Subjects 49 CFR Part 171 Exports, Hazardous materials transportation, Hazardous waste, Imports, Reporting and recordkeeping requirements. 49 CFR Part 172 Education, Hazardous materials transportation, Hazardous waste, Labeling, Markings, Packaging and containers, Reporting and recordkeeping requirements. 49 CFR Part 173 Hazardous materials transportation, Packaging and containers, Radioactive materials, Reporting and recordkeeping requirements, Uranium. 49 CFR Part 175 Air Carriers, Hazardous materials transportation, Radioactive materials, Reporting and recordkeeping requirements. 49 CFR Part 178 Hazardous materials transportation, Motor vehicle safety, Packaging and containers, Reporting and recordkeeping requirements. In consideration of the foregoing, we are amending 49 CFR chapter I as follows: PART 171—GENERAL INFORMATION, REGULATIONS, AND DEFINITIONS 1. The authority citation for part 171 continues to read as follows: Authority: 49 U.S.C. 5101-5128, 44701; 49 CFR 1.45 and 1.53; Pub. L. 101-410, section 4 (28 U.S.C. 2461 note); Pub. L. 104-134, section 31001. 2. In § 171.11, paragraph (d)(16) is revised to read as follows: § 171.11 Use of ICAO Technical Instructions.
(d)* * *
(16)A package containing Oxygen, compressed, or any of the following oxidizing gases must be packaged as required by parts 173 and 178 of this subchapter: carbon dioxide and oxygen mixtures, compressed; compressed gas, oxidizing, n.o.s.; liquefied gas, oxidizing, n.o.s.; nitrogen trifluoride; and nitrous oxide. PART 172—HAZARDOUS MATERIALS TABLE, SPECIAL PROVISIONS, HAZARDOUS MATERIALS COMMUNICATIONS, EMERGENCY RESPONSE INFORMATION, AND TRAINING REQUIREMENTS 3. The authority citation for part 172 continues to read as follows: Authority: 49 U.S.C. 5101-5128, 44701; 49 CFR 1.45 and 1.53. § 172.101 [Amended] 4. In the Hazardous Materials Table in § 172.101, for the shipping name “Air, refrigerated liquid, (cryogenic liquid),” Column
(9B)is revised to read “Forbidden.” § 172.101 [Amended] 5. In the Hazardous Materials Table in § 172.101, for the shipping name “Oxygen, compressed,” in column (7), Special Provision “A52” is removed. § 172.101 [Amended] 6. In the Hazardous Materials Table in § 172.101, for the shipping name “Oxygen generator, chemical,” in Column (7), Special Provisions “60, A51” are removed and Column
(8B)is revised to read “168.” § 172.102 [Amended] 7. In § 172.102, in paragraph (c)(1), Special Provisions “60” is removed. § 172.102 [Amended] 8. In § 172.102, in paragraph (c)(2), Special Provisions “A51” and “A52” are removed. PART 173—SHIPPERS—GENERAL REQUIREMENTS FOR SHIPMENTS AND PACKAGINGS 9. The authority citation for part 173 continues to read as follows: Authority: 49 U.S.C. 5101-5128, 44701; 49 CFR 1.45 and 1.53. 10. Section 173.168 is added to read as follows: § 173.168 Chemical oxygen generators. An oxygen generator, chemical (defined in § 171.8 of this subchapter) may be transported only under the following conditions:
(a)*Approval.* A chemical oxygen generator that is shipped with a means of initiation attached must be classed and approved by the Associate Administrator in accordance with the procedures specified in § 173.56 of this subchapter.
(b)*Impact resistance.* A chemical oxygen generator, without any packaging, must be capable of withstanding a 1.8 meter drop onto a rigid, non-resilient, flat and horizontal surface, in the position most likely to cause actuation or loss of contents.
(c)*Protection against inadvertent actuation.* A chemical oxygen generator must incorporate one of the following means of preventing inadvertent actuation:
(1)A chemical oxygen generator that is not installed in protective breathing equipment (PBE):
(i)Mechanically actuated devices:
(A)Two pins, installed so that each is independently capable of preventing the actuator from striking the primer;
(B)One pin and one retaining ring, each installed so that each is independently capable of preventing the actuator from striking the primer; or
(C)A cover securely installed over the primer and a pin installed so as to prevent the actuator from striking the primer and cover.
(ii)Electrically actuated devices: The electrical leads must be mechanically shorted and the mechanical short must be shielded in metal foil.
(iii)Devices with a primer but no actuator: A chemical oxygen generator that has a primer but no actuating mechanism must have a protective cover over the primer to prevent actuation from external impact.
(2)A chemical oxygen generator installed in a PBE must contain a pin installed so as to prevent the actuator from striking the primer, and be placed in a protective bag, pouch, case or cover such that the protective breathing equipment is fully enclosed in such a manner that the protective bag, pouch, case or cover prevents unintentional actuation of the oxygen generator.
(d)*Packaging.* After September 30, 2009 a chemical oxygen generator and a chemical oxygen generator installed in equipment, (e.g., a PBE) must be placed in a rigid outer packaging that—
(1)Conforms to the requirements of either:
(i)Part 178, subparts L and M, of this subchapter at the Packing Group I or II performance level; or
(ii)The performance criteria in Air Transport Association
(ATA)Specification No. 300 for a Category I Shipping Container.
(2)With its contents, is capable of meeting the following additional requirements when transported by cargo-only aircraft:
(i)The Flame Penetration Resistance Test in part III of Appendix F to 14 CFR part 25, modified as follows:
(A)At least three specimens of the outer packaging materials must be tested;
(B)Each test must be conducted on a flat 16 inch x 24 inch test specimen mounted in the horizontal ceiling position of the test apparatus to represent the outer packaging design;
(C)Testing must be conducted on all design features (latches, seams, hinges, etc.) affecting the ability of the outer packaging to safely prevent the passage of fire in the horizontal ceiling position; and
(D)There must be no flame penetration of any specimen within 5 minutes after application of the flame source, and the maximum allowable temperature at a point 4 inches above the test specimen, centered over the burner cone, must not exceed 205 ° C (400 ° F).
(ii)The Thermal Resistance Test specified in Appendix D to part 178 of this subchapter.
(iii)None of the following conditions may occur when one generator in the package is actuated:
(A)Actuation of other generators in the package;
(B)Ignition of the packaging materials; and
(C)A temperature above 100 °C (212 °F) on the outside surface temperature of the package.
(iv)All features of the packaging must be in good condition, including all latches, hinges, seams, and other features, and the packaging must be free from perforations, cracks, dents, or other abrasions that may negatively affect the flame penetration resistance and thermal resistance characteristics of the packaging, verified by a visual inspection of the package before each shipment.
(e)*Equipment marking.* The outside surface of a chemical oxygen generator must be marked to indicate the presence of an oxygen generator (e.g., “oxygen generator, chemical”). The outside surface of equipment containing a chemical oxygen generator that is not readily apparent (e.g., a sealed passenger service unit) must be clearly marked to indicate the presence of the oxygen generator (example: “Oxygen Generator Inside”).
(f)*Items forbidden in air transportation.*
(1)A chemical oxygen generator is forbidden for transportation on board a passenger-carrying aircraft.
(2)A chemical oxygen generator is forbidden for transportation by both passenger-carrying and cargo-only aircraft after:
(i)The manufacturer's expiration date; or
(ii)The contents of the generator have been expended. 11. In § 173.302a, paragraph
(f)is added to read as follows: § 173.302a Additional requirements for shipment of nonliquefied (permanent) compressed gases in specification cylinders.
(f)*Compressed oxygen and oxidizing gases* . A cylinder containing oxygen, compressed; compressed gas, oxidizing, n.o.s.; or nitrogen trifluoride is authorized for transportation by aircraft only when it meets the following requirements:
(1)Only DOT specification 3A, 3AA, 3AL, and 3HT cylinders, and UN pressure receptacles ISO 9809-1, ISO 9809-2, ISO 9809-3 and ISO 7866 cylinders are authorized.
(2)Cylinders must be equipped with a pressure relief device in accordance with § 173.301(f) and, beginning with the first requalification due after October 1, 2007:
(i)The rated burst pressure of a rupture disc for DOT 3A, 3AA, and 3AL cylinders must be 100% of the cylinder minimum test pressure with a tolerance of −10 to plus zero percent; and
(ii)The rated burst pressure of a rupture disc for a 3HT must be 90% of the cylinder minimum test pressure with a tolerance of −10 to plus zero percent.
(3)After September 30, 2009, the cylinder must be placed in a rigid outer packaging that—
(i)Conforms to the requirements of either part 178, subparts L and M of this subchapter at the Packing Group I or II performance level or the performance criteria in Air Transport Association
(ATA)Specification No. 300 for a Category I Shipping Container;
(ii)Is capable of passing, as demonstrated by design testing, the Flame Penetration Resistance Test in part III of Appendix F to 14 CFR part 25, modified as follows:
(A)At least three specimens of the outer packagings materials must be tested;
(B)Each test must be conducted on a flat 16 inch x 24 inch test specimen mounted in the horizontal ceiling position of the test apparatus to represent the outer packaging design;
(C)Testing must be conducted on all design features (latches, seams, hinges, etc.) affecting the ability of the outer packaging to safely prevent the passage of fire in the horizontal ceiling position; and
(D)There must be no flame penetration of any specimen within 5 minutes after application of the flame source and the maximum allowable temperature at a point 4 inches above the test specimen, centered over the burner cone, must not exceed 205 °C (400 ° F); and
(iii)Prior to each shipment, passes a visual inspection that verifies that all features of the packaging are in good condition, including all latches, hinges, seams, and other features, and that the packaging is free from perforations, cracks, dents, or other abrasions that may negatively affect the flame penetration resistance and thermal resistance characteristics of the packaging.
(4)After September 30, 2009, the cylinder and the outer packaging must be capable of passing, as demonstrated by design testing, the Thermal Resistance Test specified in Appendix D to part 178 of this subchapter.
(5)The cylinder and the outer packaging must both be marked and labeled in accordance with part 172, subparts D and E of this subchapter.
(6)A cylinder of compressed oxygen that has been furnished by an aircraft operator to a passenger in accordance with 14 CFR 121.574, 125.219, and 135.91 is excepted from the outer packaging requirements of paragraph (f)(3) of this section. 12. In § 173.304a, paragraph
(f)is added to read as follows: § 173.304a Additional requirements for shipment of liquefied compressed gases in specification cylinders.
(f)*Oxidizing gases* . A cylinder containing carbon dioxide and oxygen mixture, compressed; liquefied gas, oxidizing, n.o.s.; or nitrous oxide is authorized for transportation by aircraft only when it meets the following requirements:
(1)Only DOT specification 3A, 3AA, 3AL, and 3HT cylinders, and UN pressure receptacles ISO 9809-1, ISO 9809-2, ISO 9809-3 and ISO 7866 cylinders are authorized.
(2)Cylinders must be equipped with a pressure relief device in accordance with § 173.301(f) and, beginning with the first requalification due after October 1, 2007:
(i)The rated burst pressure of a rupture disc for DOT 3A, 3AA, and 3AL cylinders must be 100% of the cylinder minimum test pressure with a tolerance of −10 to plus zero percent; and
(ii)The rated burst pressure of a rupture disc for a 3HT must be 90% of the cylinder minimum test pressure with a tolerance of −10 to plus zero percent.
(3)After September 30, 2009, the cylinder must be placed in a rigid outer packaging that—
(i)Conforms to the requirements of either part 178, subparts L and M, of this subchapter at the Packing Group I or II performance level, or the performance criteria in Air Transport Association
(ATA)Specification No. 300 for a Category I Shipping Container;
(ii)Is capable of passing, as demonstrated by design testing, the Flame Penetration Resistance Test in part III of Appendix F to 14 CFR part 25, modified as follows:
(A)At least three specimens of the outer packaging materials must be tested;
(B)Each test must be conducted on a flat 16 inch x 24 inch test specimen mounted in the horizontal ceiling position of the test apparatus to represent the outer packaging design;
(C)Testing must be conducted on all design features (latches, seams, hinges, etc.) affecting the ability of the outer packaging to safely prevent the passage of fire in the horizontal ceiling position; and
(D)There must be no flame penetration of any specimen within 5 minutes after application of the flame source and the maximum allowable temperature at a point 4 inches above the test specimen, centered over the burner cone, must not exceed 205 °C (400 °F); and
(iii)Prior to each shipment, passes a visual inspection that verifies that all features of the packaging are in good condition, including all latches, hinges, seams, and other features, and the packaging is free from perforations, cracks, dents, or other abrasions that may negatively affect the flame penetration resistance and thermal resistance characteristics of the container.
(4)After September 30, 2009, the cylinder and the outer packaging must be capable of passing, as demonstrated by design testing, the Thermal Resistance Test specified in Appendix D to part 178 of this subchapter.
(5)The cylinder and the outer packaging must both be marked and labeled in accordance with part 172, subparts D and E of this subchapter.
(6)A cylinder of compressed oxygen that has been furnished by an aircraft operator to a passenger in accordance with 14 CFR 121.574, 125.219, and 135.91 is excepted from the outer packaging requirements of paragraph (f)(3) of this section. PART 175—CARRIAGE BY AIRCRAFT 13. The authority citation for part 175 continues to read as follows: Authority: 49 U.S.C. 5101-5128, 44701; 49 CFR 1.53. 14. Section 175.501 is revised to read as follows: § 175.501 Special requirements for oxidizers and compressed oxygen.
(a)Compressed oxygen, when properly labeled Oxidizer or Oxygen, may be loaded and transported as provided in this section. Except for Oxygen, compressed, no person may load or transport a hazardous material for which an OXIDIZER label is required under this subchapter in an inaccessible cargo compartment that does not have a fire or smoke detection system and a fire suppression system.
(b)In addition to the quantity limitations prescribed in § 175.75, no more than a combined total of six cylinders of compressed oxygen 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.
(c)When loaded into a passenger-carrying aircraft or in an inaccessible cargo location on a cargo-only aircraft, cylinders of compressed oxygen must be stowed horizontally on the floor or as close as practicable to the floor of the cargo compartment or unit load device. This provision does not apply to cylinders stowed in the cabin of the aircraft in accordance with paragraph
(e)of this section.
(d)When transported in a Class B aircraft cargo compartment (see 14 CFR 25.857(b)) or its equivalent (i.e., an accessible cargo compartment equipped with a fire or smoke detection system, but not a fire suppression system), cylinders of compressed oxygen must be loaded in a manner that a crew member can see, handle and, when size and weight permit, separate the cylinders from other cargo during flight. No more than six cylinders of compressed oxygen and, in addition, one cylinder of medical-use compressed oxygen per passenger needing oxygen at destination—with a rated capacity of 1000 L (34 cubic feet) or less of oxygen—may be carried in a Class B aircraft cargo compartment or its equivalent.
(e)A cylinder containing medical-use compressed oxygen, owned or leased by an aircraft operator or offered for transportation by a passenger needing it for personal medical use at destination, may be carried in the cabin of a passenger-carrying aircraft in accordance with the following provisions:
(1)No more than six cylinders belonging to the aircraft operator and, in addition, no more than one cylinder per passenger needing the oxygen at destination, may be transported in the cabin of the aircraft under the provisions of this paragraph (e);
(2)The rated capacity of each cylinder may not exceed 1,000 L (34 cubic feet);
(3)Each cylinder must conform to the provisions of this subchapter and be placed in:
(i)An outer packaging that conforms to the performance criteria of Air Transport Association
(ATA)Specification 300 for a Category I Shipping Container; or
(ii)A metal, plastic or wood outer packaging that conforms to a UN standard at the Packing Group I or II performance level.
(4)The aircraft operator shall securely stow the cylinder in its overpack or outer packaging in the cabin of the aircraft and shall notify the pilot-in-command as specified in § 175.33 of this part; and
(5)Shipments under this paragraph
(e)are not subject to—
(i)Sections 173.302(f) and 173.304a(f) of this subchapter, subpart C of part 172 of this subchapter, and, for passengers only, subpart H of part 172 of this subchapter;
(ii)Section 173.25(a)(4) of this subchapter; and
(iii)Paragraph
(b)of this section. PART 178—SPECIFICATIONS FOR PACKAGINGS 15. The authority citation for part 178 continues to read as follows: Authority: 49 U.S.C. 5101-5128, 44701; 49 CFR 1.53. 16. A new Appendix D to part 178 is added to read as follows: Appendix D to Part 178—Thermal Resistance Test 1. *Scope.* This test method evaluates the thermal resistance capabilities of a compressed oxygen generator and the outer packaging for a cylinder of compressed oxygen or other oxidizing gas and an oxygen generator. When exposed to a temperature of 205 °C (400 °F) for a period of not less than three hours, the outer surface of the cylinder may not exceed a temperature of 93 °C (199 °F) and the oxygen generator must not actuate. 2. *Apparatus.* 2.1 *Test Oven.* The oven must be large enough in size to fully house the test outer package without clearance problems. The test oven must be capable of maintaining a minimum steady state temperature of 205 °C (400 °F). 2.2 *Thermocouples.* At least three thermocouples must be used to monitor the temperature inside the oven and an additional three thermocouples must be used to monitor the temperature of the cylinder. The thermocouples must be 1/16 inch, ceramic packed, metal sheathed, type K (Chromel-Alumel), grounded junction with a nominal 30 American wire gauge
(AWG)size conductor. The thermocouples measuring the temperature inside the oven must be placed at varying heights to ensure even temperature and proper heat-soak conditions. For the thermocouples measuring the temperature of the cylinder:
(1)two of them must be placed on the outer cylinder side wall at approximately 2 inches (5 cm) from the top and bottom shoulders of the cylinder; and
(2)one must be placed on the cylinder valve body near the pressure relief device. 2.3 *Instrumentation.* A calibrated recording device or a computerized data acquisition system with an appropriate range should be provided to measure and record the outputs of the thermocouples. 3. *Test Specimen.* 3.1 *Specimen Configuration.* Each outer package material type and design must be tested, including any features such as handles, latches, fastening systems, etc., that may compromise the ability of the outer package to provide thermal protection. 3.2 *Test Specimen Mounting.* The tested outer package must be supported at the four corners using fire brick or other suitable means. The bottom surface of the outer package must be exposed to allow exposure to heat. 4. *Preparation for Testing.* 4.1 It is recommended that the cylinder be closed at ambient temperature and configured as when filled with a valve and pressure relief device. The oxygen generator must be filled and may be tested with or without packaging. 4.2 Place the package or generator onto supporting bricks or a stand inside the test oven in such a manner to ensure even temperature flow. 5. *Test Procedure.* 5.1 Close oven door and check for proper reading on thermocouples. 5.2 Raise the temperature of the oven to a minimum temperature of 205 °C ± 2 °C (400 °F ± 5 °F). Maintain a minimum oven temperature of 205 °C ± 2 °C (400 °F ± 5 °F) for at least three hours. Exposure time begins when the oven steady state temperature reaches a minimum of 205 °C ± 2 °C (400 °F ± 5 °F). 5.3 At the conclusion of the three-hour period, the outer package may be removed from the oven and allowed to cool naturally. 6. *Recordkeeping.* 6.1 Record a complete description of the material being tested, including the manufacturer, size of cylinder, etc. 6.2 Record any observations regarding the behavior of the test specimen during exposure, such as smoke production, delamination, resin ignition, and time of occurrence of each event. 6.3 Record the temperature and time history of the cylinder temperature during the entire test for each thermocouple location. Temperature measurements must be recorded at intervals of not more than five
(5)minutes. Record the maximum temperatures achieved at all three thermocouple locations and the corresponding time. 7. *Requirements.* 7.1 For a cylinder, the outer package must provide adequate protection such that the outer surface of the cylinder and valve does not exceed a temperature of 93 °C (199 °F) at any of the three points where the thermocouples are located. 7.2 For an oxygen generator, the generator must not actuate. Issued in Washington, DC on January 25, 2007 under authority delegated in 49 CFR part 1. Thomas J. Barrett, Administrator. [FR Doc. E7-1487 Filed 1-30-07; 8:45 am] BILLING CODE 4910-60-P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 648 RIN 0648-AT67 [Docket No. 061109296-7009-02; I.D. 110606A] Fisheries of the Northeastern United States; Atlantic Bluefish Fisheries; 2007 Atlantic Bluefish Specifications; Quota Adjustment; 2007 Research Set-Aside Project AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Final rule; final specifications for the 2007 Atlantic bluefish fishery. SUMMARY: NMFS issues final specifications for the 2007 Atlantic bluefish fishery, including state-by-state commercial quotas, a recreational harvest limit, and recreational possession limits for Atlantic bluefish off the east coast of the United States. The intent of these specifications is to establish the allowable 2007 harvest levels and possession limits to attain the target fishing mortality rate (F), consistent with the stock rebuilding program contained in Amendment 1 to the Atlantic Bluefish Fishery Management Plan (FMP), as well as ensuring compliance with the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). This action will publish final specifications that are modified from those contained in the proposed rule. DATES: This rule is effective March 2, 2007, through December 31, 2007. ADDRESSES: Copies of the specifications document, including the Environmental Assessment
(EA)and the Initial Regulatory Flexibility Analysis
(IRFA)are available from Daniel Furlong, Executive Director, Mid-Atlantic Fishery Management Council, Room 2115, Federal Building, 300 South Street, Dover, DE 19901-6790. The specifications document is also accessible via the Internet at *http://www.nero.noaa.gov* . NMFS prepared a Final Regulatory Flexibility Analysis (FRFA), which is contained in the classification section of this rule. The FRFA consists of the IRFA, public comments and responses contained in this final rule, and a summary of impacts and alternatives contained in this final rule. The small entity compliance guide is available from Patricia A. Kurkul, Regional Administrator, Northeast Regional Office, National Marine Fisheries Service, One Blackburn Drive, Gloucester, MA 01930-2298, and on the Northeast Regional Office's website at *http://www.nero.noaa.gov/nero/nr/* . The Northeast Fisheries Science Center (Center) 41st Stock Assessment Review Committee
(SARC)Bluefish Assessment Report (updated for 2006) is available at: *http://www.nefsc.noaa.gov/nefsc/publications/crd/crd0514* . FOR FURTHER INFORMATION CONTACT: Allison McHale, Fishery Policy Analyst,
(978)281-9103, or Michael Pentony, Supervisory Policy Analyst, (978)281-9283. SUPPLEMENTARY INFORMATION: Background 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. RSA Quota 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** . Final Specifications 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. Council Recommendation: Commercial Quota and Recreational Harvest Limit 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. Final 2007 Commercial Quota and Recreational Harvest Limit 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). Adjustment Additional 2005 New York Overage 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). Final State Commercial Allocations 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. Table 1. Final Bluefish Commercial State-by-State Allocations for 2007 States Quota Percent Share 2007 Commercial Quota
(kg)Carryover 2005 Overages
(kg)2007 Commercial Quota
(kg)ME 0.6685 58,084 26,347 57,323 26,002 NH 0.4145 36,015 16,336 35,543 16,122 MA 6.7167 583,598 264,718 575,953 261,251 RI 6.8081 591,539 268,321 583,790 264,806 CT 1.2663 110,026 49,907 108,584 49,254 NY 10.3851 902,336 409,297 6,238 2,830 884,278 401,106 NJ 14.8162 1,287,344 583,935 1,270,480 576,286 DE 1.8782 163,192 74,024 161,055 73,054 MD 3.0018 260,819 118,307 257,403 116,757 VA 11.8795 1,032,181 468,194 1,018,660 462,061 NC 32.0608 2,785,686 1,263,579 2,749,194 1,247,026 SC 0.0352 3,058 1,387 3,018 1,369 GA 0.0095 825 374 815 370 FL 10.0597 874,063 396,472 862,613 391,279 Total 100.0001 8,688,769
(1)3,941,200 6,238 2,830 8,568,710
(2)3,886,741
(1)The sum of the individual states does not add up to the final commercial quota of 8,688,760 lb due to rounding.
(2)The sum of the individual states does not add up to the final RSA adjusted commercial quota of 8,574,939 lb, less the New York overage of 6,238 lb (i.e., 8,568,701 lb), due to rounding. Recreational Possession Limit 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. Comments and Responses 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. Classification 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. Final Regulatory Flexibility Analysis Statement of Objective and Need 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. Summary of Significant Issues Raised in Public Comments 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. Description and Estimate of Number of Small Entities to Which the Rule will Apply 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. Description of Projected Reporting, Recordkeeping, and Other Compliance Requirements No additional reporting, recordkeeping, or other compliance requirements are included in this final rule. Description of the Steps Taken to Minimize Economic Impact on Small Entities 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 Table 2. Comparison of New Alternative to Council Preferred and 2006 Specifications Initial TAL Post-Transfer Commercial Quota Post-Transfer Recreational Quota Research Set-Aside Adjusted Commercial Quota Adjusted Recreational Harvest Limit 2007 Final Bluefish Specifications Final Rule 27,762,000 lb 8,688,760 lb 19,073,240 lb 363,677 lb 8,574,939 lb 18,823,384 lb Preferred (12,593 mt) (3,941 mt) (8,651 mt) (165 mt) (3,890 mt) (8,538 mt) Alternative Council's Preferred Alternative for 2007 Bluefish Specifications Proposed Rule 27,762,000 lb 9,499,540 lb 18,262,460 lb 363,677 lb 9,375,098 lb 18,023,225 lb Preferred (12,593 mt) (4,309 mt) (8,284 mt) (165 mt) (4,252 mt) (8,175 mt) Alternative 2006 Final Bluefish Specifications Preferred 24,798,836 lb 8,081,096 lb 16,717,740 lb 363,677 lb 7,962,586 lb 16,472,573 lb Alternative (11,249 mt) (3,666 mt) (7,583 mt) (165 mt) (3,612 mt) (7,472 mt) Small Entity Compliance Guide 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* . Authority: 16 U.S.C. 1801 *et seq.* Dated: January 24, 2007. William T. Hogarth, Assistant Administrator for Fisheries, National Marine Fisheries Service. [FR Doc. E7-1544 Filed 1-30-07; 8:45 am] BILLING CODE 3510-22-S DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 660 [Docket No. 061003253-7008-02; I.D. 092606A] RIN 0648-AU27 Fisheries Off West Coast States; Coastal Pelagic Species Fisheries; Annual Specifications AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Final rule. SUMMARY: NMFS issues this final rule to implement the annual harvest guideline for Pacific mackerel in the U.S. exclusive economic zone off the Pacific coast for the fishing season of July 1, 2006, through June 30, 2007. This harvest guideline has been calculated according to the regulations implementing the Coastal Pelagic Species
(CPS)Fishery Management Plan
(FMP)and establishes allowable harvest levels for Pacific mackerel off the Pacific coast. DATES: Effective March 2, 2007. ADDRESSES: Copies of the report *Pacific Mackerel (Scomber japonicus) Stock Assessment for U.S. Management in the 2006-2007 Fishing Year* may be obtained by contacting Rodney R. McInnis, Regional Administrator, Southwest Region, NMFS, 501 West Ocean Blvd., Suite 4200, Long Beach, CA 90802-4213. FOR FURTHER INFORMATION CONTACT: Joshua B. Lindsay, Southwest Region, NMFS,
(562)980-4034. SUPPLEMENTARY INFORMATION: 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. Classification 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. Authority: 16 U.S.C. 1801 *et seq.* Dated: January 26, 2007. William T. Hogarth, Assistant Administrator for Fisheries, National Marine Fisheries Service. [FR Doc. E7-1546 Filed 1-30-07; 8:45 am] BILLING CODE 3510-22-S 72 20 Wednesday, January 31, 2007 Proposed Rules DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Part 94 [Docket No. APHIS-2006-0104] Classical Swine Fever Status of the Mexican State of Nayarit AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Proposed rule. SUMMARY: We are proposing to amend the regulations for importing animals and animal products by adding the Mexican State of Nayarit to the list of regions considered free of classical swine fever (CSF). We are proposing this action at the request of the Mexican Government and the State of Nayarit, and after conducting a risk evaluation that indicates that Nayarit is free of this disease. We are also proposing to add Nayarit to the list of CSF-affected regions whose exports of live swine, pork, and pork products to the United States must meet certain certification requirements to ensure their freedom from CSF. These actions would relieve certain CSF-related restrictions on the importation into the United States of pork, pork products, live swine, and swine semen from Nayarit while continuing to protect against the introduction of this disease into the United States. DATES: We will consider all comments that we receive on or before April 2, 2007. ADDRESSES: You may submit comments by either of the following methods: • *Federal eRulemaking Portal* : Go to *http://www.regulations.gov* , select “Animal and Plant Health Inspection Service” from the agency drop-down menu, then click “Submit.” In the Docket ID column, select APHIS-2006-0104 to submit or view public comments and to view supporting and related materials available electronically. Information on using Regulations.gov, including instructions for accessing documents, submitting comments, and viewing the docket after the close of the comment period, is available through the site's “User Tips” link. • *Postal Mail/Commercial Delivery:* Please send four copies of your comment (an original and three copies) to Docket No. APHIS-2006-0104, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. APHIS-2006-0104. *Reading Room:* You may read any comments that we receive on this docket in our reading room. The reading room is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue, SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call
(202)690-2817 before coming. *Other Information:* Additional information about APHIS and its programs is available on the Internet at *http://www.aphis.usda.gov* . FOR FURTHER INFORMATION CONTACT: Dr. Chip Wells, Senior Staff Veterinarian, Regionalization Evaluation Services-Import, National Center for Import and Export, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231;
(301)734-4356. SUPPLEMENTARY INFORMATION: Background The regulations in 9 CFR part 94 (referred to below as the regulations) govern the importation into the United States of specified animals and animal products in order to prevent the introduction of various animal diseases, including rinderpest, foot-and-mouth disease, African swine fever, classical swine fever (CSF), and swine vesicular disease. These are dangerous and destructive communicable diseases of ruminants and swine. Section 94.9 of the regulations restricts the importation into the United States of pork and pork products from regions where CSF is known to exist. Section 94.10 of the regulations prohibits, with certain exceptions, the importation of swine that originate in or are shipped from or transit any region in which CSF is known to exist. Sections 94.9 and 94.10 provide that CSF exists in all regions of the world except for certain regions listed in those sections. The Government of Mexico and the Mexican State of Nayarit requested that the Animal and Plant Health Inspection Service (APHIS) evaluate the animal disease status of the State of Nayarit with respect to CSF and provided information in support of that request in accordance with 9 CFR part 92, “Importation of Animals and Animal Products: Procedures for Requesting Recognition of Regions.” Using information submitted to us by the Federal Government of Mexico and State Government of Nayarit, as well as information gathered during a site visit by APHIS staff to Nayarit, we have reviewed and analyzed the animal health status of Nayarit with respect to CSF. Our determinations concerning this request, based on the information submitted to us and the information we gathered, are set forth below. Risk Analysis APHIS conducted a risk analysis to examine the risk of introducing CSF 1 from the importation of swine and swine products from Nayarit, Mexico. These findings are described in further detail in an April 2006 risk analysis that may be viewed on the Regulations.gov Web site or in our reading room. (Instructions for accessing Regulations.gov and information on the location and hours of the reading room are provided under the heading ADDRESSES at the beginning of this proposed rule.) We summarize our findings for each of the 11 factors in 9 CFR 92.2 below and summarize our risk considerations of these findings following our discussions of the factors. 1 APHIS considers all of Mexico to be affected by blue-eye disease of pigs, a disease which is not known to exist in the United States. APHIS has not evaluated Mexico, including the State of Nayarit, for blue-eye disease. As a result, APHIS denies permits for the importation of live swine and swine semen from all of Mexico, including Nayarit (9 CFR 93.504(a)(3)). CSF is the disease hazard evaluated in the risk analysis, which does not address blue-eye disease. Authority, Organization, and Veterinary Infrastructure Nayarit has the legal authority to enforce Federal and State CSF regulations and the necessary veterinary infrastructure to carry out CSF surveillance and control activities. One of the strengths observed by the joint APHIS/Canadian Food Inspection Agency
(CFIA)site-visit team was the apparent good communication and cooperation existing among the Mexican Federal, State, and municipal government officials, the Animal Agriculture Promotion and Protection Committee
(CFPP)representatives, and swine producers. APHIS could not identify any risk issues associated with this factor that would pose an unacceptable risk to the United States if trade with Nayarit in swine, pork, and pork products were to occur. Disease Status The State of Nayarit has not reported a clinical case of CSF since 1989 and was declared free of CSF by the Government of Mexico in May 1999. This 15-year time period exceeds that recommended by the World Organization for Animal Health for the disease-free period required for CSF disease freedom recognition. Wild boar are not known to exist in Nayarit, and therefore, are not considered by APHIS to be a risk for introduction or spread of CSF virus in the State. APHIS also concluded that the CSF surveillance program, which is discussed in more detail in the risk analysis, would likely detect a change in the disease status of Nayarit ( *i.e.* introduction of CSF). APHIS could not identify any risks associated with this factor that would pose any unacceptable risk to the United States if trade with Nayarit in swine, pork, and pork products were to occur. Disease Status of Adjacent Regions Nayarit shares borders with the States of Durango, Jalisco, Sinaloa, and Zacatecas. Sinaloa and Durango were declared to be CSF-free by the Mexican Government in 1993 and 1999, respectively. Zacatecas and Jalisco were declared to be in the eradication phase by the Mexican Government in 2004. On July 18, 2006 (after the risk analysis for this proposal was drafted), the Government of Mexico declared the States of Jalisco and Zacatecas to be CSF-free. Although APHIS considers Sinaloa to be CSF-free, APHIS has not evaluated Durango, Zacatecas, or Jalisco, and therefore currently considers them to be CSF-affected. The existence of common land borders with CSF-affected regions does present a risk for reintroducing CSF into Nayarit. However, movement controls and certification requirements regarding region of origin and commingling concerns are designed to mitigate this risk. Because Nayarit has common land borders with CSF-affected regions, we would add the State to the list in § 94.25 of regions considered free of CSF, but to which additional CSF-related certification requirements apply. The specific requirements are explained later in this document under the heading “Certification Requirements.” Extent of Active Disease Control Program CSF is considered exotic to Nayarit; therefore, it does not have an active disease control program. However, the Mexican Government has an ongoing active CSF disease control program which includes surveillance, movement control, and emergency response provisions for the CSF-free States such as Nayarit. The APHIS site visit team concluded that Nayarit is in compliance with provisions of the program and has maintained its CSF-free designation since 1999. Vaccination Vaccination for CSF ceased in Nayarit in March 1996, just before its status changed from control to eradication phase. Since that date, CSF vaccination has been prohibited in Nayarit. Separation From Adjacent Regions of Higher Risk The State of Nayarit is located along the Pacific coastline of central Mexico. Nayarit borders the States of Sinaloa and Durango on the north, Zacatecas to the east, and Jalisco on the east and south. Natural barriers to disease transmission include the Pacific Ocean to the west and the Sierra Madre Occidental Mountains to the east. Surface transport into and out of Nayarit primarily move along a north-south corridor from Sinaloa in the north and Jalisco in the south. There are no major seaports on the Nayarit coast and commercial air traffic is light, limited to regional passenger service and private aircraft. APHIS has determined that the natural barriers of the mountains and ocean, and the few highways into Nayarit, limit the movement of swine and products into the State, thus reducing the risk of CSF introduction. Movement Controls The movement controls established by the Mexican National CSF Campaign and implemented and enforced by the Nayarit officials limit the illegal movement of swine or pork products from CSF affected zones. The system of inspection posts in Nayarit was cited by the APHIS site visit team as a strong point in the State's CSF control program. The system of inspection posts ensures reasonable enforcement of these provisions, significantly limiting the risk of CSF introduction into Nayarit. These findings are described in further detail in the risk analysis. Livestock Demographics and Marketing Practices Nayarit is not a major swine production area. In 2004, there were 34 commercial swine farms in Nayarit, with a population of 30,634 animals. Only 2 farms had over 4,000 hogs. Another 18,650 hogs are reared in backyards, intended for personal consumption by their owners. The slaughtering and processing of swine in Nayarit is currently handled by State-inspected municipal plants, since there are no federally inspected (in Spanish, Tipo Inspección Federal, or TIF) plants handling swine in Nayarit; slaughter and processing through a TIF plant would be necessary for pork to be exported to the United States as well as to CSF-free States in Mexico. Currently, Nayarit consumes more pork than it produces and does not have the infrastructure, such as TIF plants, necessary to meet the export requirements of § 94.25 for exportation of pork or pork products to the United States. This dynamic limits the legal movement of swine and pork from Nayarit to the United States. Should producers in Nayarit develop a desire to export, they would need to identify an appropriate TIF plant outside of the State or request that a plant within the State be certified as a TIF plant in accordance with the regulatory requirements of the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS). Disease Surveillance An active CSF surveillance program is conducted in Nayarit in accordance with the National CSF Campaign. Nayarit conducts an annual serological sampling survey in commercial and backyard swine herds. APHIS concludes that the surveillance program is sufficient to detect the presence of CSF virus if it were to be introduced into Nayarit. Diagnostic Laboratory Capabilities The State of Nayarit does not have a diagnostic laboratory accredited for CSF diagnosis. All samples deemed suspicious for CSF are sent to the National Veterinary Services Diagnostic Laboratory (CENASA), located in the State of Mexico. This laboratory has been previously evaluated in other risk analyses and was not reevaluated during the site visit to Nayarit. Based on these prior assessments, APHIS has confidence that CENASA would be able to detect CSF in samples submitted for serological testing. Considering the relatively small swine population in Nayarit, this arrangement is satisfactory for CSF diagnosis and surveillance needs. However, if the swine population in the State increases significantly, this factor may need to be reassessed. Emergency Response Capacity Mexico has an established national system for surveillance and reporting of exotic animal diseases operated by their Ministry of Agriculture, Livestock Production, Rural Development, Fishery, and Food (SAGARPA) in collaboration with the Mexico-United States Commission for the Prevention of Foot and Mouth Disease and Other Exotic Animal Diseases. As a disease-free State, CSF virus is considered to be exotic in Nayarit. Whenever CSF is suspected, SAGARPA must immediately be notified and a precautionary quarantine is implemented in the focal and perifocal area to include the affected, exposed, and at-risk premises. If CSF is confirmed by CENASA, then the quarantine becomes definitive. Movement controls are implemented, sick animals are killed, dead animals are sanitarily disposed of, and an epidemiological investigation ensues. A close association and cooperation was observed between the Mexican Federal, State, and municipal government officials, the CFPP staff, and swine producers. This cooperation was especially effective in the operation of Nayarit's existing animal health checkpoints. Although no CSF suspect cases have been reported in Nayarit in recent years, these officials demonstrated knowledge of processes required under the National CSF Emergency Plan. These observations give APHIS confidence that an effective veterinary infrastructure exists in Nayarit capable of responding to a CSF outbreak. APHIS was unable to identify specific limitations in this system that would pose a risk to the United States. These findings are described in further detail in a qualitative evaluation that may be obtained from the person listed under FOR FURTHER INFORMATION CONTACT and may be viewed on the Internet at *http://www.regulations.gov.* (Instructions for accessing Regulations.gov are provided under the heading ADDRESSES at the beginning of this proposed rule.) The evaluation documents the factors that have led us to conclude that Nayarit is free of CSF. Therefore, we are proposing to recognize the Mexican State of Nayarit as free of CSF and to add it to the lists in §§ 94.9 and 94.10 of regions where CSF is not known to exist. Certification Requirements As previously noted, we are proposing to amend § 94.25 by adding the State of Nayarit to the list of regions in § 94.25, which, among other things, applies restrictions on the importation of live swine, pork, or pork products from certain regions that are listed as free of CSF in §§ 94.9(a) and 94.10(a). A CSF-free region may be added to the list in § 94.25(a) when it supplements its pork supplies with fresh (chilled or frozen) pork imported from regions considered to be affected by CSF, or supplements its pork supplies with pork from CSF-affected regions that is not processed in accordance with the requirements of 9 CFR part 94, or has a common land border with a CSF-affected region, or imports live swine from CSF-affected regions under conditions less restrictive than would be acceptable for importation into the United States. As previously noted, Nayarit shares land borders with Durango, Zacatecas, and Jalisco, which are States we have not evaluated for CSF and thus are considered by APHIS to be CSF-affected. Thus, even though we are proposing to declare Nayarit free of CSF, there is a risk that live swine, pork, or pork products originating in Nayarit may be commingled with live swine, pork, or pork products from CSF-affected regions, resulting in a risk of CSF introduction into the United States. Adding Nayarit to the list of regions in § 94.25(a) would mean that live swine, pork, or pork products and shipstores, airplane meals, and baggage containing pork or pork products, other than those articles regulated under parts 95 or 96 of this chapter, may not be imported into the United States unless the requirements described below were met. For all swine, pork, and pork products, each shipment would have to be accompanied by a certification issued by a full-time salaried veterinary officer of the Government of Mexico that would have to be presented to an authorized inspector at the port of arrival in the United States. Pursuant to § 94.25(b), the certification for live swine would have to state that: • The swine have not lived in any region where CSF is considered to exist; • The swine have not been in contact with swine that have been in a region where CSF is considered to exist; • The swine have not transited through a region where CSF is considered to exist unless moved directly through the region in a sealed means of conveyance with the seal intact upon arrival at the point of destination; and • The conveyances or materials used in transporting the swine, if previously used for transporting swine, have been cleaned and disinfected in accordance with the requirements of 9 CFR 93.502. Pursuant to § 94.25(c), the certification accompanying pork or pork products would have to state that: • The pork or pork products are derived from swine that were born and raised in a CSF-free region and were slaughtered in such a region at a federally inspected slaughter plant that is under the direct supervision of a full-time salaried veterinarian of the national government of that region and that is eligible to have its products imported into the United States under the Federal Meat Inspection Act (21 U.S.C. 601 *et seq.* ) and the FSIS regulations in 9 CFR 327.2; • The pork or pork products were derived from swine that have not lived in any region where CSF is considered to exist; • The pork or pork products have never been commingled with pork or pork products from any region where CSF is considered to exist; • The pork or pork products have not transited through a region where CSF is considered to exist unless moved directly through the region in a sealed means of conveyance with the seal intact upon arrival at the point of destination; and • If processed, the pork or pork products were processed in a CSF-free region in a federally inspected processing plant that is under the direct supervision of a full-time salaried veterinarian of the Government of Mexico. As mentioned above, the State of Nayarit currently does not have any federally inspected
(TIF)slaughtering or processing plants. Accordingly, no pork or pork products could be exported from Nayarit until this and all other requirements of § 94.25 have been met. Executive Order 12866 and Regulatory Flexibility Act This proposed rule has been reviewed under Executive Order 12866. For this action, the Office of Management and Budget has waived its review under Executive Order 12866. This proposed rule would amend the regulations for importing animals and animal products by adding the Mexican State of Nayarit to the list of regions considered free of CSF. We are proposing this action at the request of the Mexican Government and the State of Nayarit and after conducting a risk evaluation that indicates that Nayarit is free of this disease. We are also proposing to add Nayarit to a list of CSF-affected regions whose exports of live swine, pork, and pork products to the United States must meet certain certification requirements to ensure their freedom from CSF. These actions would relieve certain CSF-related restrictions on the importation into the United States of pork, pork products, live swine, and swine semen from Nayarit while continuing to protect against the introduction of this disease into the United States. This proposed rule is likely to have a minimal effect on U.S. live swine markets, both in the short term and in the medium term. Hog inventory of the State covered by this rulemaking amounted to about four-tenths of 1 percent of U.S. hog and pig inventory in 2004. 2 In 2004, there were 34 commercial swine farms in Nayarit with a population of 30,634 hogs and pigs. Another 18,650 hogs and pigs were reared in backyards, intended for consumption by the owners (table 1). Nayarit has never exported swine to the United States. This State—as is the case with Mexico as a whole—is a net importer of swine (table 2). 2 APHIS Risk Analysis on Importation of Classical Swine Fever
(CSF)Virus from Nayarit, Mexico; Regional Evaluation Services, National Center for Import and Export, VS, APHIS, USDA; and USDA, FAS, GAIN Report # MX6010, Mexico, Livestock and Products, Semiannual Report 2006. In 2004, the State of Nayarit produced around 4,000 metric tons of pork, an amount equal to 0.35 percent of Mexico's production of pork (table 3). Slaughter/processing plants handling swine in Nayarit are not TIF establishments. Only TIF plants are allowed to ship pork and pork products abroad or to CSF-free States in Mexico. Table 1.—Live Hogs in Nayarit, 2000-2004, and Mexico as a Whole, 2004 Nayarit Hogs in commercial farms Hogs in backyard operations All hogs 2000 10,809 30,006 40,815 2001 36,799 29,587 66,386 2002 34,279 30,890 65,169 2003 36,665 25,010 61,675 2004 30,634 18,650 49,284 Mexico
(2004)26,208,000 (pig crop + beginning stocks) in both commercial and backyard operations. *Source:* SAGARPA; APHIS Risk Analysis on Importation of Classical Swine Fever
(CSF)Virus from Nayarit, Mexico; Regional Evaluation Services, National Center for Import and Export, VS, APHIS, USDA; and Regionalization Evaluation Services ( *http://www.aphis.usda.gov/vs/ncie/reg-request.html* ), April 2006. This rulemaking is also unlikely to have a significant effect on U.S. pork and pork products markets because, as with live swine, the United States is unlikely to import large amounts of these commodities from Nayarit. The United States is a net exporter of pork, while Mexico, as indicated below in tables 2 and 3, is a net importer. In 2004, Mexico exported 36,000 metric tons of pork, averaging only around 3.2 percent of total Mexican pork production. Table 2.—U.S. and Mexican Trade With the World of Live Swine and Pork, 2004 Commodity Exports Imports Net trade with the world Live swine (head): Mexican swine 0 189,867 189,867 (net imports) *. U.S. swine 174,010 8,505,518 8,331,508 (net imports). Pork (metric tons): Mexican pork 36,476 86,102 49,626 (net imports). U.S. pork 747,357 469,442 277,916 (net exports). *Net Imports = Imports minus exports; Net Exports = Exports minus imports *Source:* USDA, FAS, UN Trade Statistics, 6-digit data. Table 3.—Swine Production
(Head)and Pork Production (Metric Tons) in United States and Mexico, 2004 United States Swine Pork Mexico Swine Pork Nayarit, MX Swine Pork 60,000,000 9,302,759 15,350,000 1,150,000 49,000 4,080 *Source:* USDA, FAS, GAIN Report # MX6010, Mexico, Livestock and Products, Semiannual Report 2006. Economic Impact on Small Entities The Regulatory Flexibility Act requires that agencies consider the economic impact of their rules on small entities. The domestic entities most likely to be affected by our proposal to declare the Mexican State of Nayarit free of CSF are pork producers. According to the 2002 Agricultural Census, there were about 66,036 hog and pig farms in the United States in that year, of which 93 percent received $750,000 or less in annual revenues. Agricultural operations with $750,000 or less in annual receipts are considered small entities, according to the Small Business Administration
(SBA)size criteria. We do not expect that U.S. hog producers, U.S. exporters of live hogs, or U.S. exporters of pork and pork products, small or otherwise, would be affected significantly by this proposed rule. This is because, for the reasons discussed above, the amount of live swine, pork, and other pork products imported into the United States from the Mexican State of Nayarit is likely to be small. Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action would not have a significant economic impact on a substantial number of small entities. Executive Order 12988 This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. If this proposed rule is adopted:
(1)All State and local laws and regulations that are inconsistent with this rule will be preempted;
(2)no retroactive effect will be given to this rule; and
(3)administrative proceedings will not be required before parties may file suit in court challenging this rule. National Environmental Policy Act To provide the public with documentation of APHIS' review and analysis of any potential environmental impacts associated with our proposal to list the Mexican State of Nayarit as free of CSF, we have prepared an environmental assessment. The environmental assessment was prepared in accordance with:
(1)The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 *et seq.* ),
(2)regulations of the Council on Environmental Quality for implementing the procedural provisions of NEPA (40 CFR parts 1500-1508),
(3)USDA regulations implementing NEPA (7 CFR part 1b), and
(4)APHIS' NEPA Implementing Procedures (7 CFR part 372). The environmental assessment may be viewed on the Regulations.gov Web site or in our reading room. (Instructions for accessing Regulations.gov and information on the location and hours of the reading room are provided under the heading ADDRESSES at the beginning of this proposed rule.) In addition, copies may be obtained by calling or writing to the individual listed under FOR FURTHER INFORMATION CONTACT . Paperwork Reduction Act This proposed rule contains no new information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ). List of Subjects in 9 CFR Part 94 Animal diseases, Imports, Livestock, Meat and meat products, Milk, Poultry and poultry products, Reporting and recordkeeping requirements. Accordingly, we propose to amend 9 CFR part 94 as follows: PART 94—RINDERPEST, FOOT-AND-MOUTH DISEASE, FOWL PEST (FOWL PLAGUE), EXOTIC NEWCASTLE DISEASE, AFRICAN SWINE FEVER, CLASSICAL SWINE FEVER, AND BOVINE SPONGIFORM ENCEPHALOPATHY: PROHIBITED AND RESTRICTED IMPORTATIONS 1. The authority citation for part 94 would continue to read as follows: Authority: 7 U.S.C. 450, 7701-7772, 7781-7786, and 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4. § 94.9 [Amended] 2. In § 94.9, paragraph
(a)would be amended by adding the word “Nayarit,” after the word “Chihuahua,”. § 94.10 [Amended] 3. In § 94.10, paragraph
(a)would be amended by adding the word “Nayarit,” after the word “Chihuahua,”. § 94.25 [Amended] 4. In § 94.25, paragraph
(a)would be amended by adding the word “Nayarit,” after the word “Chihuahua,”. Done in Washington, DC this 25th day of January 2007. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E7-1530 Filed 1-30-07; 8:45 am] BILLING CODE 3410-34-P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Part 113 [Docket No. APHIS-2007-0001] RIN 0579-AC28 Viruses, Serums, Toxins, and Analogous Products; Detection of Avian Lymphoid Leukosis Virus AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Proposed rule. SUMMARY: We are proposing to amend the Virus-Serum-Toxin Act regulations concerning testing for avian lymphoid leukosis in veterinary biologics to specify that the test is for the detection of extraneous replicating avian leukosis virus; require such testing to be conducted using a procedure that will detect extraneous replicating avian leukosis virus and that is acceptable to the Animal and Plant Health Inspection Service; require firms to develop a procedure to test for lymphoid leukosis virus contamination in the case of vaccine virus cytopathic to chick embryo cell cultures; and specify the equivalent inoculum dose of vaccine to be used when testing certain specified chicken vaccines for lymphoid leukosis virus. These proposed changes would update the testing for lymphoid leukosis virus contamination by prescribing a test procedure that increases the probability of detecting atypical lymphoid leukosis viruses such as those recently found in a contaminated vaccine. DATES: We will consider all comments that we receive on or before April 2, 2007. ADDRESSES: You may submit comments by either of the following methods: • *Federal eRulemaking Portal:* Go to *http://www.regulations.gov* , select “Animal and Plant Health Inspection Service” from the agency drop-down menu, then click “Submit.” In the Docket ID column, select APHIS-2007-0001 to submit or view public comments and to view supporting and related materials available electronically. Information on using *Regulations.gov* , including instructions for accessing documents, submitting comments, and viewing the docket after the close of the comment period, is available through the site's “User Tips” link. • *Postal Mail/Commercial Delivery:* Please send four copies of your comment (an original and three copies) to Docket No. APHIS-2007-0001, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. APHIS-2007-0001. *Reading Room:* You may read any comments that we receive on this docket in our reading room. The reading room is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue, SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call
(202)690-2817 before coming. *Other Information:* Additional information about APHIS and its programs is available on the Internet at *http://www.aphis.usda.gov* . FOR FURTHER INFORMATION CONTACT: Dr. Albert P. Morgan, Chief Staff Officer, Operational Support Section, Center for Veterinary Biologics, Licensing and Policy Development, APHIS, 4700 River Road Unit 148, Riverdale, MD 20737-1228;
(301)734-8245. SUPPLEMENTARY INFORMATION: Background The Virus-Serum-Toxin Act regulations in 9 CFR part 113 (referred to below as the regulations) contain standard procedures and requirements that are used to establish the purity, safety, potency, and efficacy of veterinary biological products. The regulations in §§ 113.200 and 113.300 specify general requirements for killed virus vaccine and live virus vaccine, respectively. The purity requirements for avian origin vaccine prescribed under these regulations specify that bulk or final container samples from each serial of avian origin vaccine must be tested for lymphoid leukosis virus contamination. Lymphoid leukosis viruses are ubiquitous in chickens, causing the disease lymphoid leukosis, and are considered to be potential contaminants of all biological products propagated in substrates of chicken origin. Inoculation of chickens and, possibly, other animals with veterinary biologics contaminated with lymphoid leukosis viruses may cause neoplastic diseases. Six subgroups (A, B, C, D, E, and J) of lymphoid leukosis viruses have been identified in chickens, with subgroups A (most often) and B (less frequently) being associated with disease. In order to ensure that biological products propagated in substrates of chicken origin are not contaminated with lymphoid leukosis viruses, veterinary biologics licensees and permittees are required to test such products for contaminating lymphoid leukosis viruses in accordance with the test procedure specified in § 113.31 of the regulations. The test procedure specified in § 113.31 is designed to detect contamination due to extraneous replicating subgroup A and B lymphoid leukosis viruses which are most often associated with disease in chickens. Biological products found contaminated with lymphoid leukosis viruses are unsatisfactory. Currently, the standard test procedure in § 113.31 of the regulations prescribes the complement-fixation
(CF)test for detecting lymphoid leukosis viruses in bulk pooled material or final container samples of biological products propagated in substrates of chicken origin. A negative CF test is considered evidence that the product is free of contaminating lymphoid leukosis viruses. Recently, however, in response to a reported finding of lymphoid leukosis virus contaminated vaccine, the Center for Veterinary Biologics and other laboratories, using an enzyme-linked immunosorbent assay (ELISA), detected lymphoid leukosis virus in 7 out of 129 serials of a commonly used chicken vaccine. The lymphoid leukosis virus contaminant had not been detected when the serials were tested using the CF test procedure specified in § 113.31 of the regulations. Prior to the reported finding, and confirmation of lymphoid leukosis virus contamination in the seven serials mentioned above, the CF test procedure prescribed in § 113.31 had been considered suitable for detecting previously known and/or classified lymphoid leukosis viruses. However, the failure of the CF test to detect lymphoid leukosis virus contamination in the vaccine suggests that the contaminant most likely is a previously unknown and unclassified subgroup A-like (atypical) lymphoid leukosis virus that cannot be detected using the standard CF test procedure prescribed in § 113.31, but can be detected using an ELISA for the detection of avian leukosis virus. The inability of the CF test to detect the lymphoid leukosis virus contamination that was later found using an ELISA test procedure indicates that the ELISA has a broader spectrum of specificity as compared to the CF test, and may be more suitable for detecting previously unclassified atypical lymphoid leukosis viruses. The requirement to use the CF test procedure specified in § 113.31 of the regulations to test for contaminating lymphoid leukosis viruses was promulgated prior to the development of ELISA methodology. Subsequent to the development of ELISA methodology and the licensing of ELISA based avian leukosis virus test kits, APHIS has approved the use of licensed ELISA kits to test for contaminating lymphoid leukosis viruses in place of the CF test procedure. Such approvals were based on side-by-side testing of the two methods that found the licensed ELISA kits to be equivalent to the CF test procedure for detecting lymphoid leukosis virus contamination in biological products. However, because the contaminated vaccine test results indicate that an ELISA will detect lymphoid leukosis virus contamination that cannot be detected using the CF test procedure, APHIS has concluded that the CF test procedure should no longer be specified for the detection of lymphoid leukosis viruses in § 113.31. In place of the CF test procedure, veterinary biologics licensees and permittees would be required to conduct a test that will detect extraneous replicating avian leukosis virus and that is acceptable to APHIS as specified in the product's filed Outline of Production. We are proposing to change the title of § 113.31 from “Detection of avian lymphoid leukosis” to “Detection of extraneous replicating avian leukosis virus” to clarify the fact that the test is for the detection of “extraneous replicating” avian leukosis virus that causes the disease “lymphoid leukosis” in chickens. We would also amend the introductory text of the section, where the current regulations specify that the CF test shall be conducted, to state simply that a test that will detect extraneous replicating avian leukosis virus and that is acceptable to APHIS shall be conducted. We expect that most manufacturers would specify a licensed ELISA kit for such testing, but other methods may be available and could be used provided they are acceptable to APHIS. In the case of biological product containing virus that has been propagated in substrates of chicken origin that cannot be tested for lymphoid leukosis virus contamination because the vaccine virus is cytopathic to chick embryo fibroblast cells, we would amend the regulations to require the individual firm(s) to specify a procedure to test such product for contaminating lymphoid leukosis viruses in the filed Outline of Production. Currently, § 113.31 of the regulations provides that in the case of cytopathic vaccine virus, the test for contaminating lymphoid leukosis viruses may be performed using a sample of another (alternative) vaccine prepared the same week from material harvested from each source flock used for the preparation of the product that contains the cytopathic (questionable) vaccine virus. Because both the questionable vaccine and the alternative vaccine would have been prepared using common-source avian origin substrate, the expectation was that if contaminating lymphoid leukosis viruses are not detected in the alternative vaccine, there is a strong probability that the questionable vaccine also is free of contaminating lymphoid leukosis viruses. However, as we sought to determine the source of the lymphoid leukosis virus found in the contaminated vaccine, we tested samples of another vaccine prepared the same week from material harvested from the same source flock(s) that provided the substrate used in the preparation of the contaminated vaccine. Because the substrate used to prepare both the contaminated vaccine and the vaccine used for the alternative test were derived from a common source, we expected the alternative vaccine to test positive for contaminating lymphoid leukosis viruses; however, none of the alternative vaccine samples tested positive for lymphoid leukosis viruses. These results indicate that testing an alternative vaccine for contaminating lymphoid leukosis viruses in place of a questionable vaccine does not ensure that a contaminant, if present, will be detected and, thus, should be discontinued. Therefore, when a vaccine cannot be tested for contaminating lymphoid leukosis viruses because the vaccine virus is cytopathic to the cells used for viral propagation, we are proposing to require veterinary biologics manufacturers to specify a procedure to test such vaccine for contaminating lymphoid leukosis viruses in the product's filed Outline of Production. The specified procedure would have to be acceptable to APHIS. In addition, we propose to specify that the equivalent of 200 doses of vaccine must be used as inoculum when testing bursal disease vaccine, tenosynovitis vaccine, and reovirus vaccine for contaminating lymphoid leukosis viruses. The current standard requirement specifies that when vaccines are tested for lymphoid leukosis virus contamination, the equivalent of 200 doses of Newcastle disease vaccine or 500 doses of other vaccine for use in poultry, or 1 dose of vaccine for use in other animals, shall be used as inoculum. Subsequent to codifying the requirement to use the equivalent of 200 doses as inoculum when testing Newcastle disease vaccine for contaminating lymphoid leukosis viruses, we have identified additional poultry vaccines for which the equivalent of 200 doses should be used as inoculum when testing for contaminating lymphoid leukosis viruses. APHIS now proposes to amend § 113.31 by specifying that the equivalent of 200 doses also shall be used as inoculum when testing bursal disease vaccine, tenosynovitis vaccine, and reovirus vaccine for contaminating lymphoid leukosis viruses. These amendments are being proposed in order to update the procedure used to detect lymphoid leukosis virus contamination in biological products and ensure that such products are free of material that adversely affects their safe use in animals. Executive Order 12866 and Regulatory Flexibility Act This proposed rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget. We are proposing to amend the regulations for detection of avian lymphoid leukosis to require that a test that will detect extraneous replicating avian leukosis virus and that is acceptable to APHIS shall be conducted on all biological products containing virus that has been propagated in substrates (starting material) of chicken origin. Lymphoid leukosis is a disease of chickens caused by avian leukosis viruses. Veterinary biologics containing virus that has been grown in substrates of chicken origin are at risk for contamination with avian leukosis viruses which, if present, are referred to as extraneous replicating avian leukosis virus. Inoculation of chickens, and possibly other animals, with vaccine contaminated with avian leukosis virus may cause neoplastic disease. This proposed rule, if adopted, would allow any valid method to be used for testing veterinary biologics for extraneous replicating avian leukosis virus, provided that it is acceptable to APHIS. The proposed changes would affect all licensed manufacturers of veterinary biologics who are required to test for the detection of extraneous replicating avian leukosis virus. There are approximately 125 veterinary biologics establishments, and approximately 15 of these establishments produce product that would be affected by this proposed rule. According to the standards of the Small Business Administration, most veterinary biologics establishments would be classified as small entities. The proposed changes, however, would not impose any additional economic burden since the regulations already require vaccine propagated in substrates of chicken origin to be tested for extraneous replicating avian leukosis virus; currently, the regulations require firms to use the CF test procedure for such testing. This proposed rule would discontinue required use of the CF test and instead require a test that will detect extraneous replicating avian leukosis virus and that is acceptable to APHIS to be conducted. In addition, the proposed rule would require firms to specify a procedure to test for extraneous replicating avian leukosis virus when questionable vaccine cannot be tested because the vaccine virus is cytopathic to chick embryo fibroblast cells; and would specify using the equivalent of 200 doses as inoculum when testing bursal disease, tenosynovitis, and reovirus vaccines for contaminating lymphoid leukosis viruses. The overall effect of this action would be to update the standard procedure for detecting extraneous replicating avian leukosis virus in biological products by prescribing a test procedure that has a greater probability of detecting an atypical lymphoid leukosis virus such as was recently found in contaminated vaccine. Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action would not have a significant economic impact on a substantial number of small entities. Executive Order 12372 This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 7 CFR part 3015, subpart V.) Executive Order 12988 This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. It is not intended to have retroactive effect. This rule would not preempt any State or local laws, regulations, or policies unless they present an irreconcilable conflict with this rule. The Virus-Serum-Toxin Act does not provide administrative procedures which must be exhausted prior to a judicial challenge to the provisions of this rule. Paperwork Reduction Act This proposed rule contains no new information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ). List of Subjects in 9 CFR Part 113 Animal biologics, Exports, Imports, Reporting and recordkeeping requirements. Accordingly, we propose to amend 9 CFR part 113 as follows: PART 113—STANDARD REQUIREMENTS 1. The authority citation for part 113 would continue to read as follows: Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4. 2. Section 113.31 would be revised to read as follows: § 113.31 Detection of extraneous replicating avian leukosis virus. A test that will detect extraneous replicating avian leukosis virus and that is acceptable to the Animal and Plant Health Inspection Service (APHIS) shall be conducted on all biological products containing virus that has been propagated in substrates of chicken origin: *Provided,* An inactivated viral product will be exempt from this requirement if the licensee can provide data that demonstrates to APHIS that the agent used to inactivate the vaccine virus would also inactivate lymphoid leukosis virus.
(a)Propagation of extraneous lymphoid leukosis viruses shall be done in chick embryo cell cultures or other substrate acceptable to APHIS.
(1)Each vaccine virus cytopathic to the cell culture being used shall be effectively neutralized, inactivated, or separated so that minimal amounts of extraneous replicating lymphoid leukosis virus can be propagated during the specified growth period. If the product cannot be tested for extraneous replicating lymphoid leukosis virus because the vaccine virus cannot be effectively neutralized, inactivated, or separated, an alternative procedure acceptable to APHIS shall be specified in the filed Outline of Production.
(2)When cell cultures are tested, 5 mL of the final cell suspension as prepared for seeding of production cell cultures shall be used as inoculum. When vaccines are tested, the equivalent of 200 doses of cytopathic vaccine viruses, including Newcastle disease vaccine, bursal disease vaccine, tenosynovitis vaccine, and reovirus vaccine, or 500 doses of other vaccines for use in poultry, or 1 dose of vaccine for use in other animals shall be used as inoculum. Control cultures shall be prepared from the same cell suspension as the cultures for testing the vaccine.
(3)Uninoculated chick embryo fibroblast cell cultures shall act as negative controls. One set of chick fibroblast cultures inoculated with subgroup A virus and one set of chick fibroblast cultures inoculated with subgroup B virus shall act as positive controls A and B, respectively.
(4)The cell cultures shall be passed when necessary to maintain viability, and samples harvested from each passage shall be tested for group-specific antigen.
(b)A test that will detect extraneous replicating lymphoid leukosis virus and that is acceptable to APHIS shall be used.
(1)All test materials, including positive and negative controls, shall be stored at −60 °C or colder until used in the test.
(2)The test procedure, including the cutoff value indicative of a positive test for extraneous replicating lymphoid leukosis virus, shall be specified in a filed Outline of Production or Special Outline.
(3)The detection of extraneous replicating lymphoid leukosis virus at the first passage shall be considered suspicious and the sample shall be further subcultured and tested to determine the presence of extraneous replicating lymphoid leukosis virus.
(4)Biological products or primary cells that are found contaminated with lymphoid leukosis viruses are unsatisfactory. Source flocks from which contaminated material was obtained are also unsatisfactory. Done in Washington, DC this 25th day of January 2007. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E7-1528 Filed 1-30-07; 8:45 am] BILLING CODE 3410-34-P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Part 113 [Docket No. APHIS-2006-0079] RIN 0579-AC30 Viruses, Serums, Toxins, and Analogous Products; Standard Requirements for Live Vaccines AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Proposed rule. SUMMARY: We are proposing to amend the Virus-Serum-Toxin Act regulations for certain live bacterial and viral vaccines by removing the requirement to retest the Master Seeds for immunogenicity 3 years after the initial qualifying immunogenicity test. In addition, we are proposing to amend the requirement concerning mouse safety tests prescribed for a biological product recommended for animals other than poultry. These proposed changes would update the standard requirements by eliminating unnecessary testing of Master Seed bacteria and viruses and other forms of bulk or completed biological product. DATES: We will consider all comments that we receive on or before April 2, 2007. ADDRESSES: You may submit comments by either of the following methods: • *Federal eRulemaking Portal:* Go to *http://www.regulations.gov,* select “Animal and Plant Health Inspection Service” from the agency drop-down menu, then click “Submit.” In the Docket ID column, select APHIS-2006-0079 to submit or view public comments and to view supporting and related materials available electronically. Information on using Regulations.gov, including instructions for accessing documents, submitting comments, and viewing the docket after the close of the comment period, is available through the site's “User Tips” link. • *Postal Mail/Commercial Delivery:* Please send four copies of your comment (an original and three copies) to Docket No. APHIS-2006-0079, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. APHIS-2006-0079. *Reading Room:* You may read any comments that we receive on this docket in our reading room. The reading room is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue, SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call
(202)690-2817 before coming. *Other Information:* Additional information about APHIS and its programs is available on the Internet at *http://www.aphis.usda.gov.* FOR FURTHER INFORMATION CONTACT: Dr. Albert P. Morgan, Chief Staff Officer, Operational Support Section, Center for Veterinary Biologics, Policy, Evaluation, and Licensing, APHIS, USDA, 4700 River Road Unit 148, Riverdale, MD 20737-1228;
(301)734-8245. SUPPLEMENTARY INFORMATION: Background The Virus-Serum-Toxin Act regulations in 9 CFR part 113 (referred to below as the regulations) contain standard procedures and requirements that are used to establish the purity, safety, potency, and efficacy of veterinary biological products. Current standard requirements in the regulations for certain live bacterial and viral vaccines require each lot of Master Seed virus or bacteria used for vaccine production to be tested for the ability to provoke an immune response (immunogenicity) prior to licensure. In addition, the regulations require such Master Seed virus and bacteria to be retested 3 years after completion of the initial immunogenicity test to confirm persistence of the ability to provoke an immune response. The requirement to periodically confirm the immunogenicity of a Master Seed has been in place since the adoption of the master seed concept for vaccine production; and had been considered necessary by APHIS until such time that an accumulation of data derived from such confirmatory testing established the antigenic stability of Master Seed bacteria and viruses over extended periods of storage. APHIS' analysis of data submitted by veterinary biologics licensees over several years has shown that the immunogenicity of the Master Seed is not adversely affected over extended periods of storage. Therefore, the requirement to retest Master Seed bacteria and viruses for immunogenicity 3 years after completion of the initial immunogenicity test is no longer considered necessary and would be removed. The elimination of such testing would result in a reduction in testing costs for veterinary biologics licensees and permittees. Mouse Safety Tests Safety tests are conducted to ensure that veterinary biologicals are free from properties causing undue local or systemic reactions. When the mouse safety test is prescribed in a standard requirement or filed Outline of Production for veterinary biologicals, the current regulations in § 113.33 specify that vaccine must be tested by inoculating one group of eight mice intracerebrally with 0.03 mL of vaccine and a second group of eight mice intraperitoneally with 0.5 mL of vaccine. Recent data, however, show that inoculating mice subcutaneously with 0.5 mL of vaccine is as effective as intracerebral inoculation with 0.03 mL. Therefore, we are proposing to amend the regulations regarding the mouse safety test by removing the reference to intracerebral inoculation with 0.03 mL of vaccine and replacing it with a reference to subcutaneous inoculation with 0.5 mL of vaccine. The subcutaneous and intraperitoneal routes of inoculation are considered equally sensitive for the purposes of the mouse safety test. Therefore, we are also proposing to amend the regulations to provide that only one route of inoculation—either the subcutaneous route or intraperitoneal route—be used in the test, rather than two routes as is currently required, and that the test be performed on a single group of eight mice, rather than the two groups of eight currently required. Although this proposed change would reduce the level of testing required by the regulations, we do not anticipate that the reduction in the number of mice used in the safety test would result in an increased number of vaccine-associated local or systemic reactions. These proposed amendments would update the standard requirements for veterinary biological products by eliminating test procedures which are no longer necessary to ensure the safety of veterinary biologics. Executive Order 12866 and Regulatory Flexibility Act This proposed rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget. We are proposing to amend the regulations for certain live bacterial and viral vaccines to eliminate the requirement to retest the Master Seed for immunogenicity 3 years after the initial qualifying immunogenicity test. In addition, this proposed amendment would update the regulations concerning mouse safety tests by requiring either intraperitoneal or subcutaneous inoculation of mice in place of the current requirement to inoculate mice intracerebrally and intraperitoneally. These proposed amendments, if adopted, would remove test procedures that do not provide additional assurance that such products are not worthless, contaminated, dangerous, or harmful. This proposed rule would affect veterinary biologics licensees and permittees producing live bacterial and viral vaccines and/or conducting the mouse safety test. According to the 2006 Current Veterinary Biologics Product Catalog, there are approximately 122 licensed and 21 permittee veterinary biologics establishments. The majority of these establishments produce veterinary products and would be affected by this proposal. The entities are classified under North American Industrial Classification System (NAICS) code 325414, Biological Product Manufacturing, and NAICS code 541710, Research and Development in the Physical, Engineering and Life Sciences. The small entity size standard for both groups is 500 or fewer employees. According to the Small Business Administration, most veterinary biologics establishments would be classified as small entities. In 2002, there were 296 establishments in the Biological Product Manufacturing subsector, 96 percent of which had fewer than 500 employees. However, APHIS does not have the 2006 information on the sizes of all potentially affected entities. The proposed changes would reduce testing costs for those entities by eliminating the requirement to retest the Master Seed for immunogenicity 3 years after the initial qualifying immunogenicity test. The proposed changes would also reduce, by half, the number of mice used in mouse safety tests by requiring either intraperitoneal or subcutaneous inoculation of mice in place of the current requirement to inoculate mice both intracerebrally and intraperitoneally. By revising the mouse safety test, it would only be necessary to test mice by requiring inoculation either intraperitoneally or subcutaneously. Reducing the number of mice needed for inoculation would therefore decrease the total cost of laboratory testing. This proposal would not impose any additional economic burden upon the establishments because it actually eliminates testing requirements for the Master Seed and reduces the number of mice, by half, to be tested. The overall effects of this action would be to reduce the costs associated with producing and testing veterinary and biological products. APHIS has been unable to quantify the potential cost savings, and welcomes public comment on the savings that would be afforded by the proposed rule. While the overall effect of this action would be to reduce the costs associated with producing and testing veterinary biological products, we do not expect the amount saved would represent a significant percentage of overall costs. Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action would not have a significant economic impact on a substantial number of small entities. Executive Order 12372 This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 7 CFR part 3015, subpart V.) Executive Order 12988 This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. It is not intended to have retroactive effect. This rule would not preempt any State or local laws, regulations, or policies unless they present an irreconcilable conflict with this rule. The Virus-Serum-Toxin Act does not provide administrative procedures which must be exhausted prior to a judicial challenge to the provisions of this rule. Paperwork Reduction Act This proposed rule contains no new information or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ). List of Subjects in 9 CFR Part 113 Animal biologics, Exports, Imports, Reporting and recordkeeping requirements. Accordingly, we propose to amend 9 CFR part 113 as follows: PART 113—STANDARD REQUIREMENTS 1. The authority citation for part 113 would continue to read as follows: Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4. 2. In § 113.8, paragraph
(d)would be amended as follows: a. By revising the heading to paragraph (d). b. By removing paragraph (d)(1). c. By removing the paragraph designation “(d)(2)”. § 113.8 In vitro tests for serial release.
(d)*Extending the dating of a reference.* * * * 3. In § 113.33, paragraphs (a)(1) and (a)(2) would be revised to read as follows: § 113.33 Mouse safety tests.
(a)* * *
(1)Vaccine prepared for use as recommended on the label shall be tested by inoculating eight mice intraperitoneally or subcutaneously with 0.5 mL, and the animals observed for 7 days.
(2)If unfavorable reactions attributable to the product occur in any of the mice during the observation period, the serial or subserial is unsatisfactory. If unfavorable reactions which are not attributable to the product occur, the test shall be declared inconclusive and may be repeated: *Provided* , That, if the test is not repeated, the serial or subserial shall be declared unsatisfactory. §§ 113.66, 113.68, and 113.69 [Amended] 4. In §§ 113.66, 113.68, and 113.69, paragraph (b)(6) would be removed and paragraph (b)(7) would be redesignated as paragraph (b)(6). § 113.67 [Amended] 5. In § 113.67, paragraph (b)(7) would be removed and paragraph (b)(8) would be redesignated as paragraph (b)(7). § 113.70 [Amended] 6. In § 113.70, paragraph (b)(5) would be removed. §§ 113.71, 113.306, and 113.318 [Amended] 7. In §§ 113.71, 113.306, and 113.318, paragraph (b)(4) would be removed and paragraph (b)(5) would be redesignated as paragraph (b)(4). § 113.303 [Amended] 8. In § 113.303, paragraph (c)(6) would be removed. § 113.302, 113.304, 113.314, 113.315, 113.317, 113.327, 113.331, and 113.332 [Amended] 9. In §§ 113.302, 113.304, 113.314, 113.315, 113.317, 113.327, 113.331, and 113.332, paragraph (c)(4) would be removed and paragraph (c)(5) would be redesignated as paragraph (c)(4). § 113.305 [Amended] 10. In § 113.305, paragraphs (b)(1)(iii) and (b)(2)(iii) would be removed and paragraph (b)(2)(iv) would be redesignated as paragraph (b)(2)(iii). §§ 113.308 and 113.316 [Amended] 11. In §§ 113.308 and 113.316, paragraph (b)(5) would be removed and paragraph (b)(6) would be redesignated as paragraph (b)(5). § 113.309 [Amended] 12. In § 113.309, paragraph (c)(9) would be removed and paragraph (c)(10) would be redesignated as paragraph (c)(9). § 113.310 [Amended] 13. In § 113.310, paragraph (c)(8) would be removed and paragraph (c)(9) would be redesignated as paragraph (c)(8). § 113.311 [Amended] 14. In § 113.311, paragraph (c)(7) would be removed and paragraph (c)(8) would be redesignated as paragraph (c)(7). § 113.312 [Amended] 15. In § 113.312, paragraphs (b)(5) and(b)(6) would be removed and paragraph (b)(7) would be redesignated as paragraph (b)(5). §§ 113.313 and 113.328 [Amended] 16. In §§ 113.313 and 113.328, paragraph (c)(6) would be removed and paragraph (c)(7) would be redesignated as paragraph (c)(6). §§ 113.325 and 113.326 [Amended] 17. In §§ 113.325 and 113.326, paragraph (c)(5) would be removed and paragraph (c)(6) would be redesignated as paragraph (c)(5). § 113.329 [Amended] 18. In § 113.329, paragraph (c)(5) would be removed and paragraphs (c)(6) and (c)(7) would be redesignated as paragraphs (c)(5) and (c)(6), respectively. Done in Washington, DC, this 25th day of January 2007. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E7-1531 Filed 1-30-07; 8:45 am] BILLING CODE 3410-34-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R07-OAR-2006-0973; FRL-8274-8] Approval and Promulgation of Implementation Plans; State of Kansas AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: EPA is proposing to approve a request to revise the State Implementation Plan
(SIP)made by the state of Kansas to include updates to its Prevention of Significant Deterioration
(PSD)of Air Quality rule. The Kansas revision adopts by reference provisions of 40 CFR 52.21 as in effect July 1, 2004, except for subsections with references to Clean Unit Exemptions, Pollution Control Projects, and the record keeping provisions for the actual-to-projected-actual emissions projections. Kansas did not adopt the latter provisions because of the June 24, 2005, United States Court of Appeals for the District of Columbia Circuit's decision, which vacated the Clean Unit Exemption and Pollution Control Project provisions and remanded back to EPA the record keeping provisions for the actual-to-projected-actual emissions projections standard for when a source must keep certain project related records. If approved, EPA would incorporate the revisions into the Kansas SIP. DATES: Comments must be received on or before March 2, 2007. ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R07-OAR-2006-0973, by one of the following methods: 1. *http://www.regulations.gov:* Follow the online instructions for submitting comments. 2. *E-mail:* *grier.gina@epa.gov.* 3. *Mail:* Gina Grier, Environmental Protection Agency, Air Planning and Development Branch, 901 North 5th Street, Kansas City, Kansas 66101. 4. *Hand Delivery or Courier:* Deliver your comments to: Gina Grier, Environmental Protection Agency, Air Planning and Development Branch, 901 North 5th Street, Kansas City, Kansas 66101. *Instructions:* Direct your comments to Docket ID No. EPA-R07-OAR-2006-0973. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at *http://www.regulations.gov* , including any personal information provided, unless the comment includes information claimed to be Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through *http://www.regulations.gov* or e-mail. The *http://www.regulations.gov* Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through *http://www.regulations.gov* , your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. *Docket.* All documents in the electronic docket are listed in the *http://www.regulations.gov* index. Although listed in the index, some information is not publicly available, *e.g.* , CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in *http://www.regulations.gov* or in hard copy at the Environmental Protection Agency, Air Planning and Development Branch, 901 North 5th Street, Kansas City, Kansas. EPA requests that you contact the person listed in the FOR FURTHER INFORMATION CONTACT section to schedule your inspection. The interested persons wanting to examine these documents should make an appointment with the office at least 24 hours in advance. FOR FURTHER INFORMATION CONTACT: Gina Grier at
(913)551-7078, or by e-mail at *grier.gina@epa.gov.* SUPPLEMENTARY INFORMATION: Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This section provides additional information by addressing the following questions: What is the Federal approval process for a SIP? What is being addressed in this document? What is the background for EPA's New Source Review
(NSR)Reform rule? What is Kansas's NSR Reform rule and what action has Kansas requested on the rule? Have the requirements for approval of a SIP revision been met? What action is EPA proposing? What is the Federal approval process for a SIP? In order for State regulations to be incorporated into the Federally-enforceable SIP, States must formally adopt the regulations and control strategies consistent with State and Federal requirements. This process generally includes a public notice, public hearing, public comment period, and a formal adoption by a State-authorized rulemaking body. Once a State rule, regulation, or control strategy is adopted, the State submits it to us for inclusion into the SIP. We must provide public notice and seek additional public comment regarding the proposed Federal action on the State submission. If adverse comments are received, they must be addressed prior to any final Federal action by us. All State regulations and supporting information approved by EPA under section 110 of the Clean Air Act (CAA or Act) are incorporated into the Federally-approved SIP. Records of such SIP actions are maintained in the Code of Federal Regulations
(CFR)at title 40, part 52, entitled “Approval and Promulgation of Implementation Plans.” The actual State regulations which are approved are not reproduced in their entirety in the CFR outright but are “incorporated by reference,” which means that we have approved a given State regulation with a specific effective date. What is being addressed in this document? We are proposing to approve the Kansas Department of Health and Environment's
(KDHE)revision to Kansas Administrative Regulation (K.A.R.) 28-19-350, Prevention of Significant Deterioration of Air Quality. Kansas adopted the applicable provisions of 40 CFR 52.21, except for subsections that are not applicable to Kansas or are stayed, vacated, or remanded by Federal court order, or are reserved for future use. The rules were submitted to EPA on July 25, 2006. The submission included comments on the rules made during the state's adoption process, the state's response to comments and other information necessary to meet EPA's completeness criteria. For additional information on completeness criteria, the reader should refer to 40 CFR part 51, appendix V. What is the background for EPA's New Source Review
(NSR)Reform rule? The 2002 NSR Reform rules are part of EPA's implementation of Parts C and D of title I of the CAA, 42 U.S.C. 7470-7515. Part C of title I of the CAA, 42 U.S.C. 7470-7492, is the PSD program, which applies in areas that meet the National Ambient Air Quality Standards (NAAQS), also known as “attainment areas” and in areas for which there is insufficient information to determine whether the area meets the NAAQS, also known as, “unclassifiable” areas. Part D of Title I of the CAA, 42 U.S.C. 7501-7515, is the nonattainment New Source Review
(NNSR)program, which applies in areas that are not in attainment of the NAAQS, also known as “nonattainment areas.” Collectively, the PSD and NNSR programs are referred to as the “New Source Review” or NSR programs. EPA regulations implementing these programs are contained in 40 CFR 51.165, 51.166, 52.21, 52.24, and part 51, appendix S. The CAA NSR programs are preconstruction review and permitting programs applicable to new and modified stationary sources of air pollutants regulated under the CAA. The NSR programs of the CAA include a combination of air quality planning and air pollution control technology program requirements. Briefly, section 109 of the CAA, 42 U.S.C. 7409, requires EPA to promulgate primary NAAQS to protect public health and secondary NAAQS to protect public welfare. Once EPA sets those standards, States must develop, adopt, and submit to EPA for approval, a SIP that contains emissions limitations and other control measures to attain and maintain the NAAQS. Each SIP is required to contain a preconstruction review program for the construction and modification of any stationary source of air pollution to assure that the NAAQS are achieved and maintained; to protect areas of clean air; to protect air quality related values (such as visibility) in national parks and other areas; to assure that appropriate emissions controls are applied, to maximize opportunities for economic development consistent with the preservation of clean air resources; and to ensure that any decision to increase air pollution is made only after full public consideration of the consequences of the decisions. The 2002 NSR Reform rules made changes to five areas of the NSR programs. In summary, the 2002 rules:
(1)Provide a new method for determining baseline actual emissions;
(2)adopt an actual-to-projected-actual methodology for determining whether a major modification has occurred;
(3)allow major stationary sources to comply with plant-wide applicability limits
(PALs)to avoid having a significant emission increase that triggers the requirements of the major NSR program;
(4)provide a new applicability provision for emissions units that are designated clean units; and
(5)exclude pollution control projects
(PCPs)from the definition of physical change or change in the method of operation. After the 2002 NSR Reform rules were finalized and effective, various petitioners challenged numerous aspects of the 2002 NSR Reform rules, along with portions of EPA's 1980 NSR rules (45 FR 5276 August 7, 1980). On June 24, 2005, the District of Columbia Court of Appeals issued a decision on the challenges to the 2002 NSR Reform Rules. *New York* v. *United States* , 413 F.3d (DC Cir. 2005). In summary, the Court of Appeals for the District of Columbia vacated portions of the rules pertaining to clean units and pollution control projects, remanded a portion of the rules regarding exemption from record keeping, *e.g.* , 40 CFR 52.21(r)(6) and 40 CFR 51.166(r)(6), and let stand the other provisions included as part of the 2002 NSR Reform rules. EPA has not yet responded to the Court's remand regarding record keeping provisions. What is Kansas's NSR Reform rule and what action has Kansas requested on the rule? In this action, we propose approval of revisions to Kansas's Air Quality Regulation, K.A.R. 28-19-350, Prevention of Significant Deterioration of Air Quality, into the SIP. This rule incorporates by reference the Federal PSD program in 40 CFR 52.21, including the 2002 NSR Reform rules described above, with the exception of portions of the rule relating to provisions vacated or remanded by the court. Under Part C of Title I of the CAA, states have the primary responsibility for developing a SIP and issuing permits subject to the emission limits and other control measures developed in the plan. NSR ensures the protection of air quality because it designates a specific plan customized to prevent significant deterioration of air quality from individual major source emitters of air pollutants, such as power plants, refineries or manufacturing facilities. The permit also requires the application of Best Available Control Technology
(BACT)to new or modified facilities. The NSR permit program encompassed by K.A.R. 28-19-350 is for sources located in areas where the air is designated “attainment” or unclassifiable and meets the requirement to protect human health. A major stationary source is required to obtain a permit before it can begin construction or make a major modification if the modification or construction will increase emissions by an amount large enough to trigger NSR requirements. A PSD permit places allowable limits on pollution emissions from a newly constructed or newly modified stationary source. As part of the PSD permitting process, Kansas completes required air quality modeling analysis of the project to ensure the project maintains compliance with the NAAQS. Kansas also tracks and controls the emission of air pollutants by calculating the maximum increase concentration allowed to occur above an established background level, known as a PSD increment. The revision to K.A.R. 28-19-350 incorporates by reference the provisions of the EPA NSR reform rule referenced above. This includes
(1)the new methodology for determining baseline actual emissions;
(2)the option of using the actual-to-projected-actual emissions for determining emissions increases; and
(3)the provisions relating to plant-wide applicability limits. It does not incorporate the provisions vacated or remanded by the court, described previously. In addition, the state revision adds titles to each subsection for ease of reading. Subsection
(c)clarifies the term “Administrator” in the Federal rule, to indicate where it means Administrator of EPA and where it means KDHE, as separate from state agency administration. Subsection
(h)specifies that the state construction approval requirements also apply to the PSD permit issued under the regulation. Subsection
(k)ensures that the public notice of PSD permit actions state whether the action will adversely impact Federal class I areas. Because the Kansas rule adopts by reference relevant portions of the Federal rule, EPA believes it meets the requirement of the CAA. Have the requirements for approval of a SIP revision been met? The state submittal has met the public notice requirements for SIP submissions in accordance with 40 CFR 51.102. The submittal also satisfied the completeness criteria of 40 CFR part 51, appendix V. In addition, as explained above and in more detail in the technical support document that is part of this docket, EPA believes that the revisions meet the substantive SIP requirements of the CAA, including section 110 and implementing regulations. What action is EPA proposing? We propose to approve revisions to Kansas's Air Quality Regulation, K.A.R. 28-19-350, Prevention of Significant Deterioration of Air Quality. Statutory and Executive Order Reviews Under Executive Order 12866 (58 FR 51735, October 4, 1993), this proposed action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This proposed action merely proposes to approve state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by State law. Accordingly, the Administrator certifies that the proposed approvals in this proposed rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ). Because this rule proposes to approve 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 (Pub. L. 104-4). This proposed 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 proposes to approve a State rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the CAA. This proposed rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant. In reviewing SIP submissions, EPA's role is to approve State choices, provided that they meet the criteria of the CAA. 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 CAA. 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 proposed rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ). List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds. Dated: January 24, 2007. John B. Askew, Regional Administrator, Region 7. [FR Doc. E7-1518 Filed 1-30-07; 8:45 am] BILLING CODE 6560-50-P DEPARTMENT OF STATE 48 CFR Part 601 [Public Notice 5684] RIN 1400-AB98 Department of State Acquisition Regulation AGENCY: State Department. ACTION: Proposed rule. SUMMARY: This proposed rule makes one change to the DOSAR. It revises the DOSAR to expand contracting authority to non-U.S. citizen locally employed staff, i.e., Foreign Nationals and Third Country Nationals. Presently, only U.S. citizens who are Government employees may be appointed as contracting officers. DATES: The Department will accept comments from the public up to April 2, 2007. ADDRESSES: You may submit comments, identified by any of the following methods: • *E-mail: ginesgg@state.gov.* You must include the RIN in the subject line of your message. • *Mail (paper, disk, or CD-ROM submissions):* Gladys Gines, Procurement Analyst, Department of State, Office of the Procurement Executive, 2201 C Street, NW., Suite 603, State Annex Number 6, Washington, DC 20522-0602. • *Fax:* 703-875-6155. Persons with access to the Internet may also view this notice and provide comments by going to the regulations.gov Web site at *http://www.regulations.gov/index.cfm.* FOR FURTHER INFORMATION CONTACT: Gladys Gines, Procurement Analyst, Department of State, Office of the Procurement Executive, 2201 C Street, NW., Suite 603, State Annex Number 6, Washington, DC 20522-0602; e-mail address: *ginesgg@state.gov.* SUPPLEMENTARY INFORMATION: The Department of State initiated a pilot program in which a non-U.S. citizen locally employed staff
(LES)member at an Embassy was given contracting authority at $2,500 (the micro-purchase threshold). The pilot resulted in savings in time to process transactions, allowed the Contracting Officer at the Embassy additional time to concentrate on other procurement and non-procurement issues, and increased morale among LES staff through a sense of greater empowerment. Although the pilot did not identify specific cost or headcount savings, the Department believes that further dissemination of contracting authority at increased levels up to $25,000 presents an opportunity for overseas posts (Embassies and Consulates) to achieve reductions in cost and headcount while improving service, largely by providing management flexibility to reconfigure the work portfolios of overseas contracting officers. Approximately 97% of all overseas procurement transactions are below $25,000. Effective management controls will minimize the risks associated with providing contracting authority to non-U.S. citizen LES. These controls are similar to those currently used successfully in the purchase card program for similar transactions. They consist of: • Review of LES transactions on a monthly basis by a U.S. citizen contracting officer; • Determination and approval of adequate local conditions such as rule of law and level of corruption as well as the integrity of LES staff recommended for the contracting authority; • Evaluation of LES delegated procurement by the Office of the Procurement Executive; • Certification by the Ambassadors on an annual basis that the management controls are sufficient; and • Time-limited contracting officer authority to LES to permit periodic revalidation of management controls. Because the current DOSAR language states that all contracting officers must be U.S. citizens, a change to the regulation is required. Because the rulemaking process will take some time, the Department will select several additional pilot posts to continue the deployment process during the rulemaking timeframe. Regulatory Findings Administrative Procedure Act In accordance with provisions of the Administrative Procedure Act governing rules promulgated by federal agencies that affect the public (5 U.S.C. 552), the Department is publishing this proposed rule and inviting public comment. Regulatory Flexibility Act The Department of State, in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed this regulation and, by approving it, certifies that this rule will not have a significant economic impact on a substantial number of small entities. Unfunded Mandates Act of 1995 This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any year and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Act of 1995. Small Business Regulatory Enforcement Fairness Act of 1996 This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Act of 1996. This rule will not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign based companies in domestic and import markets. Executive Order 13132 This rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with section 6 of Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to require consultations or warrant the preparation of a federalism summary impact statement. Paperwork Reduction Act The Paperwork Reduction Act does not apply because the rule does not impose information collection requirements that require the approval of the Office of Management and Budget under 44 U.S.C. 3501, *et seq.* List of Subjects in 48 CFR Part 601 Government procurement. Accordingly, for reasons set forth in the preamble, title 48, chapter 6 of the Code of Federal Regulations is proposed to be amended as follows: Subchapter A—General PART 601—DEPARTMENT OF STATE ACQUISITION REGULATION SYSTEM 1. The authority citation for 48 CFR part 601 continues to read as follows: Authority: 40 U.S.C. 486(c); 22 U.S.C. 2658. 2. Section 601.603-3 is amended by revising paragraph
(c)to read as set forth below: 601.603-3 Appointment.
(c)*Non-Federal employees.* Only United States Government employees shall be appointed as contracting officers. For acquisitions at $25,000 and below only, this includes locally employed staff ( *i.e.* , Foreign Service Nationals and Third Country nationals). Personal services contractors are not eligible for appointment as DOS contracting officers. Dated: January 23, 2007. Corey M. Rindner, Procurement Executive, Department of State. [FR Doc. E7-1534 Filed 1-30-07; 8:45 am] BILLING CODE 4710-24-P 72 20 Wednesday, January 31, 2007 Notices DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request January 25, 2007. The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments regarding
(a)whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(b)the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used;
(c)ways to enhance the quality, utility and clarity of the information to be collected;
(d)ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), *OIRA_Submission@OMB.EOP.GOV* or fax
(202)395-5806 and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250-7602. Comments regarding these information collections are best assured of having their full effect if received within 30 days of this notification. Copies of the submission(s) may be obtained by calling
(202)720-8958. An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number. Food and Nutrition Service *Title:* Form FNS-388, State Issuance and Participation Estimates. *OMB Control Number:* 0584-0081. *Summary of Collection:* Section 18(b) of the Food Stamp Act of 1977, as amended August 14, 1979 by Pubic Law 96-58, requires that “In any fiscal year, the Secretary shall limit the value of those allotments issued to an amount not in excess of the appropriation for such fiscal year.” Timely State monthly issuance estimates are necessary for the Food and Nutrition Service
(FNS)to ensure that it remains within the appropriation and will have a direct effect upon the manner in which allotments would be reduced when necessary. FNS uses the FNS-388 report to obtain monthly Statewide estimated or actual issuance and participation data for the current and previous months, and the actual participation data for the second preceding month. *Need and Use of the Information:* The FNS-388 report provides the necessary data for an early warning system to enable the Department to fulfill the requirements of Section 18(b) of the Food Stamp Act. In addition, the data is used to
(1)validate the Annual Food Stamp Household Characteristic Survey;
(2)to compile a Statistical Summary Report which is used for special studies and in response to Congressional and other inquiries; and
(3)to compare against the reconciliation points' FNS-46 issuance data (for electronic benefit transfer (EBT), cash-out, and alternative issuance) for indication of accountability problems. FNS has also used the project area data to determine where to demonstrate pilot projects to test a school-based FSP outreach initiative. *Description of Respondents:* State, Local, or Tribal Government. *Number of Respondents:* 53. *Frequency of Responses:* Recordkeeping; Reporting: Monthly. *Total Burden Hours:* 5,243. Ruth Brown, Departmental Information Collection Clearance Officer. [FR Doc. E7-1478 Filed 1-30-07; 8:45 am] BILLING CODE 3410-30-P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS-2006-0184] Public Meeting; Veterinary Biologics AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Notice of cancellation of public meeting. SUMMARY: We are advising producers and users of veterinary biological products, and other interested individuals, that the 14th public meeting on veterinary biologics previously scheduled to be held on March 28 and 29, 2007, is canceled. FOR FURTHER INFORMATION CONTACT: Dr. Byron E. Rippke, Director, Policy, Evaluation, and Licensing, Center for Veterinary Biologics, Veterinary Services, APHIS, 510 South 17th Street, Suite 104, Ames, IA 50010-8197; phone
(515)232-5785, fax
(515)232-7120, or e-mail *CVB@aphis.usda.gov.* SUPPLEMENTARY INFORMATION: In a document published in the **Federal Register** on December 1, 2006 (71 FR 69530, Docket No. APHIS-2006-0184), we gave notice that we would be holding a public meeting on Wednesday, March 28, and Thursday, March 29, 2007, in the Scheman Building at the Iowa State Center, Iowa State University, Ames, IA. The purpose of the meeting was to provide an opportunity for the exchange of information between APHIS representatives, producers and users of veterinary biological products, and other interested individuals. Due to circumstances beyond our control, we are forced to cancel the meeting. We regret any inconvenience caused by the cancellation. Done in Washington, DC, this 25th day of January 2007. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E7-1529 Filed 1-30-07; 8:45 am] BILLING CODE 3410-34-P DEPARTMENT OF AGRICULTURE Forest Service RIN 0596-AC02 National Forest System Land Management Planning Directive for Wilderness Evaluation AGENCY: Forest Service, USDA. ACTION: Notice of issuance of agency final directive. SUMMARY: The Forest Service is issuing a final directive to Forest Service Handbook 1909.12, chapter 70. Chapter 70 establishes procedures for wilderness evaluation when carrying out national forest land management planning regulations at 36 CFR part 219, subpart A, published in the **Federal Register** on January 5, 2005 (70 FR 1023). This directive provides consistent overall guidance to Forest Service line officers and employees in identifying and evaluating potential wilderness areas when developing, or revising land management plans for units of the National Forest System. DATES: This directive is effective January 31, 2007. ADDRESSES: Copies of the directive are available on the World Wide Web/Internet at *http://www.fs.fed.us/im/directives/fsh/1909.12/1909.12_70.doc* or on a compact disc (CD). Copies of the directive on a CD can be obtained by contacting Regis Terney by e-mail (rterney@fs.fed.us), by phone at 1-866-235-6652 or 202-205-0895, or by mail at Regis Terney, USDA Forest Service, Mailstop 1104, EMC, 3 Central, 1400 Independence Avenue, SW., Washington, DC 20050-1104. FOR FURTHER INFORMATION CONTACT: Regis Terney, Planning Specialist, Ecosystem Management Coordination Staff
(202)205-0895. SUPPLEMENTARY INFORMATION: Background On January 5, 2005, the Department adopted final planning regulations for the National Forest System
(NFS)at 36 CFR Part 219, subpart A (70 FR 1023) (also referred to as the 2005 planning rule). The 2005 planning rule provides broad programmatic direction in developing and carrying out land management planning. The rule explicitly directs the Chief of the Forest Service to establish planning procedures in the Forest Service directives system (36 CFR 219.1(c)). The Forest Service directives consist of the Forest Service Manual
(FSM)and the Forest Service Handbook (FSH), which contain the agency's policies, practices, and procedures and serve as the primary basis for the internal management and control of programs and administrative direction to Forest Service employees. The directives for all agency programs are set out on the World Wide Web/Internet at *http://www.fs.fed.us/im/directives.* Generally, the FSM contains legal authorities, objectives, policies, responsibilities, instructions, and guidance needed on a continuing basis by Forest Service line officers and primary staff to plan and execute programs and activities, while the FSH is generally the principal source of specialized guidance and instruction for carrying out the policies, objectives, and responsibilities contained in the FSM. Need for Direction Procedural and technical details associated with implementing the 2005 planning rule are needed by NFS units to begin consistent plan amendments or revisions across all NFS units to prevent confusion and to improve public involvement and decisionmaking associated with developing, amending, or revising a land management plan. Public Participation On March 23, 2005, the Forest Service issued 12 interim directives to FSM 1330, 1900, and 1920 and FSH 1909.12 asking for public comment (70 FR 14637). In addition, on August 8, 2005, the Forest Service issued an interim directive
(ID)1909.12-2005-10 to FSH 1909.12 to revise ID 1909.12-2005-8, issued March 23, 2005 to correct a mistake at section 71.12 (70 FR 45647). On September 7, 2006, the Forest Service issued an interim directive combining, with no change, the direction previously issued in ID 1909.12-2005-8 and ID 1909.12-2005-10. This notice of issuance involves a final amendment for FSH 1909.12, chapter 70—Wilderness Evaluation. Directives to FSMs 1900 and 1920 and FSH 1909.12, chapters zero code, 10, 20, 30, 40, 50, 60 and 80 were issued on January 31, 2006 (71 FR 5124). Comments were submitted by mail, facsimile, and electronically. During the 90-day comment period (ending on June 21, 2005), the agency received 69 original responses and 8,727 copies of one form letter that commented on wilderness evaluation. These responses were analyzed by the Content Analysis Group and documented in a Content Analysis Report. Of the 69 original responses, the Forest Service received responses from 59 individuals and 10 organizations. Response to Comments on Wilderness Evaluation Potential Wilderness Areas *Comment:* The Forest Service should not substitute the phrase “potential wilderness areas” for the phrase “roadless areas” in the Forest Service directives' terms because the term is confusing and an attempt to limit examination of roadless areas only to evaluation of their potential for wilderness. Roadless areas have their own status as areas that warrant protection and the planning process should not be limited to protecting only those areas recommended for wilderness designation. Roadless areas not recommended for wilderness will be lost to road building and timber harvest that will destroy their roadless character forever. *Response:* The term “potential wilderness areas” was substituted for “roadless areas” in the interim directives to stress the reason these areas are identified and evaluated. Many public and internal comments were received on this issue. In the final directive the term “potential wilderness areas” is used to avoid confusion with the term “inventoried roadless area” used in the Roadless Area Conservation Rule (36 CFR 294.11, 66 FR 3244, January 12, 2001). The Roadless Area Conservation Rule defined “inventoried roadless areas” as areas identified in a set of inventoried roadless area maps in the November 2000 Forest Service Roadless Area Conservation, Final Environmental Impact Statement, Volume 2 or subsequent update or revision of those maps. The Roadless Area Conservation Rule definition is different from the criteria for “potential wilderness areas” defined at section 71.1 of the final directive. The two areas (inventoried roadless areas and potential wilderness areas) may have common boundaries; however, often the areas are different. Specific Criteria *Comment:* The Forest Service should include specific criteria for inventory and evaluation of roadless areas and require a thorough review of all areas of each national forest, grassland, or prairie, including the 58.5 million acres of previously inventoried roadless areas identified in the Roadless Area Conservation Rule or the RARE II inventory. This new inventory is needed to ensure that areas are included that may have been missed in past efforts. *Response:* Criteria for identifying lands to evaluate for wilderness potential are specified in the guidance in FSH 1909.12, chapter 70. The intent is to identify and evaluate all National Forest System
(NFS)lands that meet the definition of wilderness in section 2(c) of the 1964 Wilderness Act (16 U.S.C. 1131 *et seq.* ) The inventory process outlined in chapter 70 of the handbook requires a thorough review of not only those areas that were identified in previous inventories, but also other areas that may meet the criteria. This “inventory” of areas is updated during land management plan revision, and each area meeting inventory criteria is then evaluated following the policy in FSM 1923 and the procedural guidance in FSH 1909.12, chapter 70. Based on the evaluation, some potential wilderness areas may be administratively recommended for wilderness designation. But, only the Congress can designate an area as wilderness. Inventory *Comment:* The Forest Service should include in the roadless area inventory all unroaded areas greater than 1,000 acres in size. *Response:* The criteria for inventory do not include any absolute size limit on what areas can be in the inventory. Areas less than 5,000 acres can be considered if they meet several criteria for wilderness characteristics and manageability. The intent is to identify and evaluate all NFS lands that meet the definition of wilderness in section 2(c) of the Wilderness Act. Criteria for Wilderness *Comment:* The Forest Service should revise the Forest Service directives' criteria for wilderness inventory and evaluation. Some criteria about evidence of past disturbance, such as old mining roads or new routes created illegally by off-road vehicle users or watershed treatments (FSH 1909.12, sec. 71.11) should not be used to eliminate areas from the roadless inventory. The Wilderness Act does not require pristine conditions for designation and that use of criteria such as “sights and sounds” coming from outside the area are erroneous and not in line with the will of Congress. The section on capability should be cut out entirely, including references to solitude, sights and sounds, challenge, and recreation. *Response:* The directive has been revised to require that all areas meet the statutory definition of wilderness to be considered for the inventory of potential wilderness (FSH 1909.12, sec. 71). This includes providing opportunities for solitude or a primitive and unconfined type of recreation. All specific references to sights and sounds as “inventory criteria” have been removed. The capability analysis includes an evaluation of an area's ability to provide outstanding opportunities for solitude or primitive and unconfined recreation, consistent with the definition of wilderness in the Wilderness Act. Evaluating the opportunity for solitude appropriately includes isolation from sights, sounds, the presence of others, development, and evidence of humans when analyzing an potential wilderness area (FSH 1909.12, sec. 72.1). Definition *Comment:* The definition of wilderness in the Wilderness Act of 1964, section 2(c) should be in FSH section 71. *Response:* That requirement was in the policy section of the interim directive at FSM 1923 so there is no need to repeat it in chapter 70 of FSH 1909.12. But, because of public and internal comment, and to make it clear that the Forest Service is identifying lands that could potentially be considered as additions to the National Wilderness Preservation System, the requirement for satisfying the definition of wilderness found in section 2(c) of the Wilderness Act has been added back into section 71. Pending Wilderness *Comment:* The Forest Service should allow potential wilderness areas to be managed as wilderness study areas until wilderness designation is achieved or settled by Congress. *Response:* The term “wilderness study area” is a specific term used in the Eastern Wilderness Act of 1975 (16 U.S.C. 1132(note)) and other statutes. To clarify, direction has been added at FSH 1909.12, sec. 71. All areas that meet the definition of wilderness (sec. 2(c) of the Wilderness Act) and the criteria in FSM 1923 and FSH 1909.12, chapter 70 are evaluated for wilderness suitability in land management plan revisions. Those areas administratively recommended for wilderness or wilderness studies are not available for any use or activity that may reduce their wilderness potential. Not all areas evaluated will be found suitable for wilderness. Wilderness Character *Comment:* The Forest Service should clarify when and how evaluation for wilderness could take place outside the planning process. FSM 1923 implies that this could happen. *Response:* There was policy direction and guidance in the interim directives at FSM 1923.12 and section 73.2 of FSH 1909.12, chapter 70 about the requirements for proposals resulting from wilderness studies not incorporated in land management plans, including legislatively mandated studies. The direction and guidance remains part of the amended directives in FSM 1923 and FSH 1909.12, chapter 70. Such a study could be directed by Congress. Boundaries for Potential Wilderness Areas *Comment:* The Forest Service should draw boundaries for roadless areas or potential wilderness areas to the edge of impact. Boundaries should be on a road, rather than buffered some distance back from the road. *Response:* The directive has been revised to specify that boundaries of areas being considered for the inventory of potential wilderness be at prominent natural or semi-permanent human-made features to help ease on-the-ground identification (FSH 1909.12, secs. 71.12 and 72.1). And, the directions state that boundaries of areas administratively recommended for wilderness designation may be adjusted. This includes setting boundary lines with a setback from features such as roads, trails, dams, powerlines, pipelines, and bridges. Such setback areas are frequently needed to provide for the operation, administration, and management of such features. Definition of Terms *Comment:* The Forest Service should clarify the meanings of the terms “road,” “unroaded,” and “roadless” as used in the Forest Service directives' wilderness review provisions. Old jeep trails and other routes that are no longer maintained should not be considered “improved” roads and their presence should not be used to exclude areas from the roadless inventory. *Response:* The term “unroaded” is not used in the final directive. The first step in the evaluation of potential wilderness areas is to identify and inventory all areas within National Forest System
(NFS)lands that satisfy the definition of wilderness found in section 2(c) of the Wilderness Act. Areas of potential wilderness identified in this process are called potential wilderness areas. The final amendment to the directive refers to forest roads using the new agency definition at Title 36, Code of Federal Regulations, Part 212—Administration of the Forest Transportation System, section 212.1. A forest road is defined as a road wholly or partly within or adjacent to and serving the NFS that the Forest Service determines is necessary for the protection, administration, and use of the NFS and the use and development of its resources. One of the criteria that must be met to include an area on the inventory is that it does not contain forest roads (36 CFR 212.1) or other permanently authorized roads, except as permitted in areas east of the 100th meridian. Areas To Be Evaluated *Concern:* The Forest Service directives should require that all areas be evaluated according to the criteria described in section 72.41 of its handbook, including those areas east of the 100th meridian. *Response:* The handbook guidance has been corrected at section 72.4 so that it applies to all areas evaluated for their wilderness potential. Overview of Changes to Content of Chapter 70—Wilderness Evaluation The final directive recodes the chapter (parent text) from a 1-digit chapter to a 2-digit chapter. Interim directive
(ID)1909.12-2005-8, ID 1909.12-2005-10, and ID 1909.12-2006-1 were issued using the 2-digit coding scheme. The final directive revises and updates the direction previously contained in the parent text. In addition, the final directive incorporates direction with adjustments made from comments on the Interim Directive 1909.12-2005-8 (ID). The digest contained within the final directive conveys the changes effected in agency policy and procedures. The major changes between the ID and the final directive are described below: Section 71, paragraph 1, of the final directive adds direction on the statutory definition of wilderness, and adds at paragraph 2 direction about the term “potential wilderness area” and explains what the identification and inventory of potential wilderness areas means. In addition paragraph 2, adds a sentence to clarify the difference in terminology between lands east and west of the 100th meridian. Paragraph 3 was added to recognize the uniqueness of each area and the use of local knowledge and judgment in the inventory process. In section 71.1, the introductory paragraph clarifies that areas qualify for placement on the inventory if they meet either criteria 1 and 3 or 2 and 3. In addition, the areas may have improvements if they meet the criteria in section 71.11, and for areas east of the 100 meridian they must also meet the criteria in 71.12. Clarifies the intent of enumerated paragraph 2, explaining that it is not necessary to meet all three criteria within paragraph 2. At paragraph 2, removes the terms “physiography or vegetation” and adds the term “physical terrain.” Revises enumerated paragraph 3, the third criterion concerning roads, from “they do not contain improved roads maintained for travel by standard passenger-type vehicles” * * * to “they do not contain forest roads (36 CFR 212.1) or other permanently authorized roads.” The term “forest roads” is defined by the new agency definition at Title 36, Code of Federal Regulations, Part 212—Administration of the Forest Transportation System, § 212.1. That is a “forest road” is a road wholly or partly within or adjacent to and serving the National Forest System
(NFS)lands that the Forest Service determines is necessary for the protection, administration, and use of the NFS and the use and development of its resources. Within section 71.12, changes the caption to “Criteria for Potential Wilderness East of the 100th Meridian.” The amendment incorporates direction on criteria for areas east of the 100th meridian (formerly in ID) with changes to the introductory paragraph, enumerated paragraph 5, and other editorial changes. At paragraph 1, the final directive clarifies that the criteria in section 71.12 are in addition to the criteria in sections 71.7 and 71.11. At enumerated paragraph 5, and revises the wording to be consistent with that at section 71.1 concerning forest roads. Within section 72.1 revises the principal wilderness characteristics from those described in the ID (environment, challenge, outdoor recreation opportunities, special features, manageability) to those described in the 1964 Wilderness Act:
(1)Natural;
(2)undeveloped;
(3)outstanding opportunities for solitude or primitive and unconfined recreation;
(4)special features and values; and
(5)manageability. At enumerated paragraph 5, incorporates wording from section 7.21 of parent text pertaining to how boundaries affect the manageability of an area (wording had been removed by the ID). However, at enumerated paragraph 5, did not incorporate the previously coded paragraph d (formerly in section 7.21 of parent text) about “boundaries acting as a shield.” Within section 73.3 removes the following unnecessary explanatory information on public hearings previously contained in the ID (formerly in section 7.33 of parent text): “Congress, in legislation subsequent to the Wilderness Act, has considered it necessary to expressly provide for public involvement by reference to section 3(d) of the original act. This section applied to those areas that, on the effective date of the Wilderness Act, were described as primitive. Therefore, there is no statutory requirement that review of selected areas that may have likelihood for wilderness designation comply with the public participation provisions of section 3(d) of the Act. However, the fact that Congress, in designating wilderness study areas, has required hearings does imply a desire for public participation in a hearing or some comparable proceeding, such as a public meeting, in order to obtain comment about wilderness recommendations while developing or revising a land management plan.” Other changes were made throughout the document for clarity. Regulatory Certifications Environmental Impact This final directive provides the detailed direction to agency employees necessary to carry out the provisions of the final 2005 planning rule adopted at 36 CFR part 219 governing land management planning. Section 31.12 of FSH 1909.15 (57 FR 43208; Sept. 18, 1992) excludes from documentation in an environmental assessment or impact statement “rules, regulations, or policies to establish Service-wide administrative procedures, program processes, or instructions.” The agency's conclusion is that this final directive falls within this category of actions and that no extraordinary circumstances exist as currently defined that require preparation of an environmental assessment or an environmental impact statement. Regulatory Impact This directive has been reviewed under USDA procedures. The final directive would not have an annual effect of $100 million or more on the economy nor adversely affect productivity, competition, jobs, the environment, public health or safety, nor state or local governments. The directive would not interfere with an action taken or planned by another agency nor raise new legal or policy issues. Finally, the directive would not alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients of such programs. Moreover, the directive has been considered in light of Executive Order 13272 regarding proper consideration of small entities and the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), which amended the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ). No direct or indirect financial impact on small businesses or other entities has been identified. Therefore, it is hereby certified that this final directive will not have a significant economic impact on a substantial number of small entities as defined by the act. No Takings Implications This final directive has been analyzed in accordance with the principles and criteria contained in Executive Order 12360, Governmental Actions and Interference with Constitutionally Protected Property Rights, and it has been determined that it would not pose the risk of a taking of private property as they are limited to the establishment of administrative procedures. Energy Effects This final directive has been analyzed under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. It has been determined that it does not constitute a significant energy action as defined in the Executive order. Civil Justice Reform This final directive has been reviewed under Executive Order 12988, Civil Justice Reform. This final directive will direct the work of Forest Service employees and is not intended to preempt any state and local laws and regulations that might be in conflict or that would impede full implementation of this directive. The directive would not retroactively affect existing permits, contracts, or other instruments authorizing the occupancy and use of National Forest System lands and would not require the institution of administrative proceedings before parties may file suit in court challenging its provisions. Unfunded Mandates Pursuant to Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538), which the President signed into law on March 22, 1995, the effects of this final directive on state, local, and tribal governments, and on the private sector have been assessed and do not compel the expenditure of $100 million or more by any state, local, or tribal government, or anyone in the private sector. Therefore, a statement under section 202 of the act is not required. Federalism The agency has considered this final directive under the requirements of Executive Order 13132, Federalism. The agency has made an assessment that the final directive conforms with the federalism principles set out in this Executive order; would not impose any significant compliance costs on the states; 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 responsibilities among the various levels of government. Moreover, this final directive addresses the land management planning process on national forests, grasslands, or other units of the National Forest System, which do not directly affect the states. Consultation and Coordination With Indian Tribal Governments This final directive does not have tribal implications as defined by Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, and therefore, advance consultation with tribes is not required. Controlling Paperwork Burdens on the Public This final directive does not contain any record keeping or reporting requirements or other information collection requirements as defined in 5 CFR part 1320 and, therefore, impose no paperwork burden on the public. Accordingly, the review provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ) and implementing regulations at 5 CFR part 1320 do not apply. Conclusion This final directive provides consistent interpretation of the 2005 planning rule for line and staff officers, and interdisciplinary teams. Therefore, the agency can fulfill its commitment to improve public involvement and decisionmaking associated with developing, amending, or revising a land management plan. The full text of this handbook is available on the World Wide Web at *http://www.fs.fed.us./im/directives* . Single paper copies are available upon request from the address and telephone numbers listed earlier in this notice as well as from the nearest regional office, the location of which are also available on the Washington Office headquarters homepage on the World Wide Web at *http://www.fs.fed.us* . Dated: December 21, 2006. Dale N. Bosworth, Chief, Forest Service. [FR Doc. E7-1554 Filed 1-30-07; 8:45 am] BILLING CODE 3410-11-P DEPARTMENT OF AGRICULTURE Forest Service Notice of New Fee Site; Federal Lands Recreation Enhancement Act, (Title VIII, Pub. L. 108-447) AGENCY: Chugach National Forest, USDA Forest Service. ACTION: Notice of New Fee Site. SUMMARY: The Chugach National Forest will begin charging a fee for the overnight use and occupancy of new campsites and a fee for rental of the new group use pavilion at the Childs Glacier Recreation Area. Projected fees will range from $10 to $30 per night for existing walk in and new campsites and $75 and $150 per day for the new group use pavilion. No Campgrounds currently exist on the Cordova Ranger District. The Childs Glacier Recreation Area redevelopment project, 2005-2006, will provide this new facility for public use. Funds from the rental will be used for the continued operation and maintenance of Childs Glacier Recreation Area. DATES: Childs Glacier Campground will become available for use August, 2007. ADDRESSES: Forest Supervisor, Chugach National Forest, 3301 “C” Street, Suite 300, Anchorage, AK 99503. FOR FURTHER INFORMATION CONTACT: Robert Behrends, Public Services Staff Officer, Cordova Ranger District, 907-424-4729. SUPPLEMENTARY INFORMATION: The Federal Recreation Lands Enhancement Act (Title VII, Pub. L. 108-447) directed the Secretary of Agriculture to publish a six month advance notice in the **Federal Register** whenever new recreation fee areas are established. Childs Glacier Recreation Area is located on the 700,000 acre Copper River Delta and is the most visited site on the Cordova Ranger District. The site is situated in a unique setting beside a large glacier where ice chunks frequently calve into the world renowned Copper River. Currently campground rental on the Chugach National Forest ranges from $10-$22 per night and $130 per day for pavilion rental. A projected range of fees from $10 to $30 per night for camping and $75 to $150 per day for the pavilion is both reasonable and acceptable for a new campground and group use facility providing a unique recreation experience in a dynamic setting in Alaska. Dated: January 24, 2007. Joe Meade, Chugach National Forest Supervisor. [FR Doc. 07-407 Filed 1-30-07; 8:45 am]
Connectionstraces to 57
Traces to 57 documents
CFR
- Gateway Incentive.§ 402.8
- Interpretation.§ 402.3
- New Business Incentive Program.§ 402.5
- Items subject to inspection.§ 1280.2
- Office of Government Information Services.§ 1253.7
- Cargo compartment classification.§ 25.857
- Cargo or baggage compartments.§ 25.855
- Oxygen and portable oxygen concentrators for medical use by passengers.§ 121.574
- Prevention of significant deterioration of air quality.§ 52.21
- Permit requirements.§ 51.165
- Prevention of significant deterioration of air quality.§ 51.166
- Public hearings.§ 51.102
- Purpose and applicability.§ 219.1
- Definition.§ 294.11
- Definitions.§ 212.1
U.S. Code
- Waiver of collection of charges or tolls§ 988a
- Functions of Corporation§ 983
- Administrative provisions§ 2104
- Definitions§ 601
- Establishment, functions, and activities§ 272
- Purposes§ 3501
- SHORT TITLE.§ 801
- EXPEDITED PROCESSING OF REQUESTS FOR JAPANESE IMPERIAL GOVERNMENT RECORDS.§ 804
- Congressional findings and declaration of purpose§ 7401
- Tolerances and exemptions for pesticide chemical residues§ 346a
- Definitions; generally§ 321
- Federal Communications Commission§ 154
- Discrimination against individuals with disabilities§ 41705
- Purpose§ 5101
- General requirements§ 44701
- General regulatory authority§ 5103
- Administrative§ 40113
- Judicial review§ 5127
- Preemption§ 5125
- Avoidance of duplicative or unnecessary analyses§ 605
- Mode of recovery§ 2461
- Final regulatory flexibility analysis§ 604
- Findings, purposes and policy§ 1801
- Definitions§ 601
- Congressional declaration of purpose§ 4321
- Transferred§ 450
- Additional inspection services§ 136
- SHORT TITLE.§ 9701
- National primary and secondary ambient air quality standards§ 7409
- Public information; agency rules, opinions, orders, records, and proceedings§ 552
- Repealed. Pub. L. 103–236, title I, § 162(a), Apr. 30, 1994, 108 Stat. 405§ 2658
- National Wilderness Preservation System§ 1131
- Extent of System§ 1132
60 references not yet in our index
- 33 CFR 402
- 49 USC 4321
- Pub. L. 104-4
- 109 Stat. 48
- 49 CFR 1.52
- 36 CFR 1280
- 40 CFR 52
- 40 CFR 180
- 40 CFR 178
- 40 CFR 2
- 40 CFR 166
- 40 CFR 180.242
- Pub. L. 104-113
- 47 CFR 73
- 14 CFR 25
- 49 CFR 175.8(a)(3)
- 49 CFR 173.201
- 49 CFR 173.302
- 49 CFR 175.10(b)
- 49 CFR 175.8(b)(1)
- 49 CFR 106.100
- 49 USC 5101-5127
- 42 USC 4321-4347
- 49 CFR 171
- 49 CFR 172
- 49 CFR 173
- 49 CFR 175
- 49 CFR 178
- 49 USC 5101-5128
- 49 CFR 1.45
- Pub. L. 101-410
- Pub. L. 104-134
- 49 CFR 1.53
- 49 CFR 1
- 50 CFR 648
- 50 CFR 648.160(f)(4)
- 50 CFR 660
- 9 CFR 94
- 9 CFR 92
- 9 CFR 92.2
+ 20 more
Citation graph
cites case law
Notices
Final rule
Cite33 CFR 402
Cite49 USC 4321
Pub. L.Pub. L. 104-4
Cites 117 · showing 12Cited by 0 across 0 sources