Federal Register Vol. 81, No.8,

AMS administers the Shell Egg Surveillance Program, a mandatory inspection program for shell eggs under the Egg Products Inspection Act (EPIA) (21 U.S.C. 1031 et seq.). This inspection program ensures that shell eggs sold to consumers contain no more restricted eggs than are permitted in the standards for consumer grades. Restricted eggs may contain dirty or cracked shells, eggs leaking internal contents, and eggs with meat or blood spots in the interior. Regulations governing EPIA are contained in 7 CFR part 57.

On February 19, 2014, the President signed Executive Order (EO) 13659, streamlining the export/import process for America's businesses. EO 13659 outlines the use of the International Trade Data System (ITDS), an efficient and cost effective trade processing infrastructure that will modernize and simplify the export and import of cargo. The goal of ITDS is to eliminate the redundant reporting of data, replacing multiple filings, many of which are on paper, with a single electronic filing. AMS participated in the development of ITDS, a government-wide project that will allow traders to file shipment data through an electronic “single window” instead of completing multiple paper-based forms to report the same information to different government agencies. ITDS will reduce the burden on America's export and import trade, while still providing information necessary for the U.S. to ensure compliance with its laws. AMS will incorporate electronic filing of import requests for shell eggs to comply with EO 13659.

CBP has developed the Automated Commercial Environment (ACE), a U.S. commercial trade processing system that automates border processing of products. The ACE system connects the trade community and participating government agencies by providing a single, centralized, online access point. When applicants file entries with CBP through ACE, relevant data is electronically distributed to appropriate government agencies. AMS considers all electronic data entered in ACE as certified by the applicant. In addition, AMS considers any electronic records, digital images, data, or information from a foreign government for foreign inspection and foreign establishment certification to be equivalent to paper records and certified by the foreign government. When developing, procuring, maintaining, or using electronic information technology (EIT), Federal agencies are required by Section 508(a)(1)(a) of the Rehabilitation Act of 1973 (29 U.S.C. 794d) to ensure that EIT is accessible to people with disabilities, including employees and members of the public. The ACE interface meets these requirements.

Therefore, for the reasons specified above, we are revising the shell egg import regulations to include that applicants may submit LPS Form 222-Import Request electronically.

A proposed rule to streamline the importation process was published in the Federal Register (80 FR 32867) on June 10, 2015. Comments on the proposed rule were solicited from interested parties until August 10, 2015. No comments were received.

This action has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget (OMB).

In accordance with the Regulatory Flexibility Act, 5 U.S.C. 603, we have performed an initial regulatory flexibility analysis regarding economic effects of this final rule on small entities. Copies of the analysis are available by contacting the person listed under FOR FURTHER INFORMATION CONTACT.

Based on the information we have, AMS has determined that this regulation, as revised, will not have a significant impact on a substantial number of small entities.

This action has been reviewed under Executive Order 12988, Civil Justice Reform. This action would have no retroactive effects and would not require administrative proceedings before parties may file suit in court challenging this rule. Pursuant to section 23 of the EPIA (21 U.S.C. 1052), states or local jurisdictions are preempted from requiring the use of standards of quality, condition, weight, quantity, or grade which are in addition to or different from Federal standards for any eggs which have moved or are moving in interstate or foreign commerce.

This action has been reviewed in accordance with the requirements of Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. The review reveals that this regulation will not have substantial and direct effects on tribal governments and will not have significant tribal implications.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), OMB has approved the information collection and recordkeeping requirements included in this final rule, and there are no new requirements. Should any changes become necessary, they would be submitted to OMB for approval. The assigned OMB control number is 0581-0113.

AMS is committed to compliance with the Government Paperwork Elimination Act, which requires that, when practicable, Federal agencies allow individuals to submit information and transact with the agency electronically.

AMS is committed to complying with the E-Government Act of 2002 to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to government information and services, and for other purposes.

For the reasons set forth in the preamble, 7 CFR part 57 is amended as follows:

On October 1, 2015, the final rule, “Changes to Production Certificates and Approvals,” 80 FR 59021, was published in the Federal Register. In that final rule the FAA revised the regulations pertaining to certification requirements for products and articles in part 21 of Title 14 of the Code of Federal Regulations (14 CFR) and removed certain marking requirements in 14 CFR part 45 applicable to fixed-pitch wooden propellers. The final rule afforded production approval holders (PAHs) a number of privileges not currently permitted under current regulations.

On December 17, 2015, a correction to the final rule, “Changes to Production Certificates and Approvals; Correction,” 80 FR 78650, was published in the Federal Register. In that correction, the FAA revised the effective date of the final rule to permit an earlier implementation of the rule's provisions that allow production approval holders to issue authorized release documents for aircraft engines, propellers, and articles. It also permits an earlier implementation date for production certificate holders to manufacture and install interface components, and provides earlier relief from the current requirement that fixed-pitch wooden propellers be marked using an approved fireproof method.

In the correction to the final rule, it stated that the FAA and EASA have agreed to delay the implementation of Change 5 to the Maintenance Annex Guidance (MAG) until March 29, 2016. The March 29, 2016 referenced date is incorrect, and the correct date is April 1, 2016. This action corrects an error in the preamble of that document.

In FR Doc. 2015-31639, beginning on page 78650 in the Federal Register of December 17, 2015, make the following correction to the preamble:

On page 78651, in the first column, twelfth line, correct “March 29” to read “April 1”.

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all ATR—GIE Avions de Transport Régional Model ATR42 airplanes. The NPRM published in the Federal Register on January 26, 2015 (80 FR 3921).

European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2012-0193, dated September 25, 2012 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all ATR—GIE Avions de Transport Régional Model ATR42 airplanes. The MCAI states:

We gave the public the opportunity to participate in developing this AD. We have considered the comment received. The following presents the comment received on the NPRM (80 FR 3921, January 26, 2015) and the FAA's response.

Empire Airlines requested that a conflict between the affected airplanes identified in paragraph (h) of the proposed AD (80 FR 3921, January 26, 2015) and the effectivity of certain SSI tasks listed in table 1 to paragraph (h) of the proposed AD be removed. Empire Airlines noted that paragraph (h) of the proposed AD would apply to Model ATR42 airplanes on which ATR Modification 02805 was not embodied in production. The ATR MRBRs, however, identify certain SSI tasks as being effective only for airplanes on which ATR Modification 02805 has been embodied. Empire Airlines suggested that revising the NPRM to address this conflict could result in avoiding the need to request an alternative method of compliance (AMOC).

We agree and have revised table 1 to paragraph (h) of this AD to remove the tasks that are associated only with post-Modification 02805 airplanes, i.e., tasks 572301-3 and -5 for Model ATR-42-200, -300, and -320 airplanes. As stated in the MCAI, the time limit documents and the MRBR/MPD documents will be updated to include the new compliance times.

We have clarified paragraph (h) of this AD by replacing the text “incorporating the SSI tasks” with the text “incorporating the applicable SSI tasks and compliance times” to match the title of table 1 to paragraph (h) of this AD.

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 NPRM (80 FR 3921, January 26, 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 3921, January 26, 2015).

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

Avions de Transport Régional (ATR) has issued Job Instruction Card 535100 DVI 10097, “DVI of FR26 Floor Beam Around Cut-outs for Cooling & Hydrau Ducts,” dated February 9, 2012 (for Model ATR42-200, -300, -320, and -500 airplanes). The service information describes procedures for a detailed inspection for damage (cracks, corrosion, dents, scratches, scores and abrasions) of the floor beam at FR 26, on the left-hand (LH) and right-hand (RH) sides, and, for certain inspection findings, contacting the manufacturer for repair instructions. 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 31 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. Based on these figures, we estimate the cost of this AD on U.S. operators to be $10,540, per inspection cycle, or $340, per inspection cycle, per product.

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

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

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

For the reasons discussed above, I certify 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.

You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2015-0080; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone 800-647-5527) is in the ADDRESSES section.

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

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2013-13-04, Amendment 39-17492 (78 FR 41286, July 10, 2013). AD 2013-13-04 applied to certain Airbus Model A318, A319, A320, and A321 series airplanes. The NPRM published in the Federal Register on March 31, 2015 (80 FR 17007).

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2013-0202, dated September 5, 2013 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for Airbus Model A318-111, -112, -121, and -122 airplanes; Model A319-111, -112, -113, -114, -115, -131, -132, and -133 airplanes; Model A320-211, -212, -214, -231, -232, and -233 airplanes; and Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes. The MCAI states:

The additional actions include a new modification of any previously modified LGCIU, and reducing a certain functional check interval. This AD also adds airplanes on which Airbus modification 37866 has been embodied in production to the applicability. You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2015-0678-0002.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM (80 FR 17007, March 31, 2015) and the FAA's response to the comment.

United Airlines (UAL) stated that paragraphs (i) and (j) of the proposed AD (80 FR 17007, March 31, 2015) would be required to be done in accordance with the instructions of Airbus Service Bulletin A320-32-1346, Revision 05, dated January 13, 2012. UAL asked that we allow use of the latest revision available, Airbus Service Bulletin A320-32-1346, Revision 07, dated February 10, 2015, for accomplishing the modification.

We agree with the commenter's request. Airbus has issued Service Bulletin A320-32-1346, Revision 06, dated January 12, 2015, and Airbus Service Bulletin A320-32-1346, Revision 07, dated February 10, 2015. These revisions state that no additional work is necessary on airplanes changed in accordance with Airbus Service Bulletin A320-32-1346, Revision 05, dated January 13, 2012, which was specified as the appropriate source of service information in the NPRM (80 FR 17007, March 31, 2015).

We have changed paragraphs (i) and (j) of this AD to specify accomplishing the modification in accordance with Airbus Service Bulletin A320-32-1346, Revision 07, dated February 10, 2015. We have also added a new paragraph (l)(2) to this AD (paragraph (l) of the proposed AD (80 FR 17007, March 31, 2015) has been changed to paragraph (l)(1) in this AD) to give credit for actions done before the effective date of this AD using Airbus Service Bulletin A320-32-1346, Revision 05, dated January 13, 2012; or Airbus Service Bulletin A320-32-1346, Revision 06, dated January 12, 2015.

UAL stated that the NPRM (80 FR 17007, March 31, 2015) does not include a terminating action. UAL asked that we create a new paragraph detailing all actions that will be terminated by accomplishing the modification of the LGCIU, as specified in Airbus Service Bulletin A320-32-1346, Revision 07, dated February 10, 2015.

We do not agree with the request. Paragraph (i) of this AD specifies that the modification terminates the actions required by paragraphs (g) and (h) of this AD. Therefore, no change to this AD is necessary in this regard.

We reviewed the relevant data 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 17007, March 31, 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 17007, March 31, 2015).

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 A320-32-1346, Revision 07, dated February 10, 2015, including Appendices 01 and 02, dated February 10, 2015; and Task 32.30.00.17, “Functional Check of LGCIU Power Supply Relays,” of Section C-32 of Section C, Systems and Powerplant, of the Airbus A318/A319/A320/A321 Maintenance Review Board Report, Revision 18, dated March 2013. The service information describes procedures for installing a power interruption protection circuit for the LGCIU, and for a new modification of any previously modified LGCIU. 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 851 airplanes of U.S. registry.

The actions required by AD 2013-13-04, Amendment 39-17492 (78 FR 41286, July 10, 2013), take about 48 work-hours per product, at an average labor rate of $85 per work-hour. Required parts will cost about $8,220 per product. Based on these figures, the estimated cost of the actions that are required by AD 2013-13-04 is $12,300 per product.

We estimate that it takes about 46 work-hours per product to comply with the new modification in this AD. The average labor rate is $85 per work-hour. Required parts will cost about $9,650 per product. Based on these figures, we estimate the cost of the new modification on U.S. operators to be $11,539,560, or $13,560 per product.

We estimate that it takes about 1 work-hour per product to revise the maintenance or inspection program in this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of revising the maintenance program on U.S. operators to be $72,335, or $85 per product.

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

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

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

For the reasons discussed above, I certify 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.

You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2015-0678; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone 800-647-5527) is in the ADDRESSES section.

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 2005-01-09, Amendment 39-13933 (70 FR 1340, January 7, 2005). AD 2005-01-09 applied to certain 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, and 747SR series airplanes. The NPRM published in the Federal Register on June 24, 2015 (80 FR 36255) (“the NPRM”). The NPRM was prompted by additional cracking found in the same area after completion of the one-time detailed inspection. The NPRM proposed to continue to require a one-time detailed inspection for discrepancies of the frame web and inner chords on the forward edge frame of the number 5 main entry door cutout, and corrective action if necessary. The NPRM also proposed to require repetitive HFEC inspections for cracking of the frame inner chords (forward and aft), and corrective action if necessary. We are issuing this AD to detect and correct discrepancies of the frame web and inner chords, which could result in cracking, subsequent severing of the frame, and consequent rapid depressurization 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 NPRM.

UPS asked that credit be included in the proposed AD (80 FR 36255, June 24, 2015) for accomplishing the inspections required by AD 2013-17-08. UPS stated that paragraph (g) of the proposed AD would require accomplishing the same inspections that are required by AD 2013-17-08. UPS added that the proposed AD has a lower threshold for accomplishing the inspections than that in AD 2013-17-08. UPS noted that Boeing confirmed that these inspections are duplicated and stated that a revision of the service information may be forthcoming to provide clarification.

We agree with the commenter that accomplishing the inspections required by AD 2013-17-08 before the effective date of this AD is acceptable for compliance with the inspections required by this AD. We had already included credit for accomplishing the inspections required by AD 2013-17-08 in paragraph (i)(2) of the proposed AD.

However, since the compliance time in AD 2013-17-08 is later than the compliance time required by this AD, we have not given credit for inspections that will be done for AD 2013-17-08 on or after the effective date of this AD. Operators may apply for approval of an AMOC in accordance with the provisions specified in paragraph (j) of this AD, by submitting data substantiating that the request would provide an acceptable level of safety. Therefore, we have made no further change to this AD.

UPS also recommended adding a sentence to paragraph (h) of the proposed AD to terminate the repetitive inspections required by AD 2013-17-08, after accomplishment of the initial inspections required by the proposed AD.

We do not agree to specify that the actions required by paragraph (h) of this AD terminate the repetitive inspections required by AD 2013-17-08, because those inspections are more extensive than the inspections in this AD. However, affected operators who wish to terminate the repetitive inspections required by AD 2013-17-08 may apply for approval of an AMOC in accordance with the provisions specified in paragraph (j) of this AD, by submitting data substantiating that the request would provide an acceptable level of safety. We have not changed this AD in this regard.

Boeing asked that a typographical error in the “Related AD” section of the proposed AD be corrected. Boeing stated that the description of the inspection area in AD 2013-17-08 of the frame segment should be changed from “between 16 and 31” to “between 15 and 31.” Boeing noted that this is a typographical error.

We agree that there is a typographical error in the “Related AD” section of the proposed AD, as noted by the commenter. That section should specify “the frame segment between 15 and 31”; however, since that section of the preamble does not reappear in the final rule, no change to this AD is necessary in this regard.

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD as proposed, with 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 reviewed and approved Boeing Alert Service Bulletin 747-53A2494, Revision 1, dated January 9, 2015. The service information describes procedures for a one-time detailed inspection and repetitive surface HFEC inspections of the Station 2231 frame inner chords (forward and aft), and repair of discrepancies. 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 174 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

Comments Invited

This AD is a final rule that involves requirements affecting flight safety, and we did not provide you with notice and an opportunity to provide your comments prior to it becoming effective. However, we invite you to participate in this rulemaking by submitting written comments, data, or views. We also invite comments relating to the economic, environmental, energy, or federalism impacts that resulted from adopting this AD. The most helpful comments reference a specific portion of the AD, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should send only one copy of written comments, or if comments are filed electronically, commenters should submit them only one time. We will file in the docket all comments that we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning this rulemaking during the comment period. We will consider all the comments we receive and may conduct additional rulemaking based on those comments.

We are adopting a new AD for Agusta Model AB139 and AW139 helicopters with certain slip rings installed. This AD requires inspecting each slip ring for chatter marks, witness marks, or scoring. Based on the findings from the inspection, the AD requires either re-identifying the slip ring by marking a letter “T” after the serial number or replacing the slip ring with a slip ring that is not affected by this AD. This AD is prompted by two reports of detached slip ring bodies from the supporting flange due to improperly low torque of the affected screws during installation. These actions are intended to prevent separation of the mounting flange from the slip ring body and subsequent loss of control of the helicopter.

This AD was prompted by AD No. 2015-0155, dated July 28, 2015, issued by EASA, which is the Technical Agent for the Member States of the European Union, to correct an unsafe condition for the Agusta Model AB139 and AW139 helicopters. EASA advises of two incidents of the screws being found loose and broken on two Model AW139 helicopter tail rotor slip rings. EASA states that subsequent technical investigation revealed that the torque of the screws was improperly low. The slip ring manufacturer established that this occurred on the production line by improper installation of the affected screws on a number of slip rings. EASA advises that this condition, if not detected and corrected, could lead to other events of detachment of the slip ring, possibly resulting in reduced control of the helicopter.

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

We reviewed AgustaWestland Bollettino Technico No. 139-404, dated December 22, 2014 (BT), including Annex A Moog Service Bulletin SB 14-02, Revision D, undated (Moog SB). The BT specifies inspecting and replacing the slip ring mounting screws and reinstalling the lockwire by complying with the Moog SB. The Moog SB advises of insufficient torqueing of the screws and incorrect lock wiring used to affix the tail rotor mountain plate to the slip ring frame. If the slip ring does not pass the inspection, the BT specifies returning the slip ring to AgustaWestland, replacing it, and marking the letter “T” after the serial number of the unit. AgustaWestland states that slip rings already marked with a “T” after the serial number or “MOD 1” marked in the manufacturing plate do not have to be inspected. 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.

This AD requires within 25 hours time-in-service:

• Removing each slip ring, lockwire, fastener, and washer.

• Inspecting the wall of the mounting plate hole for a chatter mark, witness mark, or scoring. If there is a chatter mark, witness mark, or scoring, replacing the slip ring with an airworthy slip ring.

• Determining the depth of the mounting plate hole. If the depth exceeds the grip length of the screw, replacing the slip ring with an airworthy slip ring.

• Re-identifying the slip ring by marking a letter “T” after the serial number with permanent black pen and applying acrylic lacquer (CO81 or equivalent).

This AD also prohibits installing an affected slip ring on any helicopter unless the slip ring has passed the inspections in accordance with this AD.

This AD requires compliance within 25 hours time-in-service; the EASA AD requires compliance within 14 days.

We estimate that this AD will affect 106 helicopters of U.S. Registry. We estimate that operators may incur the following costs in order to comply with this AD. Labor costs are estimated at $85 per work hour. We estimate 3 work hours to inspect the slip ring for a cost of $255 per helicopter and $27,030 for the fleet. We estimate $56,806 in required parts and no additional labor costs to replace a slip ring.

Providing an opportunity for public comments before adopting these AD requirements would delay implementing the safety actions needed to correct this known unsafe condition. Therefore, we found that the risk to the flying public justifies waiving notice and comment prior to the adoption of this rule because the previously described unsafe condition can adversely affect the controllability of the helicopter and the required corrective actions must be accomplished within 25 hours TIS. These helicopters have a variety of uses including offshore and emergency medical flights and are expected to accumulate 25 hours TIS within a few weeks.

Since an unsafe condition exists that requires the immediate adoption of this AD, we determined that notice and opportunity for public comment before issuing this AD are impracticable and contrary to the public interest and that good cause exists for making this amendment effective in less than 30 days.

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, 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 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.

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

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 737-400 series airplanes, as modified by a certain supplemental type certificate. The NPRM published in the Federal Register on July 2, 2015 (80 FR 38033). The NPRM was prompted by the discovery of a design drawing error regarding placards that identified incorrect squibs and pressure switches for certain fire extinguisher bottles. The NPRM proposed to require a detailed inspection of certain cargo placards to determine if they are the correct placards and in the correct location, a detailed inspection of the harnesses to verify that they are marked and installed correctly, and corrective action if necessary. We are issuing this AD to detect and correct incorrectly installed harnesses for the cargo fire suppression system bottles, which could result in an incorrect activation sequence of the bottles, the inability to suppress a cargo fire quickly, and a possible uncontrollable fire.

We gave the public the opportunity to participate in developing this AD. We have considered the comments received. The European Aviation Safety Agency stated that it is following the progress of this activity of the NPRM (80 FR 38033, July 2, 2015). Boeing stated that the NPRM does not address any Boeing designs; therefore, Boeing can neither review the data, nor comment on the content of the NPRM, and that no file attachment accompanies its comment.

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 38033, July 2, 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 38033, July 2, 2015).

We reviewed Advanced Aircraft Extinguishers Service Bulletin TFA10-26-0020, Revision IR, dated January 12, 2015. The service information describes procedures for a detailed inspection of Advanced Aircraft Extinguishers cargo fire protection system placards to determine if they are the correct placards and in the correct location, and applicable corrective actions; and a detailed inspection of the harnesses to verify that they are correctly marked and installed, and doing steps C.(5) through C.(11) of Advanced Aircraft Extinguishers Service Bulletin TFA10-26-0020, Revision IR, dated January 12, 2015, if necessary. 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 3 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

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

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2011-24-05, Amendment 39-16869 (76 FR 73496, November 29, 2011). AD 2011-24-05 applied to certain Airbus Model A330-201, -202, -203, -223, -243, -301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes; and Model A340-200 and -300 series airplanes. The NPRM published in the Federal Register on May 4, 2015 (80 FR 25249).

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2014-0010R1, dated May 5, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Model A330-201, -202, -203, -223, -243, -301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes; and Model A340-200 and -300 series airplanes. The MCAI states:

The compliance times vary depending on airplane utilization and configuration. The earliest compliance time for the initial rotating probe inspections is the later of (1) before 10,400 total flight cycles or 67,800 total flight hours, whichever occurs first; and (2) within 24 months or 14,590 flight cycles or 43,790 flight hours, whichever occurs first. The latest compliance time for the initial inspections is the later of (1) before 20,800 total flight cycles or 67,900 total flight hours, whichever occurs first; and (2) within 24 months or 21,180 flight cycles or 63,560 flight hours, whichever occurs first. The compliance times for the repetitive intervals range between 7,800 flight cycles or 50,900 flight hours and 10,700 flight cycles or 35,200 flight hours. The compliance times for the one-time ultrasonic inspection are the latest of (1) 21,000 flight cycles or 60,600 flight hours and within 2,400 flight cycles or 24 months; or the latest of (2) 22,100 flight cycles and 64,400 flight hours, or within 1,300 flight cycles or 24 months.

You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2015-0937-0002.

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (80 FR 25249, May 4, 2015) or on the determination of the cost to the public.

We reviewed the available data and determined that air safety and the public interest require adopting 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 25249, May 4, 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 25249, May 4, 2015).

Airbus has issued the following service information.

• Airbus Service Bulletin A330-57-3081, Revision 05, dated November 13, 2012.

• Airbus Service Bulletin A330-57-3090, Revision 01, dated June 15, 2011.

• Airbus Service Bulletin A330-57-3098, dated August 30, 2007.

• Airbus Service Bulletin A330-57-3098, Revision 02, June 15, 2011.

• Airbus Service Bulletin A330-57-3098, Revision 03, dated September 24, 2012.

• Airbus Service Bulletin A330-57-3117, dated January 25, 2013.

• Airbus Service Bulletin A340-57-4089, Revision 05, dated November 13, 2012.

• Airbus Service Bulletin A340-57-4098, Revision 01, dated June 15, 2011.

• Airbus Service Bulletin A340-57-4106, dated August 30, 2007.

• Airbus Service Bulletin A340-57-4106, Revision 02, dated June 15, 2011.

• Airbus Service Bulletin A340-57-4106, Revision 03, dated September 24, 2012.

• Airbus Service Bulletin A340-57-4126, dated January 25, 2013.

This service information describes procedures for inspections for cracking of the hole(s) of the horizontal flange of the keel beam, and contacting the manufacturer for repair instructions. Additionally, this service information describes procedures for a one-time ultrasonic inspection for cracking at fastener hole “Nr 6,” and provides optional terminating action for the repetitive inspections.

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 35 airplanes of U.S. registry.

The actions that were required by AD 2011-24-05, Amendment 39-16869 (76 FR 73496, November 29, 2011), and retained in this AD take about 41 work-hours per product, at an average labor rate of $85 per work hour. Required parts cost about $191 per product. Based on these figures, the estimated cost of the actions that were required by AD 2011-24-05 is $3,676 per product.

We also estimate that it takes about 23 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD on U.S. operators to be $68,425, or $1,955 per product.

We have received no definitive data that would 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 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.

You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2015-0937; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone 800-647-5527) is in the ADDRESSES section.

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 Piper Aircraft, Inc. Model PA-46-500TP airplanes. The NPRM published in the Federal Register on October 19, 2015 (80 FR 63151). The NPRM was prompted by a report of wing upper skin joints on Piper Aircraft, Inc. Model PA-46-500TP airplanes being manufactured without sealant, which allows water to enter and stay in sealed, bonded stringers. The NPRM proposed to require inspecting the upper wing surface for sealant; inspecting the wing stringers for water intrusion; inspecting for deformation and corrosion if evidence of water intrusion exists; and taking corrective actions as necessary. We are issuing this AD to correct the unsafe condition on these products.

We reviewed Piper Aircraft, Inc. Service Bulletin No. 1262B, dated April 23, 2015. The service bulletin provides instructions for inspecting the upper wing surface for sealant and sealing or resealing (if necessary). This service bulletin also provides instructions for inspecting the wing stringers for water intrusion, and, if water intrusion was found as a result of the inspection, inspecting for corrosion or deformation. 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 gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (80 FR 63151, October 19, 2015) or on the determination of the cost to the public.

We reviewed the relevant data 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 63151, October 19, 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 63151, October 19, 2015).

We estimate that this AD affects 440 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

We estimate the following costs to do any additional necessary inspections, rework of the stringers, and installation of sealant that will be required based on the results of the initial inspection. We have no way of determining the number of airplanes that might need this rework of the stringers and installation of sealant:

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 issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Airbus Model A330-200 Freighter, A330-200, A330-300, A340-200, and A340-300 series airplanes. The NPRM published in the Federal Register on June 15, 2015 (80 FR 34098).

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2014-0222, dated October 6, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Model A330-200 Freighter, A330-200, A330-300, A340-200, and A340-300 series airplanes. The MCAI states:

Required actions also include a detailed inspection of the cadmium plating for discrepancies (gray in color), measurement of the depth of the cadmium plating if necessary, and a general visual inspection of the base metal for corrosion or damage, and a detailed inspection of repaired areas for cracking or corrosion. Corrective actions include removing cadmium plating and repairing any cracked, corroded, or damaged areas; re-applying cadmium plating and paint; and re-applying temporary corrosion protection to the bores of the MLG bogie beams.

You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2015-1981-0002.

We gave the public the opportunity to participate in developing this AD. We have considered the comments received. The following presents the comments received on the NPRM (80 FR 34098, June 15, 2015) and the FAA's response to each comment.

Air France and American Airlines (AA) requested that paragraph (j) of the proposed AD (80 FR 34098, June 15, 2015) be revised to clarify that after accomplishment of the actions in the Accomplishment Instructions of Messier-Dowty Service Bulletin A33/34-32-272, dated November 16, 2007, including Appendixes A, B, C, and D, dated November 16, 2007; or Service Bulletin A33/34-32-272, Revision 1, dated September 22, 2008, including Appendixes A, B, C, and D, dated September 22, 2008; the actions specified in the Messier-Dowty service information identified in paragraphs (j)(1) through (j)(5) of the proposed AD must not be accomplished on that same MLG unit.

We agree with the commenters' request and have revised paragraph (j) of this AD to clarify that after accomplishment of the actions in the Accomplishment Instructions of Messier-Dowty Service Bulletin A33/34-32-272, dated November 16, 2007, including Appendixes A, B, C, and D, dated November 16, 2007; or Service Bulletin A33/34-32-272, Revision 1, dated September 22, 2008, including Appendixes A, B, C, and D, dated September 22, 2008; the actions specified in the Messier-Dowty service information identified in paragraphs (j)(1) through (j)(5) of this AD must not be accomplished on that same MLG unit. The actions in the Accomplishment Instructions of Messier-Dowty service information identified in paragraphs (j)(1) through (j)(5) do not provide sufficient corrosion protection for the MLG units.

Air France requested that the references to the Airbus component maintenance manual in paragraph (g) of the proposed AD be changed to Messier-Dowty component maintenance manual.

We agree with the commenter's request because the component maintenance manuals were published by Messier-Dowty, not Airbus. We have revised paragraphs (g) and (k) of this AD accordingly.

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 34098, June 15, 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 34098, June 15, 2015).

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 Alert Operators Transmission A32L004-14, dated July 28, 2014, including Appendixes 1, 2, 3, and 4. This service information describes procedures for inspections of the bogie beam bore of the MLG.

Messier-Dowty has issued the following service information, which describes procedures for inspections of the internal diameter of the bogie beam for corrosion.

• Service Bulletin A33/34-32-272, dated November 16, 2007, including Appendixes A, B, C, and D, dated November 16, 2007.

• Service Bulletin A33/34-32-272, Revision 1, dated September 22, 2008, including Appendixes A, B, C, and D, dated September 22, 2008.

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 89 airplanes of U.S. registry.

We also estimate that it will take about 12 work-hours per product to comply with the basic requirements of this AD, and 1 work-hour to report the inspection findings. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD on U.S. operators to be $98,345, or $1,105 per product.

We have received no definitive data that would enable us to provide cost estimates for any necessary follow-on actions.

A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB control number. The control number for the collection of information required by this AD is 2120-0056. The paperwork cost associated with this AD has been detailed in the Costs of Compliance section of this document and includes time for reviewing instructions, as well as completing and reviewing the collection of information. Therefore, all reporting associated with this AD is mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at 800 Independence Ave. SW., Washington, DC 20591, ATTN: Information Collection Clearance Officer, AES-200.

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.

You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2015-1981; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone 800-647-5527) is in the ADDRESSES section.075

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 Bombardier, Inc. Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes. The NPRM published in the Federal Register on January 23, 2015 (80 FR 3522).

Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian Airworthiness Directive CF-2013-14, dated June 4, 2013 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Bombardier, Inc. Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes. The MCAI states:

This AD also requires revising the AFM and maintenance or inspection program, as applicable. You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2014-1049-0002.

We gave the public the opportunity to participate in developing this AD. We have considered the comments received. The following presents the comments received on the NPRM (80 FR 3522, January 23, 2015) and the FAA's response to each comment.

SkyWest Airlines (SWA) requested that the compliance time in paragraph (j)(2)(iii) of the proposed AD (80 FR 3522, January 23, 2015) be extended to alleviate the impact on its fleet. SWA stated that currently HSTAs are replaced prior to the accumulation of 19,200 total flight hours, and in paragraph (j)(2)(iii) of the proposed AD, the replacement time is reduced to 10,000 total flight hours. SWA stated that it has 86 airplanes with HSTAs that are approaching 10,000 total flight hours. SWA is concerned that replacement HSTAs might not be available in time to comply with the requirements proposed in the NPRM.

We do not agree that the compliance time in paragraph (j)(2)(iii) of this AD should be extended. In developing an appropriate compliance time for this action, we considered not only the degree of urgency associated with addressing the subject unsafe condition, but the manufacturer's recommendation for an appropriate compliance time, and the availability of required parts. Under the provisions of paragraph (m)(1) of this AD, however, we may consider 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 regarding this issue.

Air Line Pilots Association International (ALPA) requested that the compliance time for replacement of the HSTAs be reduced to ensure that the identified safety issue is corrected within the Bombardier, Inc. CRJ fleet as soon as possible.

We do not agree with the commenter's request to reduce the compliance time. In developing an appropriate compliance time, we considered the safety implications, parts availability, and normal maintenance schedules for timely replacement of the HSTAs. In consideration of all of these factors, we determined that the compliance time, as proposed, represents an appropriate interval in which the HSTAs can be replaced in a timely manner within the fleet, while still maintaining an adequate level of safety. Most ADs, including this one, permit operators to accomplish the requirements of an AD at a time earlier than the specified compliance time; therefore, an operator may choose to replace the HSTAs before the applicable compliance times specified in paragraph (j) of this AD. If additional data are presented that would justify a shorter compliance time, we may consider further rulemaking on this issue. We have not changed this AD regarding this issue.

ALPA also requested that once the HSTAs have been replaced the FAA re-evaluate the need for the revision to the AFM to include a first flight check of the horizontal stabilizer trim. No justification was provided for the request to omit the AFM revision.

We do not agree with the commenter's request to remove the requirement to revise the AFM. We have determined that the first flight check of the horizontal stabilizer trim is still necessary after the HSTAs have been replaced to ensure the safety of the Bombardier, Inc. Model CL-600-2B19 (Regional Jet Series 100 & 440) airplane fleet. Also, this AFM revision requirement is included in Canadian AD CF-2013-14, dated June 4, 2013, which corresponds to this final rule. 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 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 3522, January 23, 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 3522, January 23, 2015). We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.

Bombardier has issued the following service information.

• Supplement 23, “Horizontal Stabilizer Trim Check,” of Chapter 7 “Supplements,” of Bombardier CL -600-2B19 Airplane Flight Manual CSP A-012, Volume 3, Revision 61, dated April 2, 2013. This service information includes procedures for revising the AFM.

• Bombardier Service Bulletin 601R-27-161, Revision A, dated January 30, 2014. This service information describes procedures for installing a HSTA.

• Bombardier CL-600-2B19, Temporary Revision 2A-56, dated June 4, 2012, to Appendix A, Certification Maintenance Requirements (CMR), of Part 2, Airworthiness Requirements, of the Bombardier CL-600-2B19 Maintenance Requirements Manual (MRM). This service information adds new CMR tasks to the Airworthiness Requirements of the MRM. These CMR tasks include an inspection, functional check, and operational check.

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 85 airplanes of U.S. registry.

We also estimate that it will take about 10 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 $38,569 per product. Based on these figures, we estimate the cost of this AD on U.S. operators to be $3,350,615, or $39,419 per product.

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

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

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

For the reasons discussed above, I certify 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.

You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2014-1049; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone 800-647-5527) is in the ADDRESSES section.

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

History

On November 30, 2015, the FAA published in the Federal Register a final rule, technical amendment to amend Class E airspace at Elmira/Corning Regional Airport, Elmira, NY; Ithaca Tompkins Regional Airport, Ithaca, NY; and Duchess County Airport, Poughkeepsie, NY. (80 FR 74676). Docket No. FAA-2015-4514. Subsequent to publication the FAA found errors in the airspace descriptions that now need further analysis. Therefore, the final rule is being withdrawn.

In consideration of the foregoing, the final rule technical amendment for FR Doc. FAA-2015-4514, Airspace Docket No. 15-AEA-9 as published in the Federal Register of November 30, 2015 (80 FR 74676) (FR Doc. 2015-30187), is hereby withdrawn.

This amendment to Title 14, Code of Federal Regulations (14 CFR) part 97 amends the authority citation for part 97; Standard Instrument Procedures, by adding an additional citation, 49 U.S.C. 106(f), at the beginning of the authority citation string. This action updates and clarifies the Administrator's rulemaking authority to be consistent with other parts of Title 14, Code of Federal Regulations.

This is an administrative change reflecting clarification of rulemaking authority, therefore, notice and public procedure under 5 U.S.C. 553(b) is unnecessary. Also, as provided in 5 U.S.C. 553(d), this rule is being published with an effective date of less than 30 days in order to keep current standard instrument approach procedures (SIAPs) previously published in the Federal Register with later effective dates, and other SIAPs soon to be published.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore, (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103, sovereignty and use of airspace and Subpart iii, section 44701, general requirements. Under these sections, the FAA is charged with prescribing regulations to regulate the safe and efficient use of the navigable airspace; to govern the flight, navigation, protection, and identification of aircraft for the protection of persons and property on the ground, and for the efficient use of the navigable airspace (49 U.S.C. 40103(b)), and to promote safe flight of civil aircraft in air commerce by prescribing regulations and minimum standards for other practices, methods, and procedures necessary for safety in air commerce and national security (49 U.S.C. 44701(a)(5)). This regulation is within the scope of that authority as it further describes the authority of the FAA Administrator for part 97 rulemaking.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 97 as follows:

In a document published in the Federal Register on February 25, 2015 (80 FR 10001), VA amended its regulation at 38 CFR 3.308 to provide a certificate of eligibility for financial assistance in the purchase of an automobile or other conveyance and adaptive equipment for all veterans with service-connected amyotrophic lateral sclerosis (ALS) and servicemembers serving on active duty with ALS.

VA provided 60 days in which to comment on the amendments made by the Interim Final Rule, with the comment period ending April 27, 2015. We received three comments. Two of the commenters expressed support for this amendment. The third commenter discussed the initial evaluation rating and entitlement to special monthly compensation for veterans with service-connected ALS and servicemembers serving on active duty with ALS. Because those comments were not directed to the subject of this amendment, we make no changes based on those comments. Based on the rationale set forth in the interim final rule published in the Federal Register at 80 FR 10001 on February 25, 2015, VA is adopting the provisions of the interim final rule as a final rule without change.

Pursuant to 5 U.S.C. 553(b)(B) and (d)(3), we found that there was good cause to dispense with advance public notice and opportunity to comment on the interim final rule and good cause to publish that rule with an immediate effective date. The interim final rule was necessary to implement immediately the Secretary's decision to establish entitlement for a certificate of eligibility for automobile or other conveyance and adaptive equipment for all veterans with service-connected ALS and members of the Armed Forces serving on active duty with ALS. Delay in the implementation of this rule would be impracticable and contrary to the public interest, particularly to veterans and members of the Armed Forces serving on active duty.

Because the survival period for persons suffering from ALS is generally 18-48 months or less from the onset of symptoms, any delay in establishing entitlement for a certificate of eligibility for automobile or other conveyance and adaptive equipment eligibility would have been extremely detrimental to veterans and members of the Armed Forces serving on active duty who are currently afflicted with ALS. Any delay in implementation until after a public-comment period could have delayed modifying the regulated certificate of eligibility process, depriving ALS veterans and members of the Armed Forces serving on active duty with ALS of quick and efficient access to automobile or other conveyance and adaptive equipment benefits.

Executive Orders 12866 and 13563 direct agencies to assess the 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 effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 12866 (Regulatory Planning and Review) defines a “significant regulatory action,” which requires review by the Office of Management and Budget (OMB), unless OMB waives such review, as “any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order.”

The economic, interagency, budgetary, legal, and policy implications of this regulatory action have been examined, and it has been determined not to be a significant regulatory action under Executive Order 12866. VA's impact analysis can be found as a supporting document at http://www.regulations.gov, usually within 48 hours after the rulemaking document is published. Additionally, a copy of the rulemaking and its impact analysis are available on VA's Web site at http://www.va.gov/orpm/, by following the link for VA Regulations Published From FY 2004 Through FYTD.

The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. This final rule will not affect any small entities. Only VA beneficiaries will be directly affected. Therefore, pursuant to 5 U.S.C. 605(b), this final rule is exempt from the final regulatory flexibility analysis requirements of section 604.

The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any 1 year. This final rule will have no such effect on State, local, and tribal governments, or on the private sector.

This final rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).

The Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this document are 64.100, Automobiles and Adaptive Equipment for Certain Disabled Veterans and Members of the Armed Forces and 64.109, Veterans Compensation for Service-Connected Disability.

The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Robert L. Nabors II, Chief of Staff, Department of Veterans Affairs, approved this document on January 7, 2016, for publication.

Accordingly, the Department of Veterans Affairs adopts the interim rule published February 25, 2015 (80 FR 10001), as final without change.

Throughout this document, “we,” “us” and “our” refer to EPA.

On October 20, 2015 (80 FR 63640), the EPA proposed to approve portions of California's Moderate area plan to address the 2006 primary and secondary 24-hour PM2.5 NAAQS in the South Coast and to reclassify the South Coast nonattainment area, including areas of Indian country within it, from Moderate to Serious nonattainment for these standards, based on the EPA's determination that the area cannot practicably attain these NAAQS by the applicable attainment date of December 31, 2015.1 Under section 188(b)(1) of the CAA, prior to an area's attainment date, the EPA has discretionary authority to reclassify as a Serious nonattainment area “any area that the Administrator determines cannot practicably attain” the PM2.5 NAAQS by the Moderate area attainment date.2 As part of our proposed action, we reviewed recent PM2.5 monitoring data for the South Coast available in EPA's Air Quality System (AQS) database. These data show that 24-hour PM2.5 levels in the South Coast continue to be above 35 μg/m3, the level of the 2006 PM2.5 standards, and the recent trends in the South Coast area's 24-hour PM2.5 levels are not consistent with a projection of attainment by the end of 2015.3

In the proposed rule, we explained that under section 188(c)(2) of the Act, the attainment date for a Serious area “shall be as expeditiously as practicable but no later than the end of the tenth calendar year beginning after the area's designation as nonattainment. . . .” The South Coast was designated nonattainment for the 2006 PM2.5 NAAQS effective December 14, 2009.4 Therefore, as a result of our reclassification of the South Coast area as a Serious nonattainment area, the attainment date under section 188(c)(2) of the Act for the 2006 PM2.5 NAAQS in this area is as expeditiously as practicable but no later than December 31, 2019.

Our proposed rule also identified the Serious area attainment plan elements that California would, upon reclassification, have to submit to satisfy the statutory requirements that apply to Serious areas, including the requirements of subpart 4 of part D, title I of the Act.5 The EPA explained that under section 189(b)(2) of the Act, the State must submit the required provisions to implement best available control measures (BACM), including best available control technology (BACT), no later than 18 months after reclassification and must submit the required attainment demonstration no later than 4 years after reclassification. We noted, however, that section 189(b)(2) establishes outer bounds on the SIP submission deadlines and does not preclude the EPA's establishment of earlier deadlines as necessary or appropriate to assure consistency among the required submissions and to implement the statutory requirements in a timely manner to ensure expeditious attainment of the NAAQS.6 Because an up-to-date emissions inventory serves as the foundation for a state's BACM and BACT determinations, the EPA proposed to require the State to submit the emissions inventory required under CAA section 172(c)(3) within 18 months after the effective date of final reclassification. Similarly, because an effective evaluation of BACM and BACT requires evaluation of the precursor pollutants that must be controlled to provide for expeditious attainment, the EPA proposed to require the State to submit any optional precursor insignificance demonstrations by this same date. The EPA proposed to require the State to submit the attainment demonstration required under section 189(b)(1)(A) and all other attainment-related plan elements for the South Coast area no later than three years after the effective date of final reclassification or by December 31, 2018, whichever is earlier.

With respect to the nonattainment new source review (NNSR) program revisions to establish appropriate “major stationary source” thresholds for direct PM2.5 and PM2.5 precursors in accordance with CAA section 189(b)(3), the EPA proposed to require the State to submit these NNSR SIP revisions for the South Coast area no later than 18 months after the effective date of final reclassification.

Today we are finalizing only our proposal to reclassify the South Coast area as a Serious nonattainment area for the 2006 PM2.5 NAAQS. We are not taking final action at this time on our proposal to approve elements of California's Moderate area plan for the 2006 PM2.5 NAAQS in the South Coast and will complete that action at a later time.

As a consequence of our reclassification of the South Coast area as Serious nonattainment for the 2006 PM2.5 NAAQS, California is required to submit additional SIP revisions to satisfy the statutory requirements that apply to Serious areas, including the requirements of subpart 4 of part D, title I of the Act. For the reasons provided in Section III of this preamble, the EPA is requiring the State to adopt and submit all required components of the Serious Area plan for the South Coast area, including nonattainment new source review (NNSR) SIP revisions to address the statutory requirements for Serious areas under subpart 4, no later than 18 months after the effective date of this reclassification.

The attainment date under section 188(c)(2) of the Act for the 2006 PM2.5 standards in this area is as expeditiously as practicable but no later than December 31, 2019.

Because we are finalizing only our proposal to reclassify the South Coast area as Serious nonattainment for the 2006 PM2.5 NAAQS, we are responding only to comments pertaining to the reclassification and its consequences. The EPA received several comment letters on our proposed actions, only one of which contains comments relevant to the reclassification. The comment letter was submitted by Earthjustice on behalf of the Center for Biological Diversity, Coalition for Clean Air, Communities for a Better Environment, East Yard Communities for Environmental Justice, and Sierra Club (“Earthjustice”) on November 19, 2015, prior to the close of the comment period on our proposal.7

We summarize and respond to the relevant comments below. In a separate rulemaking, we will take final action on California's submitted Moderate area plan for the 2006 PM2.5 NAAQS in the South Coast and will respond to comments pertaining to our proposed action on the submitted plan at that time.

Comment 1: Earthjustice argues that section 188(b)(1) establishes specific outside deadlines for the EPA's reclassification of appropriate areas as Serious nonattainment and “does not provide general authority to reclassify areas anytime EPA chooses before the attainment deadline.” Citing CAA section 188(b)(1)(B), Earthjustice asserts that the EPA's discretionary authority to reclassify a Moderate area as a Serious area before the attainment deadline is available only within 18 months after the required date for the submission of a Moderate area SIP, which in turn is due within 18 months after the area's designation as nonattainment. Because the South Coast area was designated nonattainment for the 2006 p.m.2.5 NAAQS on December 14, 2009, according to Earthjustice, the Moderate area SIP for the area was due June 14, 2011, and the “deadline for approving a voluntary reclassification request” was therefore December 14, 2012. Thus, Earthjustice argues, “EPA no longer has authority under the statute to use section 188(b)(1) to voluntarily reclassify the South Coast basin and provide four years for submission of a serious area plan.”

In support of these arguments, Earthjustice quotes from EPA's 1992 General Preamble,8 which states that “[f]or areas designated nonattainment after enactment of the 1990 [Clean Air Act Amendments], EPA must reclassify appropriate areas as serious within 18 months of the required submittal date for the moderate area SIP” and that, read together with the statutory requirement to submit such SIPs within 18 months after nonattainment designations, the Act requires EPA to reclassify these areas as serious within three years of the nonattainment designation.

Response 1: We disagree with the commenter's argument that the EPA's discretionary authority in section 188(b)(1) is limited to the timeframes set forth in sections 188(b)(1)(A) and (B).

The EPA is reclassifying the South Coast area as Serious nonattainment pursuant to the general authority in CAA section 188(b)(1),9 not pursuant to section 188(b)(1)(B). As explained in the 1992 General Preamble, “[u]nder the plain meaning of the terms of section 188(b)(1), EPA has general discretion to reclassify at any time before the applicable attainment date any area EPA determines cannot practicably attain the standards by such date” (emphases added).10 With respect to the dates specified in subsections (A) and (B) of section 188(b)(1), the EPA specifically explained in the General Preamble that “[t]hese subparagraphs do not restrict the general authority [in section 188(b)(1)] but simply specify that, at a minimum, it must be exercised at certain times.”11 This interpretation of section 188(b)(1) as allowing the EPA to reclassify moderate areas as serious “at any time EPA determines that an area cannot practicably attain the standards by the applicable attainment date” facilitates the statutory objective of attaining the PM-10 standards—e.g., by ensuring that additional control measures such as BACM are implemented sooner and by expediting the application of more stringent new source review requirements.12 The EPA reiterated this interpretation of section 188(b)(1) in the 1994 p.m.-10 Addendum 13 and in several discretionary reclassification actions subsequent to the 1990 CAA Amendments.14

Specifically, with respect to areas designated nonattainment by operation of law upon enactment of the 1990 CAA Amendments (i.e., “initial” PM-10 nonattainment areas), the EPA's longstanding interpretation of section 188(b)(1)(A) has been that “the amended Act specifies certain dates by which EPA must propose to reclassify appropriate moderate areas as serious . . . and take final action,” where the EPA determines that the area cannot “practicably” attain the PM-10 NAAQS by December 31, 1994.15 The EPA further explained, however, that “EPA also has discretionary authority under section 188(b)(1) to reclassify any of these areas as serious at any time, if EPA determines they cannot practicably attain the PM-10 NAAQS by December 31, 1994,” 16 and provided examples of the circumstances that may warrant such discretionary reclassification at a later date—i.e., after the December 31, 1991 date specified in section 188(b)(1)(A).17 In the PM-10 Addendum, the EPA stated that “[s]ection 188(b)(1)(A) provides an accelerated schedule by which EPA is to reclassify appropriate initial PM-10 nonattainment areas” but reiterated the Agency's interpretation of section 188(b)(1) as a general grant of authority to also reclassify initial PM-10 areas at later points in time before the attainment date.18

Likewise, the EPA has long interpreted section 188(b)(1)(B) as establishing a “timeframe within which EPA is to reclassify appropriate areas designated nonattainment for PM-10 subsequent to enactment of the 1990 Amendments” but not as a limitation on EPA's general authority to reclassify such areas at any time before the applicable attainment date.19 In the PM-10 Addendum, the EPA reiterated its view that the directive in section 188(b)(1)(B) “does not restrict EPA's general authority, but simply specifies that it is to be exercised, as appropriate, in accordance with certain dates.” 20 The EPA recently finalized a discretionary reclassification action for a PM2.5 nonattainment shortly before the applicable attainment date, consistent with this interpretation of CAA section 188(b)(1).21

The commenter quotes selectively from a portion of the General Preamble addressing areas designated nonattainment after enactment of the 1990 CAA Amendments but fails to acknowledge both the more extensive discussion of section 188(b)(1) that precedes the quoted text, as explained above, and the text in the PM-10 Addendum that reiterates the Agency's interpretation of section 188(b)(1)(B) specifically. Moreover, both the statutory text in CAA section 188(b)(1)(B) and the interpretive language in the General Preamble that the commenter quotes explicitly state that the EPA's obligation under CAA section 188(b)(1)(B) is to reclassify “appropriate” areas within 18 months after the required date for the State's submission of a SIP for the Moderate Area.22 Congress granted the EPA broad discretion to identify the areas that are “appropriate” for such reclassification 23 and to reclassify additional areas after the timeframes specified in subsections (A) or (B). Thus, the fact that the EPA did not find the South Coast area “appropriate” for discretionary reclassification within the timeframe specified in section 188(b)(1)(B) does not preclude the EPA's discretionary reclassification of the area at a later date, based on a determination that the area cannot practicably attain the PM2.5 NAAQS by the applicable attainment date.

Furthermore, under the commenter's interpretation of section 188(b)(1)(B), the EPA would have no authority to reclassify a Moderate area to Serious at any time between the date 3 years after designation (18 months after the required date for the State's submission of a Moderate Area SIP) and the applicable attainment date, which under section 188(c)(1) may be as late as the end of the sixth calendar year after the area's designation as nonattainment. Thus, for a period of up to 3 years, the EPA would be unable to reclassify such an area to Serious in order to require the State to adopt BACM measures and other Serious Area plan elements, even if information before the Agency indicated the area could not attain the NAAQS by the moderate area attainment date. Such a reading of section 188(b)(1) would frustrate the Congressional intent to ensure that areas that cannot attain the NAAQS in a timely manner adopt the best available controls and develop revised plans to provide for expeditious attainment. EPA's interpretation of section 188(b)(1) as a general grant of discretionary reclassification authority is reasonable in light of the overarching requirement in subpart 4 to ensure attainment of the NAAQS as expeditiously as practicable.

In sum, we disagree with the commenter's contention that the EPA's authority to reclassify a Moderate area as a Serious area under CAA section 188(b)(1) is available only within 18 months after the due date for the State's Moderate Area SIP. As the EPA explained in the General Preamble, in the PM-10 Addendum, and in several actions reclassifying PM-10 and PM2.5 nonattainment areas as Serious areas under CAA section 188(b)(1), the EPA has consistently interpreted section 188(b)(1) as a general expression of delegated rulemaking authority that authorizes the Agency to reclassify any Moderate area as a Serious area at any time before the applicable attainment date, based on a determination that the area cannot practicably attain the relevant NAAQS by that date.

Comment 2: Earthjustice argues that even if the EPA had discretion to reclassify the South Coast area under section 188(b)(1), a December 31, 2018 deadline for the Serious Area plan is “arbitrary in the extreme” and inconsistent with other deadlines that EPA has proposed to establish. First, Earthjustice asserts that the EPA's proposed deadline ignores the statutory requirement to demonstrate attainment by the most expeditious attainment date and allows the District to “assume the maximum amount of time without any such demonstration.” Second, Earthjustice claims that the EPA's proposed approach “undermines the strict schedule established in subpart 4” and cannot be reconciled with either December 14, 2016 or December 31, 2017, the statutory SIP submission deadlines that allegedly apply following voluntary reclassification or failure to attain, respectively. Third, Earthjustice argues that there is no basis for claiming that the District needs 3 years to prepare a serious area plan, in light of the 18-month deadlines in sections 189(a)(2)(B) and 189(b)(2) for moderate area plans and serious area plans, respectively, and the 18-month timeframe allowed in section 179(a) for states to cure disapprovals or failures to submit. Finally, Earthjustice argues that the proposed deadline is internally inconsistent with other components of the EPA's proposal, including the requirements for RFP and quantitative milestones, and undermines the EPA's and the public's ability to ensure timely compliance with these requirements.

Response 2: We disagree with the commenter's argument that the outside deadline for submitting a Serious area attainment plan for the 2006 PM2.5 NAAQS following discretionary reclassification is December 14, 2016. This argument is premised on the commenter's assertion that the EPA's discretionary authority to reclassify the area under CAA section 188(b)(1) was available only within three years after the area's designation as nonattainment (i.e., until December 14, 2012), and that CAA section 189(b)(2) established a deadline 4 years after this date (December 14, 2016) for the State to submit its Serious area attainment plan. The EPA did not reclassify the South Coast area by December 14, 2012 and was not obligated to do so under CAA section 188(b)(1), as explained above in Response 1. Thus, section 189(b)(2) does not establish a December 14, 2016 outer deadline for submission of the Serious area attainment plan.

Upon further consideration and in light of the specific circumstances in the South Coast PM2.5 nonattainment area, however, the EPA is exercising its discretion to establish a deadline of 18 months from the effective date of this final reclassification action for the State to submit all required components of the Serious Area plan for the 2006 PM2.5 NAAQS in the South Coast air basin. An 18-month deadline for submission of these SIP elements is appropriate in this instance because it both enables the EPA to evaluate the required attainment plan well before the outermost attainment date applicable to the area under CAA section 188(c)(2) and enables the State to develop its strategy for attaining the 2006 PM2.5 NAAQS in conjunction with its development of a plan to provide for attainment of the 2012 primary annual PM2.5 NAAQS in this same area, which is due October 15, 2016.24 Although the State's obligations with respect to implementation of a Moderate area plan for the 2012 PM2.5 NAAQS are separate and distinct from its obligations with respect to implementation of a Serious area plan for the 2006 PM2.5 NAAQS, it is reasonable in this instance to require the State to develop its control strategies for both PM2.5 NAAQS in the South Coast area in a similar timeframe, considering the benefits of streamlining these planning processes to the extent possible.

In addition, as the commenter notes, an 18-month deadline for submission of the Serious area plan is consistent with both the timeframe for initial Moderate area plan submissions upon designation of an area as nonattainment and the timeframe for Serious area plan submissions following an EPA determination of failure to attain and reclassification by operation of law under CAA section 188(b)(2).25 It is reasonable for the EPA to exercise its discretion to establish a similar SIP submission deadline in this instance, given the proximity of this action to the Moderate area attainment date (December 31, 2015) and the likelihood that, should the attainment date pass, the EPA would have to determine under section 188(b)(2) that the South Coast area failed to attain the PM2.5 NAAQS by that date. Although CAA section 189(b)(2) generally provides for up to 4 years after a discretionary reclassification for the State to submit the required attainment demonstration, we find it appropriate in this case to establish an earlier SIP submission deadline to assure timely implementation of the statutory requirements.26 Furthermore, the 18-month SIP submission deadline that we are finalizing in this action requires California to submit its Serious Area plan for the South Coast area before the statutory SIP submission deadline that would apply upon reclassification by operation of law under section 188(b)(2).27

In accordance with section 188(b)(1) of the Act, the EPA is taking final action to reclassify the South Coast area from Moderate to Serious nonattainment for the 2006 24-hour PM2.5 standards of 35 μg/m3, based on the EPA's determination that the South Coast area cannot practicably attain these standards by the applicable attainment date of December 31, 2015.

Under section 188(c)(2) of the Act, the attainment date for a Serious area “shall be as expeditiously as practicable but no later than the end of the tenth calendar year beginning after the area's designation as nonattainment. . . .” The South Coast area was designated nonattainment for the 2006 PM2.5 standards effective December 14, 2009.28 Therefore, as a result of our reclassification of the South Coast area as a Serious nonattainment area, the attainment date under section 188(c)(2) of the Act for the 2006 PM2.5 standards in this area is as expeditiously as practicable but no later than December 31, 2019.

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2015-0718 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before March 14, 2016. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2015-0718, by one of the following methods.

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.

In the Federal Register of November 23, 2015 (80 FR 72941) (FRL-9936-73), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN-10843) filed by BASF Corporation, 26 Davis Dr. Research Triangle Park, NC, 27709. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of 2-propenoic acid, 2-methyl-, polymers with tert-Bu acrylate, Me methacrylate, polyethylene glycol methacrylate C16-C18-alkyl ethers and vinylpyrrolidone, tert-Bu 2-ethylhexaneperoxoate-initiated, compounds with 2-amino-2-methyl-1-propanol; CAS Reg. No. 1515872-09-9. That document included a summary of the petition prepared by the petitioner and solicited comments on the petitioner's request. EPA received one comment to the Notice of Filing.

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

EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be shown that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.

Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers expected to present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b) and the exclusion criteria for identifying these low-risk polymers are described in 40 CFR 723.250(d). 2-Propenoic acid, 2-methyl-, polymers with tert-Bu acrylate, Me methacrylate, polyethylene glycol methacrylate C16-C18-alkyl ethers and vinylpyrrolidone, tert-Bu 2-ethylhexaneperoxoate-initiated, compounds with 2-amino-2-methyl-1-propanol conforms to the definition of a polymer given in 40 CFR 723.250(b) and meets the following criteria that are used to identify low-risk polymers.

1. The polymer is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment.

2. The polymer does contain as an integral part of its composition the atomic elements carbon, hydrogen, and oxygen.

3. The polymer does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii).

4. The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize.

5. The polymer is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption.

6. The polymer is not a water absorbing polymer with a number average molecular weight (MW) greater than or equal to 10,000 daltons.

Additionally, the polymer also meets as required the following exemption criteria specified in 40 CFR 723.250(e).

7. The polymer does not contain, as an integral part of its composition, perfluoroalkyl moieties consisting of a CF3- or longer chain length.

8. The polymer's number average MW of 2,600 is greater than 1,000 and less than 10,000 daltons. The polymer contains less than 10% oligomeric material below MW 500 and less than 25% oligomeric material below MW 1,000, and the polymer does not contain any reactive functional groups.

Thus, 2-propenoic acid, 2-methyl-, polymers with tert-Bu acrylate, Me methacrylate, polyethylene glycol methacrylate C16-C18-alkyl ethers and vinylpyrrolidone, tert-Bu 2-ethylhexaneperoxoate-initiated, compounds with 2-amino-2-methyl-1-propanol meets the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the criteria in this unit, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to 2-propenoic acid, 2-methyl-, polymers with tert-Bu acrylate, Me methacrylate, polyethylene glycol methacrylate C16-C18-alkyl ethers and vinylpyrrolidone, tert-Bu 2-ethylhexaneperoxoate-initiated, compounds with 2-amino-2-methyl-1-propanol.

For the purposes of assessing potential exposure under this exemption, EPA considered that 2-propenoic acid, 2-methyl-, polymers with tert-Bu acrylate, Me methacrylate, polyethylene glycol methacrylate C16-C18-alkyl ethers and vinylpyrrolidone, tert-Bu 2-ethylhexaneperoxoate-initiated, compounds with 2-amino-2-methyl-1-propanol could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The number average MW of 2-propenoic acid, 2-methyl-, polymers with tert-Bu acrylate, Me methacrylate, polyethylene glycol methacrylate C16-C18-alkyl ethers and vinylpyrrolidone, tert-Bu 2-ethylhexaneperoxoate-initiated, compounds with 2-amino-2-methyl-1-propanol is 2600 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since 2-propenoic acid, 2-methyl-, polymers with tert-Bu acrylate, Me methacrylate, polyethylene glycol methacrylate C16-C18-alkyl ethers and vinylpyrrolidone, tert-Bu 2-ethylhexaneperoxoate-initiated, compounds with 2-amino-2-methyl-1-propanol conform to the criteria that identify a low-risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health.

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

EPA has not found 2-propenoic acid, 2-methyl-, polymers with tert-Bu acrylate, Me methacrylate, polyethylene glycol methacrylate C16-C18-alkyl ethers and vinylpyrrolidone, tert-Bu 2-ethylhexaneperoxoate-initiated, compounds with 2-amino-2-methyl-1-propanol to share a common mechanism of toxicity with any other substances, and 2-propenoic acid, 2-methyl-, polymers with tert-Bu acrylate, Me methacrylate, polyethylene glycol methacrylate C16-C18-alkyl ethers and vinylpyrrolidone, tert-Bu 2-ethylhexaneperoxoate-initiated, compounds with 2-amino-2-methyl-1-propanol does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that 2-propenoic acid, 2-methyl-, polymers with tert-Bu acrylate, Me methacrylate, polyethylene glycol methacrylate C16-C18-alkyl ethers and vinylpyrrolidone, tert-Bu 2-ethylhexaneperoxoate-initiated, compounds with 2-amino-2-methyl-1-propanol does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of 2-propenoic acid, 2-methyl-, polymers with tert-Bu acrylate, Me methacrylate, polyethylene glycol methacrylate C16-C18-alkyl ethers and vinylpyrrolidone, tert-Bu 2-ethylhexaneperoxoate-initiated, compounds with 2-amino-2-methyl-1-propanol, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary.

Based on the conformance to the criteria used to identify a low-risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of 2-propenoic acid, 2-methyl-, polymers with tert-Bu acrylate, Me methacrylate, polyethylene glycol methacrylate C16-C18-alkyl ethers and vinylpyrrolidone, tert-Bu 2-ethylhexaneperoxoate-initiated, compounds with 2-amino-2-methyl-1-propanol.

Not available.

An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has not established a MRL for 2-propenoic acid, 2-methyl-, polymers with tert-Bu acrylate, Me methacrylate, polyethylene glycol methacrylate C16-C18-alkyl ethers and vinylpyrrolidone, tert-Bu 2-ethylhexaneperoxoate-initiated, compounds with 2-amino-2-methyl-1-propanol.

Accordingly, EPA finds that exempting residues of 2-propenoic acid, 2-methyl-, polymers with tert-Bu acrylate, Me methacrylate, polyethylene glycol methacrylate C16-C18-alkyl ethers and vinylpyrrolidone, tert-Bu 2-ethylhexaneperoxoate-initiated, compounds with 2-amino-2-methyl-1-propanol from the requirement of a tolerance will be safe.

This action establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply.

This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

EPA received one comment to the Notice of Filing. The commenter stated that the application of these chemicals on food should not be allowed and are poisoning the environment. The Agency understands the commenter's concerns and recognizes that some individuals believe that pesticides should be banned on agricultural crops and that they are poisoning the environment. However, the existing legal framework provided by section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) states that tolerances may be set when persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute. The citizen's comment appears to be directed at the underlying statute and not EPA's implementation of it; the citizen has made no contention that EPA has acted in violation of the statutory framework.

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/test-guidelines-pesticides-and-toxic-substances.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify the request by the docket ID number EPA-HQ-OPP-2014-0680 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before March 14, 2016. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2014-0680, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

In the Federal Register of Wednesday, December 17, 2014 (79 FR 75109) (FRL-9918-90), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 4F8301) by Dow AgroSciences, LLC, 9330 Zionsville Rd., Indianapolis, IN 46268-1054. The petition requested that 40 CFR 180.317 be amended by establishing a tolerance for residues of the herbicide pronamide (propyzamide) and its metabolite containing the 3,5-dichlorobenzoyl moiety calculated as 3,5-dichloro-N-(1,1-dimethyl-2-propynyl)benzamide, in or on lettuce, leaf at 1.0 part per million (ppm). That document referenced a summary of the petition prepared by Dow AgroSciences, LLC, the registrant, which is available in the docket EPA-HQ-OPP-2014-0680 at http://www.regulations.gov. There were no comments received in response to the notice of filing.

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

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for propyzamide including exposure resulting from the tolerance established by this action. EPA's assessment of exposures and risks associated with propyzamide follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

Propyzamide has low acute toxicity via the oral, dermal, and inhalation routes of exposure, is non-irritating to the eyes or skin, and is not a dermal sensitizer.

The primary target organ for propyzamide is the liver. There are other target organs as well, including the thyroid, testes, and pituitary, but effects on these organs are secondary to primary effects on the liver. Liver-related effects include increases in absolute and relative liver weights, hypertrophy, elevated levels of enzymes associated with liver damage, and histopathology of liver cells. Adverse liver effects were consistently observed in every animal species studied, with progression towards more severe effects over time ultimately leading to tumorigenesis in rats and mice. Based on the studies submitted, the rat is the most sensitive species. In most studies, there is no gender sensitivity in response to propyzamide.

Propyzamide is a carcinogen in rats and mice, causing liver tumors in mice, thyroid tumors in male rats, and testicular tumors in rats. Based on MOA studies, tumorigenesis for all three tumor types has been shown to be mediated by liver enzymes induced in response to treatment with propyzamide. In mice, the MOA data clearly show rapid induction of Cyp2b10 associated with the constitutive androstane nuclear receptor (CAR), as well as induction of peroxisomes and peroxisomal enzymes such as Cyp4a10 associated with a second nuclear receptor, PPAR-α. Induction of the nuclear receptors leads to mitogenesis followed by hepatocellular proliferation and eventually, liver tumors.

In rats, propyzamide induces Cyp2b1 200-fold over background levels, but has no effect on other CYPs commonly associated with carcinogenic modes of action. In the rat Cyp2b1 is a biological marker for the CAR receptor. The CAR pathway is associated with the activation of uridine diphosphate glucuronyl transferase (UGT) which catalyzes the condensation of glucuronic acid with thyroxine (T4), leading to enhanced biliary excretion of T4. Eventually the continued stimulus to produce more T4 leads to the formation of thyroid follicular tumors. In male rats, the tumorigenic dose of propyzamide for both thyroid tumors and Leydig cell tumors is 1,000 ppm in the diet (34-75 mg/kg/day based on age of the rats). Tumor precursor effects such as decreases in T4 levels, increases in liver weight, liver hypertrophy, and elevated testosterone metabolism occur at doses below or equivalent to the tumorigenic dose.

In nearly every oral repeated-dose study of propyzamide as well as in the 28-day dermal toxicity study in rats, there were dose-related decreases in body weight, body weight gain, and food consumption. Typically, these effects on body weight occurred at or above effects on the liver such as hypertrophy or increases in liver weight.

There was evidence of neurotoxicity in rats based on an increase in landing foot splay in females and decreases in motor activity in both genders in the acute neurotoxicity study. In the subchronic neurotoxicity study however, there was no evidence of neurotoxicity following dietary administration, and only body-weight effects were observed. There was no evidence of neurotoxicity in the rest of the toxicology database across other species or other strains of rat. There was no evidence of immunotoxicity.

There was no evidence of quantitative or qualitative increased susceptibility in the fetuses or the offspring of rats or rabbits following pre- and/or postnatal exposure to propyzamide. In the prenatal developmental toxicity study in rabbits and the multi-generation reproduction study in rats, any observed toxicity to the fetuses or offspring occurred at equivalent or higher doses than effects to parental animals.

Specific information on the studies received and the nature of the adverse effects caused by propyzamide as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document “Pronamide Human Health Risk Assessment for Registration Review and to Support New Section 3 Use on Leaf Lettuce (Revised)” on pages 14-22 in docket ID number EPA-HQ-OPP-2014-0680.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

A summary of the toxicological endpoints for propyzamide used for human risk assessment is shown in Table 1 of this unit.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to propyzamide, EPA considered exposure under the petitioned-for tolerance as well as all existing propyzamide tolerances in 40 CFR 180.317. EPA assessed dietary exposures from propyzamide in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. Such effects were identified for propyzamide. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA assumed that propyzamide residues were present at tolerance levels in all commodities for which tolerances have been established or proposed, and that 100% of the crops were treated with propyzamide.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA assumed that propyzamide residues were present at tolerance levels in all commodities for which tolerances have been established or proposed, and that 100% of the crops were treated with propyzamide.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that propyzamide does not pose a cancer risk to humans at doses that do not result in induction of hepatic cell proliferation or metabolic enzymes leading to disruption of thyroid or gonadal endrocrine axes. The MOAs were adequately supported by studies that clearly identified the sequence of key events, dose-response concordance and temporal relationship to the particular tumor type. Quantification of carcinogenic risk is not required. The chronic RfD would be protective of both carcinogenic and non-carcinogenic effects observed in the mouse and rat carcinogenicity studies and MOA studies conducted at higher doses. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for propyzamide. Tolerance-level residues and 100 PCT were assumed for all food commodities.

2. Dietary exposure from drinking water. The Agency used Tier II screening level water exposure models in the dietary exposure analysis and risk assessment for propyzamide in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of propyzamide. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.

Based on the Tier II Surface Water Concentration Calculator (SWCC) and Pesticide Root Zone Model Ground Water (PRZM-GW), the estimated drinking water concentrations (EDWCs) of propyzamide for acute exposures are estimated to be 102 parts per billion (ppb) for surface water and 21 ppb for ground water; for chronic exposures for non-cancer assessments are estimated to be 47 ppb for surface water and 18.6 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 102 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 47 ppb was used to assess the contribution to drinking water.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Propyzamide is currently registered for the following uses that could result in residential exposures: Turf grass and golf courses. EPA assessed residential exposure using the following assumptions: Post-application dermal and incidental oral exposures for children 1 to < 2 years old (physical activities on turf and hand-to-mouth ingestion of treated soil); and post-application dermal exposure for children 6 to < 11 years old (golfing), children 11 to < 16 years old (golfing and mowing), and adults (golfing, mowing, and physical activities on turf). Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.

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

EPA has not found propyzamide to share a common mechanism of toxicity with any other substances, and propyzamide does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that propyzamide does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. There was no evidence of quantitative or qualitative increased susceptibility in developing fetuses or in offspring of rats or rabbits following prenatal and/or postnatal exposure to propyzamide.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF was reduced to 1X. This decision is based on the following findings:

i. The toxicity database for propyzamide is complete.

ii. There is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity despite evidence of neurotoxicity in the acute study based on the increase in landing foot splay in female rats and the decrease in motor activity seen in both genders on day 1. This decision is based on no evidence of neurotoxicity in the subchronic study at dose levels tested via different routes of administration, and no evidence of neurotoxicity in the rest of the toxicology database across other species and other strains of rat.

iii. There is no evidence that propyzamide results in increased susceptibility in in utero rabbits in the prenatal developmental toxicity study or in young rats in the two-generation reproduction study.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to propyzamide in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by propyzamide.

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to propyzamide will occupy 46% of the aPAD for all infants < 1 year old, the population subgroup receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic dietary exposure to propyzamide from food and water will utilize 11% of the cPAD for children 1 to 2 years old, the population subgroup receiving the greatest exposure. Based on the explanation in Unit III.C.3. regarding residential use patterns, chronic residential exposure to residues of propyzamide is not expected.

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be background exposure level). Propyzamide is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that the combined short-term food, water, and residential exposure results in an aggregate MOE of 1,700 for children 1 to < 2 years old (chronic dietary exposure with post-application incidental oral exposure from turf use). Because EPA's level of concern for propyzamide is a MOE of 1,000 or below, this MOE is not of concern.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be background exposure level). Propyzamide is currently registered for uses that could result in intermediate-term residential exposure. However, since the maximum single and yearly application rates are the same, the short-term assessment is protective of intermediate-term incidental oral exposure.

5. Aggregate cancer risk for U.S. population. As discussed in Unit III.C.iii., Propyzamide is classified as “Not Likely to be Carcinogenic to Humans” at doses that do not result in induction of hepatic cell proliferation or metabolic enzymes leading to disruption of thyroid or gonadal endocrine axes. Therefore, quantification of aggregate cancer risk is not required.

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

Adequate enforcement methodologies are available to enforce the tolerance expression of residues in/on plant commodities (PAM II Method I, using gas-liquid chromatography with electron-capture detection (GLC/ECD)) and livestock commodities (Method GRM 02.21, using gas chromatography with negative-ion chemical ionization mass spectrometry detection (GC/MS)). These methods may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [email protected].

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established any MRLs for propyzamide.

Therefore, tolerances are established for residues of propyzamide (pronamide), 3,5-dichloro-N-(1,1-dimethyl-2-propynyl)benzamide, in or on lettuce, leaf at 1.0 ppm.

This action establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply.

This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

GSA is amending the GSAR to make editorial changes throughout the GSAM. There are no significant content changes resulting from this technical amendment.

Outdated references and links have been updated. Throughout multiple GSAM parts, the Central Contractor Registration (CCR) and the Excluded Parties List System (EPLS) have been changed to System for Award Management (SAM). This follows similar Federal Acquisition Regulation (FAR) updates resulting from FAR Case 2012-033, for which a final rule was published in the Federal Register at 78 FR 37676 on June 21, 2013. Commerce Business Daily has also been replaced with its successor system, FedBizOpps. Multiple Web page links have also been updated, as have organizational references.

Repetitive information has been removed from the GSAM. Definitions for certain terms have been deleted from their respective sections because these definitions have been added to the non-regulatory portion of the GSAM at Part 502 as a result of GSAR Case 2013-G503.

Therefore, GSA amends 48 CFR parts 501, 504, 509, 519, 522, 536, 537, 552, and 570 as set forth below:

Under the Lacey Act (18 U.S.C. 42, as amended), the Secretary of the Interior may list by regulation those wild mammals, wild birds, fish, mollusks, crustaceans, amphibians, reptiles, and the offspring or eggs of any of the foregoing that are injurious to human beings, to the interests of agriculture, horticulture, or forestry, or to the wildlife or wildlife resources of the United States.

We have determined that salamanders that can carry the fungus Batrachochytrium salamandrivorans (Bsal) are injurious to wildlife and wildlife resources of the United States. This determination was based on a review of the literature and an evaluation under the criteria for injuriousness by the Service. The salamander species listed by this interim rule are those found within a genus for which we have confirmation that at least one species in that genus is a carrier of Bsal, and there is no countervailing conclusive evidence suggesting that some species within the genus are not carriers. We find that, due to shared characteristics by species within a genus, other species within these genera are also highly likely to be carriers of Bsal. Although additional salamander species could be at risk from Bsal infection or could serve as a carrier, we are not listing species in those genera because they have not yet been tested.

The U.S. Fish and Wildlife Service (Service, USFWS, or we) is amending its regulations under the Lacey Act to add to the list of injurious wildlife all species of live and dead specimens from 20 genera, including body parts, from the amphibian order Caudata, which includes animals commonly referred to as salamanders, newts, and other names (hereafter, salamanders). The purpose of listing these species as injurious wildlife is to prevent the introduction, establishment, and spread of the fungus (Bsal) in the wild in the United States. The fungus affects only salamanders, has lethal effects on many salamander species, and is not yet known to be found in the United States.

The United States has the greatest diversity of salamanders in the world, the salamanders are a vital part of native ecosystems, and numerous salamander populations are at risk of endangerment from Bsal. Experience with the introduction of Bsal into the Netherlands and associated deleterious effects to native salamanders, along with laboratory research, confirms that Bsal can be introduced and cause substantial and immediate harm in the United States.

A risk assessment conducted by the U.S. Geological Survey concluded that the potential for Bsal introduction into the United States is high, the United States has suitable conditions for Bsal survival, and the consequences of introduction into the United States are expected to be severe and occur across a wide range of the United States. The main pathway for the global spread of Bsal is the international trade in salamanders. The ability and effectiveness of measures to prevent or control Bsal is currently low. Trade in wildlife occurs on a global scale, and amphibians are one of the most commonly traded animals. Therefore, listing the 20 genera will be effective at reducing the likelihood that Bsal enters the United States and presents a threat to native salamander species.

Of the 190 native U.S. salamander species, at least 2 species are lethally vulnerable to Bsal and at least 1 is tolerant of Bsal infection. At least four are resistant to Bsal infection, of which one is expected to be a carrier because Bsal was able to invade the skin of that species long enough to move or transmit the fungus to other salamanders. In addition, researchers have identified a non-native species that is lethally vulnerable to Bsal that is found within a fifth genus that also includes native species. On this basis, the Service finds that at least 67 native species from 5 genera are carriers of Bsal.

Native salamander species that demonstrate limited disease under experimental conditions may demonstrate more severe clinical disease when infection is combined with additional stressors in the wild. We concluded from our analysis that the introduction of Bsal into the United States can cause significant, adverse, population-level effects in native species. As keystone species, loss of salamanders from Bsal infection would have significant impacts on ecosystems, including food webs and nutrient cycling.

All 20 genera of salamanders, plus any new species that may be identified in the future within the genera listed by this interim rule, are found to be injurious. Even if a salamander found to be injurious could not establish a population in the wild, an infected salamander in captivity can still transmit Bsal to native populations if that salamander escapes or if material touching it is disposed of improperly. Bsal is capable of surviving outside of a host and causing extensive damage to wildlife and wildlife resources, including federally endangered and threatened species. Eradicating Bsal would be extremely difficult once introduced and established, the ability to rehabilitate disturbed ecosystems is expected to be low, and controlling Bsal is not practical. Prophylactic treatments for imports of salamanders to manage Bsal are in development but are not yet fully tested or feasible.

We are amending our regulations under an interim rule and are foregoing a proposed rule. The interim rule will take effect on the date specified above in DATES, with public comment to conclude as set forth in DATES. Based on public comments received, the interim rule may be revised. If Bsal is introduced into the United States, it is expected to have negative effects on many species of native salamanders. No conclusive evidence exists that suggests that Bsal is found in the United States. Therefore, the opportunity exists to take urgent action now to prevent the introduction of Bsal. Listing 20 genera of salamanders as injurious wildlife is an essential step in helping to keep Bsal out of the United States by preventing introduction of salamanders that serve as carriers of the fungus and are capable of introducing it to the United States. This interim rule lists some species that are currently in trade and some that are not; the focus is on species that are likely carriers of Bsal and capable of transmitting it to the same or other species.

Consistent with the statutory language and congressional intent, it is the Service's longstanding and continued position that the Lacey Act, 18 U.S.C. 42, prohibits both the importation into the United States and all interstate transportation between States, the District of Columbia, the Commonwealth of Puerto Rico, or any territory or possession of the United States, including interstate transportation between States within the Continental United States, of injurious wildlife, regardless of the preliminary injunction decision in U.S. Association of Reptile Keepers v. Jewell, No. 13-2007 (D.D.C. May 12, 2015). The Service's interpretation of 18 U.S.C. 42(a)(1) finds support in the plain language of the statute, the Lacey Act's purpose, legislative history, and congressional ratification. First, the statute's use of the disjunctive “or” to separate the listed geographic entities indicates that each location has independent significance. Second, Congress enacted the Lacey Act in 1900 for the purpose of, among other things, regulating the introduction of species in localities, not merely large territories, where they have not previously existed. See 16 U.S.C. 701. Third, the legislative history of Congress's many amendments to the Lacey Act since its enactment in 1900 shows that Congress intended, from the very beginning, for the Service to regulate the interstate shipment of certain injurious wildlife. Finally, recent Congresses have made clear that Congress interprets 18 U.S.C. 42(a)(1) as prohibiting interstate transport of injurious wildlife between the states within the continental United States. In amending § 42(a)(1) to add bighead carp and zebra mussels as injurious wildlife without making other changes to the provision, Congress repeated and ratified the Service's interpretation of the statute as prohibiting all interstate transport of injurious species.

The prohibitions on importation and all interstate transportation are both necessary to prevent the introduction, establishment, and spread of injurious species that threaten human health or the interests of agriculture, horticulture, forestry, or the wildlife or wildlife resources of the United States. By listing the 20 genera as injurious wildlife, both importation and interstate transportation of any live or dead specimen, including parts, is prohibited, except by permit (in accordance with conditions) for zoological, educational, medical, or scientific purposes or by Federal agencies without a permit solely for their own use.

The Service conducted an economic analysis and regulatory flexibility analysis as required under the rulemaking process. The draft economic analysis considers five alternatives: (1) No action; (2) list species that were shown by Martel et al. (2014) and other sources to be carriers of Bsal; (3) list all species in genera where there is at least one confirmed carrier and all species in the genus are likely to be a carrier, and there is no countervailing conclusive evidence suggesting that some species within the genus are not carriers; (4) list all salamanders; and (5) require a health certificate stating that the animal being moved is free of Bsal, in lieu of or in addition to listing.

The annual retail sales loss of listing 201 species, based on the 20 genera listed, is estimated to be $3.9 million, of which $2.3 million are losses to small businesses. Impacts per small business may be as high as $453,000 for importers and $23,000 for domestic breeders. The cost estimate represents the loss of revenue from listing the species to companies or individuals involved in the importation, interstate movement, or final consumer sales of salamanders that are imported and moved between States. No significant economic impact on a substantial number of small entities is anticipated. The economic loss including direct, indirect, and induced effects from loss in revenue to pet stores is estimated to be $10.0 million. Benefits from decreases in risk from Bsal for ecological, commercial, recreational, and non-use values are not quantifiable. The benefits from these additional factors are unknown, but are certainly positive.

From 2004 to 2014, nearly 2.5 million live salamanders of at least 59 species were imported into the United States. The 228,000 average annually imported salamanders are primarily for the pet trade. Fewer than 100 total businesses, institutions, and individuals imported salamanders over this time period (USFWS OLE 2015) for a retail value of $44 million dollars. Salamander imports and the number of businesses declined during this period, which may lead to an overestimation of the economic losses due to the uncertainty of industry and consumer responses over the time period used. The timeframe of the trade analysis does not make a difference from a biological perspective of risk. Species are being listed regardless of whether they are in trade. The alternatives are based on the level of perceived risk, which is informed by the current state of scientific knowledge.

This interim rule is effective as of the date specified above in DATES. Interested persons are invited to submit written comments on this interim rule on or before the date set forth in DATES.

The purpose of listing the 20 genera of live and dead specimens, including parts, from the order Caudata commonly referred to as salamanders, newts, and other names (hereafter, salamanders) as injurious wildlife is to prevent the accidental or intentional introduction of salamanders into the United States that are expected to serve as carriers of Batrachochytrium salamandrivorans (hereafter, Bsal), a fungus that poses a risk to native species of salamanders. If Bsal is introduced into wild populations of native salamanders, we expect it to cause significant damage to wildlife and the wildlife resources of the United States.

Under the Lacey Act (Act) (18 U.S.C. 42, as amended), the Service, through the Secretary of the Interior, may prescribe by regulation any wild mammals, wild birds, fish, mollusks, crustaceans, amphibians, reptiles, or the offspring or eggs of any of the foregoing found to be injurious to human beings, to the interests of agriculture, horticulture, forestry, or to wildlife or the wildlife resources of the United States. Salamanders are amphibians, and the Service has the authority to list them under the Lacey Act when it finds that they are injurious to one or more of the statutory interests. We may list species before they are introduced into the United States and, therefore, are able to harm interests of the United States as defined under the Act. We have determined that salamanders that potentially carry Bsal are injurious to wildlife and wildlife resources of the United States. With this interim rule, we are attempting to prevent the introduction and subsequent establishment of the chytrid fungus, Bsal, which is a pathogen capable of causing significant harm to native salamander species and their ecosystems. As described below under Role of Salamanders in the Ecosystem, the benefits that these native salamander species provide to ecosystems in ensuring ecosystem health and stability, and, in turn, the ecosystem services that benefit people, are significant.

Martel et al. (2014) and Cunningham et al. (2015) (as explained further in Chytridcrisis (2015b)) identified some of the salamander species that can carry Bsal and are at risk from infection. The research tested a limited number of the approximately 681 known species of salamanders that exist worldwide and found that not every species was negatively affected by the fungus. However, the results clearly indicate a severe threat for many species of salamanders that will be negatively affected by this pathogen, including 2 of the 7 species tested that are also native to the United States and were found to be lethally vulnerable to the fungus. Recent research has highlighted concerns of emerging infectious disease of fungal origin that can cause a significant loss in biodiversity and ecosystem services (Fisher et al. 2012); Bsal appears to be the latest.

The research results about Bsal and concerns about emerging infectious disease, especially Spitzen-van der Sluijs et al. (2013), Martel et al. (2013), and Martel et al. (2014), have generated a strong response from academia, industry groups, and conservation and other organizations who have written the Service seeking quick and decisive action to ensure Bsal does not have a similar impact on salamander populations that Batrachochytrium dendrobatidis (Bd) has had on frogs. We also received a petition from the Center for Biological Diversity and SAVE THE FROGS! on May 18, 2015, to take action to prevent the introduction of Bsal into the United States (Center for Biological Diversity and SAVE THE FROGS! 2015). In response to the scientific findings, letters to the Service, and the petition the Service initiated a review to determine whether salamanders capable of carrying Bsal should be listed as injurious. Based on the Service's genus-level carrier extrapolation from data obtained from Martel et al. (2014), and because Bsal has not been found in the United States (Martel et al. 2014; Muletz et al. 2014; Bales et al. 2015), the opportunity exists to take urgent action to prevent the introduction of Bsal. This action will help safeguard U.S. wildlife and natural resources, while providing time for monitoring and other measures to be developed that may allow safe trade in salamanders to resume later.

We reviewed Bsal and the salamander species that carry this fungus using the Injurious Wildlife Evaluation Criteria, described in more detail as part of this interim rule in Factors That Contribute to Salamanders Being Considered Injurious, which the Service developed to evaluate whether a species qualifies as injurious under the Act. The resulting analysis serves as a basis for the Service's regulatory decision regarding injurious wildlife species listings. This interim rule finds that Bsal is a significant threat to the wildlife and wildlife resources of the United States and lists 20 genera of salamanders that we have determined to be injurious because they are likely carriers of Bsal.

Rulemaking under the Act is governed by the Administrative Procedure Act (APA) (5 U.S.C. 551 et seq.). The process of issuing a proposed rule, providing the opportunity for public comment, and completing a final rule can take a significant amount of time to complete. During this time, the species proposed for listing are still allowed to be imported and transported, offering increased opportunities for introduction, establishment, and harm. Under section 553(b)(3)(B) of the APA, however, a proposed rule is not required “when the agency for good cause finds (and incorporates the finding and a brief statement of reasons therefor in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.” There is good cause to forgo notice and public comment on a proposed rule in this instance and instead take immediate action in the form of an interim rule to help prevent this fungus from being introduced, established, or spread in the United States. Providing notice and public comment prior to implementing the injurious wildlife prohibitions would be contrary to the public interest because of the need to take immediate action due to the significant risk from Bsal. For these reasons, we also find good cause in accordance with 5 U.S.C. 553(d)(3) to make the interim rule effective less than 30 days after the date of publication. Due to the significant risk of introduction, establishment, and spread of Bsal in the United States, this interim rule will take effect 15 days after publication in the Federal Register. Based on prior experience, a shorter-than-normal effective date will also help reduce the risk that importers will rush to import these species before the listing becomes effective. For example, in the case of snakeheads (Channidae), the Service documented a nearly three-fold increase in the importation of snakeheads after the proposed rule was first announced (67 FR 48855; July 26, 2002) and before the final rule took effect, approximately two months later (67 FR 62202; October 4, 2002). However, we also recognize that an immediate effective date is not practical when live animals may be in transit on the day the interim rule takes effect. A delay of 15 days before the interim rule goes into effect will allow for the reasonable completion of imports and transports already in progress and give wildlife inspectors and other law enforcement officers time to enforce the interim rule.

Experience with the introduction of Bsal into the Netherlands and associated deleterious effects to native salamanders, along with laboratory research, confirms that Bsal can be introduced, establish, and spread and cause substantial and immediate harm in the United States (Spitzen-van der Sluijs et al. 2013; Martel et al. 2014; Cunningham et al. 2015; Chytridcrisis 2015b). The United States leads all other countries in salamander diversity (Partners in Amphibian and Reptile Conservation, Stein and Kutner 2000). Based on scientific evidence, we know that the fungus is lethal to at least 2 salamander species native to the United States. Of the 190 native U.S. species, we find that at least 67 species are carriers and 20 are not carriers. The remaining 103 species have not been evaluated, and many of these species may also be affected by this potentially deadly fungus. While the Service's greatest concern will be for species that are lethally vulnerable to Bsal, salamander species known to be tolerant of or susceptible to Bsal infection under experimental conditions may also develop clinical disease or increased severity of disease, respectively, when infection is combined with additional stressors in the wild, as has been found for other diseases, including those in amphibians (Wobeser 2007; Kerby et al. 2011; Kiesecker 2011).

In the United States, Bsal has either not been introduced, has been introduced but has failed to establish, or is present but has not been positively detected. Although we do not have any conclusive evidence showing that introductions have occurred, history from other pathogens similar to Bsal, such as Bd, however, suggests that the fungus is likely to spread quickly throughout the United States if it is not prevented from being introduced. Moreover, efforts to control or eradicate introduced or established invasive species and manage the costs they incur to society are generally less effective and more expensive and difficult than efforts that prevent establishment (Leung et al. 2002; Finnoff et al. 2007). Prevention of invasive species is typically the most cost-effective measure to avoid the damage that such species cause (Leung et al. 2002; Lodge et al. 2006; Keller and Springborn 2014). As noted in the National Invasive Species Management Plan, “prevention is the first line of defense” and “can be the most cost effective approach because once a species becomes widespread, controlling it may require significant and sustained expenditures” (National Invasive Species Council 2008).

If Bsal has unknowingly been introduced but failed to establish for unknown reasons, it is still important to take action now because additional introductions increase the likelihood of establishment and harm. As more salamanders that can carry Bsal are imported into the United States, the probability increases that one or more of those salamanders, through a phenomenon called propagule pressure or “introduction effort,” described in Lockwood et al. (2005) as a measure of the number of nonnative individuals released into a region, will give Bsal the opportunity to establish and spread.

Listing the salamanders as injurious will help keep Bsal out of the United States by preventing the importation of salamanders capable of carrying the fungus and serving as the vector of introduction into U.S. ecosystems, thereby causing injurious effects consistent with the Act. Given the expected consequences that Bsal's introduction would have to wildlife and wildlife resources of the United States, we are listing species that we have determined to be injurious. This interim rule lists some species that are currently in trade as well as some that are not. We have the authority under the Act to list certain species as injurious even if they are not currently in trade or known to exist in the United States.

The salamander species listed by this interim rule are those found within genera for which we have evidence that at least one species in that genus is a carrier of Bsal with no countervailing conclusive evidence that other species in that genus are not carriers. We describe our rationale for this course of action below under Classification and Status as Carriers. Our decision-making included the following considerations: All 20 genera of salamanders, plus any new species identified within the genera listed by this interim rule, are found to be injurious because suitable climate exists in parts of the United States to support Bsal; even if a salamander listed by this interim rule could not establish a population in the wild, an infected salamander in captivity (or the water and soil in which it came into contact) can transmit Bsal to native populations; Bsal is capable of causing extensive damage to wildlife and wildlife resources, including federally endangered and threatened species; eradicating Bsal would be extremely difficult once introduced and established; and controlling Bsal is not practical.

Although this interim rule takes effect on the date specified above in DATES, it will still provide the public with a period of time to comment on the listing and associated documents. The final rule will contain responses to comments received on the interim rule, state the final decision, and provide the justification for that decision.

Pathogens are agents such as viruses, bacteria, and fungi that cause diseases in animals and plants. The Service does not have the direct authority under the Act to list pathogens as injurious. We also cannot list or regulate fomites (materials such as water that can transmit pathogens). However, wild mammals, wild birds, fish, mollusks, crustaceans, amphibians, or reptiles that are hosts to pathogens, such as viruses, bacteria, or fungi that cause disease, can be injurious if the likelihood, scope, and severity of effects significantly affect one or more of the interests listed in the Act. Even if the host species cannot establish populations in the wild, it can present significant risk if the pathogen the host is carrying can infect wildlife or wildlife resources or affect human beings or the interests of agriculture, horticulture, or forestry in the United States. Among other impacts, diseases caused by introduced pathogens reduce biodiversity (the variety of different types of life on earth) and have been implicated in the local extinction of many animal taxa (Daszak et al. 2000).

We have previously listed species under the Act that serve as hosts to pathogens, as in the case of fish in the salmon family Salmonidae (32 FR 20655; December 21, 1967, 33 FR 6827; May 4, 1968, and 58 FR 58976; November 5, 1993). Members of the family Salmonidae (salmon, trout, and char) are not injurious provided they are free from certain pathogens. However, salmon that are alive or are dead and uneviscerated (internal organs have not been removed) without a health certificate declaring that the fish are pathogen free are injurious to wildlife and wildlife resources due to the risk of transmitting pathogens that cause devastating diseases in fish. Although prophylactic treatments for imports of salamanders to manage Bsal are in development, they are not yet fully tested or feasible.

The regulations contained in part 16 of title 50 of the Code of Federal Regulations (CFR) implement the Lacey Act and include the lists of all species determined by the Service or by Congress to be injurious. Under the terms of the Act, the Secretary of the Interior may prescribe by regulation those wild mammals, wild birds, fish, mollusks, crustaceans, amphibians, reptiles, and the offspring or eggs of any of the foregoing that are injurious to humans, to the interests of agriculture, horticulture, or forestry, or to the wildlife or wildlife resources of the United States. The lists of injurious wildlife species are found at 50 CFR 16.11-16.15. Under these regulations, species are added to the lists of injurious wildlife to protect statutorily defined interests from potential and known negative effects. Most species listed have the capacity to establish populations in the wild, spread, and cause harm. However, a species can be listed based solely on its capacity to cause harm. As noted in the previous section, dead, uneviscerated salmonids without a health certificate are not capable of establishing in the United States, but they are injurious because the pathogens they may carry are harmful.

Under the Act, the Service can list species that are nonnative or indigenous to the United States. In the case of an indigenous species, for example, the Service may find that it is injurious because its transport and release into another State outside the species' range will cause harm to human beings, agricultural or forestry interests, or natural systems. Furthermore, a species does not have to be currently imported or present in the wild in the United States for the Service to list it as injurious. For species not yet imported into the United States, the objective of listing is to prevent that species' importation and likely introduction and possible establishment and spread in the wild, thereby preventing injurious effects consistent with the purposes of the Act. For species that are present in the United States, the Act prevents the further introduction, establishment, or spread of the species by prohibiting interstate transport.

Importation into the United States of an injurious species is prohibited. Transportation between the States, the District of Columbia, the Commonwealth of Puerto Rico, or any territory or possession of the United States of an injurious species is also prohibited. These prohibited activities may be undertaken by permit for zoological, educational, medical, or scientific purposes (in accordance with permit regulations at 50 CFR 16.22), or by Federal agencies without a permit solely for their own use, upon filing a written declaration with the District Director of Customs and the U.S. Fish and Wildlife Service inspector at the port of entry. The Act does not regulate intrastate transport (transport within a State or territory) or possession of injurious species. Any regulations pertaining to the transport or use of these species within a particular State or U.S. territory are the responsibility of that State or territory.

The Service uses criteria, identified below, to evaluate whether a species does or does not qualify as injurious under the Act. The analysis that is developed using these criteria serves as a general basis for the Service's regulatory decision regarding injurious wildlife species listings. Biologists and risk managers within the Service who are knowledgeable about a species that is being evaluated assess both the factors that contribute to and the factors that reduce the likelihood of injuriousness.

(1) Factors that contribute to being considered injurious:

• The likelihood of release or escape;

• Potential to survive, become established, and spread;

• Impacts on wildlife resources or ecosystems through hybridization and competition for food and habitats, habitat degradation and destruction, predation, and pathogen transfer;

• Impacts to threatened and endangered species and their habitats;

• Impacts to human beings, forestry, horticulture, and agriculture; and

• Wildlife or habitat damages that may occur from control measures.

(2) Factors that reduce the likelihood of the species being considered as injurious:

• Ability to prevent escape and establishment;

• Potential to eradicate or manage established populations (for example, making organisms sterile);

• Ability to rehabilitate disturbed ecosystems;

• Ability to prevent or control the spread of pathogens or parasites; and

• Any potential ecological benefits to introduction.

In the case of this interim rule, the issue is not whether a given salamander species is invasive, but rather the role of salamanders in introducing the Bsal fungus into the United States and the scope and severity of effects caused by salamanders that are carriers of Bsal on human beings or the interests of agriculture, horticulture, or forestry, or the wildlife or wildlife resources of the United States.

We are soliciting public comments and supporting data on the draft economic analysis, the draft regulatory flexibility analysis, and this interim rule to add all species from 20 genera of salamanders to the list of injurious amphibians under the Act. We will review the public comments for the preparation of our final rule. The draft economic analysis and regulatory flexibility analysis and this interim rule will be available on http://www.regulations.gov under Docket No. FWS-HQ-FAC-2015-0005. You may submit your comments and materials concerning this interim rule by one of the methods listed in ADDRESSES. We will not accept comments sent by email or fax or to an address not listed in ADDRESSES.

We will post your entire comment—including your personal identifying information—on http://www.regulations.gov. If your written comments provide personal identifying information, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so.

Comments and materials we receive, as well as supporting documentation we used in preparing this interim rule, will be available for public inspection on http://www.regulations.gov under Docket No. FWS-HQ-FAC-2015-0005, or by appointment, during normal business hours at the Service's office in Falls Church, VA (see FOR FURTHER INFORMATION CONTACT).

We are soliciting public comments and supporting data to gain additional information, and we specifically seek comment on the following questions:

(1) How many of the species listed by this rule are currently in production for wholesale or retail sale, and in how many and which States?

(2) How many businesses sell one or more of the species listed by this rule?

(3) How many businesses breed one or more of the species?

(4) What species listed as threatened or endangered by one or more States would be affected by the introduction of Bsal?

(5) What provisions in the interim rule should the Service have considered with regard to: (a) The impact of the provision(s) (including any benefits and costs), if any, and (b) what alternatives, if any, the Service should consider, as well as the costs and benefits of those alternatives, paying specific attention to the effect of the rule on small entities?

(6) How could the interim rule be modified to reduce costs or burdens for some or all entities, including small entities, consistent with the Service's requirements? For example, we seek comment on the distinct benefits and costs, both quantitative and qualitative, of (a) the prohibitions on importation and (b) the prohibitions on interstate transport of the species listed by this rule. What are the costs and benefits of the modifications?

(7) Is there any evidence suggesting that Bsal has been introduced into the United States or may have already established?

(8) Are there other pathways for Bsal into the United States that we should address? If so, what are they?

(9) Is there evidence suggesting that any of the species listed by this rule are not carriers of Bsal? If so, what species?

(10) Is there any evidence suggesting that additional species are carriers of Bsal and should be listed by this rule? If so, what species?

(11) Are there methods (such as thermal exposure) that would allow salamanders imported into the United States to be reliably treated to help ensure Bsal is not introduced into the United States, and how could compliance be monitored?

(12) Should the Service add eggs or other reproductive material of listed salamanders to the list of injurious wildlife because they may also carry Bsal?

(13) For the species we are listing, are the scientific and common names the most appropriate ones accepted by the scientific community?

(14) What are relevant Federal, State, or local rules that may duplicate, overlap, or conflict with the interim rule?

We will also submit the rule for peer review concurrent with public comments. In conducting peer review, we will follow guidance from the Office of Management and Budget “Final Information Quality Bulletin for Peer Review” (OMB 2004) and the Service's own guidance.

Salamander nomenclature and taxonomy remained relatively unchanged from the 1960s until the 1990s, when advances in DNA sequencing enabled researchers to examine species relationships more closely (Petranka 1998). The Service does not have a uniform policy for taxonomically identifying amphibians. In this interim rule, we use taxonomic nomenclature as described by AmphibiaWeb (http://amphibiaweb.org) and the Integrated Taxonomic Information System (ITIS) (http://www.itis.gov). The system used by AmphibiaWeb represents one of the most widely accepted salamander taxonomic systems in the scientific community because it relies on criteria including, but not limited to, monophyly (common descent from a single ancestor), stability, expertise of scientists, and general acceptance by the amphibian community (Amphibiaweb 2015b). As a Federal resource for taxonomic information, the Service also uses ITIS as an agency resource (ITIS 2015).

The two databases have some differences. For example, AmphibiaWeb contains some species that are not in ITIS. We addressed all species found in either ITIS or AmphibiaWeb for a given genus to avoid confusion over which species we intended to list by this interim rule. We have also used additional resources where necessary to clarify taxonomy, specifically:

• The Kurdistan newt (Neurergus microspilotus) is in ITIS but is not in AmphibiaWeb. According to the American Museum of Natural History (AMNH 2015a), it is likely the same species as N. derjugini; consequently, we have included both scientific names in 50 CFR 16.14.

• Martel et al. (2014) identified the great crested newt (Triturus cristatus) as being lethally vulnerable to Bsal. Another species in the genus, T. vittatus (no common name), appears in the U.S. Fish and Wildlife Service's Office of Law Enforcement's (USFWS OLE) Law Enforcement Management Information System (LEMIS) data (USFWS OLE 2015). LEMIS is an electronic database utilized by all Service law enforcement offices, including Service Conservation Officers, Wildlife Inspectors, Refuge Officers, and Special Agents. LEMIS serves as the portal in which all Service wildlife violations are documented and intelligence is gathered and shared between law enforcement offices across the country. LEMIS also serves as the conduit for all declared (lawful) imports and exports of wildlife and wildlife products and the database of all wildlife trade data in the United States, both legal and illegal. T. vittatus does not appear in ITIS or AmphibiaWeb but is listed in AMNH (2015b). Because it appears in LEMIS data, we are including it in 50 CFR 16.14 as a species under the same genus, even though that species does not appear in either ITIS or AmphibiaWeb.

• LEMIS also includes the species Triturus hongkongensis (no common name), even though it is not a valid scientific name in ITIS or AmphibiaWeb. The name may be confused with Paramesotriton hongkongensis (no common name) due to its similarity.

• As a result, even though sources such as AmphibiaWeb state that there are approximately 679 species of salamanders (AmphibiaWeb 2015c), for purposes of this interim rule, we have identified approximately 681 species.

• Hynobius fuca and H. fucus appear to be the same species (Taiwan lesser salamander) (AMNH 2015c); we have included both of these names in 50 CFR 16.14.

• Speleomantes strinatii is a synonym for Hydromantes strinatii (Nanjappa, pers. comm.; Caudata Culture 2015b), of which the French cave salamander or Strinati's cave salamander are common names; we have included all of these names in 50 CFR 16.14.

In this interim rule, when we refer to salamanders, we include a variety of animals from the order Caudata, including those commonly referred to as salamanders and newts. Other common names, such as mudpuppy, also exist for certain animals in Caudata.

Salamanders belong to the class Amphibia, a group of cold-blooded animals with a spinal column. The word “amphibian” is derived from the fact that most of the species spend part of their lives in water and part on land. The class Amphibia also includes frogs and toads, which have legs but no tails as adults, and caecilians, which have tails but no legs. Morphologically, salamanders are characterized by their relatively large, vertically flattened tails, two front and two hind legs that are approximately the same size (Petranka 1998), and skin with glands that can be either rough or smooth (Stebbins and Cohen 1997). Salamanders range in length from around 4 centimeters (1.5 inches) to over 1.5 meters (5 feet) (Stebbins and Cohen 1997).

Salamanders can live for long periods, but documented lifespans vary. Larger salamanders tend to live longer than smaller ones, and with proper care, salamanders in captivity frequently live longer than those in the wild (Duellman and Trueb 1986). Records for captive animals range from 5 years for most plethodontids to 55 years for the Japanese giant salamander (Andrias japonicus) (Duellman and Trueb 1986). The Olm or blind cave salamander (Proteus anguinus), which lives in caves in southern Europe, has been documented living for at least 48 years in the wild, with an estimated lifespan of more than 100 years (Live Science 2015).

Salamanders are carnivorous and eat a wide variety of prey, depending on habitat and the stage of their life cycle. Terrestrial salamanders eat earthworms, insect eggs, and other small invertebrates, while aquatic salamanders eat all of these in addition to small fish, aquatic insects, and other amphibians. Some salamander larvae can also be omnivorous and eat both plants and animals.

Many salamanders have unique structural features, including costal grooves (grooves on the sides of the body that increase skin surface area for water absorption and transport) and nasolabial grooves (vertical slits between the nostril and upper lip used for sensing chemical stimuli in the environment), that can be used to differentiate between salamander species (Petranka 1998). Important features for identifying salamanders include head shape and size, fin shape and color, gill morphology, color patterns, number of toes, size, body shape, tooth patterns, and number of costal grooves. Some species appear similar. For example, similarity of appearance within the family Salamandridae can make it difficult to differentiate between species, requiring close inspection of small physical characteristics.

Salamanders occupy a wide range of habitats, including streams, trees, land (including forests, grasslands, and rocky slopes), underground, and caves (Amphibiaweb 2015a). Salamanders are cryptic (difficult to find) partly because they occupy moist, cool places, such as underneath logs and between rock crevices on land or under rocks and logs in the water.

Salamander courtship between males and females is regulated by chemicals that are released from specialized glands in the skin. Most salamanders reproduce by laying eggs in water with two exceptions: members of family Plethodontidae lay their eggs on land, and the European species known as the alpine salamander (Salamandra atra) gives birth to live young (Stebbins and Cohen 1997). Eggs are surrounded by a protective jelly or membrane that keeps them from drying out. Almost all species of salamanders breed during specific seasons, and the length of time between mating and egg-laying varies considerably between species (Petranka 1998). Species that lay aquatic eggs place them in either streams or ponds, and species that lay their eggs on land choose hidden places, such as underground burrows, decaying logs, and moist rock crevices (Petranka 1998).

One example of a species that spends most of its life on land, but that moves to aquatic areas to breed, is the California tiger salamander (Ambystoma californiense). During winter rains, this species migrates across land to aquatic pools, such as cattle tanks and ephemeral pools, for breeding purposes. At the breeding pools, individuals come in contact with each other, even though they may not come in contact with each other during most of the rest of their lives on land (Barry and Shaffer 1994).

With more native salamander species than any other country in the world, the United States is a salamander diversity hotspot (Partners in Amphibian and Reptile Conservation 2015; Stein and Kutner 2015). Salamanders are widespread in the United States. (Caudata Culture 2015a; U.S. National Park Service 2015). Areas of particularly high salamander diversity include the southeastern United States, with large numbers of plethodontid salamanders in the southern Appalachian Mountains (Richgels et al. in review).

Salamanders in the United States occupy a wide range of habitats, including streams, trees, land (including forests, grasslands, and rocky slopes), underground, and caves (Amphibiaweb 2015a). These locations are most conducive to the relatively cool, moist conditions under which both salamanders and Bsal thrive (Duellman and Trueb 1986; Piotrowski et al. 2004; Blooi et al. 2015a). Central and North American salamanders as a group are active at average temperatures of 11 °C (52 °F) to 20 °C (68 °F) (Duellman and Trueb 1986), fully encompassing the optimum temperature for Bsal growth as described below under Climate Tolerance. Most salamanders require some amount of constant moisture, either for respiration, as in the lungless family Plethodontidae, or for temperature regulation (Duellman and Trueb 1986).

Twenty species, subspecies, or populations of U.S. salamanders from six genera are currently listed as endangered or threatened under the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq.) (ESA). An additional three species (three genera) are candidates for listing (U.S. Fish and Wildlife Service 2015). The specific vulnerability and carrier status of these species to Bsal is described below in Vulnerability and Carrier Status of Threatened and Endangered Species.

Of the 190 salamander species native to the United States, we find that at least 67 species in 5 genera and in 3 families are capable of being carriers of Bsal: Salamandridae, Sirenidae, and Plethodontidae. In North America, species in the family Salamandridae occur on the west coast of the United States and Canada from southern California to southeastern Alaska, and much of the eastern half of the United States and extreme southeastern Canada (Amphibiaweb 2015a; Caudata Culture 2015a). Members of the family Sirendidae occur throughout the southeastern Atlantic and Gulf of Mexico coastal plains and the Mississippi River Valley (Leja 2005) (lesser siren (Siren intermedia)) and in the Atlantic coastal plains from south Florida to Virginia (greater siren (Siren lacertina)) (Hendricks 2005). The distribution of salamanders of the family Plethodontidae in the western hemisphere is from southern Canada to Bolivia and Brazil, except for members of the genus Hydromantes, which occur in California (Amphibiaweb 2015a, Caudata Culture 2015a).

Salamanders play important roles in ecosystem function and as indicators of ecosystem health and stability (Davic and Welsh 2004). For example, salamanders of family Plethodontidae have life-history characteristics that make them exceptional indicators of forest health (Welsh and Droege 2001).

In forests, salamanders are also among the most abundant vertebrates. Despite the relatively small size of most salamanders compared to most other native vertebrates, this sheer abundance contributes to a significant amount of biomass in the ecosystem, and, therefore, salamanders make significant contributions to nutrient cycling and transport (Burton and Likens 1975). For example, Ambystomatid salamanders can make significant contributions to energy and nutrient transport in forest ecosystems (Regester et al. 2006) and in pond ecosystems (Holomuzki et al. 1994). By consuming arthropods (insects and related invertebrates) that would otherwise release carbon dioxide into the atmosphere by decomposing leaf litter in forests, salamanders reduce carbon emissions from leaf litter decomposition, which has implications for the global carbon cycle (Wyman 1998; Best and Welsh 2014). Salamanders that live underground also contribute to soil dynamics by creating, modifying, and otherwise regulating the systems of underground burrows in which they live (Davic and Welsh 2004).

In vernal pond communities, Ambystoma species are the top predators and, therefore, control the abundance of aquatic invertebrates and other amphibians (Petranka 1998). The high numbers of many amphibians, including salamanders, in some ecosystems also provide a substantial source of prey for other vertebrates in the ecosystem (Harper et al. 2008; Davic and Welsh 2004); therefore, other native species that prey on salamanders can also be affected by disease-related declines.

In drawing some of our conclusions about the effects of Bsal on U.S. wildlife and wildlife resources, the Service has used Bd as a surrogate. Considerably more is known about Bd than Bsal due to its discovery and description more than 15 years ago (Berger et al. 1998, Longcore et al. 1999), while Bsal was discovered 2 years ago (Martel et al. 2013). The severe effects that Bd, a species closely related to Bsal, has had on amphibian populations, has raised additional alarm about the expected consequences of a Bsal introduction and the need to take immediate action under an interim rule. The two risk assessments of Bsal that have been conducted both used Bd in determining the risk of Bsal based on transmission, spread, and population-level effects (Richgels et al. in review; Stephen et al. 2015).

Until Bsal was discovered, the fungal disease chytridiomycosis was thought to be caused by a single species of pathogenic fungus, Bd, which was the only chytridiomycete taxon known to parasitize vertebrate hosts (Longcore 1999; Johnson and Speare 2003). Bd has been implicated in the decline and extinction of amphibian species at the global scale (Berger et al. 1998; Daszak et al. 2003; Lips et al. 2006; Walker et al. 2008; Vredenburg et al. 2010; Cheng et al. 2011). Bd has been found on every continent except Antarctica, and it is known to have affected more than 500 species of amphibians, including all orders of amphibians (frogs, salamanders, and caecilians) worldwide (Chytridcrisis 2015a; Fisher et al. 2009; Olson et al. 2013).

Bsal came to the attention of the scientific community only recently. Spitzen-van der Sluijs et al. (2013) observed a 96 percent decline in fire salamanders (Salamandra salamandra) in the Netherlands but was “unable to attribute this to any known cause of amphibian decline, such as chytridiomycosis [at the time, thought only to be caused by Bd], ranavirus or habitat degradation.” Martel et al. (2013) later identified the cause of the salamander decline in the Netherlands as a newly described species of fungus now known as Bsal. Their work confirmed that Bsal is related to Bd and is also capable of causing chytridiomycosis. Analysis of a broad range of representative chytrid fungi show that Bsal represents a previously undescribed species that shares early evolutionary origins with the pathogenic fungus Bd (Martel et al. 2013). Until Bsal was discovered, Bd was the only species from that phylum known to infect vertebrates.

While Bd has been found in North America, Bsal has not yet been found in North America, and the two fungi do not have the same effects on the same animals. As the authors noted, “Chytridiomycosis has resulted in the serious decline and extinction of [more than] 200 species of amphibians worldwide and poses the greatest threat to biodiversity of any known disease * * *. We [have discovered] a second * * * chytrid pathogen, [Bsal], that causes lethal skin infections in salamanders * * *. Our finding provides another explanation for the phenomenon of amphibian biodiversity loss that is emblematic of the current global biodiversity crisis.” The natural host ranges of Bsal remain unknown, but so far it has been found only in salamanders and appears capable of causing lethal chytridiomycosis only in salamanders (Martel et al. 2014).

The “salamandrivorans” in Batrachochytrium salamandrivorans translates to “salamandereating” and accurately describes the effects of the fungus on salamanders. Bsal infects the skin of amphibians but not deeper tissues or internal organs (Berger 2004; Martel et al. 2013). The cells of the fungus (thalli) embed themselves in the skin cells of the salamander, thereby causing erosive lesions.

Lesions consist of sores on the skin that erode and ulcerate, with secondary bacterial infection occurring after the sores appear (Martel et al. 2013), although many of the salamanders reported at the beginning of the European Bsal outbreak seemed to lack obvious external lesions (Spitzen-van der Sluijs et al. 2013). Experimental infections of fire salamanders in the laboratory caused death 12 to 18 days after exposure, with the same clinical signs and pathological lesions found in the European outbreak (Martel et al. 2013). Martel et al. (2013) found that infected fire salamanders developed shallow skin lesions and deep ulcerations all over the body, and became anorexic, apathetic, and suffered from neurological signs including a loss of voluntary movement and muscle coordination. Death occurred within 7 days of clinical signs first appearing in species with lethal vulnerability.

Bsal does not appear to affect reproductive tissue, such as eggs or gametes. Using Bd for comparison, Bd requires keratin, a structural component of organisms found in amphibian skin, which is not found in salamander eggs or gametes (Berger 1998).

Temperature has a significant impact on the growth and disease development of Bsal in salamanders (Martel et al. 2014). Bsal appears to prefer a temperature range for growth and infection of 10-15 °C (50-59 °F) (Blooi et al. 2015a; Stephen et al. 2015, Martel et al. 2013). Bsal has shown some growth in temperatures as low as 5 °C (41 °F) and dies at 25 °C (77 °F) and above (Martel et al. 2013). In a laboratory study, salamanders were most easily infected by Bsal at temperatures of 15 °C (59 °F) and 20 °C (68 °F), while Bsal growth was inhibited at 25 °C (77 °F) (Blooi et al. 2015a). The same temperature response was also observed for Bsal raised in culture (Blooi et al. 2015a).

This experimental data suggests that salamanders living at lower temperatures are more at risk to infection by Bsal. Animals that survive at temperatures above the optimal range for fungal growth are likely to be at reduced risk to infection. However, the average temperature ranges of North and Central American salamander species is from 11 °C (52 °F) to 20 °C (68 °F) (Duellman and Trueb 1986; the citation does not separate North and Central American data), so salamanders regularly reaching 25 °C (77 °F) in the natural environment is uncommon. Bales et al. (2015) noted that the native salamander species, and by extension ecosystems, most at risk from a Bsal introduction would likely be those that occupy similar thermal ranges as the European fire salamander (Bales et al. 2015).

The chytrid fungus Bd can live outside of a host and requires water to disperse because it reproduces asexually by forming motile zoospores; preliminary studies of Bsal indicate that similar modes of survival and transmission are highly likely (Longcore 1999; Martel et al. 2013). As the threat assessment by Stephen et al. 2015) noted, “Bd is known to remain viable for several days to weeks in water (Johnson and Speare 2013) and moist organic matter (Johnson and Speare 2003), even in the absence of nutrients. It is likely that Bsal can also survive in moist environments, independent of an amphibian host.”

The transmission and ecology of Bsal in the wild is likely to be similar to Bd based on the close taxonomic relationship between the species, their structural similarities, and their comparable pathophysiology (Martel et al. 2013, Stephen et al. (2015). Johnson and Speare (2003) reported that Bd can survive in tap water and deionized water for up to 3 and 4 weeks, respectively, and up to 7 weeks in lake water. Bsal is also likely to survive in moist environments independent of an amphibian host. While we do not have information on the response of Bsal to desiccation, Bd is highly impacted by drying and can survive desiccation for no more than 1 hour in the laboratory (Garmyn et al. 2012); Bsal would likely respond in a similar way. Bsal appears to be adapted to temperatures and humidity conditions most conducive to salamander survival, thus supporting the hypothesis that the pathogen co-evolved with salamanders in the part of the world from which it is endemic, most likely in Asia (Martel et al. 2014).

Several pathogens, including Bsal, Bd, ranaviruses, and Saprolegnia sp. (water molds), have caused significant population-level declines in a range of amphibian species, and disease is thought to be a major driver of global amphibian decline (Bosch et al. 2001; Martel et al. 2013; Daszak et al. 2003). Disease poses a greater risk to small, isolated populations as well as those with decreased genetic diversity (Smith et al. 2008). Within the United States, diseases have been cited as contributing factors in the listing or recovery of several native amphibian species under the ESA. Examples include Bd in the Ozark hellbender (Cryptobranchus alleganiensis bishopi) (76 FR 61956, October 6, 2011), an undiagnosed disease in Sonora tiger salamanders (Ambystoma tigrinum stebbinsi) (62 FR 665, January 6, 1997), and Bd in the mountain yellow-legged frog (Rana muscosa) (82 FR 24256, April 29, 2014; Vredenburg et al. 2010).

As noted above in General Description of Fungus, Bsal is the most recently discovered pathogen associated with population-level amphibian declines, including a 96 percent reduction in Dutch populations of the European fire salamander between 2010-2013 (Spitzen-van der Sluijs et al. 2013; Martel et al. 2013). Due to the overall sensitivity of amphibian populations to disease; a history of adverse, population-level effects in native amphibians; a direct association between Bsal and the decline of at least one European salamander population; and the adverse effects of some native salamanders to Bsal under experimental conditions, we conclude that the introduction of Bsal into the United States would cause significant, adverse, population-level effects in a number of native species.

The preferred temperature range of Bsal can help predict those ecosystems that are at greatest risk should Bsal be introduced into the United States (Stephen et al. 2015). The native salamander species, and by extension ecosystems, most at risk from a Bsal introduction would likely be those that occupy similar thermal ranges as the European fire salamander (Bales et al. 2015).

Salamanders are important parts of the ecosystems in which they occur. Salamanders are often the most abundant vertebrates in terrestrial forest and riparian (the banks of watercourses) ecosystems, where they may compose a total biomass greater than or equal to birds or small mammals (Davic and Welsh 2004). This means that, despite their small size, the total weight of all salamanders in a given area may be more than the combined total weight of all birds or all small mammals. Because of their abundance under normal circumstances, salamanders are important prey species themselves and are energy sources for higher predators (Davic and Welsh 2004), including fish, reptiles, birds, and mammals.

Salamanders may be the dominant predator in headwater streams and ephemeral waterbodies where fish are absent (Davic and Welsh 2004). Within some food webs, salamanders are considered keystone predators due to their control of invertebrate prey populations and their resulting regulation of detritus decomposition and nutrient cycling (Davic and Welsh 2004). By definition, keystone species are those that occupy niches that affect ecosystems and have little functional overlap with other species (Davic and Welsh 2004). Therefore, loss of these keystone species would result in significant ecosystem-level change.

In addition to their roles in food webs and nutrient cycling, salamanders participate in a number of interspecific (between species) ecological relationships. Salamander species interact with one another through competition and predation to control the composition of their assemblages (taxonomically related species that occur within the same geographic community) (Davic and Welsh 2004; Fauth et al. 1996). Frequently, a single species is dominant within a given assemblage, particularly in terrestrial habitats, but which species dominates varies by location and ecosystem (Davic and Welsh 2004). We find that ecosystems where the dominant salamander species is vulnerable to lethal or susceptible infections with Bsal would be at risk from an introduction of this pathogen.

Salamanders also interact with invertebrate species in other ecologically important ways. Semi-aquatic salamander species can move mollusks and shrimp eggs between waterbodies during their migrations, allowing these invertebrates to inhabit new areas (Davic and Welsh 2004). Additionally, one species of salamander, the mudpuppy (Necturus maculosus), is a required host for developing stages of the salamander mussel (Simpsonaias ambigua), a native, freshwater mollusk for which a positive 90-day finding has been made under the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq.) (76 FR 59836; September 27, 2011) (Davic and Welsh 2004; Gangloff and Folkerts 2006; United States Fish and Wildlife Service 2015b, United States Fish and Wildlife Service 2015c). We conclude that invertebrate species that depend on salamanders for aspects of their life cycle or ecology are likely to be adversely affected if their host species declines in response to a Bsal introduction.

Some salamanders have the ability to invade new environments in which they are not native. Globally, 90 percent of salamander introductions have occurred through intentional releases (Tingley et al. 2010). As of 2010, salamanders comprised 22 percent of all recorded amphibian introductions, with the highest number of salamander introductions (15) from the family Salamandridae, followed by salamanders from the families Ambystomatidae (4), Cryptobranchidae (2), and Proteidae (2) (Tingley et al. 2010).

Nonnative salamander introductions have been documented in the United States. As described below under Likelihood of Release or Escape, the United States Geological Survey (USGS) Nonindigenous Aquatic Species database has U.S. records for 14 salamander species that have been observed outside their native range. Of those, 11 are native to the United States but were discovered outside of their native ranges, and 3 (Japanese newt (also called the Japanese fire-bellied newt, Cynops pyrrhogaster), Oriental fire belly newt (also called the Oriental fire-bellied newt, Cynops orientalis), and the spotless stout newt (Pachytriton labiatus)) are exotic species from outside the United States (USGS 2015). In Florida, the Oriental fire belly newt and spotless stout newt, which are native to China (family Salamandridae), have been found in the wild near an animal importer's facility, either as the result of intentional releases or escapes from enclosures (Krysko et al. 2011).

Other invasions have been attributed to the use and subsequent release of salamanders used as fishing bait. Surveys of anglers have indicated that they routinely release salamanders into the areas where they fish, which includes areas that are not part of the salamander's native U.S. habitats, suggesting that animals are routinely moved long distances (Picco and Collins 2008). Furthermore, Picco and Collins (2008) found that salamanders sold as bait were highly infected with both ranavirus and Bd, thereby increasing the likelihood of disease transmission into new areas of the United States through the act of fishing.

As noted above under General Description of Fungus, Europe has been experiencing a severe decline in wild fire salamander populations in the Netherlands (Spitzen-van der Sluijs et al. 2013). This decline is so significant that fire salamander populations are facing local extinction in the Netherlands, though other populations throughout Europe appear to be stable (AmphibiaWeb 2015c). A sharp decline in numbers has been observed since 2010, despite the species being listed as endangered on the Netherlands Red List, and at population levels that were thought to be stable. This enigmatic decline was not attributed to any known cause of amphibian decline, such as chytridiomycosis due to Bd, ranavirus, or habitat degradation. In late 2013, Bsal was isolated from infected fire salamanders in the Netherlands (Martel et al. 2013).

Martel et al. (2014) later established the highly pathogenic nature of this new chytrid fungus. Molecular testing found Bsal in specimens collected from the wild (though none from North America) and even in an archival (museum) sample that was 150 years old (Martel et al. 2014). A wide variety of salamanders are negatively affected by the pathogen, but frogs, toads, and caecilians do not appear to be (Martel et al. 2014). The pathogenic nature of the fungus and its ability to infect a wide variety of salamanders, as described below in Classification and Status as Carriers, definitively demonstrate an invasive threat to salamanders in the United States.

In Bd, the ability of the pathogen to be transmitted between individuals is dependent upon the density of populations (Rachowicz and Briggs 2007) and the presence of a vector that can carry the disease to uninfected populations (Greenspan et al. 2012); we expect the same for Bsal. Experiments have shown that Bsal can be transmitted from one species to another when the species come into contact (Martel et al. 2014).

Salamanders that breed in ponds and temporary wetlands are often explosive breeders, meaning that hundreds to multiple thousands of individuals will reproduce at the same time (Gill 1978), creating dense numbers of individuals and increasing opportunities for the pathogen to spread. Pathogens are also likely to be transmitted by salamander species that travel long distances for breeding and dispersal migrations, such as those that exhibit a metapopulation structure (Bancroft et al. 2011). A metapopulation is a group of discrete breeding populations of the same species (Gill 1978). For example, within salamander metapopulations, California tiger salamanders (Ambystoma californiense) have been documented traveling up to 1.2 miles (1.9 kilometers) from upland habitat to aquatic breeding sites (USFWS 2000), and newts travel many kilometers to breeding sites (Gill 1978).

Salamander species that have abundant populations with widespread distributions can also contribute to the spread of Bsal because of the increased likelihood that they will come in close contact with other salamanders that could then become infected. Salamanders that can carry Bsal from one place to another are more likely to do so if they have a broad range where they will come in contact with other members of the same species (for abundant distributions) or other species (for widespread distributions). Species with broad distributions are adapted to a wide range of environmental conditions that are more likely to overlap with habitat suitable for Bsal as well as habitat suitable for that species, providing increased opportunities for Bsal to spread.

For example, the rough-skinned newt (Taricha granulosa) has a wide range along the West Coast from Alaska to California, and the eastern newt (Notophthalmus viridescens) ranges widely across the eastern United States, occurring in 34 States (Amphibiaweb 2015a). Both species have had lethal responses with laboratory infections of Bsal (Martel et al. 2014), and both are capable of carrying Bsal. In addition to its broad range, N. viridescens also migrates long distances; this species will frequently travel many kilometers to migrate to new ponds (Gill 1978), further increasing the risk of this species spreading Bsal.

The main pathway for the global spread of Bsal is the international trade in salamanders (Martel et al. 2014). The introduction of Bsal into mainland Europe is linked with the commercial trade of Asian salamanders (Cynops spp.) from East Asia, particularly Thailand, Vietnam, and Japan (Martel et al. 2014). As described above in How the Fungus Affects Salamanders, eggs and gametes are not expected to be pathways. However, salamanders that have been identified as carriers, whether live or dead, are expected to transmit Bsal through their skin, which contains keratin. We are also concerned that any salamanders that are infected and lethally vulnerable may die in transport and continue to carry Bsal into the United States. As such, we also expect dead salamanders and body parts to be a pathway.

Individual amphibians in trade are often transported in containers with many other individuals of the same species or with many other species that can all be from different sources. These conditions are highly conducive to pathogen transmission and dispersal. Pathogens can transfer from host to host in crowded conditions, and crowded conditions create stress on animals that can reduce amphibian hosts' natural ability to ward off infections (Rowley et al. 2007, Rachowicz et al. 2005, Rollins-Smith et al. 2011).

Bsal can also be introduced into the environment through the improper disposal of contaminated water or other materials used to transport salamanders. As described above under Environmental Conditions Needed to Survive, the fungus can likely persist in such materials independent of whether a salamander is present. Water and other materials have served as fomites to introduce other similar pathogens into the environment. For example, Bd has been found in water used to transport amphibians that were traded in Hong Kong (Kolby et al. 2014). As the authors noted, “[T]he abundance of aquatic amphibian species traded by Hong Kong . . ., prolonged environmental persistence of infectious . . . Bd particles, and employment of trade activities that neither disinfect water nor safely dispose of deceased animals creates an ideal pathway for disease transmission to native Hong Kong amphibians.”

Drawing on this evidence, the primary pathway for the entry of salamanders that are hosts of Bsal into the United States is through the international commercial wildlife trade. Overall, 99.9 percent of salamander importation into the United States is for commercial purposes (USFWS OLE 2015). From 2010 to 2014, salamanders were imported through 14 ports of entry into the United States; the 3 ports of entry with the largest numbers of imported salamanders were Los Angeles (California), Tampa (Florida), and New York (New York) (Richgels et al. in review). After import, many of the salamanders are transported to animal wholesalers, who then transport the salamanders to pet retailers.

The most likely pathway of a salamander that is a host to Bsal into the United States would include a pet store or online retailer. Individuals would purchase the salamander from a pet store (or online retailer) and keep it in captivity as a pet. Many amphibians and reptiles first kept as pets are released by their owners into the wild either intentionally or accidentally (Kraus 2009, Krysko et al. 2011). For example, owners may no longer be able to care for their pets or an animal may escape its enclosure. In addition to the risk from a release of an infected pet salamander into the wild, the water that is used to house an infected pet in captivity would feasibly contain Bsal zoospores. As a result, the discharge of untreated water used to house infected, captive animals could be a pathway for releasing infective zoospores into the environment and exposing native salamanders to Bsal (Stephen et al. 2015).

Trade in wildlife occurs on a global scale, and amphibians are one of the most commonly traded animals (Smith et al. 2009). More than 52,149,000 documented amphibians were imported into the United States from 2004 to 2014, based on the Service's LEMIS data (USFWS OLE 2015). Salamanders comprised 2,504,590 (4.8 percent) of the total imports of amphibians (USFWS OLE 2015). The 2004 to 2014 LEMIS dataset should be considered as a conservative estimate because many import records identified the animal being imported only as a member of the Class Amphibia (rather than identifying it to species or genus level). In addition, incorrect salamander identifications to genus and species level appear to have commonly occurred in reporting to LEMIS (USFWS OLE 2015). LEMIS data shows that 65 percent of imported salamanders came from captive sources and 35 percent were from wild sources (USFWS OLE 2015). The LEMIS data recorded only 83 percent of declared imports at the species level, whereas 17 percent were recorded to the genus level (USFWS OLE 2015).

The four salamander genera most commonly imported into the United States from 2004 to 2014 were Cynops, Paramesotriton, Triturus, and Pachytriton (USFWS OLE 2015). Cynops, Triturus, and Paramesotriton are three genera that can serve as carriers for Bsal (Martel et al. 2014). Of the 20 genera listed by this interim rule, 15 have been traded over the 11 years. Salamanders that can carry Bsal have comprised 95 percent of imported salamanders.

The species with the highest number of imports into the United States from 2004 to 2014 was the Oriental fire belly newt; this species comprised 54 percent of the total number of imported salamanders (USFWS OLE 2015). Twelve species of salamanders that are native to the United States were also imported into the United States from other countries from 2004 through 2014 (USFWS OLE 2015).

Two Bsal risk assessments are available to help determine the risk associated with Bsal introduction into North America. The USGS conducted a risk assessment for the United States that helped us determine the level of risk associated with Bsal introduction (Richgels et al. in review). Stephen et al. (2015) also conducted a Bsal risk assessment for Canada that showed Canada is also at risk.

The USGS risk assessment concludes that the potential for Bsal introduction into the United States is high, the United States has suitable conditions for Bsal survival, and the consequences of introduction into the United States are expected to be severe and occur across a wide range of the United States (Richgels et al. in review). To evaluate the potential for Bsal introduction, the USGS assessment combined information on the number of individual salamanders imported at each port of entry and the number of pet supply establishments by county. Based on this evaluation, Bsal introduction potential was highest in central and southern Florida, southern California, and near New York City, New York (Richgels et al. in review).

To determine the consequences of Bsal introduction into the United States, the USGS risk assessment evaluated environmental suitability, species richness, and predicted species susceptibility. Overall, the total risk of Bsal to native salamanders is high. Based on both likely introduction and resultant consequences, the risk of Bsal is the highest for the Pacific coast, southern Appalachian Mountains, and mid-Atlantic regions (Richgels et al. in review). The areas most likely to have consequences from Bsal introduction are the Pacific Coast and Appalachian Mountains (Richgels et al. in review). Based on environmental suitability, areas of the United States most suited to Bsal growth (Blooi et al. 2015a), including the Southwest, Southeast, and Pacific regions, are also the areas of highest salamander diversity (Richgels et al. in review). Yap et al. (2015) also identified the southeastern and western United States as zones of high risk.

Some species may be protected from Bsal by temperatures in their regions that are outside of the Bsal optimal growth range (Richgels et al. in review), but the average temperature preferences of salamanders from Central and North America (Duellman and Trueb 1986), which range from −2.0 °C (28.4 °F) to 30.0 °C (86.0 °F), suggest that most salamander species, including those within the United States, are active near the thermal growth optimum for Bsal (Blooi et al. 2015a). Most U.S. salamander species are also dependent upon forests, a habitat type dominated by relatively cool, moist conditions, for the majority of their life cycle (Davic and Welsh 2004).

The urgent need to prevent Bsal introduction risks was raised by evidence presented by Martel et al. (2014), who tested Bsal on 35 species from all three orders of amphibians: frogs, salamanders, and caecilians. Martel et al. (2014) further screened 5,391 specimens collected from 4 continents for evidence of Bsal infection.

Martel et al. (2014) defines a “resistant” salamander as one that either was not infected or developed a short-term infection without clinical signs following exposure to Bsal; a “tolerant” salamander is one that maintains a more prolonged infection with no signs of disease; a “susceptible” salamander becomes infected and has clinical signs of disease with the possibility of subsequent recovery; and a salamander that responds in a “lethal” manner to Bsal dies as a result of infection. According to Martel et al. (2014), resistant salamanders are not a risk for transmitting Bsal. However, based on the available scientific data, we concluded that resistant species with evidence of short-term infection, as well as those reported to have tolerant, susceptible, or lethal responses to Bsal, are “carriers” capable of transmitting Bsal to other salamanders and introducing the fungus into the United States. The Service finds that a species is considered to be a “non-carrier” when Martel et al. (2014) classified the species as “resistant” and no histologic or field surveillance data was found to suggest that short-term Bsal infection could occur; “non-carriers” are considered incapable of transmitting Bsal to other salamanders or introducing the fungus into the United States.

We also find the likelihood of a species within the same genus being a carrier can be drawn from a comparison to Bd, which as described above under General Description of Chytrid Fungus is a close relative of Bsal. As noted earlier, the two risk assessments of Bsal that have been conducted both used Bd in determining the risk of Bsal based on transmission, spread, and population-level effects (Richgels et al. in review; Stephen et al. 2015). Considerably more is known about Bd than Bsal due to its discovery and description more than 15 years ago (Berger et al. 1998; Longcore et al. 1999), while Bsal was discovered only 2 years ago (Martel et al. 2013). Bd has caused amphibian declines and extinctions worldwide (Skerratt et al. 2007). Bd affects species in patterns (Skerratt et al. 2007), and more closely related species have similar outcomes for Bd at the family level (Smith et al. 2009; Bancroft et al. 2011). Amphibians experiencing the most severe declines are grouped by relatedness, which is likely due to the shared evolutionary histories of closely related species with a similar response to chytridiomycosis (Corey and Waite 2008). The U.S. Department of Agriculture (USDA) uses a similar approach. Closely related species are considered more likely to have similar traits and are used in risk assessments to determine threats from a target species of interest; a potential pest is regarded as a threat when other species in a genus pose a similar threat (Wapshere 1974; Gilbert et al. 2012).

We find that, due to shared characteristics by species within a genus, other species within these genera are also highly likely to be carriers of Bsal if one species has been identified as a carrier, even if not every species in the genus has been tested to verify that it is a carrier of Bsal. Our analysis found no conclusive countervailing evidence that species differed within a genus with respect to their ability to act as carriers. As such, we expect all species in a genus to respond similarly as carriers or non-carriers to Bsal. Therefore, based on existing scientific evidence, and as described in more detail below, we are listing all species in the 20 genera, including 201 known species, that we now conclude constitute a threat to introducing and spreading Bsal in the United States because such species can carry the fungus and transmit it to other species which would be negatively impacted.

While frogs and caecilians showed resistance to Bsal, many salamanders exhibited a strong, adverse response to Bsal infection; many species from outside of the native range of the fungus (Asia) exhibited lethal vulnerability. Our analysis of Martel et al. (2014) and follow-up communication (Martel, pers. comm.) found 25 species from 19 genera are carriers of Bsal. Additional communications (Chytridcrisis 2015b; Cunningham et al. 2015; Nanjappa, pers. comm.) identified another two species from two separate genera as carriers: The pygmy marbled newt (Triturus pygmaeus) and the golden striped salamander (Chioglossa lusitanica). Because Martel et al. (2014) had previously identified members of the Triturus genus as carriers, it is already accounted for within the 19 genera. The addition of this species brings the total number of known carrier species to 26. In addition to Triturus, Chioglossa was identified as another genus capable of serving as a carrier by Chytridcrisis (2015b), Cunningham et al. (2015), and Nanjappa (pers. comm.). As a result, the total number of species known to serve as carriers of Bsal is 27 from 20 genera. These 20 genera include the following: Chioglossa, Cynops, Euproctus, Hydromantes, Hynobius, Ichthyosaura, Lissotriton, Neurergus, Notophthalmus, Onychodactylus, Paramesotriton, Plethodon, Pleurodeles, Salamandra, Salamandrella, Salamandrina, Siren, Taricha, Triturus, and Tylototriton.

In conducting its analysis, the Service initially focused on identifying species for listing as injurious that scientific evidence demonstrates are capable of carrying Bsal. As we described above, however, we find that, due to shared characteristics by species within a genus, other species within these genera are also highly likely to be carriers of Bsal, even if not every species in the genus has been tested to verify that it is a carrier of Bsal. This conclusion is because more closely related species, such as those found within the same genus, share common traits. Our analysis found no conclusive evidence to the contrary that suggested that all species within such genera are not carriers.

We have focused our findings on salamanders and the genera in which they are found that we concluded are capable of carrying Bsal, and we are not listing genera that Martel et al. (2014) identified are not carriers of Bsal: Based on our analysis of their data, such salamanders are not capable of introducing Bsal to the United States or otherwise transmitting Bsal to native populations. In addition, we are not listing genera at this time where there is no data because we do not have a basis for doing so, even though the Service recognizes that it is possible that untested genera may also be capable of carrying Bsal. Likewise, we are not listing hybrids derived from species consisting of a listed genera and an unlisted one because we do not know their status as carriers. However, consistent with our view that species within a genus are likely to be carriers of Bsal if one species within that genus has been identified as a carrier, hybrids consisting of two species from within the same genus are expected also to be carriers.

In conclusion, we have decided to list all 201 species in the 20 genera where at least one species has been positively identified as a carrier of Bsal and there is no countervailing conclusive evidence suggesting that some species within the genus are not carriers. Where one species has been identified as a carrier, we find that the other species in that genus are also carriers. This finding includes hybrids consisting of species found within the genus.

In reaching this conclusion, it is worth noting that Martel et al. (2014) classified the slimy salamander (or northern slimy salamander, Plethodon glutinosus) as resistant to infection. Martel et al. (2014) demonstrated by histology, however, that Bsal could invade the skin of the slimy salamander, even though it was otherwise resistant through challenge testing and did not show signs of infection. Our examination of the supplementary data of Martel et al. (2014), including histology (microscopy) tests and subsequent discussions with the authors, indicate that there is sufficient evidence that Bsal was able to invade the skin of this species long enough to move or transmit the infection to other salamanders (Martel et al. 2014; Martel, pers. comm.; Lips, pers. comm.). Because we expect all species within a genus to respond in a similar way as a carrier or not of Bsal, we conclude that all species of Plethodon are carriers.

Martel et al. (2014) also classified the palmate newt (Lissotriton helveticus) as resistant to infection even though the Italian newt (Lissotriton italicus) was identified as lethally vulnerable to Bsal. Martel conducted histological tests that showed the palmate newt could carry Bsal even though it demonstrated resistant vulnerability. Our examination of the data of Martel et al. (2014), as well as a personal communication from K. Lips (2015), indicates that there is sufficient evidence that Bsal was able to invade the skin of the palmate newt long enough to pass the infection to other salamanders. Because we expect all species within a genus to respond in a similar way as a carrier or not of Bsal, we also conclude that all species of Lissotriton are carriers.

In addition, Martel et al. (2014) classified the Hokkaido salamander (Hynobius retardatus) as resistant to Bsal under experimental conditions. However, we find that the misty salamander (H. nebulosus) is a carrier based on detection of Bsal by Martel et al. (2014) in a free-ranging specimen from Japan. The histology tests that were conducted for the slimy salamander and the palmate newt, and which we used to find that these species are carriers, were not conducted for the Hokkaido salamander. Bsal's ability to invade the skin of the Hokkaido salamander remains unknown because histologic examination of the skin was not conducted for the species. Because the Hokkaido salamander was resistant in experimental tests but was not tested histologically to look for invasion in the skin, we find that the Hokkaido salamander has an inconclusive status as a carrier and base our finding of whether species from the genus Hynobius are carriers on results identified for the misty salamander (a carrier from the same genus). Because we expect all species within a genus to respond in a similar way as a carrier or not of Bsal, we concluded that all species from the genus Hynobius are also carriers.

Finally, although Martel et al. (2014) did not test species from the genus Onychodactylus in the laboratory, Martel et al. (2014) observed Bsal on the Japanese clawed salamander (O. japonicas) in a free-ranging specimen from Japan. Based on that evidence, we concluded that this species is a carrier. Because we expect all species within a genus to respond in a similar way as a carrier or not of Bsal, we concluded that the other species in the genus Onychodactylus are also carriers.

There are 190 species of salamander in 23 genera native to the United States (AmphibiaWeb 2015b). Of the 201 salamander species that we conclude are carriers of Bsal (20 genera in 4 families), 67 species (5 genera in 3 families) are native to the United States. Of the remaining 123 species native to the United States, we found that 20 species are not carriers and the vulnerability and carrier status of the remaining 103 species from the other 16 genera is unknown.

We based our findings of the 67 native species on tests conducted by Martel et al. (2014), who tested 7 native species in the laboratory for Bsal vulnerability. The native species that Martel et al. (2014) tested were the eastern newt (Notophthalmus viridescens), rough-skinned newt (Taricha granulosa), lesser siren (Siren intermedia), slimy salamander (Plethodon glutinosus), spring salamander (Gyrinophilus porphyriticus), marbled salamander (Ambystoma opacum), and spotted salamander (A. maculatum). Of these, 2 species were found to be lethally affected, 1 was tolerant, and 4 were described as resistant, although additional evidence indicates that one of the resistant species is capable of transmitting the fungus, resulting in a positive carrier status. As we described above in Vulnerability and Carrier Status, although the Service found evidence that species within a genus may vary in their specific vulnerability (that is, lethal, susceptible, tolerant, or resistant, as defined in Martel et al. (2014)), we expect all species in a genus to respond similarly as carriers or non-carriers to Bsal due to the shared characteristics between species. Therefore, we are listing all species within a genus where at least one species in that genus has been identified as a carrier of Bsal.

Based on the results of Martel et al. (2014), at least 2 native U.S. species, the eastern newt and rough-skinned newt, were found to be lethally vulnerable to Bsal. The French cave salamander (Hydromantes strinatii), which is not native to the United States, was also tested and identified as lethally vulnerable to Bsal (Martel et al. 2014). The Notophthalmus genus has two additional native species: The black-spotted newt (N. meridionalis) and the striped newt (N. perstriatus). The Taricha genus has three additional native species: The red-bellied newt (T. rivularis), Sierra newt (T. sierra), and California newt (T. torosa). The Hydromantes genus has three native U.S. species: The limestone salamander (H. brunus), Mount Lyell salamander (H. platycephalus), and Shasta salamander (H. shastae).

At least 1 native U.S. species from the Siren genus, the lesser siren, has a tolerant vulnerability (Martel et al. (2014). The genus has one additional native species: The greater siren (S. lacertina).

Four native species have been identified as resistant by Martel et al. (2014), but we have concluded that one of these species is still capable of carrying Bsal. As we describe above in Vulnerability and Carrier Status, we conclude that the slimy salamander is resistant to sustained infection but it can serve as a short-term carrier of Bsal. The Plethodon genus has 54 other species, all of which are native to the United States (AmphibiaWeb 2015b), bringing the total number of native carrier species to 67.

Three additional native salamander species were identified as resistant to Bsal infection: The spring salamander (Gyrinophilus porphyriticus), marbled salamander (Ambystoma opacum), and spotted salamander (A. maculatum) (Martel et al. 2014). They are not expected to be carriers; therefore, we conclude that the 20 native U.S. species in their genera are not capable of carrying Bsal. This includes 4 species from the genus Gyrinophilus and 16 species from the genus Ambystoma (AmphibiaWeb 2015b).

Of the 190 native U.S. salamander species, carrier status has not been assessed in 103 species from 16 genera. The untested genera are Amphiuma, Aneides, Batrachoseps, Cryptobranchus, Desmognathus, Dicamptodon, Ensatina, Eurycea, Hemidactylium, Necturus, Phaeognathus, Pseudobranchus, Pseudotriton, Rhyacotriton, Stereochilus, and Urspelerpes (AmphibiaWeb 2015b). Although based on the gradient responses, from resisting infection to lethal response, among the genera Martel et al. (2014) tested experimentally, some of these additional species could be at risk from Bsal infection or could serve as a carrier, we are not listing species in those genera because these genera have not yet been tested.

None of the salamander species listed as endangered or threatened under the ESA in the United States has been specifically tested for Bsal vulnerability under laboratory conditions; Bsal has not been detected in their wild populations (Martel et al. 2014, Bales et al. 2015). However, several species from the same genera have been tested and on that basis identified as carriers. As we describe above in Vulnerability and Carrier Status, while the Service did find evidence that shows some species within a genus may vary in their specific vulnerability, the carrier status of tested species can be extrapolated to related species including those that are listed as endangered or threatened, are candidates for ESA listing, and under review.

Of the genera that include native species that we have identified as carriers, the following species are federally listed as threatened or endangered: Jemez Mountains salamander (P. neomexicanus), Cheat Mountain salamander (P. netting), Shenandoah salamander (P. shenandoah) and, one species, the striped newt (Notophthalmus perstriatus) is a candidate species (USFWS 2015).

Seven of the species, subspecies, or distinct population segments (DPSs) listed as federally endangered or threatened are classified within the Ambystoma genus, which we find is not a carrier of the fungus: Reticulated flatwoods salamander (A. bishopi), California tiger salamander (three DPSs), frosted flatwoods salamander (A. cingulatum), Santa Cruz long-toed salamander (A. macrodactylum croceum), and Sonora tiger salamander (Martel et al. 2014; USFWS 2015).

No information is available regarding Bsal vulnerability or carrier status of the remaining 11 ESA-listed or candidate species or subspecies native to the United States: desert slender salamander (Batrachoseps aridus), Ozark hellbender, Salado salamander (Eurycea chisholmensis), San Marcos salamander (E. nana), Georgetown salamander (E. naufragia), Texas blind salamander (E. (Typhlomolge) rathbuni), Barton springs salamander (E. sosorum), Jollyville Plateau salamander (E. tonkawae), Austin blind salamander (E. waterlooensis), Berry Cave salamander (Gyrinophilus gulolineatus), and the Alabama waterdog (Necturus alabamensis).

In addition to those species currently recognized as federally endangered, threatened, or candidates for listing under the ESA, 36 species of native salamander from 16 genera are in various stages of review for possible ESA listing in the future (USFWS 2015). Of the genera that include native species that we have identified as carriers, the following species are currently under review for ESA listing: Limestone salamander (petitioned), Shasta salamander (petitioned), the black-spotted newt (positive 90-day finding completed), Cheoah bald salamander (P. cheoah, petitioned), Fourche Mountain salamander (P. fourchensis, petitioned), Peaks of Otter salamander (P. hubrichti, positive 90-day finding completed), South Mountain gray-cheeked salamander (P. meridianus, petitioned), and the white-spotted salamander (P. punctatus, petitioned) (Martel et al. 2014; USFWS 2015).

Three species under ESA review are members of genera that are not carriers: (Streamside salamander (Ambystoma barbouri) (substantial 90-day finding completed—76 FR 59836, September 27, 2011), Tennessee cave salamander (Gyrinophilus palleucus) (substantial 90-day finding completed—76 FR 59836, September 27, 2011), West Virginia spring salamander (G. subterraneus) (substantial 90-day finding completed—76 FR 59836, September 27, 2011) (Martel et al. 2014; USFWS 2015).

No information is available regarding the carrier status for the remaining 25 native species in 11 genera that are currently under review for ESA listing (USFWS 2015).

In general, there is widespread concern over the increasing spread of pathogens moved through the wildlife trade (for example, Karesh et al. 2005). Substantial evidence shows that Bd has spread extensively throughout the world through the amphibian trade (Fisher and Garner 2007; Schloegel et al. 2009; Schloegel et al. 2012; Galindo-Bustos 2014; Kolby 2014; Kolby et al. 2014). Similar mechanisms of transmission and persistence in the closely related Bsal pathogen, along with detection of Bsal in captive salamanders imported by the pet trade into Great Britain, indicate that global movement of Bsal, similar to that of Bd, is not only possible but is already occurring (Cunningham 2015). Considering the occurrence of Bsal in the global pet trade, the risk to North American native species, and the number of salamanders that are imported into and transported throughout the United States through trade, Bsal is likely to be introduced into and spread throughout native salamander populations in the United States unless immediate action is taken to limit the import and interstate transport of salamanders that are likely to carry Bsal.

Infected salamanders can transmit Bsal to other species even if the introduced salamander fails to establish a population. Evidence indicates that at least some of the salamanders capable of carrying Bsal can escape or be released and introduce Bsal into the environment. As described earlier, evidence exists for release of salamanders into the wild in the United States (Picco and Collins 2008; USGS 2015). As noted above in Invasiveness of Salamanders, the USGS Nonindigenous Aquatic Species database has records for 14 salamander species that have been observed outside their native range. Of those, 11 are native to the United States and were discovered outside of their native ranges, and 3 are exotic species from outside the United States. These findings mean that salamanders have been shown to exist, even if temporarily, outside their native range. As such, they are capable of transmitting Bsal into nonindigenous ecosystems. Infected native species that are imported and escape or are released into native habitats would also be capable of carrying Bsal into native salamander ecosystems where Bsal has not previously been found.

Infective Bsal zoospores can also be released into the environment if water or other materials used to house infected salamanders enter the environment due to improper disinfection and disposal methods. The water and materials become fomites to introduce the fungus into the environment if not decontaminated or disposed of properly. As described above under Environmental Conditions Needed to Survive, Bsal can likely live independent of a host long enough to infect other salamanders. Bd is known to remain viable for weeks in water and moist organic matter. Given our finding that Bd can serve as a surrogate for predicting Bsal's effects in salamanders at the population level, and since Bd does not require an amphibian host to remain viable, we expect that Bsal can also persist outside salamanders (as long as it has sufficient water or soil) long enough to come into contact with uninfected salamanders and start the disease cycle anew. As stated earlier, we also find that Bsal can be transmitted on dead salamanders or body parts.

As discussed above in Introduction Pathways, there is evidence that Bd has escaped into the environment through untreated wastewater, increasing the likelihood that Bsal could also escape if brought in via contaminated water or improperly disposed of materials. While standards for the treatment and prevention of Bd exist, in part due to recognition of its status as an internationally notifiable disease under the World Organization for Animal Health (OIE), the effectiveness and widespread application of those standards are uncertain given that international protocols for responding to Bd do not exist and the need to improve international mechanisms to respond to disease-related threats to biodiversity (Voyles et al. 2014).

Given the number of specimens that have been imported into the United States and Canada, it is unclear why Bsal has not yet been found in these countries (Muletz et al. 2014; Bales et al. 2015; Richgels et al. in review; Stephen et al. 2015). A comparison of Bd, which has spread in the United States, to Bsal yields some insights. Based on genetic analyses and examination of historical specimens, Bd may have originated from different places, including Japan, South Africa, or South America (Farrer et al. 2011; Rodriguez et al. 2014). In contrast, Bsal may have originated only from Asia, giving it fewer pathways to the United States (Martel et al. 2014). Importation of salamanders into the United States has also declined in recent years, suggesting that the propagule pressure may also be a factor by limiting the number of times in which Bsal could possibly be introduced through trade (Lockwood et al. 2005; USFWS OLE 2015). Bd may have spread more quickly than Bsal because of its ability to infect frogs, whereas research suggests that Bsal does not (Martel et al. 2014). Based on LEMIS data, frogs are traded in higher volumes than salamanders, increasing the probability of trade of a Bd-infected individual over a Bsal-infected individual. The USGS Nonindigenous Aquatic Species database also provides evidence for this higher level of trade, in that greater numbers of frogs are reported than salamanders. In addition, many frogs in trade, such as Rana catesbeiana (bullfrogs), are adaptable to a wide variety of environments and can easily become invasive once released in a watershed, as bullfrogs have become in the American West (Jennings and Hayes 1994; Rosen and Schwalbe 1995; Funk et al. 2011; Sepulveda et al. 2015; USGS 2015).

Taken together with the other data we reviewed, this evidence suggests that Bsal is less likely to enter the United States than Bd. However, without action, the pathways for introduction and escape of Bsal are a significant and imminent threat that can best be managed by listing salamanders that can carry Bsal as injurious wildlife, thereby minimizing opportunities for Bsal to be introduced, establish, and spread in the United States.

There is evidence that several of the species capable of carrying Bsal can survive long enough in the wild to transmit Bsal. The USGS Nonindigenous Aquatic Species database has records of 14 species and populations that have been observed in the United States outside of their native range (USGS 2015). Of those, 11 are native and have established populations outside of their native U.S. range: Eastern tiger salamander (Ambystoma tigrinum), barred tiger salamander (Ambystoma mavortium mavortium), blotched tiger salamander (Ambystoma mavortium melanostictum), long-toed salamander (Ambystoma macrodactylum), three-toed amphiuma (Amphiuma tridactylum), black-bellied salamander (Desmognathus quadramaculatus), Santeetlah dusky salamander (Desmognathus santeetlah), mudpuppy, eastern newt, lesser siren, and rough-skinned newt. The three species from outside the United States include Japanese newt, Oriental fire belly newt, and spotless stout newt (Pachytriton labiatus).

According to Richgels et al. (in review), “Although prevalence of Bsal in live amphibian shipments, probability of release of infected materials (including live or dead animals or wastewater), and likelihood of interaction between infectious material and naïve free-ranging salamanders is unknown, given the large quantities of imported amphibians, even a small probability of infected animals or materials escaping into the wild could lead to introduction of [Bsal].” As discussed earlier under Introduction Pathways and Environmental Conditions Needed to Survive, Bsal is expected to be able to survive outside of salamander hosts for several weeks given suitable conditions in water. If a salamander comes in contact with Bsal and then transmits it during a time when salamanders congregate, such as during breeding as described above under Habitats, Reproductive Processes, and Seasonal Habits, the potential for Bsal to survive, establish, and spread through animals or animal parts is significant. As we describe above under How the Fungus Affects Salamanders, Bsal can be transmitted on dead tissue where keratin is present, particularly skin, but do not find that Bsal can be transmitted through reproductive tissue including eggs and gametes.

As Richgels et al. (in review) noted, “[T]he patterns of global Bd spread suggests that given release, exposure of native populations is likely. If Bsal follows similar patterns to the spread of Bd and no additional risk mitigation steps are taken, Bsal is likely to be introduced to the US.” The Service finds that the capacity of infected salamanders to serve as the vector for infecting wild salamanders, together with the capacity of Bsal to survive for an extended period independent of an amphibian host, suggests that Bsal has a high likelihood of surviving, establishing, and spreading once it is introduced into a new area.

If Bsal is introduced into the United States, we expect the species with lethal vulnerability would be at greatest risk. However, disease outbreaks can result from a combination of biotic and abiotic factors, including species vulnerability, exposure, behavior, immunity, co-infections, and environmental conditions (Wobeser 2007). Therefore, the vulnerability of individuals under laboratory conditions is an incomplete predictor of disease effects (Wobeser 2007). Native salamander species known to be tolerant of Bsal infection under experimental conditions may demonstrate more severe clinical disease when infection is combined with additional stressors in the wild, as has been found for other diseases, including those in amphibians (Wobeser 2007; Kerby et al. 2011; Kiesecker 2011). For example, Bodinof et al. (2011) noted that Bd may be found more frequently in hellbenders that are immune-compromised or that Bd infection increases the adverse effects of such species to other infections. Considering these cumulative factors, as well as the lack of data for the majority of native salamander species, our assessment of risk in native species is likely conservative.

Bsal can severely affect wildlife resources. At least 2 native species are lethally vulnerable to Bsal and at least 1 is tolerant to Bsal infection. At least 67 native species can act as carriers or sources of infection for other species. While not all species have been tested for their response to Bsal, based on the high rates of infection that have been observed, the fungus may have significant negative effects on additional species.

As described above in Ecosystem-Level Effects, salamanders are important parts of the ecosystems in which they occur. They are often the most abundant vertebrates in their ecosystems, and, as a vital part of the food web, they are both important prey for and predators of many species (Holomuzki et al. 1994; Regester et al. 2006). In some places, they are considered keystone species that help control some invertebrate populations and affect cycling of nutrients in an ecosystem, contributing significantly to overall ecosystem health. For example, by consuming arthropods that would otherwise release carbon dioxide into the atmosphere by decomposing leaf litter in forests, salamanders slow carbon emissions from leaf litter decomposition, which has implications for the global carbon cycle (Best and Welsh 2014). As described earlier, invertebrate species that depend on salamanders for aspects of their life cycle or ecology are likely to be adversely affected if their host species declines in response to a Bsal introduction. Loss of these keystone species would result in significant ecosystem-level change.

Salamanders constitute much of the vertebrate biomass of forests, and they play an important role in ecosystems as insect consumers, shapers of the landscape, and climate mediators (Burton and Likens 1975; Davic and Welsh 2004; Wyman 1998; Best and Welsh 2014). If native U.S. salamander species were to experience declines from Bsal infection as the fire salamander experienced in the Netherlands (Spitzen-van der Sluijs et al. 2013), we expect detrimental ecological effects.

The eastern newt, one of the lethally vulnerable species, is one of the most widespread salamander species in North America (Roe and Grayson 2008, Martel et al. 2014). As top predators in pond ecosystems, eastern newts regulate frog tadpole abundance and, therefore, affect the amount and type of nutrients available in the ponds, keeping them in ecological balance (Morin et al. 1983; Morin 1995). If eastern newt populations decline because of Bsal infection in the wild, imbalances could result in ponds and ecosystems throughout the eastern United States. Eastern newts also travel long distances between aquatic and terrestrial habitats (Roe and Grayson 2008), so if the species was to be eliminated from an area, the amount of nutrients available in upland areas would also be affected.

The other native U.S. species known to be lethally vulnerable to Bsal, the rough-skinned newt, is geographically widespread along the Pacific Coast of North America from Santa Cruz, California, to southeastern Alaska (Martel et al. 2014; Amphibiaweb 2015a). The rough-skinned newt plays an important role in ecosystems through its consumption of invertebrates that break down leaf litter and release carbon into the atmosphere (Davic and Welsh 2004). If rough-skinned newt populations were to experience severe declines from Bsal infection, a result could be significant additional inputs of carbon in the atmosphere, as has been observed with other species (Wyman 1998; Best and Welsh 2014).

As Richgels et al. (in review) noted, some parts of the United States may reach temperatures above the thermal tolerance of Bsal on a seasonal basis. However, wildlife and habitats would suffer losses if local populations of salamanders affected by Bsal prior to temperatures rising as part of the regular seasonal cycle suffered declines (and possible extirpation) and were unable to return to pre-infection levels in those ecosystems.

For these reasons, we conclude that the negative impact to wildlife resources or ecosystems is expected to be high if Bsal is introduced into U.S. ecosystems.

None of the salamander species listed as endangered or threatened under the ESA in the United States have been specifically tested for Bsal vulnerability under laboratory conditions; Bsal has not been detected in their wild populations (Martel et al. 2014, Bales et al. 2015). Of the genera that include native species that we have identified as carriers, 4 species are federally listed as threatened or endangered or are candidates for listing. In addition, 8 species of native salamanders from genera that were identified as carriers are in various stages of review for possible ESA listing in the future (USFWS 2015). Because not all species have been tested, it is possible that the fungus will negatively affect other ESA-protected species.

We do not expect direct effects to forestry, horticulture, or agriculture. Bsal does not appear to infect humans or other animals except for salamanders. Trees and other plants are also not affected. Indirectly, the introduction or establishment of Bsal would have negative effects on humans primarily from the loss of native wildlife biodiversity. These losses would affect the aesthetic, recreational, and economic values currently provided by native wildlife and healthy ecosystems. Educational values would also be diminished through the loss of biodiversity and ecosystem health. However, we are not listing the species because of the indirect impacts to forestry, horticulture, or agriculture, but rather due to their impacts to wildlife and wildlife resources.

Richgels et al. (in review) stated, “[T]here are few known viable treatment or management options for responding to the introduction of Bsal . . . hence mitigation strategies should focus on prevention or reduction of introduction events.” As discussed below in Ability to Prevent or Control the Spread of Pathogens or Parasites, current control strategies appear to focus on treating salamanders in a controlled laboratory setting. We are not aware of control measures that are effective in treating infected salamanders over a large-scale area that could eliminate Bsal without killing the salamanders themselves.

In an effort to control Bsal, it might be possible to kill all salamanders in an area and repopulate it after the fungus has been given enough time to clear from the environment. However, the life history of salamanders makes it highly unlikely that all individuals, including those that are infected, could be completely eradicated. Many species are long-lived and inhabit areas that may be hard to reach. In addition, the effects on other wildlife of chemically treating an area in order to eradicate infected salamanders is unknown but could be expected to be severe.

We considered whether it was practical for an exporting foreign nation to produce a health certificate stating that a possible carrier of Bsal has been found to be free of the fungus. Such action would help ensure that Bsal does not escape from an exporting nation by being carried on an infected salamander. However, there are significant concerns regarding the effectiveness and sensitivity of current testing methods (including the return of false negatives), lack of validation and sufficient testing capacity, and agency resources required to conduct inspections, interpret results, and issue health certificates. Although some countries may have the necessary skills to prepare a health certification that salamanders are free of Bsal, not all exporting nations may have the necessary skills or resources. Scientists and diagnostic laboratories are also working to standardize laboratory protocols (Ballard, pers. comm.).

As discussed below in Ability to Prevent or Control the Spread of Pathogens or Parasites, the ability and effectiveness of measures to prevent or control Bsal is currently low. While less certain, we also expect the ability to prevent escape and establishment is also low. Nonregulatory actions, such as implementing voluntary Best Management Practices or individual State action, are possible. The Service, for example, is working with partners on efforts such as HabitattitudeTM, which encourages responsible consumer actions with respect to pet ownership. Such actions include finding alternatives to releasing pets into the environment. Voluntary actions, such as applying heat therapy as described in Blooi et al. (2015a) and Blooi et al. (2015b), may help reduce the threat posed by Bsal. However, at this time it is not possible to determine the likelihood of success of such measures.

As described earlier under Invasiveness of Salamanders and General Description of Chytrid Fungus, salamanders have escaped into the ecosystem, and Bd, a related fungus, has also escaped and established in the United States. Therefore, we expect the likelihood of the Service's ability to prevent escape and establishment of Bsal through infected salamanders to be low. Although voluntary actions are vital to help minimize the threat of invasive species, the Service is highly concerned about the extensive damage that introduction of Bsal would do to this nation's resources. As a result, we concluded that we cannot rely on voluntary actions alone to address the severity of the threat that Bsal poses and that other measures to prevent escape and establishment are not sufficient to ensure Bsal is not successfully introduced.

Therefore, we find that we cannot rely on these approaches to prevent escape and establishment of Bsal and that our current capacity to prevent escape and establishment is low.

While some introduced salamanders in the United States have been successfully controlled, such as the lesser siren (which was eliminated from a backyard pond outside its native U.S. range), others such as the three-toed amphiuma have not (USGS 2015). However, evidence for control is sparse. Given the high rates of infection among salamanders tested by Martel et al. (2014), and the lack of control measures for Bsal that could be employed outside of a controlled facility, it is likely that Bsal would persist once introduced into the environment given appropriate environmental conditions, especially if a tolerant or susceptible salamander established a population and continued to spread Bsal.

Bsal infection can lead to the loss of keystone species in the ecosystem. The ability to rehabilitate disturbed ecosystems is expected to be low. We considered whether the Service's National Fish Hatchery System (NFHS) could be used to maintain salamanders in refugia while areas are treated, much as we maintain a population of the San Marcos salamander, which is listed as threatened, at the Uvalde National Fish Hatchery. However, it is impractical to equip NFHS facilities to be able to rapidly protect numerous salamander populations and maintain them for an extended time such as might be required due to Bsal's introduction. Although, as described in the next section, a few options exist to treat individual salamanders, none have been identified that can be used to clear Bsal from a widespread area. Consequently, we expect that once Bsal has been introduced, it will persist and spread with little opportunity for widespread disinfection from ecosystems.

Studies have also questioned the effectiveness of captive-breeding programs to address threats, such as infectious disease, to amphibians, including salamanders (Harding et al. 2015). Research on booroolong frogs (Litoria booroolongensis) demonstrated that exposing them to Bd did not improve their chances of mitigating future reinfection (Cashins et al. 2013). We expect, given similarities of Bd to Bsal, that salamanders will also show a similar response to Bsal infection. As a result, it may not be possible to stimulate an immune response in captive salamander populations that would allow them to be reintroduced into ecosystems where Bsal may still exist.

Therefore, the ability to rehabilitate disturbed ecosystems is expected to be low because the Service would be unable to ensure that it could treat and protect all salamander populations expected to be affected by Bsal in the wild.

The ability and effectiveness of measures to prevent or control Bsal is currently low. Few options can ensure potentially infected salamanders do not carry Bsal. Blooi et al. (2015a) has shown that treating salamanders infected with Bsal by exposing them “to 25 °C [77 °F] for 10 days resulted in complete clearance of infection and clinically cured all experimentally infected animals. This treatment protocol was validated in naturally infected wild fire salamanders.” The authors found that temperature treatment could be an effective option given the host salamander's thermal tolerance. However, the treatment does have some shortcomings. It is unknown whether all salamander species can tolerate the thermal regime required (Kolby, pers. comm.). Blooi et al. (2015a) also noted that there is some uncertainty as to whether the method is completely effective, as evidence of Bsal was found after thermal treatment, although it is possible that the evidence consisted of dead cells only.

Other treatment options also exist, such as treatment with antifungal medications that can be applied on animals that do not tolerate 25 °C (77 °F) (Martel, pers. comm; Blooi et al. 2015b). It may be possible to treat amphibians in the wild for Bd with antifungals by capturing individuals and soaking them in a bath of the chemical, then releasing them back into the environment. This process does not seem to be as effective as desired, but may delay the eventual outcome of an outbreak enough to help individuals persist in the population (Hardy et al. 2015). Blooi et al. (2015b) identified a method for treating infected salamanders with a combination of antifungals and temperature control that successfully cleared Bsal; however, such treatment worked only for controlled settings such as those found in a laboratory or conservation facility and is impractical to treat widespread areas in the natural environment given the likely cost, personnel, and time needed to locate and treat all salamanders in the wild. As we have noted above under Environmental Conditions Needed to Survive, Bsal is likely capable of persisting in the environment without a host by transmission to infected materials. Even if all individuals of a population could be successfully treated, the threat of reintroduction from environmental contamination would still exist.

Given the expected severity of consequences of Bsal introduction, all imported salamanders that could be carriers would need to be treated, which is not practical at this time due to the limited conditions under which this treatment is effective. Not all species will tolerate treatment, and reliable diagnostic capacity is needed to verify that animals do not carry Bsal following treatment. If an outbreak occurs, it would not be practical to locate and treat all individuals in the wild in U.S. ecosystems. While antifungal agents could be applied to all animals, either in the laboratory or perhaps applied over a large geographic area, we are concerned about side effects on the animals being treated. We are also concerned about possible negative environmental effects if a chemical was widely applied (Gyllenhammar et al. 2009; Hasselberg et al. 2008).

There are no known benefits of Bsal or of salamanders carrying Bsal. The risks to native wildlife and wildlife resources greatly outweigh any unlikely benefits. There are no other potential ecological benefits for the introduction of Bsal or of Bsal-infected or Bsal-carrier salamanders into the United States.

Overall, there is a high risk to the wildlife and wildlife resources of the United States from salamanders that are capable of carrying Bsal. The United States leads all other countries in salamander diversity. Of the 190 native U.S. species, the vulnerability of 7 has been tested. We find that the fungus can infect and is lethal to at least 2 salamander species native to the United States and that a total of 67 native species are carriers of Bsal. The vulnerability and carrier status of 103 species have not been evaluated, many of which may also be vulnerable to this potentially deadly fungus. The disease may stress species with less lethal vulnerability under wild conditions; if these species are stressed by other factors, Bsal could cause harm to additional species in the face of cumulative stressors. The benefits that these native salamander species provide to ecosystems, and in turn the ecosystem services that benefit people, are significant. The Service concludes that preventing Bsal from infecting native salamanders will prevent harmful effects to the wildlife and wildlife resources of the United States and merits listing of salamanders capable of carrying Bsal as injurious.

Salamanders capable of carrying Bsal have the potential to escape and spread Bsal. Species capable of carrying Bsal can survive long enough in the wild to transmit the fungus or can transmit it to other carriers while in transit. Bsal can also be introduced and infect native salamanders by improper disposal of material that comes in contact with infected salamanders, and persist long enough in the environment without a host to represent a threat.

There is evidence that all species within a genus, where at least one species has been identified as a carrier of Bsal, can also be a threat. Our analysis found no conclusive evidence to the contrary. We find that, due to shared characteristics by species within a genus, other species within these genera are also highly likely to be carriers of Bsal, even if not every species in the genus has been tested to verify that it is a carrier of Bsal. Hybrids consisting of species found entirely within a genus identified as a carrier are also expected to be carriers.

The main pathway for the global spread of Bsal is the international trade in salamanders. The most likely pathway of a salamander that is a host to Bsal into the United States would include a pet store or online retailer. Listing salamanders that are capable of carrying Bsal as injurious wildlife will significantly confine this pathway and limit Bsal's capacity to be introduced, establish, and spread in the United States.

The current capacity to prevent escape and establishment is low. Rehabilitation of disturbed ecosystems is expected to be very difficult. The ability and effectiveness of measures to prevent or control Bsal is currently low. There are no known benefits of Bsal.

The Service is listing live and dead specimens, including parts. We find the risk of transmission of Bsal to other salamanders is high from both live and dead specimens. Any salamanders that are infected and lethally vulnerable may die in transport and continue to carry Bsal into the United States. The risk is also high from improper disposal of materials that might be contaminated by those live or dead specimens. While we cannot list contaminated materials as injurious under the authority of the Act, by listing the carriers of Bsal, we seek to prevent the introduction of such materials.

The Service is not adding eggs or gametes because Bsal does not appear to affect reproductive tissue such as eggs or gametes. The Service is not listing genera that we find are not carriers of Bsal because such salamanders are not capable of introducing Bsal to the United States or otherwise transmitting it to native populations. We are also not listing genera where there is no data, even though it is possible that untested genera may also be capable of carrying Bsal.

For the reasons stated, the Service finds the 20 genera of salamanders to be injurious to the wildlife and wildlife resources of the United States. The potential for Bsal introduction into the United States is high, the United States has suitable conditions for Bsal survival, and the consequences of introduction into the United States are expected to be significant and occur across a wide range of the United States. By listing species that can carry Bsal, we are taking immediate action to help ensure the fungus does not enter the United States and infect native salamander populations and cause severe individual mortality, population declines, and ecosystem harm. We are not listing genera for which data is unavailable because we do not have a basis for doing so.

Executive Order 12866 provides that the Office of Information and Regulatory Affairs in the Office of Management and Budget (OMB) will review all significant rules. The Office of Information and Regulatory Affairs has determined that this rule is not significant.

Executive Order 13563 reaffirms the principles of Executive Order 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. Executive Order 13563 emphasizes further that the regulatory system must allow for public participation and an open exchange of ideas. We have developed this rule in a manner consistent with these principles.

Executive Order 12866, Economic Analysis of Federal Regulations under Executive Order 12866 (OMB 1996), and Circular A-4 (OMB 2003) identify guidelines or “best practices” for the economic analysis of Federal regulations. In the context of the specific regulation under consideration, we anticipate minor economic impacts.

The rule listing 20 genera of salamanders would prohibit an estimated 217,000 salamanders from being imported per year, and a minimum of 338 domestically bred salamanders may be affected due to the interstate transportation prohibition. The maximum annual loss to entities that deal in these species is $3.8 million in revenue. The maximum annual loss to the economy is estimated to be $10.0 million. The preferred alternative (Alternative 3, described below) does not meet the cost criteria for a significant rule. Furthermore, the preferred alternative is not expected to have a significant economic impact on a substantial number of small entities.

In the long term, the rule is expected to benefit the economy. Efforts to control or eradicate invasive species, and manage the costs they incur to society, once they have become established are generally recognized as being less effective and more expensive than efforts to prevent potentially invasive species from establishing in the first place (Leung et al. 2002, Finnoff et al. 2007). As a result, sectors of the economy that will not need to expend resources to control or manage injurious wildlife will be expected to gain from a timely listing process.

The Service considered five alternatives under Executive Order 12866 for the economic analysis for this rule: (1) No action; (2) listing species that were identified by Martel et al. (2014) and other sources to be carriers of Bsal; (3) listing all species in genera in which there is at least one confirmed carrier and all species in the genus are likely to be a carrier; (4) listing all salamanders; and (5) requiring a health certificate stating that the animal being moved is free of Bsal, in lieu of or in addition to listing. The purpose of considering alternatives is to identify whether there is a more effective option that can achieve the desired goals of the rule.

Alternative 1 was no action. This is the status quo. We would not list any species of salamanders as injurious. We did not select this option because of the significant risk that Bsal poses to native species and other wildlife resources in the United States. We expect that significantly greater financial and natural resources losses will be incurred by us and our partners in having to manage and respond to Bsal if the fungus establishes and spreads in the United States than by taking action now to prevent and minimize its introduction. No loss of retail sales or economic output due to actions by the Service would result from this alternative. It is expected that costs would be incurred by the salamander and ancillary industries due to Bsal management and the impact of Bsal on the supply of salamanders.

Alternative 2 was listing only those species that Martel et al. (2014) and Cunningham et al. (2015) (as explained further in Chytridcrisis 2015b) confirmed are carriers of Bsal. The list of species that Martel et al. (2014) and Cunningham et al. (2015) evaluated is considerably smaller and consists of 27 species. As described earlier in Vulnerability and Carrier Status, we have determined that all species in a genus will share similar characteristics that make them capable of serving as a carrier of Bsal. Between 2004 and 2014 (USFWS OLE 2015), 1.6 million salamanders of these species were imported that would have been sold for an estimated retail value of $22.8 million; the maximum annual loss to entities that deal in these species would be $2.1 million in revenue. The maximum annual loss to the economy under this alternative is estimated to be $5.6 million.

Alternative 3 was listing all species in genera where there is at least one confirmed carrier and all species in that genus are likely to be a carrier. As we described earlier, we have a sound scientific basis to conclude that all species in a genus will share similar characteristics in regards to whether they are capable of serving as a carrier of Bsal. Martel et al. (2014) did not find any examples of species in a genus where one species was likely to be a carrier and another species was not, with two exceptions as discussed above. Given the significant risk that Bsal poses, we find it is important to list all species that are likely to be carriers of the fungus. This alternative was selected for this interim rule. Between 2004 and 2014 (USFWS OLE 2015), 2.4 million salamanders of these genera were imported that would have been sold for an estimated retail value of $41.4 million; the maximum annual loss to entities that deal in these species would be $3.8 million in revenue. The maximum annual loss to the economy under this alternative is estimated to be $10.0 million.

Alternative 4 was listing all salamanders in the world. There are approximately 681 species of salamanders. Although some species that we are not listing may be negatively vulnerable to or serve as carriers of Bsal, we are taking immediate action against those species that current scientific research and analysis has confirmed are carriers of Bsal, along with other species in the genus that share the same traits that make them highly likely to be carriers of Bsal. Between 2004 and 2014 (USFWS OLE 2015), 2.5 million salamanders were imported that would have been sold for an estimated retail value of $43.9 million. The maximum annual loss to entities that deal in these species is estimated to be $4.0 million in revenue. The maximum annual loss to the economy under this alternative is estimated to be $10.7 million.

Alternative 5 would have required a health certificate that must accompany salamanders being imported and transported across State lines that states that the animal being imported or moved through interstate movement is free of Bsal in lieu of or in addition to listing. The Service did not select this option because of concerns regarding the effectiveness of current testing methods, the lack of available testing capacity, expenses associated with testing each shipment, and inadequate agency resources to conduct inspections, interpret the results, and issue health certificates. It is uncertain what the loss in revenue and economic output would be due to this alternative. The minimum effect would be identical to Alternative 1 (No Action), and the maximum effect would be that of Alternative 4 (prohibiting all salamanders). The effect on the number imported or transported depends on the cost of compliance. Therefore, of the 2.5 million salamanders that were imported between 2004 and 2014 (USFWS OLE 2015), all or none may have been imported or transported under these circumstances. They would have been sold for up to an estimated retail value of $43.9 million. The maximum annual loss to entities that deal in these species is $4.0 million in revenue. The maximum annual loss to the economy is estimated to be $10.7 million.

We considered other alternatives that we rejected because we do not have the authority under the Lacey Act to implement them ourselves. For example, we do not have the authority or capacity to establish and enforce a quarantine system. As a result, we cannot require all shipments to wait in quarantine for a period of time sufficient to prove that imported animals do not carry Bsal or to treat them prophylactically.

We also considered encouraging partners to take nonregulatory action, such as voluntary Best Management Practices or individual State action. The Service will pursue such actions as it moves forward, and we are working with partners on efforts such as HabitattitudeTM, which encourages responsible consumer actions with respect to pet ownership. Voluntary actions, such as applying heat therapy as described in Blooi et al. (2015a) and Blooi et al. (2015b), may help reduce the threat posed by Bsal. Although voluntary actions are vital to help minimize the threat of invasive species, the Service is highly concerned about the extensive damage that introduction of Bsal would do to this nation's resources and concluded that we cannot rely on voluntary actions alone in this instance to address the severity of the threat that Bsal poses.

The Secretary of the Interior certifies that this rule will not have a significant economic impact on a substantial number of small entities. A regulatory flexibility analysis under the Regulatory Flexibility Act (as amended by the Small Business Regulatory Enforcement Fairness Act [SBREFA] of 1996) (5 U.S.C. 601, et seq.), is not required. The factual basis for this certification is provided in a draft regulatory flexibility analysis in the economic analysis, prepared to accompany this rule, which we briefly summarize below. See FOR FURTHER INFORMATION CONTACT or http://www.regulations.gov under Docket No. FWS-HQ-FAC-2015-0005 for the complete document.

Although an interim rule allows us to move more quickly to implement the listing, it does not change the substantive basis for the listing decision, modify the types of organizations that would be affected by the rule, or affect the future administration of the Act as it applies to small entities to which the listing decision applies. In general, entities that are affected by an injurious listing decision would include:

(1) entities importing animals, gametes, viable eggs, and hybrids of species; and

(2) entities (including breeders and wholesalers) with interstate sales of animals, gametes, viable eggs, and hybrids. (However, this rule does not include provisions pertaining to gametes and viable eggs.)

The ultimate effects of any listing on these entities would depend on the amount of interstate sales within the taxon's market. Impacts would also depend upon whether or not close substitutes for the species listed by this rule exist. In this case, the rule:

a. Will not have an annual effect on the economy of $100 million or more.

b. Would not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions.

c. Would not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based enterprises to compete with foreign-based enterprises.

Listing 20 genera of salamanders would prohibit an estimated 217,000 salamanders imported per year; 338 domestically bred salamanders would face the interstate transportation prohibition. The maximum annual loss to entities that deal in these species is $3.8 million in revenue. Small businesses are expected to incur $2.3 million of the burden. Impacts per small business may be as high as $453,000 for importers and $23,000 for domestic breeders.

The interim rule makes no changes in the compliance requirements of any business. The Service is unaware of any duplicative, overlapping, or conflicting Federal rules. Several States implement similar acts that are more restrictive than the Federal law.

The interim rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule:

a. Would not have an annual effect on the economy of $100 million or more. The rule listing 20 genera of salamanders, including 201 species, would prohibit an estimated 217,000 salamanders imported per year, and prohibit the interstate movement of at least 338 domestically bred individuals. The maximum annual loss to entities that deal in these species is $3.8 million in revenue. Small businesses are expected to incur $2.3 million of the burden. Impacts per small business may be as high as $453,000 for importers and $23,000 for domestic breeders. In addition, businesses would also face the risk of fines if caught transporting these salamanders or their parts across State lines. The penalty for violation of the Act is not more than 6 months in prison and not more than a $5,000 fine for an individual and not more than a $10,000 fine for an organization.

b. Would not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions. Businesses breeding or selling the listed salamanders would be able to substitute other species and maintain business. Some businesses, however, may close. We do not have data for the potential substitutions, and, therefore, we do not know the number of businesses that may close.

c. Would not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based enterprises to compete with foreign-based enterprises.

In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501), the Service makes the following findings:

a. This rule would not produce a Federal mandate. In general, a Federal mandate is a provision in legislation, statute, or regulation that would impose an enforceable duty upon State, local, or tribal governments, or the private sector.

b. The rule would not have a significant or unique effect on State, local, or tribal governments or the private sector. A statement containing the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1531 et seq.) is not required.

In accordance with Executive Order 12630 (Government Actions and Interference with Constitutionally Protected Private Property Rights), the rule does not have significant takings implications. A takings implication assessment is not required. This rule would not impose significant requirements or limitations on private property use. While import and interstate transport of any of the listed species is prohibited, any person who currently owns one of the listed species can continue to possess the salamander and engage in intrastate transport and other activities within their State or territory, as allowed under State, tribal, or territorial law.

In accordance with Executive Order 13132 (Federalism), this interim rule does not have significant Federalism effects. A Federalism assessment is not required. This rule would not have any direct effects on States, on the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, we determine that this rule does not have sufficient Federalism implications to warrant the preparation of a Federalism Assessment.

In accordance with Executive Order 12988, the Office of the Solicitor has determined that the interim rule does not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of the Executive Order. The interim rule has been reviewed to eliminate drafting errors and ambiguity, was written to minimize litigation, provides a clear legal standard for affected conduct rather than a general standard, and promotes simplification and burden reduction.

This rule does not contain any new collections of information that require approval by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This rule will not impose new recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. OMB has approved the information collection requirements associated with the required permits and assigned OMB Control No. 1018-0093, which expires May 31, 2017. We may not conduct or sponsor, and you are not required to respond to, a collection of information unless it displays a currently valid OMB control number.

We have reviewed this rule in accordance with the criteria of the National Environmental Policy Act (NEPA) and our Departmental Manual in 516 DM. This rule does not constitute a major Federal action significantly affecting the quality of the human environment. Under Department of the Interior agency policy and procedures, this rule is covered by a categorical exclusion and preparation of a detailed statement under NEPA is not required because it adds species to the list of injurious wildlife under 50 CFR subchapter B, part 16, which prohibits the importation into the United States and interstate transport of wildlife found to be injurious. (For further information, see 80 FR 66554; October 29, 2015.) We have also determined that the rule does not involve any of the extraordinary circumstances listed in 43 CFR 46.215 that would require further analysis under NEPA.

We are required by Executive Orders 12866 and 12988 and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:

a. Be logically organized;

b. Use the active voice to address readers directly;

c. Use clear language rather than jargon;

d. Be divided into short sections and sentences; and

e. Use lists and tables wherever possible.

If you feel that we have not met these requirements, send us comments by one of the methods listed in ADDRESSES. To help us revise the rule, your comments should be as specific as possible. For example, you should tell us the numbers of the sections or paragraphs that are unclearly written, which sections or sentences are too long, and the sections where you feel lists or tables would be useful.

In accordance with the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951), Executive Order 13175, and the Department of the Interior's manual at 512 DM 2, we readily acknowledge our responsibility to communicate meaningfully with recognized Federal tribes on a government-to-government basis. In accordance with Secretarial Order 3206 of June 5, 1997 (American Indian Tribal Rights, Federal-Tribal Trust Responsibilities, and the Endangered Species Act), we readily acknowledge our responsibilities to work directly with tribes in developing programs for healthy ecosystems, to acknowledge that tribal lands are not subject to the same controls as Federal public lands, to remain sensitive to Indian culture, and to make information available to tribes. We have evaluated potential effects on federally recognized Indian tribes and have determined that there are no potential effects. This rule involves the importation and interstate movement of salamanders. We are unaware of such movement in these species by tribes.

Executive Order 13211 requires agencies to prepare Statements of Energy Effects when undertaking certain actions. This rule is not expected to affect energy supplies, distribution, and use. Therefore, this action is a not a significant energy action and no Statement of Energy Effects is required.

A complete list of all references used in this rulemaking is available at http://www.regulations.gov under Docket No. FWS-HQ-FAC-2015-0005.

The primary authors of this interim rule are the staff members of the U.S. Fish and Wildlife Service.

For the reasons discussed in the preamble, the U.S. Fish and Wildlife Service amends part 16, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as follows:

This final rule implements Amendment 44 to the FMP and regulatory amendments to the CR Program. NMFS published a notice of availability (NOA) for Amendment 44 on October 9, 2015 (80 FR 61150). The comment period on the NOA for Amendment 44 ended on December 8, 2015. The Secretary approved Amendment 44 on January 4, 2016, after accounting for information from the public, and determining that Amendment 44 is consistent with the FMP, the Magnuson-Stevens Fishery Conservation and Management Act, and other applicable law. NMFS published a proposed rule to implement Amendment 44 and the regulatory amendments on October 22, 2015 (80 FR 63950). The comment period on the proposed rule ended on November 23, 2015. NMFS received no comments on proposed Amendment 44 or the proposed rule.

Below is a brief description of the CR Program and the elements of the CR Program that apply to Amendment 44 and this final rule. Section 3.1 of the RIR/IRFA (see ADDRESSES) and the preamble of the proposed rule (80 FR 63950; October 22, 2015) provide a more detailed description of the CR Program and this action.

The CR Program is a catch share program for nine BSAI crab fisheries that allocates those resources among harvesters, processors, and coastal communities. Under the CR Program, NMFS issued quota share (QS) to eligible harvesters based on their historical participation during a set of qualifying years in one or more of the nine CR Program fisheries. Quota share is an exclusive, revocable privilege allowing the holder to harvest a specific percentage of the annual total allowable catch (TAC) in a CR Program fishery.

A QS holder's annual allocation, called individual fishing quota (IFQ), is expressed in pounds and is based on the amount of QS held in relation to the total QS pool for that fishery. NMFS issues IFQ in three classes: Class A IFQ, Class B IFQ, and Class C IFQ. Three percent of IFQ is issued as Class C IFQ for captains and crew. Of the remaining IFQ, 90 percent is issued as Class A IFQ and 10 percent is issued as Class B IFQ.

NMFS issued processor quota share (PQS) to qualified individuals and entities based on processing activities in CR Program fisheries during a period of qualifying years. PQS is an exclusive, revocable privilege to receive deliveries of a fixed percentage of the annual TAC from a CR Program fishery. A PQS holder's annual allocation is known as individual processing quota (IPQ). NMFS issues IPQ at a one-to-one correlation with the amount of Class A IFQ issued for each CR Program fishery. Class A IFQ must be delivered to a processor holding a matching amount of IPQ; Class C IFQ and Class B IFQ may be delivered to any registered crab receiver.

The CR Program includes several provisions intended to protect nine specific communities that had historically been active in the processing of king and Tanner crab from adverse impacts that could result from the CR Program. These communities are referred to as “eligible crab communities” for purposes of the CR Program's community protection measures.

With the exception of one eligible crab community (Adak, Alaska) the CR Program provides the other eight eligible crab communities, or ECCs, with a ROFR on certain PQS and IPQ transfers. A ROFR provides an ECC with the right to intervene in the sale (i.e., transfer) of PQS, IPQ, and “other goods” (i.e., assets) associated with that community under specific conditions. The regulations at § 680.41(l) require an ECC to identify an entity to represent it for purposes of ROFR. These provisions are described in the final rule implementing the CR Program (March 2, 2005, 70 FR 10174). Section 3.1.3 of the RIR/IRFA describes the specific amounts of PQS that were, and are, subject to ROFR.

Under the ROFR, an ECC entity is provided an opportunity to meet the same terms and conditions being offered to a proposed buyer of a proposed sale of PQS or IPQ. If an ECC entity can meet the terms and conditions of a proposed sale, then the ECC entity receives by transfer the PQS, IPQ, and any other goods instead of the proposed buyer.

The ROFR is intended to strike a balance between the interest of communities historically reliant on crab processing to retain that processing capacity within their communities, and the interest of PQS or IPQ holders to be able to engage in open market transfers of PQS, IPQ, and other goods. Section 3.1.3 of the RIR/IRFA provides a more detailed summary of the ROFR.

The ROFR is administered under the CR Program through contractual arrangements between ECC entities and PQS/IPQ holders. Persons who hold PQS/IPQ that are subject to a ROFR must enter into a contract with the ECC entity eligible to exercise a ROFR for those PQS/IPQ shares. The terms required in a ROFR contract between an ECC entity and a PQS/IPQ holder were established with implementation of the CR Program and are set forth in the FMP. ROFR applies to any proposed sale of PQS and any sale of IPQ if more than 20 percent of the PQS holders' community based IPQ in the fishery was processed outside of the community by another company (intra-company transfers within a region are excluded) in three of the preceding five years. Intra-company transfers within a region and transfers of PQS for continued use in the community are exempt from (i.e., do not trigger) the ROFR. The ROFR contract terms require that in order to complete a transfer under a ROFR, an ECC entity must meet “the same terms and conditions of the underlying [proposed sale] agreement and will include all processing shares and other goods included in that agreement.”

The ROFR contract terms also state that all terms of any ROFR and contract entered into related to ROFR will be enforced through civil law. Additional details on the rationale for the civil enforcement of the terms in a ROFR contract are provided in the EIS, RIR, and Social Impact Assessment prepared for the CR Program (see ADDRESSES), and the final rule implementing the CR Program (March 2, 2005, 70 FR 10174).

An ECC entity must meet two important requirements to complete a ROFR and receive PQS, IPQ, or other goods associated with a proposed sale. The ECC entity must do the following: (1) Exercise its ROFR, that is, provide a clear commitment to complete a purchase agreement within a specific time frame; and (2) perform under the ROFR, that is, meet all of the terms and conditions of the underlying agreement for the proposed sale within a specific time frame.

To exercise the ROFR, an ECC entity must provide the seller of PQS or IPQ subject to a ROFR with notice of its intent to exercise the ROFR and earnest money in the amount of 10 percent of the contract amount or $500,000, whichever is less, within 60 days of notice of a sale and receipt of the contract defining the sale's terms. To perform the ROFR, the ECC entity must meet the terms and conditions of the proposed sale (i.e., complete the sale) within 120 days from receipt of the sales contract, or within the time specified in the proposed sales contract, whichever is longer. If an ECC entity does not exercise its ROFR, or it cannot perform under the ROFR contract, then the open market sale may proceed.

Amendment 44 to the FMP revises several of the existing ROFR contract terms and adds two additional contract terms. These ROFR contract terms are described in detail in the NOA for Amendment 44 (80 FR 61150; October 9, 2015). As noted earlier, the terms in a ROFR contract are enforced through civil contract law rather than through regulations implemented by NMFS. Amendment 44 to the FMP and this final rule do not change the civil enforcement of the terms in a ROFR contract. This final rule only revises regulations to implement Amendment 44 and to amend the CR Program. Therefore, the regulations implemented by this final rule are subject to enforcement by NMFS.

The following briefly summarizes the provisions of Amendment 44 that do not require implementing regulations. Amendment 44 increases the time allowed for an ECC entity to exercise a ROFR from 60 days to 90 days from receipt of the sales contract. This modification also increases the time allowed for an ECC entity to perform under the ROFR from 120 days to 150 days. The time period to exercise and the time period to perform under a ROFR begin on the date of receipt of the sales contract by the ECC entity and run concurrently.

Amendment 44 removes the ROFR contract term that allows a ROFR to lapse if the IPQ derived from the PQS subject to ROFR was processed outside the community of origin for a period of three consecutive years. Under this amendment, a ROFR remains in effect for PQS subject to a ROFR regardless of the location in which the IPQ associated with that PQS was processed. Amendment 44 does not reinstate a ROFR that lapsed prior to the date that Amendment 44 was approved, January 4, 2016.

Amendment 44 removes the ROFR contract term stating that a ROFR will lapse if an ECC entity fails to exercise its ROFR after it is triggered by a transfer of PQS and replaces it with a ROFR contract term that requires the recipient of a PQS transfer to enter into a new ROFR contract with an ECC entity of its choosing in the designated region of the PQS.

Prior to Amendment 44, ROFR contract terms required that the ROFR apply to all terms and conditions of the underlying sale agreement, including all processing shares and other goods included in the agreement. Amendment 44 revised this ROFR contract term to specify that, “Any ROFR contract must be on the same terms and conditions of the underlying agreement and will include all processing shares and other goods included in that agreement, or to any subset of those assets, as otherwise agreed to by the PQS holder and the community entity.”

Amendment 44 establishes two new ROFR contract terms. First, Amendment 44 adds a ROFR contract term that requires a PQS holder to notify the ECC entity of any proposed transfer of IPQ or PQS subject to ROFR, regardless of whether the PQS holder believes the proposed transfer triggers the right. Second, Amendment 44 adds a ROFR contract term that requires a PQS holder to annually notify the ECC entity of the location at which IPQ derived from PQS subject to a ROFR was processed and whether that IPQ was processed by the PQS holder.

With the approval of Amendment 44, all ROFR contracts must contain the newly revised ROFR contract terms. PQS/IPQ holders and ECC entities must establish a new or revised ROFR contract to contain all of these terms.

This final rule contains three actions. The first action implements those aspects of Amendment 44 that require implementing regulations. The second action implements the regulatory amendment adopted by the Council. The third action implements minor administrative changes to the CR Program regulations to improve the application and reporting practices for participants in the CR Program. The following paragraphs briefly described these actions. Additional detail is provided in the preamble to the proposed rule (80 FR 63950; October 22, 2015) and is not repeated here.

This final rule modifies regulations governing transfers of PQS subject to ROFR. This final rule modifies regulations at § 680.41(i)(8) to require the seller of PQS to certify that the ECC entity did not exercise its ROFR within the time provided and to require the buyer of PQS to certify that the buyer has entered into a ROFR contract with an ECC entity in the designated region of the PQS. These changes to § 680.41(i)(8) do not alter the current requirement that NMFS wait 10 days before approving a transfer of PQS subject to ROFR when such transfer triggers the ROFR.

This final rule modifies two regulations to implement the regulatory amendment. First, this final rule modifies regulations at § 680.4(f)(2) to require an applicant for IPQ, as part of the Application for Annual Crab IPQ Permit, to certify to NMFS that a ROFR contract that includes the required ROFR contract terms specified in the FMP exists between the applicant and the ECC entity that holds the ROFR for that PQS/IPQ. Because Amendment 44 modifies the FMP and the terms required to be included in a ROFR contract, a PQS/IPQ holder and an ECC entity must establish a new or revised ROFR contract to contain all of these terms and the PQS/IPQ holder must certify annually that a ROFR contract is in place. If an applicant for IPQ is unable to establish a revised ROFR contract with an ECC entity and provide that confirmation to NMFS in the Application for Annual Crab IPQ Permit prior to the date that application is due, then NMFS will consider the application to be incomplete. NMFS will withhold issuance of IPQ until this requirement is met.

Second, this final rule modifies regulations at § 680.41(i)(8) and (9) to require specific certifications by the seller or the buyer when transferring PQS subject to ROFR. If a transfer of PQS triggers a ROFR, regulations at § 680.41(i)(8) require the seller to certify, as part of the application to transfer PQS, that the PQS holder notified the ECC entity holding the ROFR for that PQS of the proposed transfer at least 90 days prior to the date of the transfer application, and that the ECC entity did not exercise its ROFR during that period. If a transfer of PQS does not trigger a ROFR, regulations at § 680.41(i)(9) have been modified to require the buyer and the ECC entity to certify, as part of the application to transfer PQS, either that the ECC entity wishes to permanently waive ROFR for the PQS or that the buyer and the ECC entity completed a ROFR contract that includes the ROFR contract terms specified in the FMP. NMFS will not complete a transfer of PQS until these requirements are met. Section 3.2.5 of the RIR/IRFA provides additional detail on these notice requirements.

This final rule makes two minor administrative changes to CR Program regulations. First, this final rule revises regulations at § 680.4(d) to separate the application for IFQ/IPQ into two separate applications, an application for IFQ and an application for IPQ. This revision allows applicants for IFQ to use an application form specific to IFQ and allows applicants for IPQ to use an application form specific to IPQ. Except for the proposed modification to the annual IPQ application described above in the section Action 2: Regulatory Revisions Needed to Implement the Regulatory Amendment, this revision does not modify the specific information currently required of IFQ or IPQ applicants.

Second, this final rule revises reporting requirements for crab harvesting cooperatives at § 680.21(b)(1). Currently, regulations at § 680.4(f) require each member of a crab harvesting cooperative to submit to NMFS an Application for Annual Crab IFQ Permit, and regulations at § 680.21(b) require a crab harvesting cooperative to submit to NMFS a copy of each member's Application for Annual Crab IFQ Permit along with the cooperative's Application for Annual Crab Harvesting Cooperative IFQ Permit. This final rule revises the regulations at § 680.21(b)(1) so that a crab harvesting cooperative will be responsible only for submitting a list of the names of each cooperative member with the cooperative's annual IFQ application. This final rule does not modify the requirements at § 680.4(f). Therefore, each cooperative member continues to be responsible for submitting to NMFS a complete annual IFQ permit application by the deadline of June 15.

NMFS received no public comments on proposed Amendment 44 or this proposed rule.

NMFS did not make any changes from the proposed rule.

The Administrator, Alaska Region, determined that Amendment 44 and this final rule are necessary for the conservation and management of the BSAI CR Program fisheries and that they are consistent with the Magnuson-Stevens Fishery Conservation and Management Act and other applicable laws.

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

Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 states that, for each rule or group of related rules for which an agency is required to prepare a final regulatory flexibility analysis, the agency shall publish one or more guides to assist small entities in complying with the rule, and shall designate such publications as “small entity compliance guides.” The agency shall explain the actions a small entity is required to take to comply with a rule or group of rules. The preamble to the proposed rule (80 FR 63950; October 22, 2015) and the preamble to this final rule serve as the small entity compliance guide. This rule does not require any additional compliance from small entities that is not described in the preamble to the proposed rule and this final rule. Copies of the proposed rule and this final rule are available from NMFS at the following Web site: http://alaskafisheries.noaa.gov.

Section 604 of the Regulatory Flexibility Act requires an agency to prepare a FRFA after being required by that section or any other law to publish a general notice of proposed rulemaking and when an agency promulgates a final rule under section 553 of Title 5 of the U.S. Code. The following paragraphs constitute the FRFA for this action.

Section 604 describes the required contents of a FRFA: (1) A statement of the need for, and objectives of, the rule; (2) a statement of the significant issues raised by the public comments in response to the initial regulatory flexibility analysis, a statement of the assessment of the agency of such issues, and a statement of any changes made in the proposed rule as a result of such comments; (3) the response of the agency to any comments filed by the Chief Counsel for Advocacy of the Small Business Administration in response to the proposed rule, and a detailed statement of any change made to the proposed rule in the final rule as a result of the comments; (4) a description of and an estimate of the number of small entities to which the rule will apply or an explanation of why no such estimate is available; (5) a description of the projected reporting, recordkeeping and other compliance requirements of the rule, including an estimate of the classes of small entities which will be subject to the requirement and the type of professional skills necessary for preparation of the report or record; and (6) a description of the steps the agency has taken to minimize the significant economic impact on small entities consistent with the stated objectives of applicable statutes, including a statement of the factual, policy, and legal reasons for selecting the alternative adopted in the final rule and why each one of the other significant alternatives to the rule considered by the agency which affect the impact on small entities was rejected.

A description of the need for, and objectives of, the rule is contained in the preamble to the proposed rule and this final rule and is not repeated here. This FRFA incorporates the Initial Regulatory Flexibility Analysis (IRFA) and the summary of the IRFA in the proposed rule (80 FR 63950; October 22, 2015).

NMFS published a proposed rule to implement Amendment 44 on October 22, 2015 (80 FR 63950). An IRFA was prepared and summarized in the Classification section of the preamble to the proposed rule. NMFS received no comments on proposed Amendment 44, this proposed rule, the IRFA, or the economic impacts of this action generally. The Chief Counsel for Advocacy of the Small Business Administration did not file any comments on the proposed rule.

This final rule includes three separate actions described in the section The Final Rule. Action 1 makes regulatory revisions needed to implement Amendment 44; Action 2 makes regulatory revisions needed to implement the regulatory amendment; and Action 3 makes other administrative changes.

The small entities directly regulated by Action 1 and Action 2 are persons that hold PQS or IPQ under the CR Program. Currently, 21 entities hold PQS or IPQ subject (now or previously) to ROFR. Estimates of the number of large entities were made, based on available records of revenue, employment information, and known affiliations among these entities. Of these 21 entities, 10 are estimated to be large entities and 11 are deemed to be small entities. It is possible that additional entities could be directly regulated under the proposed rule if an entity that does not already hold PQS receives PQS by transfer. The new PQS holder will be directly regulated because the entity will be required to certify to NMFS that it has entered into a ROFR contract. It is not possible to estimate whether these new PQS holders will be small entities for purposes of this proposed rule.

Action 3 makes minor administrative changes to clarify permit application procedures for IFQ holders and IPQ holders, and reduce reporting requirements for crab cooperatives that are directly regulated under the CR Program. Currently, there are 10 crab harvesting cooperative entities. Based on available records of revenue, and known affiliations among these entities, 4 of the entities are estimated to be large entities and 6 are deemed to be small entities. Because these changes reduce the reporting burden for all crab harvesting cooperatives, Action 3 will not have an adverse impact on directly regulated small entities.

The recordkeeping and reporting requirements increase slightly under this final rule. This final rule includes new reporting requirements for PQS/IPQ holders. The PQS/IPQ holders are required to certify to NMFS that a current ROFR contract is in place when applying for IPQ and notify NMFS of the status of the ROFR when transferring PQS or IPQ. These additional reporting requirements are relatively straightforward and simple, and NMFS will include these certification requirements in the Application for Annual Crab IPQ Permit and the Application for Transfer of Crab PQS that are already required for directly regulated entities to receive IPQ or to transfer PQS or IPQ. To fulfill the certification requirements when completing the applications, PQS/IPQ holders will have to respond by checking “Yes” or “No” to a maximum of two questions about the status of the ROFR in addition to providing NMFS with the name of the community entity that holds the ROFR. Therefore, the additional recordkeeping and reporting requirements associated with this final rule are minimal.

A FRFA must describe the steps the agency has taken to minimize the significant economic impact on small entities consistent with the stated objectives of applicable statues, including a statement of the factual, policy, and legal reasons for selecting the alternative adopted in the final rule and why each one of the other significant alternatives to the rule considered by the agency that affect the impact on small entities was rejected. “Significant alternatives” are those that achieve the stated objectives for the action, consistent with prevailing law, with potentially lesser adverse economic impacts on small entities as a whole.

The Council and NMFS considered a range of alternatives and options to the preferred alternative that is implemented by this final rule. These alternatives and options are described in Section 2.2 of the RIR/IRFA and are not repeated here. The Council and NMFS did not identify alternatives to the preferred alternative that would minimize the impact on small entities better than the preferred alternative and still meet the objectives for this final rule—to improve available information concerning transfer and use of PQS and IPQ subject to a ROFR and to improve the administration of the CR Program.

The preferred alternative implemented by this final rule makes modifications to existing regulations necessary that are necessary to meet the objectives of this final rule. The preferred alternative is not anticipated to have adverse impacts on small entities. The regulatory modifications made under this final rule are straightforward and simple, and require PQS holders to provide information at the time of application for an annual IPQ permit or application for approval of transfer of PQS. While the new notification requirements add administrative reporting requirements for 11 PQS holders that are small entities, the administrative burden associated with the notification requirements is minimal and does not negatively impact these entities.

The Council and NMFS considered and analyzed additional alternatives that would have required regulatory changes. The Council and NMFS did not select these alternatives because they required specific ROFR contract provisions that could have resulted in adverse economic impacts accruing to directly regulated small entities. One of these alternatives applied the ROFR only to PQS, or to PQS and specific assets, within an ECC. The Council and NMFS did not select this alternative because it would impose additional costs on directly regulated small entities, would be difficult to administer, and would not provide ECCs and PQS holders with the flexibility to define the assets subject to a ROFR. The Council and NMFS also considered an alternative that would have required a PQS holder to obtain written approval from the ECC entity prior to processing IPQ subject to a ROFR (or formerly subject to a ROFR), at a facility outside the subject community. The Council and NMFS did not select this alternative because it would have imposed additional costs on directly regulated small entities. Section 3.2 of the Analysis provides additional information on these alternatives that were considered but not selected.

This final rule contains collection-of-information requirements subject to the Paperwork Reduction Act (PRA) and which have been approved by OMB under control number 0648-0514. Public reporting burden is estimated to average per response: 1.5 hours for the Annual Application for Crab IFQ Permit; 1.5 hours for the Annual Application for Crab IPQ Permit; 1 hour for the Application for an Annual Crab Harvesting Cooperative IFQ permit; and 2 hours for Application to Transfer Crab QS or PQS. These estimates include the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding these burden estimates or any other aspect of this data collection, including suggestions for reducing the burden, to NMFS (see ADDRESSES), and by email to [email protected] or fax to 202-395-5806.

Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to penalty for failure to comply with, a collection of information subject to the requirement of the PRA, unless that collection of information displays a currently valid OMB control number. All currently approved NOAA collections of information may be viewed at http://www.cio.noaa.gov/services_programs/prasubs.html.

For the reasons set out in the preamble, NMFS amends 50 CFR part 680 as follows: