The National Poultry Improvement Plan (NPIP, also referred to below as “the Plan”) is a cooperative Federal-State-industry mechanism for controlling certain poultry diseases. The Plan consists of a variety of programs intended to prevent and control poultry diseases. Participation in all Plan programs is voluntary, but breeding flocks, hatcheries, and dealers must first qualify as “U.S. Pullorum-Typhoid Clean” as a condition for participating in the other Plan programs.

The Plan identifies States, flocks, hatcheries, dealers, and slaughter plants that meet certain disease control standards specified in the Plan's various programs. As a result, customers can buy poultry that has tested clean of certain diseases or that has been produced under disease-prevention conditions.

The regulations in 9 CFR parts 145, 146, and 147 (referred to below as the regulations) contain the provisions of the Plan. The Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA) amends these provisions from time to time to incorporate new scientific information and technologies within the Plan.

On September 20, 2010, we published in the Federal Register (75 FR 57200-57215, Docket No. APHIS-2009-0031) a proposal  1 to amend the Plan and its auxiliary provisions by providing new or modified sampling and testing procedures for Plan participants and participating flocks. The proposed changes were voted on and approved by the voting delegates at the Plan's 2008 National Plan Conference. These changes were intended to keep the provisions of the Plan current with changes in the poultry industry and provide for the use of new sampling and testing procedures.

We solicited comments concerning our proposal for 60 days ending November 19, 2010. We received three comments by that date. They were from a producer and two citizens. One commenter supported the proposed rule, and one did not raise any issues related to the proposed rule.

One commenter generally objected to our proposed addition of provisions under which a flock could be designated “ Salmonella negative” to the regulations in § 145.83(f) for the U.S. Salmonella Monitored classification for primary meat-type chicken breeding flocks. However, this commenter did not raise any specific concerns.

We continue to believe that the Salmonella negative designation will provide an effective means for flock owners to demonstrate their flocks' freedom from Salmonella based on regular testing. We are not making any changes to the proposed rule in response to this comment.

We are, however, amending the proposed provisions in paragraph (f) of § 145.83 to capitalize the word Salmonella each time it is used.

In addition, our proposed changes to paragraph (b) of § 145.14 indicated that the polymerase chain reaction (PCR)-based test is an official blood test for Mycoplasma gallisepticum, M. meleagridis, and M. synoviae. As the PCR-based test is not a blood test, we are changing proposed paragraph (b) to refer simply to official tests.

Finally, we are updating the footnote to the shoe cover sampling technique we proposed to add in § 147.12 to give the NPIP's current address. It has changed since the publication of the proposal. We are also updating the NPIP's address in the other footnotes to § 147.12 and the footnote to § 147.5.

Therefore, for the reasons given in the proposed rule and in this document, we are adopting the proposed rule as a final rule, with the changes discussed in this document.

This final 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.

In accordance with the Regulatory Flexibility Act, we have analyzed the potential economic effects of this action on small entities. The analysis is summarized below. Copies of the full analysis are available on the Regulations.gov Web site (see footnote 1 in this document for a link to Regulations.gov) or by contacting the person listed under FOR FURTHER INFORMATION CONTACT .

This rule will introduce a set of minor changes to the NPIP and will not involve significant changes in program operations. These changes are in line with the industry's best practices and would likely involve no additional costs in order to meet these requirements. Additionally, the NPIP is a voluntary program established between the industry and State and Federal governments. Any person producing or dealing in products may participate in the NPIP when he or she has demonstrated that his or her facilities, personnel, and practices are adequate for carrying out the applicable provisions of the NPIP. NPIP participation allows for greater ease in moving hatching eggs/live birds within a State, across State lines, and into other countries. Most countries will not accept hatching eggs/live birds and commercial poultry from a U.S. operation unless it can be shown to be a NPIP participant. The poultry industry plays a very important role in the U.S. economy, and these amendments will help to ensure the safety of the industry and benefit the economy.

Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action will not have a significant economic impact on a substantial number of small entities.

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.)

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Has no retroactive effect; and (2) does not require administrative proceedings before parties may file suit in court challenging this rule.

This final rule contains no new information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

Accordingly, we are amending 9 CFR parts 56, 145, 146, and 147 as follows:

Commercial table-egg layer pullet flock. A table-egg layer flock prior to the onset of egg production.

On March 2, 2007, Jet Aviation Engineering Services L.P. (JAES), of Teterboro, New Jersey, applied for a supplemental type certificate for a reconfiguration of an aircraft interior in a 747-468. The Boeing Model 747-468 airplane is FAA approved under Type Certificate A20WE as a large transport-category airplane that is limited to 660 passengers or fewer, depending on the interior configuration.

This modification includes the installation of a medical lift between the main deck and upper deck. The lift allows the transport of a single occupant between the decks during cruise or ramp operations. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature.

Under the provisions of Title 14, Code of Federal Regulations (14 CFR) 21.101, JAES must show that the 747-468, as changed, continues to meet the applicable provisions of the regulations incorporated by reference in Type Certificate A20WE, or of the applicable regulations in effect on the date of application for the change. The regulations incorporated by reference in the type certificate are commonly referred to as the “original type-certification basis.” The regulations incorporated by reference in Type Certificate A20WE are as follows:

• Part 36, as amended by Amendments 36-1 through 36-15, and any later amendments in existence at the time of certification.

• Special Federal Aviation Regulation (SFAR) 27, as amended by Amendments 27-1 through 27-6 and any later amendments in existence at the time of type certification.

• Part 25, effective February 1, 1965, as amended by Amendments 25-1 through 25-59, and the part 25 section-number exceptions itemized in Type Certificate A20WE.

The following special conditions, exemptions, and equivalent safety findings, which are part of the Model 747-300 certification basis, are also part of the certification basis for the Model 747-400.

The special conditions include those enclosed with an FAA letter to The Boeing Company dated February 20, 1970, and the following:

1. Special Condition 4A, revised to apply to airplanes with the landing-gear load-evener system deleted, was recorded as an enclosure to an FAA letter to The Boeing Company dated May 12, 1971.

2. Special Condition No. 25-61-NW-1, for occupancy not to exceed 32 passengers on the upper deck of airplanes with a spiral staircase, was transmitted to The Boeing Company by FAA letter dated February 26, 1975.

3. Special Condition No. 25-71-NW-3, for occupancy not to exceed 45 passengers on the upper deck of airplanes with a straight-segmented stairway, was transmitted to The Boeing Company by FAA letter dated September 8, 1976.

4. Modification of Special Condition No. 25-71-NW-3, for occupancy not to exceed 110 passengers on the upper deck of airplanes with a straight-segmented stairway, was transmitted to The Boeing Company by FAA letter dated August 3, 1981.

5. Special Condition No. 25-77-NW-4, modification of the autopilot system to approve the airplane for use of the system under Category IIIb landing conditions, was transmitted to The Boeing Company by FAA letter dated July 8, 1977.

6. Special Condition No. 25-ANM-16, for use of an overhead crew-rest area, occupancy not to exceed ten crewmembers, was transmitted to The Boeing Company by FAA letter dated November 19, 1987. The FAA-approved procedures required for compliance with paragraph 13 of the special condition are located in Boeing Document D926U303, Appendix D.

7. Special Condition no. 25-ANM-24, applicable to flight-deck displays and propulsion-control systems, was provided to Boeing on December 22, 1988.

8. Special Condition No. 25-ANM-25, which established lightning- and radio-frequency-energy protection requirements, was provided to Boeing on December 22, 1988.

Exemption no. 1013A, dated December 24, 1969: Exemption from Section 25.471(b) to allow lateral displacement of the center of gravity from the airplane centerline.

The following optional requirements, which are part of the Model 747-300 certification basis, apply also to the 747-400:

The following equivalent-safety findings, previously made for earlier models under the provisions of § 21.21(b)(1), are also applicable to the Model 747-400:

If the Administrator finds that the applicable airworthiness regulations ( i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for the 747-468 because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

In addition to the applicable airworthiness regulations and special conditions, the 747-468 must comply with the fuel-vent and exhaust-emission requirements of 14 CFR part 34, and the noise certification requirements of 14 CFR part 36.

The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type-certification basis under § 21.101.

Special conditions are initially applicable to the model for which they are issued. Should the applicant apply for a supplemental type certificate to modify any other model included on the same type certificate to incorporate the same or similar novel or unusual design feature, the special conditions would also apply to the other model under § 21.101.

The original aircraft configuration included a straight stairway between the main deck and upper deck at Fuselage Station 870. The stairway is relocated in the new configuration, and the existing stairway is replaced with an electrically powered medical lift using the opening in the upper deck formerly occupied by the stairs. When the lift is not in operation, the upper-deck opening is covered by floor panels. These floor panels are opened up prior to operation of the lift and form a protective fencing around the upper-deck opening.

The purpose of the medical lift is to move an occupant between the master lounge in the upper deck and the medical room on the lower deck.

The lift platform is driven by two redundant electrical motors, mounted to the rear wall, between the struts. A lifting gear-drive with shafts and gear boxes is powered on the front and rear of the lift platform. The spindles are supported at the lifting gear on the lower support structure and with a strut support on the upper deck. The lift platform is guided in lateral directions with the guiding rails mounted on the struts.

Due to the novel or unusual features associated with the installation of this medical lift, the following special conditions are considered necessary to provide a level of safety equal to that established by the airworthiness regulations incorporated by reference in the type-certificate.

Notice of proposed special conditions no. 25-99-11-SC for the Boeing Model 747-468 airplane was published in the Federal Register on May 18, 2010 (75 FR 27662). No public comments were received and the special conditions are adopted as proposed.

After the public-comment deadline on June 17, 2010, the FAA added text referenced in Note 1 in Table 2, and added special conditions 14e and f, and additional text to special condition 15a. The FAA has determined that this additional information enhances, and does not compromise, safety; does not materially affect the intent of the special conditions upon which the pubic had opportunity to comment; and therefore does not warrant a second public-comment period.

As discussed above, these special conditions are applicable to the 747-468. Should JAES apply at a later date for a supplemental type certificate to modify any other model included on Type Certificate A20WE, to incorporate the same novel or unusual design feature, the special conditions would apply to that model as well.

This action affects only certain novel or unusual design features on one model of airplanes. It is not a rule of general applicability and it affects only the applicant who applied to the FAA for approval of these features on the airplane.

The authority citation for these special conditions is as follows:

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an airworthiness directive (AD) that would apply to the specified products. That NPRM published in the Federal Register on December 23, 2010 (75 FR 80742). That NPRM proposed to require repetitive inspections for cracking of the left and right upper center skin panels of the horizontal stabilizer, and corrective action if necessary.

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public.

We have revised the applicability of the existing AD to identify model designations as published in the most recent type certificate data sheet for the affected models.

We reviewed the relevant data, and determined that air safety and the public interest require adopting the AD with the change described previously. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

We also determined that these changes will not increase the economic burden on any operator or increase the scope of the AD.

We estimate that this AD affects 19 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

We estimate the following costs to do any necessary repairs that would be required based on the results of the inspection. We have no way of determining the number of aircraft that might need these repairs.

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

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

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

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

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

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

(3) Will not affect intrastate aviation in Alaska, and

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

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA AD No. 2010-0088-E, dated May 6, 2010, to correct an unsafe condition for the Model EC130 B4 helicopters. EASA advises that an uncontrolled in-flight deployment of the emergency flotation gear (not armed) on an EC130 B4 helicopter has been reported. The flight crew heard a detonation followed by heavy vibrations and noticed the emergency flotation gear floats were inflating. Investigations on the emergency flotation gear control system revealed that a wire was damaged inside the 1G unit. This wire was damaged, due to interference with the screw securing cable 1GR19E lug to the bus bar, causing a short circuit in the emergency flotation gear deployment activation circuit and the consequent deployment of the emergency flotation gear. EASA further states the possibility of interference of the 1G unit's internal wire harnesses with a fuselage metal structure member (stringer) has been identified, which could have the same consequences.

Eurocopter has issued Emergency Alert Service Bulletin No. 25A037, dated April 27, 2010, for the Model EC130 B4 helicopters, which specifies inspecting 1G units without an “*” displayed on the 1G unit panel after the part number (P/N) and taking various corrective actions at various times pending installation of a conforming 1G unit. EASA classified this EASB as mandatory and issued AD No. 2010-0088-E, dated May 6, 2010, to ensure the continued airworthiness of these helicopters.

This helicopter has been approved by the aviation authority of France and is approved for operation in the United States. Pursuant to our bilateral agreement with France, EASA, their technical representative, has notified us of the unsafe condition described in the MCAI AD. We are issuing this AD because we evaluated all information provided by EASA and determined the unsafe condition exists and is likely to exist or develop on other helicopters of this same type design.

This AD does not require the actions to be completed at the compliance times of 3 months and 8 months, nor does it require the repetitive actions specified in the EASA AD. This AD requires the actions to be done within 15 hours time-in-service (TIS). Also, this AD refers to flight hours as hours TIS.

This unsafe condition is likely to exist or develop on other helicopters of the same type design. Therefore, this AD is being issued to prevent an uncommanded in-flight deployment of the emergency flotation gear, unexpected deceleration and pitch down movement of the helicopter, and subsequent loss of control of the helicopter.

This AD requires determining if the 1G unit has an asterisk after the P/N displayed on the 1G unit panel. If an asterisk follows the P/N, the AD requires inspecting for a rubber extrusion installed on the stringer. If no rubber extrusion is installed on the stringer, the AD requires removing the 1G unit, bonding a rubber extrusion on the stringer, reinstalling the 1G unit, and functionally testing the emergency flotation gear control system. If no asterisk follows the P/N, the AD requires removing the 1G unit and inspecting the 1G unit for interference between the harness wires and the stringer and between internal parts. Also, the AD requires if no rubber extrusion is installed on the stringer, protecting the stringer by bonding a rubber extrusion on the stringer. The AD also requires inspecting for interference between the attachment screw and the wires of the nearby harness and for damage to the wires of the harness. The AD also requires modifying the 1G unit as necessary to protect the 1G unit from interference. Also, the AD requires identifying the modified 1G unit by marking an asterisk after the P/N. The AD also requires reinstalling and functionally testing the 1G unit. Installing a conforming 1G unit is terminating action for the requirements of this AD. Do the actions by following specified portions of the service bulletin described previously.

The short compliance time involved is required because the previously described critical unsafe condition can adversely affect the controllability of the helicopter. This AD requires, within 15 hours TIS, determining whether a conforming 1G unit is installed, and if not, modifying the 1G unit within 15 hours TIS. Fifteen hours TIS is a very short compliance time; therefore, this AD must be issued immediately.

Since a situation exists that requires the immediate adoption of this regulation, it is found that notice and opportunity for prior public comment hereon are impracticable, and that good cause exists for making this amendment effective in less than 30 days.

We estimate that this AD will affect about 119 helicopters of U.S. registry. Determining whether an asterisk is present on the 1G unit panel will require a minimal amount of time. We estimate that it will take about 8 work-hours per helicopter to remove, modify, and replace a 1G unit. The average labor rate is $85 per work-hour. Required parts will cost about $25 per helicopter. Based on these figures, we estimate the cost of this AD on U.S. operators is $8,460, assuming 12 helicopters will require modification of the 1G unit per this AD.

This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES . Include “Docket No. FAA-2011-0212; Directorate Identifier 2010-SW-055-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD because of those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact with FAA personnel concerning this AD. Using the search function of the docket Web site, you can find and read the comments to any of our dockets, including the name of the individual who sent the comment. You may review the DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477-78).

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

For the reasons discussed above, I certify that the regulation:

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

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

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

We prepared an economic evaluation of the estimated costs to comply with this AD. See the AD docket to examine the economic evaluation.

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

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

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on December 1, 2010 (75 FR 74665), and proposed to supersede AD 2009-11-09, Amendment 39-15919 (74 FR 25399, May 28, 2009). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

Since issuance of the NPRM, Airbus has issued Mandatory Service Bulletin A310-25-2205, Revision 01, dated November 19, 2010. This revision does not require any additional work. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI. We have updated this final rule to refer to Airbus Mandatory Service Bulletin A310-25-2205, Revision 01, dated November 19, 2010. We added a new paragraph (n) of this AD to provide credit for doing actions before the effective date of this AD in accordance with Airbus Mandatory Service Bulletin A310-25-2205, dated August 31, 2009, for Airbus Model A310 series airplanes.

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public.

We reviewed the available data, and determined that air safety and the public interest require adopting the AD with the changes described previously. We determined that these changes will not increase the economic burden on any operator or increase the scope of the AD.

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

We might also have required different actions in this AD from those in the MCAI in order to follow our FAA policies. Any such differences are highlighted in a NOTE within the AD.

Based on the service information, we estimate that this AD affects about 132 products of U.S. registry.

The actions that are required by AD 2009-11-09 and retained in this AD take about 2 work-hours per product, at an average labor rate of $85 per work hour. Based on these figures, the estimated cost of the currently required actions is $170 per product.

We estimate that it would take about 2 work-hours per product to comply with the new basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts would cost about $5,000 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these costs. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of the AD on U.S. operators to be $704,880, or $5,340 per product.

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

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

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

For the reasons discussed above, I certify this AD:

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

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

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

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

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that supersedes AD 2007-18-52, Amendment 39-15197 (72 FR 53928, September 21, 2007). The existing AD applies to all Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes. That NPRM was published in the Federal Register on January 11, 2010 (75 FR 1297). That NPRM proposed to require repetitive detailed inspections of the slat track downstop assemblies to verify that proper hardware is installed, one-time torquing of the nut and bolt, and corrective actions if necessary. That NPRM also proposed to require replacing the hardware of the downstop assembly with new hardware of the downstop assembly, doing a detailed inspection or a borescope inspection of the slat cans on each wing and the lower rail of the slat main tracks for debris, replacing the bolts of the aft side guide with new bolts, and removing any debris found in the slat can. That NPRM proposed to remove airplanes from the applicability of the existing AD.

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

Boeing requested that the NPRM refer to Boeing Service Bulletin 737-57A1302, Revision 1. Boeing stated that Revision 1 of this service bulletin will be forwarded to the FAA for approval.

We agree with Boeing's request to refer to Boeing Service Bulletin 737-57A1302, Revision 1, dated October 18, 2010. Revision 1 of this service bulletin has been published and made available to operators. There are no new actions in Boeing Service Bulletin 737-57A1302, Revision 1, dated October 18, 2010. We have revised paragraph (i) of this AD to add a reference to this service bulletin.

Air Transport Association (ATA), on behalf of its member airline American Airlines (AAL), expressed concern about the lack of optional manufacturer part numbers, and/or optional specifications concerning the parts specified in the NPRM. AAL stated that part interchangeability is allowed for airplanes with the same design that are not affected by the NPRM. AAL gave four examples:

• The NPRM allows only bolt part number (P/N) BACB30NR7DK12, but bolt P/N BACB30NR7DK12 has an optional part P/N 114A4102-19, that can be used on airplanes unaffected by the NPRM.

• The NPRM specifies retaining pin P/N BACP18BC03A06P only, but per Boeing part data, P/N MS24665-300 is fully interchangeable with P/N BACP18BC03A06P.

• The NPRM specifies to use lockwire P/N MS20995NC32 only, but for airplanes unaffected by the AD, the use of cable assembly P/N BACC13AT4K6 is allowed.

• Boeing Drawing 65-88700 allows the use of P/N MS20995C32 and P/N MS20995N32 in lieu of P/N MS20995NC32.

AAL stated that the intent of the NPRM is not to restrict parts to specific manufacturer part numbers when optional parts are readily available. AAL stated that similar airplanes unaffected by the AD with the same design allow for greater part equivalent/substitution options. AAL requested that the FAA, in an effort to assist the operator for compliance, include optional parts in the NPRM, or provide a global AMOC for acceptable substitutes per Boeing Drawing 65-88700, which is an acceptable specification interchangeability, or part substitution per Boeing Drawing D-590.

We partially agree with AAL's request that optional parts be allowed for installation. The alternative lockwire part proposed by AAL has already been approved as an AMOC for those operators who have made the request to the FAA. Boeing has not requested approval of a global AMOC for all operators. We have revised paragraph (i) of this AD to specify that installation of stainless steel lockwire, P/N MS20995C32, is acceptable for compliance with this AD.

We disagree with AAL regarding use of the alternative bolt and cotter pin. The alternative bolt was never produced and could be removed from the Boeing drawing system in the future. The alternative cotter pin proposed by AAL may require the use of special tooling for installation on in-service airplanes. The cotter pin specified in Boeing Alert Service Bulletin 737-57A1302, dated December 15, 2008; and Boeing Service Bulletin 737-57A1302, Revision 1, dated October 18, 2010; requires the use of a special tool designed to facilitate the installation by the operators. Until an alternative cotter pin and tooling are validated for use in maintenance facilities (as opposed to the manufacturing environment), the proposed AMOC by AAL cannot be approved. If AAL obtains additional data to support such a request, it may apply for approval of an AMOC in accordance with the provisions specified in paragraph (j) of this AD.

We disagree with AAL's request to approve the use of substitutions provided in Boeing Drawing 65-88700 or Drawing D-590. Boeing did not provide us with information to ensure that these parts adequately address the unsafe condition. In addition, Boeing has not requested approval of a global AMOC for all operators. However, operators may apply for approval of an AMOC in accordance with the provisions specified in paragraph (j) of this AD.

ATA, on behalf of its member airline AAL, expressed concern with requiring an AMOC for repair of a hole larger than 0.5005 inch in the slat main track as stated in the NPRM. AAL requested that the FAA clarify the boundaries of the AMOC track repair requirements and the method to identify the AMOC repaired tracks. AAL stated that the flap tracks are fully removable from the slat and are fully interchangeable with airplanes unaffected by the AD. AAL stated that the tracks do not have unique identifiers ( i.e., no serial numbers) marked on the track. AAL stated that the requirement may also be interpreted as, for Boeing Alert Service Bulletin 737-57A1302, dated December 15, 2008, listed aircraft, repairs to the downstop hole (when greater than 0.5005 inch) of a slat main track performed at any time during the life of the part would require an AMOC.

We provide the following clarifications.

For clarification of the AMOC track repair requirements, the AD requires that any time the fastener hole in an affected slat can is oversized to greater than 0.5005 inch, the track must be replaced in accordance with Boeing Alert Service Bulletin 737-57A1302, dated December 15, 2008; Boeing Service Bulletin 737-57A1302, Revision 1, dated October 18, 2010; or repaired in accordance with paragraph (j) of this AD. AMOCs can be approved for airplanes included in the AD applicability. AMOCs are not applicable to airplanes outside the AD even if AD-related parts are rotated onto them. We have not changed the AD in this regard.

For clarification, the method to identify the AMOC-repaired tracks, including the tracking of affected parts, is a requirement under Parts 39, 121, and 43 of the Federal Aviation Regulations (14 CFR 39, 121, and 43). Under these parts, each airline may develop its own unique methodology to accomplish this activity per the procedures approved in its operation specification. We have not changed the AD in this regard.

ATA, on behalf of its member airline AAL, recommended re-evaluating the impact of an out-of-spec hole (hole larger than 0.5005 inch in the slat main track), and recommended the FAA gather additional information from operators concerning the out-of-spec hole issue.

We disagree with AAL's recommendation. The proposal to provide and gather operator data should be proposed to the manufacturer. Once additional data are evaluated by technical specialists, operators may request approval of an AMOC in accordance with the provisions specified in paragraph (j) of this AD based on the new recommendation.

ATA, on behalf of its member airline AAL, expressed concern with the bushing repair of the slat main track in accordance with Boeing Alert Service Bulletin 737-57A1302, dated December 15, 2008. AAL stated that in an effort to ensure compliance with the NPRM, this repair may need to be referenced in the appropriate CMM section to provide the reference to the source of the repair data.

From these statements, we infer that AAL is requesting that the bushing repair provided in Boeing Alert Service Bulletin 737-57A1302, dated December 15, 2008; and Boeing Service Bulletin 737-57A1302, Revision 1, dated October 18, 2010; be referenced in the appropriate CMM. We do not agree with this request. CMMs are not regulated by the FAA, and Boeing does not provide us with information to ensure that these documents remain unchanged and thus adequately address the unsafe condition. We have not changed the AD in this regard.

ATA, on behalf of its member airline AAL, expressed concern regarding the requirements in Boeing Alert Service Bulletin 737-57A1302, dated December 15, 2008, as proposed in the NPRM. AAL stated that the NPRM may be misinterpreted in that “all steps” of that service bulletin must be complied with. AAL requested that the AD be clarified and highlighted to explain only those specific sections of that service bulletin that are affected by the NPRM.

AAL stated that panel open/close procedures and access procedures (slat extension/retraction) should not affect the compliance with the NPRM. AAL also stated that the actuator disconnection/reconnection and slat removal/installation also should not affect compliance with the NPRM. AAL stated that clarification may be made with the following statement: “Only the service bulletin procedures specified by the AD are affected by the AD. Other procedures described by the service bulletin not specified by the AD are not affected by FAA AD compliance requirements.”

We partially agree with AAL's request to clarify and highlight only specific sections of Boeing Alert Service Bulletin 737-57A1302, dated December 15, 2008; and Boeing Service Bulletin 737-57A1302, Revision 1, dated October 18, 2010; that are affected by the AD. For clarification, the manufacturer revises service bulletins, not the FAA. When the words “refer to” are used in Boeing Alert Service Bulletin 737-57A1302, dated December 15, 2008; or Boeing Service Bulletin 737-57A1302, Revision 1, dated October 18, 2010; and the operator has an accepted alternative procedure, the accepted alternative procedure may be used. However, we have changed paragraph (i) of this AD to delete reference to the access and close sections of the Accomplishment Instructions of Boeing Alert Service Bulletin 737-57A1302, dated December 15, 2008; this AD now requires that the actions be accomplished in accordance with Part 2 of the Accomplishment Instructions of Boeing Alert Service Bulletin 737-57A1302, dated December 15, 2008; or Boeing Service Bulletin 737-57A1302, Revision 1, dated October 18, 2010.

ATA, on behalf of its member airline AAL, stated that Boeing issued Service Bulletin Information Notice (IN) 737-57A1302 IN 01, dated February 25, 2009, to Boeing Alert Service Bulletin 737-57A1302, dated December 15, 2008. AAL stated that Boeing Service Bulletin IN 737-57A1302 IN 01 provides additional instructions to install the guide bolts and reassemble the track downstop hole. AAL stated that Boeing Service Bulletin IN 737-57A1302 IN 01 also provides additional instructions for access and panel reinstallation. AAL requested that Boeing Service Bulletin IN 737-57A1302 IN 01 be approved as a global AMOC, or be incorporated as an option into the AD requirements to allow the operator to use the best practices to accomplish the job.

We do not agree with this request. We note that a global AMOC already has been approved under FAA Letter 120S-09-528, dated September 16, 2009, for Boeing Service Bulletin IN 737-57A1302 IN 01, dated February 25, 2009, and paragraph (i) of this AD has been revised to include reference to Boeing Service Bulletin 737-57A1302, Revision 1, dated October 18, 2010, which includes the information provided in that information notice. AAL may request a copy of this global AMOC from Boeing.

ATA, on behalf of its member airline AAL, expressed concern that a validation program was not performed on Boeing Alert Service Bulletin 737-57A1302, dated December 15, 2008, to ensure that data, instructions, and processes specified in that service bulletin are correct, clear, appropriate, and understood by maintenance personnel performing the work.

From this statement we infer that AAL is requesting that validation of the instructions in Boeing Alert Service Bulletin 737-57A1302, dated December 15, 2008, be accomplished. We partially agree with AAL's request. We have confirmed that validation of Boeing Alert Service Bulletin 737-57A1302, dated December 15, 2008, was completed in December 2009. Operators may obtain further details of the validation from Boeing. We have not changed the AD in this regard.

ATA, on behalf of its member airline AAL, stated that there are no steps in Boeing Alert Service Bulletin 737-57A1302, dated December 15, 2008, to install the slat can, if removed, in accordance with Part 2 of the Accomplishment Instructions of Boeing Alert Service Bulletin 737-57A1302, dated December 15, 2008. AAL requested that to ensure compliance with the AD, a step, “If removed, install slat, refer to AMM 27-81-21,” be included in Boeing Alert Service Bulletin 737-57A1302, dated December 15, 2008, in the appropriate location.

AAL also stated that there is no procedure referenced in Boeing Alert Service Bulletin 737-57A1302, dated December 15, 2008, to reinstall the access panels removed from the lower leading edge of the wing. AAL stated that to ensure compliance with the AD, a step, “reinstall the panels that were removed from the lower leading edge of the wing, refer to AMM 27-81-21,” be included in Boeing Alert Service Bulletin 737-57A1302, dated December 15, 2008, in the appropriate location.

We disagree with AAL's request. For clarification, the manufacturer, not the FAA, revises service bulletins. Part 3.B.3.b. of the Accomplishment Instructions of Boeing Alert Service Bulletin 737-57A1302, dated December 15, 2008; and Boeing Service Bulletin 737-57A1302, Revision 1, dated October 18, 2010; specify that the airplane be returned “to a serviceable condition,” and accomplishment of this step would require reinstallation of any components that were removed from the airplane. When the words “refer to” are used in Boeing Alert Service Bulletin 737-57A1302, dated December 15, 2008; and Boeing Service Bulletin 737-57A1302, Revision 1, dated October 18, 2010; and the operator has an accepted alternative procedure, the accepted alternative procedure can be used to accomplish reinstalling the slat can assembly and access panels. Boeing Service Bulletin 737-57A1302, Revision 1, dated October 18, 2010, does include new phrasing similar to that requested by AAL. We have not changed this AD in this regard.

ATA, on behalf of its member airline AAL, expressed concern with the measurement requirements of the slat track hole diameter. AAL requested that Boeing and/or the FAA provide an optional requirement to this AD, or a global AMOC, to allow use of a “no-go” type gauge or similar device and the associated procedure to establish hole size. AAL also requested providing an additional (initial) procedure consistent with using common maintenance measurement tools to better allow the operator to comply with these requirements. AAL stated that Boeing Alert Service Bulletin 737-57A1302, dated December 15, 2008, states that if the bolt has side-to-side play in the hole, then measure the hole. AAL stated that the allowable measurement is four decimal places of accuracy (0.XXXX). AAL stated that this dimension is in Boeing Assembly Drawing 114A7511 specification for the purpose of manufacturing the part in a machine shop setting. AAL also stated that since this task is intended to be accomplished on wing, or slat removed (on bench) in a dock maintenance setting, it is not practical and may not be feasible to require measurement within four decimal places. AAL stated that the methods to machine to four decimal place accuracy are different from the requirement to measure to four decimal place accuracy. AAL stated that typical tools used in a maintenance setting would be a ball/T gauge, micrometer, and a vernier caliper in certain situations (hole not near minimum/maximum limits). AAL also stated that using these tools on the wing could result in inaccuracy due to the difficulty of the measuring location and the access to the location.

We disagree with AAL's requests to provide an optional requirement to this AD or a global AMOC to allow the use of a “no-go” type gauge or similar device and the associated procedure to establish hole size. We also disagree with AAL to add a procedure using common maintenance measurement tools.

Boeing Alert Service Bulletin 737-57A1302, dated December 15, 2008; Boeing Service Bulletin 737-57A1302, Revision 1, dated October 18, 2010; nor this AD; specify which tools are to be used to measure the hole size. In the absence of specific instructions on how to perform a maintenance task, operators have the discretion of developing their own procedures to enable their maintenance personnel to meet the requirements of this AD. In addition, it is the intent of this AD that the operators develop their own procedures to perform a routine maintenance task, such as drilling the close ream hole. Operators are referred to the manufacturer's maintenance procedures, which are published in formats such as the structural repair manual, the standard overhaul practices manual, component maintenance manuals, and other available resources. For further instruction, these maintenance procedures are best obtained from these resources. We have not changed the AD in this regard.

We have revised the applicability of the existing AD to identify model designations as published in the most recent type certificate data sheet for the affected models.

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

Since issuance of the NPRM, we have increased the labor rate used in the Costs of Compliance from $80 per work-hour to $85 per work-hour. The Costs of Compliance information, below, reflects this increase in the specified hourly labor rate.

There are about 2,699 airplanes of the affected design in the worldwide fleet. The following table provides the estimated costs for U.S. operators to comply with this AD.

We issued a supplemental notice of proposed rulemaking (SNPRM) to amend 14 CFR part 39 to include an airworthiness directive (AD) that would apply to the specified products. That SNPRM published in the Federal Register on November 19, 2010 (75 FR 70863). That SNPRM proposed to require measuring the electrical bond resistance between the motor operated valve (MOV) actuators and airplane structure for the main, center, auxiliary, and horizontal stabilizer fuel tanks, as applicable, and corrective action if necessary; revising the maintenance program to incorporate airworthiness limitation (AWL) No. 28-AWL-21 or AWL No. 28-AWL-27, as applicable; and replacing production-installed laminate phenolic spacers with metallic spacers between the fuel jettison MOV and the airplane structure, as applicable.

Since the supplemental NPRM was issued, Boeing issued Service Bulletin 747-28A2292, Revision 3, dated December 9, 2010. The changes described in this service bulletin are minor and editorial in nature. Paragraphs (c) and (g) of this AD have been revised to refer to Revision 3 of this service bulletin. In addition, credit for accomplishing the actions in Boeing Service Bulletin 747-28A2292, Revision 2, dated May 13, 2010, has been included in paragraph (o) of this AD.

We gave the public the opportunity to participate in developing this AD. We have considered the comment received. Boeing supports the NPRM.

We reviewed the relevant data, considered the comment received, and determined that air safety and the public interest require adopting the AD as proposed—except for the changes that were described above. We have determined that these changes:

• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

We estimate that this AD affects 222 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

We estimate the following costs to do any necessary modification that would be required based on the results of the proposed inspection. We have no way of determining the number of aircraft that might need this modification.

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

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

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

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

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

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

(3) Will not affect intrastate aviation in Alaska, and

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

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on January 21, 2011 (76 FR 3854), and proposed to supersede AD 2007-02-12, Amendment 39-14899 (72 FR 3047, January 24, 2007). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states that:

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public.

We reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed.

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

We might also have required different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are highlighted in a NOTE within the AD.

We estimate that this AD will affect 7 products of U.S. registry. We also estimate that it will take about 11 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $750 per product.

Based on these figures, we estimate the cost of this AD to the U.S. operators to be $11,795 or $1,685 per product.

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

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

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

For the reasons discussed above, I certify this AD:

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

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

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

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

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on December 21, 2010 (75 FR 79990). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public.

We reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed.

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

We might also have required different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are highlighted in a NOTE within the AD.

We estimate that this AD will affect 135 products of U.S. registry. We also estimate that it will take about 2 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $10,000 per product.

Based on these figures, we estimate the cost of this AD to the U.S. operators to be $1,372,950 or $10,170 per product.

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

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

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

For the reasons discussed above, I certify this AD:

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

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

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

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

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on August 5, 2010 (75 FR 47249). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

We have received Bombardier Service Bulletin 601R-24-128, Revision C, dated May 14, 2010. In the NPRM we referred to Bombardier Service Bulletin 601R-24-128, Revision A, dated November 27, 2009, as the source of service information for doing the required actions on certain models affected by this AD. Revision C of that service bulletin makes certain editorial changes. We have revised paragraph (g)(1) of this AD to specify Revision C of that service bulletin, and revised paragraph (h) of this AD to give credit for having done Bombardier Service Bulletin 601R-24-128, Revision A, dated November 27, 2009, and Revision B, dated April 16, 2010, prior to the effective date of this AD.

We gave the public the opportunity to participate in developing this AD. We considered the comment received.

Air Line Pilots Association, International (ALPA) requested that the compliance time of 72 months be reduced to 36 months, because the corrective action only requires 8 work-hours to complete and ALPA believes that 72 months is too long to comply with the AD based on the importance of this modification.

We do not agree with the request for a shorter compliance time. In developing the compliance time, we determined that the compliance time of 72 months or 6,000 flight hours, whichever occurs first, is appropriate in consideration of the safety implications, the average utilization rate of the affected fleet, the practical aspects of an orderly inspection of the fleet during regular maintenance periods, and the availability of required modification parts. In addition, our compliance time corresponds with the 72-month compliance time of the parallel AD issued by Transport Canada Civil Aviation (TCCA). We have not changed the AD in this regard.

We received notice from Bombardier, Inc. and TCCA that certain airplanes identified in the NPRM have had the actions specified by this AD already incorporated in production, and therefore are not affected by the identified unsafe condition. Specifically, Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes, serial numbers 8108 through 8111 have had the actions incorporated. We have reduced the applicability in paragraph (c)(1) of this AD accordingly.

We reviewed the available data, including the comment received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We determined that these changes will not increase the economic burden on any operator or increase the scope of the AD.

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

We might also have required different actions in this AD from those in the MCAI in order to follow our FAA policies. Any such differences are highlighted in a NOTE within the AD.

We estimate that this AD will affect 920 products of U.S. registry. We also estimate that it will take 8 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $1,881 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these parts. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $2,356,120, or $2,561 per product.

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

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

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

For the reasons discussed above, I certify this AD:

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

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

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

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

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

On January 14, 2011, the FAA published in the Federal Register a notice of proposed rulemaking to amend Class E airspace at Pueblo, CO (76 FR 2609). Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.9U dated August 18, 2010, and effective September 15, 2010, which is incorporated by reference in 14 CFR Part 71.1. The Class E airspace designations listed in this document will be published subsequently in that Order.

This action amends Title 14 Code of Federal Regulations (14 CFR) Part 71 by amending Class E airspace extending upward from 700 feet above the surface, at Pueblo Memorial Airport, to accommodate en route IFR aircraft at Pueblo Memorial Airport. The southern boundary of the 13,700 foot mean sea level section has a small gap of airspace associated with V-83-210 leaving over a .5 nautical mile gap of unprotected airspace in that area. This action will add the additional controlled airspace area necessary for the safety and management of IFR operations at Pueblo Memorial Airport. With the exception of editorial changes, this rule is the same as that proposed in the NPRM.

The FAA has determined this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, Section 106 discusses the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes additional controlled airspace at Pueblo Memorial Airport, Pueblo, CO.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

Background on the License Limitation Program

The National Marine Fisheries Service (NMFS) manages the groundfish fisheries in the exclusive economic zone of the Bering Sea and Aleutian Islands Management Area (BSAI) and the Gulf of Alaska (GOA) under the fishery management plans (FMPs) for groundfish in the respective areas. The North Pacific Fishery Management Council (Council) recommended, and NMFS approved, the FMPs under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1801 et seq. ). Regulations implementing the FMPs appear at 50 CFR part 679. General regulations governing U.S. fisheries also appear at 50 CFR part 600.

The Council and NMFS have long sought to control the amount of fishing in the North Pacific Ocean to ensure that fisheries are conservatively managed and do not exceed established biological thresholds. One of the measures used by the Council and NMFS is the license limitation program (LLP), which limits access to the groundfish, crab, and scallop fisheries in the BSAI and GOA. The LLP is intended to limit entry into federally managed fisheries. For groundfish, the LLP requires that persons hold and assign a license for each vessel that is used to fish in federally managed fisheries, with some limited exemptions. The Council initially envisioned the LLP as an early step in a long-term plan to establish a comprehensive rationalization program for groundfish in the North Pacific.

The LLP for groundfish fisheries was recommended by the Council as Amendments 39 and 41 to the BSAI and GOA groundfish FMPs, respectively. The Council adopted the LLP for groundfish in June 1995, and NMFS approved Amendments 39 and 41 on September 12, 1997. NMFS published a final rule to implement the LLP on October 1, 1998 (63 FR 52642), and LLP licenses were required for Federal groundfish fisheries beginning on January 1, 2000. The preamble to the final rule implementing the groundfish LLP and the EA/RIR/FRFA prepared for this action describe the rationale and specific provisions of the LLP in greater detail ( see ADDRESSES ) and are not repeated here. The key components of the LLP are briefly summarized below.

The LLP for groundfish establishes specific criteria that must be met to allow a person to deploy a vessel to directed fish in most federally managed groundfish fisheries. An LLP license must be assigned to each vessel that is used to participate in directed fishing for most groundfish species. The term directed fishing and the specific groundfish species for which an LLP license is required are defined in regulations at § 679.2. Exceptions to the LLP license requirement apply if the vessel is less than 26 feet length overall (LOA) and fishing in the GOA; less than 32 feet LOA and fishing in the BSAI; or less than 60 feet LOA, using jig gear in the BSAI, and deploying no more than five jigging machines ( See § 679.4(k)(2)).

Under the LLP, NMFS issues licenses that (1) endorse fishing activities in specific regulatory areas in the BSAI and GOA; (2) restrict the length of the vessel on which the LLP license may be used, known as the maximum length overall (MLOA); (3) designate the fishing gear that may be used on the vessel (i.e. , trawl or non-trawl gear designations); and (4) designate the type of vessel operation permitted ( i.e. , LLP licenses designate whether the vessel to which the LLP is assigned may operate as a catcher vessel or as a catcher/processor). The endorsements for specific regulatory areas, gear designations, and vessel operational types are non-severable from the LLP license ( i.e. , once an LLP license is issued, the components of the LLP license cannot be transferred independently). By creating LLP licenses with these characteristics, the Council and NMFS limited the ability of a person to assign an LLP license that was derived from the historic landing activity of a vessel in one area using a specific fishing gear, or operational type, to be used in other areas, with other gears, or with other operational types in a manner that could expand fishing capacity. The preamble to the final rule implementing the groundfish LLP provides a more detailed explanation of the rationale for specific provisions in the LLP (October 1, 1998; 63 FR 52642).

When the Council initially recommended the LLP, the Council intended that NMFS determine whether a vessel met a minimum number of landings to qualify the owner of that vessel to receive an LLP license with a specific gear, area, and operational type endorsement. However, the regulations that implemented the LLP used the phrase “documented harvest” instead of “landing.” NMFS asserted that the phrase documented harvest was synonymous with the phrase landing, and that the phrase documented harvest provided additional clarity to the public that the phrase landing did not. NMFS' assertion that these two phrases were synonymous was subsequently challenged in court ( Trojan Partnership v. Gutierrez , 425 F. 3d 620 (9th Cir. 2005)). The Court held that these phrases were not synonymous. In order to be consistent with Council intent when originally implementing the LLP, as well as the specific criteria recommended by the Council for this action, this action uses landings, and not documented harvests, as the basis for determining whether an LLP license holder will meet the regulatory requirements for Amendment 86.

The regulatory areas for which LLP licenses were issued include the Bering Sea (BS), Aleutian Islands (AI); Southeast Outside District (SEO); Central Gulf of Alaska (CG), which includes the West Yakutat District adjacent to the SEO; and Western Gulf of Alaska (WG). The documented harvest requirements established in the final rule implementing the LLP, for a specific area differed depending on the size of the vessel and the operational type of the vessel. The phrase “documented harvest” is used in this description of the qualifying criteria for the LLP as originally implemented to be consistent with the terminology used in that final rule (October 1, 1998; 63 FR 52642). For example, for a vessel owner to receive an endorsement for non-trawl gear in the CG with a catcher/processor designation, a vessel must have met the minimum documented harvest requirements in the CG using non-trawl gear and the documented harvests must have been caught and processed onboard the vessel.

In 2000, NMFS issued groundfish LLP licenses with the appropriate regulatory area endorsements, gear, vessel length, and vessel operational type designations based on the documented harvests of vessels. NMFS issued more than 300 LLP licenses endorsed for trawl gear, and more than 1,000 licenses for non-trawl gear for use in the BSAI and GOA. Non-trawl gear is commonly known as fixed gear and includes hook-and-line, pot, and jig gear. In many cases trawl and fixed gear LLP licenses were endorsed for multiple regulatory areas (e.g., WG, CG, and BS) if a vessel met the minimum number of documented harvests in more than one area. Additionally, a number of LLP licenses were also designated for both trawl and fixed gear in cases where the vessel met the documented harvests requirements using both trawl and fixed gear.

After LLP licenses were initially issued in 2000, NMFS became aware, through public testimony from fishing industry representatives and an independent review of landings data, that a substantial number of trawl and/or fixed gear endorsed LLP licenses were not being used for fishing in some, or all, of the regulatory areas for which they were endorsed. A variety of factors could result in the lack of use of an LLP license, including poor economic conditions in groundfish fisheries, choices by LLP license holders to focus on fisheries such as salmon or halibut that do not require the use of an LLP license, or other reasons specific to a license holder. LLP licenses that are valid but are not currently being used on a vessel are commonly known as “latent” LLP licenses.

In early 2007, the Council began reviewing the use of trawl-endorsed LLP licenses in the GOA and BSAI. In April 2008, after more than a year of review, development of an analysis, and extensive public comment, the Council adopted Amendment 92 to the BSAI FMP and Amendment 82 to the GOA FMP, both of which modified the LLP regarding eligibility criteria for trawl endorsements on LLP licenses. Amendments 92 and 82 removed trawl endorsements from LLP licenses that did not meet specific landing requirements during 2000 through 2006. NMFS published a notice of availability for Amendments 92 and 82 on December 12, 2008 (73 FR 75659). A proposed rule was published on December 30, 2008 (73 FR 79773). NMFS approved Amendments 92 and 82 on March 16, 2009, and published a final rule implementing them on August 14, 2009 (74 FR 41080).

In late 2007, the Council began a similar process of reviewing the use of LLP licenses endorsed for fixed gear in the GOA. This review was initiated primarily at the request of active GOA fixed gear fishery participants who were concerned that holders of latent fixed-gear endorsed LLP licenses could resume fishing under the licenses in the future and thereby adversely affect active GOA fixed gear LLP licenses holders' fishing operations as well as the biological health of the fishery. Specifically, fixed-gear participants were concerned about the potential effects of additional effort in the GOA Pacific cod fishery that could increase competition and overcapacity in the fishery. Pacific cod is the primary fishery targeted by vessels using fixed gear in the GOA. In both the CG and WG regulatory areas, approximately one-fourth of the eligible LLP licenses were actively being used. The potential overcapacity from the remaining latent LLP licenses could have adverse effects on management of the fisheries. Increased fishery effort could make it more difficult for NMFS to close fisheries in a timely manner, thereby exceeding the total allowable catch (TAC) for a fishery.

During the development of this action, the Council also received input from the public requesting modification to the LLP to establish minimum landing requirements that must be met to allow a vessel to continue to participate in the Pacific cod fixed-gear fisheries in the GOA consistent with the approach adopted by the Council in 2002, under Amendment 67 to the FMP for groundfish of the BSAI (April 15, 2002; 67 FR 18129). Amendment 67 established a Pacific cod endorsement on LLP licenses that is required for vessels using hook-and-line and pot gear to participate in the directed fishery for Pacific cod in the BSAI. The term “directed fishing” is defined in regulation at § 679.2 and includes retained catch of Pacific cod that exceeds a minimum proportion of the total retained catch onboard a vessel. In April 2009, after more than a year of review and extensive public comment, the Council recommended modifications to the LLP to revise eligibility criteria for fixed gear endorsements on LLP licenses. The Council amended its final action in December 2009 to incorporate a change in the specific method used to allocate Pacific cod endorsed LLP licenses for specific persons ( see the description under Action 4 of this preamble for additional detail).

NMFS published the notice of availability for Amendment 86 on July 2, 2010 (75 FR 38452), with a public comment period that closed on August 31, 2010. NMFS published the proposed rule for this action on July 23, 2010 (75 FR 43118), with a public comment period that closed on September 7, 2010. Amendment 86 was approved by NMFS on September 29, 2010. NMFS received two public comments from two unique persons on Amendment 86 and the proposed rule; these are summarized and responded to below. These comments did not result in any modification to the proposed rule.

This rule implements four different actions, all of which were components of the Council's final action.

• Action 1: Establishes a GOA Pacific cod endorsement for fixed gear LLP licenses.

• Action 2: Exempts certain vessels using jig gear in the GOA from the requirement to carry an LLP license.

• Action 3: Modifies the MLOA of certain LLP licenses.

• Action 4: Allows specific GOA community entities to request and receive LLP licenses with a Pacific cod endorsement.

The rationale and effects of these four actions are described in detail in the preamble to the proposed rule (July 23, 2010; 75 FR 43118), and are briefly summarized here. For additional detail, please see the proposed rule preamble ( See ADDRESSES ).

This rule assigns Pacific cod endorsements to LLP licenses that have met minimum landing requirements from January 1, 2002, through December 8, 2008, or that meet a specific exemption described below. This action preemptively reduces the potential adverse effects of overharvesting the GOA Pacific cod resource if latent LLP license holders became active in the fishery.

This rule assigns a Pacific cod fishery endorsement to an LLP license based on landings in the directed Pacific cod fishery in the GOA from January 1, 2002, through December 8, 2008, made by vessels operating under the authority of that LLP license. NMFS will assign Pacific cod endorsements that are designated for (1) hook-and-line, pot, or jig gear; (2) specific GOA regulatory areas ( i.e., CG and WG); and (3) specific operational types (i.e., catcher vessels or catcher/processors). LLP licenses with an MLOA of less than 60 feet have different landing requirements compared to LLP licenses with an MLOA equal to or greater than 60 feet. Table 1 summarizes the landing requirement criteria that must be met for each gear type, regulatory area, operational type, and MLOA of the LLP license.

A fixed gear LLP endorsement for Pacific cod reduces the risk that vessel operators could assign latent LLP licenses to other vessels, effectively reactivating those licenses and thereby increasing the amount of fixed gear effort in the Pacific cod fisheries. This additional effort could increase the harvest rate in the fixed-gear Pacific cod fishery as well as adversely affect currently active participants by increasing competition, diluting their potential gross revenues, and creating incentives for harvesters to race for fish in a potentially wasteful manner. This action effectively removes the potential for new effort in the fishery beyond currently active participants, as defined by this rule. This action provides additional control on fishing effort in the GOA Pacific cod fishery that is not provided under the current structure of the LLP.

This action does not include modifications to SEO-endorsed licenses because fishing effort in this regulatory area is currently low. The risk of additional effort in the fishery from latent fixed gear LLP license holders was deemed to be unlikely by the Council given the relatively small number of eligible LLP licenses and the TAC for Pacific cod in the SEO. This action does not include the BS or AI regulatory areas because a Pacific cod endorsement requirement has already been established for LLP licenses using fixed gear in these areas under Amendment 67 to the BSAI FMP (April 15, 2002; 67 FR 18129).

The Council considered a range of options and alternatives to determine the minimum number of landings required to receive a Pacific cod endorsement. The range of years was selected by the Council based on the first year that NMFS could definitively assign landings data to a specific LLP license (2002), and a period year that represented the last year for which NMFS had data available on recent participation in the Pacific cod fisheries (December 8, 2008). The specific date of December 8, 2008, corresponds to the date that the Council selected as a control date after which landings would not be considered for purposes of qualifying for a Pacific cod endorsement. The Council recommended a control date to ensure that fishery participants did not engage in fishing practices for the sole purpose of qualifying for a Pacific cod endorsement, and to ensure that fishery landings represent sustained participation in the directed Pacific cod fishery. The Council balanced more recent participation against considerations of economic dependence and historical fishing practices when selecting the nearly 7-year time frame from January 1, 2002, through December 8, 2008. Groundfish harvested incidentally by vessels participating in any other fishery are excluded for the purpose of determining recent participation for this action because it is not considered directed fishing for Pacific cod.

The Council recommended that only catch from vessels fishing under the Federal TAC in either the Federal or parallel fishery would be included. The Federal TAC may be harvested in Federal waters, or in State of Alaska waters under a “parallel fishery.” A parallel fishery occurs when the State of Alaska opens state waters concurrent with the Federal fishing season to allow vessels to access the Federal TAC in both state and Federal waters. The Council recommended including this catch because both of these fisheries have participants that are subject to Federal regulation, and vessels transit between state and Federal waters when harvesting Pacific cod that is assigned to the TAC. Catch from vessels fishing in the State of Alaska's Guideline Harvest Limit GHL Pacific cod fishery would not be included as qualifying catch to meet the requirements for a Pacific cod endorsement because this catch is not federally managed, is not subject to the TAC, and is managed exclusively by the State of Alaska.

After a review of groundfish catch history, the Council determined that different landing criteria should apply to different gear types, vessel operation types, and LLP MLOAs during the 7-year period from January 1, 2002, through December 8, 2008. The landing criteria recommended by the Council represent a minimal, but sufficient, amount of participation in the Pacific cod fishery to indicate some level of dependence on the fishery. The Council recommended that landing requirements apply to each regulatory area so that authority to fish Pacific cod could be removed only for those regulatory areas where minimum landing requirements were not met. Therefore, LLP licenses that were active in more than one regulatory area might meet the minimum landing requirements in one area but not another. The Council recommended this action to accomplish the goal of reducing the effects of potentially hundreds of new entrants into the Pacific cod fishery.

The preamble to the proposed rule, and sections 2 and 3 of the EA/RIR/FRFA prepared to support this rule contain a detailed description of the alternative landing requirements considered, and the rationale for the specific landing requirements chosen for each of the fixed gear types ( see ADDRESSES ). That discussion is not repeated here.

Under this rule, a Pacific cod endorsement is required on all LLP licenses assigned to vessels using fixed gear to directed fish for Pacific cod in the WGOA and CGOA. Catcher vessels that use jig gear and meet specific vessel size and gear requirements will be exempt from the requirement to use an LLP license with a Pacific cod endorsement. This exemption is described in detail under Action 2. Other than the exemption described under Action 2, all vessels using fixed gear that are required to have an LLP license when fishing under the Federal TAC in either Federal or state waters are required to have a Pacific cod endorsement on the LLP license when directed fishing for Pacific cod. However, this requirement does not apply to vessels fishing in the Pacific cod GHL fishery, which is managed exclusively by the State of Alaska.

If a vessel, or vessels, to which an LLP license has been assigned meets minimum landings requirements applicable to a type of fixed gear and LLP license MLOA in a specific regulatory area during the period January 1, 2002, through December 8, 2008, then the LLP license used on that vessel, or vessels, will be assigned a Pacific cod fixed gear endorsement for those specific gear type(s) or specific regulatory area(s). An LLP license qualifies for more than one endorsement ( i.e., pot, hook-and-line, and/or jig) if it has qualified landings using more than one gear type.

In addition to issuing fixed gear endorsements based on directed harvests of Pacific cod during the January 1, 2002, through December 8, 2008, period, NMFS will issue Pacific cod endorsements to a limited number of LLP licenses that meet specific conditions even if those LLP licenses did not meet the minimum landing requirements. Specifically, NMFS will assign Pacific cod endorsements to LLP licenses that currently (1) have a catcher/processor endorsement; (2) were assigned to vessels that did not meet minimum landing requirements to qualify for a Pacific cod endorsement for catcher/processors using hook-and-line gear in either regulatory area where those LLP licenses are endorsed; and (3) were assigned to vessels that participated in industry efforts to reduce halibut prohibited species catch in the directed Pacific cod fishery in the GOA during 2006, 2007, or 2008.

This provision is intended to ensure that LLP license holders who decided not to use their vessels in the GOA during 2006, 2007, or 2008 will receive a Pacific cod endorsement. Specifically, this provision applies to LLP licenses that did not fish in the GOA in order to minimize halibut prohibited species catch. Hook-and-line catcher/processors minimize bycatch through voluntary private contractual arrangements. NMFS has a record of all LLP licenses that were used on catcher/processor vessels participating in the voluntary private contractual arrangements from 2006 through 2008. A list of LLP licenses, based on the best available catch data, eligible for this exemption (and thus able to receive an endorsement) appears at table 2 of this preamble.

In some cases, an LLP license is eligible to receive an endorsement if it met the landing requirement in either the CG or WG, and it qualifies for the exemption in the other regulatory area if it did not otherwise meet the landing requirement in that area. Table 2 notes whether an LLP license qualifies for the exemption in an area, or qualifies under the landing requirements in an area. An LLP license is not eligible for an endorsement exemption to a regulatory area if that LLP license had not been assigned an endorsement for that area prior to this action.

Table 2 indicates that under this exemption, NMFS will issue 12 CG and three WG endorsements. An LLP license that receives a Pacific cod hook-and-line catcher/processor endorsement under this exemption can only be assigned to a vessel participating in the Pacific cod offshore sector that is fishing in the regulatory area of the GOA for which the endorsement is received. Regulations at § 679.2 define the inshore and offshore sector for Pacific cod. Current regulations assign the offshore sector of the GOA Pacific cod fishery 10 percent of the TAC in the CG and WG. The remaining 90 percent of the TAC will be assigned for vessels in the inshore sector.

In this rule, NMFS implements the Council's recommendation that LLP licenses receiving an endorsement under this provision “only be allowed to participate in the offshore fishery” by requiring that vessels fishing in a regulatory area for which they receive an endorsement under this exemption register and fish only in the offshore sector in that area.

The rule retains the requirement that vessel owners elect annually on their Federal Fisheries Permit application whether to participate in the inshore or the offshore sector of the GOA. Therefore, a vessel operator who is assigned an LLP license with a Pacific cod endorsement exemption cannot participate in the inshore sector in one regulatory area and the offshore sector in another regulatory area in the GOA during the same calendar year.

This rule modifies regulations at § 679.7 to clarify that once an LLP holder operates in either the inshore or the offshore sector in the GOA, any vessel to which that LLP license is assigned cannot participate in the sector not selected for the remainder of the calendar year. This modification ensures that LLP license holders cannot alternate activities between the inshore and offshore sector, and potentially disadvantage other fishery participants who are only able to, or only choose to, annually participate in one sector. Additional detail on the inshore and offshore sector management is provided in the preamble to the proposed rule (see ADDRESSES ). That discussion is not repeated here.

Starting in 2002, NMFS has required that an LLP license designate a specific vessel on which it was being used. This requirement provides NMFS the information necessary to assign landings to a specific LLP, and allows NMFS to verify the use of an LLP license on a specific vessel. When information about the use of an LLP license on a specific vessel is combined with vessel landings records, NMFS can determine how many landings may be assigned to a specific LLP license during the January 1, 2002, through December 8, 2008, qualifying period. If an LLP license is not assigned a sufficient amount or number of landings in a specific regulatory area by vessel operation type and gear type for that MLOA, then under this rule NMFS will not issue a Pacific cod endorsement for that LLP license, unless that LLP license is eligible for an exemption from landing requirements as previously described for specific hook-and-line catcher/processor endorsed LLP licenses.

If a vessel was designated on more than one LLP license at the time of a creditable landing, NMFS will assign the credit for any of the vessel's landings to all LLP licenses assigned to, or “stacked,” on that vessel at that time. Therefore, NMFS may credit a single landing to more than one LLP license. Because NMFS' catch accounting system does not indicate how specific landings should be assigned to multiple LLP licenses assigned to a vessel at the time a landing was made, this provision should resolve any potential disputes that could arise about the assignment of specific landings.

In order to receive a Pacific cod endorsement for either the CG or WG, an LLP holder with a valid LLP license will have to either demonstrate that it had sufficient cumulative landings of Pacific cod for fishing years 2002 through 2008, or that it landed a sufficient total amount of fish during that period, or that the LLP license holder qualifies for such an endorsement pursuant to the exception listed above.

The second action under this rule exempts vessels using jig gear in the GOA from the requirement to be assigned an LLP license, provided those vessels do not use more than five jigging machines, more than one line per machine, and more than 30 hooks on any one line.

This exemption is similar to an exemption that currently applies to jig gear vessels operating in the BSAI. Regulations at § 679.4 exempt vessels less than 60 ft LOA using a maximum of five jig machines, no more than one line per jig machine, and no more than 15 hooks per line, from the requirements of the LLP in the BSAI. The restrictions on jig gear are consistent with the gear allowed in the GOA state waters Pacific cod jig fisheries. State regulations allow the use of up to 150 hooks for vessels participating in the state GHL fishery.

Jig gear operators who meet the landing threshold described under Action 1 will receive a Pacific cod endorsement for jig gear that allows a vessel using an LLP license with this endorsement to use more than five jigging machines, more than five lines, and more than 30 hooks per line.

Additional detail on the rationale for the jig gear exemption is provided in the preamble to the proposed rule ( see ADDRESSES ). That discussion is not repeated here.

The third action under this rule modifies the MLOA specified on certain LLP licenses that are eligible to receive a Pacific cod endorsement under two different scenarios.

The first modification applies if (1) an LLP license has a specified MLOA greater than or equal to 60 feet; (2) that LLP license was consistently assigned to a single vessel under 60 feet LOA from January 1, 2002, through December 8, 2008; and (3) the vessel to which the LLP license was assigned met the landing thresholds applicable to LLP licenses with a specified MLOA under 60 feet. If these criteria are met, NMFS will issue a Pacific cod endorsement for the applicable gear type to the LLP license but modify the MLOA of the LLP license to match the LOA of the vessel to which the LLP license was assigned. In no case can the resulting MLOA specified on the LLP license be greater than 60 feet. This modification ensures that vessel owners can continue to use the vessel and LLP licenses in the fisheries as they had during the January 1, 2002, through December 8, 2008, time period and the LLP licenses receive a Pacific cod endorsement applicable to the length of the vessel to which the LLP license was assigned. This modification reduces the overall MLOA specified on those LLP licenses that meet these criteria.

To determine the MLOA that will be specified on the LLP license, NMFS will use the LOA of the vessel to which the LLP license is assigned on the effective date of this rule. If the LLP holder disagrees with the LOA on file with NMFS and wishes to provide data to NMFS to establish a different LOA for the vessel, this rule requires that the LLP license holder provide a survey conducted by a naval architect or marine surveyor independent from the vessel owner or LLP license holder to verify the LOA of the vessel. A vessel owner has 90 days from the effective date of this rule to provide the survey to NMFS. NMFS will not assign a Pacific cod endorsement to an LLP license holder with a greater vessel LOA than that shown in NMFS' record unless a timely independent survey was submitted and received by NMFS. If no survey is provided within the 90-day time frame, NMFS will reissue the LLP license with the MLOA equal to the LOA of the vessel to which the LLP license was assigned based on the LOA on file with NMFS. No LLP license that receives a Pacific cod endorsement under this provision can have an MLOA greater than 60 feet under any circumstance to ensure that the intent of the Council's recommendation is met. This procedure provides an opportunity for an LLP license holder to amend NMFS' official record consistent with the appeals process described below in this preamble.

This exemption applies only if an LLP license had been continuously assigned to a vessel under 60 feet LOA during that period. The redesignation of the MLOA on an LLP license that qualifies under this provision effectively prohibits the use of that LLP license on larger vessels that may have greater harvest capacity, but allows smaller vessels that had been assigned that LLP license to continue to operate in the Pacific cod fishery.

The second modification of an LLP MLOA applies if an LLP license (1) is eligible to receive a pot catcher vessel Pacific cod endorsement, and (2) has a specified MLOA of less than 50 feet. If these criteria are met, NMFS will redesignate the MLOA of those LLP licenses to be 50 feet. This modification ensures that a limited number of vessel owners who had recently purchased vessels that are longer than the MLOA of the LLP license that is eligible to receive the Pacific cod endorsement can continue to use those LLP licenses on their longer vessels. This recommendation is consistent with the Council's goals of providing continuing opportunities for recent fishery participants and minimizing the potential for active participants to expand effort in the GOA Pacific cod fishery.

Additional detail on the rationale for both MLOA modifications is provided in the preamble to the proposed rule ( see ADDRESSES ). That discussion is not repeated here.

The fourth action under this rule allows entities representing specific communities in the WG and CG to request a limited number of non-transferrable Pacific cod endorsed LLP licenses. NMFS will issue licenses that are endorsed for hook-and-line or pot gear with an MLOA of 60 feet. Once the community entity receives the LLP license, the community entity can assign that LLP license for use on a vessel designated by the entity. Prior to receiving the LLP license, the community entity eligible to receive the LLP license must submit a detailed plan describing how it will assign the LLP license to a specific vessel.

Previously, the Council recommended, and the Secretary approved, Amendment 66 to the GOA FMP, which implemented management measures to provide harvest opportunities to specific communities in the GOA (April 30, 2004; 69 FR 23681). Under Amendment 66, the Council defined a specific suite of smaller GOA communities that have historically participated in GOA fisheries but may lack some of the infrastructure and population base that could facilitate participation by residents of those communities in GOA fisheries, as compared to larger communities. Under Amendment 66, a community quota entity (CQE) was authorized to purchase halibut and sablefish quota share on behalf of the community it represents, and assign the resulting annual individual fishing quota (IFQ) to specific members of the community that meet minimum residency standards and other requirements. The CQE is intended to serve the interests of the community as a whole by providing access to fishery resources for residents of the community.

Communities eligible under Amendment 66 (1) have a population of less than 1,500 and at least 20 persons based on the 2000 United States Census; (2) are located on the GOA coast of the North Pacific Ocean; (3) have direct saltwater access; (4) lack direct road access to communities with a population greater than 1,500 persons; (5) have historic participation in the halibut and sablefish fisheries; and (6) are listed in Table 21 to part 679. Seventeen communities that meet these criteria are located in the CG, and four communities are located in the WG.

The Council chose to rely on the six criteria listed above under Amendment 66 to determine coastal communities that may benefit from the ability to retain or expand participation opportunities in the GOA Pacific cod fishery for their residents. This rule provides the CQEs that represent these communities the opportunity to enhance their access to fishery resources by providing CQEs with a limited number of Pacific cod endorsed fixed-gear LLP licenses.

The Council recommended that if an eligible community in the CG or WG forms a CQE under existing regulations at § 679.41(l)(3), that CQE could apply to receive a specified number of Pacific cod endorsed fixed-gear LLP licenses. If a CQE submitted a complete application for LLP licenses, NMFS will issue the CQE new LLP licenses with the applicable gear and area endorsements. CQEs that have already formed and been approved by NMFS are eligible to apply to receive LLP licenses.

If new CQE communities are identified that meet the criteria established under Amendment 66, the Council could choose to recommend that those communities be included as eligible to receive a Pacific cod endorsed LLP license if those CQEs represented a community in the CG or WG. Adding new CQE communities and specifying the number of Pacific cod endorsed LLP licenses that a community could receive would need to be undertaken in future rulemaking. In December 2010, the Council recommended that three additional communities be allowed to form CQE's based on the fact that they meet the criteria established under Amendment 66. Those communities would need to be added to the CQE eligibility list in Table 21 to part 679 under separate rulemaking. Only one of the three communities, Cold Bay, is located in the WG and would be eligible to receive a non-transferable Pacific cod endorsed LLP license. Cold Bay would not be eligible to receive an additional license until subsequent rule making is completed.

The Council clarified that a CQE can request a Pacific cod endorsed LLP license only for the area in which that community is located. CQE communities in the WG could receive only WG endorsed LLP licenses, and CQE communities in the CG could receive only CG endorsed LLP licenses.

In order to receive LLP licenses, the CQE must meet several requirements. Prior to requesting LLP licenses, the CQE must provide NMFS with a plan for soliciting and determining recipients of the LLP licenses issued to the CQE. Specifically, CQEs need to provide NMFS with (1) a statement describing the procedures that will be used to determine the distribution of LLP licenses to residents of the community represented by that CQE; (2) procedures used to solicit requests from residents to be assigned an LLP license; and (3) criteria used to determine the distribution of the use of LLP licenses among qualified community residents and the relative weighting of those criteria.

Second, once the CQE has submitted the application to NMFS and the CQE has selected a potential recipient to use the LLP license, NMFS requires that the CQE provide a letter of authorization to the vessel operator listing the specific person(s) and the specific vessel eligible to use an LLP license held by the CQE during a calendar year. An LLP license issued to a CQE cannot designate more than one vessel per calendar year. The CQE can amend the authorization letter to add additional persons authorized to use the LLP license on a vessel. The person designated to use the LLP license issued to the CQE is required to be onboard the vessel while the vessel is used to directed fish for Pacific cod or any other species authorized by that license. A copy of the authorization letter and any amendments to the authorization letter must be provided to NMFS, and a copy of that authorization letter and any amendments must be maintained onboard the vessel assigned the CQE's LLP license. Likewise, NMFS requires that the authorization letter be provided on or before the date that the LLP license is used on a vessel during a calendar year. Any amendments to the authorization to designate new authorized persons must be provided to NMFS prior to those persons using the CQE's Pacific cod LLP.

As part of this authorization letter, NMFS requires that the CQE attest that the persons authorized to use the LLP license meet residency requirements. Specifically, the CQE must attest that the authorized person (1) is a citizen of the United States; and (2) has maintained a domicile in a CQE community in the CG or WG eligible to receive an LLP license endorsed for Pacific cod for the 12 consecutive months immediately preceding the time when the assertion of residence is made; and (3) is not claiming residency in another community, state, territory, or country, with an exception made for residents of the Village of Seldovia. Consistent with the definition of a resident under Amendment 66, residents of the Village of Seldovia shall be considered to be eligible community residents of the City of Seldovia for the purposes of eligibility to serve as an authorized vessel operator.

These requirements ensure that residents of communities receive the benefits of the LLP licenses issued to CQEs. Only one vessel can use a specific LLP license issued to a CQE per year to eliminate the potential that an LLP license could be used on multiple vessels. A CQE may not designate more than one vessel in cases of vessel loss. Because a CQE can designate a new vessel each year prior to the start of the fishing season, the effect of restricting the use of an LLP to only one vessel per year would not be expected to be a long-term constraint on fishing operations.

The CQE must provide an authorization letter assigning a specific vessel and designating the person(s) authorized use of the LLP license. The authorization letter requires that the CQE attest to individuals' residency, but does not require individuals to submit proof of residency to NMFS in order to use the LLP license issued to the CQE.

The Council identified the specific communities that would be eligible to receive LLP licenses if they formed a CQE. Those communities are listed in this final rule in Table 50 to part 679.

Several limitations apply to any LLP license that a CQE would receive. These include (1) all LLP licenses issued are non-transferable; (2) a limited number of LLP licenses can be issued to each CQE; (3) the LLP licenses have an MLOA of 60 feet; and (4) the LLP licenses have specific gear endorsements.

The number of LLP licenses that each CQE can request on behalf of a community is based on information indicating the number of LLP licenses held by residents of each eligible community and the estimated number of LLP licenses that will be extinguished under the other provisions of this action.

The number of LLP licenses that each CQE community can request is based on the Council's December 2009 action, and that number is listed in this final rule at Table 50 to part 679.

This rule modifies regulations at § 679.7(i)(1)(i), which limit to 10 the maximum number of LLP licenses that a person may hold, to fully implement the Council's intent to allow CQEs to provide harvest opportunities for local residents. This rule amends regulations at § 679.7(i) to prohibit the CQE representing the City of Sand Point from holding more than 14 groundfish LLP licenses, rather than prohibiting the CQE representing Sand Point from holding more than 10 groundfish LLP licenses. The limit on the number of LLP licenses that a CQE may hold includes all LLP licenses that a CQE may receive under the provisions of this rule, and any LLP licenses a CQE may receive by transfer under the provisions at § 679. The provision at 679.7(i)(1)(i) is specific to Sand Point and not for all CQE's.

The LLP licenses issued will have a specified MLOA of 60 feet. The gear endorsements on LLP licenses that can be requested by a CQE generally represent the overall harvest patterns by vessels using hook-and-line and pot gear within each regulatory area. NMFS will issue LLP licenses endorsed only for pot gear to CQEs representing communities in the WG. CQEs representing communities in the CG, including Yakutat, have the option of selecting what proportion of their LLP licenses would have a pot endorsement or a hook-and-line endorsement, provided the CQE notified NMFS within six months of the effective date of this rule of their choice. Selection of gear type is a one-time permanent choice. If a CQE does not notify NMFS within this time frame, then NMFS will issue any LLP licenses that are requested by a CQE so that half the LLP licenses issued to the CQE are endorsed for pot gear and half are endorsed for hook-and-line gear. In cases where the total number of groundfish licenses issued on behalf of a community listed in Table 50 to part 679 is not even, NMFS will issue one more groundfish license with a pot gear Pacific cod endorsement than the number of groundfish licenses with a hook-and-line gear Pacific cod endorsement.

CQEs must submit annual reports consistent with the annual report requirements established under Amendment 66. CQE annual reports must be submitted to NMFS and the governing body of the community that the CQE represents. The Council requested that the CQE provide information in the annual reports describing the use of LLP licenses during a calendar year. The annual report includes (1) the number of community residents requesting an LLP license from the CQE; (2) a description of the distribution of LLP licenses among community residents; (3) vessels assigned to use the LLP licenses; (4) the number and residency of crew employed on a vessel using the LLP license; and (5) the amount of payments made to CQEs for use of the LLP licenses, if any. These annual reports are due by January 31 for the prior fishing year for each community represented by the CQE for which those LLP licenses were granted.

NMFS did not establish an appeal process for CQEs to receive LLP licenses. NMFS is not removing or otherwise restricting existing harvest opportunities available to CQEs, so no appeal process is required. This rule allows CQEs to request LLP licenses provided the specific requirements detailed here are met. If those conditions are not met, NMFS will not issue LLP licenses to the CQEs. A potential CQE does have an opportunity to challenge and appeal the decision to certify its designation for a specific community. That provision is described in regulation at § 679.41(l)(3).

Additional detail on the issuance of Pacific cod endorsed LLP licenses to CQEs is provided in the preamble to the proposed rule ( see ADDRESSES ). That discussion is not repeated here.

NMFS will create an official record with all relevant information necessary to assign landings to specific LLP licenses. Prior to modifying any LLP licenses, NMFS will notify all fixed gear LLP license holders of the status of their LLP license endorsements (i.e., the endorsements for specific fixed gear, operational types, and regulatory areas). Should an LLP license holder disagree with NMFS' official record, NMFS will provide an opportunity for a person to submit information to rebut the presumptions made by NMFS.

The official record created by NMFS contains vessel landings data, and the LLP licenses to which those landings are attributed. Evidence of the number and amount of landings in the Pacific cod fishery is based only on legally submitted NMFS weekly production reports for catcher/processors and state fish tickets for catcher vessels. In order to ensure that landings in the directed Pacific cod fishery are properly attributed to an LLP license, NMFS will assign any delivery of Pacific cod up to seven days after the closure of the Pacific cod season to an LLP license. The seven-day period accommodates any final deliveries. The official record includes the records of the specific LLP licenses assigned to vessels and other relevant information necessary to attribute landings to specific LLP licenses. NMFS presumes the official record is correct, and a person wishing to challenge the presumptions in the official record bears the burden of proof through an evidentiary and appeals process. Regulations pertaining to appeals are described under § 679.43. A description of the official record and the appeals process is provided in the preamble to the proposed rule ( see ADDRESSES ). That discussion is not repeated here.

NMFS received two comments during the public comment period for Amendment 86 and the proposed rule. One comment provided a general criticism of fishery management, and was not relevant to Amendment 86 or the proposed rule. A second public comment noted that the proposed rule is consistent with the principles of Amendment 86, the needs, goals, and objectives of the GOA Pacific Cod fixed gear fishery, the Magnuson-Stevens Fishery Conservation and Management Act (MSA), and other applicable laws. Neither comment raised issues requiring a specific response.

NMFS makes two changes in the final rule to clarify specific regulatory provisions that were addressed in the preamble to the proposed rule, but that were not adequately described in the regulatory text. The first change adds a paragraph at § 679.4(k)(10)(vi)(C)( 9 ) to note that an LLP license with a Pacific cod endorsement issued to a CQE may not be assigned to more than one vessel per calendar year. This addition is consistent with text in the preamble and the Council's motion to the proposed rule noting that “An LLP license issued to a CQE could not designate more than one vessel per calendar year” (July 23, 2010; 75 FR 43127). The preamble to the proposed rule also notes:

The added regulatory text at § 679.4(k)(10)(vi)(C)( 9 ) gives full effect to the clear intent expressed in the preamble to the proposed rule. This added regulatory text is consistent with, and a logical outgrowth of, the proposed rule.

The second change to the regulatory text adds text at § 679.4(k)(10)(vi)(D) to specify that a CQE's authorization letter, or any subsequent amendments to that letter, must be sent to NMFS. The added text also specifies the address where that letter must be sent. This addition is consistent with the text in the preamble to the proposed rule that notes:

The regulatory text in the proposed rule at § 679.4(k)(10)(vi)(D) noted that the CQE must provide a copy of the authorization letter and any amendments to that letter to the vessel operator, but failed to specify that NMFS must also receive the authorization letter and any amendments. This final rule clarifies the regulatory text at § 679.4(k)(10)(vi)(D) to specify that that NMFS must also receive the authorization letter and any amendments. This clarification is consistent with the clear intent expressed in the preamble to the proposed rule and is consistent with, and a logical outgrowth of, the proposed rule.

The Assistant Administrator for Fisheries, NOAA, has determined that this rule is consistent with Amendment 86 to the Fishery Management Plan for Groundfish of the Gulf of Alaska, the MSA, and other applicable laws.

This rule has been determined to be not significant for purposes of Executive Order 12866.

A FRFA was prepared as required by section 604 of the Regulatory Flexibility Act (5 U.S.C. 604). The FRFA describes the economic impact this final rule will have on small entities. The EA/RIR/FRFA prepared for this final rule is available from NMFS ( see ADDRESSES ). The FRFA for this action explains the need for, and objectives of, the rule; notes that no public comments on the initial regulatory flexibility analysis were submitted; describes and estimates the number of small entities to which the rule will apply; describes projected reporting, recordkeeping, and other compliance requirements of the rule; and describes the steps the agency has taken to minimize the significant economic impact on small entities, including a statement of the factual, policy, and legal reasons for selecting the alternative adopted in the final rule and why each one of the other significant alternatives to the rule considered by the agency that affect the impact on small entities was rejected. The need for and objectives of this action; a summary of the comments and responses; a description of the action, its purpose, and its legal basis; and a statement of the factual, policy, and legal reasons for selecting the alternative implemented by this action are described elsewhere in this preamble and are not repeated here.

The proposed rule was published in the Federal Register on July 23, 2010 (75 FR 43118). An Initial Regulatory Flexibility Analysis (IRFA) was prepared and described in the classification section of the preamble to the rule. The public comment period ended on September 7, 2010. NMFS received two comments from two individuals. None of the comments directly addressed the IRFA.

The entities directly regulated by this action are holders of LLP licenses endorsed for fixed-gear activity who conducted directed fishing for Pacific cod in the GOA. NMFS estimates that under this rule a maximum of 956 entities hold LLP licenses with fixed-gear endorsements designated for catcher vessel or catcher/processor operations may be affected by this rule; of these, an estimated 908 small entities will be directly regulated by this action.

The Small Business Administration (SBA) has established that a business involved in fish harvesting is a small business if it is independently owned and operated, not dominant in its field of operation (including its affiliates), and if it has combined annual gross receipts not in excess of $4.0 million for all its affiliated operations worldwide. A seafood processor is a small business if it is independently owned and operated, not dominant in its field of operation, and employs 500 or fewer persons on a full-time, part-time, temporary, or other basis, at all its affiliated operations worldwide. Because the SBA does not have a size criterion for businesses that are involved in both the harvesting and processing of seafood products, NMFS has in the past applied, and continues to apply, SBA's fish harvesting criterion for these businesses because catcher/processors are first and foremost fish harvesting businesses. Therefore, a business involved in both the harvesting and processing of seafood products is a small business if it meets the $4.0 million criterion for fish harvesting operations. NMFS is reviewing its small entity size classification for all catcher/processors in the United States. However, until new guidance is adopted, NMFS will continue to use the annual receipts standard for catcher/processors. Even if additional catcher/processors would have been identified as small entities under a revised small entity size classification, NMFS would have analyzed the effect on small entities using the same methods that were used in the IRFA prepared for the proposed rule. NMFS considered the effects of the proposed rule and attempted to reduce costs to all directly regulated entities regardless of the number of small entities.

The EA/RIR/FRFA ( see ADDRESSES ) prepared for this action analyzed projected reporting, recordkeeping, and other compliance requirements on directly regulated entities. Under this final rule, NMFS will require additional reporting, recordkeeping, and other compliance requirements. Specifically, CQEs must submit an application to receive fixed-gear LLP licenses endorsed for Pacific cod, the selection of fixed gear type by CQEs in the CG, a description of the methods used to assign any fixed gear LLP licenses received, a letter of authorization for persons using LLP licenses assigned to a CQE, and an annual report detailing the distribution and use of LLP licenses. In addition, persons who qualify to receive a fixed-gear endorsement for an LLP license that was used under specific conditions on a vessel that was less than 60 feet LOA must submit a vessel survey prior to receiving an endorsement on that LLP license if they disagree with existing LOA data held by NMFS. Existing recordkeeping and reporting requirements for registering vessels in the inshore or offshore sector, and the LLP appeals process have not been modified.

The objective of this action is to limit the number of potential participants in Federal fixed-gear Pacific cod fisheries in the GOA by assigning and requiring Pacific cod endorsements on LLP licenses, and to provide additional fixed gear licenses that may be used on behalf of specific GOA communities. NMFS expects this action will reduce uncertainty for active participants and provide additional harvest opportunities for residents of specific communities in the Western and Central GOA and the community of Yakutat whose residents have historically participated in Central GOA fisheries.

The Council's preferred alternative for this action, as implemented by this final rule, will reduce the number of potential participants in the directed Pacific cod fishery using fixed gear. NMFS estimates that a total of 1,227 fishery endorsements may be affected under this action. These fixed gear fishery endorsements are assigned to LLP licenses held by an estimated 956 entities. As a result of this action, NMFS estimates that 376 fishery endorsements for directed fishing for Pacific cod will be issued. It is not possible to determine the precise number of the 956 entities that will continue to hold fishery endorsements for directed fishing for Pacific cod.

As noted above, all or most of the entities that are directly impacted by this regulation are small entities. This action likely will not have a significant adverse impact on some of these entities relative to the status quo alternative. The EA/RIR/FRFA ( see ADDRESSES ) prepared for this action notes that this action removes latent LLP licenses, but would not be expected to adversely affect active participants in the fixed gear directed Pacific cod fishery. On balance, these changes are not likely to have a significant economic impact on an LLP license holder.

The Council and NMFS considered and analyzed two alternative approaches for the management of Pacific cod fishing by non-trawl LLP licenses in the CG and WG in the EA/RIR/IRFA: Alternative 1, status quo/no action; and Alternative 2, the preferred alternative, add a Pacific cod endorsement on the CG and WG GOA LLP licenses if minimum landing requirements are met. Alternative 2 includes a provision to issue new Pacific cod endorsed fixed gear LLP licenses to non-profit CQEs, representing specific communities in the CG and WG. These two alternatives examined ranges of options for a varying range of landing criteria and mechanisms for assigning Pacific cod endorsements. These alternative landing criteria and mechanisms and the options examined in the context of these alternatives constitute the suite of “significant alternatives” for this action for the purposes of the RFA.

During the development of this action, the Council considered and rejected alternatives that would have allocated quota to specific fishery participants, or allocated a portion of the TAC to specific fishery sectors and gear types. These alternatives were considered to be overly broad to address the goal of limiting the potential entry of latent effort into the Pacific cod directed fishery.

Compared with the status quo, Alternative 2, and the associated suite of elements and options comprising Alternative 2, minimizes adverse economic impacts on the directly regulated small entities. The action provides greater economic stability for fixed-gear LLP license holders with recent participation in the CG and WG Pacific cod fisheries. Alternative 2 reduces the potential for substantial increases in fishing effort from latent LLP license holders, and provides additional harvesting opportunities for CQEs who hold fixed-gear LLP licenses. In no case are these combined impacts expected to be substantial. Alternative 2 does not assign Pacific cod fishery endorsements to fixed-gear LLP licenses that have had little or no participation in Pacific cod fisheries in the CG and WG since 2002. Therefore, the effect of this action on those directly regulated entities is expected to be minimal. The effects should be minimal because the holders of latent LLP licenses are not expected to rely on the Pacific cod resource or have substantial revenue from this fishery given the lack of consistent participation in the fishery over a broad range of years. Furthermore, the addition of new Pacific cod endorsed fixed-gear licenses and the removal of LLP requirements for most vessels using jig gear may provide additional harvest opportunities for some catcher vessels in Federal waters. Many vessels currently active in state waters are catching fish assigned to the Federal TAC under the parallel fishery. It is not clear that these new Pacific cod endorsed fixed-gear licenses would substantially increase fishing effort. Although none of the alternatives are expected to have any significant economic or socioeconomic impacts, Alternative 2, the preferred alternative, minimizes the potential negative impacts, such as less control over potential fishing effort in the GOA Pacific cod fishery and greater risk that the fishery could be subject to overharvest that could arise under Alternative 1, the status quo alternative.

NMFS has posted a small entity compliance guide on its Web site at http://alaskafisheries.noaa.gov to satisfy the Small Business Regulatory Enforcement Fairness Act of 1996 requirement for a plain language guide to assist small entities in complying with this rule.

This rule contains a collection-of-information requirement subject to the Paperwork Reduction Act and which has been approved by OMB under Control Number 0648-0334. Public reporting burden per response is estimated to average four hours for an appeal of an initial administrative determination; 20 hours for a CQE to apply to receive an LLP license and select the applicable gear type of that license if that CQE is operating in the CG; 40 hours for the CQE annual report; 1 hour to submit a letter of authorization for a vessel and vessel operator from a CQE; and 1 hour to submit a vessel length survey for LLP license holders who qualify for a Pacific cod endorsement for vessels less than 60 feet LOA under specific conditions. Estimates include the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

Send comments regarding this burden estimate, or any other aspect of this data collection, including suggestions for reducing the burden, to NMFS ( see ADDRESSEES ), by e-mail to OIRA_Submission@omb.eop.gov, or fax to 202-395-7285. Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the Paperwork Reduction Act, unless that collection of information displays a currently valid OMB control number.

For the reasons set out in the preamble, NMFS amends 15 CFR Chapter IX and 50 CFR Chapter VI as follows:

FDA published a notice in the Federal Register of October 19, 1999 (64 FR 56351), announcing the filing of a food additive petition (FAP 9M4682) by the National Fisheries Institute and the Louisiana Department of Agriculture and Forestry. In the Federal Register of August 16, 2005 (70 FR 48057), FDA issued a final rule permitting the irradiation of fresh or frozen molluscan shellfish for the control of Vibrio spp. and other food-borne pathogens. FDA based its decision on data in the petition and in its files. In the preamble to the final rule, FDA outlined the basis for its decision and responded to questions raised in several comments from Public Citizen and the Center for Food Safety (PC/CFS). The preamble to the final rule advised that objections to the final rule and requests for a hearing were due within 30 days of the publication date ( i.e., by September 15, 2005).

Section 409(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 348(f)(1)) provides that, within 30 days after publication of an order relating to a food additive regulation, any person adversely affected by such order may file objections, specifying with particularity the provisions of the order “deemed objectionable, stating reasonable grounds therefore, and requesting a public hearing upon such objections.”

Under part 171 (21 CFR part 171) in § 171.110 of the food additive regulations, objections and requests for a hearing are governed by part 12 (21 CFR part 12) of FDA's regulations. Under § 12.22(a), each objection must meet the following conditions: (1) Must be submitted on or before the 30th day after the date of publication of the final rule; (2) must be separately numbered; (3) must specify with particularity the provision of the regulation or proposed order objected to; (4) must specifically state each objection on which a hearing is requested; failure to request a hearing on an objection constitutes a waiver of the right to a hearing on that objection; and (5) must include a detailed description and analysis of the factual information to be presented in support of the objection if a hearing is requested; failure to include a description and analysis for an objection constitutes a waiver of the right to a hearing on that objection.

Following publication of the final rule permitting the irradiation of fresh or frozen molluscan shellfish for the control of Vibrio spp. and other food borne pathogens, FDA received numerous submissions within the 30-day objection period. All but two of these timely submissions express general opposition to the final rule, and are form letters urging the FDA to conduct additional studies on irradiating molluscan shellfish specifically and food in general. Although most of these letters request a hearing, no evidence is identified in support of these objections that could be considered in an evidentiary hearing (§ 12.22(a)(5)). Therefore, they have waived their right to a hearing. The Agency will not discuss these submissions further. FDA received two submissions that met the requirements of § 12.22(a), One of these two submissions is a letter sent jointly by PC/CFS containing 10 numbered objections to the final rule and requesting a hearing on each one. The second is a letter sent by Samuel Epstein (Dr. Epstein), containing six numbered objections, requesting a hearing on each. All but one of the issues raised by Dr. Epstein are identical to certain of those raised in the PC/CFS submission. Both PC/CFS and Dr. Epstein also requested a stay of action on the final rule. FDA addresses the PC/CFS and Dr. Epstein objections and hearing requests in section IV of this document.

FDA also received a large number of submissions after the close of the objection period; their content was identical or similar to the form letters expressing general opposition to the final rule. These tardy submissions failed to satisfy the requirements of 21 U.S.C. 348(f)(1) and need not be considered further by the Agency ( see ICMAD v. HEW, 574 F.2d 553, 558 n.8 (DC Cir), cert. denied, 439 U.S. 893 (1978)).

Additionally, most of the issues raised in the PC/CFS and Dr. Epstein objections are similar or identical to issues that have been raised previously and that have been previously addressed in the rule being objected to (70 FR 48057) and in other Agency rulemaking concerning irradiation. The Agency will address these issues briefly; please refer to the cited Federal Register documents for a more comprehensive discussion.

Specific criteria for deciding whether to grant or deny a request for a hearing are set out in § 12.24(b). Under that regulation, a hearing will be granted if the material submitted by the requester shows, among other things, the following: (1) There is a genuine and substantial factual issue for resolution at a hearing; a hearing will not be granted on issues of policy or law; (2) the factual issue can be resolved by available and specifically identified reliable evidence; a hearing will not be granted on the basis of mere allegations or denials or general descriptions of positions and contentions; (3) the data and information submitted, if established at a hearing, would be adequate to justify resolution of the factual issue in the way sought by the requestor; a hearing will be denied if the data and information submitted are insufficient to justify the factual determination urged, even if accurate; and (4) resolution of the factual issue in the way sought by the person is adequate to justify the action requested; a hearing will not be granted on factual issues that are not determinative with respect to the action requested ( e.g., if the action would be the same even if the factual issue were resolved in the way sought).

A party seeking a hearing is required to meet a “threshold burden of tendering evidence suggesting the need for a hearing” ( Costle v. Pacific Legal Foundation, 445 U.S. 198, 214-215 (1980), reh. denied, 446 U.S. 947 (1980), citing Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 620-621 (1973)). An allegation that a hearing is necessary to “sharpen the issues” or to “fully develop the facts” does not meet this test ( Georgia Pacific Corp. v. U.S. EPA, 671 F.2d 1235, 1241 (9th Cir. 1982)). If a hearing request fails to identify any factual evidence that would be the subject of a hearing, there is no point in holding one. In judicial proceedings, a court is authorized to issue summary judgment without an evidentiary hearing whenever it finds that there are no genuine issues of material fact in dispute and a party is entitled to judgment as a matter of law ( see Rule 56, Federal Rules of Civil Procedure). The same principle applies in administrative proceedings ( see § 12.28).

A hearing request must not only contain evidence, but that evidence should raise a material issue of fact concerning which a meaningful hearing might be held ( Pineapple Growers Association v. FDA, 673 F.2d 1083, 1085 (9th Cir. 1982)). Where the issues raised in the objection are, even if true, legally insufficient to alter the decision, the Agency need not grant a hearing ( see Dyestuffs and Chemicals, Inc. v. Flemming, 271 F.2d 281, 286 (8th Cir. 1959), cert. denied, 362 U.S. 911 (1960)). FDA need not grant a hearing in each case where an objector submits additional information or posits a novel interpretation of existing information ( see United States v. Consolidated Mines & Smelting Co., 455 F.2d 432 (9th Cir. 1971)). In other words, a hearing is justified only if the objections are made in good faith and if they “draw in question in a material way the underpinnings of the regulation at issue” ( Pactra Industries v. CPSC, 555 F.2d 677 (9th Cir. 1977)). Finally, courts have uniformly recognized that a hearing need not be held to resolve questions of law or policy ( see Citizens for Allegan County, Inc. v. FPC, 414 F.2d 1125 (DC Cir. 1969); Sun Oil Co. v. FPC, 256 F.2d 233, 240 (5th Cir.), cert. denied, 358 U.S. 872 (1958)).

Even if the objections raise material issues of fact, FDA need not grant a hearing if those same issues were adequately raised and considered in an earlier proceeding. Once an issue has been so raised and considered, a party is estopped from raising that same issue in a later proceeding without new evidence. The various judicial doctrines dealing with finality can be validly applied to the administrative process. In explaining why these principles “self evidently” ought to apply to an Agency proceeding, the U.S. Court of Appeals for the District of Columbia Circuit wrote: “The underlying concept is as simple as this: Justice requires that a party have a fair chance to present his position. But overall interests of administration do not require or generally contemplate that he will be given more than a fair opportunity.” Retail Clerks Union, Local 1401 v. NLRB, 463 F.2d 316, 322 (DC Cir. 1972). ( See Costle v. Pacific Legal Foundation, supra at 215-220. See also Pacific Seafarers, Inc . v. Pacific Far East Line, Inc., 404 F.2d 804 (DC Cir. 1968), cert. denied, 393 U.S. 1093 (1969)).

The letter from PC/CFS contains 10 numbered objections and requests a hearing on each of them. The letter from Dr. Epstein includes six numbered objections and requests a hearing on each. The issues raised in five of the six objections in the letter from Dr. Epstein are identical to issues raised in the letter from PC/CFS; in those cases, the issues will be considered together. FDA addresses each of the objections, as well as the evidence and information filed in support of each, comparing each objection and the information submitted in support of it to the standards for granting a hearing in § 12.24(b) as follows:.

One objection raised by PC/CFS and Dr. Epstein states that the Agency failed to consider two animal feeding studies that include toxicological evidence of harmful effects from consumption of irradiated molluscan shellfish. In support of this objection, PC/CFS submitted copies of brief summary reports of the two studies.

The first study is a 1976 reproduction study  1 in which irradiated (4 kiloGray (kGy) and 8 kGy) soft-shell clams were fed to chickens for 2 years. In a note appended to the summary report, the study authors state that the study was replicated (for differing durations) in the F1 and F2 generation birds ( i.e., the second and third generation birds bred from the parent generation used in the original study). The objection notes that FDA did not include this study on chickens in the Agency's September 15, 1982, master bibliography of more than 400 studies on the safety of irradiated foods and, that therefore, this study was not assessed by the Task Group for the Review of Toxicology Data on Irradiated Food. 2

The objection goes on to describe certain of the reported results from the study on chickens, specifically results in the F1 and F2 generations, including the following: Higher hemoglobin values and smaller gonad weights in males of the F1 generation fed irradiated clams; and a decrease in “hatchability” of eggs, enlargement of kidneys in females (an effect that increased with increasing irradiation dose), decreases in egg fertility and embryonic viability, and lower body weights in females, in the F2 generation.

FDA acknowledges that this study was not included in the inventory of studies reviewed by the Bureau of Foods Irradiated Food Task Group in the early 1980s, and agrees that the endpoints cited in the objection were reported by the study authors. However, the Agency does not agree that FDA's failure to assess the study calls into question the safety of irradiated molluscan shellfish, as the objectors contend. The objection fails to note that many of the findings cited in the experimental report were observed both in chickens fed irradiated clams and in chickens fed unirradiated clams, and that the report discusses the need to supplement the diets of the clam-fed chickens with thiamine. Therefore, the observed effects may have been related to the nutritional effects of feeding diets consisting of 50 percent wet-weight of soft-shell clams to chickens. More importantly, if the negative effects cited by the objectors were due to the consumption of irradiated food, one would expect the findings to be reproducible in other studies on irradiated foods; however, such reproducibility is not seen in the large number of feeding studies that have been reviewed by FDA.

The objection also cites a second paper by the same researchers  3 describing a study on feeding clams irradiated at 4 kGy or 8 kGy to beagle dogs. According to the objection, the study showed a significant inverse correlation between the irradiation dose applied to the clams and the blood urea nitrogen (BUN) level of male dogs fed on them. PC/CFS and Dr. Epstein both go on to state that “[t]hough the researchers did not speculate, low blood urea nitrogen levels are usually a symptom of liver damage.”

The Agency included this beagle dog study in the review of toxicology studies conducted in the early 1980s. The FDA reviewer noted the reported BUN results and also noted that, although the researchers indicated that organs were weighed and examined histopathologically, no results of the histopathological examination were included in the report. This suggests that the researchers did not find any evidence of liver (or other organ) damage, and in fact the study report includes no information that supports the objectors' contention that liver damage was an underlying condition in the animals tested. Furthermore, the Agency, as part of its rulemaking pertaining to the irradiation of meat and meat products, re-examined the findings reported in this study. As stated in the December 3, 1997, final rule (62 FR 64107 at 64113), FDA concluded that the decrease in BUN levels in this study was not of toxicological significance, and laid out its reasoning in that document and in a memorandum to the record (Ref. 1). Thus, the Agency disagrees with PC/CFS' and Dr. Epstein's contention that this study “* * * found serious toxicity concerns associated with irradiated molluscan shellfish.”

A hearing will be denied if the data and information are insufficient to justify the factual determination urged, even if accurate (§ 12.24(b)(3)). FDA concludes the data and information are insufficient and, therefore, FDA is denying the request for a hearing on this issue.

PC/CFS' second objection asserts that the final rule fails to ensure that the irradiation of molluscan shellfish will result in a product that is microbiologically safe. In support of this objection, PC/CFS cites a 1996 PhD dissertation by Dustin W. Dixon on the effects of irradiation on Vibrio vulnificus in shellstock oysters (raw oysters in their shell) harvested in Florida and Texas (Ref. 2). The objection states that there is a potential for microbial outgrowth post-irradiation, and cites Dixon's observation that the V. vulnificus count in oysters irradiated at 1.0 kGy and 3.0 kGy rose nearly to the level of that in unirradiated oysters after 2 and 9 days of storage, respectively. The objection states that Dixon concluded that “* * * irradiation processing cannot be considered as a method to sterilize shellstock oysters, and provide a shelf-stable product.”

The objection also notes the potential for improper temperature control of irradiated molluscan shellfish prior to consumption by the consumer. The objection states that there is no guarantee that temperature conditions will be properly maintained and asserts that FDA is assuming that Hazard Analysis and Critical Control Point (HACCP) plans  4 will ensure consistent and adequate temperature control.

As noted by PC/CFS, the Dixon dissertation was submitted to the Agency as part of the molluscan shellfish petition. The stated objectives of the research presented in that document were to determine the effects of gamma irradiation on Florida and Texas shellstock oysters in terms of shelf life and microbial consequences. FDA does not dispute the findings of Dr. Dixon, and agrees that irradiation of molluscan shellfish to an absorbed dose of 5.5 kGy will not sterilize molluscan shellfish or create a shelf-stable product. FDA also agrees with Dr. Dixon's conclusion in his dissertation that irradiation may not be sufficient by itself to eliminate V. vulnificus in molluscan shellfish and that proper conditions of storage must be maintained after shellfish have been irradiated.

FDA disagrees, however, with PC/CFS' assertion that the final rule must “[en]sure the microbiological safety of fresh oysters.” The standards for microbiological safety of molluscan shellfish are independent of the final rule permitting the irradiation of molluscan shellfish. Irradiation is but one measure for the control of Vibrio spp. and other food-borne pathogens. The rule is not predicated on the approved treatment, by itself, resulting in shellfish that are sterile or shelf-stable. A hearing will not be granted on factual issues that are not determinative with respect to the action requested (§ 12.24(b)(4)). Therefore, FDA is denying the request for a hearing based on this objection.

PC/CFS' third objection states that “there is no reasonable certainty in the minds of competent scientists that irradiation is not harmful as applied to molluscan shellfish.” In support of this objection, PC/CFS makes several assertions. First, PC/CFS refers to several sets of comments that it submitted to the docket for the molluscan shellfish rulemaking. PC/CFS states that those comments cite 11 “peer-reviewed papers or other publications stating safety concerns associated with irradiated foods” and that these comments refer to “at least 25 other highly `competent' Ph.D.s or MDs who have stated that they have safety concerns in published literature.” The objection states that, although these comments and papers refer to irradiation of food types other than molluscan shellfish, the Agency should have specifically considered the statements of these authors. Second, PC/CFS asserts that FDA misstated what is contained in its literature reference numbered as “Ref 20” in the final rule. Third, PC/CFS, as well as Dr. Epstein, asserts that FDA mischaracterized the findings of the Raltech study. In support of this assertion, PC/CFS submitted a copy of two summary reports from the “Raltech studies” and a 1984 trade press article that quotes Dr. Thayer of USDA. Finally, PC/CFS states that neither FDA's final rule nor the underlying petition actually contains data from, or references to, any toxicity studies on irradiated mollusks.

As evidence that there is not a “reasonable certainty of safety in the minds of competent scientists” PC/CFS notes that they have submitted comments including journal articles and other publications that express concerns with food irradiation. However, the articles do not contain any evidence that could be resolved at a hearing, nor has PC/CFS pointed to any evidence in the cited articles. Nor has PC/CFS pointed to any specific factual information in the cited articles on foods analogous to molluscan shellfish, which the Agency has ignored and which would call into question the Agency's conclusions. A hearing will not be granted on the basis of mere allegations or general descriptions of positions and contentions (§ 12.24(b)(2)). Therefore, FDA is denying the request for a hearing based on this objection.

The Agency agrees that reference 20 as cited in the final rule is incorrect. The proper reference is: S.G. Armstrong, S.G. Wylie, and D. N. Leach, “Effects of Preservation by Gamma Irradiation on the Nutritional Quality of Australian Fish,” Food Chemistry 50 (1994) 351-357. This error does not demonstrate a lack of reasonable certainty of safety. A hearing will be denied if the information submitted is insufficient to justify the factual determination urged (§ 12.24(b)(3)).

The Agency disagrees with PC/CFS' and Dr. Epstein's assertion that the final rule mischaracterizes the findings of the “Raltech study.” The Raltech studies were sponsored by the United States Department of Agriculture and conducted by Raltech Scientific Services. In this series of studies, conducted in the late 1970s and early 1980s, irradiation-sterilized chicken (doses ranged from 45-59 kGy) was fed to various types of animals. PC/CFS alleges that there were several negative health effects seen in these studies, including a significant dose-related decrease in the number of offspring of Drosophila melanogaster (fruit flies), and a high incidence of testicular tumors and significantly reduced survival in mice.

The Agency evaluated the results of the Raltech studies and has extensively discussed its conclusions regarding these studies in previous rulemaking documents ( see 51 FR 13376 at 13386, 53 FR 53176 at 53188, and 55 FR 18538 at 18540). The Agency specifically discussed the results of the feeding study in mice and the mutagenicity study in fruit flies ( see, e.g., 55 FR 18538 at 18540). The Agency has described its reasoning in finding no evidence in any of the Raltech studies of adverse effects that could be attributed to consumption of irradiation-sterilized chicken. The Agency has found that the quantity and breadth of testing and the number and significance of endpoints assessed would have identified meaningful risks, if any existed. On those few occasions where adverse effects were reported, FDA found that those effects were not attributable to irradiation. PC/CFS does not submit or otherwise identify any factual data that would cause the Agency to alter its conclusions about these studies. Accordingly, FDA is denying the request for a hearing based on this objection (§ 12.24(b)(2)).

Finally, the Agency agrees that there were no toxicological studies conducted using irradiated molluscan shellfish submitted in the petition. As noted in the molluscan shellfish final rule (70 FR 48057 at 48068), the Agency has reviewed a large body of data that are relevant to the assessment of the potential toxicity of irradiated flesh foods. FDA has consistently taken the position that various scientifically validated types of data may properly support a safety determination for a proposed use of a food additive ( see part 170 (21 CFR part 170) in § 170.20). For example, in the case of food irradiation, the Agency has taken advantage of the extensive research and large body of knowledge concerning the principles of radiation chemistry and the chemical composition of foods. PC/CFS' suggestion that data and information derived from studies of analogous irradiated foods are not sufficient to support a determination that irradiated molluscan shellfish are safe, is unsupported by specific data or other factual information. Further, the question of whether safety has been shown requires the application of the legal standard of safety as defined by FDA's regulations (“reasonable certainty of no harm”) to a set of facts ( see § 170.3(i)). As such, FDA concluded as a matter of law that the proposed use of irradiation to treat fresh and frozen molluscan shellfish with absorbed doses not to exceed 5.5 kGy is safe. A hearing will not be granted on issues of policy or law (§ 12.24(b)(1)). Therefore, FDA is denying the request for a hearing based on this objection.

PC/CFS objects to the molluscan shellfish final rule on the grounds that the Agency and the underlying petition failed to consider several factors that could make irradiated molluscan shellfish unsafe. These factors are: (1) Safety of irradiated salt water; (2) chemicals that irradiated molluscan shells may `off-gas'  5 ; (3) effects of irradiation on undigested shellfish stomach contents such as plankton and algae; (4) attenuation of irradiation effects from shell thickness ( i.e., that thicker shells may attenuate the effectiveness of irradiation); and (5) lack of data on furan creation from the shells. Dr. Epstein also objects on the basis of the issues relating to chemical byproducts from irradiated molluscan shells, and the attenuation of irradiation effects from shell thickness.

First, the Agency notes that there is no basis to suggest that the presence of salts in water will affect the irradiation of molluscan shellfish because ionizing radiation, under the petitioned conditions, does not affect inorganic salts (Ref. 3). Second, the objection provides no information to show that mollusk shells (composed of approximately 95 percent calcium carbonate and 5 percent protein), when irradiated, would produce any chemicals that may off-gas into the meat, nor is there any information to suggest that such chemicals, were they to be formed, would render the food unsafe. Third, the objection provides no evidence that the stomach contents of irradiated molluscan shellfish are materially different from any other irradiated food ( i.e., composed predominantly of protein, fat, and carbohydrate). Fourth, the Agency agrees that varying shell thickness may attenuate the effectiveness of irradiation, and that this attenuation would increase with shell thickness. However, the objection provides no evidence that would cause the Agency to find that consumption of irradiated molluscan shellfish is not safe. As explained in section IV.B of this document, it is not necessary that irradiation “[en]sure the microbiological safety of fresh oysters.” Parties irradiating molluscan shellstock are responsible for ensuring that treated food receives the minimum irradiation dose reasonably required to accomplish its intended technical effect and not more than the maximum dose specified by the applicable regulation ( see 21 CFR 179.25(b)) . Finally, the Agency discussed the potential generation of furan in the final rule (70 FR 48057 at 48059) and concluded that irradiated molluscan shellfish do not generate furan at a rate that is higher than the background generation of furan in un-irradiated molluscan shellfish (Ref. 4). Although in the final rule the Agency cited data concerning furan formation from shucked oysters, the objection points to no factual data to suggest that irradiation of mollusks in the shell (which is approximately 95 percent calcium carbonate) would lead to furan formation from irradiation of the shell.

A hearing will not be granted on the basis of mere allegations or general descriptions of positions and contentions (§ 12.24(b)(2)). Neither PC/CFS nor Dr. Epstein has provided a basis for a hearing and FDA is denying the request for a hearing on this objection.

PC/CFS and Dr. Epstein cite 21 CFR 170.22  6 and object to the molluscan shellfish final rule (70 FR 48057) on the basis that FDA improperly failed to apply a 100-fold safety factor regarding the production of 2-alkylcyclobutanones (2-ACBs) from the irradiation of esterified fatty acids in considering the safety of irradiated molluscan shellfish. In support of their contention that the Agency should have applied a 100-fold safety factor to 2-ACBs, PC/CFS and Dr. Epstein make several assertions. First, the objection asserts that 2-ACBs are found only in irradiated foods and are known to be potentially toxic at certain concentrations and to promote tumor formation in the presence of known carcinogenic substances. The objection also asserts that the flesh of molluscan shellfish is distinct from that of other flesh foods because it contains a “unique combination” of fatty acids and that these fatty acids, when irradiated, produce a unique combination of 2-ACBs. The objection, therefore, maintains that FDA's reliance on the Raltech study to address concerns about 2-ACBs is flawed because that study involved chicken which has a lower stearic acid content than oysters. Finally, the objection asserts that “there are no adequate long-term safety studies that assist in assessing the overall health hazards that consuming 2-ACBs could pose, including likely variations in sensitivities to 2-ACBs among the human consumer population” and refers particularly to children and other vulnerable populations. In relation to this last point, PC/CFS submitted a publication on the susceptibility of children to environmental substances by William Au. 7

The applicability of § 170.22 is a legal issue, and a hearing will not be granted on issues of law. The Agency notes that § 170.22 refers to safety factors to be used in determining whether a proposed use of a food additive will be safe. In the present instance, 2-ACBs are not the food additive that is the subject of the rulemaking. Therefore, the 100-fold safety factor discussed in § 170.22 does not apply to 2-ACBs. Further, as noted in the molluscan shellfish final rule (70 FR 48057 at 48066), applying a 100-fold safety factor to a processed food or to individual components of a processed food is not feasible or appropriate.

The Agency agrees that 2-ACBs have been reported to be formed in small quantities as a result of irradiation of fats and that these compounds have been identified in irradiated meat and poultry. In the final rule permitting the irradiation of molluscan shellfish, the Agency described in detail its assessment of the significance of the formation of 2-ACBs to a safety assessment of molluscan shellfish, which like poultry and meat, contain appreciable amounts of triglycerides. This assessment included a discussion of the contentions that 2-ACBs may cause DNA damage and may be tumor promoters at certain concentrations (70 FR 48057 at 48065 to 48067). While the objection repeats assertions made in comments to the final rule about the toxicity of 2-ACBs and the failure of the Agency to apply a 100-fold safety factor for 2-ACBs, the objection includes no new information or analysis that would call into question the Agency's rationale for its decision.

The objection states that molluscan shellfish contain a unique combination of fatty acids that differ from those in poultry, and that therefore, the Agency's reliance on the Raltech study to address concerns about 2-ACBs is flawed. In particular, the objection states that chicken meat contains less stearic acid than do oysters. It is true that the Agency considers the Raltech studies useful in assessing the effects of 2-ACBs in animals fed irradiated flesh foods (70 FR 48057 at 48066). In the Raltech studies, animals were fed chicken irradiated at a dose approximately 10 times the dose permitted in the molluscan shellfish final rule, at a level of 35 percent of the diet, for their lifetime. Thus, although the concentration of stearic acid in chickens is lower than in molluscan shellfish, the amount of 2-ACBs in the diets of the animals in the Raltech studies, including those formed from irradiation of stearic acid is likely to be higher than the amount in the human diet from irradiated molluscan shellfish (70 FR 48057 at 48066). As noted previously, there were no adverse toxicological effects seen in the Raltech studies that could be attributed to the consumption of irradiated chicken. In addition, it is important to note that the Agency has not relied solely on the Raltech studies in concluding that irradiation of molluscan shellfish under the conditions permitted in the final rule is safe. As pointed out in the final rule (70 FR 48057 at 48066), the Agency's review included studies in which animals were fed diets containing irradiated beef, pork, poultry, horse meat, and fish, and found no evidence of toxicity attributed to the consumption of these foods, which contain various levels and combinations of fatty acids that may potentially form 2-ACBs. The objection has thus misrepresented the basis for the Agency's decision when it contends that the final rule relies on the Raltech studies to discount concerns about 2-ACBs in irradiated molluscan shellfish.

In the molluscan shellfish final rule, the Agency noted that it had reviewed a multitude of studies on irradiated foods that would have contained radiolytic products including 2-ACBs, and which include long-term safety studies. FDA noted that it had previously concluded that “The results of the available toxicological studies of irradiated flesh foods * * * demonstrate that a toxicological hazard is highly unlikely because no toxicologically significant adverse effects attributable to consumption of irradiated flesh foods were observed in any of these studies” (62 FR 64107 at 64114). Although the objection alleges that there are no “adequate long-term safety studies that assist in assessing the overall health hazards that consuming 2-ACBs could pose,” the objection provides no factual information to call into question the studies on which the Agency has relied, nor does it provide any new information or data to refute the analysis set out in the molluscan shellfish final rule.

The objection also cites the FDA's “rejection” of the 100-fold safety margin as inappropriate, given the need to “protect children and other vulnerable consumers.” The paper by Dr. Au, which was submitted in support of this objection, is a commentary discussing the need to consider data and information that indicate that children are more susceptible to toxic contaminants than are adults in setting guidelines for protecting children's health. The objection provides no evidence to show that the Agency's conclusion that molluscan shellfish, irradiated under the conditions permitted by the regulation, are safe, fails to protect children and other vulnerable consumers. The submitted commentary includes no information or data relevant to the safety of irradiated molluscan shellfish.

In sum, the Agency is denying a hearing on the objection that FDA improperly rejected application of the 100-fold safety factor in § 170.22 to 2-ACBs produced in irradiated molluscan shellfish. The interpretation of the applicability of this regulation is a legal issue, and a hearing will not be granted on issues of law. Moreover, PC/CFS and Dr. Epstein have not presented any evidence supporting their contention that the potential levels of 2-ACBs in irradiated molluscan shellfish may render the food unsafe. PC/CFS' request for a hearing merely alleges that there is potential for harm, without providing any evidence that the Agency has not already considered. An objector must make an adequate proffer of evidence to support its allegations and to show that they provide a basis on which to call into question the Agency's conclusions (§ 12.24(b)(2)). Thus, neither PC/CFS nor Dr. Epstein has provided a basis for a hearing and FDA is denying their requests for a hearing based on this objection.

PC/CFS cites their comment submitted on May 14, 2001, and repeats the assertion made in that comment that the Agency ignored or improperly discounted a number of positive in vivo and in vitro mutagenicity studies, including five peer-reviewed published studies performed by the Indian National Institute of Nutrition (NIN) in which purported mutagenic effects were found in mice, rats, and monkeys, and in malnourished children, consuming freshly-irradiated wheat. In support of the objection, PC/CFS submitted excerpts from 1987 Congressional testimony by S.G. Srikantia, the former Director of NIN, who testified that FDA committed an error of judgment in accepting a report by a committee of Indian scientists discrediting the NIN studies ( see 53 FR 53176 at 53182). The objection also asserts that FDA neglected to consider a statement made in 1988 by an Australian genotoxicity expert to a Committee of the Australian House of Representatives, stating that the malnourished children study's results seemed reasonable. In addition, the objection refers to two later publications by the NIN researchers rebutting criticisms of the study, and cites a statement by the former Director of NIN stating that the NIN's results were mirrored in a study on hamsters (Ref. 5) that found that polyploidy cells occurred five times more frequently in animals fed irradiated wheat in their diet, and that this increased incidence of polyploidy was related to irradiation dose.

The Agency has previously considered all of the various in vitro and in vivo mutagenicity studies cited by PC/CFS and discussed its conclusions in detail in previous documents ( see e.g., 51 FR 13376 at 13383 and 13385; 53 FR 53176 at 53181-3 and 53191-2; 70 FR 48057 at 48064 and 48067). Several of the studies cited in the comment refer to reports of in vitro mutagenicity of irradiated sugars in solution. The Agency previously has discussed in detail why it has concluded that the irradiation of simple sugars in solution is not a suitable model for predicting and extrapolating toxicity of irradiated foods. In the final rule permitting additional uses of ionizing radiation for the treatment of food, the Agency noted: “In feeding studies where sugars are present in a typically complex food matrix there is no increase in mutagenicity after irradiation. Studies have demonstrated that when a food containing sugars is irradiated, the food does not produce the same toxic effects that occur when these sugars are irradiated in simple solution. Thus, the Agency concluded that irradiated aqueous sugar solutions are unsuitable models for predicting and extrapolating toxicity of irradiated foods and that there is no evidence that radiolytic products from sugars present in irradiated foods cause toxic effects to animals or humans (51 FR 13376 at 13383).”

The objection provides no new evidence or rationale that provides a basis on which to find that FDA's conclusion on the relevance of these studies is incorrect.

The Agency also has previously repeatedly addressed in detail the interpretation of the NIN studies using freshly irradiated wheat and concluded that none of the studies on polyploidy done at NIN were reliable and that the studies do not demonstrate that adverse effects would be caused by ingestion of irradiated foods (51 FR 13376 at 13385; 53 FR 53176 at 53183; 70 FR 48057 at 48068). In the molluscan shellfish final rule, the Agency noted, citing earlier rulemaking: “A committee of Indian scientists critically examined the techniques, the appropriateness of experimental design, the data collected, and the interpretations of NIN scientists who claimed that ingestion of irradiated wheat caused polyploidy in rats, mice, and malnourished children. After careful deliberation, this committee concluded that the bulk of these data are not only mutually contradictory, but are also at variance with well-established facts of biology. The committee was satisfied that once these data were corrected for biases that had given rise to these contradictions, no evidence of increased polyploidy was associated with ingestion of irradiated wheat.

The Agency agreed with the conclusions of the committee of Indian scientists that the studies with irradiated foods do not demonstrate that adverse effects would be caused by ingesting irradiated foods.” (70 FR 48057 at 44067 and 44068)

Dr. Srikantia's testimony states that the FDA was wrong to accept the report of the committee of Indian scientists; he states that NIN has not repudiated the studies on polyploidy and that the Director of NIN submitted a rebuttal to the report of the committee of Indian scientists, and that “[h]ad it seen the Institute's rejoinder to the * * * report, surely, it would have been in a better position to evaluate that report.” FDA previously has addressed all issues raised in Dr. Srikantia's testimony ( see e.g. , 53 FR 53176 at 53182-3). As noted previously (53 FR 53176 at 53183) FDA did not state that NIN had repudiated the studies, nor did it base its own conclusions about the studies on a finding that the data were repudiated by NIN. FDA concluded that the available data from NIN did not provide an appropriate basis on which to conclude that increased polyploidy was caused by ingesting irradiated wheat. Furthermore, FDA in 1986 invited Dr. Srikantia to submit any information to FDA that would be relevant. Dr. Srikantia replied, but did not submit a copy of his rebuttal to the Indian government or any other report ( see footnote 1, 53 FR 53176 at 53183).

The hamster study by Renner referenced by PC/CFS also has been discussed previously (53 FR 53176 at 53183 and 531834). The study involved the irradiation of hamster diets (composed primarily of carbohydrates) at high doses. The investigator concluded that at doses above 30 kGy there was a “[* * *] transitory effect [* * *] as evidenced by an increased incidence of polyploidy cells” but that “there was no evidence of any mutagenic effect being produced as a result of feeding an irradiated diet.” He noted that no effects on incidence of polyploidy were seen at doses below 20 kGy. The objection contains no information that explains why this study is relevant to the molluscan shellfish (composed primarily of protein and fats) irradiated at doses up to 5.5 kGy.

In summary, all of the studies referenced by PC/CFS have been considered previously by FDA and the Agency's rationale for its conclusions on those studies has been discussed at length in previous rulemakings. Neither the objection, nor the testimony of Dr. Srikantia, nor the statement of the Australian expert, includes any new information or data that would refute the Agency's findings about the studies. PC/CFS' request for a hearing merely alleges that there is potential for harm, without providing any evidence that the Agency has not considered previously. An objector must make an adequate proffer of evidence to support its allegations and to show that they provide a basis on which to call into question the Agency's conclusions (§ 12.24(b)(2)). Thus, PC/CFS has not provided a basis for a hearing and FDA is denying PC/CFS' request for a hearing based on this objection.

PC/CFS' seventh objection alleges that the “FDA misrepresents important published and unpublished warnings from qualified scientists calling for additional research on 2-ACBs.”

The Agency previously has addressed the allegations of the potential harm of the long-term consumption of 2-ACBs that are produced from the irradiation of esterified fatty acids (70 FR 48057 at 48066) and the research performed on 2-ACBs. The Agency concluded: “2-ACBs have been reported as radiolysis products of fats (Refs. 6 and 7). Studies performed by researchers have reported that certain alkylcyclobutanones can cause single strand DNA breaks detectable by the COMET assay (Ref. 8). Several animal feeding studies have been conducted with fat-containing foods irradiated at doses far higher than would be used on molluscan shellfish. If 2-ACBs, at the level present in irradiated foods, were of sufficient toxicity to cause significant DNA damage, one would expect to have seen adverse effects in those studies where animals were fed meat as a substantial part of their diet.”

The objection provides no additional information on 2-ACBs that the Agency has not addressed previously. The Agency does not consider the statements in the cited papers on 2-ACBs to be warnings; rather, the comments are statements presented by the authors that research should continue on 2-ACBs. These statements do not affect the Agency's determination that 2-ACBs do not cause the food to be unsafe at levels present in irradiated food.

Moreover, PC/CFS' request for a hearing merely alleges that there is potential for harm, without providing any evidence that the Agency has not already considered and determined did not demonstrate a potential for harm. An objector must make an adequate proffer of evidence to support its allegations and to show that they provide a basis on which to call into question the Agency's conclusions (§ 12.24(b)(2)). Thus, PC/CFS has not provided a basis for a hearing and FDA is denying PC/CFS' request for a hearing based on this objection.

PC/CFS and Dr. Epstein allege that FDA failed to follow “critical guidelines” for food additives. Specifically, the objections assert that although use of an irradiation source is statutorily defined as a food additive, 21 U.S.C. section 321(s), the final rule incorrectly characterizes irradiated molluscan shellfish as “processed foods” (70 FR 48057 at 48069), and as such, applied a lower safety standard. Second, the objections cite § 170.20 and assert that the Agency ignored provisions of that regulation. For example, the objections assert that the rule provides no evidence to support FDA's decision to ignore the current National Academy of Sciences-National Research Council (NAS-NRC) publication “Risk Assessment/Safety Evaluation of Food Chemicals” ( see § 170.20(a)). Also citing § 170.20, the objections assert that the final rule provides no evidence that FDA gave due weight to anticipated levels and patterns of consumption of irradiated molluscan shellfish ( see § 170.20 (a)). Third, the objections cite § 170.22 and state that the Agency failed to justify not using a 100-fold safety factor in the final rule. Fourth, the objection maintains that FDA failed to comply with the testing protocols set forth in the Redbook. 8 Finally, the objections state that FDA ignored the recommendations put forth in 1980 by the Bureau of Foods Irradiated Foods Committee (BFIFC) regarding the evaluation of irradiated foods.

A source of radiation used to process food is defined as a food additive in section 201(s) of the FD&C Act (21 U.S.C. 321(s)); the exposure of molluscan shellfish to ionizing radiation is what makes irradiated molluscan shellfish a processed food. The FD&C Act requires that a food additive, including a source of radiation used to process food, must be shown to be safe under the proposed conditions of use before the use can be approved. That is, the Agency must find that there is a reasonable certainty that consumption of an irradiated food is not harmful. FDA applied the same standards and guidelines that the Agency uses to evaluate all food additives to evaluate the safety of a source of ionizing radiation used to treat molluscan shellfish. The Agency's reference to irradiated molluscan shellfish as a “processed” food in the final rule did not change the Agency's finding that such shellfish is safe.

The Agency has previously addressed its reasoning in interpreting and applying its own regulations at §§ 170.20 and 170.22 in the molluscan shellfish final rule, in response to comments submitted by PC/CFS (70 FR 48057 at 48066 and 48068). The regulation at § 170.20(a) reads in part: “In reaching a decision on any petition filed under section 409 of the Act, the Commissioner will give full consideration to the specific biological properties of the compound and the adequacy of the methods employed to demonstrate safety for the proposed use, and the Commissioner will be guided by the principles and procedures for establishing the safety of food additives stated in current publications of the National Academy of Sciences-National Research Council. A petition will not be denied, however, by reason of the petitioner's having followed procedures other than those outlined in the publications of the National Academy of Sciences-National Research Council if, from available evidence, the Commissioner finds that the procedures used give results as reliable as, or more reliable than, those reasonably to be expected from the use of the outlined procedures. In reaching a decision, the Commissioner will give due weight to the anticipated levels and patterns of consumption of the additive specified or reasonably inferable.”

In the molluscan shellfish final rule, the Agency explained that FDA has consistently taken the position that many scientifically valid types of data may properly support a finding that a proposed use of a food additive is safe. The Agency pointed out that NAS-NRC testing standards and guidelines have been stated in relatively general terms and that in practice, FDA has applied exposure and toxicological criteria that were current for the time, and appropriate for assessing the safety of a particular food additive (70 FR 48057 at 48068). In its objection, PC/CFS repeats its assertion that FDA failed to properly interpret its own regulation, but has provided no new information that would refute the Agency's reasoning. The objection implies that the Agency is obligated to explicitly discuss its consideration of NAS-NRC guidelines in its rules, but there is nothing in § 170.20 that imposes such an obligation on the Agency. The regulation requires the Commissioner of Food and Drugs (the Commissioner) to make a finding that the procedures used by the petitioner give results that are as reliable as, or more reliable than, those reasonably expected from use of the NAS-NRC guidelines. Acceptance of a petition based on alternate procedures implies that the Commissioner has made such a finding.

With respect to the assertion that FDA failed to give due weight to anticipated levels and patterns of consumption of irradiated molluscan shellfish, FDA previously has reviewed a large body of data relevant to the assessment of potential toxicity of irradiated flesh foods. In its evaluations of the safety of a source of radiation to treat food intended for human consumption, the Agency has identified three areas of concern to be addressed: (1) Potential toxicity, (2) nutritional adequacy, and (3) potential microbiological risk from treated foods. Each of these areas was discussed in detail in the molluscan shellfish final rule. FDA asserted that the Agency “can draw conclusions about the amounts of radiolysis products expected to be generated at radiation doses relevant to the subject petition by extrapolating from data obtained at higher doses for foods of similar composition irradiated under similar conditions (70 FR 48057 at 48059).” In its review of studies in which animals were fed diets containing beef irradiated at 56 kGy, fish at 6 kGy, horse meat at 6.5 kGy, fish at 56 kGy, and others (62 FR 64107 at 64113), the Agency found no evidence of toxicity attributable to the consumption of these foods.

FDA has concluded that products formed (typically oxidation products of food constituents) following irradiation of molluscan shellfish are the same as or similar to those found in non-irradiated foods after cooking. Further, radiolysis products in shellfish are essentially the same as those in red meat and poultry, since the composition is roughly the same. Additionally, shellfish make a smaller contribution to the average daily diet; therefore, exposure to radiolysis products from shellfish will be smaller than that from foods for which irradiation currently is regulated. Cooking and other heat processing methods remain the principle means for introducing such substances into the diet (Ref. 9). PC/CFS' assertion provides no basis to challenge FDA's assessment of the safety of irradiated molluscan shellfish.

In like manner, the assertions that FDA failed to follow its regulation in § 170.22, or to comply with recommendations in the Redbook or set forth by the BFIFC committee, have been raised previously by PC/CFS, Dr. Epstein, and others, and have been responded to by the Agency in the molluscan shellfish final rule (70 FR 48057 at 48066 and 48069) and in other previous rulemakings ( see e.g., 57 FR 6667 at 6669; 62 FR 64102 at 64105; and Section IV.E., above). The Agency has described its reasoning for concluding that the data and information considered in the evaluation of the petition to permit the irradiation of molluscan shellfish, when considered in its entirety, are sufficient to support the safety of molluscan shellfish irradiated under the conditions specified in the regulation. Once the Agency makes a finding of safety in a listing document, the burden shifts to an objector to come forward with evidence that calls into question FDA's conclusion ( see § 12.24(b)(2)). PC/CFS and Dr. Epstein provide no new information on how the Agency failed to follow the regulations to establish the safety of irradiating molluscan shellfish to an absorbed dose of 5.5 kGy. A hearing will not be granted on the basis of mere allegations or general descriptions of positions and contentions (§ 12.24(b)(2)). The objectors must, at a minimum, raise a material issue concerning which a meaningful hearing might be held. Neither PC/CFS nor Dr. Epstein has provided a basis for a hearing and FDA is denying their request for a hearing based on this objection.

PC/CFS states that “FDA's final rule fails to address recent studies in its possession indicating that irradiation at low dose levels in oysters may cause unpleasant—perhaps unwholesome—byproducts.” The objection discusses a report  9 presented at the 2002 annual meeting of the Institute of Food Technologists that suggests that molluscan shellfish irradiated at 2.0 kGy produced an “unpleasant yellow exudate.” The objection goes on to discuss other potential organoleptic changes that may occur in irradiated molluscan shellfish (such as “grassy” and “oxidized” odors) as noted in Dixon's 1996 dissertation (Ref. 2). PC/CFS states that FDA's final rule failed to address these issues of “wholesomeness,” and requests a hearing on these issues.

FDA previously has acknowledged that irradiation may cause organoleptic changes in foods (62 FR 64107 at 64110). Such organoleptic changes may make the food unappealing and unmarketable; however, undesirable organoleptic changes do not render the food unsafe. Neither the author of the report cited by PC/CFS nor PC/CFS itself suggests that there is any evidence that the noted “unpleasant yellow exudate” or other organoleptic changes would render irradiated molluscan shellfish unsafe.

PC/CFS' request for a hearing suggests that there is potential for harm from possible organoleptic changes from irradiation of molluscan shellfish, without providing any evidence to support this suggestion. An objector must make an adequate proffer of evidence to support its allegations and to show that they provide a basis on which to call into question the Agency's conclusions. A hearing will be denied if the Commissioner concludes that the data and information submitted are insufficient to justify the factual determination urged, even if accurate (§ 12.24(b)(3)). FDA concludes that the data and information are insufficient; therefore, FDA is denying the request for a hearing based on this objection.

PC/CFS alleges that there are errors in some of the FDA review memoranda used to support the final rule. The objection states that these errors call into question the adequacy of the Agency's review processes that led to the Agency's conclusion that irradiated molluscan shellfish are safe. There are four parts to this objection; the Agency will address each part below.

Part one of this objection asserts that “FDA significantly misrepresents published research on the tumor-promoting qualities of 2-ACBs.” Specifically, the objection states that an FDA memorandum in the record (Ref. 10) mischaracterizes the findings of a publication submitted by PC/CFS as part of a comment to the petition to irradiate molluscan shellfish (Ref. 11). The objection states that these alleged mischaracterizations “severely bias the Agency's analysis of 2-ACBs.”

The disputed memorandum included a discussion of the Raul et al. (2002) paper submitted to the Agency by PC/CFS as part of its comment to the molluscan shellfish petition; the memorandum also discussed a commentary on the paper that was submitted with the comment (Ref. 12). The objection cited three selected sentence fragments from the memorandum which PC/CFS maintains are incorrect. The memorandum discussed the authors' observations and the limitations of the Raul, et al. study and stated that those limitations and inconsistencies in the data made it difficult to draw conclusions from the study. In the final rule (70 FR 48057 at 48067) the Agency discussed the limitations of the study and its reasoning in concluding that the results of long-term feeding studies were more relevant to a finding of safety than the Raul et al. study.

As FDA noted in the final rule (70 FR 48057 at 48067): “Given the limitations of the animal model and study design, ambiguous data, and the absence of close relationship between the chemical exposure used in the study and the expected human exposure, the Agency finds that the comment provides no substantial or reliable scientific information to show that there is reason to believe that the consumption of 2-ACBs will promote colon cancer. Moreover, the Agency notes that long term feeding studies performed using irradiated foods that contain 2-ACBs did not show any promotion of colon cancer. The results of these latter long term feeding studies are more relevant than results from the Raul paper because 2-ACBs were fed in the diet as in human exposure and the levels of exposure would still have been increased over usual dietary levels.”

The Agency maintains that the disputed memorandum taken as a whole, including the sentence fragments highlighted by PC/CFS, accurately and reliably reflects the information in the Raul and Rao publications. Importantly, the factual issues raised by the three disputed statements were not determinative in the Agency's overall conclusions about the relevance of the Raul et al. study or to its determination that the irradiated molluscan shellfish under the conditions of the regulation are safe. A hearing will not be granted on factual issues that are not determinative with respect to the action requested (§ 12.24(b)(4)). Thus, PC/CFS has not provided a basis for a hearing and FDA is denying PC/CFS' request for a hearing based on this objection.

Part two of this objection asserts that FDA cites no evidence to dismiss the COMET assay as a valid technique for testing genetic toxicity. The objection asserts that the “technique has broad support within the scientific community” and quotes excerpts from several published reports that state that the COMET assay has utility, and is being increasingly used in the screening of various substances.

The Agency does not dispute the statements quoted by the PC/CFS nor the fact that the COMET assay is being increasingly studied and used to study the cellular response to DNA damage and repair. In the final rule, the Agency has addressed its conclusions pertaining to the COMET assay results (70 FR 48057 at 48065), as they are presented with respect to 2-ACBs and has determined that, when the totality of evidence is examined with other more standard genotoxicity testing methods, “the potential risk of 2-DCB, if any, is very low.” The cited quotations do not provide any information related to the safety of consumption of 2-ACBs that may be present in irradiated molluscan shellfish that the Agency has not considered, and the objection contains no information that would cause the Agency to change its safety determination. A hearing will not be granted on factual issues that are not determinative with respect to the action requested (§ 12.24(b)(4)).

Part three of this objection states that certain FDA review memoranda (Chen to Highbarger, 12/21/2001, FAP 9M4697), (Morehouse to Highbarger, 6/l/2002, 9M4697), and (Chen to Highbarger, 4/7/2003, FAP 9M4695) are irrelevant to the analysis of irradiated molluscan shellfish, because they were written as part of the review of other petitions to permit the irradiation of certain other foods. This objection also states that one of the memoranda (Chen to Highbarger, 12/21/2001, FAP 9M4697) is inaccurate, because it states that “the radiolysis products of irradiated lipids and proteins are either the same as, or structurally very similar to, compounds found in foods that have not been irradiated.” PC/CFS state that “numerous published articles show—and the FDA now admits—that 2-ACBs are fundamentally unique from any naturally occurring food component.” Additionally, the objection states that this memorandum ignores the FDA Redbook's statement that genotoxicity tests can contribute to safety assessments.

The Agency acknowledges that the review memoranda cited were written as part of the review of two petitions to permit the irradiation of certain foods (other than molluscan shellfish) that are pending at the Agency: FAP 9M4695, submitted by the U.S. Department of Agriculture (64 FR 71792)  10 and FAP 9M4697, submitted by the National Food Processors Association on behalf of the Food Irradiation Coalition (65 FR 493 and 66 FR 23943). 11 The objection does not explain, however, why the information in those memoranda is irrelevant to the irradiation of molluscan shellfish to an absorbed dose of 5.5 kGy. These review memoranda describe chemistry and toxicology information related to the irradiation of protein, fat, and carbohydrate; these are components of molluscan shellfish. The Agency has repeatedly noted that its conclusions on safety of irradiating molluscan shellfish are based on the evaluation of the totality of evidence before it, and in particular, that information related to the irradiation of flesh foods is relevant to an evaluation of the safety of irradiated molluscan shellfish. The objection provides no information that would suggest the information in the cited memoranda is irrelevant to the molluscan shellfish final rule except to point out that they were written as part of the review of other petitions.

The objection also cites a statement from a memorandum written in 2001 that stated that “ * * * radiolysis products of irradiated lipids and proteins are either the same as, or structurally very similar to, compounds found in foods that have not been irradiated” and points out that the Agency has since acknowledged that 2-ACBs have thus far not been found in food that has not been irradiated. 12 As noted in the objection itself, there is no factual issue in dispute, and the objection points to no reason why the statement in the 2001 memorandum calls into question the Agency's subsequent conclusions about the safety of irradiated molluscan shellfish.

Finally, this part of the objection alleges that the 2001 memorandum ignores the FDA Redbook's statement that genotoxicity tests can contribute significantly to safety assessments. The Agency agrees that genotoxicity testing can be useful in the assessment of the safety of food additives. In the molluscan shellfish final rule the Agency discussed the use of genotoxicity tests, and of long-term feeding studies, in the context of the safety assessment of irradiated foods (70 FR 48057 at 48064) concluding: “The Bureau of Foods Irradiated Foods Committee (BFIFC) recommended that foods irradiated at a dose above 1 kGy be evaluated using a battery of mutagenicity tests to assess whether long-term feeding studies in animals were necessary (Ref. 36). Mutagenicity studies are primarily used to screen for potential mutagenic effects. Animal feeding studies are more reliable for determining the true mutagenic potential of a compound that is consumed in food. (Ref. 37). Moreover, one cannot draw valid conclusions from data simply by summing positive and negative results without fully evaluating the individual studies and assessing what conclusions such studies support and considering the totality of evidence. If the occasional report of a mutagenic effect were valid and significant to health, one should have seen consistent adverse toxicological effects in the many long term and reproduction studies with animals. This has not been the case.”

Thus, the Agency has acknowledged the utility of genotoxicity tests, but also states that when long-term animal feeding studies are available, that these latter studies are more reliable for determining the mutagenic potential of a compound consumed in food. Nothing in the objection would suggest that the Agency's position is in contradiction to the recommendations in the Redbook.

An objector must make an adequate proffer of evidence to support its allegations and to show that they provide a basis on which to call into question the agencies conclusions (§ 12.24(b)(2)). PC/CFS has not provided a basis for a hearing and FDA is denying PC/CFS’ request for a hearing based on this objection.

Finally, part four of the objection states that an FDA memorandum (Folmer-Jensen to Highbarger, 8/2/2002, FAP 9M4697) states that other food processing methods (such as freezing, canning and drying) can result in loss of vitamins, but neglects to consider the potential for additional vitamin reduction if irradiated foods were to be subsequently processed by freezing, canning or drying. This part further cites a 1986 trade press article as evidence that irradiation, when combined with other food processing techniques, has a greater effect on reducing levels of vitamins than each process individually. The objection then questions the Agency's conclusion that the contribution of thiamine, niacin and vitamin B6 from fish and shellfish represents an insignificant contribution to the nutritional needs of Americans. The objection cites two studies that showed a substantial reduction in thiamine level in irradiated cod.

The Agency agrees that irradiation may reduce some vitamins in foods. Additionally, further processing may further reduce some vitamins in foods. The extent to which vitamin loss is nutritionally significant depends in part on the relative contribution of the food in question to the overall dietary intake of the vitamin. The Agency has concluded that the reductions of vitamins in molluscan shellfish will cause negligible changes in total dietary intake of the affected vitamins as a result of irradiating molluscan shellfish under the conditions of the regulation. The objection questions the Agency's analysis and conclusion, but offers no data or information to support a contention that permitting the irradiation of molluscan shellfish would have an adverse impact on the nutritional adequacy of the diet. Moreover, the objection contains no information that would cause the Agency to change its conclusion that the consumption of irradiated molluscan shellfish to an absorbed dose of 5.5 kGy is safe.

A hearing will be denied if the Commissioner concludes that the data and information submitted are insufficient to justify the factual determination urged, even if accurate ((§ 12.24(b)(3)). FDA concludes that the data and information are insufficient; therefore, FDA is denying the request for a hearing based on this objection.

One objection submitted by Dr. Epstein alleges that FDA has “ignore[d] the fact that irradiation can dramatically increase the concentration of many potentially toxic chemicals.” Dr. Epstein specifically mentions benzene and toluene, quoting a statement from D.U. Ahn of Iowa State University: “[B]enzene and toluene * * * could be formed from amino acids upon irradiation * * * Benzene has deleterious effects on human health (Ref. 13).” In support of the quoted statement, the objection references a paper entitled “Effects of Electron Beam Irradiation and Antimicrobials on the Volatiles, Color, and Texture of Ready-to-Eat Turkey Breast Roll.”

The Agency acknowledges that benzene, toluene, and other compounds are formed, albeit in very small amounts, when meats are irradiated at sterilizing doses (Ref. 14.). The formation of benzene and other volatile compounds (including toluene) in irradiated foods and their possible risk to human health has been extensively evaluated by FDA and discussed in previous rulemaking ( see 62 FR 64107 at 64110-64111, 55 FR 18538 at 18542-18543 and 53 FR 53176 at 53197). Regarding benzene specifically, the Agency has stated: “The select Committee concluded that the small addition of benzene from radiation sterilized beef would contribute only a trivial increment to the normal body burden and is unlikely to increase significantly whatever hazard exists from other sources. FDA is not aware of any evidence that call this conclusion into question” (53 FR 53176 at 53197).

The objection identifies no evidence that the Agency overlooked, and does not provide any new evidence that would indicate benzene, toluene, or other chemicals are formed in irradiated molluscan shellfish in quantities that would pose a risk to human health. Thus, Dr. Epstein's request for a hearing based on this objection is denied because a hearing will not be granted on the basis of mere allegations or general descriptions of positions and contentions (§ 12.24(b)(2)).

The objection also criticizes the Agency for making “[a] blanket statement which the Agency fails to explain further: “FDA and food scientists worldwide have long agreed that the evaluation of the safety of irradiated foods requires consideration of the whole food, not the testing of each component.” Dr. Epstein also takes issue with the Agency's statement that “* * * identification of major radiolysis products will aid in the interpretation of data.”

Contrary to Dr. Epstein's remarks, the Agency provided a detailed explanation of its statement about safety testing of irradiated whole foods versus the testing of individual components of those foods in the context of its response to a comment expressing a different view about requirements for testing irradiated food ( see 70 FR 48057 at 48066). Additionally, the Agency has provided detailed discussions of the role of chemical identification of radiolysis products in the evaluation of data from safety testing ( see 70 FR 48507 at 48059 and 62 FR 64107 at 64110-64111 and section IV. H of this document).

In conclusion, the submitted objection contains no evidence that the Agency has overlooked and no new evidence that would call into question the Agency's previous conclusion that consumption of irradiated molluscan shellfish is safe. The objection merely alleges that there may possibly be formation of benzene and toluene and alleges a potential of harm. A hearing will not be granted on the basis of mere allegations or denials or general descriptions of positions and contentions (§ 12.24(b)(2)); therefore, FDA is denying the request for a hearing based on this objection.

The FD&C Act requires that a food additive be shown to be safe prior to marketing under section 409 of the FD&C Act. Under § 170.3(i), a food additive is “safe” if there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use. In the Agency's August 16, 2005, final rule approving the use of irradiation on fresh or frozen molluscan shellfish, FDA concluded that the studies conducted to establish the safety of this additive demonstrate that this use of irradiation is safe for its intended use on fresh or frozen molluscan shellfish.

The petitioner has the burden to demonstrate the safety of the additive to gain FDA approval. Nevertheless, once FDA makes a finding of safety in an approval document, the burden shifts to an objector, who must come forward with evidence that calls into question FDA's conclusion ( American Cyanamid Co. v. FDA, 606 F.2d 1307, 1314-1315 (DC Cir. 1979)).

Despite their many allegations, PC/CFS and Dr. Epstein have not established that FDA overlooked significant information in the record in reaching its conclusion that the use of irradiation on fresh or frozen molluscan shellfish is safe. In such circumstances, FDA has determined that the objections do not raise any genuine and substantial issue of fact that can be resolved by an evidentiary hearing (§ 12.24(b)).

Accordingly, FDA is denying the requests for a hearing. In addition, PC/CFS' and Dr. Epstein's requests for a stay of the effectiveness of the August 16, 2005, regulation until a hearing is held are moot because FDA is denying all hearing requests. Thus, FDA is confirming August 16, 2005, as the effective date of the final rule published at 70 FR 48057.

The following references are on display at the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20857, under Docket No. FDA-1999-F-0056 (formerly 1999F-4372), and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

Table of Contents I. What is the background for today's final action? II. Analysis of Nebraska's SIP Revision III. What is EPA's response to comments received on the proposed action? IV. What is the effect of today's final action? V. When is today's action effective? VI. Final Action VII. Statutory and Executive Order Reviews I. What is the background for today's final action?

EPA has recently undertaken a series of actions pertaining to the regulation of GHGs that, although for the most part distinct from one another, establish the overall framework for today's final action for the Nebraska SIP. The first four of these actions include, as they are commonly called, the “Endangerment Finding” and “Cause or Contribute Finding,” which EPA issued in a single final action, 1 the “Johnson Memo Reconsideration,”  2 the “Light-Duty Vehicle Rule,”  3 and the “Tailoring Rule.”  4 Taken together, these actions established regulatory requirements for GHGs emitted from new motor vehicles and new motor vehicle engines; determined that such regulations, when they took effect on January 2, 2011, subject GHGs emitted from stationary sources to PSD requirements; and limited the applicability of PSD requirements to GHG sources on a phased-in basis.

In a separate action, the “GHG PSD SIP Call,”  5 EPA called on the State of Nebraska and 12 other States with SIPs that do not provide authority to issue PSD permits governing GHGs to revise their SIPs to provide such authority. In that action, EPA took steps to ensure that in the 13 States that do not have authority to issue PSD permits to GHG-emitting sources at present, either the State or EPA would have the authority to issue such permits by January 2, 2011, or soon thereafter. EPA explained that although for most States, either the State or EPA is already authorized to issue PSD permits for GHG-emitting sources as of that date, Nebraska and the other 12 States have EPA-approved PSD programs that do not include GHG-emitting sources and therefore do not authorize these States to issue PSD permits to such sources. Accordingly, EPA issued the GHG PSD SIP Call to require a SIP revision that applies Nebraska's SIP PSD programs to GHG-emitting sources. EPA also established a SIP submittal deadline. In the proposed SIP call, EPA had stated that the deadline could range from as little as three weeks after the final SIP call was signed to as long as 12 months after the final SIP call was signed, and that each affected State was authorized to indicate to EPA a deadline to which it did not object. In the final SIP call, EPA established deadlines that ranged, for the various States, from December 22, 2010 (three weeks after signature), to December 1, 2011 (12 months after signature), based, in general, on each State's preference. Nebraska was one of the States for which EPA proposed and finalized the SIP Call. The State's comments regarding the proposed SIP call, submitted September 30, 2010, are included in the docket for this rulemaking. In the SIP call, EPA established a SIP submittal deadline for Nebraska of March 1, 2011, in accordance with Nebraska's preferences in that letter. As stated previously, Nebraska met this deadline by submitting a final rule addressing the SIP deficiency by letter dated January 14, 2011.

In addition, in the SIP call rulemaking, EPA stated certain requirements that the corrective SIP revision must meet, which are that the corrective SIP revision must—

(i) Apply the SIP PSD program to GHG-emitting sources;

(ii) Define GHGs as the same pollutant to which the Light-Duty Vehicle Rule  6 (LDVR) applies, that is, a single pollutant that is the aggregate of the group of six gases (carbon dioxide (CO 2 ), methane (CH 4 ), nitrous oxide (N 2 O), hydrofluorocarbons (HFCs), perfluorocarbons (PFCs), and sulfur hexafluoride (SF 6 )); and

(iii) Either limit PSD applicability to GHG-emitting sources by adopting the applicability thresholds included in the Tailoring Rule or adopt lower thresholds and show that the State has adequate personnel and funding to administer and implement those lower thresholds.

In addition, if the corrective SIP revision adopts the Tailoring Rule thresholds, then it must either adopt the CO 2 e metric and use short tons (as opposed to metric tons) for calculating GHG emissions in order to implement those thresholds, or assure that its approach is at least as stringent as under the Tailoring Rule, so that the State does not exclude more sources than under the Tailoring Rule. 75 FR 77713 to 77715.

On October 19, 2010, in response to the Tailoring Rule and earlier GHG-related EPA rules, and in anticipation of the GHG PSD SIP Call rulemaking, NDEQ submitted a draft revision of its air quality regulations to EPA for approval into the Nebraska SIP to: (1) Provide the State of Nebraska with the authority to regulate GHGs under its PSD program; and (2) establish appropriate emission thresholds and time-frames for determining which new or modified stationary sources become subject to Nebraska's PSD permitting requirements for GHG emissions. Subsequently, on December 27, 2010, EPA published a proposed rulemaking to approve NDEQ's October 19, 2010, SIP revision under parallel processing ( see 75 FR 81179).

EPA's December 27, 2010, proposed approval was contingent upon the State of Nebraska providing a final SIP revision that was substantially the same as the draft revision proposed for approval. On January 14, 2011, Nebraska submitted its final SIP revision. This SIP revision is the same as the proposed revision NDEQ submitted on October 19, 2010, for parallel processing. EPA is approving the final SIP revision in today's action.

In the December 27, 2010, proposed rulemaking, EPA also proposed to approve updates to Nebraska's SIP that reflected Nebraska's adoption of portions of EPA's 2002 NSR Reform Rules. In today's action EPA is also approving these NSR Reform updates.

Section 110(k)(3) of the CAA provides that EPA shall approve a SIP revision as a whole if it meets all of the applicable requirements of the CAA. Nebraska received a SIP call because its PSD program does not apply to GHGs, and as a result, Nebraska is required to submit a SIP revision that applies PSD to GHGs and does so either at the Tailoring Rule thresholds or at lower thresholds, and, if the latter, then Nebraska is required to demonstrate that it has adequate resources for implementation.

Nebraska has submitted a SIP revision that provides this authority. Nebraska's SIP revision updates the definition in its regulations of “regulated NSR pollutant” to explicitly include GHGs as a regulated NSR pollutant. In addition, the Nebraska rules incorporate the same thresholds and phase-in schedule as the Tailoring Rule and they adopt the carbon dioxide equivalent (CO 2 e) metric and use of short tons for determining the thresholds.

EPA has determined that Nebraska's GHG revisions meet the requirements of the SIP call and are consistent with the CAA and its implementing regulations regarding GHG.

In addition, EPA is also approving the portion of Nebraska's SIP revisions which address portions of EPA's 2002 NSR Reform rules. As EPA explained in the proposed rulemaking, Nebraska had previously made changes to its existing State regulations to adopt portions of the NSR Reform rules. 75 FR 81185. 7 Although these revisions were effective at the State level, NDEQ had not previously submitted these changes to EPA for approval into the Nebraska SIP. Thus, on November 19, 2010, NDEQ submitted these revisions to the Nebraska Administrative Code relating to NSR Reform to EPA for approval. These revisions included changes to the following Chapters of Title 129 of the Nebraska Administrative Code: Chapter 1 ( Definitions ), Chapter 2 ( Definition of Major Source ), Chapter 14 ( Permits: Public Participation ), Chapter 15 ( Permit Revisions; Reopening for Cause ), Chapter 17 ( Construction Permits—When Required ), 8 and Chapter 19 ( Prevention of Significant Deterioration of Air Quality ).

Nebraska's proposed SIP revision addressing NSR reform tracks the Federal NSR Reform Rules, and as stated previously, EPA has determined that the implementation of the Federal NSR Reform Rules will be environmentally beneficial. See 68 FR 44620 and 63021. EPA explained its analysis of the Nebraska revisions in detail in the proposal, at 75 FR 81186, and incorporates that explanation by reference in this final action. Accordingly, EPA determines that these changes are consistent with the requirements of section 110(l).

EPA received a single comment letter in response to the December 27, 2010, proposed rulemaking to approve revisions to Nebraska's SIP. These comments, provided by the Sierra Club, were supportive of Nebraska's proposed revisions and EPA's actions with respect to GHGs and the PSD and Title V GHG Tailoring Rule (75 FR 31514). The comments are provided in the docket for today's final action. EPA did not receive any comments on its proposal to approve the NSR reform revisions.

Final approval of Nebraska's January 14, 2011, SIP revision will make Nebraska's SIP adequate with respect to PSD requirements for GHG-emitting sources. Today's approval will incorporate into the SIP the GHG emission thresholds for PSD applicability that were set forth in EPA's Tailoring Rule, ensuring that smaller GHG sources emitting below these thresholds will continue to not be subject to permitting requirements. Today's approval will also incorporate portions of EPA's 2002 NSR Reform Rules, as adopted by Nebraska, into the SIP. Pursuant to section 110 of the CAA, EPA is approving the changes made in Nebraska's January 14, 2011, proposed SIP revision into the State's SIP. However, as we noted in the proposed approval of Nebraska's submittal, 75 FR 81183, this action only addresses the State's revisions as they relate to the PSD program, including regulation of GHGs under the State's PSD program. We intend to act separately on the State's revisions to its Title V program, as well as Nebraska's separate submittal of changes to the applicability of the PSD program to contain ethanol production facilities (the “Ethanol Rule”). 9

The GHG revisions to Nebraska's SIP-approved PSD program that EPA is approving today have been reviewed and determined to be consistent with the Tailoring Rule. EPA has also determined that the GHG revisions are adequate to correct the deficiencies which EPA found for Nebraska in the GHG SIP call. Finally, EPA has also determined that the Nebraska SIP revisions relating to NSR Reform are, in substantive content, the same as EPA's December 2002 NSR reform rule, as it relates to PALs, the “actual to projected actual” test, and the calculation of baseline actual emissions. Thus, EPA has determined that the January revisions to Nebraska's SIP are consistent with section 110 of the CAA.

The effective date of today's final action is the date that this rule is published in the Federal Register . In accordance with 5 U.S.C. 553(d), a rule cannot be made effective less than 30 days from the date of publication unless it qualifies for an exception under that provision. Under 5 U.S.C. 553(d)(1), one such exception is “a substantive rule which grants or recognizes an exemption or relieves a restriction.” Today's final action relieves a restriction because it allows Nebraska to issue permits, under the Federally approved SIP, to sources which are already required to have PSD permits covering GHGs, but which previously did not have a permit issuing authority available from which to seek such a permit. In addition, 5 U.S.C. 553(d)(3) allows an effective date less than 30 days after publication “as otherwise provided by the agency for good cause found and published with the rule.” Because, as stated above, this rule allows Nebraska to issue PSD permits under the approved SIP for sources of GHGs already required to seek such permits, it avoids disruption in the State's permitting process which might otherwise occur. Additionally, the State's permitting process would potentially be disrupted if the NSR Reform provisions do not have the same effective date as the other provisions being approved today. Therefore, EPA finds good cause under 5 U.S.C. 553(d)(3) for this action to become effective immediately upon publication. For these reasons, the effective date of this rule is the date of publication.

EPA is taking final action to approve the State of Nebraska's SIP revisions, which adopt changes to Title 129 the Nebraska Administrative Code. The SIP revisions: (1) Provide the State with the authority to regulate GHGs under its PSD program, and (2) establish appropriate emissions thresholds, and timing, for determining PSD applicability with respect to new or modified GHG-emitting stationary sources in accordance with EPA's Tailoring Rule. The SIP revisions also adopt portions of EPA's 2002 NSR Reform rule as identified above. EPA has made the determination that the SIP revisions are approvable because they are in accordance with the CAA and EPA regulations, including regulations pertaining to PSD permitting.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve State choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves State law as meeting Federal requirements and does not impose additional requirements beyond those imposed by State law. For those reasons, this action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. );

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. );

• 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);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have Tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the State, and EPA notes that it will not impose substantial direct costs on Tribal governments or preempt Tribal law.

The Congressional Review Act, 5 U.S.C. 801 et seq., as amended 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 action 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 CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by May 23, 2011. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action 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).)

40 CFR part 52 is amended as follows:

On May 24, 2010, the Clean Air Task Force (CATF), the National Wildlife Federation, the World Wildlife Fund and the Friends of the Earth petitioned the Administrator to reconsider an EPA rule, published on March 26, 2010 (75 FR 14670), which amended the Renewable Fuel Standard Program. This amendment (commonly referred to as RFS2) was adopted in response to Clean Air Act Section 211(o) as amended by the Energy Independence and Security Act of 2007 (EISA). The petitioners alleged that EPA failed to properly require producers of renewable fuels to verify domestic crops and crop residues used to produce the renewable fuels complied with the land use restrictions in EISA. The petitioners other than CATF requested a stay of the aggregate compliance portion of the RFS2 rules. Additionally, the CATF alleged that in this rule, EPA did not properly account for the “global rebound effect” in the final analysis of the lifecycle greenhouse gas (GHG) emission impacts of renewable fuel production and use. CATF requested a stay of the entire RFS2 final rule.

The EPA considers the lifecycle GHG emission assessment of renewable fuels and the land use restrictions applicable to renewable biomass provisions to be important parts of the RFS2 program and carefully reviewed the arguments and information provided by the petitioners on these two issues. On February 17, 2011, the Administrator responded by denying the petitions to reconsider. The EPA also denied all requests for a stay of implementation of the RFS2 regulations. The letters of denial and the supporting rationale have been posted on the EPA Web site at: http://www.epa.gov/otaq/fuels/renewablefuels/notices.htm.

The General Services Administration (GSA) published a final rule at 61 FR 56399, November 1, 1995 which codified GSA's supplemental standards of ethical conduct in the new 5 CFR part 6701. At that time, GSA removed from the CFR its old standards of conduct, which had been codified at 41 CFR part 105-735 and provided a number of cross-references to the new Government-wide standards of ethical conduct regulations and GSA's new supplemental regulations. GSA is removing part 105-735 because the cross-reference to the GSA Order is no longer applicable and employees are familiar with the remaining cross-referenced provisions and no longer refer to 41 CFR part 105-735 for guidance on employee standards of conduct.

Pursuant to 5 U.S.C. 553(b) and (d), GSA has determined that good cause exists for waiving the general notice of proposed rulemaking and 30-day delay in effectiveness as to these minor revisions. This action is being taken because this rule concerns matters of agency organization, practice and procedure and merely serves to remove a part of the Code of Federal Regulations which no longer provides guidance to GSA employees.

GSA has determined that this final rule is not a significant rule for the purposes of Executive Order 12866, Regulatory Planning and Review, dated September 30, 1993.

In accordance with Executive Order 13563, Improving Regulation and Regulatory Review, dated January 18, 2011, GSA determined that this rule is not excessively burdensome to the public, and is consistent with 5 U.S.C. 7301.

GSA has determined under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) that this rulemaking will not have significant economic impact on a substantial number of small entities because it relates solely to agency management and personnel.

The Paperwork Reduction Act does not apply because this rulemaking does not impose recordkeeping or information collection requirements, or the collection of information from offerors, contractors, or members of the public that require the approval of the Office of Management and Budget under 44 U.S.C. chapter 35.

This final rule is also exempt from congressional review prescribed under 5 U.S.C. 801 since it relates solely to agency management and personnel.

This is a synopsis of the Commission's Report and Order, MB Docket No. 09-181, adopted March 2, 2011, and released March 4, 2011. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC Information Center, Portals II, 445 12th Street, SW., Room CY-A257, Washington, DC 20554. The complete text of this decision also may be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20554, (800) 378-3160, or via the company's Web site, http://www.bcpiweb.com. This document does not contain proposed information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any proposed information collection burden “for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506 (c)(4). The Commission will send a copy of this Report and Order in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see U.S.C. 801(a)(1)(A).

For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 73 as follows:

In October 2002, the U.S. Fish and Wildlife Service (Service) received a petition signed by members of Congress representing the Great Lakes region to add bighead, silver, and black carp to the list of injurious wildlife under the Lacey Act (18 U.S.C. 42). In a final rule of July 10, 2007 (72 FR 37459), the Service added silver and largescale silver carp to the list of injurious wildlife at 50 CFR 16.13, and in a final rule of October 18, 2007 (72 FR 59019), the Service added black carp to this list. The Service published a Federal Register notice of inquiry on bighead carp (68 FR 54409; September 17, 2003) and provided a 60-day public comment period, but the listing process for this species was delayed. Another letter from members of Congress in 2009 supported the petitioned action for bighead carp.

The Asian Carp Prevention and Control Act (Pub. L. 111-307) was passed by the Senate on November 17, 2010, and by the House of Representatives on December 1, 2010, and signed into law by President Obama on December 14, 2010. The law amends the Lacey Act (18 U.S.C. 42) by adding the bighead carp ( Hypophthalmichthys nobilis ) to the list of injurious animals contained therein. The statutory prohibitions and exceptions for this species went into effect upon signature into law. This rule adds the bighead carp to the list of injurious fish, mollusks, and crustaceans at 50 CFR 16.13.

The regulations contained in 50 CFR part 16 implement the Lacey Act (18 U.S.C. 42) as amended. Under the terms of that law, the importation and interstate transportation of certain named wildlife is prohibited, with exceptions. Additionally, the Secretary of the Interior is authorized to prescribe by regulations other wild animals, or viable eggs thereof, that are deemed to be injurious or potentially injurious to the health and welfare of human beings, to the interests of agriculture, forestry, or horticulture, or to the welfare and survival of the wildlife or wildlife resources of the United States.

The Asian Carp Prevention and Control Act added the bighead carp to the statutory list. The Service accordingly amends 50 CFR 16.13 to reflect the current list of prohibited wildlife. By adding all forms of live bighead carp ( Hypophthalmichthys nobilis ), gametes, viable eggs, and hybrids thereof to the list of injurious fish, mollusks, and crustaceans in 18 U.S.C. 42 and now in 50 CFR 16.13, their importation into the United States or transportation between States, the District of Columbia, the Commonwealth of Puerto Rico, or any territory or possession of the United States by any means whatsoever is prohibited except by permit for zoological, educational, medical, or scientific purposes, or by Federal agencies without a permit solely for their own use upon filing a written declaration with the District Director of Customs at the port of entry. In addition, no live bighead carp, gametes, viable eggs, or hybrids thereof acquired under permit may be sold, donated, traded, loaned, or transferred to any other person unless such person has a permit issued by the Director of the Service. The interstate transportation of any live bighead carp, gametes, viable eggs, or hybrids thereof that currently may be held in the United States for any purpose is prohibited, unless authorized by permit.

In adding bighead carp to the list of injurious fish, we are revising some of the current text in 50 CFR 16.13. These changes are nonsubstantive and for the purposes of creating a consistent format for the list and helping to ensure clarity.

We are making this rule effective upon publication in the Federal Register . In accordance with the Administrative Procedure Act (5 U.S.C. 553 (d)(3)), we find good cause to make this rule effective less than 30 days after publication in the Federal Register . With the signing of Public Law 111-307, the listing of bighead carp and the statutory prohibitions on importation into the United States and interstate transport went into effect on December 14, 2010. The Service does not have the authority to delay the effectiveness of the listing or the prohibitions. Therefore, we find good cause to make this rule effective immediately.

This rulemaking amends the list of prohibited species in 50 CFR 16.13 to accurately reflect the addition made by Public Law 111-307, the Asian Carp Prevention and Control Act, which amends the U.S. Code (18 U.S.C. 42) by adding the bighead carp to its list of injurious animals. To update the Code of Federal Regulations to conform with Public Law 111-307, it is necessary to add this species to the implementing regulations (50 CFR 16.13). The Administrative Procedure Act requires publication of a proposed rule and the opportunity for public comment, except when such notice and comment would be impracticable, unnecessary, or contrary to the public interest. In this situation, public notice and the opportunity to comment are unnecessary because there would be nothing for the public to comment on. The Service does not have the authority to remove or alter either the listing that Congress put in place with Public Law 111-307 or the prohibitions that went into effect on December 14, 2010. The facts of this situation may also meet the “contrary to the public interest” standard under the APA to the extent that publication of a proposed rule would likely mislead the public by implying either that the prohibitions are not yet in effect or that the agency has discretion over whether the species should be listed or discretion over the scope or timing of the prohibitions. This rulemaking involves no discretionary or policy decisionmaking on the part of the Service, but merely amends regulations to reflect a change in statute. As such, neither an economic analysis nor an environmental assessment was required in conjunction with this rulemaking.

This final rule contains no information collection requirements for which Office of Management and Budget approval is required under the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq. ).

Accordingly, 50 CFR part 16 is amended as described below: