Procedural Background

The NRC is using the direct final rule procedure because it considers this action noncontroversial and routine. The amendments make a routine adjustment to the access authorization fees and are of a minor and administrative nature. Adequate protection of public health and safety continues to be ensured. The direct final rule will become effective on June 22, 2012. However, if the NRC receives significant adverse comments on the direct final rule by June 4, 2012, then the NRC will publish a document that withdraws the direct final rule. If the direct final rule is withdrawn, the NRC will address the comments received in response to the proposed revisions in a subsequent final rule. Absent significant modifications to the proposed revisions requiring republication, the NRC will not initiate a second comment period on this action in the event the direct final rule is withdrawn.

A significant adverse comment is a comment where the commenter explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. A comment is adverse and significant if:

(1) The comment opposes the rule and provides a reason sufficient to require a substantive response in a notice-and-comment process. For example, a substantive response is required when:

(a) The comment causes the NRC staff to reevaluate (or reconsider) its position or conduct additional analysis;

(b) The comment raises an issue serious enough to warrant a substantive response to clarify or complete the record; or

(c) The comment raises a relevant issue that was not previously addressed or considered by the NRC staff.

(2) The comment proposes a change or an addition to the rule, and it is apparent that the rule would be ineffective or unacceptable without incorporation of the change or addition.

(3) The comment causes the NRC staff to make a change (other than editorial) to the rule.

Certain individuals employed by NRC licensees or their contractors are assigned duties which require access to special nuclear material (plutonium, uranium-233, and uranium enriched in the isotopes uranium-233 or uranium-235) or to restricted data or national security information. Individuals who require access to this material or information must obtain an access authorization from the NRC. When a licensee requests access authorization for an employee or a contractor, the NRC initiates a background investigation of the individual seeking access authorization. Based on the results of that investigation, the NRC determines whether permitting that individual to have access to special nuclear material, restricted data, or national security information would create a security risk.

The OPM conducts the required access authorization background investigations for the NRC and sets the rates charged for these investigations. The combined cost of the OPM background investigation and any related NRC processing activities (NRC processing fee) are recovered from the licensee through an access authorization fee assessed by the NRC. It is the NRC's practice to publish the fee schedule for special nuclear material access authorization in Title 10 of the Code of Federal Regulations (10 CFR) 11.15(e) and the corresponding fee schedule for restricted data and national security information access authorization in Appendix A to 10 CFR Part 25. Both schedules are based on rates charged by OPM for conducting the required background investigations (OPM investigation billing rates).

This direct final rule amends § 11.15(e), § 25.17(f), and Appendix A to 10 CFR Part 25 by modifying the NRC processing fee charged to licensees for work performed under the MAAP and the IAAP from 31.7 percent of the OPM investigation billing rates to 55.8 percent. This direct final rule will continue to allow licensees to calculate the NRC access authorization fee for any given application by referencing to the current OPM investigation billing rates schedule for background investigation services. Reimbursable billing rates for personnel background investigations are published by OPM's Federal Investigative Services in a Federal Investigations Notice (FIN). The current OPM investigation billing rates were published in FIN 11-05 on August 29, 2011, and became effective on October 1, 2011. The FIN 11-05 is available on the OPM's Federal Investigative Services Web site at http://www.opm.gov/investigate/fins/2011.aspx . The NRC's licensees can also obtain the current OPM investigation billing rates schedule by contacting the NRC's Personnel Security Branch (PSB), Division of Facilities and Security (DFS), Office of Administration (ADM) by email to Licensee_Access_Authorization_Fee@nrc.gov.

The fee-calculation formula is designed to recover the NRC's actual in-house processing fee for each application received from the licensee. The NRC's access authorization fee for any given request is determined using the following formula: the OPM investigation billing rates on the day of NRC receipt of the application + the NRC processing fee = the NRC material access authorization fee. The NRC processing fee is determined by multiplying the OPM investigation billing rate on the day of NRC receipt of the application by 55.8 percent (i.e., OPM rate × 55.8 percent). The percentage used to determine the NRC processing fee is increasing from 31.7 percent to 55.8 percent based on a 2010 NRC audit of actual in-house costs incurred in processing licensee applications for access authorization. Specifically, the amended cost is due to an increase in the review time for each application for access authorization. It is also important to note that collection of fees to recover the NRC's costs is required by statute (42 U.S.C. 2214(b)). Specifically, the amendments are necessary to implement the Omnibus Budget Reconciliation Act of 1990, as amended, which requires the NRC to recover through fees the full cost incurred in providing a service or thing of value.

As noted previously, the OPM investigation billing rates are pulled directly from the current OPM fee schedule for investigations. The tables in new § 11.15(e)(3) and Appendix A to 10 CFR Part 25 cross-references each type of NRC access authorization request to the appropriate investigation service listed in the OPM's investigation billing rates schedule. For example, a licensee seeking a special nuclear material “NRC-U” access authorization requiring a single scope background investigation is directed by the table in new § 11.15(e)(3) to calculate the NRC processing fee based on the OPM investigation billing rates for a “Code C” Single Scope Background Investigation (SSBI). According to the current OPM investigation billing rates schedule (FIN 11-05), the OPM charges $4,005 for a “Code C” SSBI. The table instructs the licensee to calculate the NRC's application processing fee by multiplying $4,005 by 55.8 percent, which equals $2,234.79. The licensee then rounds the NRC's processing fee to the nearest dollar, or $2,235, and adds that amount to the OPM investigation billing rate of $4,005 to determine the total NRC access authorization fee: $6,240.

The following table illustrates the calculation process:

Licensees applying for restricted data or national security information access authorization follow a similar procedure. The table in Appendix A to 10 CFR Part 25 cross-references each type of ``Q'' or ``L'' access authorization to the corresponding OPM investigation type. The OPM investigation billing rate for the type of investigation referenced is determined by consulting the current OPM investigation billing rates schedule. This rate is then plugged into the formula used to calculate the correct NRC access authorization fee for the type of application submitted. Copies of the current NRC access authorization fee can be obtained by contacting the NRC's Personnel Security Branch, Division of Facilities Security, Office of Administration by email to: Licensee_Access_Authorization_Fee@nrc.gov. Any change in the NRC's access authorization fees will be applicable to each access authorization request received on or after the effective date of the OPM's most recently published investigation billing rates schedule.

To more clearly explain the access authorization process, the NRC is amending the rule language as follows: § 11.15(e)(1), and (2) are revised; § 11.15(e)(3) is redesignated as § 11.15(e)(4); and a new § 11.15(e) introductory text and (e)(3) are added. Additional changes were made for grammatical or clarification purposes. The authority citation was changed to reflect the current statutory framework for agency fee recovery.

Section 11.15(e) introductory text is added to further explain how the OPM bills the NRC for the cost of each background investigation conducted in support of an application for special nuclear material access authorization.

Section 11.15(e)(1) is revised to clearly define the formula used in calculating the NRC material access authorization fee (the OPM investigation billing rates on the day of NRC receipt of the application + the NRC processing fee = the NRC access authorization fee). The NRC processing fee is determined by multiplying the OPM investigation billing rate on the day of NRC receipt of the application by 55.8 percent (i.e., OPM rate × 55.8 percent). Significantly, as noted above, the percentage of the OPM investigation billing rates in the processing fee is being changed from 31.7 percent of the OPM investigation billing rate to 55.8 percent of that rate to reflect NRC's increased costs in processing licensee applications for access authorization.

Section 11.15(e)(2) is revised to further explain how to access the OPM billing rates schedule. Also, the telephone contact is changed to an email contact.

The current § 11.15(e)(3) is redesignated as § 11.15(e)(4). A new § 11.15(e)(3) is added to clearly explain that the NRC's MAAP is considered reimbursable work representing services provided to an organization for which the NRC is entitled to payment. The NRC is authorized to receive and retain fees from licensees for services performed. The NRC's Office of the Chief Financial Officer (OCFO) periodically reviews the fees charged for MAAP and makes recommendations on revising those charges to reflect costs incurred by the NRC in providing those services. The reviews are performed using cost analysis techniques to determine the direct and indirect costs. The new § 11.15(e)(3) also provides information on where to obtain current copies of the NRC access authorization fee via an email contact and includes a table of the NRC's MAAP fee schedules. The NRC fee schedule for NRC-R (expedited processing) is removed given that this type of access authorization is no longer being performed by OPM. Other minor changes to the table are made to reflect the types of access authorization currently being performed by OPM.

To more clearly explain the access authorization process, the NRC is amending the rule language as follows: § 25.17(f)(1), and (2) are revised; § 25.17(f)(3) is redesignated as § 25.17(f)(4); and a new § 25.17(f) introductory text and (f)(3) are added. Additional changes were made for grammatical or clarification purposes. The authority citation was changed to reflect the current statutory framework for agency fee recovery.

Section 25.17(f) introductory text is added to further explain how OPM bills the NRC for the cost of each background investigation conducted in support of an application for access authorization.

Section 25.17(f)(1) is revised to clearly define the formula used in calculating the NRC access authorization fee (the OPM investigation billing rates on the day of NRC receipt of the application + the NRC processing fee = the NRC access authorization fee). The NRC processing fee is determined by multiplying the OPM investigation billing rate on the day of NRC receipt of the application by 55.8 percent (i.e., OPM rate × 55.8 percent). Significantly, as noted above, the percentage of the OPM investigation billing rates in the processing fee is being changed from 31.7 percent of the OPM investigation billing rate to 55.8 percent of that rate to reflect the NRC's increased costs in processing licensee applications for access authorization.

Section 25.17(f)(2) is revised to further explain how to access the OPM billing rates schedule. Also, the telephone contact is changed to an email contact.

The current § 25.17(f)(3) is redesignated as § 25.17(f)(4). A new § 25.17(f)(3) is added to clearly explain that the NRC's IAAP is considered reimbursable work representing services provided to an organization for which the NRC is entitled to payment. The NRC is authorized to receive and retain fees from licensees for services performed. The NRC's OCFO periodically reviews the fees charged for IAAP and makes recommendations on revising those charges to reflect costs incurred by the NRC in providing those services. The reviews are performed using cost analysis techniques to determine the direct and indirect costs. The new § 25.17(f)(3) also provides information on where to obtain current copies of the NRC access authorization fee via an email contact.

The revised table in Appendix A to 10 CFR Part 25 cross-references each type of NRC “Q” or “L” access authorization request to a type of investigation in the current OPM investigation billing rates schedule, and directs licensees to calculate the application fee according to the stated formula: the OPM investigation billing rates on the day of NRC receipt of the application + the NRC processing fee = the NRC access authorization fee. The NRC processing fee is determined by multiplying the OPM investigation billing rate on the day of NRC receipt of the application by 55.8 percent (i.e., OPM rate × 55.8 percent). The NRC fee schedule for Initial “L” access authorization (expedited processing) is removed given that this type of access authorization is no longer being performed by OPM. Other minor changes to the table are made to reflect the types of access authorization currently being performed by OPM and for grammatical or clarification purposes.

The National Technology Transfer and Advancement Act of 1995, Public Law 104-113, requires Federal agencies to use technical standards developed or adopted by voluntary consensus standards bodies unless the use of such a standard is inconsistent with applicable law or is otherwise impractical. This direct final rule amends the formula for calculating the NRC's access authorization fee charged to licensees for work performed under MAAP and IAAP from 31.7 percent of the OPM investigation billing rate for an investigation of a given type to 55.8 percent.

This action is administrative in nature and does not involve the establishment or application of a technical standard containing generally applicable requirements.

The NRC has determined that this direct final rule is the type of action described in categorical exclusions § 51.22(c)(1) and (2). Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this direct final rule.

This direct final rule does not contain new or amended information collection requirements subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). Existing requirements were approved by the Office of Management and Budget (OMB), Approval Numbers 3150-0046 and 3150-0062.

The NRC may not conduct or sponsor, and a person is not required to respond to, a request for information or an information collection requirement unless the requesting document displays a currently valid OMB control number.

A regulatory analysis has not been prepared for this direct final rule. This direct final rule ensures that the NRC recovers the full cost of application processing from licensees submitting access authorization requests, as is required by statute (42 U.S.C. 2214(b)). The formula method for calculating these fees continues to provide an efficient and effective mechanism for updating the NRC access authorization fees in response to changes in the underlying OPM investigation billing rates schedule for required personnel background investigations. These amendments are administrative in nature and will neither impose new safety requirements nor relax existing ones and therefore do not call for the sort of safety/cost analysis described in the NRC's regulatory analysis guidelines in NUREG/BR-0058, Revision 4, “Regulatory Analysis Guidelines of the USNRC,” September 2004 (ADAMS Accession No. ML042820192).

Under the Regulatory Flexibility Act (5 U.S.C. 605(b)), the Commission certifies that this direct final rule amending 10 CFR Parts 11 and 25 does not have a significant economic impact on a substantial number of small entities. This direct final rule applies to those licensees who use, process, store, transport, or deliver to a carrier for transport, formula quantities of special nuclear material (as defined in 10 CFR Part 73) or generate, receive, safeguard, and store National Security Information or Restricted Data (as defined in 10 CFR Part 95). Two licensees, both fuel cycle facilities, are currently required to comply with 10 CFR Part 11. Seventy-eight licensees and other organizations, mostly power reactors and fuel cycle facilities, are currently required to comply with 10 CFR Part 25. None of these licensees are “small entities” as defined in the Regulatory Flexibility Act or the size standards established by the NRC (10 CFR 2.810). This direct final rule also applies to contractors of those licensees required to comply with this direct final rule who use, process, store, transport, or deliver to a carrier for transport, formula quantities of special nuclear material (as defined in 10 CFR Part 73) or generate, receive, safeguard, and store National Security Information or Restricted Data (as defined in 10 CFR Part 95). Some of these contractors may be “small entities” as defined in the Regulatory Flexibility Act or the NRC's size standards. However, some of these contractors are reimbursed through the contract for the cost of securing access authorization. There are not a substantial number of unreimbursed “small entity” contractors who apply for access authorization, nor is the NRC aware of any significant impact on these unreimbursed “small entity” contractors.

The NRC has determined that the backfit rule does not apply to this direct final rule and that a backfit analysis is not required. Collection of fees to recover the NRC's costs is required by statute (42 U.S.C. 2214(b)). Therefore, changes to rules designating the amount to be collected are not subject to the backfitting provisions or issue finality provisions in 10 CFR Chapter I.

In accordance with the Congressional Review Act, the NRC has determined that this action is not a major rule and has verified this determination with the Office of Information and Regulatory Affairs of OMB.

For the reasons set forth in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 552 and 553, the NRC is adopting the following amendments to 10 CFR Parts 11 and 25.

The Bureau of Consumer Financial Protection (Bureau) published an interim final rule republishing and making technical and conforming amendments to regulations of the Department of Housing and Urban Development (HUD) in connection with the transfer of rulemaking authority for ILSA from HUD to the Bureau. The interim final rule contained a typographical error, which this document corrects. The heading of Part 1012—Special Rules of Practice is incorrectly labeled as “Regulation J” and should be labeled “Regulation L.”

Accordingly, 12 CFR Part 1012 is amended by making the following correcting amendments:

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on February 6, 2012 (77 FR 5726). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (77 FR 5726, February 6, 2012) or on the determination of the cost to the public.

We reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed, except for minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM (77 FR 5726, February 6, 2012) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (77 FR 5726, February 6, 2012).

We estimate that this AD will affect about 15 products of U.S. registry. We also estimate that it will take about 2 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $6,541 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these parts. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $100,665, or $6,711 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.

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

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM 77 FR 5726, February 6, 2012), the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

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

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM published in the Federal Register on January 19, 2012 (77 FR 2659). That NPRM proposed to require an inspection of the torque lug and surrounding components (wheel base, side rim, lock ring) for damage (such as corrosion, cracks, dents, bent areas, damaged or missing paint or primer, or wear on the metal), and of the bearing cup for corrosion, turned cup, or clearance that exceeds limits, and repair as applicable; measuring the torque lugs for width and replacing screws and inserts with new, improved screws and inserts; and re-identifying the wheel assemblies.

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (77 FR 2659, January 19, 2012) 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 the AD as proposed, except for minor editorial changes. In addition, we have re-identified Note 2 of the NPRM (77 FR 2659, January 19, 2012) as paragraph (h) of this final rule. We also revised the language in paragraph (j) of this AD; this change does not affect the intent of this AD. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM (77 FR 2659, January 19, 2012) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (77 FR 2659, January 19, 2012).

We estimate that this AD affects 473 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

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

According to the manufacturer, all 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 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on December 29, 2011 (76 FR 81889). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

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

Saab AB (the commenter) requested that we revise the NPRM (76 FR 81889, December 29, 2011) to include a statement as follows: “In addition, a quality issue during the replacement of the base material in the end parts of the accumulator may have affected the service life of the accumulator.”

We infer that the commenter requested that we add the statement to the Discussion section of the NPRM (76 FR 81889, December 29, 2011). We agree that Saab Service Bulletin 2000-29-024, Revision 01, dated November 5, 2010, states, “In addition, a qualification issue during the change of the base material, for the end parts of the accumulator back in 1993, can have affected the life limit of the accumulator.” However, we have not included the statement in the final rule because we do not restate the Discussion section in the final rule. We have not changed the AD in this regard.

We have revised the heading and wording in paragraph (i) of this AD; this change has not changed the intent of that paragraph.

We reviewed the available data, including the comment received, and determined that air safety and the public interest require adopting the AD with the changes described previously—except for minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM (76 FR 81889, December 29, 2011) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (76 FR 81889, December 29, 2011).

We estimate that this AD will affect 8 products 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. The average labor rate is $85 per work-hour. Required parts will cost about $9,995 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these parts. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $88,120, or $11,015 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.

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

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM (76 FR 81889, December 29, 2011), the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

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

History

After a recent review of aeronautical data, the Aeronautical Navigation Products Group identified the VOR Federal airway V-14 description published in FAA Order 7400.9, Airspace Designations and Reporting Points, did not match the airway information contained in the FAA's aeronautical database or the charted depiction of the airway. When V-14 was amended in the Federal Register of May 7, 1990 (55 FR 18862), the St. Louis, MO, VOR/DME was deleted from the description in error. The FAA aeronautical database retained the navigation aid in the route description correctly and the associated aeronautical charts were published accordingly. To overcome any confusion or flight safety issues associated with conflicting route description information being published, the FAA is amending the V-14 legal description to reflect the airway aligned over the St. Louis, MO, VOR/DME. Accordingly, since this is an administrative correction to update the V-14 description to be in concert with the FAA's aeronautical database and charting, notice and public procedures under Title 5 U.S.C. 553(b) are unnecessary.

The FAA amends Title 14 Code of Federal Regulations (14 CFR) part 71 by amending the legal description of VOR Federal airway V-14 in the vicinity of St. Louis, MO. Specifically, the FAA amends V-14 to reflect the airway aligned over the St. Louis, MO, VOR/DME; thus, matching the information currently contained in the FAA's aeronautical database and the charted depiction of the airway.

VOR Federal airways are listed in paragraph 6010 of FAA Order 7400.9V dated August 9, 2011, and effective September 15, 2011, which is incorporated by reference in 14 CFR 71.1. The VOR Federal airway listed in this document will be revised subsequently in the Order.

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. Therefore, this regulation: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the 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. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends an existing VOR Federal airway within the NAS.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with 311a, FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures.” This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

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

FDA's Center for Veterinary Medicine is adopting the use of a monthly Federal Register document to codify approval actions for NADAs and ANADAs. CVM will no longer publish a separate rule for each action. This approach will allow a more efficient use of available resources.

In this document, FDA is amending the animal drug regulations to reflect the original and supplemental approval actions during February 2012, as listed in table 1 of this document. FDA is also informing the public of the availability of summaries of the basis of approval (FOI Summaries) under the Freedom of Information Act (FOIA) and of environmental review documents required under the National Environmental Policy Act (NEPA), where applicable.

The basis of approval of actions requiring review of safety or effectiveness data is discussed in an FOI Summary that may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 522 and 558 are amended as follows:

This rule revises the sterility requirements for most biological products under title 21 of the Code of Federal Regulations (CFR), subchapter F, parts 600 through 680 (21 CFR parts 600 through 680)  1 and is intended to promote improvement and innovation in the development of sterility test methods by allowing manufacturers the flexibility needed for sterility testing of some novel products that may be introduced to the market, enhancing sterility testing of currently approved products, and encouraging manufacturers to utilize scientific and technological advances in sterility test methods as they become available.

In the Federal Register of June 21, 2011 (76 FR 36019), FDA published a proposed rule that proposed revisions to update requirements for sterility testing of biological products. As described in the preamble of the proposed rule (76 FR 36019 at 36019 to 36020), any product that purports to be sterile should be free of viable contaminating microorganisms to assure product safety (§ 600.3(q) (21 CFR 600.3(q)). Absolute sterility of a lot cannot be practically demonstrated without complete destruction of every finished article in that lot (USP, Chapter 1211). Therefore, sterility assurance is accomplished primarily by validation of the sterilization process or of aseptic processing under current good manufacturing practice (CGMP), and is supported by sterility testing using validated and verified test methods (see e.g., USP Chapter 71, European Pharmacopeia 2.6.1.).

In the Federal Register of November 20, 1973 (38 FR 32048), we reorganized and republished the biologics regulations, which included regulations governing sterility testing, as parts 600 through 680.

Over the years, FDA has amended the biologics regulations, as necessary, to clarify and update the sterility test requirements. On March 11, 1976 (41 FR 10427) and March 2, 1979 (44 FR 11754), we updated § 610.12 (21 CFR 610.12) to clarify the procedures for repeat testing. On December 15, 1986 (51 FR 44903), we clarified and updated certain requirements for sterility testing to ensure the reliability of the growth-promoting qualities of the sterility test culture media and to provide greater consistency with the test methods of USP XXI. Finally, on September 15, 1997 (62 FR 48174), we incorporated by reference into § 610.12(f) the 1995 edition of the USP concerning the procedures for the membrane filtration test method.

Prior to this final rule, § 610.12 required that the sterility of most licensed biological products  2 be demonstrated through the performance of tests prescribed in § 610.12(a) and (b). Specifically, § 610.12 provided that the sterility of each lot of each product, with the exception of certain products, 3 be demonstrated by the performance of prescribed sterility tests for both bulk and final container material, unless different sterility tests were prescribed in the license (see § 610.12(g)(1)) or the manufacturer submitted adequate data  4 establishing that the mode of administration, the method of preparation, or the special nature of the product precluded or did not require a sterility test, or that the sterility of the lot was not necessary to assure the safety, purity, and potency of the product (§ 610.12(g)(4)(ii)).

The regulation also specified the test method and culture media to be used. For example, the prescribed sterility test methods relied upon culture media (either Fluid Thioglycollate Medium or Soybean-Casein Digest Medium) to detect growth of microorganisms (§ 610.12(a)(1) and (a)(2)). Moreover, § 610.12 specified criteria, such as incubation conditions (time and temperature) to be used during testing, suitable test organisms for the evaluation of the growth-promoting qualities of the culture media, storage and maintenance of test organism cultures, and storage and condition of media.

Since we last clarified and updated our regulations governing sterility testing, advances in technology in recent years have allowed the development of new sterility test methods that yield accurate and reliable test results in less time and with less operator intervention than the currently prescribed methods. Some examples of novel methods include the Adenosine Triphosphate bioluminescence, chemiluminescence, and carbon dioxide head space measurement. Manufacturers may benefit from using such sterility test methods with rapid and advanced detection capabilities.

Accordingly, we have amended § 610.12 to promote improvement and innovation in the development of sterility test methods, to address the challenges of novel products that may be introduced to the market in the future, and to potentially enhance sterility testing of currently approved products. This final rule provides manufacturers the flexibility to take advantage of methods as they become available, provided that these methods meet certain criteria.

FDA is adopting as final, without material change, the proposed requirements for sterility testing. Specifically, this final rule:

• Eliminates specified sterility test methods, culture media formulae (or formulation), and culture media test requirements;

• Eliminates specified membrane filtration procedure requirements for certain products;

• Eliminates specified sterility test requirements for most bulk material;

• Modifies the repeat sterility test requirements, so that repeat tests will occur only once for each lot. These repeat tests are limited to situations when the quality control unit conclusively determines, after conducting an investigation upon detection of viable microbial contamination during the initial test of the lot, that the contamination is the result of laboratory error or faulty materials used in conducting the sterility test;

• Replaces the storage and maintenance requirements for cultures of test organisms used to determine the “growth-promoting qualities” of culture media with: (1) Validation requirements specifying that any sterility test used is able to consistently detect the presence of viable contaminating microorganisms and (2) verification of “growth-promoting properties” or microorganism-detection capabilities of test and test components;

• Replaces the sample size or amount requirement with a requirement that the sample be appropriate to the material being tested;

• Replaces the Interpretation of test results section under § 610.12(c) with a requirement that manufacturers establish, implement, and follow written procedures for sterility testing that describe, at a minimum, the test method used, the method of sampling, and the written specifications for acceptance or rejection of each lot;

• Simplifies and clarifies the Exceptions section under § 610.12(h); and

• Identifies the Director of CDER as one of the two Center directors authorized to grant an exemption under the exception provision at § 610.12(h)(2). In the proposed rule, the Center for Devices and Radiological Health was erroneously identified in this exception, instead of the Center for Drug Evaluation and Research.

• Revises the definition of the term “sterility” under § 600.3(q); and

• Eliminates certain exceptions for allergenic products related to sterility testing under § 680.3(c).

We received 17 letters of comments on the proposed rule. These comments were received from biologics manufacturers, industry associations, and other interested persons. A summary of the comments received and our responses follow. We first respond to general comments and then respond to comments on the specific topics set forth in the preamble of the proposed rule.

To make it easier to identify the comments and our responses, the word “Comment,” in parentheses, will appear before the comment's description, and the word “Response,” in parentheses, will appear before our response. We have also numbered each comment to help distinguish between different comments. The number assigned to each comment is purely for organizational purposes and does not signify the comment's value or importance or the order in which it was received. Certain comments were grouped together because the subject matter of the comments was similar.

(Comment 1) Thirteen of the letters of comments supported the proposed rule. Many of the comments agreed that the proposed amendments would provide manufacturers of biological products greater flexibility and would promote improvement and innovation in the development of sterility test methods. Several comments agreed that the proposed amendments would allow manufacturers to use the most appropriate and state-of-the-art test methods for assuring the safety of biological products. Several comments applauded FDA's effort to amend sterility test requirements to permit the use of new methods and systems in assessing microbiological contamination in sterile products. Another comment was pleased to see FDA's commitment to advancing the principles of innovation in product development for public health.

(Response) FDA acknowledges and appreciates the supportive comments. As stated previously, the rule provides needed flexibility and encourages manufacturers to benefit from scientific and technological advances in sterility test methods as they become available.

(Comment 2) One comment noted an error in the reference to the European Pharmacopeia 2.6.2. provided in the first paragraph in section I of the preamble to the proposed rule. The comment pointed out that European Pharmacopeia 2.6.2. is the chapter for Mycobacteria testing.

(Response) We agree with this comment. The reference should have been to European Pharmacopeia 2.6.1. Sterility testing.

(Comment 3) One comment concurred with the preamble statement that “* * * sterility assurance is accomplished primarily by validation of the sterilization process or by the aseptic processing procedures under CGMP, and is supported by sterility testing using validated and verified test methods,” (76 FR 36019 at 36019). However, the commenter went on to state that “* * * the regulations would be better suited by ensuring that the aseptic manufacturing processes follow strict GMP, further leveraging the requirements for aseptic environments, media fill programs, and strict oversight of the aseptic process as opposed to the perceived assurance that sterility testing of samples provides. This is best illustrated through existing verbiage in § 211.113(b) (21 CFR 211.113(b)) but should be further expanded upon to provide improved guidance to industry and investigators.”

(Response) We acknowledge that product sterility testing does not provide absolute assurance of product sterility. However, we believe validation of aseptic processes, 5 using process simulations or media fills, together with operational controls and product sterility testing, provide a sufficient level of assurance that products purported to be sterile are in fact sterile. Therefore, we do not agree that additional requirements are necessary because the existing CGMP requirements under parts 210 and 211 (21 CFR parts 210 and 211) and the other applicable regulations in parts 600 through 680 already address the concerns raised by the commenter. We believe this final rule, together with the other applicable regulations and Agency guidance, provide manufacturers appropriate latitude to determine how to achieve the level of control necessary for compliance.

(Comment 4) One comment expressed a concern that an environmental requirement is not part of the proposed rule. The commenter stated, “Environmental conditions are important to avoid cross-contamination” and proposed the addition of the following wording described in European Pharmacopeia 2.6.1. “The test for sterility is carried out under aseptic conditions. In order to achieve such conditions, the test environment has to be adapted to the way in which the sterility test is performed. The precautions taken to avoid contamination are such that they do not affect any microorganisms which are to be revealed in the test. The working conditions in which the tests are performed are monitored regularly by appropriate sampling of the working area and by carrying out appropriate controls.”

(Response) In discussing “environmental conditions,” we understand the comment to mean environmental controls. We have considered the issue, including the points raised in this comment and have decided not to adopt the suggested language or revise the rule in light of the suggested language because the concerns expressed by the commenter are currently addressed in the CGMP requirements in parts 210 and 211 and the applicable regulations in parts 600 through 680. In addition, manufacturers may turn to relevant Agency guidance documents for additional guidance. Furthermore, as the commenter states, the proposed wording regarding environmental controls under which the sterility test is to be performed is already described in European Pharmacopeia 2.6.1., and USP Chapter 71, both of which are additional, valuable resources for manufacturers.

(Comment 5) One comment noted that while § 610.12 addresses aspects of sterility, the current theme of the section is specific to sterility testing. The commenter therefore suggested either renaming the title of § 610.12 as “Sterility Test,” or broadening § 610.12 so that the regulation addresses all critical elements in the content area of sterility.

(Response) We decline to adopt either recommended change because we believe that the current title of § 610.12 remains appropriate and that the suggested title change is unnecessary. In response to the comment expressing a desire to broaden § 610.12 to address all critical elements in the content area of sterility, FDA notes that this comment is outside the scope of this final rule.

The following are comments and FDA's responses, as identified by the specific topic in the proposed rule to which the comment and FDA's response applies.

For the reasons discussed in the preamble to the proposed rule (76 FR 36019 at 36020 to 36021), we proposed amending § 610.12 to eliminate the sterility test requirement for most bulk materials. We have determined that, in most cases, for purposes of sterility testing, the most appropriate test material is the final container material. We recognize that due to the nature of some biological products, testing the final container material may not always be feasible or appropriate. Thus, as finalized, § 610.12 requires that prior to release, manufacturers of biological products must perform sterility testing of each lot of each biological product's final container material or other material (e.g., bulk material or active pharmaceutical ingredient (API), in-process material, stock concentrate material), as appropriate, and as approved in the biologics license application (BLA) or BLA supplement. For example, as discussed in the preamble to the proposed rule (76 FR 36019 at 36021), certain allergenic and cell and gene therapy products may need to be tested for sterility at an in-process stage or some other stage of the manufacturing process (e.g., intermediate, API, bulk drug substance) instead of the final container material because the final container material may interfere with the sterility test. Likewise, as discussed in the preamble to the proposed rule, some cell therapy products and cell-based gene therapy products may need to be tested for sterility at an in-process stage or some other stage of manufacturing process because low production volumes may result in an insufficient final container material sample for sterility testing or a short product shelf-life may necessitate administration of the final product to a patient before sterility test results on the final container material are available.

(Comment 6) Three comments were particularly supportive of FDA's proposal to eliminate the sterility test requirements for bulk material. One comment noted this change will be particularly helpful for cellular therapy products.

(Response) We appreciate the supportive comments. We agree that the elimination of specified sterility test requirements for most bulk materials will provide manufacturers with greater flexibility and in most cases, for purposes of sterility testing, the most appropriate test material is the final container (76 FR 36019 at 36021). We also acknowledge that due to the nature of some biological products, this change could result in the need for some manufacturers to modify their testing procedures to eliminate testing for bulk materials. However, we note that these modifications to eliminate testing for bulk materials would be made following existing change control procedures and a submission to FDA to report the change would not be required.

If it is determined that sterility testing needs to be performed on material other than the final product, due to the nature of the final product, we would expect the manufacturer, as required under §§ 601.2 and 601.12, to include in its BLA or BLA supplement: (1) A description of the details of the sterility test method used, including the procedure for testing the alternate material instead of the final container material; and (2) the scientific rationale for selecting the specific test material instead of the final container material.

As discussed in the preamble to the proposed rule (76 FR 36019 at 36021), a manufacturer who desires to utilize an alternate sterility test method other than the one approved in its BLA must submit a BLA supplement in accordance with § 601.12(b).

(Comment 7) One comment asserted that upon finalization of the rule, a manufacturer who desires to utilize an alternative sterility test other than the one approved in its BLA should be permitted to submit the change to FDA in its annual report in accordance with § 601.12(d), as opposed to a prior approval supplement to an approved application under § 601.12(b).

(Response) We consider changes that may affect the sterility assurance level of a product to have substantial potential to affect the safety, purity, or potency of a product and have consistently identified this change as one that requires prior approval. Therefore, a manufacturer who desires to utilize an alternate sterility test method other than the one approved in its BLA must submit a prior approval supplement to an approved application in accordance with § 601.12(b). We note that approval of the supplement will be based on the determination that the data submitted with the request establishes a regulatory basis for approval.

a. Test methods —We proposed amending § 610.12 to eliminate references to specific test methods and culture media for sterility testing and to instead require that the sterility test be appropriate to the material being tested such that the material does not interfere with or otherwise hinder the test. As discussed in the preamble to the proposed rule (76 FR 36019 at 36021), we believe this revision recognizes current practices and provides manufacturers the flexibility to take advantage of suitable modern sterility test methods and keep pace with advances in science and technology.

As also discussed in the preamble to the proposed rule (76 FR 36019 at 36021), because we are expanding potentially acceptable sterility test methods to include non-culture-based methods in addition to culture-based methods, we also have removed the definition of “a lot of culture medium.” Previously, § 610.12(e)(2)(i) defined this term as “* * * that quantity of uniform material identified as having been thoroughly mixed in a single vessel, dispensed into a group of vessels of the same composition and design, sterilized in a single autoclave run, and identified in a manner to distinguish one lot from another.” Although we have deleted this term from § 610.12, we believe (as stated in the preamble to the proposed rule) that this concept is captured by the definition of “lot” in § 600.3(x). We note that this change is also consistent with our understanding that prepared culture media may be purchased, in which case a lot may be predetermined by the vendor.

(Comment 8) Two comments opposed the elimination of the specified sterility test methods and culture media because eliminating the specific requirements may lead to different interpretations by industry, as well as FDA investigators. One comment stated that the current text on acceptable culture media, reference organisms, and incubation temperatures for sterility testing represents essential guidance for industry. The comments suggested that either the current regulations be retained in addition to the proposed amendments or retained as guidance.

(Response) We reiterate that the purpose of this rule is to provide manufacturers of biological products greater flexibility and to encourage use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. Accordingly, at this time, we decline to retain the current specified sterility test methods, culture media, reference organisms, and incubation temperatures in regulation or guidance. Furthermore, we disagree that this rule may lead to inconsistent interpretations by industry and FDA staff because sterility test methods for biological products are approved in the manufacturer's BLA or BLA supplement, and hence, the data submitted with the request are reviewed in a consistent manner in accordance with review management procedures. Therefore, we believe the commenters' concerns about inconsistencies in interpretation are unfounded.

(Comment 9) One commenter expressed concern about the applicability of the proposed changes in the global regulatory market in that the use of approved alternative sterility methods would not be globally applicable in the absence of compendial harmonization. The commenter inquired whether FDA has plans to harmonize the use of alternative sterility methods with the three main global compendia.

(Response) We do not agree that the final rule and the use of a suitable modern sterility test method will interfere with the global regulatory market. The purpose of the rule is to provide for greater flexibility and to encourage use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. We believe this final rule will foster the adoption of novel methods and that alignment with global pharmacopeial methods will occur over time. With respect to FDA's future plans to harmonize the use of alternative sterility methods with the three main global compendia, we note that any such discussion is outside the scope of this rule.

(Comment 10) One comment proposed adding a reference in the regulations to a compendial method and allowing for the implementation of alternative methods. The commenter expressed concern that, in the global marketplace, implementation of a novel method different from USP Chapter 71 would not be harmonized with other compendia and might pose risks to approval of marketing authorizations if new tests are not recognized or accepted by foreign health authorities.

(Response) We do not agree with the comment and note that incorporating such a reference would be inconsistent with the intent of this rule. We reiterate that we do not agree that this final rule will interfere with the global marketplace. Rather, we believe that facilitating flexibility and encouraging the use of the most appropriate and state-of-the-art test methods will foster the adoption of novel method technologies and that alignment with pharmacopeia methods will occur over time. Furthermore, as we have explained in the preamble to the proposed rule, FDA considers established USP compendial sterility test methods to already have been validated using an established validation protocol; therefore their accuracy, specificity, and reproducibility need not be reestablished to fulfill the validation requirements under the final rule. Only a manufacturer who desires to utilize an alternative method other than the one approved in its BLA must submit a BLA supplement in accordance with § 601.12(b). This rule does not require manufacturers to utilize an alternative method other than the one approved in their BLA.

(Comment 11) One comment stated that the absence of references to standards such as USP Chapter 71 within § 610.12 may lead to confusion and suggested that a general disclaimer that FDA is not endorsing any particular standard or the provision of specific examples within the regulation may provide an important point of reference for compliance. Two comments stated that USP Chapter 71 and European Pharmacopeia 2.6.1. should be listed within § 610.12 as a baseline or standard for sterility testing. Two other comments recommended referring to the USP Chapter 71 as the “referee” method instead of referring to it as an example.

(Response) The concerns expressed in the comments are unfounded. We reiterate that we consider the current sterility test methods in a manufacturer's BLA or BLA supplement to already have been validated. In contrast, newer methods (for example, non-culture-based methods that have not been validated according to an established protocol) or those that deviate from the official compendial sterility test methods will require validation.

Moreover, the final rule requires that a novel method be validated in accordance with an established protocol to demonstrate that the test is capable of consistently detecting the presence of viable microorganisms. We believe methods validation is a well recognized activity and can be performed without comparison to a “referee” test method.

Furthermore, we note that there is no single “referee” test method that would work for all products and that some novel methods cannot be easily compared to culture-based methods such as USP Chapter 71 because these testing methods do not measure microbial growth. Therefore, we believe that it is neither necessary nor appropriate to add a reference to a standard or “baseline” in this final rule.

(Comment 12) We received two comments regarding growth-promotion testing. One comment asserted that the proposal to eliminate the requirements to test culture media with specific test organisms, to eliminate the number of organisms that must be used to demonstrate growth-promoting qualities of culture media, and to eliminate specific incubation conditions and visual examination requirements may lead to different interpretations on which organisms can and should be used. The comment proposed that a reference to a “referee” method be added to the regulation including requirements for growth promotion and the strains and number of organisms to be used. The other comment supported the elimination of the list of specified organisms, while also stating that providing a list of organisms for manufacturers to consider would be a benefit to facilities that do not have the necessary expertise or staffing.

(Response) Because we are providing manufacturers the flexibility to use sterility test methods that are either culture-based or non-culture-based, which may necessitate different verification activities, we decline to retain the existing requirements for specified sterility test reference organisms. For similar reasons, we do not believe a reference to a “referee” method is necessary or appropriate and we decline to adopt the recommended change.

Instead of specifying the number and type of test organisms, under § 610.12(b) of the final rule, we require that: (1) The sterility test must be appropriate to the material being tested such that the material does not interfere with or otherwise hinder the test; (2) the sterility test must be validated to demonstrate that the test is capable of reliably and consistently detecting the presence of viable contaminating microorganisms; and (3) the sterility test and test components must be verified to demonstrate that the test method can consistently detect the presence of viable contaminating microorganisms.

Due to the variety of currently available and potential future sterility test methods, we have eliminated specified incubation conditions (time and temperature) and visual examination requirements previously prescribed in § 610.12. Since we are allowing any validated sterility test method that is appropriate to the material being tested, rather than specifying the test and the media used, we have also eliminated the Fluid Thioglycollate Medium incubation temperatures previously prescribed in § 610.12(a)(1)(ii) for the final container material containing a mercurial preservative.

(Comment 13) One comment recommended that, with respect to validation, a definition for the terms “reliably” and “consistently” be added to the regulation for greater utility in understanding expectations when validating a method. The commenter offered, for example, “* * * that a validated method, though performing consistently and reliably, may still not be centered on the true value of the specific parameter being tested. Consequently, when this method would be used during testing the results may be in a statistical state of control, but not necessarily statistically capable of measuring the true value.” The commenter asked FDA to consider “* * * that the use of the terms `reliably and consistently' may infer that the validation of a test for non-sterility does not require proof of performance at least equivalent to the USP referee method.” The comment therefore asked that § 610.12(b)(2) be revised to require that the sterility test be validated to demonstrate an equivalent or superior detection of viable contaminating microorganisms compared to the USP compendial or like method.

(Response) FDA has considered the issues raised by these comments and has determined that making the suggested changes would be inconsistent with the intent of this rule. With respect to the comment that the rule should be revised to require that the sterility test be validated to demonstrate an equivalent or superior detection of viable contaminating microorganisms compared to the USP compendial or like method, we reiterate that some novel methods cannot be easily compared to culture-based methods such as USP Chapter 71 because they do not measure microbial growth. Moreover, we note that the final rule requires that a novel method be validated in accordance with an established protocol to demonstrate that the test is capable of consistently detecting the presence of viable microorganisms. With respect to the comment that the terms “reliably” and “consistently” should be defined, we note that these terms are already well understood in the industry.

b. Validation— As discussed in the preamble to the proposed rule (76 FR 36019 at 36021 to 36022), the International Conference on Harmonisation (ICH) publication entitled “Validation of Analytical Procedures: Text and Methodology Q2(R1)” dated November 2005, states that “The objective of validation of an analytical procedure is to demonstrate that it is suitable for its intended purpose.”  6 Similarly, USP General Chapter 1223, “Validation of Alternative Microbiological Methods,” states “Validation of a microbiological method is the process by which it is experimentally established that the performance characteristics of the method meet the requirements for the intended application.” For sterility testing, this means that the test can consistently detect the presence of viable contaminating microorganisms.

We have eliminated the prescribed sterility test methods found in § 610.12 and instead will allow the use of sterility test methods that are validated in accordance with established protocols to be capable of consistently detecting the presence of viable contaminating microorganisms. If an established USP compendial sterility test method is used, a manufacturer must verify that this established method is suitable for application to the specific product (see §§ 211.165(e) and 211.194(a)); however, FDA considers established USP compendial sterility test methods to already have been validated using an established validation protocol, so their accuracy, specificity, and reproducibility need not be reestablished to fulfill the validation requirement under the final rule. In contrast, novel methods and any methods that deviate from the USP compendial sterility test methods require the detailed validation discussed in this document and elsewhere in this preamble.

We again note that § 610.12 requires the use of a material sample that does not interfere with or otherwise hinder the sterility test from detecting viable contaminating microorganisms. This requirement is crucial because the material itself or substances added to the material during formulation may make some sterility tests inappropriate for use. A validated sterility test method is a critical element in assuring the safety, purity, and potency of the product. USP General Chapter 1223, as well as the ICH guideline referenced earlier entitled “Text on Validation of Analytical Procedures,” dated March 1995 (ICH-Q2A), provide general descriptions of typical validation parameters, how they are determined, and which subset of each parameter is required to demonstrate validity, based on the method's intended use. Validation of each test method should be performed on a case-by-case basis to ensure that the parameters are appropriate for the method's intended use. In the context of reviewing sterility test methods as part of BLAs and BLA supplements, FDA may decide, as appropriate, to encourage the use of the compendial method as a benchmark or starting point for validation of novel methods and certain other methods.

(Comment 14) One comment requested clarification regarding validation of novel methods and any methods that deviate from the USP. This commenter stated that to validate novel test methods, “the sponsor not only has to test the matrix effects”, but also has to validate the new method against the USP compendial method. The commenter also stated that this would impede the use of innovative technologies and increase the risk and cost to the sponsor. In addition, the commenter recommended that duplicative testing requirements be avoided and that the manufacturer of the technology or a third party be allowed to perform the validation of new methods.

(Response) The commenter misinterpreted the validation requirements under the proposed (and final) rule. The revisions we are adopting in the final rule do not require duplicative validation of novel methods against the USP compendial method or testing under a separate validation procedure. Instead, novel methods and any methods that deviate from the USP compendial sterility test methods will require a single, detailed validation study to be conducted, which may include the use of the compendial method as a benchmark or starting point. We disagree that such validation will impede the use of innovative technologies and will increase the risk and cost to the sponsor. Instead, we believe that, as discussed elsewhere in this document and in the preamble to the proposed rule, that this final rule will encourage the use of innovative technology.

(Comment 15) One comment referenced the preamble statement that “* * * FDA may decide, as appropriate, to encourage the use of the compendial method as a benchmark or starting point for validation of novel methods and certain other methods.” (76 FR 36019 at 36022) and suggested that the use of the compendial method as a benchmark or starting point should be more strongly encouraged.

(Response) While FDA may decide, as appropriate, to encourage the use of the compendial method as a benchmark or starting point for validation of some novel or other methods, we also may decide not to encourage such use for some (for example, non-culture-based) methods that cannot easily be compared to culture-based methods such as the USP compendial method. Therefore, we disagree that the use of the compendial method as a benchmark or starting point should be more strongly encouraged or required.

(Comment 16) We received two comments in response to our request in the proposed rule for comments on whether the proposed requirements are sufficient to ensure adequate validation of novel sterility test methods or whether additional criteria or guidance is needed. One comment recommended that any guidance to accompany the final rule be developed to include such things as a list of organisms for manufacturers to consider in the development of their validation and verification plans, including examples of when verification is required. One comment suggested that such additional guidance include information related to a determination of the panel of relevant organisms in the sample matrix used in challenging the sterility test during validation.

(Response) We appreciate the interest in additional guidance for validation of novel sterility test methods and will consider the need to develop future guidance in accordance with the good guidance practices set out in 21 CFR 10.115.

As discussed in the preamble to the proposed rule, it is important to consider validation principles, such as limit of detection, specificity, ruggedness, and robustness, while developing the validation protocol and performing validation studies. These terms are defined as follows:

• The “limit of detection” reflects the lowest number of microorganisms that can be detected by the method in a sample matrix. This is necessary to define what is considered contaminated.

• “Specificity” is the ability of the test method to detect a range of organisms necessary for the method to be suitable for its intended use. This is demonstrated by challenging the sterility test with a panel of relevant organisms in the sample matrix.

• “Ruggedness” is the degree of reproducibility of results obtained by analysis of the same sample under a variety of normal test conditions, such as different analysts, different instruments, and different reagent lots.

• “Robustness” is the capacity of the test method to remain unaffected by small, but deliberate, variations in method parameters, such as changes in reagent concentration or incubation temperatures.

(Comment 17) One comment stated that for the detailed validation of a novel method, the validation principles should be restricted to the limit of detection, specificity, and robustness (i.e., to not include ruggedness).

(Response) We agree that the validation principles of limit of detection, specificity, and robustness are important to consider when developing protocols and performing validation studies. However, we understand the comment to suggest excluding ruggedness. We view ruggedness as an important validation principle to be considered, and we do not agree with excluding it from the scope of this rule. We note that the final rule does not include prescriptive details on how to conduct validation studies; it simply codifies our longstanding policy that the sterility test must be validated to demonstrate that the test is capable of reliably and consistently detecting the presence of viable contaminating microorganisms.

(Comment 18) One comment objected to the requirement in existing § 211.160(b) as to the establishment of sampling plans because “* * * it is not practical or feasible to develop a scientifically sound sampling plan to ensure a product conforms to standards of sterility.” The comment recommended as a solution to either remove the requirement for scientific sampling plans with respect to sterility testing or to provide a clarification of “scientifically sound” versus “appropriate.”

(Response) The suggested revisions go beyond the scope of the proposed changes to the sterility test requirements. Furthermore, § 211.160(b) is an existing current good manufacturing practice requirement for finished pharmaceuticals, which states that laboratory controls must include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity. We consider such laboratory controls to be needed for both culture-based and non-culture-based sterility test methods. As stated in the preamble to the proposed rule (76 FR 36019 at 36022), the manufacturer must establish and document the test method's accuracy, sensitivity, specificity, and reproducibility (§ 211.165(e)), as specified in the BLA or BLA supplement (§§ 601.2, 601.12). For sterility tests, FDA believes that a validation protocol that would meet these standards would, at a minimum, include samples of the material to be marketed and incorporate appropriate viable contaminating microorganisms to demonstrate the sterility test's growth-promoting properties or the method's detection system capabilities, depending on the type of test method used. In addition, validation protocols for culture-based methods should include both aerobic and anaerobic microorganisms when selecting test organisms and include microorganisms that grow at differing rates so that manufacturers can establish that the test media are capable of supporting the growth of a wide range of microorganisms.

When utilizing culture-based methods, where appropriate, validation protocols should require that challenge organisms be added directly to the product prior to membrane filtration or direct inoculation. If this is not possible due to inhibition by the product, then validation protocols should require that the challenge organism be added to the final portion of sterile diluent used to rinse the filter, if a membrane filtration test method is used, or directly to the media containing the product if a direct inoculation test method is used.

For non-culture-based methods, the feasibility of identifying microorganisms from a contaminated sample should be evaluated during validation. If a method does not have the capability to identify microorganisms to the species level, the validation protocol should require that an additional method for species identification be utilized for investigation of detected contaminants. The test organisms selected should reflect organisms that could be found in the product, process, or manufacturing environment.

(Comment 19) Two comments sought clarification of the following statement in the preamble to the proposed rule: “When utilizing culture-based methods, validation protocols should require that challenge organisms be added directly to the product prior to membrane filtration or direct inoculation. If this is not possible due to inhibition by the product, then validation protocols should require that the challenge organism be added to the final portion of sterile diluent used to rinse the filter if a membrane filtration test method is used, or directly to the media containing the product if a direct inoculation test method is used.” (76 FR 36019 at 36022)

One commenter stated that this language is inconsistent with the harmonized compendial method suitability test which states, “After transferring the content of a container or containers to be tested to the membrane, add an inoculum of small number of viable microorganisms (not more that 100 colony-forming units) to the final portion of sterile diluents used to rinse the filter.” Another comment sought clarification of the suggested limits for the density of the inoculum of challenge organisms added directly to the product.

(Response) The intent of these statements was to clarify that for certain biological products utilizing culture-based methods, method suitability testing necessitates adding the challenge organism directly to the product prior to membrane filtration or direct inoculation. Therefore, we are now clarifying that when utilizing culture-based methods, where appropriate, validation protocols should require that challenge organisms be added directly to the product before membrane filtration or direct inoculation. If this is not possible due to inhibition by the product, then validation protocols should require that the challenge organism be added to the final portion of sterile diluent used to rinse the filter if a membrane filtration test method is used or directly to the media containing the product if a direct inoculation test method is used.

(Comment 20) One comment addressed the selection of organisms to be used. The comment suggested that with respect to validation protocols, for consistency, the wording regarding the selection of organisms should specifically include wild-type isolates that have been recovered from the controlled manufacturing environment and past contaminants of the product or any of its sterile components. The comment also suggested that this requirement should extend beyond culture-based methods. Further, the comment suggested that the statement in the preamble that “ ` The test organisms selected should reflect organisms that could be found in the product, process, or manufacturing environment (emphasis added) [76 FR 36019 at 36022],' should be tightened to require use of strains actually isolated from the product, process, or manufacturing environment, as the word `reflect' probably implies use of relevant species that might be sourced from culture collections rather than explicitly requiring use of wild-type strains (plant isolates).”

(Response) Our intention with respect to this statement was to include those organisms recovered both from the controlled manufacturing environment and from the product. Furthermore, the preamble statement was intended to refer to validation protocols in general, where appropriate, to both culture-based and non-culture-based test methods.

The validation study design should contain the appropriate controls to evaluate the product sample's potential to generate false-positive and false-negative results. Validation of the sterility test should be performed on all new products, and repeated whenever there are changes in the test method or production method that could potentially inhibit or enhance detection of viable contaminating microorganisms.

(Comment 21) One comment recommended the addition of “or production method” to the statement in the preamble so that it would now read, “Validation of the sterility test should be performed on all new products, and repeated whenever there are changes in the test method or production method that could potentially inhibit or enhance detection of viable contaminating microorganisms.” (See original statement 76 FR 36019 at 36022.) The commenter stated that the additional language is appropriate because the production process may influence the matrix of the test article, which may in turn influence the sterility test verification.

(Response) We agree that changes in the production method or manufacturing process could affect the results of testing conducted on the product. Therefore, we agree that validation of the sterility test should be performed on all new products and repeated whenever there are changes in the test method or production method that could potentially inhibit or enhance detection of viable contaminating microorganisms.

c. Verification —As stated in the proposed rule (76 FR 36019 at 36022), verification is the confirmation that specified requirements have been fulfilled as determined by examination and provision of objective evidence. While validation of a sterility test method is the initial process of demonstrating that the procedure is suitable to detect viable contaminating microorganisms, verification occurs over the lifetime of the sterility test method and is the process of confirming that the sterility test and test components continue to be capable of consistently detecting viable contaminating microorganisms in the samples analyzed. This verification activity may be necessary on a periodic basis or each time a sample is tested, depending upon the test method used. Under § 610.12(e) of the final rule, we require that the sterility test and test components be verified, as appropriate, to demonstrate that they can continue to consistently detect viable contaminating microorganisms.

(Comment 22) One comment maintained that the section of the preamble to the proposed rule regarding verification was not totally clear and should be reworded to explain the intended purpose. Specifically, the comment suggested, in order to clarify the goal of verification, adding the following sentence, “The intended purpose of the verification is to confirm that all the reagents utilized in the sterility test are qualified.” The commenter also noted that validation is to be done using the product to be tested and proposed adding the phrase “in the product to be tested” to the following statement in the preamble “While validation of a sterility test method is the initial process of demonstrating that the procedure is suitable to detect viable contaminating microorganisms, verification occurs over the lifetime of the sterility test method and is the process of confirming that the sterility test and test components continue to be capable of consistently detecting viable contaminating microorganisms in the samples analyzed.” (76 FR 36019 at 36022 to 36023)

(Response) To the extent that the commenter is arguing that our explanation is unclear, we disagree. As stated in the preamble to the proposed rule at section III.E (76 FR 36019 at 36022 to 36023), we believe that in order to verify the sterility test, verification activities are necessary to demonstrate that sterility test methods can continue to reliably and consistently detect viable contaminating microorganisms and that verification is the process of confirming that the sterility test and test components continue to be capable of consistently detecting viable contaminating microorganisms in the samples analyzed. In addition, we acknowledge that method suitability testing using the product is an important part of a validation protocol for a sterility test method.

We have finalized, as proposed, the replacement of the requirements found in current § 610.12(c) entitled Interpretation of test results, with the requirements that manufacturers must establish, implement, and follow written procedures for sterility testing. Written procedures are essential to ensure consistency in sampling, testing, and interpretation of results and to provide prospective acceptance criteria for the sterility test. Written procedures should include all steps to be followed in the sterility test method for initial and repeat tests and be detailed, clear, and unambiguous. Under the current good manufacturing practice regulations, manufacturers are required to document that a drug product satisfactorily conforms to final specifications for the drug product (§ 211.165(a)). As such, scientifically sound and appropriate specifications, standards, sampling plans, and test procedures must be designed and written to ensure that materials conform to appropriate standards of sterility; and written procedures must include a description of the sampling method and the number of units per batch to be tested (see § 211.165(c)).

Under the final rule, manufacturers may use either culture-based or non-culture-based sterility test methods to evaluate material for sterility. There are marked differences between culture-based and non-culture-based sterility tests. Section 610.12(c) provides the minimum critical considerations that must be included in the written procedures for culture-based and non-culture-based sterility tests.

For culture-based sterility test methods, the written procedures must include, at a minimum, a description of the composition of the culture media, growth-promotion test requirements, and incubation conditions (time and temperature). For non-culture-based sterility test methods, the written procedures must include the composition of test components, test parameters, including the acceptance criteria, and the controls used to verify the test method's ability to consistently detect the presence of viable contaminating microorganisms.

Selection of an appropriate sample of a lot is critical for purposes of sterility testing. Under § 610.12(d) as finalized, due to the variety of products covered under § 610.12, the regulation requires that the sample be appropriate to the material being tested.

(Comment 23) Five comments requested clarification of the proposed requirement that the sample be “appropriate to the material being tested,” with respect to the size or volume of the final product lot. The comments asserted that the example provided in the preamble of the proposed rule, “For example, a final product lot size of 100,000 units would necessitate a greater number of samples to be evaluated than a final product lot size of 5,000 units,” (76 FR 36019 at 36023), conflicts with USP Chapter 71 regarding the minimum number of articles to be tested in relation to the number of articles in the batch.

(Response) We acknowledge that the example provided in the preamble of the proposed rule erroneously compared a final product lot size of 100,000 units to one of 5,000 units. We had intended to compare a final product lot size of 100,000 to one of 500 units. We recognize that this error may have caused confusion among some readers, and that the example was inconsistent with the USP Chapter 71 methods for the minimum number of articles to be tested in relation to the number of articles in the batch. It was not our intent to suggest that established USP compendial sterility test methods, including the minimal number of articles to be tested in relation to the number of articles in the batch, were unacceptable under the new requirements in § 610.12(d).

In order to clarify the new requirement that the sample be “appropriate to the material being tested,” we reiterate that in selecting an appropriate sample size, § 610.12(d) requires that the following minimal criteria be considered:

• The size or volume of the final product lot. For example, a final product lot size of 100,000 units would necessitate a greater number of samples to be evaluated than a final product lot size of 500 units;

• The duration of manufacturing of the drug product. 7 For example, it is important that samples be taken at different points of manufacture, which, at a minimum, should include the beginning, middle, and end of manufacturing, in an effort to provide evidence of sterility of the drug product throughout the duration of the manufacturing process;  8

• The final container configuration and size. We believe this will ensure appropriate representation of the lot;

• The quantities or concentrations of inhibitors, neutralizers, and preservatives, if present, in the test material;

• For a culture-based test method, the volume of test material that results in a dilution of the product that was determined not to be bacteriostatic or fungistatic; and

• For a non-culture-based test method, the volume of test material that results in a dilution of the product that does not inhibit or otherwise hinder the detection of viable contaminating microorganisms.

(Comment 24) Two comments stated that the proposed changes related to sample size are vague and leave too much room for interpretation by industry as well as investigators or auditors when determining an appropriate sample size.

(Response) We disagree that requiring the sample to be appropriate to the material being tested is vague and leaves too much open to interpretation. Our intent in requiring that the sample be “appropriate to the material being tested,” with consideration of a list of minimal criteria, is to provide manufacturers flexibility to retain their existing procedures for sterility testing using culture-based methods, or to take advantage of modern methods as they become available, provided that these modern methods meet certain criteria, as described in our response to Comment 23. In addition, as noted previously, sterility test methods are approved by FDA in either a manufacturer's BLA or BLA supplement, thereby alleviating concern that the final rule leaves too much room for interpretation.

(Comment 25) One comment asked FDA to clarify whether the quantities or concentrations of inhibitors, neutralizers, and preservatives, if present in the test material, have an impact on sample size and selection. The comment also asked about the relationship between the impact of preservatives and any increase in the sample size.

(Response) In selecting an appropriate sample size, § 610.12(d) requires consideration of certain minimal criteria, including the quantities or concentrations of inhibitors, neutralizers, and preservatives, if present in the test material. The consideration of the quantities or concentrations of inhibitors, neutralizers, and preservatives, if present in the test material, will depend upon the product and the test method utilized. This provides both manufacturers of future innovative products, as well as manufacturers of currently approved products, the flexibility to take advantage of modern methods or to retain the sterility testing method as approved in the BLA or BLA supplement.

As discussed in the preamble to the proposed rule (76 FR 36019 at 36023), verification activities are necessary to demonstrate that sterility test methods can continue to reliably and consistently detect viable contaminating microorganisms. The degree of verification that is necessary depends upon the sterility test method employed. Depending upon the sterility test method, verification of each individual test might be appropriate. On the other hand, some sterility test methods may only need verification activities performed on the selected culture media or test organisms. Under § 610.12(e), a manufacturer must perform verification activities appropriate for the sterility test method chosen, as set forth in the final rule.

(Comment 26) In the proposed rule (76 FR 36019 at 36020, footnote 6), we proposed to refer to “growth-promoting properties” rather than “growth-promoting qualities” and requested comments on which term is most appropriate. We received two comments in response to our request. Both comments support the use of “growth-promoting properties” and agree that “growth-promoting properties” reflects more accurate and current terminology.

(Response) We appreciate and agree with these comments and have retained the term “growth-promoting properties” in the final rule.

(Comment 27) Two comments requested clarification of the requirements for verification of culture-based test methods. One comment asked if, for culture-based test methods, all media must undergo growth-promotion testing over their shelf-life, and if validation were performed for three lots, whether it is acceptable to perform growth-promotion testing on the media only when it is initially received. One comment acknowledged that each media lot would have to be tested for growth-promotion at least at the beginning and the end of its use; however, the comment sought clarification whether companies would be expected to keep performing the test at regular intervals.

(Response) For culture-based methods, it is important that each lot of all culture media undergo growth-promotion testing at regular intervals over the shelf-life of the media, not just when the media is initially received. The final rule requires that the sterility test and test components be verified, as appropriate, to demonstrate that they can continue to consistently detect viable contaminating microorganisms. The degree of verification depends upon the sterility test method employed.

For culture-based test methods, studies must be conducted to demonstrate that the performance of the test organisms and culture media are suitable to consistently detect the presence of viable contaminating microorganisms, including tests for each lot of culture media to verify its growth-promoting properties over the shelf-life of the media and not only at the beginning and end of use. Growth-promotion testing is important to demonstrate that the culture media are capable of supporting the growth of microorganisms.

(Comment 28) One comment recommended that with the proposal to remove the definition of a lot of culture medium currently defined in § 610.12(e)(2)(i), revisions to the rule should clearly state that each delivery of each vendor lot of media be “QC tested” by the end user to verify its ability to detect viable microorganisms. The comment states, “It must be made clear that the vendor cannot be totally in control of the product once it has been shipped from the distribution centre.” Further, the comment states it is the user's responsibility to test each delivery of each vendor lot to ensure that undetected mistreatment of the testing product during its shipment and delivery to the end-user has not caused deterioration in its efficacy.

(Response) We agree that the user of the culture media must verify that each lot can continue to consistently detect viable contaminating microorganisms. For the reasons noted previously, we do not believe the suggested changes are needed because the rule, as proposed and now finalized, already reflects this requirement.

(Comment 29) One comment stated that usually validation data provided by the media suppliers are used to cover the shelf-life of the media and proposed adding the following text “or media supplier validation data must be available” after the text “over the shelf-life of the media” in proposed § 610.12(e)(1) to capture the fact that the supplier of the media may also supply this parameter.

(Response) We do not agree that reliance on media supplier validation data alone, in lieu of testing by the manufacturer, would be acceptable. Under § 610.12(e)(1) of the final rule, for culture-based test methods, manufacturers must conduct tests to demonstrate that the performance of the test organisms and culture media are suitable to consistently detect the presence of viable contaminating microorganisms, including tests for each lot of culture media to verify its growth-promoting properties over the shelf-life of the media. Therefore, reliance on media supplier validation data alone, in lieu of testing by the manufacturer, would not be acceptable.

For the reasons discussed in the preamble to the proposed rule (76 FR 36019 at 36023 to 36024), we have amended the regulations in § 610.12(b) for repeat testing. Therefore, we have eliminated the reference to repeat testing of bulk material because, under the final rule, sterility testing is no longer required on bulk material in most instances. We also have finalized the proposal to eliminate the use of a second repeat test for final container material to harmonize our regulatory expectations with current scientific understanding of quality manufacturing controls. 9 Under the final rule, consistent with USP Chapter 71, if the initial test indicates the presence of microorganisms, then the product being examined does not comply with the sterility test requirements, unless a thorough investigation by the quality control unit can conclusively ascribe the initial evidence of microbial presence to a laboratory error or faulty materials used in conducting the test.

If the test of the initial sample is conclusively found to be invalid, due to laboratory error or faulty test materials, the sterility test may be repeated one time. If no evidence of microorganisms is found in the repeat test, the product examined complies with the test requirements for sterility. If, however, evidence of microorganisms is found in the repeat test, the product examined does not comply with the test requirements for sterility.

Further, as discussed in the preamble to the proposed rule, both a comparable product that is reflective of the initial sample in terms of sample location and the stage in the manufacturing process from which it was taken, and the same sterility test method must be used for both the initial and repeat tests. This is intended to ensure that the same volume of material is used for the initial test and each repeat test, and that the interpretation of the results is conducted in the same manner.

(Comment 30) One comment supported FDA's proposal to modify the provision for repeat testing to harmonize regulatory expectations with current scientific understanding of quality manufacturing controls by eliminating the use of a second repeat test of final container material and agreed with FDA that the proposed modification of the provision for repeat testing is in accordance with the USP and the European Pharmacopeia. However, the commenter noted that FDA's proposed requirement to take repeat test samples that are reflective of the initial samples may be difficult to fulfill. For instance, the commenter states, “* * * at the time when the sterility test might show a positive result (after a few days), it could be that it is no longer possible to distinguish which vials were filled at which point in time.” The comment suggested deleting the requirement in proposed § 610.12(f)(3) that the repeat test must be conducted with “comparable product that is reflective of the initial sample in terms of sample location and the stage in the manufacturing process from which it was obtained.”

(Response) We appreciate the supportive comments. However, we do not agree with the recommended change to § 610.12(f)(3). We believe the final rule is consistent with current scientific understanding of quality manufacturing controls. If a repeat test is conducted, the same test method must be used for both the initial and repeat tests, and the repeat test must be conducted with comparable product that is reflective of the initial sample in terms of sample location and the stage in the manufacturing process from which it was obtained.

As discussed in the preamble to the proposed rule, we appreciate that this final rule could result in the need for some manufacturers to modify their repeat test procedures. We continue to consider these modifications to be minor changes in accordance with § 601.12(d) and to have a minimal potential for an adverse effect on the identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness of the product. Therefore, such changes must be reported in the annual report within 60 days of the anniversary date of approval of the BLA.

Previously, § 610.12(h) incorporated by reference the record keeping and maintenance requirements contained in §§ 211.167 and 211.194. We continue to maintain these requirements. As discussed in the preamble to the proposed rule (76 FR 36019 at 36024), this is intended to assure that data derived from sterility tests comply with established specifications. This includes describing the samples received for testing, stating the method used to test the samples, identifying the location of relevant validation or verification data, recording all calculations performed, and stating how the results of tests performed compare to set specifications.

In the proposed rule we invited comments on whether any of the current exceptions should be removed (76 FR 36019 at 36024). We specifically requested comments on whether to remove the exemption for platelets. Bacterial contamination of platelets is a recognized public health risk, and the blood collection industry has already called for and implemented methods to detect and limit or inactivate bacteria in platelet components. Requiring testing for platelets would be consistent with these industry practices.

(Comment 31) In response to our request for comment, a joint comment from industry groups recommended that FDA continue to except Whole Blood, Cryoprecipitated Antihemophilic Factor (AHF), Platelets, Red Blood Cells, and Plasma from the sterility test requirements in § 610.12. The comment acknowledged that the blood industry has called for and implemented methods to detect and limit or inactivate bacteria in platelet components and that some culture-based methods are in wide use as a quality control tool. However, there are currently no available tests that will ensure the sterility of platelet products. In addition, the joint comment noted that if the current exception for platelets would be removed, manufacturers of blood and blood components would not be able to satisfy the new requirement. Further, the comment recommended that FDA vigorously support applications for pathogen inactivation processes for platelet components. Moreover, the joint comment noted that any sterility test requirement tied to a BLA is too narrow an approach to ensure optimal bacterial testing of platelet products, as any platelet collected or manufactured by a facility that does not have a BLA would not be subject to the sterility test regulation. Accordingly, the joint comment recommended that FDA use a different mechanism to require testing of all platelet products for bacterial contamination when testing becomes technologically feasible.

(Response) We appreciate these comments and we generally agree. We recognize that blood establishments have begun to take steps to test for bacterial contamination in platelet components. We welcome the acknowledgement of the importance of bacterial testing and pathogen inactivation processes for platelet components and believe that appropriate microbial testing of platelet components may be necessary to assure product quality. However, while these technologies are developing, we have retained the exception from this rule for these products. Instead, we will continue to review these issues and available technologies and will take appropriate steps at another time to address microbial testing of blood components.

(Comment 32) One comment recommended adding an exception stating that a manufacturer with parametric release programs is not required to comply with the sterility test requirements. The comment noted that parametric release for articles sterilized with moist heat has been recognized by FDA since 1987, and that many companies have adopted this approach.

(Response) We disagree with the proposed change and decline to add an exception for drug products terminally sterilized by moist heat processes and subject to parametric release because the exception under § 610.12(h) (previously under § 610.12(g)) already provides for an exception for such parametric release programs. As noted in FDA's guidance document entitled “Guidance for Industry: Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes,” dated February 2010, FDA approval of parametric release must be requested either in an original application submission under 21 CFR 314.50 or 601.2, or in a prior approval supplement under 21 CFR 314.70 or 601.12.

(Comment 33) Two comments recommended adding other exceptions to the sterility test requirements. One comment recommended adding granulocytes to the exception, and one comment recommended adding in vitro diagnostic devices regulated as biological products, which do not purport to be sterile.

(Response) We decline to adopt the suggested changes because neither granulocytes nor in vitro diagnostic devices, which do not purport to be sterile, are subject to the sterility test requirements in § 610.12. Therefore, we believe the recommendations are beyond the scope of this rule.

(Comment 34) One comment recommended that the exceptions provision be revised to “specifically include or exclude various biological product types such as Bioequivalent/Biosimilars and combination products.”

(Response) We do not believe the suggested change is needed. Biological products must comply with the applicable requirements in parts 600 through 680, in addition to other applicable regulations.

For the reasons discussed in the preamble to the proposed rule (76 FR 36019 at 36024), we have finalized the proposed minor modifications to the current exception in § 610.12(g)(4)(ii), under which the Director of CBER or CDER, as appropriate, determines that data submitted adequately establish that the mode of administration, the method of preparation, or the special nature of the product precludes or does not require a sterility test or that the sterility of the lot is not necessary to assure the safety, purity, and potency of the product. Specifically, the minor modification that we refer to is the “route of administration” rather than the “mode of administration” and to “any other aspect of the product” rather than “the special nature of the product” in finalized § 610.12(h)(2) so as to account for novel products that may be introduced to the market in the future. This exception allows the Director of CBER or CDER, as appropriate, to exempt biological material from the sterility test requirements of this section if, based upon the scientific evidence presented in the BLA or BLA supplement, the data adequately establish that the route of administration, method of preparation, or any other aspect of the product precludes or does not necessitate a sterility test to assure the safety, purity, and potency of the product. We note that in the proposed rule, the Center for Devices and Radiological Health was erroneously identified in this exception, instead of CDER. In the final rule, we have correctly identified CDER in the exception provision at § 610.12(h)(2).

In addition to comments regarding exceptions as stated in this document, we have also eliminated, as proposed, the current exceptions under § 610.12(g)(1) and (2) because they are no longer necessary given the flexibility now built into the final rule. In addition, we have eliminated, as proposed, the current exceptions in § 610.12(g)(5) through (g)(9) because they are no longer necessary and because the revised rule now requires manufacturers to determine the appropriate sample volume and size for the material being tested and requires that the sterility test be “appropriate to the material being tested.” (See 76 FR 36019 at 36024 to 36025 for more information.)

In addition to the revisions to the sterility regulation in § 610.12, we have also revised, as proposed, two other FDA regulations in this final rule. These revisions are as follows:

• Section 600.3(q): Previously, § 600.3(q) defined “sterility” to mean “freedom from viable contaminating microorganisms, as determined by the tests prescribed in § 610.12 of this chapter.” As proposed, we have reworded this definition to eliminate the term “prescribed” since § 610.12 no longer prescribes specific test methods. Thus, we have amended § 600.3(q) to define “sterility” as “freedom from viable contaminating microorganisms, as determined by tests conducted under § 610.12 of this chapter.”

• Section 680.3(c) (21 CFR 680.3(c)): As proposed, we have amended § 680.3(c) to eliminate the term “prescribed.” Section 680.3(c) now states that “A sterility test shall be performed on each lot of each Allergenic Product, as required by § 610.12 of this chapter.” Additionally, we have eliminated § 680.3(c)(1) through (c)(4) because these exceptions are no longer necessary under the revisions to § 610.12. (See 76 FR 36019 at 36025 for more information.)

FDA is issuing this regulation under the biological products provisions of the Public Health Service Act (the PHS Act) (42 U.S.C. 262 and 264) and the drugs and general administrative provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (sections 201, 301, 501, 502, 503, 505, 510, 701, and 704) (21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 371, and 374). Under these provisions of the PHS Act and the FD&C Act, we have the authority to issue and enforce regulations designed to ensure that biological products are safe, effective, pure, and potent, and to prevent the introduction, transmission, and spread of communicable disease.

FDA has examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1996 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Agency believes that this final rule is not a significant regulatory action under Executive Order 12866.

The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. While the rule restricts retesting when sterility tests are failed, the change codifies an approach for retesting that is similar to the approach prescribed by the USP. The rule does not otherwise add any new regulatory responsibilities and generally increases flexibility for sterility testing. Therefore, the Agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that Agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $136 million, using the most current (2010) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount.

These amendments would generally provide manufacturers of biological products with more flexibility as to how they evaluate the sterility of their products and reduce the number of evaluations required. The net effect would be to reduce costs.

One part of these amendments might impose some additional costs on manufacturers, however. Under the current regulations, if a biological product fails a sterility test, the test may be repeated. If the product passes a subsequent test, it is inferred that the first test was flawed and only the latter results are used. Under the new regulations, the test may be repeated only if it is possible to “ascribe definitively” the initial failure to “a laboratory error or faulty materials used in conducting the sterility testing.”

This change could increase costs for manufacturers because additional products could be discarded. The size of the increase, if any, would be determined by the number of additional lots discarded, the lot sizes, and the production costs per unit. Some or all of the costs of this change, could, in turn, be mitigated by the reduction in losses associated with the provision of contaminated products.

This change is expected to affect few manufacturers. The method for sterility testing described in USP Chapter 71 already limits the repetition of tests to circumstances similar to those described in these amendments. It is anticipated that, in the absence of these amendments, the majority of manufacturers would limit the repetition of sterility tests in order to comply with USP Chapter 71.

The benefit of limiting retests would be fewer illnesses caused by contaminated biological products. We are unable to quantify the value of the reduction in illnesses because we do not have an estimate of the risk of illness from contaminated biological products or the decline in that risk associated with limiting retests.

The Agency has determined under 21 CFR 25.31(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

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

This final rule contains collections of information that were submitted for review and approval to the Director of the Office of Management and Budget (OMB), as required by section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in §§ 211.165 and 610.12 have been approved and assigned OMB control number 0910-0139.

Therefore, under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and under the authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 600, 610, and 680 are amended as follows:

The collection of information contained in these final regulations has been reviewed and approved by the Office of Management and Budget in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) under control number 1545-2088. The collection of information is required for an owner to provide a written request to a housing credit agency to obtain a qualified contract (as defined in section 42(h)(6)(F) of the Internal Revenue Code) for the acquisition of a low-income housing credit building. The collecting of information is voluntary to obtain a benefit.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by the Office of Management and Budget.

Books or records relating to a collection of information must be retained as long as their contents might become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.

This document contains final regulations that amend the Income Tax Regulations (26 CFR part 1) relating to the low-income housing credit under section 42 of the Internal Revenue Code (Code). On June 19, 2007, a notice of proposed rulemaking (REG-114084-04) and notice of public hearing relating to the qualified contract provisions under section 42(h)(6)(F) was published in the Federal Register (72 FR 33706). Written and electronic comments responding to the proposed regulations were received and a public hearing was held on the proposed regulations on October 15, 2007. After consideration of all the comments, the proposed regulations are adopted as amended by this Treasury decision.

Section 42 provides a tax credit for investment in low-income housing buildings placed in service after December 31, 1986. The section 42 credit is a general business credit subject to the provisions of section 38.

Section 42(h)(6)(A) provides that no credit will be allowed with respect to any building for the taxable year unless an extended low-income housing commitment (commitment) (as defined in section 42(h)(6)(B)) is in effect as of the end of the taxable year.

Section 42(h)(6)(B) provides in part that the term commitment means any agreement between the owner and the housing credit agency (Agency) that requires that the applicable fraction (as defined in section 42(c)(1)(B)) for the building for each taxable year in the extended use period will not be less than the applicable fraction specified in the commitment. Section 42(h)(6)(E)(ii) prohibits the eviction or termination of tenancy (other than for good cause) of an existing tenant of any low-income unit or any increase in the gross rent with respect to such unit not otherwise permitted under section 42 until three years after the termination of such an agreement.

Section 42(h)(6)(D) defines the term extended use period as the period beginning on the first day in the compliance period (as defined in section 42(i)(1)) on which the building is part of a qualified low-income housing project and ending on the later of: (1) The date specified by the Agency in the commitment, or (2) the date which is 15 years after the close of the compliance period.

Section 42(h)(6)(E)(i)(II) provides for the termination of the extended use period if the Agency is unable to present within a specified period of time a qualified contract for the acquisition of the low-income portion of the building by any person who will continue to operate such portion as a qualified low-income building.

Section 42(h)(6)(F) defines the term qualified contract as a bona fide contract to acquire (within a reasonable period of time after the contract is entered into) the non low-income portion of the building for fair market value and the low-income portion of the building for an amount not less than the applicable fraction (specified in the commitment) of the sum of: (I) The outstanding indebtedness secured by, or with respect to the building, (II) the adjusted investor equity in the building, plus (III) other capital contributions not reflected in these amounts; reduced by cash distributions from (or available for distribution from) the project.

Section 42(h)(6)(F) also provides that the Secretary shall prescribe regulations as may be necessary or appropriate to carry out that paragraph, including regulations to prevent the manipulation of the amount determined under section 42(h)(6)(F).

Section 42(h)(6)(I) provides that the Agency must present the qualified contract within the 1-year period beginning on the date (after the 14th year of the compliance period) the owner submits a written request to the Agency to find a person to acquire the owner's interest in the low-income portion of the building.

The proposed regulations addressed the application of the qualified contract provisions of section 42. Section 1.42-18(c)(1) of the proposed regulations defined the qualified contract formula used to compute the purchase price amount of the low-income housing building generally as: (1) The non low-income portion of the building for fair market value; plus (2) the low-income portion of the building for the low-income portion amount.

Section 1.42-18(c)(2) of the proposed regulations defined the low-income portion amount as an amount not less than the applicable fraction (as specified in the commitment) of the total of: (a) Outstanding indebtedness secured by, or with respect to the building; plus (b) the adjusted investor equity in the building; plus (c) other capital contributions, not including amounts described in (a) and (b); minus (d) cash distributions from (or available for distribution from) the building.

Prior to the issuance of the proposed regulations, comments were received recommending the inclusion of a fair-market-value cap for the low-income portion of the qualified contract amount as defined in section 42(h)(6)(F). These comments noted that the qualified contract price may, in some cases, exceed the fair market value of a project. One reason given to explain why the qualified contract price might exceed the fair market value of a project is the formula component for adjusted investor equity, which includes the Consumer-Price-Index-based cost of living adjustments. As explained in the preamble to the proposed regulations, this recommendation was not adopted as a proposed rule because section 42(h)(6)(F) defines a qualified contract, in part, as a contract to acquire the low-income portion of the building for an amount “not less than” the applicable fraction of the statutorily provided formula. Similar comments were received after publication of the proposed regulations. The IRS and the Treasury Department continue to believe that they do not have the authority under section 42(h)(6)(F) to adopt a fair-market-value cap. Accordingly, the final regulations do not provide a rule providing a fair-market-value cap under section 42(h)(6)(F).

The IRS and the Treasury Department in the preamble to the proposed regulations requested comments on the extent of Agency and State authority to provide more stringent requirements than those contained in section 42(h)(6)(F). The preamble referenced the flush language of section 42(h)(6)(E)(i), which provides that the qualified contract exception to the termination of an extended use period shall not apply to the extent more stringent requirements are provided in the agreement or in State law. Specifically, the IRS and the Treasury Department requested comments on the authority of Agency or State regulators to require in agreements a fair-market-value cap that would restrict any qualified contract price to fair market value. In response, two comments were received, both opining that an Agency did not possess authority under section 42(h)(6)(E) to set a fair market value limitation. The commentators reasoned that the language “more stringent requirements” relates to the date the extended use period will terminate, rather than to the qualified contract formula. The IRS and Treasury Department received no comment asserting the view that section 42(h)(6)(E)(i) authorizes an Agency or State regulators to require in agreements a fair-market-value cap that would restrict a qualified contract price to fair market value. The IRS and Treasury Department do not believe that section 42(h)(6)(E)(i) was intended to authorize a fair-market-value cap on the low-income portion of the building, and, accordingly, the final regulations do not provide for such a cap.

Some commentators questioned the provision in the proposed regulations that would allow Agencies to adjust the fair market value of a building, if, after a reasonable period of time within the one-year offer-of-sale period, no buyer has made an offer or market values have adjusted downward. One commentator noted that, as a result of this provision, in order to secure a more favorable price for the building, prospective buyers might wait out the qualified contract process until an Agency reduces the qualified contract price. Another commentator noted the unfairness of granting Agencies the unilateral right to reduce the fair market value of the non low-income portion of the building, particularly when the proposed regulations provide no limitation on how much the Agency may reduce the fair market value.

The IRS and the Treasury Department believe these concerns are valid. Accordingly, the final regulations revise this provision to provide that the Agency may adjust the fair market value of the non low-income portion of the building after the Agency's offer of sale of the building to the general public and before the close of the one-year offer of sale period only with the consent of the owner. If no agreement between the Agency and owner is reached, the fair market value of the non low-income portion of the building determined at the time of the Agency's offer of sale of the building to the general public remains unchanged.

The proposed regulations provide that the fair market value of the non low-income portion of a building is determined at the time of an Agency's offer of sale of the building to the general public. This valuation must take into account the existing and continuing requirements contained in the commitment for the building. The non low-income portion also includes the fair market value of the land underlying the entire building, including the land underlying the low-income portion of the building.

Commentators questioned the statutory authority of the IRS under section 42(h)(6)(F) to include land value in the qualified contract amount. Specifically, commentators noted that the language under section 42(h)(6)(F) refers to the fair market value of the non low-income portion of the building without addressing the issue of land valuation. Other commentators asserted that adopting a fair market value approach for land underlying the entire building may decrease the likelihood of finding a qualified buyer willing to pay the qualified contract price while continuing to operate the building as a low income building.

The IRS and the Treasury Department believe that land is inherently part of the cost underlying the acquisition or construction of a building and should not be ignored in determining the qualified contract amount. Applying fair market value to land is consistent with industry practice regarding land valuation and provides an equitable means for arriving at a contract price between buyers and owners. By valuing land underlying the entire building at fair market value, taking into account the existing and continuing requirements contained in the commitment for the building, the proposed regulations provided an approach that maintains industry practice for valuing land and provided an objective and equitable solution that favors neither the buyer nor the owner. Accordingly, the final regulations provide that the land underlying the entire building (both low-income and non low-income units) is valued at fair market value subject to the existing and continuing restrictions contained in the commitment for the building.

One commentator expressed concern that the proposed regulations would impose too much burden on Agencies by requiring them to adjust the qualified contract amount between the date on which the sales price under a qualified contract is first determined and the sale's actual closing date. (For example, an adjustment is needed to reflect mortgage payments that reduce outstanding indebtedness.) The IRS and the Treasury Department concur with this comment, and the final regulations provide that the buyer and owner, and not the Agency, must adjust the amount of the low-income portion of the qualified contract formula to reflect changes in the components of the qualified contract formula, such as mortgage payments that reduce outstanding indebtedness between the time the Agency first offers the property for sale and the actual sale closing date.

One commentator recommended that the final regulations clarify that the rule in the proposed regulations providing that cash available for distribution includes reserve funds should apply only to the extent that the reserve funds are not legally required to remain with the project after the sale. Other commentators noted the potential for double-counting if cash available for distribution includes the proceeds from refinancing indebtedness or additional mortgages, while simultaneously any refinancing indebtedness or additional mortgages in excess of qualifying building costs are not outstanding indebtedness for purposes of section 42(h)(6)(F).

The IRS and the Treasury Department agree with these comments. Accordingly, the final regulations provide that cash available for distribution includes reserve funds that are not legally required by mortgage restrictions, regulatory agreements, or third party contractual agreements to remain with the building following the sale of the building. The final regulations further provide that proceeds from refinancing indebtedness or additional mortgages that are in excess of qualifying building costs are not considered cash available for distribution. The text of the final regulations also adopts the rule discussed in the preamble to the proposed regulations, but not stated in the text of the proposed regulations, that any refinancing indebtedness or additional mortgages in excess of qualifying building costs do not qualify as outstanding indebtedness for purposes of section 42(h)(6)(F).

Some commentators questioned the rationale for the requirement in the proposed regulations that would discount outstanding indebtedness having an interest rate below the applicable Federal rate (AFR) under section 1274 of the Code. In response, the final regulations remove the provision of discounting indebtedness altogether. Instead, the final regulations define outstanding indebtedness to include only those amounts secured by, or with respect to, the building that (1) do not exceed qualifying building costs, (2) are indebtedness under general principles of Federal income tax law, and (3) upon the sale of the building, are actually paid to the lender or are assumed by the buyer as part of the sale.

Several commentators noted the absence of any uniform standards for appraisal methodology and qualifications for appraisers. Rather than adopt appraisal standards, the final regulations provide that Agencies shall not utilize any individual or organization as an appraiser if that individual or organization is currently on any list for active suspension or revocation for performing appraisals in any State or is listed on the Excluded Parties Lists System (EPLS) maintained by the General Services Administration for the United States Government. The final regulations also provide the Agencies with the discretion to select the appraisers involved in the qualified contract process and to require all appraisers to be State-certified general appraisers.

The proposed regulations provide that in order to satisfy the qualified contract requirements under section 42(h)(6)(F), the Agency must offer the building for sale to the general public at the determined qualified contract price upon receipt of a written request by the owner to find a buyer to acquire the building. In addressing the issue of how Agencies should advertise the availability of a building to the general public, the final regulations provide a reasonable efforts standard for guiding Agencies in their efforts to find a qualified buyer during the one year offer period. If the determined qualified contract price is not a multiple of $1,000, the final regulations permit the Agency to round up the offering price of the building to the next highest multiple of $1,000.

Some commentators suggested the inclusion of a specific definition of a bona fide contract under section 42(h)(6)(F), addressing issues such as whether the terms and conditions of any offered contract are unreasonable or impractical. Further, commentators suggested the creation of a mechanism for resolving disputes among the parties concerning the meaning of a bona fide contract. The IRS and the Treasury Department believe that because of variations under State laws concerning the terms of a bona fide contract and methods for resolving disputes, the final regulations should not explicitly address these issues. Instead, the final regulations provide that an Agency has the administrative discretion to specify other conditions applicable to the qualified contract consistent with section 42 of the Code and the final regulations.

To avoid ambiguity in the determination of the qualified contract amount, the final regulations require adjusted investor equity to be calculated in a manner that is consistent with inflation adjustments made under section 1(f). Thus, as was required in the proposed regulations, the calculations must use not seasonally adjusted values of the Consumer Price Index for all urban consumers (the data series that the Bureau of Labor Statistics refers to as “CPI-U”). The final regulations provide a computational process that is mathematically equivalent to the process described in the proposed regulations but that will be simpler to implement. Because of the uncertainty that can be introduced when one number is divided by another and because different people might choose to retain in the answer different numbers of digits, the regulations require the quotient in this process to be carried out to 10 decimal places. (If standard, off-the-shelf spreadsheet software is used to compute the adjusted investor equity, the computations will generally have at least this degree of accuracy by default.) In addition, the example in the final regulations has been updated to use more recent data. Finally, the final regulations make it possible for the Commissioner to reduce the computational burden by, for example, providing the possible adjustment factors in annual publications or creating a calculator on the IRS Web site.

It has been determined that this Treasury decision is not a significant regulatory action as defined in Executive Order 12866, as supplemented by Executive Order 13563. Therefore, a regulatory assessment is not required. It also has been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations. It is hereby certified that the collection of information in these regulations will not have a significant economic impact on a substantial number of small entities. The information required to be provided by a taxpayer (that is, by the owner of a low-income building) to a State agency to determine the qualified contract amount is already maintained by the taxpayer for other purposes of the low-income tax credit under section 42. Because only a minimal amount of additional time is required for a taxpayer to access and provide the information, this collection of information does not impose a significant burden on the taxpayer. Accordingly, a Regulatory Flexibility Analysis under the provisions of the Regulatory Flexibility Act (5 U.S.C. chapter 6) is not required. Pursuant to section 7805(f) of the Code, the notice of proposed regulations preceding these final regulations was submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on their impact on small business, and no comments were received.

The principal author of these regulations is David Selig of the Office of Associate Chief Counsel (Passthroughs and Special Industries). However, other personnel from the IRS and Treasury Department participated in their development.

Accordingly, 26 CFR Parts 1 and 602 are amended as follows:

The Federal Tort Claims Act (FTCA), 28 U.S.C. 1346(b), 2671-2680, provides a remedy for injury or loss of property, or personal injury or death caused by the negligent or wrongful act or omission of any employee of the Government while acting within the scope of his office or employment, under circumstances where the United States, if a private person, would be liable to the claimant in accordance with the law of the place where the act or omission occurred. Prior to filing suit, a claimant must file an administrative tort claim with the appropriate agency. 28 U.S.C. 2675. Pursuant to 28 U.S.C. 2672, the head of each Federal agency or his designee, in accordance with regulations prescribed by the Attorney General, may consider, ascertain, adjust, determine, compromise, and settle FTCA claims.

In the present organizational regulations of the Department of Justice, the Attorney General delegated his authority to settle FTCA claims for amounts of $50,000 or less to the Director of the Bureau of Prisons, the Commissioner of Federal Prison Industries, the Commissioner of the Immigration and Naturalization Service (INS), the Director of the United States Marshals Service, and the Administrator of the Drug Enforcement Administration (28 CFR 0.172), and to the Director of the Federal Bureau of Investigation (FBI) (28 CFR 0.89a) and the Director of the Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF) (28 CFR 0.132). The Director of the FBI is further authorized to redelegate this authority to the FBI General Counsel or his designee within the Office of the General Counsel or to the primary legal advisers of the FBI field offices.

This rule amends §§ 0.89a, 0.132, and 0.172 in order to ensure conformity across the different components of the Department of Justice, to update agency references, and to clarify the scope of the delegated FTCA settlement authority. In addition, the FTCA settlement authority of the Director of the FBI, currently contained in § 0.89a, and of the Director of ATF, currently contained in § 0.132, are being transferred by this rule to § 0.172, where the FTCA settlement authority of the other specified Department component heads is located.

Section 0.172 is being amended to remove a reference to the Commissioner of the INS. Pursuant to the Homeland Security Act of 2002, the functions of the former INS were transferred to the Department of Homeland Security. Section 0.172 also is being amended to clarify that the approval of the Assistant Attorney General in charge of the Civil Division will be required if two or more claims arise from the same subject matter and the aggregate amount of the settlement would exceed $50,000. In addition, § 0.172 is being amended to clarify when proposed settlements, regardless of amount, should be referred to the Assistant Attorney General in charge of the Civil Division. In particular, § 0.172 is being amended to require the referral of settlements to the Assistant Attorney General in charge of the Civil Division or his delegee, if the settlement, as a practical matter, would or may control or adversely influence the disposition of other claims and the total settlement value of all claims would or may exceed $50,000; or if, in the opinion of the head of the referring component, the settlement presents a question of law or policy or other issue that should receive the personal attention of the Assistant Attorney General or his delegee. Section 0.172 also is being amended to more closely conform to the language contained in 28 U.S.C. 2672 by clarifying that the Attorney General's delegees have the authority to consider or ascertain claims involving their respective agencies, in addition to their authority to adjust, determine, compromise, and settle such claims.

Finally, § 0.132 is being amended to allow the Director of ATF to delegate this authority under § 0.172 to the agency's Chief Counsel and to allow the Chief Counsel to redelegate this authority to attorneys within the Office of Chief Counsel, but not below the Associate Chief Counsel level, provided that the settlement of any one claim does not exceed $50,000. Without this provision for delegation and redelegation, the ATF Director must personally approve all submitted FTCA claims, regardless of size or merit. This rule provides flexibility to the Director of ATF and is consistent with the redelegation authority of the FBI Director under current § 0.89a(c) (which is being redesignated by this rule as § 0.89a(b)). With this flexibility, the ATF can more efficiently process FTCA claims.

The Attorney General believes that consolidating under § 0.172 the authority of heads of certain components within the Department of Justice to settle FTCA claims and ensuring uniform language across §§ 0.89a, 0.132, and 0.172 that is consistent with 28 U.S.C. 2672 will facilitate more consistent treatment of these claims.

Notice and comment rulemaking is not required for this final rule. Under the APA, “rules of agency organization, procedure or practice,” 5 U.S.C. 553(b)(A), that do not “affect[] individual rights and obligations,” Morton v. Ruiz, 415 U.S. 199, 232 (1974), are exempt from the general notice and comment requirements of section 553. See JEM Broad. Co. v. FCC, 22 F.3d 320, 326 (D.C. Cir. 1994) (holding that the procedural exception applies to “agency actions that do not themselves alter the rights or interests of parties, although [they] may alter the manner in which the parties present themselves or their viewpoints to the agency” (quoting Batterton v. Marshall, 648 F.2d 694, 707 (D.C. Cir. 1980) (internal quotation marks omitted)). The revision to 28 CFR 0.89a, 0.132, and 0.172 is purely a matter of agency organization, procedure, and practice. The final rule will not affect substantive rights or interests of persons presenting their FTCA claims to the relevant agencies of the Department of Justice.

The Attorney General, in accordance with the Regulatory Flexibility Act, 5 U.S.C. 605(b), has reviewed this rule and, by approving it, certifies that it will not have a significant economic impact on a substantial number of small entities because it pertains to personnel and administrative matters affecting the Department. Further, a Regulatory Flexibility Analysis is not required for this final rule because the Department was not required to publish a general notice of proposed rulemaking for this matter.

This rule has been drafted and reviewed in accordance with Executive Order 12866, Regulatory Planning and Review, section 1(b), Principles of Regulation, and in accordance with Executive Order 13563, Improving Regulation and Regulatory Review, section 1(b), General Principles of Regulation. This rule is limited to agency organization, management, or personnel matters as described by Executive Order 12866, section 3(d)(3), and therefore is not a “regulation” or “rule” as defined by Executive Order 12866. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. The Department has assessed the costs and benefits of this rule and believes that the regulatory approach selected maximizes net benefits.

This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform.

This rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, Federalism, the Department has determined that this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.

This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions are necessary under the provisions of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1501 et seq.

This rule is not a major rule as defined by section 251 of the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 804. This rule will not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets.

This action pertains to agency management, personnel, and organization and does not substantially affect the rights or obligations of non-agency parties. Accordingly, it is not a “rule” for purposes of the reporting requirement of 5 U.S.C. 801.

Accordingly, by virtue of the authority vested in me as Attorney General, including 5 U.S.C. 301, and 28 U.S.C. 509, 510, and for the reasons set forth in the preamble, part 0 of title 28 of the Code of Federal Regulations is amended as follows:

This document adopts as a final rule without change a proposed rule amending the Department of Veterans Affairs (VA) regulations. On November 10, 2011, VA published in the Federal Register (76 FR 70076) a proposal to amend VA regulations to update the reference to the required resident assessment tool for State homes providing nursing home care, CMS Resident Assessment Instrument/MDS. The MDS is a core set of screening, clinical, and functional status elements that form the foundation of the comprehensive assessment for all residents of long term care facilities certified to participate in Medicare and Medicaid. The MDS is the standardized assessment instrument in long term care that is used to identify the health care needs of residents and generate a plan of care, regardless of source of payment for the individual resident. VA therefore requires State homes receiving per diem for the provision of long term care to veterans to use the MDS, and implements this requirement in 38 CFR 51.110(b)(1)(i).

On October 1, 2010, all CMS certified long term care facilities were required to update their assessment from MDS 2.0 to MDS 3.0. VA in turn proposed in a rulemaking that State homes receiving per diem to provide long term care to veterans use the most up to date version of MDS. Interested persons were invited to submit comments to the proposed rule on or before January 9, 2012, and we received no comments. Therefore, based on the rationale set forth in the proposed rule, VA is adopting the proposed rule as a final rule without change.

Title 38 of the Code of Federal Regulations, as revised by this rulemaking, represents VA's implementation of its legal authority on this subject. Other than future amendments to this regulation or governing statutes, no contrary guidance or procedures are authorized. All existing or subsequent VA guidance must be read to conform with this rulemaking if possible or, if not possible, such guidance is superseded by this rulemaking.

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

The Secretary hereby certifies that this regulatory amendment 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 amendment will not directly affect any small entities, as the State homes that are subject to this rulemaking are State government entities under the control of State governments. All State homes are owned, operated, and managed by State governments except for a small number that are operated by entities under contract with State governments. These contractors are not small entities. Therefore, under 5 U.S.C. 605(b), this amendment is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.

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), 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.

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 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 given year. This rule will have no such effect on State, local, and tribal governments, or on the private sector.

The Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this document are 64.005, Grants to States for Construction of State Home Facilities; 64.009, Veterans Medical Care Benefits; 64.010, Veterans Nursing Home Care; 64.015, Veterans State Nursing Home Care; 64.018, Sharing Specialized Medical Resources; 64.019, Veterans Rehabilitation, Alcohol and Drug Dependence.

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. John R. Gingrich, Chief of Staff, Department of Veterans Affairs, approved this document on April 24, 2012, for publication.

For the reasons stated in the preamble, the Department of Veterans Affairs is amending 38 CFR part 51 as follows:

Background

On March 2, 2012, the Postal Service published a proposed rule in the Federal Register (77 FR 12764-12769) to discontinue price eligibility for POSTNET barcodes. For automation letters and flats and for Qualified Business Reply Mail (QBRM), an Intelligent Mail barcode (IMb TM ) will be required.

The Postal Service received 27 comments from a variety of mailers and from several mailer associations. Some of the initial comments were critical of one proposed element to require a barcode clear zone on all letters. To maintain focus on the discontinuation of price eligibility based on the POSTNET barcode, USPS® quickly responded by deleting that element from the proposal. There were 11 comments specifically critical of the main proposal to discontinue POSTNET barcodes for automation letter and flat price eligibility. There were six comments specifically in agreement with the main proposal. One association strongly recommended that two IMbs be allowed on each piece, to facilitate processing by presort companies. We added language to specifically allow more than one barcode on automation letters under certain conditions. For flats, we also changed the proposed language to allow more than one barcode on each automation flat under certain circumstances, due to anticipated flats sortation software upgrades in early 2013. Other comments, and our responses, follow.

Comment: Mailers may be forced to make considerable investments in new printers; and some felt they will not be able to and will be forced to stop mailing.

Response: Print technology has evolved over the past several years increasing in efficiency, and in many instances, lowering unit cost. Additionally, instead of replacing printers, existing models may be able to be upgraded with fonts that assist in maintaining speed while printing IMbs. The Postal Service RIBBS® Web site (ribbs.usps.gov) has a tool that enables fonts to be downloaded to assist in printing IMbs.

Comment: Allow the use of the POSTNET barcode for automation prices, but at higher prices than for the use of the Intelligent Mail barcode (IMb).

Response: Since the POSTNET barcode is not capable of including information other than the routing code, we will not be including its use for any automation pricing as of January 2013.

Comment: There were problems for some mailers when they tried to convert to IMb and not enough USPS support to surmount problems.

Response: The staff of the district Business Mail Entry offices are available for customer assistance, RIBBS material and tools are being updated, and local Postal Customer Councils will be assisting customers. There will be designated support personnel at the district level to help with the transition.

Comment: There is no perceived benefit to converting to IMb for local mailers who are satisfied with their current level of service.

Response: Converting to IMb is an important first step on the way to full-service automation, which allows for free address correction as well as better mailpiece visibility. Increased mail visibility not only helps the mailers directly, but also helps them indirectly by allowing the Postal Service to fine tune its processes.

Comment: The USPS has provided plenty of time to convert to IMb. The industry as a whole will benefit by standardizing to the use of one barcode format.

Response: We appreciate the supportive comments.

The Postal Service will discontinue price eligibility for the use of POSTNET barcodes and allow only IMbs for automation price eligibility purposes (including QBRM prices). The Postal Service understands that some mailers currently use POSTNET barcodes and we are committed to providing information to and working with individual mailers and software providers to ensure that the use of an Intelligent Mail barcode is achievable for all mailing customers.

For the past several years, both USPS and the mailing industry have used the IMb to gain information about letters and flats as they move from induction to delivery. As of January 27, 2013, the use of the IMb will be required for all automation letters, including Business Reply Mail® letters that qualify for Qualified Business Reply Mail prices, Permit Reply Mail letters, and automation flats.

To maintain focus on the POSTNET barcode discontinuation, the Postal Service removed the proposal to require barcode clear zones on all automation letters and cards and all letters and cards claiming an automation carrier route letter price, and to require all machinable letters to have barcode clear zones. We will retain the current language for barcode clear zones.

Currently, the POSTNET barcode is an available option to satisfy the parcel barcode requirement for Standard Mail® parcels. We will discontinue the eligible use of the POSTNET barcode on parcels, and disallow its use on parcels unless it is printed in the address block. EVS® parcels would not be allowed to bear POSTNET barcodes in any location.

The Postal Service adopts the following changes to Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM), which is incorporated by reference in the Code of Federal Regulations. See 39 CFR 111.1.

Accordingly, 39 CFR Part 111 is amended as follows:

Executive Summary

Why we need to publish a rule. We listed the wood bison as endangered in 1970. Since listing, the status of wood bison has improved because enactment and enforcement of national and international laws and treaties have minimized the impacts of hunting and trade, and reintroduction of disease-free herds has increased the number of free-ranging herds in Canada from 1 population of 300 in 1978, to 7 populations totaling 4,414 bison in 2008. These free-ranging populations are stable or increasing. Therefore, we have determined that the wood bison no longer meets the definition of endangered under the Endangered Species Act.

This rule changes the listing of the wood bison from endangered to threatened.

Basis for our action. While we have determined that the wood bison no longer meets the definition of endangered under the Endangered Species Act, some threats to wood bison remain. Habitat loss has occurred in Canada from agricultural development, and we expect losses will continue in concert with human growth and expansion of agriculture, including commercial bison production. The presence of disease in Canada constrains herd growth, and regulatory mechanisms are inadequate to prevent disease transmission within Canada. However, the continued reintroduction of disease-free herds, the ongoing development and updating of management plans, the active management of herds, the ongoing research, and the protections provided by laws and protected lands provide compelling evidence that recovery actions have been successful in reducing the risk of extinction associated with the threats identified. Therefore, we are reclassifying the wood bison from endangered to threatened.

The majority of comments we received support this action. The majority of comments (13 of 19) supported downlisting. A subset of these comments (7 of the 13) asserted that the Service should delist the species immediately. Three comments stated that wood bison should remain listed as endangered. The peer review comments provided very specific corrections to details about two of the wood bison herds in Canada, and we have updated our information in this rule accordingly, but these changes do not alter our finding.

The listing history for wood bison is extensive and was described in the proposed rule published on February 8, 2011 (76 FR 6734). Please refer to that proposed rule for the complete listing history. Here we present only the most pertinent facts.

The wood bison became listed in the United States under the 1969 Endangered Species Conservation Act when it was included on the first List of Endangered Foreign Fish and Wildlife, which was published in the Federal Register on June 2, 1970 (35 FR 8491). In 1974, the first list of federally protected species under the 1973 Endangered Species Act (Act; 16 U.S.C. 1531 et seq. ) appeared in the Code of Federal Regulations (CFR), and the wood bison appeared on this list based on its inclusion on the original 1969 list. Because the wood bison was listed under the 1969 Endangered Species Conservation Act and grandfathered in for protection under the Act, there is not a separate Federal Register notice that defined the population(s) and their range or analyzed threats to the species. The wood bison was classified as endangered and has retained that designation since the original listing.

On May 14, 1998, the Service received a petition from a private individual requesting that the Service remove the wood bison from the List of Endangered and Threatened Wildlife, primarily because it had been downgraded from an Appendix I to an Appendix II species under the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES). In a 90-day finding published on November 25, 1998 (63 FR 65164), we found that the petitioner did not provide substantial information to indicate that the delisting may be warranted.

On November 26, 2007, we received a petition from the co-chairs of Canada's National Wood Bison Recovery Team, requesting that we reclassify the wood bison from endangered to threatened. On February 3, 2009, we published a 90-day finding (74 FR 5908) acknowledging that the petition provided sufficient information to indicate that reclassification may be warranted and that we would initiate a status review. On February 8, 2011, we announced the completion of our status review of the species, which also constituted our 5-year review under section 4(c)(2) of the Act, and issued a proposed rule to reclassify the wood bison from an endangered species to a threatened species (76 FR 6734). This document is our final rule to reclassify the wood bison from endangered to threatened.

Wood bison ( Bison bison athabascae ) belongs to the family Bovidae, which also includes cattle, sheep, and goats. Debate over the generic name Bison continues with some authorities using Bos and others using Bison depending on the methodology used to determine relationships among members of the tribe Bovini (Asian water buffalo, African buffalo, cattle and their wild relatives, and bison) (Boyd et al. 2010, pp. 13-15). In this discussion, we will use Bison, which is consistent with “Wild Mammals of North America” (Reynolds et al. 2003, p. 1010), “Mammal Species of the World” (Wilson and Reeder 2005, p. 689), and the Wood Bison Recovery Team (Gates et al. 2001, p. 25). Wood bison was first described as a subspecies in 1897 (Rhoads 1897, pp. 498-500). One other extant bison subspecies, the plains bison ( B. b. bison ), occurs in the United States and Canada. Based on the historical physical separation and quantifiable behavioral, morphological, and phenological (appearance) differences between the two subspecies, the scientific evidence indicates that subspecific designation is appropriate (van Zyll de Jong et al. 1995, p. 403; FEAP 1990, p. 24; Reynolds et al. 2003, p. 1010; Gates et al. 2010, pp. 15-17).

Wood bison is the largest native extant terrestrial mammal in North America (Reynolds et al. 2003, p. 1015). Average weight of mature males (age 8) is 910 kilograms (kg) (2,006 pounds (lb)) and the average weight of mature females (age 13) is 440 kg (970 lb) (Reynolds et al. 2003, p. 1015). They have a large triangular head, a thin beard and rudimentary throat mane, and a poorly demarcated cape (Boyd et al. 2010, p. 16). In addition, the highest point of their hump is forward of their front legs; they have reduced chaps on their front legs; and their horns usually extend above the hair on their head (Boyd et al. 2010, p. 16). These physical characteristics distinguish them from the plains bison (Reynolds et al. 2003, p. 1015; Boyd et al. 2010, p. 16).

The exact extent of the original range of wood bison cannot be determined with certainty based on available information, but was limited to North America (Gates et al. 2001, p. 11). However, historically, the range of the wood bison was generally north of that occupied by the plains bison and included most boreal regions of northern Alberta, northeastern British Columbia east of Cordillera, a small portion of northwestern Saskatchewan, the western Northwest Territories south and west of Great Slave Lake, the Mackenzie River Valley, most of The Yukon Territory, and much of interior Alaska (Reynolds et al. 2003, pp. 1011-1012). Skinner and Kaisen (1947, pp. 158, 164) suggested that the prehistorical U.S. range extended from Alaska to Colorado, and Stephenson et al. (2001, p. 140) concluded that wood bison were present within the boundaries of what is now defined as Alaska until their disappearance during the last few hundred years. Currently, there is a wild population neither in Alaska nor in the continental United States (Harper and Gates 2000, p. 917; Stephenson et al. 2001, p. 140).

During the early 1800s, wood bison numbers were estimated at 168,000, but by the late 1800s, the subspecies was nearly eliminated, with only a few hundred remaining (Gates et al. 2001, p. 11). In the words of Soper (1941, p. 362), wood “bison appear to have been practically exterminated,” and based on the fate of plains bison, in which 40 to 60 million animals were reduced to just over 1,000 animals in less than 100 years (Hornaday 1889; Wilson and Strobeck 1998, p. 180), overharvest may have been the cause for the decline (Harper and Gates 2000, p. 915). The fact that populations began to rebound once protection was in place and enforced supports this idea (Soper 1941, pp. 362-363). In 1922, Wood Buffalo National Park (WBNP) was set aside for the protection of the last remnant population of wood bison. Since that time, several additional herds have been established (Table 1).

Another factor that is thought to have played a role in the decline in wood bison is a gradual loss of meadow habitat through forest encroachment (Stephenson et al. 2001, p. 143; Quinlan et al. 2003, p. 343; Strong and Gates 2009, p. 439). Although not quantified, it is likely that because of fire suppression, and subsequent forest encroachment on meadows, there was a net loss of suitable open meadow habitat for wood bison throughout their range through about 1990. More intensive fire management began in Canada in the early 1900s with the philosophy that fire was destructive and should be eliminated to protect property and permit proper forest management (Stocks et al. 2003, p. 2). However, wildfire is an integral component of boreal forest ecology (Weber and Flannigan 1997, p. 146; Rupp et al. 2004, p. 213; Soja et al. 2007, p. 277). Without fire, trees encroach on meadows and eventually the meadow habitat is lost and replaced by forest.

The foraging habitats most favored by wood bison are grass and sedge meadows occurring on alkaline soils. These meadows are typically interspersed among tracts of coniferous forest, stands of poplar or aspen, bogs, fens, and shrublands. Meadows typically represent 5 to 20 percent of the landscape occupied by wood bison (Larter and Gates 1991a, p. 2682; Gates et al. 2001, p. 23). Wet meadows are rarely used in the summer, probably because of the energy required to maneuver through the mud, but they are used in late summer when they become drier, and in the winter when they freeze (Larter and Gates 1991b, pp. 133, 135; Strong and Gates 2009, p. 438).

Because wood bison can thrive on coarse grasses and sedges, they occupy a niche within the boreal forest that is not utilized by other northern herbivores such as moose or caribou (Gates et al. 2001, p. 25). Several studies indicate that wood bison prefer sedges ( Carex spp.), which can comprise up to 98 percent of the winter diet (Reynolds et al. 1978, p. 586; Smith 1990, p. 88; Larter and Gates 1991a, p. 2679; Fortin et al. 2003, pp. 224-225). Seasonally, other important diet items include grasses, willow, and lichen (Reynolds et al. 1978, p. 586; Smith 1990, p. 88; Larter and Gates 1991a, pp. 2680-2681; Fortin et al. 2003, pp. 224-225).

Free-ranging wood bison roam extensively with annual maximum traveling distance from each individual's center-of-activity averaging from 45 to 50 kilometers (km) (28 to 31 miles (mi)) (Chen and Morley 2005, p. 430). However, some captive animals released into the wild have traveled over 250 km (155 mi) (Gates et al. 1992, pp. 151-152). Herds are fluid, and individuals interchange freely (Fuller 1960, p. 15; Wilson et al. 2002, p. 1545). Wood bison travel between favored foraging habitats along direct routes including established trails, roads, river corridors, and transmission lines (Reynolds et al. 1978, p. 587; Mitchell 2002, p. 50). Bison are also powerful swimmers and will cross even large rivers such as the Peace, Slave, Liard, and Nahanni to reach forage, provided that there are low banks for entry and exit (Fuller 1960, p. 5; Mitchell 2002, pp. 32, 50; Larter et al. 2003, pp. 408-412).

The wood bison's breeding season is from July to October. The age of first reproduction depends on nutritional condition and disease status, and is therefore variable (Gates et al. 2010, p. 49). Females typically produce their first calf when they are 3 years old and may be reproductively successful up to age 20 (Wilson et al. 2002, p. 1545). Although capable of reproduction at age 2, males typically do not participate in the rut until they are 5 or 6, and reproductive success is at its maximum between ages 7 and 14 (Wilson et al. 2002, pp. 1538, 1544). Bison have a polygynous mating system, in which one male mates with several females (Wilson et al. 2002, p. 1538). When habitat is adequate and there are no other limiting factors such as disease and predation, wood bison populations have expanded exponentially (FEAP 1990, pp. 34-35; Gates and Larter 1990, p. 233). Consequently, newly introduced populations have the capacity to grow quickly, as demonstrated by the Mackenzie herd (Gates and Larter 1990, p. 235).

Wood bison are susceptible to a variety of diseases that may affect their population dynamics. The most important are anthrax, bovine brucellosis, and bovine tuberculosis, none of which are endemic to wood bison (Gates et al. 2010, pp. 28-32). Anthrax is an infectious bacterial disease that is transmitted through the inhalation or ingestion of endospores (Gates et al. 2010, p. 28). The disease is rapidly fatal, with death usually occurring within several days once the clinical signs appear (Dragon et al. 1999, p. 209). Between 1962 and 1993, nine outbreaks were recorded in northern Canada, killing at least 1,309 bison (Dragon et al. 1999, p. 209). Additional outbreaks continued to occur through at least 2010 (GNT 2010, p. 9). Factors associated with outbreaks are high ambient temperatures, high densities of insects, and high densities of bison as they congregate in areas of diminishing forage and water (Dragon et al. 1999, p. 212). Sexually mature males are more susceptible than cows, juveniles, or calves, perhaps because of elevated levels of testosterone (Dragon et al. 1999, p. 211). Anthrax is not treatable in free-ranging wildlife, but captive bison can be vaccinated effectively and treated with antibiotics (Gates et al. 2001, p. 22)

Bovine brucellosis is caused by the bacterium Brucella abortus (Tessaro 1989, p. 416). Although the primary hosts are bovids, other ungulates such as elk can be infected. The disease is primarily transmitted through oral contact with aborted fetuses, contaminated placentas, and uterine discharges. Greater than 90 percent of infected female bison abort during their first pregnancy (Gates et al. 2010, p. 30). Naturally acquired immunity reduces the abortion rate with subsequent pregnancies (Aune and Gates 2010, p. 30). Male bison experience inflammation of their reproductive organs and, in advanced cases, sterility. Both sexes are susceptible to bursitis and arthritis caused by concentrations of the bacterium in the joints, which may make them more susceptible to predation (Joly 2001, pp. 97-98). Two vaccines, S19 and SR B51, have been developed in an attempt to prevent bovine brucellosis (Aune and Gates 2010, pp. 30-31); however, brucellosis remains extremely difficult to eradicate in ungulates. The combined use of quarantine protocols, serum testing, slaughter, and vaccination is being explored as a means of controlling the disease (Nishi et al. 2002, pp. 230-233; Bienen and Tabor 2006, pp. 324-325; Aune and Gates 2010, p. 31).

Bovine tuberculosis is a chronic infectious disease caused by the bacterium Mycobacterium bovis (Tessaro 1989, p. 417). Historical evidence indicates that bovine tuberculosis did not occur in bison prior to contact with infected domestic cattle (Tessaro 1989, p. 416). Wood bison were infected in the 1920s, when plains bison were introduced into the range of wood bison (Tessaro 1989, p. 417). Currently, the disease is concentrated in bison in and near WBNP (Wabasca, Wentzel, and Slave River Lowlands herds). The disease is primarily transmitted by inhalation and ingestion of the bacterium, but may also pass to offspring through the placenta or contaminated milk (FEAP 1990, p. 11). Bovine tuberculosis is a chronic disease that progressively becomes debilitating; advanced cases are fatal. There is not an effective vaccine for immunization against tuberculosis (FEAP 1990, p. 2).

Wood bison herds in and around WBNP, Alberta and the Northwest Territories, Canada, are infected with brucellosis and bovine tuberculosis. These diseased herds account for about half of the free-ranging wood bison and are the only known reservoirs of tuberculosis and brucellosis among the herds (Gates et al. 2010, pp. 4, 35). Approximately 30 percent of the animals in these herds test positive for brucellosis, and 21 to 49 percent test positive for tuberculosis. The combined prevalence of the two diseases is 42 percent (Tessaro et al. 1990, p. 174; Gates et al. 2010, p. 35). Wood bison cows infected with both tuberculosis and brucellosis are less likely to be pregnant, and infected herds are more likely to have their populations regulated by wolf predation (Tessaro et al. 1990, p. 179; Joly and Messier 2004, p. 1173; Joly and Messier 2005, p. 549). Unlike anthrax, which occurs in outbreaks in which many animals die at one time, brucellosis and tuberculosis are chronic diseases that weaken animals over time.

In Canada, the Committee on the Status of Endangered Wildlife in Canada (COSEWIC) was established in 1977, to assess species' status and evaluate their risk of extinction. In 1978, the COSEWIC designated wood bison as endangered, based primarily on the fact that there were only about 400 disease-free wood bison: 100 in a captive herd and 300 in a free-ranging herd. In 1988, wood bison was downlisted to threatened in Canada because of data presented in a status report prepared by the National Wood Bison Recovery Team that documented progress towards recovery (Gates et al. 2001, p. 28; Gates et al. 2010, p. 65). A review by the COSEWIC in 2000 confirmed that “threatened” was the appropriate designation at that time (Gates et al. 2010, p. 65).

The wood bison was listed in Appendix I of the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) on July 1, 1975, when the treaty first went into effect. On September 18, 1997, it was transferred to Appendix II, based on a proposal from Canada that described progress in implementation of the Canadian recovery plan (Government of Canada 1997, entire). CITES Appendix-II species are not necessarily considered to be threatened with extinction now but may become so unless trade in the species is regulated. The United States supported this change.

Section 4(f) of the Act directs us to develop and implement recovery plans for the conservation and survival of endangered and threatened species, unless the Director determines that such a plan will not promote the conservation of the species. The Service has not developed a recovery plan for wood bison, because no wild populations of wood bison currently exist in the United States. In Canada, the National Wood Bison Recovery Team published a national recovery plan in 2001 (Gates et al. 2001), and is currently preparing a revision to the plan. The purpose of the recovery plan is to advance the recovery of the wood bison; specific criteria for delisting under Canada's Species at Risk Act (SARA) were not specified. Management plans for the provinces support the goals and objectives of the National Recovery Plan (e.g., Harper and Gates 2000, p. 917; GNT 2010, p. 1). Four goals were established to advance the recovery of wood bison (Gates et al. 2001):

(1) To reestablish at least four discrete, free-ranging, disease-free, and viable populations of 400 or more wood bison in Canada, emphasizing recovery in their original range, thereby enhancing the prospects for survival of the subspecies and contributing to the maintenance of ecological processes and biological diversity.

(2) To foster the restoration of wood bison in other parts of their original range and in suitable habitat elsewhere, thereby ensuring their long-term survival.

(3) To ensure that the genetic integrity of wood bison is maintained without further loss as a consequence of human intervention.

(4) To restore disease-free wood bison herds, thereby contributing to the aesthetic, cultural, economic, and social well-being of local communities and society in general.

Revisions to the U.S. List of Endangered and Threatened Wildlife (adding, removing, or reclassifying a species) must reflect determinations made in accordance with sections 4(a)(1) and 4(b) of the Act. Section 4(a)(1) requires that the Secretary determine whether a species is endangered or threatened, as defined by the Act, because of one or more of the five factors outlined in section 4(a)(1). In other words, an analysis of the five factors under 4(a)(1) can result in a determination that a species is no longer endangered or threatened. Section 4(b) requires that the determination made under section 4(a)(1) be based on the best scientific and commercial data available and after taking into account those efforts, if any, being made by any State or foreign nation to protect such species. Here, we rely on the five-factor analysis to determine if it is appropriate to reclassify wood bison. We also take into consideration the conservation actions that have occurred, are ongoing, and are planned.

In 1978, there was one free-ranging, disease-free herd with 300 individuals: the MacKenzie herd (see Table 1, above). By 2000, when the last Canadian status review was conducted, the number of disease-free herds had grown to 6, with a total of approximately 2,800 individuals (see Table 1, above). Since 2000, an additional herd has been established bringing the total number to 7, and the number of disease-free, free-ranging bison has increased to approximately 4,400 (see Table 1, above). Four of the herds have a population of 400 or more, meeting recovery goal number 1 (see Table 1, above). The free-ranging, disease-free herds are discussed in detail below.

The Mackenzie bison herd was established in 1963, with the translocation of 18 wood bison that were originally captured in an isolated area of WBNP. This herd is currently the largest free-ranging, disease-free herd of wood bison, with approximately 1,600 to 2,000 animals (Reynolds et al. 2004, p. 7). The Mackenzie Bison Sanctuary was established in 1979, and encompasses an area of 6,300 km 2 (2,432 mi 2 ) northwest of Great Slave Lake. The current range of the Mackenzie bison herd (12,000 km 2 (4,633 mi 2 )) extends well beyond the boundaries of the sanctuary. In 2010, the Government of Northwest Territories released the final Wood Bison Management Strategy. It indicates that there is sufficient habitat in the Northwest Territories to support expanding bison populations (GNWT 2010, p. 9). Habitat protection within the range of the Mackenzie bison herd is facilitated through the Species at Risk Act (SARA), Canada's equivalent to the Act, and the Mackenzie Valley Resource Management Act of 1998. Although the Mackenzie Valley Resource Management Act does not specifically provide protection to wood bison, it did create a Land and Water Board (LWB), which is given the power to regulate the use of land and water, including the issuance of land use permits and water licenses. Under current management, an annual harvest is allowed (described under Factor B below), and the Mackenzie herd size has been greater than the recovery target of 400 since 1987, with approximately 1,600 to 2,000 animals (Gates and Larter 1999, p. 233; see Table 1, above). Thus, the Mackenzie herd contributes to recovery goals 1 and 4.

Five releases of wood bison totaling 170 animals from 1988 to 1991 established the Aishihik herd in southwestern Yukon, in a remote area west of Whitehorse, Canada. Herd size has totaled over 400 since 1999 (Gates et al. 2001, p. 14; see Table 1, above). With a current population of approximately 1,100 animals, it is the second-largest herd. The herd inhabits approximately 9,000 km 2 (3,475 mi 2 ) of largely undeveloped habitat near the community of Haines Junction, adjacent to Kluane National Park. Less than 5 percent of the range of the Aishihik herd is on private lands (First Nation Settlement Lands), and these landowners participate in a management planning team specifically for this herd. The remainder of the herd's range is owned by the Government of Canada, and there are no threats to habitat in this area (Reynolds et al. 2004, p. 9). The herd has room to expand or shift its range, because there are no large-scale developments east, west, or north of the present range for several hundred kilometers. Small-scale agricultural development to the south of the present range, however, could restrict range expansion in that direction (Reynolds et al. 2004, p. 9). Regulated hunting occurs on this herd (described under Factor B below). Other than regulated harvest, no other limiting factors have been identified (Reynolds et al. 2004, p. 17). The Aishihik herd contributes to recovery goals 1, 2, and 4.

The Hay-Zama herd was established in 1984, when 29 wood bison were transferred from Elk Island National Park to the holding corral site near Hay-Zama Lakes, Alberta (Gates et al. 2001, p. 17). A herd of 48 wood bison became free-ranging when portions of the corral they were being held in collapsed in 1993 (Gates et al. 2001, p. 17). Since then, the free-ranging herd has grown to approximately 750 animals (Table 1), thus contributing to recovery goals 1, 2, and 4. In 1995, the Government of Alberta established a 36,000 km 2 (13,900 mi 2 ) Bison Management Area around the Hay-Zama herd in the northwestern corner of the province. In this area, all wood bison are legally protected from hunting under Alberta's Wildlife Act; outside of the area they are not protected. Collisions with vehicles are the largest source of known mortality for individuals in this herd (Mitchell and Gates 2002, p. 9).

The Nahanni herd, established in 1980 with the release of 28 wood bison, occurs primarily in the Northwest Territories and extends into southeast Yukon and northeast British Columbia. The population was bolstered by two supplemental releases in 1989 and 1998, of 12 and 59 animals, respectively (Larter and Allaire 2007, p. 3). Population size has been approximately 400 animals or more since 2006, and, based on surveys, was estimated at 413 in 2010 (Larter, GNWT, 2010, pers. comm.). There is currently sufficient habitat to support the expanding population (GNT 2010, p. 9).

The Nordquist herd was established in 1995, near the Laird River in northeastern British Columbia (see Table 1, above). Because the majority of the herd occupies habitat near the Alaska Highway, vehicle collisions are a source of mortality (Reynolds et al. 2009, p. 6). It is anticipated that the Nordquist and Nahanni herds will eventually coalesce into one herd because of their close proximity and the presence of river corridors that provide travel corridors (Gates et al. 2001, p. 18). Although it has not yet occurred, combination of the two herds would create a herd with numbers that exceed the recovery criterion of 400 (see Table 1, above).

The Etthithun herd was established in 2002, near Etthithun Lake, British Columbia. Factors limiting the size of this herd include the amount and location of suitable habitat, conflicts with humans and industrial development, and potential contact with commercial plains bison (BC MOE, pers. comm., 2010). Current population size is approximately 124 (see Table 1, above); consequently, this herd does not currently meet the recovery criterion of 400 individuals. However, it does contribute to recovery goals 2 and 4.

The Chitek Lake herd was established in 1991, in Manitoba, Canada. The Chitek Lake Wood Bison Management Committee plans to maintain the herd at approximately 300 animals to keep the herd within carrying capacity of the habitat. The 100,300-hectare (ha) (25,452-acre (ac)) Chitek Lake Park Reserve provides habitat protection for the core range of the herd. Limiting factors for the herd include accidental mortality from drowning, starvation in bad winters, and predation from wolves (Manitoba Conservation, pers. comm., 2010). Although outside of the historic range of wood bison, Chitek Lake herd plays an important role in wood bison conservation because it is an isolated, disease-free herd and, consequently, provides security to the species through population redundancy, thus contributing to recovery goal 2.

In addition to the free-ranging wood bison herds discussed above, four captive herds have been established, although only three are currently viable. The Elk Island National Park herd in Alberta, Canada, was established in 1965, from wood bison transferred from an isolated portion of WBNP. It is the national conservation herd and has provided disease-free stock for six of the free-ranging populations and several captive breeding herds in zoos and private commercial ranches (Gates et al. 1992, p. 153). Carrying capacity at Elk Island National Park is approximately 350 animals; animals above this number are regarded as surplus and are removed to establish and supplement free-roaming populations in former areas of their historic range (Parks Canada 2009a, unpaginated). Although the herd is fenced, the animals are semi-wild and spend the majority of their time roaming the 65 km 2 (25 mi 2 ) enclosure, interacting with the environment in a largely natural manner (Gates et al. 2001, p. 18). The herd is rounded up annually to test for disease and to vaccinate for common cattle diseases. The age, sex, and condition of all the individuals are determined to inform management decisions. Using this information, individuals are selected for sale, donation, or the establishment of new herds, which also controls the population size of the herd (Parks Canada 2009b, unpaginated). This conservation herd contributes to recovery goals 2, 3, and 4.

The Hook Lake Wood Bison Recovery Project was initiated to establish a captive, disease-free herd from a wild herd infected with brucellosis and tuberculosis. The overall objective of the project was to determine the feasibility of genetic salvage from a diseased herd (Nishi et al. 2002, p. 230). Specific objectives of the project were to conserve the genetic integrity of the wild herd by capturing an adequate number of calves, provide intensive veterinary and preventative drug treatment to eliminate disease from the calves, and raise a disease-free herd from the salvaged calves (Nishi et al. 2002, p. 229). From 1996 to 1998, 62 calves were captured. The disease eradication protocol included orphaning newborn, wild-caught calves to minimize their exposure to B. abortus and M. bovis; testing calves for antibodies to brucellosis prior to inclusion in the new herd; treating with antimycobacterial and anti- Brucella drugs; and intensive, whole-herd testing for both diseases (Nishi et al. 2002, p. 229). By 2002, the herd size was 122. In 2006, after 9 years of intensive management, the herd was destroyed because bovine tuberculosis was discovered in 2005 in 2 founding animals and 10 captive-born animals, even though all animals initially tested disease-free. The herd provided valuable information on genetic salvage, genetic management, captive breeding for conservation, disease testing, and the difficulties involved in eradicating disease (Wilson et al. 2003, pp. 24-35). The Hook Lake Herd contributed to recovery goal 3.

In April 2006, 30 wood bison calves were transferred from Elk Island National Park to Lenski Stolby Nature Park near Yakutsk, Sahka Republic (Yakutia), Russia. An additional 30 head were transferred in 2011. Although outside the historical range, this was an opportunity to create another geographically separate population that provides added security to the species through population redundancy, thereby contributing to recovery goal 2. Transfer of wood bison to Russia was specifically mentioned in the recovery plan because it would contribute to the global security of the species (Gates et al., 2001, p. 14).

In June 2008, 53 disease-free wood bison were transferred from Elk Island National Park to the Alaska Wildlife Conservation Center in Portage, Alaska. Consequently, this captive herd currently contributes to recovery goal number 2 through population redundancy. Ultimately, the Alaska Department of Fish and Game (ADFG) plans to restore wood bison populations in one to three areas in interior Alaska, with potential herd size of 500 to 2,000 or more depending on the location (ADF&G 2007, p. 79). Environmental analysis of the project is currently under review. The National Wood Bison Recovery Team in Canada recommended establishing one or more populations in Alaska in areas that can support 400 or more animals (Gates et al. 2001, p. 31). Establishment of one or more herds in Alaska would be a significant contribution to increasing the number of secure, disease-free, free-roaming herds.

In summary, since 1978, the number of free-ranging, disease-free herds has increased from 1 to 7, and the number of wood bison has increased from approximately 400 to over 4,000. The first recovery goal of establishing 4 free-ranging, disease-free herds with 400 or more animals has been met, and planning is underway to create one or more herds in Alaska. Although the number of herds needed to meet recovery goal 2 was not specified, progress has been made on the second goal with the establishment of disease-free herds in Russia; Manitoba, Canada; and Alaska. The Hook Lake Bison Recovery Project was a well-planned, science-based attempt to conserve the genetic diversity of a diseased herd and would have contributed greatly to recovery goal 3. Although ultimately the project was unsuccessful, a great deal of knowledge was gained (Wilson et al. 2003, pp. 62-67). The wood bison recovery team is very aware of the need to maintain genetic diversity in the herds and establishes new herds with the goal of maintaining genetic diversity through multiple introductions (i.e., the Aishihik herd, Nahanni, and Hook Lake herds). The establishment of six additional herds on the landscape since 1978 contributes to recovery goal 4. In addition, the captive population at Elk Island National Park has provided disease-free stock for those six additional herds and two captive herds. It is clear that there is active management of the herds, and multiple avenues of research are being funded and pursued regarding the biology and management of wood bison. Progress towards the recovery goals outlined in the national recovery plan, published by the National Wood Bison Recovery Team, is moving forward steadily.

In the proposed rule published on February 8, 2011 (76 FR 6734), we requested that all interested parties submit written comments on the proposal by April 11, 2011. We also contacted appropriate Federal and State agencies, scientific experts and organizations, and other interested parties and invited them to comment on the proposal. We did not receive any requests for a public hearing.

During the comment period for the proposed rule, we received 19 comment letters directly addressing the proposed listing of wood bison with threatened status. All substantive information provided during the comment period has either been incorporated directly into this final determination or addressed below. Several of the comments included opinions or information not directly related to the proposed rule, such as views relating to the reintroduction of wood bison into Alaska. We do not address those comments as they do not have bearing on the reclassification of wood bison.

In accordance with our peer review policy published on July 1, 1994 (59 FR 34270), we solicited expert opinion from three knowledgeable individuals with scientific expertise that included familiarity with wood bison and its habitat, biological needs, recovery efforts, and threats. We received a response from one of the peer reviewers.

We reviewed all comments received for substantive issues and new information regarding the listing of wood bison. The majority of comments (13 of 19) supported downlisting. A subset of these commenters (7 of the 13) thought the Service should delist the species immediately. Three commenters felt that wood bison should remain listed as endangered. The peer reviewer comments are addressed in the following summary and incorporated into the final rule as appropriate.

(1) Comment: The peer reviewer provided very specific corrections to details about two of the wood bison herds in Canada, the Nahanni and Mackenzie.

Our Response: As the reviewer noted, and we agree, the changes do not alter our finding. We have incorporated the details and updates for the Canadian herds provided by the reviewer into this final rule.

Comments received from the State of Alaska regarding the proposal to reclassify the wood bison are addressed below.

(2) Comment: The State agrees that “endangered” is not the appropriate designation for wood bison but states that the species should be removed from the List of Endangered and Threatened Wildlife (delisted), not reclassified as threatened. Several other commenters came to the same conclusion. They argue that recovery efforts in Canada have been successful enough that delisting is warranted.

Our Response: We agree that conservation efforts in Canada have led to significant increases in the number of herds and herd size. However, we also recognize that threats to the species, in particular disease, loss of habitat, and hybridization with plains bison, persist, and delisting is therefore not yet appropriate. We will continue to follow the progress of conservation efforts, and we will propose to delist wood bison if and when appropriate.

(3) Comment: The State and several commenters argued that listing under the Act provides no conservation benefits for the species in the United States, and may in fact be impeding conservation by making it more difficult to reintroduce wood bison into Alaska.

Our Response: Under section 4(b)(1)(A) of the Act, the Service must base a status determination solely on the best scientific and commercial data available. Thus, we cannot and did not base the decision to reclassify the wood bison under the Act on the efficacy of this action to conserve the species. Nevertheless, we disagree that listing is impeding conservation by making it more difficult to reintroduce the species to Alaska. Under the provisions of the Act's section 10(j), wood bison could be reintroduced into Alaska as an experimental, nonessential population. We have been working with the Alaska Department of Fish and Game on such a proposal, and both agencies agree that this approach may be a viable method for the reintroduction. Designating wood bison as an experimental, nonessential population would not only provide the means for reintroducing the animals, it would also provide assurances that conflicts with potential development would be minimal. Critical habitat is not designated for experimental, nonessential populations.

(4) Comment: The State commented that the only real impact from listing was to deny sportsmen the opportunity to import legally harvested wood bison trophies from Canada.

Our Response: We recognize that regulated hunting is an important component of Canada's recovery plan for the species; however, as explained above, listing determinations are based on evaluation of the factors affecting the species under section 4(a)(1) of the Act, using the best scientific and commercial information available. It is important to note that, under section 9(c)(2) of the Act, when the wood bison is reclassified to threatened status (see DATES , above), importation into the United States of sport-hunted trophies taken from Canada would not require a permit under 50 CFR 17.32, provided that a CITES Appendix-II export permit issued by the Canadian government accompanies the trophy when it arrives into the United States.

(5) Comment: We received two responses from the Northwest Territories. Both included specific minor corrections regarding herds, and both supported downlisting.

Our Response: The commenters stated, and we agree, that none of the corrections were significant in terms of the finding. We have incorporated the details and updates for the Canadian herds provided by the reviewers in this final rule.

(6) Comment: A few commenters argued that wood bison should remain listed as endangered. In summary, the reasoning presented was that the populations were too small, there is not enough habitat available, and hunting should not be allowed because of the small population sizes.

Our Response: The Canada's National Wood Bison Recovery Team and recovery plan set forth the reasoning for maintaining a minimum population (herd) size of 400 (Gates et al. 2001, p. 32). At this point, there are more than 4,000 disease-free wood bison in 7 herds and an additional 4,000 animals in WBNP that are subject to disease but have a stable population. Four separate disease-free populations have 400 or more animals (see Table 1, above). In addition, it has been demonstrated that wood bison, like plains bison and cattle, are relatively easy to breed and their populations can be managed for growth either in the wild (given adequate resources) or in captivity.

Although we agree that there has been a loss of suitable habitat, there has been enough suitable and available habitat for the reintroduction of six herds within their historical range in Canada. All of the herds that have been established in the wild have expanded in size and are self-sustaining (see Table 1, above). Regulations prevent excess harvest on the free-ranging herds. Regardless of classification type (endangered or threatened), regulation of hunting in Canada is outside the jurisdiction of the Act. Currently, Canada uses hunting of wood bison as a management tool for population control and to minimize the chances that disease will spread from one population to another. We found no evidence that hunting, as it is currently managed, is a threat to the species. For these reasons, we have concluded that wood bison are no longer on the brink of extinction and are, therefore, not endangered; rather, they are progressing steadily towards recovery.

(7) Comment: One commenter argued that wood bison should remain listed as endangered because Alaska is a significant portion of the wood bison's range. Because wood bison are extinct in Alaska, they should remain endangered until they are successfully introduced back into Alaska.

Our Response: The Service disagrees that the wood bison's historical range, which includes Alaska, constitutes a significant portion of the range such that the endangered classification under the Act must be retained because of the species' extirpation in that portion of the historical range. The text of the Act supports our conclusion that we cannot base this determination on the status of the species in lost historical range. As defined by the Act, a species is endangered only if it “is in danger of extinction” in all or a significant portion of its range. The phrase “is in danger” denotes a present-tense condition of being at risk of a current (or future) undesired event. Hence, to say a species “is in danger” in an area where it no longer exists—i.e., in its historical range where it has been extirpated—is inconsistent with common usage. Thus, we consider “range” within the definition of an “endangered species” to mean current range, not historical. In addition, in determining whether a species is an endangered species, the Act requires the Secretary to consider “present” or “threatened” (i.e., future), rather than past, “destruction, modification, or curtailment” of a species' habitat or range (16 U.S.C. 1533(a)(1)(A)). Furthermore, additional support for this conclusion is found in the Act's requirement that a summary of a proposed listing regulation be published in a newspaper “in each area of the United States in which the species is believed to occur” (16 U.S.C. 1533(b)(5)(D)). There is no requirement to such notice in areas where the species no longer occurs. For these reasons, Alaska cannot be a significant portion of the wood bison's range.

(8) Comment: One commenter felt that the proposed rule was deficient because we did not address the status of wood bison in Alaska and only looked at where wood bison currently exists. Thus, we should have included Alaska in our analysis as part of wood bison's historical range.

Our Response: As explained above in our response to Comment 7, a species' listing determination cannot be based on the status of the species within its lost historical range. Nevertheless, we did consider the effect of the loss of the wood bison's historical range on the viability of the species throughout all or a significant portion of its current range. Although the species has been extirpated from Alaska for quite some time and the historic population in Alaska is unknown, we conclude that the loss of species' historic range in Alaska does not place the species in danger of extinction throughout all or a significant portion of the range. As detailed more fully in our final determination, the wood bison populations in Canada have stabilized or are increasing, and are self-sustaining in the absence of a population in Alaska.

(9) Comment: Two commenters argued that wood bison is not a valid subspecies and that they should not be listed for that reason. One commenter stated that differences between wood and plains bison are only phenotypic (they look different), and that all wood bison are hybrids with plains bison. The commenter cites the work of Douglas et al. 2011, which concludes that based on mitochondrial sequences, wood and plains bison should not be considered separate subspecies.

Our Response: In the proposed rule (76 FR 6734), we outlined our reasoning for concluding that wood bison are a valid subspecies. We also acknowledged that because of the introduction of plains bison into WBNP there had been some introgression of plains bison genetic material into the wood bison genome. However, based on the historical physical separation, and quantifiable behavioral, morphological, and phenological (appearance) differences between the two subspecies, the scientific evidence indicates that subspecific designation is appropriate (van Zyll de Jong et al. 1995, p. 403; FEAP 1990, p. 24; Reynolds et al. 2003, p. 1010; Gates et al. 2010, pp. 15-17).

Douglas et al. (2011, p. 167) included mitochondrial sequences from only two wood bison in their analysis. Considering the history of wood and plains bison on the landscape, two animals cannot accurately represent the range of genetic variation present between wood and plains bison, and it is not reasonable to conclude that the two subspecies should be considered as one, based on a sample size of two. In addition, the authors (Douglas et al. 2011, p. 173) include the important qualifying clause, “with respect to their mitochondrial genomic sequences” B. b. bison and B. b. athabascae should not be considered distinct subspecies. Mitochondrial DNA is maternally inherited and therefore presents only a partial picture of an animal's total genome. Mitochondrial DNA is used primarily to look at the more recent divergence between species. Differences in nuclear DNA sequences (which represent contributions from both the male and female) are used to determine differences that originate further back in time. Unless a peer-reviewed revision of the phylogeny of the subfamily Bovinae occurs that indicates wood and plains bison do not vary enough genetically to be considered distinct subspecies, and that revision is accepted by the scientific community, we will continue to acknowledge the two subspecies of bison.

(10) Comment: One commenter stated that we did not provide a convincing argument that the threats to wood bison rise to the level that the species is likely to become endangered in the foreseeable future. The commenter states, “[t]he Proposed Rule does not show that these risks are both sufficiently severe and likely to justify the “threatened” classification.”

Our Response: In the proposed rule (76 FR 6734), we identified threats under Factors A, C, D, and E. Although we did not identify an individual factor that might be responsible for the extinction of wood bison in the future, the combination of these threats are currently acting on the populations and will continue into the foreseeable future. The species is being actively managed in Canada to address these threats. Of these threats, disease is the most problematic for the species because there is not a clear path forward on how disease will be handled. No effective vaccines exist for brucellosis, tuberculosis, or anthrax for free-ranging populations and developing new disease-free herds is very challenging. In addition, although recommendations for the management of the diseased herds in and around WBNP have been suggested (FEAP 1990, p. 2), they have not yet been implemented, it is unknown if they will be implemented, and it is unknown how implementation of the recommendations would affect the status of the subspecies. It is possible many animals could be purposefully euthanized if disease spreads to currently uninfected herds that are in proximity to commercial cattle and bison operations, or as a solution to the diseased herds found in and around WBNP. As described in the proposed rule, the Hook Lake Herd, which was initiated as a disease-free herd, was eliminated when disease was detected. We also know that Canada has not yet made the decision to delist the species under SARA. We will continue to evaluate the status of wood bison and propose to delist the species when appropriate.

(11) Comment: One commenter said that the Service cannot conclude that the wood bison remains threatened without establishing a timeframe for the foreseeable future.

Our Response: We disagree. In some listings we have used very specific timeframes for our threats analysis (e.g., polar bear, see 73 FR 28212, May 15, 2008), especially when we are using models that are projecting into the future for a specific amount of time. In the case of wood bison, we are not relying on modeling to describe or understand the threats into the future. In analyzing how threats will affect the status of this species, we assessed the foreseeable future for the wood bison in terms of the threats that are currently operating on the populations as well as those we could reliably expect to continue to affect the populations.

(12) Comment: One commenter states that bison are inherently social creatures and are subject to rules of group behavior. As the size of herds changes, so too do their actions and lifestyles. There is simply not enough data from small herds over a few decades about wood bison sociology to make any confident predictions about the future. They argue that there are too few wood bison to contemplate easing protections on the species at this time.

Our Response: We agree that wood bison are social animals and that new herds have been established for a relatively short time. However, the growth of the herds gives ample evidence that when suitable habitat is present the herds will grow until controlled. In reality, the protections provided to a species listed as threatened do not differ significantly from the protections provided to an endangered species. Wood bison will continue to be protected under the Act as a threatened species.

(13) Comment: One commenter argued that B. b. athabascae is present in Yellowstone National Park (YNP) and it is endangered there.

Our Response: Peer-reviewed published papers present a compelling opposing view to this comment. The published literature indicates that the only place where free-ranging wood bison occur, or have occurred in the recent past (last several hundred years), is in Canada and Alaska (Skinner and Kaisen 1947, p. 164; Stephenson et al. 2001, pp. 137, 146; Wilson and Strobeck 1998, p. 186). We disagree that wood bison currently persists in YNP and that it is endangered there.

We reanalyzed the data from the United Nations Environment Programme—World Conservation Monitoring Center CITES Trade Database and, for clarity, reported data in specimens rather than shipments. However, this change did not alter our finding. We have not made any substantive changes in this final rule based on the comments we received. Although many commenters thought that wood bison no longer need the protections provided by the Act and should be delisted, no new or compelling information was provided to support such a recommendation. We recognize that conservation actions are continuing and that the status of wood bison is improving. However, because of the threats that are still present, delisting is premature. Therefore, just as we proposed, we are changing the listing of the wood bison from endangered to threatened.

Section 4 of the Act and implementing regulations (50 CFR part 424) set forth procedures for adding species to, removing species from, or reclassifying species on the Federal Lists of Endangered and Threatened Wildlife and Plants. Changes in the Lists can be initiated by the Service or through the public petition process. Under section 4(a)(1) of the Act, a species may be determined to be endangered or threatened based on any of the following five factors:

(A) The present or threatened destruction, modification, or curtailment of Its habitat or range;

(B) Overutilization for commercial, recreational, scientific, or educational purposes;

(C) Disease or predation;

(D) The inadequacy of existing regulatory mechanisms; or

(E) Other natural or manmade factors affecting its continued existence.

We must consider these same factors in downlisting a species. For species that are already listed as endangered or threatened, we evaluate both the threats currently facing the species and the threats that are reasonably likely to affect the species in the foreseeable future following the delisting or downlisting and the removal or reduction of the Act's protections.

Under section 3 of the Act, a species is “endangered” if it is in danger of extinction throughout all or a significant portion of its range and is “threatened” if it is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range. “Foreseeable future” is determined by the Service on a case-by-case basis, taking into consideration a variety of species-specific factors such as lifespan, genetics, breeding behavior, demography, threat projections timeframes, and environmental variability. The word “range” in the phrase “significant portion of its range” (SPR) refers to the range in which the species currently exists, and the word “significant” refers to the value of that portion of the range being considered to the conservation of the species.

For the purposes of this analysis, we will evaluate all five factors currently affecting, or that are likely to affect, the wood bison to determine whether the currently listed species is endangered or threatened.

Wood bison depend on a landscape that includes sufficient grasslands and meadows for foraging habitat (Larter and Gates 1991b, p. 133). It appears that primarily through fire suppression, there was an overall loss of meadow habitat in Canada through the 1900s. More intensive fire management began in Canada in the early 1900s, with the philosophy that fire was destructive and should be eliminated to protect property and permit proper forest management (Stocks et al. 2003, p. 2). However, wildfire is an integral component of boreal forest ecology (Weber and Flannigan 1997, p. 146; Rupp et al. 2004, p. 213; Soja et al. 2007, p. 277). Without fire, trees encroach on meadows and eventually the meadow habitat is lost and replaced by forest.

Fire alone, or in combination with grazing, can facilitate the conversion and maintenance of grasslands (Lewis 1982, p. 24; Chowns et al. 1997, p. 205; Schwarz and Wein 1997, p. 1369). Burning by Native groups within the range of wood bison was apparently a common practice through the 1940s outside WBNP but ended within the park when it was established in 1922 (Lewis 1982, pp. 22-31; Schwarz and Wein 1997, p. 1369). An examination of aerial photographs taken at WBNP over time showed that a semi-open grassland that covered about 85 ha (210 ac) in 1928 supported a grassland of only 3 ha (7.4 ac) in 1982 (Schwarz and Wein 1997, p. 1369). In addition, a number of sites previously identified as prairie are now dominated by trembling aspen (Schwarz and Wein 1997, p. 1369). Although not quantified, it is likely that because of fire suppression and forest encroachment on meadows, there was a net loss of suitable open meadow habitat for wood bison throughout their range through about 1990. More recently, several factors may be counteracting the loss of open meadow habitat including controlled burns, timber harvest, oil and gas development, agricultural development, and the effects of climate change, as discussed below.

Controlled burns have been implemented since 1992 in wood bison habitat in the Northwest Territories to increase meadow habitat (Chowns et al. 1997, p. 206). Approximately 4,400 to 26,900 ha (10,873 to 66,471 ac) were burned from 1992 to 1997, with some sites being burned up to three times (Chowns et al. 1997, pp. 206-207). In addition, lightning fires burned 300,000 ha (741,316 ac), or almost 20 percent of the wood bison range in this area, from 1994 to 1996 (Chowns et al. 1997, p. 209). Plants favored by bison were more abundant in unburned areas and in meadows that had burned only once (Quinlan et al. 2003, p. 348), indicating that prescribed burns must be used judiciously to be effective in creating foraging habitat for wood bison. A study of vegetation recovery and plains bison use after a wildfire near Farewell, Alaska (Campbell and Hinkes 1983, p. 18), showed that grass and sedge-dominated communities increased from 38 percent to approximately 97 percent of the study area. Plains bison use also increased in subsequent years after the fire, and winter distribution of the Farewell herd expanded due to fire-related habitat changes (Campbell and Hinkes 1983, pp. 18-19). Because sedges are important winter forage for wood bison, the amount of such habitat has a major influence on herd size. Newly created habitats will be used by wood bison when these habitats are contiguous with existing summer or winter ranges (Campbell and Hinkes 1983, p. 20).

In summary, studies that have looked at the exclusion of fire or the effect of wildfire on wood bison habitat have concluded that fire is a necessary component of the landscape to maintain clearings and create conditions that favor forage preferred by wood bison. Controlled burns can have the same effect as wildfire by creating openings in the forest. However, repeated burns in the same location can be detrimental to creating suitable forage.

The volume of timber logged in Canada rose 50 percent from 1970 to 1997; in Alberta, the logging rate increased 423 percent, from 3.4 to 17.8 million meters (m) 3 (120 to 628 million feet (ft) 3 ) per year during the same time (Timoney and Lee 2001, p. 394). These values are conservative because forests logged on private land and those harvested on government land after fire, insect outbreaks, or disease may go unrecorded (Timoney and Lee 2001, p. 395). The primary method of harvest is clearcutting (Timoney and Lee 2001, p. 394). Compared to a closed canopy forest, clearcuts improve the amount of suitable habitat available to wood bison because they create openings and increase the amount of summer forage available. However, the quantity and quality of forage is less than what is found in preferred wood bison foraging habitats, and the increased productivity seen after a clearcut is not maintained, as woody vegetation becomes more dominant over time (Redburn et al. 2008, p. 2233). In addition, clearcuts do not provide adequate winter forage because wood bison's preferred food, sedges, typically do not colonize these areas. Clearcutting is not being used as a management tool to increase wood bison habitat currently, and whatever gains in habitat that have occurred from clearcutting are most likely low.

In summary, although timber harvest occurs throughout the range of wood bison, it is unclear to what extent it is creating suitable habitat. Clear cuts can increase summer forage, but they need to be in proximity to sedge meadows (wintering habitat) to increase the annual carrying capacity for wood bison, and the openings created by the clear cuts must be maintained over time. Although timber harvest has the potential to increase the amount of suitable habitat for wood bison, the amount that may have been created is most likely low and is undocumented.

Oil and gas exploration and production in Canada has increased in the last 20 years (Timoney and Lee 2001, pp. 397-398). Seismic mapping to determine the oil and gas reserves below the surface involves cutting paths 5 to 8 m (16.4 to 26 ft) wide across the landscape. The seismic lines become persistent features in the forested boreal landscape (Lee and Boutin 2006, p. 249). Approximately 70 percent of landscape disturbance for non-renewable resource extraction in Alberta is due to seismic lines (Timoney and Lee 2001, p. 397). There are an estimated 1.5 to 1.8 million km (932,000 to 1,100,000 mi) of seismic lines in Alberta (Timoney and Lee 2001, p. 397). Lee and Boutin (2006, p. 244) found that only 8.2 percent of seismic lines in Alberta's northeastern forested stands recovered to greater than 50 percent woody vegetative cover after 35 years, and 64 percent of these seismic lines maintained a cover of grasses and herbs. In terms of creating forest openings, more suitable foraging habitat, and linear paths, seismic lines may be beneficial for wood bison. However, because vehicular routes were established in 20 percent of the seismic lines, they also become corridors for off-road vehicles, recreationalists, and poachers (Trombulak and Frissell 2000, pp. 19-20; Timoney and Lee 2001, p. 400; Lee and Boutin 2006, p. 244). Although wood bison are known to occupy linear clearings such as roads, and seismic lines have increased dramatically within their range, potentially creating suitable habitat, we do not have documentation of wood bison use of this type of habitat.

The popularity of bison as an alternative to beef in human diets has led to a growth of commercial bison ranches in Canada and the United States (Gates et al. 1992, p. 155). Exports of bison meat from Canada doubled to over 2 million kilograms (2.3 tons) from 2001 to 2006 (Statistics Canada 2009a, unpaginated). Plains bison dominate agricultural production in Canada because commercial production of this subspecies has been in place much longer than it has been for wood bison (Gates et al. 1992, p. 156; Harper and Gates 2000, p. 919). Bison production in Canada is concentrated in the western provinces, within the historical range of wood bison. In 2006, there were 195,728 plains bison on 1,898 farms reporting in the Canadian National Census; this amounts to an increase of 35 percent from 2001 (Statistics Canada 2009b, unpaginated). Thus, plains bison represented approximately 95 percent of the total bison on the landscape in Canada in 2006. Existence and expansion of commercial plains bison production reduce the amount of land available for wild wood bison populations and increase the risk of hybridization when plains bison escape captivity (Harper and Gates 2000, p. 919; Gates et al. 2001, pp. 24, 29). Demand currently exceeds supply; therefore, expansion of commercial plains and wood bison operations is expected to continue (Gates et al. 2001, p. 24).

Escape of plains bison from fenced enclosures within the range of the wood bison in Canada poses a threat to the genetic integrity of wood bison (Gates et al. 1992, p. 156; Gates et al. 2001, p. 24). Because of their size, strength, and undomesticated nature, typical fences are insufficient to restrain bison (FEAP 1990, p. 29; Harper and Gates 2000, p. 919). Maintenance of fences can be a challenge in harsh environments where tree-fall, snow, ice, and frost heave can impair the integrity of the fence and necessitate frequent repairs. The import of plains bison to a private ranch near Pink Mountain, British Columbia, led to the establishment of a free-ranging herd of plains bison after they escaped their enclosure (Gates et al. 1992, p. 156).

In addition to commercial production, free-ranging, publicly managed plains bison herds have been established outside their historical range and within the historical range of wood bison in Alaska and Canada (Gates et al. 2010, p. 56). Because of the potential for hybridization, these herds limit where wood bison can be reintroduced. Five plains bison herds occur in Alaska and one occurs in British Columbia, Canada (Gates et al. 2010, p. 56). None of these plains bison herds occur in close proximity to free-ranging wood bison herds with the exception of one herd—the Pink Mountain herd, British Columbia—which also occupies habitat that could have been used for wood bison (Harper et al. 2000, p. 11). Preventing interbreeding between free-ranging plains bison and wood bison is a management objective in British Columbia and is accomplished by maintaining a large physical separation between the herds and having a management zone around the plains bison herd that allows harvest of plains bison within this zone (Harper et al. 2000, p. 23).

Agricultural development, including plains bison ranching, is the least compatible land use for wood bison recovery (Harper and Gates 2000, p. 921). Loss of habitat for agricultural production is a threat to wood bison because of the large areas involved. Agricultural development near Fort St. John and Fort Nelson, British Columbia, has reduced habitat for wood bison, and continuing expansion of agriculture in the north will further limit the ability to meet population recovery objectives (Harper and Gates 2000, p. 921). Based on a conservative estimate of historical habitat only in Canada, Gates et al. (1992, p. 154) estimated that human activities and development exclude wood bison from approximately 34 percent of their historic range. When an updated Canadian historical range (Stephenson et al. 2001, p. 136) and the Alaskan historical range are included in the calculation, the amount of compromised habitat drops to approximately 16.5 percent if only Canada is considered, and 13 percent if the historical habitat in Canada and Alaska are combined (Stephenson 2010, pers. comm.). Sanderson et al. (2002, pp. 894-896; 2008, p. 257) found that the level of human influence in the range occupied by wood bison to be extremely low (less than 10 percent). Although human development and influence is very low over the majority of range occupied by wood bison, we assume that because of human population growth, increased commercial production of plains bison, and increased agricultural production, there will be continued loss of suitable wood bison habitat into the foreseeable future.

Climate change models project that the largest temperature increases will occur in the upper latitudes of the northern hemisphere, and that there will be an increase in extreme climate events in these areas (IPCC 2007, p. 11.5.3.1). This area includes the boreal forest of Canada and Alaska in the range of wood bison. Some of the predicted outcomes of climate change are: An increase in temperature; an increase in insect outbreaks; an increase in wildfire severity, area burned, and fire season length with potential landscape-scale ecotype effects; and a shift northward of boreal forest (Hamann and Wang 2006, pp. 2780-2782; Soja et al. 2007, p. 277). These aspects of climate change have the potential to increase the amount of habitat suitable for wood bison over the next 100 years.

The mean annual temperature of interior Alaska and northern Canada has increased by 2 degrees Celsius (°C) (3.6 degrees Fahrenheit (°F)) in the last four decades (Serreze et al. 2000, p. 163). Warming has triggered bark beetle outbreaks in western North America, including south-central Alaska and British Columbia. In British Columbia, by the end of 2006, 130,000 km 2 (50,193 mi 2 ) of forested lands were affected (Kurz et al. 2008, p. 987). The outbreak in British Columbia was an order of magnitude greater in area and severity than all previous recorded outbreaks (Kurz et al. 2008, p. 987).

The effect of insect outbreaks on wood bison habitat includes a potential increase in suitable wood bison habitat, and an increase in susceptibility to fire. In insect-infested plots studied on the Kenai Peninsula, cover of bluejoint grass ( Calamagrostis canadensis ), a summer forage species, increased to more than 50 percent compared to uninfested forest stands (Werner et al. 2006, p. 198). These results indicate forests affected by beetle kill may become more suitable to wood bison by creating openings and changing the vegetative composition. This would be particularly true in areas where, because of climate change, there was a permanent change in landscape cover from forest to grassland (Rizzo and Wiken 1992, p. 53; Flannigan et al. 2000, pp. 226-227). Werber and Flannigan (1997, p. 157), and Malmström and Raffa (2000, p. 36), indicate that insect outbreaks increase an area's susceptibility to fire ignition and spread.

Since the mid-1980s, wildfire frequency in western forests has nearly quadrupled compared to the average frequency during the period 1970-1986. The total area burned is more than six and a half times the previous level (Westerling et al. 2006, p. 941). In addition, the average length of the fire season during 1987-2003 was 78 days longer compared to that during 1970-1986, and the average time between fire discovery and control was 29.6 days longer (Westerling et al. 2006, p. 941). In Alaska, the largest fire on record was in 2004, and the third largest was in 2003 (Soja et al. 2007, p. 281).

The area burned by forest fires in Canada has increased over the past four decades (Stocks et al. 2003, p. 2; Gillett et al. 2004, p. 4; Soja et al., 2007, p. 281). In Canada, weather/climate is the most important natural factor influencing forest fires (Gillett et al. 2004, p. 2; Flannigan et al. 2005, p. 1). Projections based on the Canadian and Hadley General Circulation Models, which predict future carbon dioxide and temperature increases, indicate that the area burned in boreal forests of Canada will double by the end of the century (Flannigan et al. 2005, pp. 11-12), the area exhibiting high to extreme fire danger will increase substantially, and the length of the fire season will increase (Stocks et al. 1998, pp. 5-11).

In the absence of fire, vegetation changes would occur relatively slowly in response to relatively slow changes in the climate. Because of its immediate and large-scale effect, fire is seen as an agent of change that will hasten the modification of the landscape to a new equilibrium with climate. Area burned may overshadow the direct effects of climate change on plant species distribution and migration (Werber and Flannigan 1997, p. 157). The new fire regime is expected to affect the age class distribution, species composition, landscape mosaics, and boundaries, including a retraction of the southern boreal forest (Werber and Flannigan 1997, pp. 157, 160).

The increase in temperature, predicted by the Canadian and Hadley General Circulation Models described above, is expected to cause major shifts in ecosystems (Rizzo and Wiken 1992, p. 37; Hogg and Schwarz 1997, p. 527). The amount of grassland in Canada may increase by about 7 percent and shift northward (Rizzo and Wiken 1992, p. 52). Several modeling efforts suggest that boreal forests will shift northward into the area now characterized as subarctic (Rizzo and Wiken 1992, pp. 48-50; Rupp et al. 2002, p. 214). These changes may favor the expansion of suitable habitat for wood bison over the next century. Because one of the anticipated outcomes under climate change and the new fire regime is a retraction of the southern boreal forest and expansion of grasslands, we anticipate that habitat for wood bison, which require meadows intermixed with forest, will increase over the next century.

Our analysis of habitat threats to wood bison under Factor A includes management actions that are being taken (controlled burns, timber harvest, oil and gas development), anticipated changes to the landscape based on climate change (increased insect outbreaks, increased fire, ecotype transition), and agricultural development. In summary, most likely there was loss of suitable meadow foraging habitat for wood bison from fire suppression in the 20th century. Several factors, including fire, timber harvest, oil and gas exploration, and insect infestations, could create more forest openings and grassland habitat. However, neither the loss nor potential gain in habitat from these sources has been quantified, and the suitability of habitat for wood bison created as a by-product of resource development is largely unknown. The primary loss of habitat for wood bison has occurred from agricultural development (including commercial production of plains bison). Although the current level of human influence in the range of wood bison is low, we anticipate human population growth will continue, and loss of suitable habitat from agricultural development is expected in the foreseeable future. In the short term, habitat loss is expected to outstrip gain because of the increasing demand and production of commercial bison. Based on model projections of the effects of climate change, it is anticipated that there will be increased insect infestations, increased fire frequency and area burned, and warmer temperatures, leading to shifts in ecosystems. In the long term, these changes will likely create more forest openings and landscapes in early successional stages and may increase the amount of suitable habitat available to wood bison. Whether the potential gain in habitat will offset the loss from development in the long term is unknown. Consequently, based on the best scientific and commercial data available, we conclude that loss of habitat remains a threat to wood bison in the foreseeable future.

Overharvesting for the fur trade and westward expansion by Europeans resulted in near extinction of wood bison by the late 1800s (Gates et al. 1992, pp. 143-145). Currently, the utilization of free-ranging, disease-free wood bison populations is closely regulated and managed for sustainability. Under the SARA, a species listed as threatened may not be killed on Federal lands such as National Parks or National Wildlife Areas, except where permitted under a national recovery strategy (GNT 2010, p. 10). Harvest is used as a recovery management tool to regulate herd size when other limiting factors, such as predation or disease, do not. Without harvest, herd size can expand beyond the carrying capacity of the landscape, may grow to the point where overlap with either plains bison or diseased herds is more likely, or may expand into areas such as highway rights-of-way. Regulated harvest is allowed from the disease-free Mackenzie herd, Nahanni herd (quota of two bison annually), the Aishihik herd, and the Hay-Zama herds under permit systems controlled by the respective territorial wildlife agencies, and is managed on a conservative sustained-yield basis. The regulated harvests for the Mackenzie, Aishihik, and Hay-Zama herds are described below.

Hunting of the Mackenzie wood bison herd is regulated under a quota system based on population size, with consideration given to Native community interests in subsistence hunting through a co-management process with the Fort Providence Resource Management Board. Regulated hunting was initiated in 1987. Non-resident hunting licenses were first issued for the winter hunt in 1992-1993. The quota for resident and non-residents has been adjusted over time based on herd size and community input. The allowable quota for harvest has never been taken and has ranged from 20 to 93.6 percent of the quota (Reynolds et al. 2004, p. 39). The current annual allowable harvest is 118 bison ( http://www.justice.gov.nt.ca/PDF/REGS/WILDLIFE/Big%20Game%20Hunting.pdf, viewed January 23, 2012).

Sport hunting is the primary method of regulating the growth of the Aishihik herd because natural predation on the herd is low. The Yukon Wood Bison Technical Team provides advice on wood bison management that is sensitive to local conditions (i.e., to remove wood bison from highway rights-of-way, competition of bison with other native ungulates) and consistent with the National Wood Bison Recovery Plan (Yukon Environment 2009, p. 1). The annual allowable harvest is determined each year based on population size and calf recruitment rate. Harvest from 1999 to 2007-2008 winter season ranged from 65 to 75 animals. In the 2008-2009 winter season, the allowable harvest increased to 200 because the population continued to grow under the old quota. Increased harvest is expected to restrict the movement of wood bison away from their traditional range, address highway safety concerns, and achieve bison management objectives (Government of Yukon 2009, p. 1). Resident, non-resident, and First Nations hunters are required to have a permit to hunt wood bison. Harvest regulations are strictly enforced by Yukon Department of Environment conservation officers, often in collaboration with local First Nations Game Guardians.

Hunting in the Hay-Zama herd began in 2008. Hunting was initiated to regulate the population size, reduce wood bison conflicts with humans in the communities of Zama City and Chatey, reduce wood bison-vehicle collisions on two highways, and limit wood bison distribution eastward, preventing potential contact with diseased bison from WBNP (Government of Alberta 2010a, unpaginated). Harvest removed 128 and 155 animals in the 2008-2009 and 2009-2010 seasons, respectively (Government of Alberta 2010b, unpaginated). Three hundred licenses were issued each year, 200 to Aboriginal hunters and 100 to recreational hunters. Because the objectives of reducing herd size and human conflicts have been met, the total number of licenses has been reduced in the 2010-2011 season to 105 (Government of Canada 2010b, unpaginated). Based on the success rate of the past two seasons, approximately 50 animals will likely be harvested. It is estimated that a population objective of 400-600 wood bison can be sustained by harvesting approximately 60 to 70 animals per season (Government of Canada 2010b, unpaginated).

In addition to regulating herd size, harvest is also used to prevent the spread of bovine tuberculosis and brucellosis infection in wood bison. Under the Northwest Territories Big-Game Hunting Regulations, hunters may shoot any bison sighted within the Bison Control Area (BCA), an area located between the WBNP diseased herd and the Mackenzie and Nahanni disease-free herds. The goal is to reduce the risk of bovine tuberculosis and brucellosis infection of the Mackenzie and Nahanni herds by removing infected animals dispersing from WBNP (see discussion under Factor C, below). Thirteen bison were removed from the BCA in the mid-1990s (Nishi 2002, pp. 12-13). There is currently no authorized harvest of wood bison in British Columbia.

Under Canada's SARA, all collection of listed species such as wood bison for scientific purposes is closely regulated. Scientific research on disease, genetics, diet, and other aspects of wood bison life history can and has been done using animals that have been legally taken by hunters, animals that died through natural factors, or road kill (e.g., Tessaro et al. 1990, p. 175). Scientific research must relate to the conservation of the species and be conducted by qualified persons; the activity must benefit the species or enhance its chance of survival in the wild. In addition, activities affecting the species must be incidental to carrying out an otherwise lawful activity. Researchers must demonstrate awareness of the provisions of SARA, that measures are being taken to minimize harm to listed species, and that the most effective measures for minimizing harm are adopted.

Commercial harvest of free-ranging wood bison does not occur and only a small number of wood bison have been sporadically taken from disease-free herds for display in zoos or wildlife parks. This occurs only when surplus animals are available, and these surplus animals have typically come from Elk Island National Park (Gates et al. 2010, p. 81).

The wood bison was placed in Appendix I of CITES on July 1, 1975, when the treaty first went into effect. CITES is an international agreement between governments to ensure that the international trade of CITES-listed plant and animal species does not threaten their survival in the wild. There are currently 175 CITES Parties (member countries or signatories to the Convention). Under this treaty, CITES Parties regulate the import, export, and reexport of CITES-listed plant and animal species (also see discussion under Factor D, below). Trade must be authorized through a system of permits and certificates that are provided by the designated CITES Scientific and Management Authorities of each CITES Party (CITES 2010, unpaginated). Species included in CITES Appendix I are considered threatened with extinction, and international trade is permitted only under exceptional circumstances, which generally precludes commercial trade.

Beginning in 1993, the European Economic Community CITES Working Group authorized the import of wood bison trophies from the Mackenzie population, one of the disease-free herds with regulated harvest. On September 18, 1997, the wood bison was transferred to Appendix II of CITES based on a proposal from Canada, which described progress made in recovery plan implementation (Government of Canada 1997, entire). The United States supported this change. Appendix II allows for regulated trade, including commercial trade, as long as the exporting country issues a CITES permit based on findings that the specimen was legally acquired and the export will not be detrimental to the survival of the species.

Data obtained from the United Nations Environment Programme-World Conservation Monitoring Center (UNEP-WCMC) CITES Trade Database show that, from July 1975, when the wood bison was listed in Appendix I, through 2009, a total of 23,344 specimens of this subspecies were reported to UNEP-WCMC as (gross) exports. Of those 23,344 specimens, 264 were live animals, 36 were skins, 10 were skin pieces, 5 were bodies, 26 were shoes, 21,300 were horn products, 461 were teeth, 46 were carvings, 5 were garments, 14 were leather products, 1,074 were scientific specimens, 31 were trophies, 59 were parts of trophies (horns, skulls, bones, feet, tails, and hair), and 13 were unspecified specimens. An additional 1,930 kilograms of meat were reported as exports.

In analyzing these data, it appears that several records may be over-counts due to slight differences in the manner in which the importing and exporting countries reported their trade. It is likely that the actual number of wood bison specimens in international trade during this period was 23,210, plus 1,074 kilograms of meat. Of the 23,210 specimens, 264 were live animals, 34 were skins, 10 were skin pieces, 5 were bodies, 26 were shoes, 21,300 were horn products, 461 were teeth, 46 were carvings, 4 were garments, 14 were leather products, 945 were scientific specimens, 30 were trophies, 58 were parts of trophies (horns, skulls, bones, feet, tails, and hair), and 13 were unspecified specimens.

With the information obtained from the UNEP-WCMC CITES Trade Database, 1,606 specimens and 1,910 kilograms of meat were reported in international trade since the wood bison was transferred from Appendix II to Appendix I in 1997. 1,398 of these specimens (87 percent) were reported as imported into the United States and 20 (1 percent) were reported as exported from the United States. Also, 1,900 of the total of 1,910 kilograms of meat (99 percent) were reported as imported into the United States. Of the 264 live wood bison reported in international trade between 1975 and 2009, 235 were traded since the subspecies was transferred from Appendix II to Appendix I in 1997. Of these 235 live specimens, 174 (74 percent) were reported as captive-bred or captive born, 13 (6 percent) were reported as ranched specimens, and 48 (20 percent) were reported as having been obtained from the wild. There has been no trade in live, wild wood bison since 2006.

As a species listed in Appendix II of CITES, commercial trade of wood bison is allowed. However, the Appendix-II listing requires that before an export can occur, a determination must be made that the specimens were legally obtained (in accordance with national laws) and that the export will not be detrimental to the survival of the species in the wild. Because CITES requires that all international shipments of wood bison must be legally obtained and not detrimental to the survival of the species, we believe that international trade controlled via valid CITES permits is not a threat to the species. Furthermore, we have no information indicating that illegal trade is a threat to this species.

It is possible that, with the ongoing recovery actions, a status review of wood bison in Canada could lead to delisting under SARA within the next 10 years. If this were to happen, we expect that regulations for recreational hunting, import of wood bison trophies, and permitting would change. Our ability to predict how these changes would affect the status of the species is limited; consequently, we can only reliably project for a short time into the future.

Because harvest rates of free-ranging wood bison are based on sustainability, harvest is closely monitored and regulated, scientific collecting is tightly controlled, commercial harvest does not occur in wild populations, and import and export are controlled via CITES permits, we have determined that overutilization for commercial, recreational, scientific, or educational purposes is not a threat to wood bison now or in the foreseeable future.

In the early 1920s, 6,673 plains bison were introduced into WBNP, Alberta, Canada, where approximately 1,500 disease-free wood bison resided (FEAP 1990, p. 6; Gates et al. 1992, pp. 146-147). Although initially separated by fairly large distances, the plains bison eventually co-occurred and interbred with the wood bison and also transmitted bovine tuberculosis and brucellosis to them (FEAP 1990, p. 6; Gates et al. 1992, pp. 146-147). By the late 1940s and early 1950s, the population of wood bison in WBNP increased to between 12,500 and 15,000 animals (Fuller, 1950, p. 450). From that level, wood bison numbers began to decline from 11,000 in 1971, to approximately 2,300 by 1998 (Carbyn et al. 1998, p. 464). The reasons for the population decline are not known with certainty, but disease, predation by wolves, and habitat condition may all have played a role (Carbyn et al. 1998, pp. 467-468; Joly and Messier 2004, pp. 1165-1166). Population numbers at WBNP have stabilized at about 4,000 to 5,000 since 2002 (see Table 1, above).

Bovine tuberculosis and bovine brucellosis receive special attention because they cause production losses in domestic animals, can potentially infect humans, and are required to be reported under the Canadian Food and Inspection Agency's (CFIA) Health of Animals Act and Regulations (FEAP 1990, p. 7). Although wildlife is not under their jurisdiction, the CFIA recognizes the threat of reportable diseases to the commercial livestock industry and international trade. The CFIA follows a strict testing and eradication program for bovine tuberculosis and brucellosis in domestic animals, requiring that all infected animals and all exposed susceptible animals be destroyed (Canadian Food Inspection Agency 2002, unpaginated). Consequently, there is great concern from the Canadian cattle industry, which is currently recognized as disease-free, that disease will spread from wood bison to domestic cattle (GNT 2010, p. 8). The goal of the CFIA's National Bovine Tuberculosis/Brucellosis Eradication Program is to detect and eradicate tuberculosis and brucellosis in farmed animals in Canada in order to protect the health of food-producing and companion animals, safeguard human health, and safeguard the health of free-roaming wildlife. Canada recognizes an obligation to detect, identify, report, and contain important diseases in wildlife, especially those with the potential to impact biodiversity, human and livestock health, the environment, and the economy within and beyond their borders.

Wood bison in and around WBNP are a reservoir for bovine brucellosis and bovine tuberculosis. Because there is a risk that these diseases could spread to uninfected free-ranging bison herds or to commercial cattle and bison operations, limits are placed on herd expansion to minimize the chance that the diseased animals come into contact with either free-ranging, disease-free herds, or with domestic cattle or bison operations. In addition, the diseased herds occupy suitable habitat that could be used for the establishment of disease-free herds of wood bison. Therefore, the existence of diseased bison herds in and around WBNP compromises further recovery of wood bison in northern Alberta, the Northwest Territories, and British Columbia (Gates et al. 2001, p. 29). The total area compromised by diseased herds is approximately 218,516 km 2 (84,369 mi 2 ) or about 12 percent of the original range of the wood bison in Canada (Gates et al. 2001, p. 24). As mentioned earlier, there are no effective vaccines for the treatment of animals in free-ranging populations.

The disease-free herds most at risk from infection from animals at WBNP are the Mackenzie, Hay-Zama, and Nahanni. Regulated harvest is allowed from the Mackenzie herd, Nahanni herd, and the Hay-Zama herd under permit systems (as described above under Factor B), in part to prevent overlap with the diseased herd. In addition, the Governments of the Northwest Territories, Alberta, and British Columbia have designated management zones to reduce the risk of dispersing animals transmitting disease to disease-free herds in their provinces. In 1987, the Government of the Northwest Territories implemented a program to reduce the risk of contact between infected bison in and around WBNP and disease-free bison in the Mackenzie and Nahanni herds by establishing a Bison Free Management Area (BFMA) (Nishi 2002, pp. 5-6). The BFMA (39,000 km 2 (15,058 mi 2 )) encompasses the area between the Alberta-Northwest Territories border and southern shoreline of the Mackenzie River. In 1992, the Government of the Northwest Territories established the Nuisance Bison Control Regulations under the Northwest Territories Wildlife Regulations Act, permitting eligible hunters to legally shoot any bison sighted in the BFMA. All bison within this area are presumed disease carriers. The objectives of the program are to detect and remove any bison, and to prevent establishment of herds in the management area (Nishi 2002, p. 6). No bison were observed in the area during annual aerial surveys in the period 1988-2006, but 13 bison were killed in the mid-1990s (Nishi 2002, pp. 12-13; Hartop et al. 2009, p. 41). Aerial surveillance occurs annually.

In 1995, the Government of Alberta established a 36,000-km 2 (13,900-mi 2 ) bison management area around the Hay-Zama herd to protect all bison from hunting. Within this area, all wood bison are legally protected under Alberta's Wildlife Act; outside of the area they are not protected and can be hunted. The area outside of the protected management area creates a large buffer zone between the disease-free Hay-Zama herd and the diseased herds within WBNP (Gates et al. 2001, p. 38).

Control areas and buffer zones between diseased and non-diseased populations may not prevent disease transmission (Canadian Food Inspection Agency 2002, unpaginated) because they are sporadically patrolled and imperfectly enforced. As discussed earlier, fences are an ineffective method to contain herds long term, especially those in large areas (FEAP 1990, p. 29). Consequently, a long-term, more sustainable solution is needed to address this problem.

A Federal Environmental Assessment Panel (FEAP) was assembled to evaluate four courses of action to address the diseased herds at WBNP. These actions were initially proposed by the Bison Disease Task Force: (1) Do nothing; (2) fence WBNP to contain the diseased bison and prevent the spread of disease; (3) use a combination of strategically placed fences, buffer zones exterior to the Park from which all bison would be eliminated, and land-use restrictions on cattle grazing; and (4) phased elimination of the diseased herd and replacement with disease-free wood bison (FEAP 1990, p. 15). After public hearings, and consultation with technical experts, the panel recommended eradication of the existing diseased bison population to eliminate the risk of transmission of disease from bison in and around WBNP to domestic cattle, wood bison, and humans (FEAP 1990, p. 2). Public response to this recommendation was largely negative (Carbyn et al. 1998, p. 464). The recommendation was not implemented; consequently, control of disease spread currently depends on the buffer zones.

Annual examinations and serological studies of bison harvested from the Mackenzie herd indicate that the herd continues to be disease-free (Nishi 2002, p. 23). Over 220 samples were received from harvested bison from the Hay-Zama herd that could be tested for disease. All samples tested negative (Government of Canada 2010a, unpaginated). There is also no evidence of bovine brucellosis and bovine tuberculosis in reintroduced herds in the Yukon Territory, British Columbia, western Alberta, or Manitoba. Free-ranging, disease-free herds currently include approximately 4,414 wood bison (see Table 1, above). Because of their distance from WBNP, the Aishihik and Chitek Lake herds are the most secure from disease.

Recovery and conservation efforts for wood bison emphasize the importance of preventing the spread of tuberculosis and brucellosis to disease-free populations and eliminating diseases in infected populations (Gates et al. 2001, p. 30). The focus on disease prevention and control is consistent with the recovery goals of increasing the number of disease-free populations. Parks Canada, through Elk Island National Park, has worked with the recovery team and others to develop and maintain a disease-free, captive-breeding herd, which has provided healthy stock for several restoration projects (Gates et al. 2001, p. 18).

Because the northern latitudes are experiencing the greatest changes in climate, this area may also be at the greatest risk for the emergence of diseases and parasites that may threaten the stability of wildlife populations (Kutz et al. 2004, pp. 109, 114). Warming may be of particular concern for wildlife in northern regions because the life-history patterns of most hosts and parasites are currently constrained by climatic conditions (Kutz et al. 2004, p. 114). Researchers have hypothesized that climate change will accelerate pathogen development rates, lead to greater overwinter survival of pathogens, and modify host susceptibility to infection in such a way that the effects of disease will increase (Ytrehus et al. 2008, p. 214). Wood bison are susceptible to many diseases and parasites (Reynolds et al. 2003, pp. 1030-1032). How climate change may affect the number of animals infected, a pathogen's virulence, and, consequently, wood bison viability is unknown.

One potential effect of climate change may be an increase in anthrax outbreaks because of increased summer air temperatures. Between 1962 and 1993, nine anthrax outbreaks were recorded in northern Canada, killing at least 1,309 wood bison (Dragon et al. 1999, p. 209). Additional outbreaks continued to occur through at least 2010 (GNT 2010, p. 9). Wood bison appear most susceptible to outbreaks when they are stressed, including heat stress and high densities of biting insects (Dragon et al. 1999, p. 212; Gates et al. 2010, p. 28). In addition, if climate change leads to widespread or intense drought, there could be changes in the quality and availability of forage that may cause animals to concentrate around available food and water. These factors could contribute to stress levels and increase susceptibility to anthrax (Dragon et al. 1999, p. 212; Gates et al. 2010, p. 28). Although isolated anthrax outbreaks occur currently, it is possible that outbreaks may become more frequent, become more widespread, or affect a greater number of animals in the future. Thus far, anthrax outbreaks have occurred sporadically when the necessary factors have come together to affect portions of one herd at a time. Anthrax is not currently having a population-level effect, and we do not have enough information to predict with confidence if anthrax will have a population-level effect on wood bison in the future as a result of climate change.

Wolf predation can be a significant limiting factor for diseased populations of wood bison (Reynolds et al. 1978, p. 581; Van Camp 1987, p. 25). Wood bison were the principle food of two wolf packs from 1975 to 1977 in the Slave River lowlands (Van Camp 1987, pp. 29, 32). Of the adult and subadult wood bison that died in 1976-1977, wolves killed 31 percent; however, hunters killed 39.3 percent (Van Camp 1987, p. 33). Joly and Messier (2004, p. 1173) found that productivity of the diseased WBNP herd was insufficient to offset losses to both predation and disease, but that in the absence of either factor, positive population growth was possible. Presence of disease likely increased the killing success of wolves through bison debilitation (Joly and Messier 2004, p. 1174). Wood bison evolved with wolves, and we have no data showing that predation by wolves is limiting the recovery of any of the disease-free herds or would cause the extirpation of a herd (ADF&G 2007, p. 98).

The presence of disease and diseased herds is recognized as a factor limiting recovery (Mitchell and Gates 2002, p. 12). The effectiveness of current management actions such as maintaining spatial separation between diseased and disease-free herds by limiting herd size is yet to be determined over long timeframes. Research is continuing on creation of disease-free herds. No effective vaccines exist for brucellosis, tuberculosis, or anthrax for free-ranging populations. In addition, although recommendations for the management of the diseased herds in and around WBNP have been suggested (FEAP 1990, p. 2), they have not yet been implemented, it is unknown if they will be implemented, and it is unknown how implementation of the recommendations would affect the status of the subspecies.

Predation by wolves is a natural threat that will persist indefinitely into the future. Although diseased herds may be more susceptible to predation, healthy herds, which now represent approximately half of the free-ranging wood bison, are not. As long as wolves are present on the landscape, they will present an ongoing, low level of threat, especially to diseased herds.

The presence of disease in the largest potential donor population of wood bison (WBNP herd) has limited the number of animals available for establishing or augmenting herds throughout the wood bison's historical range and has removed otherwise optimal habitat from consideration for expansion of wild populations. The presence of reportable diseases will continue to lead to actions that impact conservation, in particular restriction of herd expansion and the reintroduction of herds in particular areas. Although brucellosis and tuberculosis may limit wood bison population growth and productivity in some herds, they are unlikely to cause extirpation of any population (Bradley and Wilmshurst 2005, p. 1204; Gates et al. 2010, p. 60), but when combined with predation, herd size can be limited. Anthrax outbreaks occur sporadically when critical factors come together. Climate change could affect the frequency of outbreaks if increased temperatures or drought cause increased levels of stress in the animals, especially during the rut. Because disease constrains and inhibits full recovery of the species, until a solution for the diseased animals at WBNP is found, or effective vaccines are discovered and used, disease will continue to be a threat to wood bison now and in the foreseeable future.

The first protective legislation for wood bison, making it illegal for anyone to molest the species, was passed by the Canadian Government in 1877, but not until the law was enforced beginning in 1897 did the population increase (Soper 1941, pp. 362-363; Gates et al. 2001, p. 12).

Canada's Species at Risk Act (SARA), enacted on December 12, 2002, became fully effective on June 1, 2004, and is the Canadian counterpart to the U.S. Endangered Species Act. The purpose of SARA is to prevent listed wildlife species from becoming extinct or lost from the wild (extirpated); to help in the recovery of extirpated, endangered, or threatened species; and to ensure that species of special concern do not become endangered or threatened. The SARA also requires the development of recovery strategies and action plans for covered species. In the SARA, the COSEWIC was established as the scientific body that identifies and assesses a species' status; however, the government makes the final decision on whether to list a species.

Species such as wood bison that were designated as endangered or threatened by the COSEWIC before SARA was enacted had to be reassessed before being included on the official list of wildlife species under SARA. The wood bison is currently listed as a threatened species under Schedule 1 of SARA. The National Recovery Plan for wood bison was published in 2001 (Gates et al. 2001) and is currently under revision. As discussed in the Recovery Actions section above, many recovery actions have been implemented and more are in progress. As discussed under Factor B (above), SARA requires permits for all scientific collection of listed species.

The SARA covers all species on Federal lands such as national parks, national wildlife areas, Prairie Farm Rehabilitation Administration pastures, aboriginal reserve lands, and military training areas. It prohibits the killing, harming, harassing, or taking of extirpated, endangered, or threatened species, and the destruction of their residences (e.g., nest or den) on Federal lands, except where permitted under a national recovery strategy (GNT 2010, p. 10). Because the recovery strategy includes managing herd size for the health of the habitat and herds (Gates et al. 2001, pp. 35-39), bison hunting is allowed under a quota system in the Nahanni, MacKenzie, and Aishihik herds (described above under Factor B). The Northwest Territories Big Game Hunting Regulations consider bison in the Slave River Lowlands to be hybrids, which General Hunting License holders may hunt without limit or closed season. In the Yukon, the Aishihik herd size is managed through hunting. In Alberta, Hay-Zama herd size is managed by hunting to reduce the likelihood that the herd will come into contact with animals from WBNP (GNT 2010, p. 7).

Habitat protection within the range of the Mackenzie bison herd is facilitated through the SARA and the Mackenzie Valley Resource Management Act of 1998. Although the Mackenzie Valley Resource Management Act does not specifically provide protection to wood bison, it did create a Land and Water Board (LWB), which is given the power to regulate the use of land and water, including the issuance of land use permits and water licenses. The LWB's Environmental Impact Review Board is the main instrument in the Mackenzie Valley for the examination of the environmental impact of proposed developments. The LWB's Land Use Planning Board is given the power to develop land use plans and to ensure that future use of lands is carried out in conformity with those plans.

As described below, several wood bison herds occur wholly or partially in National Parks, ecological reserves, or Provincial Parks (Table 2). In 1922, WBNP was established in Alberta and the Northwest Territories for the protection of wood bison. Habitat protection of 44,807 km 2 (17,300 mi 2 ) within WBNP occurs through the Canada National Parks Act, the purpose of which is to maintain or restore the ecological integrity of parks, through the protection of natural resources and natural processes. With respect to a park, ecological integrity means a condition characteristic of its natural region, including abiotic (nonliving) components and the composition and abundance of native species and biological communities. Renewable harvest activities can be regulated or prohibited, and is enforced through this legislation (Canada National Parks Act, 2000). National parks are protected by Federal legislation from all forms of extractive resource use such as mining, forestry, agriculture, and sport hunting. Only activities consistent with the protection of park resources are allowed. Efforts are directed at maintaining the physical environment in as natural a state as possible. Sport hunting is prohibited; however, traditional subsistence-level harvesting by First Nations is allowed in some areas as long as the resources are conserved (The Canadian Encyclopedia 2010a, unpaginated).

Ecological reserves are established in part for the protection of rare and endangered plants and animals in their natural habitat; preservation of unique, rare, or outstanding botanical, zoological, or geological phenomena; and perpetuation of important genetic resources. Research and educational functions are the primary uses for ecological reserves, but are open to the public for non-consumptive, observational uses. Plans are developed by the Ministry of Environment to provide protection and management to ensure long-term maintenance. Resource use, such as tree cutting, hunting, fishing, mining, domestic grazing, camping, lighting of fires and removal of materials, plants or animals, and the use of motorized vehicles are prohibited (British Columbia 2010, unpaginated).

Although there are numerous parks and ecological reserves throughout the range of the wood bison, these areas do not necessarily encompass all of the individuals of a herd. Individuals frequently move into and out of these areas; therefore, wood bison herds are only afforded protection while within the boundaries of the park or ecological reserve.

The Federal Environmental Assessment and Review Process (EARP) was introduced in Canada in 1973. In 1995, the Canadian Environmental Assessment Act replaced EARP and strengthened the Environmental Impact Assessment (EIA). The Canadian Environmental Assessment Act outlines responsibilities and procedures for the EIA of projects for which the Canadian Government holds decision-making authority. The purposes of EIAs are to minimize or avoid adverse environmental effects before they occur and to incorporate environmental factors into decision making. All projects in National Parks must have an EIA. An EIA is also required under the law of the provinces and territories. Municipalities and corporations are subject to the EIA requirements of their respective provincial, territorial, or land claim jurisdictions, and are also subject to the Canadian Environmental Assessment Act if the Canadian Government holds some decision-making authority concerning the proposed development or the acceptability of its impacts. This legislation ensures that any projects conducted on Canada's government-owned lands, including National Parks, are carefully reviewed before Canadian authorities take action so that projects do not cause significant adverse environmental effects, including areas surrounding the project. It encourages Canadian authorities to take actions that promote sustainable development (Canadian Environmental Assessment Agency 2010, unpaginated). If a project is likely to cause significant adverse environmental effects that cannot be justified in the circumstances, even after taking into account appropriate mitigation measures, the project will not be carried out in whole or in part (Canadian Environmental Assessment Act (20)(b) and (37)(b)).

Provincial and territorial governments within Canada can use the Wild Animal and Plant Protection and Regulation of International and Interprovincial Trade Act (WAPPRIITA) to control transport of wood bison across their borders. This law applies to wood bison because it is on the CITES control list (CITES is discussed below, under “International Regulatory Mechanisms”). The WAPPRIITA prohibits the import, export, and interprovincial transportation of CITES-listed species or any Canadian species whose capture, possession, and transportation are regulated by provincial or territorial laws, unless the specimens are accompanied by the appropriate documents (licenses, permits). In all cases, the WAPPRIITA applies to the animal, alive or dead, as well as to its parts and any derived products (Environment Canada 2010, p.1).

In addition to national-level legislation that provides protection to wood bison, there is also protection at the provincial level. Alberta, the Northwest Territories, British Columbia, Manitoba, and the Yukon Territory classify wood bison as wildlife, which is the property of the provincial or territorial government. In 1995, the Government of Alberta established a Wildlife Management Area to protect the Hay-Zama herd and listed the wood bison as endangered within the protected area under the Alberta Wildlife Act (Gates et al. 2010, p. 71). In this area, all wood bison are legally protected from hunting; outside of the area they are not protected.

The Northwest Territories Wildlife Act enables the Minister of Environment and Natural Resources to prohibit the importation of any wildlife into the Northwest Territories without a permit. This prohibits uncontrolled importation of plains bison. In May 1964, wood bison were declared in danger of becoming extinct under the Northwest Territories Act and are now designated as a protected species in the Northwest Territories. As such, sport hunting and subsistence hunting by aboriginal people may occur, but is regulated.

Wood bison are on British Columbia's Red List of species and subspecies that are candidates for legal designation as endangered or threatened under the Wildlife Act (Harper 2002, p. 3). Wood bison are an endangered species under the Yukon Act, a “specially protected species” under the Wildlife Act (Yukon legislation), and are listed as protected under Manitoba's Wildlife Act. Bison are considered domestic when held in captivity under permit or license for game farming purposes. If a wood bison escapes captivity, the provincial or territorial government acquires ownership of the animal, and it, therefore, becomes protected (Harper and Gates 2000, p. 919).

Although there is tight control over the transmission of disease across the Canadian border, control of disease within Canada is more challenging. As explained above (Factor C), there is a program to detect and eradicate tuberculosis and brucellosis in farmed animals in Canada in order to protect the health of food-producing and companion animals, safeguard human health, and safeguard the health of free-roaming wildlife. In addition, buffer zones in which dispersing animals may be harvested have been created around the diseased herds to reduce the risk of bovine tuberculosis and brucellosis infection of the Mackenzie and Nahanni herds, which are most at risk from infection from animals at WBNP. In addition, the Governments of the Northwest Territories, Alberta, and British Columbia have designated management zones to reduce the risk of dispersing animals transmitting disease to disease-free herds in their provinces. However, as noted above, buffer zones are not ideal for preventing the spread of disease because they are sporadically patrolled and imperfectly enforced. Existing regulations and policies address the transmission of disease within Canada, but it is impossible to regulate the movement of wild animals across a large, mostly uninhabited landscape. Thus, we conclude that regulatory mechanisms are in place to minimize the spread of disease but because of the difficulty in containing herds of wild animals, the mechanisms are inadequate to prevent the spread of disease.

Under Factor E, we conclude that loss of genetic integrity through hybridization is a threat to wood bison. Preventing hybridization between plains bison and free-roaming wood bison is a goal of the recovery plan and is important to the conservation of the subspecies (Gates et al. 2001, p. 33). There is one free-ranging plains bison herd in Canada, in British Columbia, which was established as a result of the plains bison escaping from their enclosure. Preventing interbreeding between free-ranging plains bison and wood bison is a management objective in British Columbia and is accomplished by maintaining a large physical separation between the herds and having a management zone around the plains bison herd that allows harvest of plains bison within this zone (Harper et al. 2000, p. 23).

As discussed earlier under Factor A, plains bison presence on the landscape is increasing and commercial plains bison operations in Canada are expanding. The presence of plains bison within the historical range of wood bison increases the probability that wood bison will come into contact with them. Ranchers are most likely highly motivated by economics to prevent the escape of their animals and to recapture them if they do escape. It is unlikely that additional government regulations would improve on this basic incentive; therefore, although there may not be specific regulations regarding how plains bison should be contained, such regulations are not viewed as necessary or effectual. As mentioned above, buffer zones are not ideal for preventing the movement of free-ranging bison. Thus, although regulations are in place by which the Pink Mountain plains bison herd (a free-ranging herd) can be managed, and there is no indication that they have not been effective, they may not be 100 percent effective in preventing hybridization in the future because of the difficulty of managing wild animals over large areas of forested landscape.

In the United States, as an endangered species under the Act, pure wood bison can be imported only by permit for scientific research or enhancement of propagation or survival of the species. Wood/plains bison hybrids, however, are not protected by the Act and can be imported if the required CITES Foreign Export Permits are obtained from Canada prior to the import. When the wood bison is reclassified to threatened (see DATES , above), import of trophies legally taken and properly permitted can also occur. Because of the regulations in place in Canada for all hunts and the permits required for import and export under CITES, we do not anticipate that reclassification will cause any increase in the number of animals killed or have any effect on the herds that are hunted.

The wood bison is listed on Appendix II of CITES. CITES, an international treaty among 175 nations, including Canada and the United States, became effective in 1975. In the United States, CITES is implemented through the U.S. Endangered Species Act. The Secretary of the Interior has delegated the Department of the Interior's responsibility for CITES to the Director of the Service and established the CITES Scientific and Management Authorities to implement the treaty.

CITES provides varying degrees of protection to more than 32,000 species of animals and plants that are traded as whole specimens, parts, or products. Under this treaty, member countries work together to ensure that international trade in animal and plant species is not detrimental to the survival of wild populations by regulating the import, export, and reexport of CITES-listed animal and plant species (USFWS 2010, unpaginated). Under CITES, a species is listed on an Appendix and receives varying levels of regulation of international trade through permit and certification requirements depending upon the particular Appendix in which the species is listed (CITES 2010b, unpaginated). CITES Appendix-II species are not necessarily considered to be threatened with extinction now but may become so unless trade in the species is regulated. Appendix II allows for regulated trade, including commercial trade, as long as the exporting country issues a CITES permit based on findings that the specimen was legally acquired and the export will not be detrimental to the survival of the species. As discussed above under Factor B, we do not consider international trade to be a threat impacting the wood bison. Therefore, protection under this treaty is an adequate regulatory mechanism.

The wood bison is currently protected through a variety of regulatory mechanisms, and we anticipate those protections to continue. The wood bison and its habitat is protected by Canadian Federal, provincial, and territorial law. Internationally, its trade is regulated by CITES. International trade is limited to animals surplus to recovery needs in Canada, as determined under guidance of the National Wood Bison Recovery Team. In the United States, activities involving wood bison are regulated by the Endangered Species Act, and with reclassification, they will continue to be regulated. Federal agencies will need to consult with the Service on activities within the United States that may affect the species, and Federal permits will be required for scientific collection or any other form of take.

Disease and hybridization have been identified as threats to wood bison. Although buffer zones have been established and regulations implemented for the management of the buffer zones to minimize the potential of disease spread and hybridization, buffer zones have limitations and are an imperfect means by which to prevent animal movement. Therefore, we conclude that existing regulatory mechanisms are inadequate to completely protect wood bison from these threats.

Because bison follow linear landmarks and prefer open areas, vehicles on roads and other linear developments, such as railroad lines, present a hazard to wood bison. Collisions with vehicles are the largest source of known mortality for individuals in the Hay-Zama herd (Mitchell and Gates 2002, p. 9). For the Nordquist herd, vehicle collisions are a significant mortality factor (Wildlife Collision Prevention Program. 2010, pp. 22-23). The herd was established in the Nordquist Flats area, near the Liard River in northeastern British Columbia; however, individuals, and then the majority of the herd, moved to the Alaska Highway corridor. In January 2007, a limited aerial survey counted 97 wood bison, all of which were on the highway right-of-way, except for four bulls, which were observed within 500 m (1,640 ft) of the road (Reynolds et al. 2009, p. 6). Three of 15 wood bison introduced to the Etthithun Lake area in 1996 were killed in collisions with industrial road traffic during the first winter (Harper and Gates 2000, p. 921). The Yukon government has a “bison-free” policy in the vicinity of the Alaska Highway that includes deterrence, capture, and ultimately the destruction of problem animals (Yukon Fish and Wildlife Co-management undated, p. 1). During the growth phase of the Aishihik herd from 1988 to 1993, 49 wood bison were removed from the Alaska Highway right-of-way because of vehicle collisions and problem wildlife complaints (Boyd 2003, p. 187). Of these, 36 were captured and moved to a game farm, 8 were killed in collisions, and 5 were intentionally killed (Wildlife Collision Prevention Program 2010, unpaginated). From 1989 to 2007, collisions with vehicles killed from 1 to 30 wood bison annually from three herds combined in the Northwest Territories; fewer than 10 were killed annually in 11 of the 18 years (Wildlife Collision Prevention Program 2010, unpaginated).

Because of continued or increased resource development, tourism, and off-road vehicle use, it is anticipated that mortality from collisions with vehicles will be a source of individual mortality for several populations. Because mortality from road collisions represents a small portion of the total subspecies population, and efforts are made to reduce bison/highway conflicts, this source of mortality is not expected to have a significant impact at the subspecies population level.

Spring flooding in the Peace-Athabasca River Delta in 1958, 1961, and 1974 killed approximately 500, 1,100, and 3,000 wood bison, respectively (Reynolds et al. 2003, p. 1029). Autumn flooding in the same area in 1959 killed an estimated 3,000 wood bison (Reynolds et al. 2003, p. 1029). This region is within WBNP where the diseased herds reside. Most likely a small number of animals drown each year when caught by floods or when they break through ice (Soper 1941, p. 403; Larter et al. 2003, p. 411). Large drowning events have not been documented from other rivers, and no large mortality events have been documented in recent years. Drowning is also recognized as a cause of mortality in the Chitek Lake, Mackenzie, and Nahanni herds (Larter et al. 2003, p. 411). Because mortality due to drowning typically affects only a portion of a herd and herd sizes are increasing (see Table 1, above), drowning does not appear to be having a population-level effect on wood bison.

Although wood bison are hardy and very cold tolerant (Gates et al. 2010, p. 24), above-average snowfall, long periods of sub-zero temperatures, and midwinter thaws followed by freezing can cause mortality. Such severe winter conditions reduce forage availability (Reynolds et al. 2003, p. 1030). Rain-on-snow events can also form an ice layer that creates a barrier to forage for herbivores (Putkonen 2009, p. 221). Freezing rain in autumn that causes ground-fast ice to form before snow cover accumulates, ice layering in the snow cover, crusting of the snow, and the formation of ground-fast ice in spring increase the energy required to obtain forage or make forage unobtainable (Gunn and Dragon 2002, p. 58). Soper (1941, pp. 403-404) recounts several stories in which excessive snowfall caused mass mortalities of wood bison, and Van Camp and Calef (1987, p. 23) report that 33 percent of the diseased wood bison herd in the Slave River lowlands was lost during the severe winter of 1974-1975. Starvation in bad winters is recognized as a source of mortality for wood bison in the Chitek Lake herd. We have no information indicating that starvation is having a population-level effect on any of the herds currently.

Rain-on-snow events may increase in the face of climate change (Rennert et al. 2009, p. 2312). A doubling of carbon dioxide is estimated to cause a 40 percent increase in the area impacted by rain-on-snow events in the Arctic by 2080 (Rennert et al. 2009, p. 2312). Rain-on-snow events may become more prevalent primarily in northwestern Canada, Alaska, and eastern Russia (Rennert et al. 2009, p. 2312). We have no reports that rain-on-snow events have led to the deaths of bison, but they could be susceptible to starvation by such events.

Genetic diversity in wood bison has been reduced through the large historic reduction in overall population size and the starting of new populations with very few individuals (founder effect). Genetic diversity is the primary means by which organisms can adapt to changing environmental conditions over time. Low levels of genetic diversity can reduce the ability of a population to respond to environmental changes. Current wood bison herds were established from relatively few founders (Wilson and Strobeck 1999, pp. 484-486). For example, the Elk Island National Park herd was started from 11 individuals, and the Mackenzie herd was started from 16 (Gates et al. 1992, p. 150; Wilson and Strobeck 1999, p. 494). Inbreeding, the mating of related individuals, can lead to lower fecundity, increased abnormalities, reduced growth rates, and other issues. Although inbreeding is more likely to occur in small herds or in herds that are isolated, it has not been documented in wood bison. Starting new populations with multiple groups of animals is one way to avoid or minimize the founder effect as was done in the establishment of the Aishihik and Nahanni herds. Moving disease-free animals from one herd to another is another method to maintain genetic diversity. One of the wood bison recovery goals is to ensure that the genetic integrity of wood bison is maintained. Because no effects of inbreeding have been documented and management actions have been shown to be effective, we conclude that loss of genetic diversity is not a threat to wood bison now or in the foreseeable future.

Hybridization occurs when individuals from genetically distinct groups such as wood bison and plains bison interbreed. The introduction of plains bison to WBNP in the 1920s put the two distinct subspecies in contact with each other and threatened the genetic purity of wood bison (Gates et al. 2010, p. 17). The discovery of an isolated subpopulation of wood bison in 1957, and subsequent translocation of individuals, created the Mackenzie and Elk Island National Park herds, which were thought to be pure wood bison. Genetic analysis has indicated that these bison did have limited contact with plains bison, but it was minimal enough that the animals exhibit predominantly wood bison traits and wood bison herds originating from these founders are genetically more similar to one another than they are to plains bison (van Zyll de Jong et al. 1995, pp. 401-404; Wilson and Strobeck 1999, p. 493). Although recovery actions emphasize maintaining the genetic integrity of wood bison (i.e., recovery goal number 3) (Gates et al. 2001, p. 33), as discussed earlier under Factor A, the presence of plains bison on the landscape is increasing. Commercial plains bison operations in Canada are expanding, and the Pink Mountain plains bison herd was established in British Columbia as a result of plains bison escaping from an enclosure. The commercial plains bison operations and plains bison herds remove potential habitat for wood bison, and the presence of plains bison within the historical range of wood bison increases the probability that wood bison will come into contact with them. For these reasons, loss of genetic integrity through hybridization is a threat to wood bison and will remain so in the foreseeable future.

Accidental mortality typically occurs randomly and cannot be predicted. We expect accidents to continue at the same rate and scale as they have in the past, into the future, but only expect this to affect individuals and not be significant enough to affect the species as a whole. Relative to genetic diversity, inbreeding in wood bison has not been documented, and management actions are in place to prevent further loss of genetic diversity. The status of genetic issues relating to hybridization could change relatively rapidly, especially if plains bison were to escape from captivity in close proximity to a wood bison herd. Currently, free-ranging wood bison and plains bison herds are widely separated from one another, but as herd size grows, the separation shrinks, increasing the odds that they may come into contact with one another. Furthermore, bison are difficult animals to contain, they can travel long distances, and the wood and plains bison can readily interbreed.

In summary, accidental mortality will continue to occur regularly, primarily through collisions with vehicles and drowning. In addition, climate change may create localized weather conditions such as above-average snowfall, long periods of sub-zero temperatures, or ground-fast ice formation that can lead to winter mortality of portions of herds. Given the number of herds and their wide distribution across the landscape, we conclude that accidental mortality and starvation are not threats to wood bison now or in the foreseeable future. It is recognized that genetic diversity in wood bison is relatively low, and that the herds must be managed to maintain genetic diversity. Loss of genetic diversity is a factor that may limit the ability of wood bison to adapt to changing conditions in the future, but the magnitude of that limitation, if it exists, is unknown. Lack of genetic diversity is potentially limiting over the long term, depending on the magnitude of environmental change wood bison may face. Because no effects of inbreeding have been documented and management actions have been shown to be effective, we conclude that loss of genetic diversity is not a threat to wood bison now or in the foreseeable future. Hybridization with plains bison is a threat that most likely will increase in the future. Because of consumer demand for bison meat, we expect commercial bison production will continue to expand, removing suitable habitat for wood bison recovery herds, and increasing the probability that escaped plains bison will be free on the landscape. Hybridization is a threat to wood bison now and in the foreseeable future.

As required by the Act, we considered the five factors in assessing whether the wood bison is endangered or threatened throughout all or a significant portion of its range. We reviewed the petition, information available in our files, comments and information we received after the publication of our 90-day finding (74 FR 5908, February 3, 2009), comments and information we received after the publication of our proposed rule to reclassify wood bison (76 FR 6734, February 8, 2011), and other available published and unpublished information. We also consulted with recognized experts. We have carefully assessed the best available scientific and commercial data regarding the past, present, and future threats faced by wood bison. We found that threats to wood bison are still present in factors A, C, D, and E. Habitat loss has occurred from agricultural development, and we expect losses will continue in concert with human growth and expansion of agriculture, including commercial bison production. The presence of bovine brucellosis and bovine tuberculosis constrains herd growth as: Managers attempt to maintain physical separation between diseased and disease-free wood bison and cattle herds, the diseased herds are occupying habitat that could be restored with disease-free herds, and disease in the largest potential donor population (WBNP herd) prevents those animals from being used in reintroduction projects. Plains bison are commercially produced in historical wood bison habitat. These operations remove potential habitat from wood bison recovery efforts, and the escape of plains bison poses a threat to wood bison because of hybridization and the loss of genetic integrity. Finally, we found that regulatory mechanisms are inadequate to prevent disease transmission and hybridization within Canada.

In addition to the five-factor analysis, we took into consideration the conservation actions that have occurred, are ongoing, and are planned. Since listing, the subspecies' status has improved as a result of the following:

• Enactment and enforcement of national and international laws and treaties have minimized the impacts of hunting and trade.

• Reintroduction of disease-free herds has increased the number of free-ranging herds from 1 population of 300 in 1978, to 7 populations totaling 4,414 bison in 2008.

• Diseased and disease-free, free-ranging populations are stable or increasing.

In sum, the continued reintroduction of disease-free herds, the ongoing development and updating of management plans, the active management of herds, the ongoing research, and the protections provided by laws and protected lands provide compelling evidence that recovery actions have been successful in reducing the risk of extinction associated with the threats identified. We anticipate that continued growth and expansion of the herds would further reduce the risk of extinction in the future.

The primary factor that led to the listing of the wood bison was the small number of free-ranging, disease-free animals on the landscape. However, the trend today is towards increasing numbers of disease-free herds and population sizes. We find that the threats identified under factors A, C, D, and E, when combined with the increase in number of herds and population sizes, ongoing active management, and protections provided by laws, are not of sufficient imminence, intensity, or magnitude to indicate that the wood bison is presently in danger of extinction. The wood bison therefore no longer meets the definition of endangered under the Act. However, threats to wood bison still exist and will likely continue into the foreseeable future. In particular, there are no easy solutions for dealing with the diseased animals. No effective vaccines exist for brucellosis, tuberculosis, or anthrax for free-ranging populations. In addition, although recommendations for the management of the diseased herds in and around WBNP have been suggested (FEAP 1990, p. 2), they have not yet been implemented, it is unknown if they will be implemented, and it is unknown how implementation of the recommendations would affect the status of the subspecies. Therefore, we have determined that the wood bison meets the definition of threatened under the Act. Consequently, we are reclassifying the wood bison's listing status from endangered to threatened with this rule.

In our February 8, 2011, proposed rule (76 FR 6734), we determined that the Aishihik and Chitek Lake herds are discrete under our Distinct Vertebrate Population Segment policy (61 FR 4722, February 7, 1996), but are not significant, and therefore, did not qualify as a distinct population segment. In that proposed rule, we also considered whether there is a significant portion of the range where the wood bison is in danger of extinction and did not identify any area or herd whose loss would result in a decrease in the ability to conserve the species as a whole. Consequently, as described in the proposed rule, we are not listing a distinct population segment of wood bison and we have not identified a portion of the range that is so significant to the species that threats there imperil the species as a whole.

Conservation measures provided to species listed as endangered or threatened under the Act include recognition, requirements for Federal protection, and prohibitions against certain practices. Recognition through listing results in public awareness, and encourages and results in conservation actions by Federal governments, private agencies and groups, and individuals. The Act encourages cooperation with the States and requires that recovery actions be carried out for all listed species. The protection measures required of Federal agencies and the prohibitions against certain activities are discussed, in part, below.

Section 7(a) of the Act, as amended, and as implemented by regulations at 50 CFR part 402, requires Federal agencies to evaluate their actions within the United States or on the high seas with respect to any species that is proposed or listed as endangered or threatened, and with respect to its critical habitat, if any is being designated. If a species is listed subsequently, section 7(a)(2) of the Act requires Federal agencies to ensure that activities they authorize, fund, or carry out are not likely to jeopardize the continued existence of the species or destroy or adversely modify its critical habitat. However, given that there are no wild populations of wood bison in the United States, critical habitat is not being designated for this species under section 4 of the Act.

Section 8(a) of the Act authorizes limited financial assistance for the development and management of programs that the Secretary of the Interior determines to be necessary or useful for the conservation of endangered and threatened species in foreign countries. Sections 8(b) and 8(c) of the Act authorize the Secretary to encourage conservation programs for foreign endangered species and to provide assistance for such programs in the form of personnel and the training of personnel.

The Act and its implementing regulations set forth a series of general prohibitions and exceptions that apply to all endangered and threatened wildlife. As such, these prohibitions are, and will continue to be when this rule is effective (see DATES , above), applicable to the wood bison. These prohibitions, under 50 CFR 17.21 (50 CFR 17.31 for threatened wildlife species), make it illegal for any person subject to the jurisdiction of the United States to “take” (take includes harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, collect, or to attempt any of these) within the United States or upon the high seas, import or export, deliver, receive, carry, transport, or ship in interstate or foreign commerce in the course of a commercial activity, or to sell or offer for sale in interstate or foreign commerce, any endangered wildlife species. It also is illegal to possess, sell, deliver, carry, transport, or ship any such wildlife that has been taken in violation of the Act. Certain exceptions apply to agents of the Service and State conservation agencies.

We may issue permits to carry out otherwise prohibited activities involving endangered and threatened wildlife species under certain circumstances. Regulations governing permits are codified at 50 CFR 17.22 for endangered species, and at 50 CFR 17.32 for threatened species. With regard to endangered wildlife, a permit must be issued for the following purposes: for scientific purposes, to enhance the propagation or survival of the species, and for incidental take in connection with otherwise lawful activities. For threatened species, a permit may be issued for the same activities, as well as zoological exhibition, education, and special purposes consistent with the Act.

This final rule revises 50 CFR 17.11(h) to reclassify the wood bison from endangered to threatened. This rule formally recognizes that this species is no longer presently in danger of extinction throughout all or a significant portion of its range. However, this reclassification does not significantly change the protection afforded this species under the Act. The regulatory protections of section 9 and section 7 of the Act remain in place. Anyone taking, attempting to take, or otherwise possessing a wood bison, or parts thereof, in violation of section 9 of the Act is still subject to a penalty under section 11 of the Act, unless their action is covered under a special rule under section 4(d) of the Act. We are not currently publishing a special rule under section 4(d) of the Act for the wood bison at this time. However, section 9(c)(2) of the ESA sets out an exemption to the general import prohibition for threatened, Appendix-II wildlife, both live and dead, when: (1) The taking and export meet all provisions of CITES; (2) all other import and reporting requirements under section 9 of the ESA are met; and (3) the import is not made in the course of a commercial activity. Since the wood bison is currently listed in Appendix II of CITES, upon the effective date of this publication, and the reclassification of the wood bison from endangered to threatened, this ESA exemption is generally applicable. Because a sport-hunted trophy is not a specimen obtained or imported in the course of a commercial activity, the section 9(c)(2) ESA exemption would typically apply to the import of sport-hunted trophies, provided that all other requirements of section 9(c)(2) of the ESA are met.

Under section 7 of the Act, Federal agencies must ensure that any actions they authorize, fund, or carry out are not likely to jeopardize the continued existence of the wood bison. Because no free-ranging herds of wood bison occur in Alaska or any other State, we do not anticipate that there will be an additional regulatory responsibility because of this rule.

This rule does not contain any new information collections or recordkeeping requirements for which Office of Management and Budget (OMB) approval is required under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). We may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

We have determined that we do not need to prepare an environmental assessment or environmental impact statement, as defined under the authority of the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq. ), in connection with regulations adopted pursuant to section 4(a) of the Endangered Species Act. We published a notice outlining our reasons for this determination in the Federal Register on October 25, 1983 (48 FR 49244).

A complete list of the references cited is available at http://www.regulations.gov at Docket No. FWS-R9-IA-2008-0123 or upon request from the Alaska Regional Office (see ADDRESSES ).

The primary author of this rule is Marilyn Myers, Ph.D., Fisheries and Ecological Services, Alaska Regional Office, 1011 E. Tudor Road, Anchorage, AK 99503; 907-786-3559.

Accordingly we amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below:

NMFS manages the groundfish fishery in the BSAI exclusive economic zone according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

The A season allowance of the 2012 Atka mackerel TAC, in the CAI, allocated to vessels participating in the BSAI trawl limited access fishery was established as a directed fishing allowance of 476 metric tons by the final 2012 and 2013 harvest specifications for groundfish in the BSAI (77 FR 10669, February 23, 2012).

In accordance with § 679.20(d)(1)(iii), the Administrator, Alaska Region, NMFS, finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Atka mackerel in the CAI by vessels participating in the BSAI trawl limited access fishery.

After the effective dates of this closure, the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

This action responds to the best available information recently obtained from the fishery. The Acting Assistant Administrator for Fisheries, NOAA, (AA) finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such a requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of the Atka mackerel fishery in the CAI for vessels participating in the BSAI trawl limited access fishery. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of April 27, 2012. The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

This action is required by § 679.20 and is exempt from review under Executive Order 12866.