Federal Register Vol. 81, No.53,

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all Airbus Model A319-131, -132, and -133 airplanes; Model A320-232 and -233 airplanes; and Model A321-131, -231, and -232 airplanes. The NPRM published in the Federal Register on July 30, 2015 (80 FR 45462) (“the NPRM”).

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2015-0004, dated January 13, 2015 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Airbus Model A319-131, -132, and -133 airplanes; Model A320-232 and -233 airplanes; and Model A321-131, -231, and -232 airplanes. The MCAI states:

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM and the FAA's response to each comment.

United Airlines (UAL) requested that paragraph (h) of the proposed AD be re-written to clarify which attachment pin part numbers can be used as replacement parts.

We partially agree with the commenter's request. We agree to provide clarification but we do not agree to revise paragraph (h) of this AD. Paragraph (h) of this AD states to replace with a serviceable part having a part number other than part number(P/N) 740-2022-501, and having a serial number that is not identified in figure 1 to paragraphs (h) and (j) of this AD. In other words, the replacement part cannot have a combination of P/N 740-2022-501 and any serial number that is included in figure 1 to paragraphs (h) and (j) of this AD. We have not changed this AD in this regard.

JetBlue requested clarification of the intent of paragraph (i) of the proposed AD. JetBlue asserted that the way this paragraph is written it contradicts the requirements in EASA AD 2015-0004, dated January 13, 2015, and the intent of the inspection in paragraph (h) of the proposed AD.

We agree with the commenter's request to clarify the intent of paragraph (i) of this AD. Airplanes with manufacturer serial numbers not identified in figure 2 to paragraph (i) of this AD that have not had an engine replaced after March 1, 2011, are not required to do the actions mandated by paragraphs (g) and (h) of this AD, which corresponds to paragraph (2) of the MCAI AD. In paragraph (i) of the proposed AD we inadvertently specified “airplanes with manufacturer serial numbers identified in figure 2 to paragraph (i) of this AD.” We have changed paragraph (i) of this AD to specify “airplanes with manufacturer serial numbers not identified in figure 2 to paragraph (i) of this AD.”

UAL requested that the compliance times in paragraph (g) of the proposed AD be extended. UAL stated that this would keep costs down and “make engine removal the most likely time the inspection would occur.” UAL also asserted that the safety concern is overstated based on information in the Goodrich Aerostructures service information. The “Background” paragraph of the Goodrich Aerostructures service information states that “a minor metallurgical discontinuity” was found on some forward engine mount crossbeam to main beam attach pins (P/N 740-2022-501). UAL stated that a minor metallurgical issue should not drive a significant safety concern.

We do not agree with the commenter's request to extend the compliance time. Even a “minor metallurgical discontinuity” can result in a safety concern. Forward engine mount attachment pins that were manufactured from discrepant raw material can lead to the failure of a forward engine mount attachment pin; this condition could result in possible loss of an engine in-flight and consequent reduced controllability of the airplane.

After considering all of the available information, we have determined that the compliance time, as proposed, represents an appropriate interval of time in which the required actions can be performed in a timely manner with the affected fleet, while still maintaining an adequate level of safety. In developing an appropriate compliance time, we considered the safety implications, parts availability, and normal maintenance schedules for timely accomplishment of the replacement. However, under the provisions of paragraph (m)(1) of this AD, we may approve requests for adjustments to the compliance time if data are submitted to substantiate that such an adjustment would provide an acceptable level of safety. We have not changed this AD in this regard.

UAL requested that the estimated costs of compliance in the NPRM be increased from $156,740 to $313,480. UAL also requested that the costs for opening and closing the reversers be mentioned as costs that cannot be calculated. Furthermore, UAL stated that based on the proposed compliance times in paragraph (g) of the proposed AD and the size of the UAL fleet, the proposed requirements would have to be scheduled independently from its maintenance schedule.

We agree with the commenter's request to increase the estimated costs for compliance with the requirements of this AD. We note that these are only estimated costs and may vary based on an airplane's configuration. We also acknowledge that the costs for opening and closing the reversers are not known and are not included in the “Costs of Compliance” paragraph of this AD. However, as specified in the service information, the inspection takes approximately 4 work-hours, with an estimated cost of $313,480 for U.S. operators. We have changed the “Costs of Compliance” paragraph of this AD accordingly.

JetBlue Airways (JetBlue) requested that the NPRM be revised to refer to Airbus Service Bulletin A320-71-1064, Revision 01, dated April 1, 2015; and Goodrich Aerostructures Service Bulletin V2500-NAC-71-0323, Revision 01, dated January 28, 2015. JetBlue noted that the service information for both Airbus and Goodrich Aerostructures had been revised since the NPRM was published.

We agree with the commenter's request and have revised the “Related Service Information under 1 CFR part 51” section and paragraphs (g) and (h) of this AD to refer to Airbus Service Bulletin A320-71-1064, Revision 01, dated April 1, 2015; and Goodrich Aerostructures Service Bulletin V2500-NAC-71-0323, Revision 01, dated January 28, 2015. We have also added new paragraph (l) to this AD to give credit for actions done using Airbus Service Bulletin A320-71-1064, dated November 5, 2014; and Goodrich Aerostructures Service Bulletin V2500-NAC-71-0323, dated September 18, 2014. We redesignated subsequent paragraphs accordingly.

JetBlue requested that paragraph (g) of the proposed AD be revised to allow operators to use either the Airbus service information or the Goodrich Aerostructures service information to do the actions required by that paragraph. JetBlue stated that if the engine is being inspected at the shop, the actions in the Airbus service information would not be accomplished because the Airbus service information addresses inspections of the wing. JetBlue also stated this revision would correspond with the requirements in corresponding EASA AD 2015-0004, dated January 13, 2015.

We do not agree with the commenter's request to allow operators to have the option of doing the actions required by paragraph (g) of this AD in accordance with either the Accomplishment Instructions of the Airbus service information or the Goodrich Aerostructures service information. The Airbus service information includes steps that are considered “required for compliance” (RC) and those steps are not included in the Goodrich Aerostructures service information. In addition, Goodrich Aerostructures Service Bulletin V2500-NAC-71-0323, Revision 01, dated January 28, 2015, does not distinguish between “RC” and non-“RC” steps and refers to the Airbus service bulletin for incorporation of several steps. Therefore, regardless of whether the AD requirements are accomplished “on wing” or “in shop,” operators must use a combination of Airbus and Goodrich Aerostructures service information for accomplishing the AD requirements. We have not changed this AD regarding this issue.

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD with the changes described previously and minor editorial changes. 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 this AD.

Airbus has issued Service Bulletin A320-71-1064, Revision 01, dated April 1, 2015; and Goodrich Aerostructures has issued Service Bulletin V2500-NAC-71-0323, Revision 01, dated January 28, 2015. The service information describes procedures for an inspection to determine the serial number of the attachment pins for the forward engine mount crossbeam to main beam for each engine, and replacement of affected pins. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

We estimate that this AD affects 922 airplanes of U.S. registry.

We also estimate that it will take about 4 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 $0 per product. Based on these figures, we estimate the cost of this AD on U.S. operators to be $313,480, or $340 per product.

In addition, we estimate that any necessary follow-on actions will take about 4 work-hours and require parts costing $1,724, for a cost of $2,064 per attachment pin replacement. We have no way of determining the number of aircraft that might need this action.

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 that 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);

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 supersede AD 2012-15-13, Amendment 39-17142 (77 FR 47267, August 8, 2012) (“AD 2012-15-13”). AD 2012-15-13 applied to certain The Boeing Company Model 747-100B SUD, 747-300, 747-400, and 747-400D series airplanes; and Model 747-200B series airplanes having a stretched upper deck. The NPRM published in the Federal Register on July 24, 2015 (80 FR 43974) (“the NPRM”). The NPRM was prompted by an evaluation that indicated that the upper deck is subject to WFD. The NPRM proposed to continue to require inspections for cracking and discrepancies of certain fasteners; modification of the frame-to-tension-tie joints; repetitive post-modification inspections; related investigative and corrective actions if necessary; and repetitive inspections for cracking in the tension tie channels, and repair if necessary. For certain airplanes, the NPRM also proposed to continue to require an inspection to determine if the angle is installed correctly, and re-installation if necessary; and an inspection at the fastener locations where the tension tie previously attached to the frame prior to certain modifications, and repair if necessary. The NPRM also proposed to add a new inspection for cracking in the tension tie channels and post-modification inspections of the modified tension ties for cracking, and repair if necessary. We are issuing this AD to prevent fatigue cracking of the tension ties, shear webs, and frames of the upper deck, which could result in rapid decompression and reduced structural integrity of the airplane.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM and the FAA's response to each comment.

United Airlines concurred with the contents of the NPRM.

Boeing and United Parcel Service (UPS) asked that we add a new paragraph to the proposed AD that includes an option to perform the inspections specified in Boeing Alert Service Bulletin 747-53A2507, Revision 2, dated May 9, 2014. Boeing stated that these inspections are equivalent to the inspections done in accordance with Boeing Alert Service Bulletin 747-53A2507, Revision 1, dated January 14, 2010. UPS recommended that Boeing Alert Service Bulletin 747-53A2507, Revision 2, dated May 9, 2014, be added to paragraphs (g) through (o) of the proposed AD. UPS noted that, for clarity, the proposed AD should refer to the revised service information rather than relying on paragraph (t)(4) of the proposed AD, which allows alternative methods of compliance (AMOCs) previously approved for AD 2012-15-13 to be approved as AMOCs for the proposed AD.

We acknowledge the commenters' requests and note that we normally add reference to later revisions of service information in the restated paragraphs of supersedure ADs. However, in most cases, the later revisions do not include new compliance times and the procedures are closely aligned with those in the previous service information. Boeing Alert Service Bulletin 747-53A2507, Revision 2, dated May 9, 2014, adds alternative compliance times for certain airplanes and refers to different procedures in the Accomplishment Instructions of Boeing Alert Service Bulletin 747-53A2507, Revision 2, dated May 9, 2014, for accomplishing the actions required by AD 2012-15-13. Therefore, we cannot simply add a reference to paragraphs (g) through (o) of this AD as requested by the commenter. We have determined that, in this case, adding additional paragraphs to this AD to specify the alternative method of compliance, including new compliance times and procedures, is not necessary since Boeing Alert Service Bulletin 747-53A2507, Revision 2, dated May 9, 2014, was already approved as an AMOC to AD 2012-15-13. As stated by the commenter, paragraph (t)(4) of this AD already allows the use of previous AMOCs, such as Boeing Alert Service Bulletin 747-53A2507, Revision 2, dated May 9, 2014, as AMOCs for the corresponding provisions of this AD. We have made no change to this AD in this regard.

Boeing and UPS asked that we add a new paragraph to allow an alternative compliance time for airplanes on which the station (STA) 1120, 1160, 1200, and 1220 tension ties were modified during a freighter conversion, as provided in table 4 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-53A2559, Revision 2, dated May 13, 2014. Boeing stated that the compliance time for modification of those airplanes can be increased because the modification has been done during a freighter conversion. UPS noted that paragraph (p) of the proposed AD should be changed to require modification and all related inspections and corrective actions be accomplished in accordance with Boeing Alert Service Bulletin 747-53A2559, Revision 2, dated May 13, 2014, at the applicable time specified in Boeing Service Bulletin 747-53A2559, Revision 1, dated August 4, 2011; or Boeing Alert Service Bulletin 747-53A2559, Revision 2, dated May 13, 2014.

We agree with the commenter to include the alternative compliance times for certain airplanes to accomplish the actions required by paragraph (p) of this AD. We have added a new paragraph (p)(3) to this AD for Group 3 through 5, Configuration 1 airplanes identified in Boeing Alert Service Bulletin 747-53A2559, Revision 2, dated May 13, 2014, to specify that operators may accomplish the actions required by paragraph (p) of this AD within the applicable compliance times specified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-53A2559, Revision 2, dated May 13, 2014.

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD with the changes described previously and minor editorial changes. 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 this AD.

We reviewed Boeing Alert Service Bulletin 747-53A2559, Revision 2, dated May 13, 2014. The service information describes procedures for modifying the tension tie and frame at certain center sections, including related investigative and corrective actions; post-modification inspections for cracking of the tension tie and frame structure and corrective actions; an additional modification; an inspection of all areas of the modified tension ties for cracking; an inspection of the tension tie center section for cracking in certain tension tie channels; and repair.

This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

We estimate that this AD affects 120 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

We have received no definitive data that will enable us to provide a cost estimate for the on-condition actions specified in this AD.

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

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

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

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

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

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

(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:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain The Boeing Company Model 777 airplanes. The NPRM published in the Federal Register on July 9, 2015 (80 FR 39392). The NPRM was prompted by reports of fire and smoke at the engine aft pylon area resulting from fuel leakage caused by a damaged O ring in the fuel coupling attached to the wing front spar. The fuel was captured by the fuel coupling rubber boot and was discharged into the flammable fluid leakage zone of the strut-to-wing cavity, as intended. However, the fuel did not follow its intended drain paths into the aft strut and lower wing panel drains, but instead followed an unintended drain path through an unsealed gap between the lower wing panels above the strut aft vapor barrier. The leaking fuel then followed gaps and seams in the aft fairing structure to the outside of the strut fairing side panels, ignited after contact with the hot engine exhaust heat shield, and caused a fire and smoke. We are issuing this AD to prevent fire and smoke at the engine aft pylon area in the event of a fuel leak, which could cause personal injury during ground operations. A fire spreading back and up to the aft fairing pylon can result in an uncontrolled fire in the strut and ignite the fuel tank.

We gave the public the opportunity to participate in developing this AD. We have considered the comments received. Boeing concurred with the NPRM (80 FR 39392, dated July 9, 2015), and FedEx had no technical objection.

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD as proposed—except for minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM (80 FR 39392, dated July 9, 2015) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (80 FR 39392, dated July 9, 2015).

We have reviewed Boeing Special Attention Service Bulletin 777-54-0035, dated October 30, 2014. The service information describes procedures for applying sealant to fill the gap between wing panels. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

We estimate that this AD affects 196 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

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

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

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 by adding an AD that would apply to the specified products. The NPRM was published in the Federal Register on November 10, 2015 (80 FR 69623). The 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 (80 FR 69623, November 10, 2015).

We updated the revision number and date of P&WC Service Bulletin No. PT6A-72-14389.

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

P&WC has issued Service Bulletin (S.B.) No. PT6A-72-14389, Revision No. 4, dated February 3, 2016 (P&WC S.B. No. 14389R4) and S.B. No. PT6A-72-13473, Revision No. 1, dated May 26, 2015 (P&WC S.B. No. 13473R1). The service information describes procedures for replacing Woodward FCUs. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section of this final rule.

We estimate that this AD affects 341 engines installed on airplanes of U.S. registry. We also estimate that it will take about 1.5 hours per engine to comply with this AD. The average labor rate is $85 per hour. Required parts cost about $1,000 per engine. Based on these figures, we estimate the cost of this AD on U.S. operators to be $384,478.

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),

(3) Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction, 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:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Quest Aircraft Design, LLC Model KODIAK 100 airplanes. The NPRM published in the Federal Register on November 5, 2015 (80 FR 68477). The NPRM was prompted by a report of limited control yoke movement of the elevator control system due to cushion edging jammed in the elevator control anti-rotation guide slot. The NPRM proposed to require repetitively inspecting the elevator control system cushion edging for proper condition; replacing the cushion edging; and at a specified time terminating the repetitive inspections by installing wear pads on the elevator bearing assemblies. We are issuing this AD to correct the unsafe condition on these products.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM (80 FR 68477, November 5, 2015) and the FAA's response to each comment.

Quest Aircraft Design revised one of the related service bulletins and requested that Quest Aircraft Company KODIAK 100 Mandatory Service Bulletin SB14-07, Revision 01, dated November 23, 2015, be incorporated into the final rule AD action.

We agree. We revised this AD as requested.

Quest Aircraft Design stated that the instructions for doing the actions required in the AD are actually contained in the Field Service Instructions (FSIs) issued by Quest Aircraft and that there is no need to include reference to the related service bulletins since they are basically cover letters that point to the FSIs for the instructions. The commenter requested to have the related service bulletins removed from the AD to make the AD clearer to the reader and to eliminate any confusion.

We agree that the FSIs contain the instructions for completing the actions required in this AD; however, the service bulletins contain additional pertinent information, such as company contact information and FAA approval status that is not included in the associated FSI.

We do not agree that the service bulletins should be removed from the AD. We did not revise this AD as requested.

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

• Are consistent with the intent that was proposed in the NPRM (80 FR 68477, November 5, 2015) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (80 FR 68477, November 5, 2015).

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

We reviewed Quest Aircraft Company KODIAK 100 Mandatory Service Bulletin SB14-07, Revision 01, dated November 23, 2015; Quest Aircraft KODIAK Mandatory Service Bulletin SB14-07, dated August 26, 2014; Quest Aircraft Company Field Service Instruction, Elevator Control System—Cushion Edging Inspection, Report No. FSI-105, Revision 00, not dated; Quest Aircraft KODIAK 100 Recommended Service Bulletin SB15-01, dated March 26, 2015; and Quest Aircraft Field Service Instruction, Yoke Anti-Rotation Guide Wear Pad Upgrade, Report No. FSI-108, Revision 00, not dated. The service information describes procedures for repetitively inspecting the cushion edging installed on the elevator control anti-rotation guide for proper condition, wear, and security, and replacing if necessary; and removing the cushion edging and installing wear pads on the pilot and co-pilot arms of the elevator bearing assemblies as a terminating action to the repetitive inspections of the cushion edging. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

We estimate that this AD affects 60 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

We estimate the following costs to do any necessary replacements that will be required based on the results of the inspection. We have no way of determining the number of aircraft that might need this replacement:

According to the manufacturer, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.

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 received a report of a significant GE GEnx-1B PIP2 engine fan rub event, apparently caused by partial fan ice shedding and a resulting fan imbalance that in turn caused substantial damage to the engine and an in-flight non-restartable power loss. We continue to investigate this issue with Boeing and GE; however, the engine damage appears to be a result of reduced fan tip clearances common to the GEnx-1B PIP2 engine. The other engine on the event airplane was a GEnx-1B PIP1 configuration that incurred expected wear and minor damage during the icing event and continued to operate normally. The event occurred in icing conditions at an altitude of 20,000 feet. Reduced fan tip clearance, if not corrected, could result in engine damage and a possible in-flight non-restartable power loss of one or both engines. We are issuing this AD to correct the unsafe condition on these products.

We reviewed GE GEnx-1B Service Bulletin 72-0309 R00, dated March 11, 2016, which describes procedures for reworking the fan stator module assembly on GEnx-1B PIP2 engines. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

We are issuing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.

This AD requires accomplishing the actions specified in the GE service information described previously. This AD also requires revising the airplane flight manual (AFM) to provide the flight crew a new fan ice removal procedure to reduce the likelihood of engine damage due to fan ice shedding.

We consider this AD interim action. The engine manufacturer is currently developing a modification that will address the unsafe condition identified in this AD. Once this modification is developed, approved, and available, we may consider additional rulemaking.

An unsafe condition exists that requires the immediate adoption of this AD. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because reduced fan tip clearance could result in engine damage and a possible in-flight non-restartable power loss of one or both engines. Therefore, we find that notice and opportunity for prior public comment are impracticable and that good cause exists for making this amendment effective in less than 30 days.

This AD is a final rule that involves requirements affecting flight safety and was not preceded by notice and an opportunity for public comment. However, we invite you to send any written data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include the docket number FAA-2016-4227 and Directorate Identifier 2016-NM-025-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 we receive about this AD.

We estimate that this AD affects 34 airplanes of U.S. registry. We estimate the following costs to comply with this AD:

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

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

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 supplemental notice of proposed rulemaking (SNPRM) to amend 14 CFR part 39 to supersede AD 2006-22-15, Amendment 39-14812 (71 FR 64884, November 6, 2006) (“AD 2006-22-15”). AD 2006-22-15 applied to all The Boeing Company Model 747-100, 747-100B, 747-100B SUD, 747-200B, 747-200C, 747-200F, 747-300, 747-400, 747-400D, 747-400F, 747SR, and 747SP series airplanes. The SNPRM published in the Federal Register on September 18, 2015 (80 FR 56407) (“the SNPRM”). We preceded the SNPRM with a notice of proposed rulemaking (NPRM) that published in the Federal Register on November 17, 2014 (79 FR 68388) (“the NPRM”). The NPRM proposed to continue to require repetitive inspections for cracking of certain panel webs and stiffeners of the NWW, and corrective actions if necessary; and replacement of certain panels with new panels, which terminates the repetitive inspections. The NPRM proposed to reduce a compliance time and add certain inspections and repair if necessary. The NPRM was prompted by reports of fatigue cracking in the panel webs and stiffeners of the NWW found prior to the inspection threshold of AD 2006-22-15. The SNPRM revised the NPRM by specifying a repetitive inspection interval for a certain NWW area inspection. We are issuing this AD to prevent fatigue cracking of the NWW side and top panels, which could result in a NWW depressurization event severe enough to reduce the structural integrity of the fuselage.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the SNPRM and the FAA's response to each comment.

Two commenters supported the SNPRM. One commenter stated that the FAA should continue to execute its administrative power to ensure traveler safety and industry compliance, adding that while the original rule was good, ensuring that specifics are covered and timetables are available is an important improvement.

Boeing requested that we allow credit for the compliance times in previously approved AMOCs, if the compliance times are acceptable according to the SNPRM.

We agree with the commenter's request. We have revised paragraph (p)(4) of this AD to state that: AMOC actions approved previously for AD 2006-22-15 are approved as AMOCs for the corresponding actions of this AD. In addition, paragraph (p)(4) of this AD states that the compliance times in AMOCs approved previously for AD 2006-22-15 are not approved for the corresponding actions and compliance times in this AD, if this AD specifies an earlier compliance time than that specified in AD 2006-22-15; and that compliance times in AMOCs approved previously for AD 2006-22-15 that meet the requirements of this AD are acceptable.

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

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

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

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

We reviewed the following Boeing service bulletins.

• Boeing Alert Service Bulletin 747-53A2808, dated November 30, 2012. This service information describes procedures for replacement of the side and top panel webs, support beams, and stiffeners of the NWW; an inspection for cracking of the attaching structural elements that are common to the removed top and side panels of the NWW; repetitive post-modification inspections for cracks in the top and side panel webs and stiffeners; and repairs.

• Boeing Service Bulletin 747-53A2465, Revision 5, dated July 11, 2013. This service information describes procedures for doing inspections for cracking of the NWW side panel and top panel webs and longitudinal stiffeners for cracks, and related investigative and corrective actions.

• Boeing Service Bulletin 747-53A2562, Revision 3, dated July 11, 2013. This service information describes procedures for replacement of the side and top panel webs and certain stiffeners of the NWW; an inspection for cracks in attaching structural elements that are common to the removed top panel and side panels; repetitive post-modification inspections for cracks in the top and side panel webs and stiffeners; and repairs.

This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

We estimate that this AD will affect 255 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

We have received no definitive data that would enable us to provide cost estimates for the on-condition actions specified in this AD.

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

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

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

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

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

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

(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 by adding an AD that would apply to certain The Boeing Company Model 737-300, -400, and -500 series airplanes. The NPRM published in the Federal Register on March 24, 2015 (80 FR 15523) (“the NPRM”). The NPRM was prompted by reports of cracking at certain fastener locations in the window corners of the window belt area. The NPRM proposed to require repetitive HFEC inspections for fatigue cracking in certain fastener locations in the window corners of the window belt area, and related investigative and corrective actions if necessary. We are issuing this AD to detect and correct fatigue cracking around fastener locations that could cause multiple window corner skin cracks, which could result in rapid decompression and loss of structural integrity of the airplane.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM and the FAA's response to each comment.

Southwest Airlines (SWA) requested that a correction be made to paragraph (g) of the proposed AD to clarify the areas for the inspection of the twelve fastener locations. SWA noted that paragraph (g) of the proposed AD stated to inspect locations “at the upper forward and lower aft corners of each window between station (STA) 360 and STA 540 and between STA 727 and STA 908.” SWA stated that between STA 727 and STA 908, Boeing Alert Service Bulletin 737-53A1328, dated July 22, 2014, specifies the location as the lower forward and upper aft corners.

We agree with the commenter for the reason provided. We have revised paragraph (g) of this AD to require an inspection of the twelve fastener locations at the upper forward and lower aft corners of each window between STA 360 and STA 540 and at the upper aft and lower forward corners of each window between STA 727 and STA 908.

SWA requested that we clarify the intent of paragraph (g) of the proposed AD. SWA stated that paragraph (g) of the proposed AD states to accomplish the inspections at the times specified in tables 1 and 2 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 737-53A1328, dated July 22, 2014, and then repeat the inspections at the applicable times specified in tables 1 and 2 until “the terminating action in paragraph (h) of this AD is accomplished,” which is the optional preventive modification in Part 3 of the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1328, dated July 22, 2014. SWA stated that, per note (b) in tables 1 and 2, accomplishment of the preventive modification in accordance with Boeing Alert Service Bulletin 737-53A1328, dated July 22, 2014, is terminating action for both the initial and repeat inspections at the modified locations. SWA stated that paragraph (g) of the proposed AD does not mention the option to accomplish the actions specified in paragraph (h) of the proposed AD in lieu of the initial inspection specified in paragraph (g) of this AD; it only states to “repeat the inspections . . . until the terminating action specified in paragraph (h) of this AD is done.” SWA noted it is unclear if the intent of paragraph (g) of this AD is to require accomplishment of the Part 1 external surface HFEC inspections of the skin prior to accomplishing the Part 3 preventive modification instructions, or if the intent of paragraph (g) of the proposed AD is to provide the operator the option to accomplish paragraph (h) of the proposed AD (preventive modification) in lieu of accomplishing paragraph (g) of the proposed AD (inspections), since the Part 3 modification instructions include open hole HFEC inspections of the skin.

We agree to provide clarification. Paragraph (g) of this AD is not required at the time of accomplishment of the preventive modification specified in paragraph (h) of this AD. Paragraph (h) of this AD states that the preventive modification (including all applicable related investigative and corrective actions) terminates the inspections in paragraph (g) of this AD. This means all inspections (initial and repetitive) in paragraph (g) of this AD are not required if paragraph (h) of this AD is done. We have not changed this AD in this regard.

SWA requested clarification about existing repairs that meet the requirements of note (a) in tables 1 and 2 of paragraph l.E., “Compliance,” of Boeing Alert Service Bulletin 737-53A1328, dated July 22, 2014. SWA also requested to extend the note to apply to existing repairs that address damage other than cracking, provided that the repairs are evaluated and approved by Boeing via an FAA Form 8100-9. In addition, SWA requested we clarify whether note (a) applies only to reinforcing repairs that encompass all twelve fastener locations at a window corner, or if note (a) also applies to existing non-reinforcing oversize hole repairs.

We partially agree with the commenter. We agree with adding a paragraph to this AD to provide credit for previously approved repairs to address cracking issues, because Boeing Organization Designation Authorization (ODA) approved repairs installed prior the effective date of this AD are acceptable for terminating the initial and repetitive inspections in the area under the repair. We disagree with allowing any other repair as an alternative method of compliance (AMOC) because other repairs may or may not address the cracking issue. However, operators may request approval of an AMOC for these repairs using the procedures specified in paragraph (l) of this AD.

We have added new paragraph (g)(1) to this AD to specify that the inspections required by the introductory text of paragraph (g) of this AD may be terminated in areas with repairs installed prior to the effective date of this AD, provided the repairs are reinforcing and address the cracking issue addressed in this AD, and installation was approved by the Boeing Commercial Airplanes ODA via FAA Form 8100-9.

All Nippon Airways (ANA) requested we clarify if, for Group 1 airplanes as identified in paragraph 1.A.1 “Effectivity,” of Boeing Alert Service Bulletin 737-53A1328, dated July 22, 2014, areas repaired using Boeing Alert Service Bulletin 737-53A1328, dated July 22, 2014, is terminating action for the repaired area. ANA pointed out that table 1 of Boeing Alert Service Bulletin 737-53A1328, dated July 22, 2014, includes this wording.

We agree to provide clarification. Accomplishing a repair in accordance with Part 6 of the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1328, dated July 22, 2014, also terminates the inspection of the repaired area for Group 1 airplanes. We have added new paragraph (g)(2) to this AD to specify that repairs done in accordance with Part 6 of the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1328, dated July 22, 2014, terminate the inspection required by paragraph (g) of this AD in only the repaired area for Group 1 airplanes only.

SWA requested that we revise the NPRM to include provisions for airplanes that were previously inspected, modified, and/or repaired using step 3 of the Accomplishment Instructions of Boeing Service Bulletin 737-53-1306, dated September 22, 2010; Revision 1, dated March 17, 2010; Revision 2, dated October 25, 2011; or Revision 3, dated January 22, 2014; as terminating action for the inspections required by paragraph (g) of the proposed AD, as well as any documented deviations that were approved by the Boeing ODA via an FAA Form 8100-9.

SWA stated that step 3 of Boeing Service Bulletin 737-53-1306 (all revisions) includes inspection, preventive modification, and repair instructions for the window corner locations addressed by the proposed AD. Figures 8 through 10 of Boeing Service Bulletin 737-53-1306 (all revisions) provide inspection and preventive modification instructions, which also include instructions for a fastener oversize repair, edge margin requirements, and window forging replacement. Figures 13 through 18 provide external reinforcing repair instructions. Figures 40 through 43 were added in Boeing Service Bulletin 737-53-1306, Revision 3, dated January 22, 2014, to incorporate the option to replace the window belt panels in lieu of accomplishing the window corner inspections, preventive modification, and approved repairs. SWA stated that it considers the instructions in Step 3 of Boeing Service Bulletin 737-53-1306 (all revisions) to meet the intent of the proposed AD since the instructions address and eliminate the unsafe condition that prompted the proposed AD.

We do not agree to revise this AD because Boeing Service Bulletin 737-53-1306 is specific for SWA. We do not consider it appropriate to include various provisions in an AD applicable only to a single operator's unique configuration of affected airplanes. However, SWA may submit a request for an approval of an AMOC using the procedures specified in paragraph (l) of this AD. We have not changed this AD in this regard.

SWA and ANA requested that we clarify which actions specified in Boeing Alert Service Bulletin 737-53A1328, dated July 22, 2014, are required. SWA stated that paragraph (j)(3) of the proposed AD (paragraph (l)(3) in this AD) indicates that steps identified as “RC” (Required for Compliance) in Boeing Alert Service Bulletin 737-53A1328, dated July 22, 2014, must be accomplished “in order to comply with this AD.”

The commenters noted that there are “RC” steps in Boeing Alert Service Bulletin 737-53A1328, dated July 22, 2014, that are not clearly addressed in the proposed AD. SWA noted that Parts 7 and 8 of Boeing Alert Service Bulletin 737-53A1328, dated July 22, 2014, contain steps that are identified as “RC;” however, the proposed AD does not mention the compliance times for these actions. SWA stated that Part 7 of Boeing Alert Service Bulletin 737-53A1328, dated July 22, 2014, provides window frame replacement instructions, and steps 5 and 6 in Part 8 of Boeing Alert Service Bulletin 737-53A1328, dated July 22, 2014, provide post-repair/post-modification inspection instructions for window frames with short edge margin conditions at the compliance times specified in tables 3, 4, and 8 of Boeing Alert Service Bulletin 737-53A1328, dated July 22, 2014. SWA assumed that actions identified in Table 3 and Table 8 are not required for compliance and that the actions identified in Table 4 are required for compliance. SWA also pointed out that step 10 of Part 2 of Boeing Alert Service Bulletin 737-53A1328, dated July 22, 2014, is not “RC,” but could result in accomplishment of Part 7 of Boeing Alert Service Bulletin 737-53A1328, dated July 22, 2014, which has “RC” steps.

We agree to clarify the actions required by this AD. The post-modification and post-repair inspections identified in Table 4 and Table 5 in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 737-53A1328, dated July 22, 2014, are required by this AD. The accomplishment instructions of Boeing Alert Service Bulletin 737-53A1328, dated July 22, 2014, are unclear. Therefore, we have added new paragraph (i) to this AD to specify the actions identified in Table 4 and Table 5 in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 737-53A1328, dated July 22, 2014. We have redesignated subsequent paragraphs accordingly.

Regarding Part 7 of Boeing Alert Service Bulletin 737-53A1328, dated July 22, 2014, if operators chose to do the modification, certain actions specified in Part 3, Part 4, and Part 5 of Boeing Alert Service Bulletin 737-53A1328, dated July 22, 2014, are identified as “RC” steps. Within those steps, there is an on-condition action, which specifies to do Part 7; thus, step 1 of Part 7 of Boeing Alert Service Bulletin 737-53A1328, dated July 22, 2014 is required for compliance.

Steps 2, 3, and 4 of Part 8 of Boeing Alert Service Bulletin 737-53A1328, dated July 22, 2014, are referenced in Table 3 and Table 8 in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 737-53A1328, dated July 22, 2014, and are not required by this AD. We have added new paragraph (k) of this AD to clarify that the post-modification inspections specified in Table 3 and Table 8 in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 737-53A1328, dated July 22, 2014, are airworthiness limitations that are required by maintenance and operational rules; therefore, these inspections are not required by this AD. We have redesignated subsequent paragraphs accordingly.

ANA requested that we clarify the office responsible for AMOCs. ANA stated that paragraph (j) of the proposed AD specifies that the Seattle ACO has the authority to approve AMOCs. However, ANA noted it has seen other ADs for out of production airplanes that refer to the Los Angeles ACO.

We agree to clarify. The Los Angeles ACO is currently responsible for AMOCs for the airplanes identified in this AD. We have revised paragraphs (l)(1) and (l)(4) of this AD (paragraphs (j)(1) and (j)(4) of the proposed AD) to refer to the Los Angeles ACO.

Boeing and SWA requested that we clarify incorrect references in Boeing Alert Service Bulletin 737-53A1328, dated July 22, 2014. The commenters stated that note (e) in Figure 5 of Boeing Alert Service Bulletin 737-53A1328, dated July 22, 2014, incorrectly references table 2 of paragraph 3.B., Work Instructions, for post repair/modification inspections of short edge margins on window frames. The commenters stated that these references should be to table 3 of paragraph 3.B., Work Instructions. Boeing also identified the notes in figures 9, 10, 11, and 12 as additional locations where the reference to table 2 should be to table 3. The commenters requested that we clarify in this AD that repeat post repair and modification inspections for window frames with short edge margins are defined in table 3 rather than table 2 of paragraph 3.B, Work Instructions, in Boeing Alert Service Bulletin 737-53A1328, dated July 22, 2014.

We agree with the commenters that the identified table references in Boeing Alert Service Bulletin 737-53A1328, dated July 22, 2014, are incorrect. We have added new paragraphs (j)(3) and (j)(4) to this AD to specify the correct table references. We have also added new paragraph (j)(5) to this AD to clarify that operators must comply with the edge margin requirements in Table 3 of the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1328, dated July 22, 2014. We have also revised paragraphs (g) and (h) of this AD to include references to paragraphs (j)(3), (j)(4), and (j)(5) of this AD.

Aviation Partners Boeing stated that accomplishing Supplemental Type Certificate (STC) ST01219SE (http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgstc.nsf/0/be866b732f6cf31086257b9700692796/$FILE/ST01219SE.pdf) does not affect the actions specified in the NPRM.

We concur with the commenter. We have redesignated paragraph (c) of the proposed AD as paragraph (c)(1) of this AD and added new paragraph (c)(2) to this AD to state that installation of STC ST01219SE does not affect the ability to accomplish the actions required by this AD. Therefore, for airplanes on which STC ST01219SE is installed, a “change in product” AMOC approval request is not necessary to comply with the requirements of 14 CFR 39.17.

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD with the changes described previously—and minor editorial changes. 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 this AD.

We reviewed Boeing Alert Service Bulletin 737-53A1328, dated July 22, 2014. The service information describes procedures for HFEC inspections for fatigue cracking in certain fastener locations in the window corners of the window belt area, and related investigative and corrective actions. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

We estimate that this AD affects 142 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 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 AGOA (Title I of the Trade and Development Act of 2000, Pub. L. 106-200) (19 U.S.C. 2466a et seq.), as amended, contains provisions for enhanced trade benefits for eligible sub-Saharan African countries.

Section 506(c) of the TPEA, which was signed into law on June 29, 2015 (Pub. L. 114-27, sec. 105(d)(3), 129 Stat. 366-367)), requires the President to establish a process to allow any interested person, at any time, to file a petition with USTR concerning the compliance of any sub-Saharan African country listed in section 107 of the AGOA (19 U.S.C. 3706), with the eligibility requirements set forth in section 104 of the AGOA (19 U.S.C. 3703) and the eligibility criteria set forth in section 502 of the Trade Act of 1974 (19 U.S.C. 2462). On February 26, 2016, the President delegated this authority to USTR. See E.O. 13720 of Feb. 26, 2016, 81 FR 11087, Mar. 2, 2016.

The interim final rule adds 15 CFR part 2017. The new Part 2017 establishes a petition process that supplements the annual (normal cycle) request for public comments on whether a beneficiary sub-Saharan African country is meeting the eligibility criteria and requirements of the AGOA program (see, e.g., 80 FR 48951, Aug. 14, 2015).

Section 2017.0 defines acronyms used throughout Part 2017.

Section 2017.1 permits any interested party to submit a petition, at any time, regarding whether a beneficiary sub-Saharan African country meets the eligibility requirements in section 104 of the AGOA and the eligibility criteria in section 502 of the Trade Act of 1974. It requires that a petition adequately identify the country and the concern. A petition indicating the existence of exceptional circumstances warranting an out-of-cycle review must contain a statement of reasons explaining why an out-of-cycle review is warranted.

Section 2017.2 explains how USTR will process petitions. USTR will consider petitions filed in accordance with the public comment period of the annual (normal cycle) review of all beneficiary countries in conjunction with that review. USTR will consider petitions filed outside of that time frame in the next (normal cycle) annual review. If USTR receives a petition outside of the annual (normal cycle) review process that indicates the existence of exceptional circumstances, the AGOA Implementation Subcommittee will consider whether there is a basis for the initiation of an out-of-cycle review and make recommendations to the Trade Policy Staff Committee, which will, in turn, advise the U.S. Trade Representative. If the U.S. Trade Representative finds that there are exceptional circumstances warranting an out-of-cycle review, within 30 days of that determination USTR will announce a schedule for the review in the Federal Register.

Section 2017.3 requires USTR to publish a summary of the actions taken in response to petitions in the Federal Register. The notice also will include a list of pending petitions upon which no decision has been made.

Section 2017.4 provides that all submitted materials will be made available for public inspection at www.regulations.gov other than appropriately designated confidential business information.

The TPEA extended the AGOA until September 30, 2025. See Pub. L. 114-27, sec. 103, 129 Stat. 364, June 29, 2015. Section 2017.5 provides that the AGOA petition process will expire on that date unless extended by statute.

All submissions must be in English and must be submitted electronically via http://www.regulations.gov. USTR will not accept hand-delivered submissions. To make a submission using http://www.regulations.gov, enter the docket number USTR-2016-0002 in the “Search for” field on the home page and click “Search.” The site will provide a search-results page listing all documents associated with this docket. Find a reference to this notice by selecting “Notice” under “Document Type” in the “Filter Results by” section on the left side of the screen and click on the link entitled “Comment Now.” The http://www.regulations.gov Web site offers the option of providing comments by filling in a “Type Comment” field or by attaching a document using the “Upload file(s)” field. (For further information on using the http://www.regulations.gov Web site, please consult the resources provided on the Web site by clicking on “How to Use This Site” on the left side of the home page.) The http://www.regulations.gov Web site allows users to provide comments by filling in a “Type Comment” field or by attaching a document using the “Upload file(s)” field. The AGOA Implementation Subcommittee prefers that submissions be provided in an attached document.

USTR will grant business confidential status to information you submit if you certify that you would not customarily release the information to the public and clearly designate it as confidential business information. You must mark your submission “BUSINESS CONFIDENTIAL” at the top and bottom of the cover page and on each succeeding page, and the submission should indicate, via brackets, the specific information that is confidential. Additionally, you must include “Business Confidential” in the “Type Comment” field. If you submit a comment containing business confidential information, you also must submit a separate non-confidential version that is not a part of the same submission as the confidential version, indicating where confidential information has been redacted. The non-confidential version will be placed in the docket and open to public inspection.

All comments we receive, except for information granted “business confidential” status, will be available for public viewing without change, including any personal information you provide, such as your name and address. You can find the comments by entering docket number USTR-2016-0002 in the search field at www.regulations.gov.

USTR is promulgating these changes as an interim final rule in order to meet the statutory deadline for establishment of a petition process. Accordingly, USTR for good cause finds that the notice and publication requirements of the Administrative Procedure Act are unnecessary. See 5 U.S.C. 553(b)(3)(B). However, because this type of rulemaking generally requires notice and receipt of public comment, USTR will accept written comments on the interim final rule on or before April 18, 2016.

For the reasons stated in part IV above, USTR for good cause finds that the interim final rule should become effective on March 18, 2016. See 5 U.S.C. 553(d)(3).

USTR is adopting 15 CFR part 2017 in the form of an interim final rule and not as a proposed rule. Therefore, the provisions of the Regulatory Flexibility Act do not apply. See 5 U.S.C. 601(2), 603(a).

The interim final rule does not contain any collections of information under the Paperwork Reduction Act of 1995. See 44 U.S.C. 3501 et seq. Consequently, USTR has not submitted any information to the Office of Management and Budget for review.

BSE is a fatal neurological disorder of cattle that has a long incubation period (2 to 8 years). It is transmitted when cattle ingest protein meal containing the BSE infectious agent. Cattle affected by BSE are usually apart from the herd and will show progressively deteriorating behavioral and neurological signs. Cattle will react excessively to noise or touch and will eventually stumble, fall, and experience seizures, coma, and death. Studies have linked variant Creutzfeldt-Jakob disease (vCJD) in humans to exposure to the BSE agent, most likely through human consumption of beef products contaminated with the BSE agent. There is no known treatment of vCJD, and it is invariably fatal.

The final rule completes a rulemaking process that began with an interim final rule (IFR) in 2004 and was followed by IFRs in 2005 and 2008. The final rule establishes measures to prohibit the use of certain cattle material in FDA-regulated human food and cosmetics to address the potential risk of BSE. Because the United States has had measures in place to prevent the introduction and spread of BSE, including those affirmed in this rule, the risk of human exposure to the BSE agent from FDA-regulated human food and cosmetics is negligible.

We are issuing these regulations under the adulteration provisions in sections 402, 409, 601, and under section 701 (21 U.S.C. 342, 348, 361, and 371) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The final rule provides definitions for prohibited cattle materials and prohibits their use in human food, dietary supplements, and cosmetics, to address the potential risk of BSE. We designate the following items as prohibited cattle materials: SRMs, the small intestine from all cattle unless the distal ileum has been properly removed, material from nonambulatory disabled cattle, material from cattle not inspected and passed, or MS (Beef). We also confirm that milk and milk products, hides and hide-derived products, tallow that contains no more than 0.15 percent insoluble impurities, and tallow derivatives are not prohibited cattle materials. Further, we are amending the final rule to provide a definition of gelatin and to clarify that gelatin is not considered a prohibited cattle material under 21 CFR 189.5(a)(1) and 700.27(a)(1) as long as it is manufactured using the customary industry processes specified. Finally, we are finalizing the process for designating a country as not subject to BSE-related restrictions applicable to FDA regulated human food and cosmetics. Specific requirements regarding record maintenance, retention, and accessibility, for manufacturers and processors of a human food or cosmetic product made with material from cattle were previously finalized (see 71 FR 59653).

This final rule reaffirms the provisions in the 2004 IFR, as well as the 2005 and 2008 amendments, to address the potential risk of BSE in human food including dietary supplements, and in cosmetics. As the final rule's coverage does not differ from the 2004 IFR and the 2005 and 2008 amendments, no additional costs or benefits will accrue from this rulemaking.

BSE is a progressive and fatal neurological disorder of cattle caused by an unconventional transmissible agent. BSE belongs to the family of diseases known as transmissible spongiform encephalopathies (TSEs). In the late stages of disease, all TSEs affect the central nervous system of infected animals. However, the distribution of infectivity in the body of the animal and mode of transmission differ according to the species and TSE agent. Other types of TSEs include scrapie in sheep and goats, chronic wasting disease in deer and elk, and Creutzfeldt-Jakob disease (CJD) in humans.

BSE has a long incubation period (2 to 8 years), and is most likely transmitted when tissues from infected cattle are rendered and processed into protein meal, which is then used as an additive in livestock feed (Refs. 1 and 2). The clinical signs of BSE include behavioral, gait, and postural abnormalities. Cattle with the disease often present with increased apprehension, increased reaction to sound and touch, and a swaying gait. These signs may be accompanied by subtle changes in the normal behavior of the cow, such as separation from the herd while at pasture, disorientation, staring, and excessive licking of the nose or flanks. The disease progresses to stumbling and falling, and ends with seizures, coma, and death (Ref. 3).

Scientific and epidemiological studies have linked vCJD in humans to exposure to the BSE agent, most likely through human consumption of beef products contaminated with the agent. In several cases that occurred in the United Kingdom (UK), it is believed that the persons became infected through transfusion of blood from an asymptomatic infected donor. There is no known treatment of vCJD, and it is invariably fatal (Ref. 4).

As of June 2, 2014, vCJD has been identified in 229 patients from 12 countries. One hundred seventy-seven probable and confirmed cases of vCJD have been reported in the UK, 27 in France, 5 in Spain, 4 in Ireland, 4 in the United States, 3 in the Netherlands, 2 in Portugal, 2 in Italy, 2 in Canada, and one each from Japan, Saudi Arabia, and Taiwan (Ref. 5). In two of the four U.S. cases, exposure to the BSE agent is believed to have occurred while the individuals were residing in the UK. A third case was likely exposed while residing in Saudi Arabia. An investigation of the fourth case found that the patient's exposure to the BSE agent likely occurred before the patient moved to the United States (Ref. 5). In the United States, where measures to prevent the introduction and spread of BSE have been in place for some time, the risk of human exposure to the BSE agent is extremely low. Indeed, in May 2013, the World Organization for Animal Health (OIE) recognized the effectiveness of these mitigation measures and categorized the United States as negligible BSE risk, in accordance with Chapter 11.4 of the OIE Terrestrial Animal Health Code (Refs. 6 and 7).

In the Federal Register of July 14, 2004 (69 FR 42256), we issued an IFR entitled “Use of Materials Derived From Cattle in Human Food and Cosmetics” (also referred to as “the 2004 IFR”) to prohibit the use of certain cattle material, to address the potential risk of BSE in human food, including dietary supplements, and cosmetics. The 2004 IFR designated the following items as prohibited cattle materials: SRMs, the small intestine from all cattle, material from nonambulatory disabled cattle, material from cattle not inspected and passed or MS (Beef). SRMs include the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia (DRG) of cattle 30 months of age and older, and the tonsils and distal ileum of the small intestine from all cattle. These restrictions were codified at § 189.5, “Prohibited cattle materials,” and § 700.27, “Use of prohibited cattle materials in cosmetic products.” The requirements in §§ 189.5 and 700.27 are almost identical, except that the latter pertains only to cosmetic products.

Previously, the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA) published an IFR in the Federal Register on January 12, 2004 (69 FR 1862) (FSIS IFR). The FSIS IFR prohibited certain cattle material from use in meat and meat products. The FSIS IFR designated the same items as SRMs as specified in FDA's 2004 IFR. In the Federal Register of July 13, 2007, FSIS affirmed the FSIS IFR with amendments (72 FR 38700) (“2007 FSIS affirmation”). In the Federal Register of September 7, 2005 (70 FR 53063), we amended our regulations to permit the use of the small intestine of cattle in human food and cosmetics provided the distal ileum portion has been removed properly (also referred to as the “2005 amendment”). The 2005 amendment also clarified that milk and milk products, hides and hide-derived products, and tallow derivatives are not prohibited cattle materials, and we provided for a different method for determining impurities in tallow. FSIS also amended its regulations on September 7, 2005, to permit the use of the small intestine of cattle in human food provided the distal ileum is removed properly (70 FR 53043).

In the Federal Register of April 17, 2008 (73 FR 20785), we amended our regulations again to provide a process for designating certain countries as not subject to certain BSE-related restrictions (also referred to as the “2008 amendment”). FSIS provided a similar country-specific exception from certain BSE restrictions covered in its regulations.

We also published a notice in the Federal Register on March 4, 2013 (78 FR 14012) (also referred to as the 2013 notice), reopening the comment period for the interim final rule. We invited comment on our assessment of recently published peer-reviewed scientific studies in which trace amounts of BSE infectivity were found in parts of the small intestines other than the distal ileum of cattle with both experimental and natural occurring BSE.

In this rule, we are finalizing, with changes related to gelatin, the 2004 IFR, as amended in 2005 and 2008, to restrict certain cattle materials used in human foods and cosmetics that carry a risk of transmitting BSE. The final rule complements similar restrictions that apply to meat and meat products regulated by USDA.

We are issuing these regulations under the adulteration provisions in sections 402, 409, 601, and under section 701 of the FD&C Act.

Under section 402(a)(3) of the FD&C Act, a food is deemed adulterated “if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food.” The term “otherwise unfit for food” in section 402(a)(3) of the FD&C Act does not require that a food be filthy, putrid, or decomposed for it to be “otherwise unfit for food.” A food can be “otherwise unfit for food” based on health risks. Further, the possibility of disease transmission to humans from exposure to prohibited cattle material, SRM, MS Beef, material from nonambulatory disabled cattle, and material from cattle not inspected and passed) may present a risk to human health. Under section 402(a)(3) of the FD&C Act, these materials are unfit for food. Under section 402(a)(4) of the FD&C Act, a food is adulterated “if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.” The failure to ensure that food is prepared, packed, or held under conditions in which prohibited cattle materials do not contaminate the food constitutes an insanitary condition whereby it may have been rendered injurious to health and thus renders the food adulterated under section 402(a)(4) of the FD&C Act. Under section 402(a)(5) of the FD&C Act, food is deemed adulterated if it is, in whole or in part, the product of an animal which has died otherwise than by slaughter. Some cattle are not inspected and passed because they have died before slaughter. Material from cattle that die otherwise than by slaughter is adulterated under section 402(a)(5) of the FD&C Act. As further explained in the 2004 IFR, prohibited cattle materials for use in human food are food additives subject to section 409 of the FD&C Act, except when used as dietary ingredients in dietary supplements. The use or intended use of any prohibited cattle material in human food, except for dietary ingredients in dietary supplements, causes the material and the food to be adulterated under section 402(a)(2)(C) of the FD&C Act.

Under section 601(c) of the FD&C Act, a cosmetic is adulterated “if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.” The failure to ensure that a cosmetic is prepared, packed, or held under conditions in which prohibited cattle materials do not contaminate the cosmetic constitutes an insanitary condition whereby it may have been rendered injurious to health and, thus, renders the cosmetic adulterated under section 601(c) of the FD&C Act.

Under section 701(a) of the FD&C Act, we may issue regulations for the efficient enforcement of the FD&C Act. A regulation that requires measures to prevent human food from being unfit for food, from being or bearing an unsafe food additive, from being the product of an animal that died otherwise than by slaughter, and to prevent human food and cosmetics from being held under insanitary conditions, allows for efficient enforcement of the FD&C Act.

We received approximately 1,464 comments, each containing one or more issues, to the 2004 IFR, and approximately 20 comments, each containing one or more issues, to the 2005 and 2008 amendments, and 31 comments to the 2013 notice. Animal welfare advocacy organizations, private consultants, consumer groups, foreign governments, Members of Congress, industry, and consumers submitted comments. Comments previously addressed in the 2005 and 2008 amendments, and comments addressing issues outside the scope of this rulemaking (e.g., those addressing potential concerns regarding diseases other than BSE; those addressing animal welfare concerns, which are covered in the Humane Methods of Slaughter Act of 1978 (7 U.S.C. 1901 et seq.) and administered by USDA); the prohibition of the use of materials from nonambulatory animals other than cattle (i.e., deer, elk, and sheep); and those responding to rules issued by other federal agencies will not be addressed in this document.

To make it easier to identify the comments and FDA's responses, the word “Comment,” in parentheses, appears before the comment's description and the word “Response,” in parentheses, appears before FDA's response. Each comment is numbered to help distinguish between different comments. The number assigned to each comment is purely for organizational purposes and does not signify the comment's value or importance.

Sections 189.5(a) and 700.27(a) state that the definitions and interpretations of terms in section 201 of the FD&C Act apply (21 U.S.C. 321) and also define the following terms: “prohibited cattle materials,” “inspected and passed,” “mechanically separated,” “nonambulatory disabled cattle,” “specified risk material,” “tallow,” “tallow derivative,” and “gelatin.” Several comments pertained to our regulatory definitions, and we discuss those comments here.

The 2004 interim final rule defined “prohibited cattle materials” as specified risk materials, small intestine of all cattle, material from nonambulatory disabled cattle, material from cattle not inspected and passed, or MS (Beef). The 2004 IFR also defined “prohibited cattle material” as not to include tallow that contains “no more than 0.15 percent hexane-insoluble impurities and tallow derivatives.” The 2005 amendment made an exception in the case of the small intestine such that the small intestine would not be considered prohibited cattle material if the distal ileum is removed by a procedure that removes at least 80 inches of the uncoiled and trimmed small intestine in a manner specified in § 189.5(b)(2) (or, in the case of § 700.27, § 700.27(b)(2)) and also changed “hexane-insoluble” to “insoluble” in the definition of “tallow.” The 2005 amendment also excluded hides and hide-derived products, and milk and milk products from the definition of “prohibited cattle materials.” The 2008 amendment provided that FDA may designate a country as not subject to certain BSE-related restrictions applicable to FDA regulated human food and cosmetics.

We did not receive comments specific to the definition of “prohibited cattle materials at §§ 189.5(a)(1) and 700.27(a)(1), and we have finalized that portion of the definition without change.

(Comment 1) One comment supported the exclusion of hides and hide-derived products from the definition of prohibited cattle materials but said that we need to address the possible cross-contamination of hides and other non-prohibited cattle materials with prohibited cattle materials during slaughter and processing.

(Response 1) As noted in the 2005 amendment, manufacturers and processors must take precautions to avoid cross contamination of hides and other non-prohibited cattle material with prohibited cattle material during slaughter and processing (70 FR 53063 at 53066). Further, food establishments are subject to the current good manufacturing practice requirements (CGMPs) at 21 CFR part 110, and the failure to take adequate measures to prevent cross-contamination could result in insanitary conditions whereby the food may be rendered injurious to health and, therefore, adulterated under section 402(a)(4) of the FD&C Act.

(Comment 2) While most comments found the clarification as to the allowable composition of tallow source material used in tallow derivatives in the preamble to the 2005 amendment helpful, one comment suggested that we revise the definition of “prohibited cattle materials” to state that: “Prohibited cattle materials do not include tallow that contains no more than 0.15 percent insoluble impurities, tallow derivatives (regardless of the source of tallow), hides and hide-derived products, and milk and milk products.”

(Response 2) We understand that the intent of the parenthetical “regardless of the source of the tallow” is to make clear that the chemical processes (hydrolysis, transesterification, and saponification) involving high temperature and pressure are sufficiently rigorous even if the starting tallow is, for example, inedible tallow or tallow containing greater than 0.15 percent insoluble impurities. We agree that the processes to produce tallow derivatives are sufficiently rigorous, but believe that by excluding tallow derivatives, without the parenthetical, from the definition of prohibited cattle material, it is clear that we are excluding all tallow derivatives. Prohibited cattle material does not include tallow derivatives. We do not believe the parenthetical “regardless of the source of tallow” is needed.

(Comment 3) One comment would revise the definition of prohibited cattle materials to emphasize the rigorousness of the processing involved in the production of tallow derivatives (i.e., transesterification or saponification) to minimize the risk of transmitting TSE agents. The comment was concerned that the “lack of alignment” between U.S. and non-U.S. requirements and guidance with respect to tallow derivatives will continue to affect the acceptance of U.S.-origin materials in non-U.S. markets.

(Response 3) We decline to revise the definition as suggested by the comment. Our objective in developing our BSE regulations for human food and cosmetics, including these involving tallow derivatives, is to apply appropriate measures to safeguard life and health and be no more trade restrictive than necessary to achieve the food and cosmetic safety objective. As to the degree of processing involved in producing tallow derivatives, we addressed this subject in the preamble to the 2004 IFR (69 FR 42256 at 42261) and discussed how tallow derivatives are produced by subjecting tallow to chemical processes (hydrolysis, transesterification, and saponification) that involve high temperature and pressure. We further noted in the 2004 IFR that FDA's Transmissible Spongiform Encephalopathy Advisory Committee (TSEAC) considered the safety of tallow and tallow derivatives in 1998 and “determined that the rigorous conditions of manufacture are sufficient to further reduce the BSE risk in tallow derivatives” (69 FR 42256 at 42261).

We have revised the list of materials not considered prohibited cattle materials at §§ 189.5(a)(1)(i) and 700.27(a)(1)(i) to include gelatin. To ensure that only gelatin derived from customary industry processes qualifies for this exclusion, §§ 189.5(a)(8) and 700.27(a)(8) of the final rule provide that “Gelatin means a product that has been obtained by the partial hydrolysis of collagen derived from hides, connective tissue, and/or bone bones of cattle and swine. Gelatin may be either Type A (derived from an acid-treated precursor) or Type B (derived from an alkali-treated precursor) that has gone through processing steps that include filtration and sterilization or an equivalent process in terms of infectivity reduction.”

There has been increasing recognition based on scientific evidence as to the safety of gelatin for human use irrespective of the source materials from which it is made. For example, laboratory studies have indicated that gelatin manufacturing processes are capable of reducing inoculated BSE prion titers by at least six to eight orders of magnitude (Ref. 8). The OIE Code does not recommend any restrictions, regardless of the BSE status of a country, in trade of gelatin prepared from bones and intended for food, cosmetics, pharmaceuticals including biologicals, or medical devices, among other items (Ref. 9). A 2006 scientific panel of the European Food Safety Authority (EFSA)—reviewing a 2003 EFSA Scientific Steering Committee opinion—concluded that there was no support for prohibition of or restrictions on the use of skull and vertebrae of cattle that had passed ante mortem and post mortem inspections in the production of gelatin (Ref. 10). Based on this evidence, we conclude that gelatin manufactured from bovine raw materials using customary industry processes presents a negligible risk of transmitting the agent that causes BSE.

(Comment 4) One comment supporting a mechanism to designate countries as not subject to certain BSE-related restrictions (provided under § 189.5(a)(1)(ii)) expressed concerns that interested countries would need to go through separate application and evaluation processes at USDA and FDA for a country to receive a USDA and FDA-granted designation. The comment requested that the application and evaluation procedures used by the different U.S. regulating agencies be streamlined to reduce the potential duplication of time and effort by the applying country.

(Response 4) We understand the concern expressed by the comment. However, as we explained in the 2008 amendment, FDA and USDA have different regulatory responsibilities with respect to preventing BSE and ensuring food safety (73 FR 20785 at 20788). While we have our own evaluation process, we will consult with USDA as part of this process (73 FR 20785 at 20788). Further, we will take into consideration available risk assessments of other competent authorities in conducting our evaluations (73 FR 20785 at 20788.). Although not required, a previous BSE evaluation performed by USDA's FSIS or Animal and Plant Health Inspection Service (APHIS), or by OIE, or by another country or competent authority, could be used by FDA as part of our review (73 FR 20785 at 20788).

(Comment 5) Several comments from the gelatin industry requested that gelatin be excluded from consideration as a prohibited cattle material. The comments noted that standard industry practice is to produce gelatin using raw materials from animals inspected and passed for human consumption, that SRMs and materials from nonambulatory disabled cattle are excluded, that the safety of gelatin is based on adherence to industry practices, as well as our CGMPs and USDA regulations, and that gelatin made from bovine raw materials undergoes manufacturing processes that inactivate possible BSE infectivity, citing studies by the European Commission (EC) and the Gelatine Manufacturers of Europe. Several comments noted that TSEAC reviewed these studies and concluded on July 17, 2003, that these studies “demonstrate a reduction in infectivity that is sufficient to protect human health.”

(Response 5) We agree with the comments and have revised §§ 189.5(a)(1)(i) and 700.27(a)(1)(i) to include gelatin in the list of materials not considered “prohibited cattle materials.” We are making this change because gelatin manufactured according to customary industry processes present a negligible risk of transmitting the BSE agent and should not be considered “prohibited cattle materials.”

(Comment 6) Several comments took issue with an FDA statement appearing in the background section to the 2004 IFR that provided certain products, such as gelatin and collagen, “have traditionally been produced from cattle material deemed inedible by the USDA” (69 FR 42256 at 42261). The comments pointed out that U.S. raw materials used to produce gelatin come from cattle that have been inspected and passed by USDA for human consumption and are produced in accordance with FDA and USDA regulations, and in accordance with applicable FDA human food CGMPs. These comments further noted that only safe raw materials are used to produce gelatin and that SRMs and materials from nonambulatory disabled cattle are excluded. One comment specifically requested that we publish a correction in the Federal Register clarifying that gelatin is not produced from inedible material.

(Response 6) The quoted statement was included in a broader discussion explaining in part why we were extending similar protections to FDA-regulated human foods and cosmetics as USDA had already imposed in USDA-inspected facilities. We agree that gelatin is manufactured from raw materials that have been inspected and passed for human consumption.

(Comment 7) Several comments requested that we clarify whether our gelatin guidance document published in 1997 (Ref. 11) will be revoked or revised in light of this regulation. The comments expressed concern that gelatin manufacturers would face an unnecessary regulatory burden depending on whether the product the gelatin is used in is a food product or dietary supplement, or a pharmaceutical product, or for other FDA-regulated uses. The comments also requested that we explicitly state that our gelatin guidance document is no longer applicable for products intended for oral consumption or cosmetic use by humans.

(Response 7) This final rule supersedes the 1997 guidance with respect to human food and cosmetics. We intend to review the 1997 guidance and will consider withdrawing or revising the guidance, as appropriate, consistent with this final rule.

The regulations define “inspected and passed” as meaning that the product has been inspected and passed for human consumption by the appropriate regulatory authority, and at the time it was inspected and passed, it was found to be not adulterated. We did not receive comments specific to our definition of “inspected and passed,” and we have finalized the definition without change.

The regulations define “mechanically separated (MS) (beef)” as a meat food product that is finely comminuted, resulting from the mechanical separation and removal of most bone from the attached skeletal muscle of cattle carcasses or parts of carcasses that meet certain USDA specifications. We did not receive comments specific to our definition of “(MS) (Beef).”

On our own initiative, we have revised the definition of “mechanically separated (MS) (Beef)” to clarify that 9 CFR 319.5, which we cite in §§ 189.5(a)(3) and 700.27(a)(3), refers to a USDA regulation. Thus, the final rule adds “U.S. Department of Agriculture” before “regulation.”

The regulations define “nonambulatory disabled cattle” as cattle that cannot rise from a recumbent position or that cannot walk, including, but not limited to, cattle with broken appendages, severed tendons or ligaments, nerve paralysis, fractured vertebral column, or metabolic conditions.

(Comment 8) One comment suggested that downer animals should be tested first for BSE and held pending the outcome of the testing before deciding to prohibit the use of material from nonambulatory disabled cattle in human food and cosmetics. If the test results are negative, then the carcass could be used for human food and cosmetics.

(Response 8) This option is not feasible due to the limitations of currently available tests. No validated ante mortem test for BSE currently exists. Available post mortem tests, although useful for disease surveillance purposes in terms of determining the rate of disease in the population of cattle, are not appropriate as a safety indicator for human food or cosmetics because there is a potentially long period in the life of an infected animal where tests using the current methodology would not detect the disease (Refs. 12 through 14). This is due, in part, to limitations on existing testing methods, which rely on the use of post mortem brain tissue. Experimental evidence demonstrates that for cattle infected orally, certain potentially infective tissues (such as the distal ileum and tonsils) are the first tissues to accumulate infectivity in the incubation period and this infectivity occurs prior to any demonstrated infectivity in brain tissue (Refs. 12 through 14). Therefore, tests conducted on brain tissue may not accurately reflect the potential infectivity in other tissues that develop infectivity earlier, such as the distal ileum.

As a result, we have finalized the definition of “nonambulatory disabled cattle” without change.

(Comment 9) One comment stated that our restrictions relating to materials from nonambulatory disabled cattle should not apply to custom slaughtered animals.

(Response 9) This final rule does not apply to custom slaughtered cattle because such cattle are for the owner's exclusive use and not for use in FDA regulated human food and cosmetics. FDA notes that, in our 2007 affirmation of our interim final rule with amendments, FSIS determined that it cannot permit the custom slaughter or preparation of products of nonambulatory disabled cattle for human food even if it is for the owner's exclusive use because FSIS considers the carcasses of these animals to be adulterated (72 FR 38700 at 38703 to 38704).

The regulations define “specified risk material” as meaning the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months and older. The definition also includes tonsils and distal ileum of the small intestine of all cattle as “specified risk material.”

In the Federal Register of March 4, 2013 (78 FR 14012), we reopened the comment period for the IFR due to new studies showing infectivity in parts of the small intestine other than the distal ileum. We noted that there were studies showing the presence of some infectivity in the proximal ileum, jejunum, ileocecal junction, and colon of cattle with BSE. We also noted that the infectivity levels reported in the studies were lower than the infectivity levels previously demonstrated for the distal ileum (78 FR 14012 at 14013). We put the studies into the administrative record and invited comment on them, and also said that we had tentatively concluded that the effect of these traces of infectivity on the risk of human or ruminant exposure to BSE in the United States is negligible (78 FR 14012). We tentatively concluded that “requiring the removal of additional parts of the small intestine would not provide a measurable risk reduction compared to that already being achieved by removal of the distal ileum in all cattle and that it would be appropriate to finalize our interim final rule without changing any provisions related to the small intestine” (78 FR 14012).

(Comment 10) One comment asked whether the pituitary gland of cattle is considered an SRM and would have to be removed from the carcass when the brain is removed if the cattle is 30 months of age or older.

(Response 10) The pituitary gland or hypophysis lies at the base of the brain, contacting the hypothalamus. Anatomically, it is considered part of the brain. Thus, the pituitary gland or hypophysis is considered an SRM in cattle 30 months or age or older and must be removed from the carcass when the brain is removed.

(Comment 11) One comment requested that the vertebral column not be considered an SRM because the attached DRG as well as the loosely attached spinal cord, which are sources of BSE infectivity, can be safely separated and removed from the vertebral column. (In general terms, DRG are nerves attached to the spinal cord.) The comment did not submit any data in support of its position nor did it explain the method or methods for safely separating and removing the DRG from the vertebral column.

(Response 11) We decline to revise the rule as suggested by the comment. While the vertebral column has not been shown to harbor BSE infectivity, it does contain tissues (i.e., DRG, spinal cord) that have been shown to be infectious. Technologies are not currently available to safely remove the DRG without removing part of the vertebral column (see 2007 FSIS affirmation, 72 FR 38700 at 38710). The 2007 FSIS affirmation also noted that while the DRG is located within the vertebral bones, it could potentially become dislodged during consumption of bone-in-beef products. Therefore, the vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum) from cattle 30 months of age and older is included in the list of SRMs. We will reconsider this issue if technology becomes available to safely remove the DRG from the vertebral column, but we have finalized the definition of “specified risk material” without change.

(Comment 12) One comment requested that we revise the definition of SRMs to include meat obtained from vertebral columns processed with Advanced Meat Recovery (AMR) systems because of the instances of DRG and spinal cord being detected in AMR products.

(Response 12) We decline to revise the rule as suggested by the comment. USDA regulations, at 9 CFR 318.24, provide that vertebral columns of cattle 30 months of age and older (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum) are SRMs and therefore cannot be used as source materials for AMR systems.

(Comment 13) One comment stated that, although we noted that the OIE has not designated any intestinal sections other than the distal ileum as SRM, the OIE did not conduct a risk assessment to support that statement.

(Response 13) We did not intend to imply that the OIE had conducted a risk assessment or studied the new research findings and published its conclusions about the significance to human health. We meant that the OIE had not added parts of the small intestine other than the distal ileum to its recommendations on commodities that should not be traded (Ref. 15).

(Comment 14) Some comments recommended that the 30-month age cutoff, which provides a basis for designating certain cattle materials as SRMs, should be changed to a 12-month cutoff because of scientific uncertainty about how BSE spreads in cattle, and because the true prevalence of the disease in the United States is not fully known.

(Response 14) We disagree with these comments. Experimental and epidemiological evidence have clearly linked transmission of BSE to using protein derived from BSE infected cattle as an additive in cattle feed. FDA's 1997 and 2008 BSE feed regulations prohibit this practice. Further, ongoing BSE surveillance conducted by USDA APHIS, which tests approximately 40,000 animals from the highest risk cattle population per year, shows that the prevalence in the United States is less than one case per million adult cattle in the United States (Ref. 16). We therefore believe that the 30-month cutoff is appropriate for the BSE risk status in the United States, as we first discussed in our 2004 IFR (69 FR 42256 at 42259-60).

(Comment 15) One comment recommended that a 12-month cutoff for purposes of designating certain cattle materials as SRMs would be more prudent given the scientific uncertainty in fully understanding the possible ways that the BSE agent might infect humans.

(Response 15) We disagree that an additional margin of safety in the age cutoff is needed because of scientific uncertainty about how humans are exposed to the BSE agent. The 30-month cutoff is internationally recognized and well supported by pathogenesis studies that were designed to determine the tissue distribution of the BSE agent as the disease progresses in BSE-infected cattle.

(Comment 16) Several comments recommended that materials currently designated as SRMs if they are from cattle 30 months of age and older should be considered SRMs regardless of the animal's age and should be prohibited from entering the food supply. According to the comment, a broad prohibition on the use of SRMs regardless of the animal's age would significantly reduce the need of determining the age of each animal, and thereby improve enforcement. Some comments pointed out that, in the absence of a national animal identification system, any determination of an animal's age is based typically on a physical assessment, and such an assessment can be subjective.

(Response 16) We disagree that the full list of SRMs should be removed from all cattle to eliminate the need for aging the animals. Methods of aging allowed under FSIS regulations, such as documentation and dentition, are reliable for identifying cattle over 30 months of age.

(Comment 17) One comment recommended that vertebral columns of cattle of all ages should be considered SRMs, not just vertebral columns of cattle 30 months of age and older, but the comment did not provide evidence or data to support the change.

(Response 17) We disagree with this recommendation. As previously stated in Comment and Response 14, pathogenesis studies support a 30-month cutoff in low BSE prevalence countries like the United States.

(Comment 18) Several comments noted that available post mortem tests are capable of identifying the presence of the BSE agent only near the end of the animal's incubation period; therefore cattle younger than 30 months of age in the early stages of BSE that do not test positive for the disease may be harboring the BSE agent. The comments suggested that the definition of SRM not exclude certain materials from cattle younger than 30 months.

(Response 18) We agree about the limitation of BSE test methods, but disagree that the limitations should influence the SRM definition. The 30-month cutoff is based on pathogenesis studies, not on diagnostic capabilities.

(Comment 19) One comment supported a 12-month cutoff for classifying animal age-related SRMs due to uncertainty surrounding a published study that suggested that there may be another form of TSE in cattle, referred to as bovine amyloidotic spongiform encephalopathy (BASE).

(Response 19) We do not agree that the 12-month cutoff is necessary for the BASE strain of BSE, also known as L-type BSE. FSIS pointed out in the 2007 FSIS affirmation that the available data on the BASE strain do not indicate that cattle with this form of BSE are more likely to contain higher levels of the infective agent early in the incubation period than cattle with the “typical” BSE strain (72 FR 38700 at 38707). As FSIS concluded, additional study on the BASE form of BSE will be needed to determine its significance.

(Comment 20) One comment recommended expanding the SRM definition to include the entire head of cattle 30 months of age and older. The comment also stated that cheek and head meat of cattle 12 months of age and older should be removed before the skull is fragmented or split, based on concerns that the head or cheek meat may contain central nervous system materials if the meat is not removed before the skull is fragmented or split. To support its arguments, the comment referred to a 2002 USDA FSIS paper that discussed the prohibition of cheek meat from cattle aged 24 months and older for human food if the meat is not removed before the skull is fragmented or split.

(Response 20) We disagree that the entire head of cattle 30 months of age and older should be condemned because of concerns that head meat and cheek meat could be contaminated with central nervous system tissue. FSIS regulations (9 CFR 310.22(e)) require that establishment procedures for removal of SRMS at slaughter must address potential contamination of edible materials with specified risk materials. Such procedures would include taking steps to ensure that cheek meat, for example, is not cross-contaminated with brain matter or central nervous system matter.

(Comment 21) One comment recommended using a 12-month cutoff for purposes of designating certain cattle materials as SRMs so that it would be consistent with the European Union (EU) standard 12-month cutoff period.

(Response 21) We decline to revise the rule as suggested by the comment. The EU established its BSE requirements because of a small number of BSE cases detected in young animals. These cases are now believed to be the result of cattle being exposed to large exposure doses of the BSE agent at the height of their BSE outbreak, before appropriate mitigations were put in place to reduce high levels of BSE infectivity circulating in their cattle population. In contrast, early control measures were put in place in the United States to protect against the establishment and amplification of BSE in the U.S. cattle population.

Further, the EC has published a roadmap for relaxing its BSE mitigations, including age cutoffs, because of the downward trend in BSE cases across the EU (Ref. 17).

(Comment 22) Several comments supported using a 12-month cutoff for purposes of designating certain cattle materials as SRMs because cattle as young as 21 months have tested positive for BSE in the UK and Japan.

(Response 22) We disagree with these comments. As discussed in the 2004 IFR (69 FR 42256 at 42259), we are aware of documented cases of BSE in the UK in animals younger than 30 months of age. As noted in the 2004 IFR (69 FR 42256 at 42259), at the height of the epidemic in the UK when thousands of animals were being diagnosed with BSE each year, fewer than 20 animals younger than 30 months were confirmed with the disease (Ref. 18). The youngest animal with a confirmed case of BSE was 20 months old (Ref. 19). The occurrence of BSE in young animals in the UK was most likely the result of exposure to a high infective dose of the BSE agent at a young age.

We also noted in the 2004 IFR the two reported cases of BSE in 21-month and 23-month-old animals in Japan discovered during the testing of animals presented for slaughter (69 FR 42256 at 42259). FSIS addressed a similar comment in the 2007 FSIS affirmation (72 FR 38700 at 38721) and concluded that the available evidence surrounding the two very young cases reported in Japan is insufficient to support any changes in FSIS's existing measures to prevent human exposure to the BSE agent. FSIS referred to a report by EFSA's Scientific Panel on Biological Hazards, which stated that “it is unclear whether the very young cases [reported in Japan] were adequately identified and formally confirmed” (Ref. 20). This same EFSA report concluded that these cases “seem to be epidemiologically peculiar as their cohort would have been expected to yield further cases.”

(Comment 23) One comment said a 12-month age cutoff would be consistent with the International Review Team (IRT) recommendation that the brain, skull, spinal cord, and vertebral column of cattle over 12 months of age be excluded from both human food and animal food chains unless aggressive surveillance shows that the BSE risk in the United States is minimal (Ref. 21).

(Response 23) We decline to revise the rule in response to the comment. The IRT was convened at the request of the U.S. Secretary of Agriculture on December 30, 2003, to review the actions taken by the United States in response to the confirmation of BSE in an imported dairy cow in Washington State on December 23, 2003. The IRT recommended that, among other things, the brain, skull, spinal cord, and vertebral column of cattle over 12 months be excluded from both the human food and animal food chains unless aggressive surveillance proves the BSE risk in the United States to be minimal (Ref. 22). As a follow up to the IRT report, USDA's APHIS conducted the aggressive surveillance and found the BSE prevalence in the United States to be minimal. Therefore, a 30-month cutoff is consistent with the recommendations of the IRT.

(Comment 24) One comment noted that many countries have imported vast amounts of meat-and-bone meal from countries with BSE-infected cattle, some of which do not have adequate surveillance and other mitigations in place to prevent contamination of the animal feed and human food chains. The comment further noted that these countries may still serve as a source of disease, and if the entire intestine is not designated as SRM, BSE-infected bovine products could be imported and enter the U.S. food or feed supply.

(Response 24) We disagree that the scenario described provides sufficient justification for designating the entire intestine as SRM. Our trading partners in cattle and cattle derived products are countries that have performed a BSE risk assessment, conducted the required level of BSE surveillance, and have the necessary BSE mitigations in place to meet OIE requirements for negligible or controlled risk status.

(Comment 25) One comment stated that we should err on the side of caution when it comes to protecting public health and designate the entire length of the intestines as SRM. The comment noted that scientific research demonstrates that immunostaining was observed in the myenteric plexus of the distal ileum in both naturally infected and experimentally challenged cattle with BSE, so one cannot eliminate the possibility of infectivity in other sections because the myenteric plexus exists throughout the entire intestine. Another comment stated that even a trace of BSE infectivity is concern enough to prohibit the use of the jejunum, proximal ileum, ileocecal junction, and colon of cattle.

(Response 25) We agree that it is reasonable to assume that increasingly sensitive detection methods could demonstrate that BSE infectivity is present anywhere along the intestinal tract, associated either with the enteric nervous system or lymphoreticular tissue. However, all available evidence to date shows that levels outside the distal ileum are much lower than levels in the distal ileum. As we explained in the 2013 notice, our tentative conclusion took into consideration not just the lower levels, but also the other safeguards in place in the United States, the sharp decline in the worldwide incidence of BSE, and the extremely low prevalence of BSE in the U.S. cattle population as indicated by USDA's BSE surveillance program (78 FR 14012). This conclusion is consistent with the recommendation in the 2009 EFSA Scientific Opinion that future consideration of risk associated with infectivity in the intestine take into account the BSE prevalence in cattle at that time (Ref. 18).

(Comment 26) Comments from the Biological Hazards Unit of EFSA in response to FDA's 2013 notice reopening the comment period clarified EFSA's current thinking on BSE infectivity in bovine intestines. EFSA stated that it had concluded that BSE infectivity in the bovine ileum is found mainly in association with the lymphoid follicles, the ileal Peyer's patches (Refs. 23 through 25). The ileal Peyer's patches are aggregated into a long continuous structure called the ileocecal plate. The ileocecal plate extends the full length of the ileum, and may extend proximally into the jejunum. EFSA concluded that, when assessing the BSE infectious load potentially present in the intestines of BSE-infected cattle, the ileocecal plate should be considered as the main contributor to BSE infectivity in the intestine.

(Response 26) Since submitting comments to the 2013 notice, the EFSA Panel on Biological Hazards (BIOHAZ) published on May 13, 2014, a Scientific Opinion on BSE risk in bovine intestines and mesentery (Ref. 25). This scientific opinion provides additional information about the distribution of intestinal lymphoid tissue with which BSE infectivity is associated in the early stages of disease. EFSA concluded that the BSE infectious load in the intestines is primarily associated with the lymphoid tissue making up the ileocecal plate. According to anatomical data presented in the report, the length of the ileocecal plate could reach four meters (157 inches), with considerable animal-to-animal variation, in cattle younger than 18 month of age, before the ileocecal plate starts to diminish in length as the animal ages. So, while studies to date show that infectivity levels outside the distal ileum are much lower than in the distal ileum, the anatomical data in the report show that in young cattle lymphoid tissue could extend two meters outside (proximal to) the distal ileum. This anatomical data does not alter our decision to leave the SRM definition unchanged. We believe that given the United States and worldwide BSE prevalence data, removal of prohibited cattle materials as required by this rule, together with the other effective BSE mitigations implemented by the U.S. government, provides the appropriate level of protection against human exposure to the BSE agent.

The regulations define “tallow” as the rendered fat of cattle obtained by pressing or by applying any other extraction process to tissues derived directly from discrete adipose tissue masses or to other carcass parts and tissue. The definition also states that tallow must be produced from tissues that are not prohibited cattle materials and must not contain more than 0.15 insoluble impurities as determined by the method entitled “Insoluble Impurities” (AOCS Official Method Ca 3a-46, American Oil Chemists' Society (AOCS), 5th Edition, 1997, or another equivalent method.

(Comment 27) One comment questioned the basis (i.e., underlying data) for selecting the 0.15 percent level as the allowable cutoff for insoluble impurities in tallow, but did not provide evidence or data to support changing the allowable level.

(Response 27) We discussed the underlying research that provided the basis for permitting tallow to be used in human food and cosmetics if it contains no more than 0.15 percent insoluble impurities in the 2004 IFR (69 FR 42256 at 42260 through 42261). In addition, the 0.15 percent cutoff is consistent with the level used by the Office International des Epizooties (OIE) in the BSE chapter of the OIE Terrestrial Animal Health Code (Ref. 7). Therefore, we are not making any further changes with respect to using the 0.15 percent level as the allowable cutoff of insoluble impurities.

The regulations define “tallow derivative” as any chemical obtained through initial hydrolysis, saponification, or transesterification of tallow. The definition also states that chemical conversion of material obtained by hydrolysis, saponification, or transesterification may be applied to obtain the desired product.

We did not receive comments specific to our definition of “tallow derivative,” and we have finalized the definition without change.

Our regulations at §§ 189.5 and 700.27 mention, but do not define, “gelatin.” Thus, on our own initiative, we have decided to define gelatin as a product that has been obtained by the partial hydrolysis of collagen derived from hides, connective tissue, and/or bones of cattle and swine. Gelatin may be either Type A (derived from an acid-treated precursor) or Type B (derived from an alkali-treated precursor) that has gone through processing steps that include filtration and sterilization or an equivalent process in terms of infectivity reduction (Ref. 26).

The regulations at §§ 189.5(b)(1) and 700.27(b)(1) provide that no human food or cosmetic shall be manufactured from, processed with, or otherwise contain, prohibited cattle materials. We further clarify in §§ 189.5(b)(2) and 700.27(b)(2) that the small intestine is not considered prohibited cattle material as long as the distal ileum is removed by a procedure that removes at least 80 inches of the small intestine or by another procedure that the establishment can show is equally effective at ensuring the distal ileum is completely removed.

(Comment 28) One comment objected to the use of cattle materials in any products and believed that our “published policy” is much too lenient, but did not provide evidence or data to support this assertion.

(Response 28) We disagree with the comment's broad generalization. In the absence of data or other information, we do not have a basis on which to evaluate the comment's assertion that our published policy is too lenient.

(Comment 29) One comment questioned the validity of relying on the Harvard-Tuskegee study to support the restrictions being applied by this regulation to externally applied cosmetics. The comment also questioned whether the restrictions that cover materials derived from cattle not inspected and passed are predicated on unfounded assumptions with respect to potential infectivity.

(Response 29) The Harvard-Tuskegee study does not specifically address potential human exposure to the BSE agent from cosmetics (69 FR 42256 at 42258), so it was not relied on to support the restrictions applied by the 2004 IFR to externally applied cosmetics. However, we are concerned that cosmetics, because of the ways they are used, could serve as another potential route for BSE infectivity to enter the human system. We therefore conclude that the wide range of cattle-derived ingredients used in cosmetics should not contain prohibited cattle materials (Ref. 27).

(Comment 30) One comment said that the United States should test every cow for TSEs, extend and enhance the feed ban, enhance surveillance and testing programs to test all cattle destined for human and animal consumption, ban all animal tissue in vaccines and nutritional supplements, and stop feeding ruminant and non-ruminant protein to all species.

(Response 30) We disagree with the recommendation to change current U.S. BSE control measures. The mitigations currently in place in the U.S. adequately protect human and animal health from BSE. Testing cattle and enhancing surveillance and testing programs fall under the purview of USDA. USDA's surveillance strategy is to target testing on those animals in the cattle population where the disease is most likely to be found if it is present. USDA has concluded that this is the most effective way to meet OIE and domestic surveillance standards. USDA determined that a level of 40,000 samples per year from these targeted, high-risk cattle far exceeds the standards recommended by the OIE (Ref. 16). With respect to animal feed restrictions, FDA's 1997 feed ban prohibited the use of ruminant protein in cattle feed, while the 2008 enhanced feed ban prohibits the use of the highest risk cattle tissues in all animal feed. Lastly, we are not aware of scientific justification for banning all animal tissue in vaccines and nutritional supplements.

(Comment 31) While many comments supported the use of material from nonambulatory disabled cattle, a few comments requested that these materials be prohibited regardless of the reason for the animal's condition (e.g., obesity, fatigue, stress, nerve paralysis, or physical injury such as a fractured appendage, severed tendon or ligament, or dislocated joint). Other comments were concerned that visual examination was not sufficient for determining whether an animal is safe to be slaughtered. Other comments thought the current prohibition involving nonambulatory disabled cattle is too broad in its application, particularly when applied to animals that are nonambulatory due to clear physical injuries, such as a broken limb.

(Response 31) We decline to make changes to the rule regarding the prohibition on the use of cattle materials from nonambulatory disabled cattle in human food and cosmetics. As discussed in the 2007 FSIS affirmation, surveillance data from the EU indicate that cattle that cannot rise from a recumbent position are among the cattle that have a greater prevalence of BSE than healthy slaughter cattle, and the typical clinical signs of BSE may not always be observed when cattle are nonambulatory (72 FR 38700 at 38701 to 38706).

(Comment 32) Several comments requested that SRMs be kept out of all cosmetics over which FDA has jurisdiction.

(Response 32) Under § 700.27, no cosmetic shall be manufactured from, processed with, or otherwise contain, prohibited cattle materials. This includes SRMs.

(Comment 33) One comment stated that human consumption of any trace of BSE can be fatal, and that the use of materials derived from cattle should not be allowed in human food and cosmetics.

(Response 33) We strongly disagree that cattle derived products should not be used in human food and cosmetics. The sharp decline in vCJD cases worldwide demonstrates that internationally recognized BSE mitigations that remove only specified risk materials are highly effective in protecting humans against BSE. (Refs. 4, 22, 28, and 29). We note that the World Health Organization (WHO), in the 2010 update to the WHO Tables on Tissue Infectivity Distribution in Transmissible Spongiform Encephalopathies (Ref. 30), stated that the amount of pathological prion or infectious agent detected by exquisitely sensitive assays may well fall below the threshold of transmissibility for humans, and that consideration also has to be given to the level of infectivity in tissue, the amount of tissue to which a person is exposed, and that oral exposure is a comparatively inefficient route of transmission.

(Comment 34) One comment stated that one of the most important and still unanswered questions is the significance of atypical BSE with respect to human and animal health. The comment said that if the U.S. government considers atypical BSE to be a sporadic disease, at present there is no means to eliminate cases from the national herd, and thus the food supply. The comment noted that in atypical BSE the extent of infectivity in bovine tissue is unknown, and hence, it would be important to at least remove the tissues having infectivity in classical BSE cases.

(Response 34) We agree with the comment's assertion that there are still unanswered questions about the significance of atypical BSE with respect to human and animal health. We also agree that if atypical cases are sporadic, their occurrence will continue to be an ongoing rare event in our cattle population. However, based on the available science, we believe that the mitigations currently in place in the United States to protect against classical BSE are adequate to protect against atypical BSE. We note that this was also the conclusion of the OIE Scientific Commission for Animal Diseases. The February 2013 meeting report concluded that “the ruminant-to-ruminant feed ban which mitigates the risk of classical BSE concurrently reduces the recycling of atypical BSE in the cattle populations of the controlled and negligible BSE risk countries within which it is applied.” (Ref. 31).

In the 2004 IFR, FDA required that manufacturers and processors of human food and cosmetics that are manufactured from, processed with, or otherwise contain, cattle material must make existing records relevant to compliance available to FDA for inspection and copying. In a companion rulemaking at the same time, FDA proposed a rule entitled “Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing Material from Cattle” (69 FR 42275). The rule proposed to require that manufacturers and processors of human food and cosmetics that are manufactured from, processed with, or otherwise contain, material from cattle establish and maintain records sufficient to demonstrate the food or cosmetic is not manufactured from, processed, with, or does not otherwise contain, prohibited cattle materials. The records requirements were finalized in 2006 and incorporated the requirement from the 2004 IFR that existing records relevant to compliance be made available to FDA (71 FR 59653).

Under § 189.5(d)(1), failure of a manufacturer or processor to operate in compliance with the requirements or records provisions renders human food adulterated under section 402(a)(4) of the FD&C Act. Under § 700.27(d), failure of a manufacturer or processor to operate in compliance with the requirements or records provisions renders a cosmetic adulterated under section 601(c) of the FD&C Act. Further, under § 189.5(d)(2), human food manufactured from, processed with, or otherwise containing, prohibited cattle materials is unfit for human food and deemed adulterated under section 402(a)(3) of the FD&C Act. Under § 189.5(d)(3), the use or intended use of any prohibited cattle material in human food causes the material and the food to be adulterated under section 402(a)(2)(C) of the FD&C Act if the prohibited cattle material is a food additive, unless it is the subject of a food additive regulation or of an investigational exemption for a food additive under § 170.17.

We did not receive comments specific to the adulteration provisions, and we have finalized them without change.

Sections 189.5(e) and 700.27(e) establish a process for designating a country as not subject to certain BSE-related restrictions applicable to FDA-regulated human food and cosmetics. A country seeking to be so designated must send a written request to the Director of FDA's Center for Food Safety and Applied Nutrition, including information about the country's BSE case history, risk factors, measures to prevent the introduction and transmission of BSE, and any other relevant information.

We did not receive comments specific to the process for designating countries, and we have finalized those aspects of the rule without change.

Several comments addressed matters that were not specific to a particular provision in the IFRs. We address those comments here.

(Comment 35) Several comments said that prohibiting the use of cattle materials from nonambulatory disabled cattle in human food and cosmetics also should apply to the use of such materials in animal food or feed.

(Response 35) This final rule applies to the use of cattle materials in human food and cosmetics regulated by FDA. Our regulations in effect at the time of the 2004 IFR prohibited the use of certain protein from mammalian tissues in ruminant feed and have since been revised to prohibit the use of certain cattle-derived risk materials (e.g., the brains and spinal cords from cattle 30 months of age and older, as well as the entire carcass of cattle not inspected and passed for human consumption) in all animal feeds. In a feed rule published in the Federal Register on April 25, 2008 (73 FR 22720), FDA's Center for Veterinary Medicine (CVM) explained that, because of the low prevalence of BSE in the United States, it is not necessary to prohibit all ruminant material from animal feed, nor is it necessary to prohibit all animal or all mammalian products in cattle feed. (See 73 FR 22720 at 22724, as well as similar discussion provided in the preamble to the earlier CVM proposal published in the Federal Register on October 6, 2005 (70 FR 58570 at 58578).)

(Comment 36) One comment stated that we do not truly know or understand the real risk to the public in regards to vCJD as caused by classical BSE. The comment said that based on results of an appendix tissue survey in the UK, the dose to infect humans may be much smaller than previously considered, and even small amounts of the BSE agent could infect humans resulting in a subclinical disease that may pose a risk to other people via blood transfusions, etc. According to the comment, this is justification for prohibiting the use of the entire intestine for human consumption or cosmetics.

(Response 36) We are aware of the results of the appendix survey published October 15, 2013, in the British Medical Journal (Ref. 32). We agree that the survey results underscore the need for better understanding of BSE and vCJD. In the appendix survey, 32,441 archived appendix samples collected during surgical operations performed in the UK between 2000 and 2012 were analyzed for the presence of abnormal prion protein. Sixteen samples were positive for abnormal prions. We did not conclude from these findings that they provide the scientific justification to modify our SRM definition to include the entire intestine of cattle. As the article points out, the samples were collected after the large BSE epizootic in the United Kingdom that resulted in a substantial amount of BSE infectivity entering the human food supply. We continue to believe that the SRM definition we are finalizing is appropriate for managing the BSE situation risk in the United States.

(Comment 37) One comment stated that FDA does not require reporting on CJD, so the United States is unable to track the incidence rate of the disease.

(Response 37) Tracking the incidence of CJD and vCJD is the responsibility of the Center for Disease Control and Prevention (CDC). The CDC collaborates with the American Association of Neuropathologists, the National Prion Disease Pathology Surveillance Center, and State health departments to monitor the prevalence of human prion diseases in the United States (Ref. 33).

(Comment 38) Several comments were from individuals who had suffered the loss of a loved one from sporadic CJD (sCJD) and were concerned about sCJD risks as well as vCJD risks. Many comments said that, because the etiology of sCJD is unknown, FDA should take every precaution possible to eliminate human exposure to what could potentially be a causative agent of sCJD.

(Response 38) Although sCJD and vCJD are both prion diseases of humans and are similar in many respects, the available scientific evidence does not support a conclusion that the BSE agent causes sCJD. Therefore, we believe that requiring removal of parts of the small intestines other than the distal ileum would not provide any additional protection against sCJD.

(Comment 39) A comment inquired as to the impact of sequestration and budget cuts upon the availability of FDA inspectors in slaughter facilities to insure the proper removal of the distal ileum and keep the public safe.

(Response 39) FDA does not inspect cattle slaughter facilities. They are inspected by USDA under the provisions of the Federal Meat Inspection Act (21 U.S.C. 601).

(Comment 40) One comment requested that bovine blood-derived products, such as beef blood plasma and fibrinogen, be prohibited until it is more certain that such blood-derived products do not have the potential for transmitting TSEs to humans. While noting the current thinking that the lymphatic system is the primary route of infectivity for TSEs, the comment suggested that TSEs may be transmitted via the blood through cut or abraded skin and damaged oral mucosal tissue.

(Response 40) We recognize that there are a number of animal species in which blood from TSE-infected animals have been shown to be capable of transmitting the TSE agent, and that there have been several cases in the UK of people acquiring vCJD after receiving transfusions of blood from donors who later were found to have vCJD. However, there is no evidence that blood from infected cattle can transmit the BSE agent to humans when the blood is incorporated into human food or cosmetics. Therefore, the final rule does not prohibit use of cattle blood or impose any special requirements on cattle blood materials that might be used in human food, including dietary supplements, and in cosmetics.

(Comment 41) One comment said that the U.S. government issued an official communication that it has a longstanding system of interlocking safeguards against BSE that protects public and animal health in the United States and that the most important safeguard is the removal of SRM or the parts of an animal that would contain BSE should an animal have the disease from all animals presented for slaughter in the United States. The comment stated that this could lead the public to believe any tissue that may contain BSE infectivity is removed at slaughter and concluded that this is definitely not the case with certain parts of the intestine and potentially other tissue such as peripheral nerves.

(Response 41) We understand the concern about how the message on the removal of SRM could be interpreted. We intend for the term SRM to mean the list of tissues identified in our final rule that must be removed from beef products for human consumption. We believe the official communication was correct that the United States has interlocking safeguards in place in addition to removal of specified risk material. These interlocking safeguards include a strong ruminant-to-ruminant feed ban, an ongoing BSE surveillance program capable of detecting the disease at very low levels in the U.S. cattle population, and strict controls on imports of animals and animal products from countries at risk for BSE.

(Comment 42) One comment expressed concern about the possibility of SRMs getting into the food supply through rendering.

(Response 42) In edible rendering (applying the rendering process to edible tissues for use as human food) only materials from cattle sources that have been inspected and passed for human consumption and do not contain SRMs or other materials considered to be prohibited cattle materials may be rendered for use in human food and cosmetics. It is the responsibility of manufacturers and processors, including renderers, to take precautions to avoid cross contamination of non-prohibited cattle material with prohibited cattle material during slaughter and processing. In this regard, manufacturers and processors of human food and cosmetics manufactured from, processed with, or that otherwise contain, material from cattle must maintain records sufficient to demonstrate that the human food and cosmetics are not manufactured from, processed with, or otherwise contain, prohibited cattle materials under §§ 189.5(c)(1) and 700.27(c)(1). Further, food establishments are subject to the CGMP requirements in part 110, and failure to take adequate measures to prevent cross-contamination could result in insanitary conditions whereby the food may be rendered injurious to health and, therefore, adulterated under section 402(a)(4) of the FD&C Act.

We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We believe that this final rule is not a significant regulatory action as defined by Executive Order 12866.

The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this rule finalizes an existing IFR with no substantive changes, we certify that the final rule will not have a significant economic impact on a substantial number of small entities.

The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $144 million, using the most current (2014) Implicit Price Deflator for the Gross Domestic Product. This final rule would not result in an expenditure in any year that meets or exceeds this amount.

This final rule reaffirms the provisions in the 2004 IFR, as well as the 2005 and 2008 amendments, to address the potential risk of BSE in human food including dietary supplements, and in cosmetics. As the final rule's coverage and requirements do not differ from the 2004 IFR and the 2005 and 2008 amendments, no additional costs or benefits will accrue from this rulemaking.

The summary analysis of benefits and costs included in this document is drawn from the detailed IFR RIA (69 FR 42255 at 42265-42271).

We received two comments on our interim final regulatory impact analysis and are declining to make changes to the RIA in the final rule.

(Comment 43) One comment stated that our economic analysis appears to consider only the industries that are end users of cattle materials and to overlook industries that produce intermediate products. As a result, there is no mention of the rule's impact on manufacturers of collagen casings, gelatin, and other intermediate products.

(Response 43) We disagree. We did estimate the impact of the 2004 IFR (and amendments) to both producers of intermediate cattle-derived products and producers of cattle-derived end products (69 FR 42256 at 42266). In the case of gelatin, depending on the product, we had information on cattle-derived materials manufactured by intermediate producers (i.e., input suppliers to cosmetics manufacturers) or information on end products that contained cattle-derived materials (i.e. foods). Whether our information was on intermediate manufacturers or end products, we estimated the impact of the 2004 IFR on both the upstream and downstream facilities.

The final rule clarifies that gelatin was never considered a prohibited cattle material. This final rule defines “gelatin” to clarify that gelatin is not considered to be a prohibited cattle material as long as it is manufactured using the customary industry processes specified in the Gelatin Manufacturers Institute of America's (GMIA) Gelatin Manual.

In the 2005 amendment to the 2004 IFR, we revised the definition of “prohibited cattle materials” that appears at §§ 189.5(a)(1) and 700.27(a)(1) to clarify that “hides and hide-derived products” are not to be considered prohibited cattle materials (70 FR 53063 at 53066). Thus, collagen casings made from hides are not banned by this final rule, since the cattle hides from which they are made are not prohibited cattle materials.

(Comment 44) One comment stated that the 2004 IFR does not consider the cost to gelatin producers of tracing cattle to their origin, nor does it consider that other cattle-derived ingredients from inedible rendering (i.e., tallow-derived products) are commonly used in cosmetics.

(Response 44) The final rule does not require users of cattle material to certify from which animal a specific material was derived. Users of cattle-derived material must only maintain records sufficient to demonstrate that cattle derived material is not made from, processed with, or does not otherwise contain prohibited cattle materials. We included the costs of generating and keeping records on cattle-derived material in the BSE recordkeeping rule (71 FR 59653 at 59661).

Our 2004 IFR analysis (69 FR 42256 at 42267) took into consideration the potential costs to cosmetic manufacturers to switch from inedible rendering to using edible tallow (and derivatives) in cosmetic products. We estimated in the 2004 IFR analysis that the cost of this change would range from $0 to $18 million.

This final rule reaffirms the provisions in the 2004 IFR, as well as the 2005 and 2008 amendments, to address the potential risk of BSE in human food including dietary supplements, and in cosmetics. As the final rule's coverage does not differ from the 2004 IFR and the 2005 and 2008 amendments, no additional costs or benefits will accrue from this rulemaking.

We have designated certain materials from cattle as “prohibited cattle materials” and banned the use of such materials in human food, including dietary supplements, and in cosmetics. We have designated the following items as prohibited cattle materials: SRMs, the small intestine of all cattle unless the distal ileum is removed, material from nonambulatory disabled cattle, material from cattle not inspected and passed (for human consumption), and mechanically separated MS (Beef). SRMs include the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and DRG of cattle 30 months of age and older, and the tonsils and distal ileum of the small intestine from all cattle. These restrictions appear in §§ 189.5 and 700.27 (21 CFR 189.5 and 21 CFR 700.27). Milk and milk products, cattle hides and hide-derived products, tallow that contains no more than 0.15 percent insoluble impurities, tallow derivatives (regardless of the tallow source), and gelatin are not prohibited cattle materials. In addition, we may designate a country as not subject to certain BSE-related restrictions following an evaluation of the country's BSE situation.

Because of the 2004 IFR and 2005 and 2008 amendments already in effect, manufacturers and processors of food and cosmetic products using bovine materials such as the brain, skull, and spinal cord are obtaining these ingredients exclusively from cattle younger than 30 months of age. The manufacturers and processors of products that use the tonsils or the distal ileum of small intestine of cattle, material from nonambulatory disabled cattle, material from cattle not inspected and passed for human consumption, or MS (Beef) have found substitutes for those ingredients. To the extent that the 2004 IFR and 2005 and 2008 amendments led to increased use of alternative ingredients or ingredients from cattle under the age of 30 months, exposure to potentially BSE-infected cattle materials was reduced.

This final rule also clarifies that gelatin made from cattle-derived material is not, and never was, considered a prohibited cattle material so long as it is manufactured using customary industry processes. If there remained in the marketplace any confusion as to the status of gelatin derived from cattle materials, the new definition provided by this final rule should remove that confusion.

To date, New Zealand and Australia have requested and received designation as not subject to certain FDA restrictions on cattle-derived materials. No other countries have applied to the FDA for designation. In the 2008 amendment, we estimated that it would cost a country about $9,000 to assemble a petition package for us to consider, and it would cost us $3,700 to review each package (73 FR 20785 at 20790). We did not receive any comments on these costs.

The benefits of this final rule are the value of the public health benefits. The public health benefit is the reduction in the risk of the human illness associated with consumption of the agent that causes BSE. In the 2004 IFR and 2005 and 2008 amendments, we were unable to quantify the benefits of these rule-makings, but provided estimates of the illness burden that could be avoided if we reduced the potential exposure to BSE agents.

In the 2004 IFR we estimated the benefits as the value of preventing a case of vCJD, the human illness that results from being infected from eating contaminated cattle-derived materials. (69 FR 42256 at 42267) The cost of a case of vCJD is the value of a statistical life (VSL) plus the value of preventing a year-long or longer illness that precedes certain death for victims of vCJD. In 2004 we estimated this value to be in the range of $5.7 to $7.1 million. Updating using a central estimate of $369,000 for the value of a statistical life year (VSLY) and a central estimate of $8.3 million for VSL,3 results in a single case of vCJD being valued at about $10 million in 2013 dollars. This estimate included direct medical costs, reduced ability of the ill person to function at home and at work, and the cost of premature death.

As we stated in the 2004 IFR, we do not know the baseline expected annual number of cases, but based on the epidemiology of vCJD in the UK, we anticipated much less than one case of vCJD per year in the United States. Because the IFR and amendments were expected to reduce, rather than eliminate, the risk of exposure to BSE infectious materials, the reduction in the number of cases was estimated to be an unknown fraction of the less than one case annually. We stated in the 2004 IFR RIA that the IFR, in conjunction with USDA's requirements on cattle-derived materials, would help reduce a potential human exposure in the United States that was previously estimated at less than 1 percent (69 FR 1862 at 1867).

The benefits of this final rule have already been realized as the IFR has been in place since 2004. We do not estimate any additional benefits as a result of this finalizing this IFR.

We have determined under 21 CFR 25.32(m) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

The collection of information provisions of this final rule are subject to review by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in §§ 189.5(e) and 700.27(e), added by the 2008 amendment, have been previously approved under OMB control number 0910-0623. This final rule does not revise the information collection requirements of §§ 189.5(e) and 700.27(e). Therefore we are not submitting this final rule to OMB as a revision of the information collection approved under OMB control number 0910-0623.

We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. We have determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we have concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

The following references have been placed on display in the Division of Dockets Management (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday they are also available electronically at http://www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.)

Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, the interim final rule amending 21 CFR parts 189 and 700, which was published on July 13, 2004, at 69 FR 42255, and amended on September 7, 2005, at 70 FR 53063, and amended on April 17, 2008, at 73 FR 20785, is adopted as a final rule with the following changes:

California Department of Transportation has requested a temporary change to the operation of the Tower Drawbridge, mile 59.0, over Sacramento River, at Sacramento, CA. The vertical lift bridge navigation span provides a vertical clearance of 30 feet above Mean High Water in the closed-to-navigation position. The draw operates as required by 33 CFR 117.189(a). Navigation on the waterway is commercial and recreational.

The drawspan will be secured in the closed-to-navigation position from 8:30 a.m. to 10:30 a.m. on March 26, 2016, to allow the community to participate in the Peace Love run. This temporary deviation has been coordinated with the waterway users. No objections to the proposed temporary deviation were raised.

Vessels able to pass through the bridge in the closed position may do so at anytime. The bridge will be able to open for emergencies and there is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.

The Marine Parkway Bridge, mile 3.0, across the Jamaica Bay, has a vertical clearance in the closed position of 55 feet at mean high water and 59 feet at mean low water. The existing bridge operating regulations are found at 33 CFR 117.795(a).

The waterway is transited by commercial oil barge traffic of various sizes.

The bridge owner, MTA Bridges and Tunnels, requested a temporary deviation from the normal operating schedule to facilitate auxiliary clutch shafts replacement at the bridge.

Under this temporary deviation, the Marine Parkway Bridge shall remain in the closed position from 7 a.m. on April 4, 2016 to 5 p.m. April 15, 2016.

Vessels able to pass under the bridge in the closed position may do so at anytime. The bridge will not be able to open for emergencies and there is no immediate alternate route for vessels to pass.

The Coast Guard will inform the users of the waterways through our Local Notice and Broadcast to Mariners of the change in operating schedule for the bridge so that vessel operations can arrange their transits to minimize any impact caused by the temporary deviation. The Coast Guard notified various companies of the commercial oil and barge vessels and they have no objections to the temporary deviation.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.

California Department of Transportation has requested a temporary change to the operation of the Tower Drawbridge, mile 59.0, over Sacramento River, at Sacramento, CA. The vertical lift bridge navigation span provides a vertical clearance of 30 feet above Mean High Water in the closed-to-navigation position. The draw operates as required by 33 CFR 117.189(a). Navigation on the waterway is commercial and recreational.

The drawspan will be secured in the closed-to-navigation position from 5 a.m. to 11 a.m. on April 3, 2016, to allow the community to participate in the Sactown 10 race. This temporary deviation has been coordinated with the waterway users. No objections to the proposed temporary deviation were raised.

Vessels able to pass through the bridge in the closed position may do so at anytime. The bridge will be able to open for emergencies and there is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the and of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.

I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background Information and Regulatory History

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because publishing an NPRM would be “impracticable, unnecessary, or contrary to the public interest,” due to the exigent need to conduct investigations and clean up operations following an explosion and fire that occurred at Dozier's Point Urbanna Marina in Urbanna Creek, Urbanna, VA on the morning of February 29, 2016. Two persons lost their lives in the fire and over 50 boats burned or sustained damage. The nature of the incident and extent of damage makes it impracticable to provide a full comment period due to the lack of time. It is impracticable to publish an NPRM because we must establish this safety zone to continue the prior safety zone that is expiring 4 p.m. on March 4, 2016 that was established for the fire response.

We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective less than 30 days after publication in the Federal Register. Given the severity of the incident, a delay in enacting this safety zone would be contrary to public interest because recovery actions are necessary to ensure the navigable waters do not contain safety hazards as a result of the explosion and subsequent fire.

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Hampton Roads (COTP) has determined that hazards resulting from the fire as well as clean-up and removal operations will be a safety concern for anyone within a 300-yard radius of the Dozier's Point Urbanna Marina. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while investigative and clean up operations are being conducted in response to the substantial damage which resulted from the fire.

This rule establishes a safety zone from 4 p.m. on March 4, 2016 through 4 p.m. on April 8, 2016. The safety zone will cover all navigable waters within 300 yards of vessels and machinery being used by personnel to conduct recovery operations at Dozier's Point Urbanna Marina. The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters while recovery operations are conducted. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.

We developed this rule after considering numerous statutes and Executive order related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.

This regulatory action determination is based on the size, location, and duration of the safety zone. The safety zone will impact a small designated area of Urbanna Creek in Urbanna, VA as needed to support clean-up and until recovery operations are complete. The safety zone is in an area where and during a time of year when vessel traffic is normally low. Moreover, the Coast Guard will issue Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has 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. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969(42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting five weeks that will prohibit entry within 500 yards of vessels and being used by personnel to conduct recovery operations. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are not required. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

Section 553 of the APA, 5 U.S.C. 553(b)(3)(B), provides that, when an agency for good cause finds that notice and public procedure are impracticable, unnecessary or contrary to the public interest, the agency may issue a rule without providing notice and an opportunity for public comment. The EPA has determined that there is good cause for making this final agency action without prior proposal and opportunity for comment because no significant EPA judgment is involved in making a finding of failure to submit SIPs, or elements of SIPs, required by the CAA, where states have made no submissions, or incomplete submissions, to meet the requirement. Thus, notice and public procedures are unnecessary. The EPA finds that this constitutes good cause under 5 U.S.C. 553(b)(3)(B).

The EPA has established a docket for this action under Docket ID No. EPA-HQ-OAR-2016-0098 for this action. All documents in the docket are listed on http://www.regulations.gov Web site. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information or information whose disclosure is restricted by statue. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form through http://www.regulations.gov.

For questions related to specific states mentioned in this notice, please contact the appropriate EPA Regional office:

This final rule amends the NFS to correct 1852.245-70 section heading.

Therefore, 48 CFR part 1852 is amended as follows:

NMFS manages the GOA groundfish fisheries in the exclusive economic zone of the GOA under the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP). The Council prepared the FMP under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), 16 U.S.C. 1801 et seq. Regulations governing U.S. fisheries and implementing the FMP appear at 50 CFR parts 600, 679, and 680.

The FMP and its implementing regulations require NMFS, after consultation with the Council, to specify the total allowable catch (TAC) for each target species, the sum of which must be within the optimum yield (OY) range of 116,000 to 800,000 metric tons (mt). Section 679.20(c)(1) further requires NMFS to publish and solicit public comment on proposed annual TACs, Pacific halibut prohibited species catch (PSC) limits, and seasonal allowances of pollock and Pacific cod. Upon consideration of public comment received under § 679.20(c)(1), NMFS must publish notice of final harvest specifications for up to two fishing years as annual target TAC, per § 679.20(c)(3)(ii). The final harvest specifications set forth in Tables 1 through 30 of this document reflect the outcome of this process, as required at § 679.20(c).

The proposed 2016 and 2017 harvest specifications for groundfish of the GOA and Pacific halibut PSC limits were published in the Federal Register on December 9, 2015 (80 FR 76405). Comments were invited and accepted through January 8, 2016. NMFS received two responses, containing five general categories of comments. A summary of the comments and NMFS's responses is found in the Response to Comment section of this rule. In December 2015, NMFS consulted with the Council regarding the 2016 and 2017 harvest specifications. After considering public testimony, as well as biological and economic data that were available at the Council's December 2015 meeting, NMFS is implementing the final 2016 and 2017 harvest specifications, as recommended by the Council. For 2016, the sum of the TAC amounts is 590,809 mt. For 2017, the sum of the TAC amounts is 573,872 mt.

In May 2015, NMFS published a final rule implementing regulations associated with Amendment 45 to the FMP for Bering Sea/Aleutian Islands King and Tanner Crabs (Amendment 45) (80 FR 28539, May 19, 2015). Pursuant to § 680.22(e)(1)(ii), NMFS will permanently remove Pacific cod sideboard limits applicable to specified hook-and-line catcher/processors (C/P) in the Western and Central GOA regulatory areas once it receives an affidavit affirming that all eligible participants in these regulatory areas recommend removal of the Crab Rationalization Program GOA Pacific cod sideboard limits. NMFS received an affidavit that all eligible fishery participants in the Western and Central GOA recommend removal of these sideboard limits. Therefore, NMFS is permanently removing the sideboard limits and does not establish 2016 and 2017 Pacific cod sideboard limits for the hook-and-line C/P sector. These sideboard limits have been removed from Tables 21 and 22 of this rule.

In December 2014, the Council took final action to reduce the maximum retainable amount (MRA) for skates in the Gulf of Alaska (GOA). Per the Council's recommendation, NMFS published a proposed rule to modify regulations that specify the MRA for skates in the GOA (80 FR 39734, July 10, 2015). An MRA is expressed as a percentage and is the maximum amount of a species closed to directed fishing (i.e., skate species) that may be retained on board a vessel relative to the retained amount of other groundfish species or halibut open for directed fishing (basis species). An MRA serves as a management tool to slow the harvest rates of incidental catch species and limit retention up to a maximum percentage of the amount of retained groundfish or halibut on board the vessel. NMFS has established a single MRA percentage for big skate (Raja binoculata), longnose skate (Raja rhina), and for all remaining skate species (Bathyraja spp.). The proposed rule would reduce the MRA for skates in the GOA from 20 percent to 5 percent. The reduced MRA would apply to all vessels directed fishing for groundfish or halibut in the GOA. NMFS anticipates that the proposed regulatory revisions associated with the skate MRA reduction will be effective in 2016.

In December 2015, the Council, its Advisory Panel (AP), and its Scientific and Statistical Committee (SSC) reviewed the most recent biological and harvest information about the condition of groundfish stocks in the GOA. This information was compiled by the Council's GOA Groundfish Plan Team and was presented in the draft 2015 SAFE report for the GOA groundfish fisheries, dated November 2015 (see ADDRESSES). The SAFE report contains a review of the latest scientific analyses and estimates of each species' biomass and other biological parameters, as well as summaries of the available information on the GOA ecosystem and the economic condition of the groundfish fisheries off Alaska. From these data and analyses, the Plan Team estimates an overfishing level (OFL) and ABC for each species or species group. The 2015 report was made available for public review during the public comment period for the proposed harvest specifications.

In previous years, the greatest changes from the proposed to the final harvest specifications have been based on recent NMFS stock surveys, which provide updated estimates of stock biomass and spatial distribution, and changes to the models used for producing stock assessments. At the November 2015 Plan Team meeting, NMFS scientists presented updated and new survey results, changes to stock assessment models, and accompanying stock assessment estimates for all groundfish species and species groups that are included in the final 2015 SAFE report. The SSC reviewed this information at the December 2015 Council meeting. Changes from the proposed to the final 2016 and 2017 harvest specifications are discussed below.

The final 2016 and 2017 OFLs, ABCs, and TACs are based on the best available biological and socioeconomic information, including projected biomass trends, information on assumed distribution of stock biomass, and revised methods used to calculate stock biomass. The FMP specifies the formulas, or tiers, to be used to compute OFLs and ABCs. The formulas applicable to a particular stock or stock complex are determined by the level of reliable information available to fisheries scientists. This information is categorized into a successive series of six tiers to define OFL and ABC amounts, with Tier 1 representing the highest level of information quality available and Tier 6 representing the lowest level of information quality available. The Plan Team used the FMP tier structure to calculate OFL and ABC amounts for each groundfish species. The SSC adopted the final 2016 and 2017 OFLs and ABCs recommended by the Plan Team for all groundfish species. The Council adopted the SSC's OFL and ABC recommendations and the AP's TAC recommendations. The final TAC recommendations were based on the ABCs as adjusted for other biological and socioeconomic considerations, including maintaining the sum of all TACs within the required OY range of 116,000 to 800,000 mt.

The Council recommended 2016 and 2017 TACs that are equal to ABCs for pollock, sablefish, deep-water flatfish, rex sole, Pacific ocean perch, northern rockfish, shortraker rockfish, dusky rockfish, rougheye rockfish, demersal shelf rockfish, thornyhead rockfish, big skate, longnose skate, other skates, sculpins, sharks, squids, and octopuses in the GOA. The Council recommended TACs for 2016 and 2017 that are less than the ABCs for Pacific cod, shallow-water flatfish in the Western GOA, arrowtooth flounder, flathead sole in the Western and Central GOA, “other rockfish” in the Southeast Outside district, and Atka mackerel. The Pacific cod TACs are set to accommodate the State of Alaska's (State's) guideline harvest levels (GHLs) for Pacific cod so that the ABCs are not exceeded. The shallow-water flatfish, arrowtooth flounder, and flathead sole TACs are set to allow for increased harvest opportunities for these target species while conserving the halibut PSC limit for use in other, more fully utilized fisheries. The “other rockfish” TAC in the Southeast Outside District (SEO) is set to reduce the amount of discards. The Atka mackerel TAC is set to accommodate incidental catch amounts in other fisheries.

The final 2016 and 2017 harvest specifications approved by the Secretary of Commerce (Secretary) are unchanged from those recommended by the Council and are consistent with the preferred harvest strategy alternative in the EIS (see ADDRESSES). NMFS finds that the Council's recommended OFLs, ABCs, and TACs are consistent with the biological condition of the groundfish stocks as described in the final 2015 SAFE report. NMFS also finds that the Council's recommendations for OFLs, ABCs, and TACs are consistent with the biological condition of groundfish stocks as adjusted for other biological and socioeconomic considerations, including maintaining the total TAC within the OY range. NMFS reviewed the Council's recommended TAC specifications and apportionments, and approves these harvest specifications under 50 CFR 679.20(c)(3)(ii). The apportionment of TAC amounts among gear types and sectors, processing sectors, and seasons is discussed below.

Tables 1 and 2 list the final 2016 and 2017 OFLs, ABCs, TACs, and area apportionments of groundfish in the GOA. The sums of the 2016 and 2017 ABCs are 727,684 mt and 708,629 mt, respectively, which are higher in 2016 and 2017 than the 2015 ABC sum of 685,597 mt (80 FR 10250, February 25, 2015).

NMFS' apportionment of groundfish species is based on the distribution of biomass among the regulatory areas over which NMFS manages the species. Additional regulations govern the apportionment of pollock, Pacific cod, and sablefish. Additional detail on the apportionment of pollock, Pacific cod, and sablefish are described below.

The ABC for the pollock stock in the combined Western, Central, and West Yakutat Regulatory Areas (W/C/WYK) includes the amount for the GHL established by the State for the Prince William Sound (PWS) pollock fishery. The Plan Team, SSC, AP, and Council have recommended that the sum of all State and Federal water pollock removals from the GOA not exceed ABC recommendations. For 2016 and 2017, the SSC recommended and the Council approved the W/C/WYK pollock ABC, including the amount to account for the State's PWS GHL. At the November 2015 Plan Team meeting, State fisheries managers recommended setting the PWS GHL at 2.5 percent of the annual W/C/WYK pollock ABC. For 2016, this yields a PWS pollock GHL of 6,358 mt, an increase of 1,575 mt from the 2015 PWS GHL of 4,783 mt. For 2017, the PWS pollock GHL is 6,264 mt, an increase of 1,481 mt from the 2015 PWS pollock GHL. The 2016 and 2017 pollock ABCs (247,952 mt and 244,280 mt, respectively) are then apportioned between the W/C/WYK management areas, as described below and detailed in Tables 1 and 2.

Apportionments of pollock to the W/C/WYK management areas are considered to be “apportionments of annual catch limit (ACLs)” rather than “ABCs.” This more accurately reflects that such apportionments address management, rather than biological or conservation, concerns. In addition, apportionments of the ACL in this manner allow NMFS to balance any transfer of TAC from one area to another pursuant to § 679.20(a)(5)(iv)(B) to ensure that the area-wide ACL and ABC are not exceeded.

NMFS establishes pollock TACs in the Western, Central, West Yakutat Regulatory Areas, and the Southeast Outside District of the GOA (see Tables 1 and 2). NMFS also establishes seasonal apportionments of the annual pollock TAC in the Western and Central Regulatory Areas of the GOA among Statistical Areas 610, 620, and 630. These apportionments are divided equally among each of the following four seasons: the A season (January 20 through March 10), the B season (March 10 through May 31), the C season (August 25 through October 1), and the D season (October 1 through November 1) (§ 679.23(d)(2)(i) through (iv), and § 679.20(a)(5)(iv)(A) and (B)). Additional detail is provided below; Tables 3 and 4 list these amounts.

The 2016 and 2017 Pacific cod TACs are set to accommodate the State's GHL for Pacific cod in State waters in the Western and Central Regulatory Areas, as well as in PWS. The Plan Team, SSC, AP, and Council recommended that the sum of all State and Federal water Pacific cod removals from the GOA not exceed ABC recommendations. Accordingly, the Council set the 2016 and 2017 Pacific cod TACs in the Western, Central, and Eastern Regulatory Areas to account for State GHLs. Therefore, the 2016 and 2017 Pacific cod TACs are less than the ABCs by the following amounts: (1) Western GOA, 12,151 mt; (2) Central GOA, 12,328 mt; and (3) Eastern GOA, 2,196 mt. These amounts reflect the State's 2016 and 2017 GHLs in these areas, which are 30 percent of the Western GOA ABC and 25 percent of the Eastern and Central ABCs.

NMFS establishes seasonal apportionments of the annual Pacific cod TAC in the Western and Central Regulatory Areas. Sixty percent of the annual TAC is apportioned to the A season for hook-and-line, pot, and jig gear from January 1 through June 10, and for trawl gear from January 20 through June 10. Forty percent of the annual TAC is apportioned to the B season for hook-and-line, pot, and jig gear from September 1 through December 31, and for trawl gear from September 1 through November 1 (§§ 679.23(d)(3) and 679.20(a)(12)). The Western and Central GOA Pacific cod TACs are allocated among various gear and operational sectors. The Pacific cod sector apportionments are discussed in detail in a subsequent section of this preamble.

The Council's recommendation for sablefish area apportionments takes into account the prohibition on the use of trawl gear in the SEO District of the Eastern Regulatory Area and makes available 5 percent of the combined Eastern Regulatory Area ABCs to trawl gear for use as incidental catch in other groundfish fisheries in the WYK District (§ 679.20(a)(4)(i)). Tables 7 and 8 list the final 2016 and 2017 allocations of sablefish TAC to hook-and-line and trawl gear in the GOA.

In October 2015, the Council's recommendations for the proposed 2016 and 2017 harvest specifications (80 FR 76405, December 9, 2015) were based largely on information contained in the final 2014 SAFE report for the GOA groundfish fisheries, dated November 2014 (see ADDRESSES). The Council proposed that the final OFLs, ABCs, and TACs established for the 2016 groundfish fisheries (80 FR 10250, February 25, 2015) be used for the proposed 2016 and 2017 harvest specifications, pending completion and review of the final 2015 SAFE report at its December 2015 meeting.

As described previously, the SSC adopted the final 2016 and 2017 OFLs and ABCs recommended by the Plan Team. The Council adopted the SSC's OFL and ABC recommendations and the AP's TAC recommendations for 2016 and 2017. The final 2016 ABCs are higher than the proposed 2016 ABCs published in the proposed 2016 and 2017 harvest specifications (80 FR 76405, December 9, 2015) for pollock, shallow-water flatfish, arrowtooth flounder, Pacific ocean perch, rougheye rockfish, demersal shelf rockfish, thornyhead rockfish, other rockfish, big skate, sculpins, and octopuses. The final 2016 ABCs are lower than the proposed 2016 and 2017 ABCs for Pacific cod, sablefish, deep-water flatfish, rex sole, flathead sole, northern rockfish, shortraker rockfish, dusky rockfish, longnose skate, other skates, and sharks.

The final 2017 ABCs are higher than the proposed ABCs for shallow-water flatfish, arrowtooth flounder, Pacific ocean perch, rougheye rockfish, demersal shelf rockfish, thornyhead rockfish, other rockfish, big skate, sculpins, and octopuses. The final 2017 ABCs are lower than the proposed ABCs for pollock, Pacific cod, sablefish, deep-water flatfish, rex sole, flathead sole, northern rockfish, shortraker rockfish, dusky rockfish, longnose skate, “other skates,” and sharks. For the remaining target species—Atka mackerel and squids—the Council recommended, and the Secretary approved, the final 2016 and 2017 ABCs that are the same as the proposed 2016 and 2017 ABCs.

Additional information explaining the changes between the proposed and final ABCs is included in the final 2015 SAFE report, which was not available when the Council made its proposed ABC and TAC recommendations in October 2015. At that time, the most recent stock assessment information was contained in the final 2014 SAFE report. The final 2015 SAFE report contains the best and most recent scientific information on the condition of the groundfish stocks, as previously discussed in this preamble, and is available for review (see ADDRESSES). The Council considered the final 2015 SAFE report in December 2015 when it made recommendations for the final 2016 and 2017 harvest specifications. In the GOA, the total final 2016 TAC amount is 590,809 mt, an increase of less than one percent from the total proposed 2016 TAC amount of 590,161 mt. The total final 2017 TAC amount is 573,872 mt, a decrease of 3 percent from the total proposed 2017 TAC amount of 590,161 mt. The following table in this preamble summarizes the difference between the proposed and final TACs. Annual stock assessments incorporate a variety of new or revised inputs, such as survey data or catch information, as well as changes to the statistical models used to estimate a species' biomass and population trend.

Based on changes in the estimates of overall biomass made by stock assessment scientists for 2016 and 2017, as compared to the estimates previously made for 2015 and 2016, the greatest TAC increases are for shallow-water flatfish, Pacific ocean perch, rougheye rockfish, thornyhead rockfish, other rockfish, big skate, and octopuses. Notable increases include those for octopuses and other rockfish. The increase in the octopus ABC and TAC is a result of the increased octopus biomass estimates derived from the 2015 GOA trawl survey. The catch of octopus in the survey was unusually large, with octopus present in more than 15 percent of the survey tows. The estimated octopus biomass for the octopus assemblage is an order of magnitude higher than previous estimates. The rougheye rockfish biomass increase is due to both an increase in the catch in the GOA trawl survey, as well the adoption of a revised statistical model incorporating improvements to growth estimation, and a number of other model changes.

Based on changes in the estimates of biomass, the greatest decreases in TACs are for Pacific cod, sablefish, deep-water flatfish, rex sole, northern rockfish, other skates, and sharks. Notable decreases in TAC include those for deep-water flatfish, rex sole, other skates, and sharks. The GOA trawl survey biomass for deep-water flatfish was the lowest on record. The last full assessment of rex sole was completed in 2011. Incorporating the 2015 trawl survey data and a number of changes to the assessment model resulted in a decrease to estimated biomass, and the corresponding rex sole ABC and TAC. The estimated biomass for other skates decreased due to a combination of the decrease in the survey biomass for other skates and a continue refinement of incorporating a random effects model in the other skates assessment model. Finally, the shark TAC decreased primarily due to the implementation of a random effects model for biomass estimation.

For all other species and species groups, changes from the proposed to the final TACs are within plus or minus five percent of the proposed TACs. These TAC changes correspond to associated changes in the ABCs and TACs, as recommended by the SSC, AP, and Council.

Additionally, based on the Council's recommended changes in setting the TACs at amounts below ABCs, the greatest decreases in TACs are for shallow-water flatfish, arrowtooth flounder, flathead sole, and “other rockfish.” The Council believed, and NMFS concurs, that setting TACs for the three preceding flatfish species equal to ABCs would not reflect anticipated harvest levels accurately, as the Council and NMFS expect halibut PSC limits to constrain these fisheries in 2016 and 2017.

Detailed information providing the basis for the changes described above is contained in the final 2015 SAFE report. The final TACs are based on the best scientific information available. These TACs are specified in compliance with the harvest strategy described in the proposed and final rules for the 2016 and 2017 harvest specifications. The changes in TACs between the proposed rule and this final rule are compared in Table 1a.

The final 2016 and 2017 TAC recommendations for the GOA are within the OY range established for the GOA and do not exceed the ABC for any species or species group. Tables 1 and 2 list the final OFL, ABC, and TAC amounts for GOA groundfish for 2016 and 2017, respectively.

Section 679.20(b)(2) requires NMFS to set aside 20 percent of each TAC for pollock, Pacific cod, flatfish, sculpins, sharks, squids, and octopuses in reserve for possible apportionment at a later date during the fishing year. For 2016 and 2017, NMFS proposed reapportionment of all the reserves in the proposed 2016 and 2017 harvest specifications published in the Federal Register on December 9, 2015 (80 FR 76405). NMFS did not receive any public comments on the proposed reapportionments. For the final 2016 and 2017 harvest specifications, NMFS reapportioned, as proposed, all the reserves for pollock, Pacific cod, flatfish, sculpins, sharks, squids, and octopuses. The TACs listed in Tables 1 and 2 reflect reapportionments of reserve amounts for these species and species groups.

In the GOA, pollock is apportioned by season and area, and is further allocated for processing by inshore and offshore components. Pursuant to § 679.20(a)(5)(iv)(B), the annual pollock TAC specified for the Western and Central Regulatory Areas of the GOA is apportioned into four equal seasonal allowances of 25 percent. As established by § 679.23(d)(2)(i) through (iv), the A, B, C, and D season allowances are available from January 20 to March 10, March 10 to May 31, August 25 to October 1, and October 1 to November 1, respectively.

Pollock TACs in the Western and Central Regulatory Areas of the GOA are apportioned among Statistical Areas 610, 620, and 630, pursuant to § 679.20(a)(5)(iv)(A). In the A and B seasons, the apportionments are in proportion to the distribution of pollock biomass based on the four most recent NMFS winter surveys. In the C and D seasons, the apportionments are in proportion to the distribution of pollock biomass based on the four most recent NMFS summer surveys. However, for 2016 and 2017, the Council recommended, and NMFS approves, averaging the winter and summer distribution of pollock in the Central Regulatory Area for the A season instead of using the distribution based on only the winter surveys. The average is intended to reflect the migration patterns and distribution of pollock, and the anticipated performance of the fishery, in that area during the A season for the 2016 and 2017 fishing years. For the A season, the apportionment is based on an adjusted estimate of the relative distribution of pollock biomass of approximately 6 percent, 73 percent, and 21 percent in Statistical Areas 610, 620, and 630, respectively. For the B season, the apportionment is based on the relative distribution of pollock biomass at 6 percent, 85 percent, and 9 percent in Statistical Areas 610, 620, and 630, respectively. For the C and D seasons, the apportionment is based on the relative distribution of pollock biomass at 41 percent, 26 percent, and 33 percent in Statistical Areas 610, 620, and 630, respectively.

Within any fishing year, the amount by which a seasonal allowance is underharvested or overharvested may be added to, or subtracted from, subsequent seasonal allowances in a manner to be determined by the Regional Administrator (§ 679.20(a)(5)(iv)(B)). The rollover amount is limited to 20 percent of the subsequent seasonal apportionment for the statistical area. Any unharvested pollock above the 20-percent limit could be further distributed to the other statistical areas, in proportion to the estimated biomass in the subsequent season in those statistical areas (§ 679.20(a)(5)(iv)(B)). The pollock TACs in the WYK and SEO District of 9,348 mt and 9,920 mt, respectively, in 2016, and 9,209 mt and 9,920 mt, respectively, in 2017, are not allocated by season.

Section 679.20(a)(6)(i) requires the allocation of 100 percent of the pollock TAC in all regulatory areas and all seasonal allowances to vessels catching pollock for processing by the inshore component after subtraction of amounts projected by the Regional Administrator to be caught by, or delivered to, the offshore component incidental to directed fishing for other groundfish species. Thus, the amount of pollock available for harvest by vessels harvesting pollock for processing by the offshore component is that amount that will be taken as incidental catch during directed fishing for groundfish species other than pollock, up to the maximum retainable amounts allowed by § 679.20(e) and (f). At this time, these incidental catch amounts of pollock are unknown and will be determined during the fishing year during the course of fishing activities by the offshore component.

Tables 3 and 4 list the final 2016 and 2017 seasonal biomass distribution of pollock in the Western and Central Regulatory Areas, area apportionments, and seasonal allowances. The amounts of pollock for processing by the inshore and offshore components are not shown.

Section 679.20(a)(12)(i) requires the allocation of the Pacific cod TACs in the Western and Central Regulatory Areas of the GOA among gear and operational sectors. Section 679.20(a)(6)(ii) requires the allocation of the Pacific cod TACs in the Eastern Regulatory Area of the GOA between the inshore and offshore components. NMFS allocates the 2016 and 2017 Pacific cod TAC based on these sector allocations annually between the inshore and offshore components in the Eastern GOA; seasonally between vessels using jig gear, catcher vessels (CVs) using hook-and-line gear, C/Ps using hook-and-line gear, CVs using trawl gear, and vessels using pot gear in the Western GOA; seasonally between vessels using jig gear, CVs less than 50 feet length overall using hook-and-line gear, CVs greater than or equal to 50 feet length overall using hook-and-line gear, C/Ps using hook-and-line gear, CVs using trawl gear, C/Ps using trawl gear, and vessels using pot gear in the Central GOA. The overall seasonal apportionments in the Western and Central GOA are 60 percent of the annual TAC to the A season and 40 percent of the annual TAC to the B season.

Under § 679.20(a)(12)(ii), any overage or underage of the Pacific cod allowance from the A season will be subtracted from, or added to, the subsequent B season allowance. In addition, any portion of the hook-and-line, trawl, pot, or jig sector allocations that NMFS determines is likely to go unharvested by a sector may be reapportioned to other sectors for harvest during the remainder of the fishery year.

Pursuant to § 679.20(a)(12)(i)(A) and (B), a portion of the annual Pacific cod TACs in the Western and Central GOA will be allocated to vessels with a Federal Fisheries Permit (FFP) that use jig gear before TAC is apportioned among other non-jig sectors. In accordance with the FMP, the annual jig sector allocations may increase to up to 6 percent of the annual Western and Central GOA Pacific cod TACs, depending on the annual performance of the jig sector (See Table 1 of Amendment 83 to the FMP for a detailed discussion of the jig sector allocation process (76 FR 74670, December 1, 2011)). Jig sector allocation increases are established for a minimum of 2 years. NMFS has evaluated the 2015 harvest performance of the jig sector in the Western and Central GOA, and is establishing the 2016 and 2017 Pacific cod apportionments to this sector as follows.

NMFS allocates the jig sector 3.5 percent of the annual Pacific cod TAC in the Western GOA. This is the same amount as the 2015 jig sector allocation, because in 2015 this sector harvested less than 90 percent of the initial 2015 allocation. The 2016 and 2017 allocations include a base allocation of 1.5 percent, and an additional 2.0 percent because this sector harvested greater than 90 percent of its initial 2012 and 2014 allocations in the Western GOA. NMFS also allocates the jig sector 1.0 percent of the annual Pacific cod TAC in the Central GOA. This is the same amount as the 2015 jig sector allocation, because in 2015 this sector harvested less than 90 percent of the initial 2015 allocation. The 2016 and 2017 allocations consist of a base allocation of 1.0 percent and no additional increases in the Central GOA. Tables 5 and 6 list the seasonal apportionments and allocations of the 2016 and 2017 Pacific cod TACs.

Section 679.20(a)(4)(i) and (ii) require allocations of sablefish TACs for each of the regulatory areas and districts to hook-and-line and trawl gear. In the Western and Central Regulatory Areas, 80 percent of each TAC is allocated to hook-and-line gear, and 20 percent of each TAC is allocated to trawl gear. In the Eastern Regulatory Area, 95 percent of the TAC is allocated to hook-and-line gear, and 5 percent is allocated to trawl gear. The trawl gear allocation in the Eastern Regulatory Area may only be used to support incidental catch of sablefish in directed fisheries for other target species (§ 679.20(a)(4)(i)).

In recognition of the prohibition against trawl gear in the SEO District of the Eastern Regulatory Area, the Council recommended and NMFS approves the allocation of 5 percent of the combined Eastern Regulatory Area sablefish TAC to trawl gear in the WYK District, making the remainder of the WYK sablefish TAC available to vessels using hook-and-line gear. NMFS allocates 100 percent of the sablefish TAC in the SEO District to vessels using hook-and-line gear. This action results in a 2016 allocation of 190 mt to trawl gear and 1,285 mt to hook-and-line gear in the WYK District, a 2016 allocation of 2,317 mt to hook-and-line gear in the SEO District, and a 2017 allocation of 173 mt to trawl gear in the WYK District. Table 7 lists the allocations of the 2016 sablefish TACs to hook-and-line and trawl gear. Table 8 lists the allocations of the 2017 sablefish TACs to trawl gear.

The Council recommended that the hook-and-line sablefish TAC be established annually to ensure that this Individual Fishery Quota (IFQ) fishery is conducted concurrently with the halibut IFQ fishery and is based on recent sablefish survey information. The Council also recommended that only a trawl sablefish TAC be established for two years so that retention of incidental catch of sablefish by trawl gear could commence in January in the second year of the groundfish harvest specifications. Since there is an annual assessment for sablefish and the final harvest specifications are expected to be published before the IFQ season begins March 19, 2016, the Council recommended that the hook-and-line sablefish TAC be set on an annual basis, rather than for two years, so that the best scientific information available could be considered in establishing the sablefish ABCs and TACs. With the exception of the trawl allocations that were provided to the Rockfish Program cooperatives, directed fishing for sablefish with trawl gear is closed during the fishing year. Also, fishing for groundfish with trawl gear is prohibited prior to January 20. Therefore, it is not likely that the sablefish allocation to trawl gear would be reached before the effective date of the final 2016 and 2017 harvest specifications.

The recommended 2016 and 2017 DSR TAC is 231 mt, and management of DSR is delegated to the State. The Alaska Board of Fish has apportioned the annual SEO District DSR TACs between the commercial fishery (84 percent) and the sport fishery (16 percent) after deductions were made for anticipated subsistence harvests (7 mt). This results in 2016 and 2017 allocations of 188 mt to the commercial fishery and 36 mt to the sport fishery.

The State deducts estimates of incidental catch of DSR in the commercial halibut fishery and test fishery mortality from the DSR commercial fishery allocation. In 2015, this resulted in 32 mt being available for the directed commercial DSR fishery apportioned in one DSR district. The State estimated that there was not sufficient DSR quota available to have orderly fisheries in the three other DSR districts. DSR harvest in the halibut fishery is linked to the annual halibut catch limits; therefore the State can only estimate potential DSR incidental catch because halibut catch limits are established by the International Pacific Halibut Commission (IPHC). Federally permitted CVs using hook-and-line or jig gear fishing for groundfish and Pacific halibut in the SEO District of the GOA are required to retain all DSR (§ 679.20(j)).

These final 2016 and 2017 harvest specifications for the GOA include the various fishery cooperative allocations and sideboard limitations established by the Central GOA Rockfish Program. Program participants are primarily trawl CVs and trawl C/Ps, with limited participation by vessels using longline gear. The Rockfish Program assigns quota share and cooperative quota to participants for primary and secondary species, allows participants holding a license limitation program (LLP) license with rockfish quota share to form a rockfish cooperative, and allows holders of C/P LLP licenses to opt out of the fishery. The Rockfish Program also has an entry level fishery for rockfish primary species for vessels using longline gear.

Under the Rockfish Program, rockfish primary species (Pacific ocean perch, northern rockfish, and dusky rockfish) in the Central GOA are allocated to participants after deducting for incidental catch needs in other directed groundfish fisheries. Participants in the Rockfish Program also receive a portion of the Central GOA TAC of specific secondary species (Pacific cod, rougheye rockfish, sablefish, shortraker rockfish, and thornyhead rockfish).

Additionally, the Rockfish Program establishes sideboard limits to restrict the ability of harvesters operating under the Rockfish Program to increase their participation in other, non-Rockfish Program fisheries. Besides groundfish species, the Rockfish Program allocates a portion of the trawl halibut PSC limit (191 mt) from the third season deep-water species fishery allowance for the GOA trawl fisheries to Rockfish Program participants (§ 679.81(d)), which includes 117 mt to the trawl CV sector and 74 mt to the trawl C/P sector.

Section 679.81(a)(2)(ii) requires allocations of 5 mt of Pacific ocean perch, 5 mt of northern rockfish, and 30 mt of dusky rockfish to the entry level longline fishery in 2016 and 2017. The allocation for the entry level longline fishery would increase incrementally each year if the catch exceeds 90 percent of the allocation of a species. The incremental increase in the allocation would continue each year until it is the maximum percent of the TAC for that species. In 2015, the catch did not exceed 90 percent of any allocated rockfish species. Therefore, NMFS is not increasing the entry level longline fishery 2016 and 2017 allocations in the Central GOA. Longline gear includes hook-and-line, jig, troll, and handline gear. The remainder of the TACs for the rockfish primary species would be allocated to the CV and C/P cooperatives. Table 9 lists the allocations of the 2016 and 2017 TACs for each rockfish primary species to the entry level longline fishery, the incremental increase for future years, and the maximum percent of the TAC for the entry level longline fishery.