Federal Register Vol. 80, No.90,

Background

The regulations in Title 9, Code of Federal Regulations (9 CFR), parts 101-118 (referred to below as the regulations) contain provisions implementing the Virus-Serum-Toxin Act (the Act), as amended (21 U.S.C. 151-159). These regulations are administered by the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA). The Act prohibits the preparation, sale, and shipment of veterinary biological products in or from the United States unless such products have been prepared under and in compliance with USDA regulations at an establishment holding an unsuspended and unrevoked license issued by USDA.

In part 102 of the regulations, §§ 102.1 and 102.2 require that each establishment and every person preparing biological products subject to the Act must hold an unexpired, unsuspended, and unrevoked U.S. Veterinary Biologics Establishment License issued by the Administrator and a U.S. Veterinary Biological Product License for each product prepared in such establishment. Part 107 of the regulations contains exemptions from the requirement for preparation pursuant to unsuspended and unrevoked establishment and product licenses. One of those exemptions, found in § 107.1(a)(1), allows for product to be prepared by a veterinary practitioner solely for administration to animals in the course of his or her State-licensed professional practice of veterinary medicine under a veterinarian-client-patient relationship. The regulations in § 107.1(a)(1) also set forth the criteria that must be satisfied in order to establish the existence of a veterinarian-client-patient relationship.

On July 18, 2012, we published in the Federal Register (77 FR 42195-42197, Docket No. APHIS-2011-0048) a proposal 1 to amend the regulations to require that veterinary biologics prepared under the veterinary practitioner exemption be prepared at the same facility the veterinarian utilizes in conducting the day-to-day activities associated with his or her practice. The proposal was intended to ensure that veterinary biologics are not prepared in unlicensed establishments in violation of the Virus-Serum-Toxin Act and to clarify the regulations regarding the preparation of product by a veterinary practitioner under a veterinarian-client-patient relationship.

We solicited comments concerning our proposal for 60 days ending September 17, 2012. We reopened and extended the deadline for comments until November 16, 2012, in a document published in the Federal Register on September 20, 2012 (77 FR 58323, Docket No. APHIS-2011-0048). We received 55 comments by that date. They were from veterinarians and veterinary associations, several State universities, pork producers' associations, trade organizations, veterinary biologics companies, private laboratories, aquaculture companies, officials from the State of Iowa, and individuals. These comments are discussed below by topic.

Some commenters not only supported the proposal but recommended that we speed the implementation process along.

We are finalizing this rule as expeditiously as possible. Given the number of comments we received on the proposed rule and the substantive nature of most of them, however, we determined that we needed to carefully review and evaluate those comments before implementing any regulatory changes.

Several organizations and a number of veterinary practitioners raised concerns about what they termed the “forced relocation” of preparation sites for veterinary biologics to the same facility in which the veterinarian conducts day-to-day activities connected with his or her practice. Commenters stated that a veterinary practice is an environment poorly suited to the aseptic conditions required for biologics production and that personnel working in these facilities are trained in animal care rather than in specialized laboratory work. Several commenters recommended that APHIS revise the rule to require that, regardless of the location of the production facility, veterinarians that use the facility must document regular involvement in the management of the facility, provide such documentation on request, and allow regular on-site inspections, presumably by APHIS.

APHIS disagrees with the commenters' recommendation. As noted in the preamble to the July 2012 proposed rule, the intent of the veterinary practitioner exemption in § 107.1(a)(1) is to allow a practitioner to prepare exempt biological products at a location not licensed under the Act, where the practitioner operates a veterinary practice, and to transport such products away from that facility when necessary for administration to an animal or animals under a veterinarian-client-patient relationship without violating the Act. The intention behind the proposed rule was to clarify the relationship between the veterinary practitioner and the facility where exempt veterinary biological product is prepared. No provision in the Act or the regulations allows an unlicensed commercial laboratory, acting as the agent for the practitioner, to prepare, produce, sell, and ship the veterinary biological product under the exemption in § 107.1(a)(1). Such an arrangement would violate the Act. Nothing in this rule or in the Act, however, prevents veterinarians from working with establishments with a license to produce autogenous products, i.e., limited use biologics.

Commenters expressed concern about how this rule would affect practitioners who have offices in multiple locations in which there are multiple practitioners. It was stated that changes within the swine industry have led many veterinarians to practice in this manner. According to the commenters, this rule would potentially require that a “brick and mortar” location for vaccine production would have to be the same as the physical location of the veterinarian. In the commenters' view, such a requirement could prove problematic for a multi-location veterinary practice in which there may only be one location suitable for the preparation of exempt veterinary biological product. Commenters questioned how we would address the issue of multiple locations managed by the same veterinarian or practice even though the prescribing veterinarian may not routinely work out of the office where the exempt biological product is prepared.

APHIS acknowledges that it has become a common occurrence in the swine industry for swine practitioners to work in multi-veterinarian, multi-location corporate practices. Nothing in this rule, however, prohibits a veterinarian from producing an exempt biological product in any of the locations routinely used in his or her day-to-day practice, provided that the other conditions in § 107.1 are met.

Noting that § 107.1(a)(2) of the proposed rule stated that a biological product may be prepared by a veterinary assistant under the veterinarian's “direct supervision,” some commenters, while generally supportive of the rule, requested that we clarify how we define that term.

APHIS interprets “direct supervision” to mean that the licensed veterinarian is readily available on the premises where the product is being prepared and has the responsibility for its preparation by the assistant working under his or her direction.

Some commenters suggested that the emphasis of the rule should be redirected away from location of the exempt facilities and toward the quality and management of the facilities where the products are prepared. It was stated that the rule focuses too much on location and not enough on animal health.

As noted above, the purpose of this rule is to clarify who may prepare exempted biological products and where those exempted products may be prepared under the regulations. Requirements pertaining to the quality and management of veterinary biologics establishments are already addressed in 9 CFR part 108.

Some commenters maintained that unlicensed laboratories should be allowed to prepare and ship exempt veterinary biological products on behalf of veterinary practitioners, that the rule may hinder innovative practices, and that the relationship between the veterinarian and the facility should be legal rather than location-based. The commenters expressed concern that the rule will restrict veterinarians' access to certain customized vaccines that are prepared in specialized settings and thus prevent practitioners from responding rapidly to mutating viruses. Several commenters cited the case of an Iowa manufacturer, which they viewed as an innovative company with expertise in new technologies that enabled it to prepare vaccines quickly and effectively. The commenters stated that that company's activities may be restricted under this rule.

The purpose of this rule is to clarify the relationship between the veterinary practitioner and the facility where exempt veterinary biological products are prepared. We do not intend to hinder innovation and the development of valuable new technologies, nor do we anticipate that this rule will have such an effect. Any manufacturing establishment wishing to provide its technology and expertise to veterinarians has several licensing options that will allow it to market its product. To cite one example, in 2012, APHIS published guidelines for obtaining a conditional veterinary biologics license using production platform technology. These guidelines, which describe the policies and procedures regarding the licensure of product platforms based on recombinant technology, can be viewed at http://www.aphis.usda.gov/animal_health/vet_biologics/publications/memo_800_213.pdf.

Some commenters expressed concerns about how this rule may affect minor species, in particular, the aquaculture industry. It was stated that the language contained in the proposed rule was too restrictive, as it was based on an erroneous assumption of a homogenous type of veterinary practice involving mainly major species where there is only in-patient or on-the-farm care. Veterinary practitioners in the aquaculture industry routinely prepare autogenous vaccines, which may be isolated from a particular school of fish. A commenter stated that for minor species and minor indications, it is not cost-effective to have separate facilities for the preparation of existing exempt vaccines and autogenous vaccines. The commenter recommended that, for minor species applications, we add a provision to the final rule allowing the production of exempt biological products in a veterinary establishment that has either full or autogenous licensure to produce biologics, provided that the practitioner can demonstrate temporal and sanitary separation between exempt and non-exempt products.

We do not agree that adding such a provision to the regulations is necessary. This rule does not affect the preparation of exempt veterinary biological product for minor species, such as farmed fish; it merely clarifies where such products can be prepared. Veterinarians who service minor species will continue to have the options currently available to them of preparing an exempt product or working with a licensed establishment to produce an autogenous vaccine.

The July 2012 proposed rule included some additional changes to § 107.1. Specifically, we proposed to replace the term “establishments” with “facilities” in the introductory text and in paragraph (a)(1). One commenter favored retaining the original terminology. The commenter stated that “facilities” is too narrow a term and that, conversely, “establishments” correctly reflects many of the types of operations that licensed veterinarians are associated with (ambulatory, zoos, aquarium, fish culture facilities, feedlots, etc.).

We do not agree with this comment. The reason for the proposed change in terminology was to distinguish between manufacturers that produce licensed biological products in licensed establishments and those that produce exempt veterinary biological products under the conditions described in § 107.1. The introductory text of § 107.1 contains a reference to establishment licenses. Elsewhere in the regulations, including § 107.2, only production sites that are not exempt from licensing requirements are referred to as establishments. Drawing a clear distinction between establishments, where vaccines are prepared in accordance with our licensing requirements, and facilities, where exempt products are produced, helps to clarify the regulations and eliminate possible confusion.

Therefore, for the reasons given in the proposed rule and in this document, we are adopting the proposed rule as a final rule, without change.

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

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

This final rule amends the regulations in § 107.1 to clarify that the preparation of biological products pursuant to the exemption in paragraph (a)(1) of that section must take place at the same facility that the veterinarian preparing the product utilizes in conducting the day-to-day activities associated with his/her State-licensed professional practice of veterinary medicine.

The exemption applies to veterinary biologics prepared by a veterinary practitioner solely for administration to animals in the course of a State-licensed professional practice of veterinary medicine under a veterinarian-client-patient relationship. No provision in the Act or the regulations allows a veterinary practitioner to take advantage of the licensing exemption while at the same time consigning the actual preparation of the product to a commercial laboratory or other manufacturing establishment which would then exchange or deliver the product to a third party.

The Regulatory Flexibility Act requires agencies to consider whether a rule will have a significant economic impact on a substantial number of small entities.

Some commenters on the July 2012 proposed rule expressed concerns that the rule would adversely affect how veterinary practitioners conduct day-to-day activities connected with their practices, prevent veterinarians from working with commercial labs or manufacturing facilities in preparing vaccines, and hinder the development of innovative practices.

For the most part, there should be little or no effect on veterinary practitioners. Veterinary practitioners who are in compliance with the regulations do not need to alter the way they conduct their veterinarian-client-patient relationships. This final rule will not change the nature of the exemption, the number of veterinary practitioners eligible to take advantage of the exemption, or the criteria that must be satisfied in order to establish the existence of a veterinarian-client-patient relationship. Also, this final rule will not add any additional reporting or recordkeeping burden.

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

This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 7 CFR part 3015, subpart V.)

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. It is not intended to have retroactive effect. This rule will not preempt any State or local laws, regulations, or policies where they are necessary to address local disease conditions or eradication programs. However, where safety, efficacy, purity, and potency of biological products are concerned, it is the Agency's intent to occupy the field. This includes, but is not limited to, the regulation of labeling. Under the Act, Congress clearly intended that there be national uniformity in the regulation of these products. There are no administrative proceedings which must be exhausted prior to a judicial challenge to the regulations under this rule.

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

Accordingly, we are amending 9 CFR part 107 as follows:

The Farm Credit Administration adopted a final rule related to System bank and association disclosures to shareholders and investors of senior officer compensation in the Summary Compensation Table. Under the final rule, System banks and associations are not required to report in the Table the compensation of employees who are not senior officers and who would not otherwise be considered “highly compensated employees” but for the payments related to, or change(s) in value of, the employees' qualified pension plans, provided that the plans were available to all employees on the same basis at the time the employees joined the plans. In accordance with 12 U.S.C. 2252, the effective date of the final rule is 30 days from the date of publication in the Federal Register during which either or both Houses of Congress are in session. Based on the records of the sessions of Congress, the effective date of the regulations is April 29, 2015.

Good Cause for Immediate Adoption

Section 553(b)(3)(B) of title 5, U.S. Code, authorizes agencies to dispense with notice and comment procedures for rules when the agency for “good cause” finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” In this instance, the FAA finds that notice and public comment to this immediately adopted final rule, as well as any delay in the effective date of this rule, are impracticable and contrary to the public interest due to the immediate need to address the potential hazard to civil aviation that now exists in the ORBB FIR, as described in the Background section of this rule.

The FAA is responsible for the safety of flight in the U.S. and for the safety of U.S. civil operators, U.S.-registered civil aircraft, and U.S.-certificated airmen throughout the world. The FAA's authority to issue rules on aviation safety is found in title 49, U.S. Code. Subtitle I, section 106(f), describes the authority of the FAA Administrator. Subtitle VII of title 49, Aviation Programs, describes in more detail the scope of the agency's authority. Section 40101(d)(1) provides that the Administrator shall consider in the public interest, among other matters, assigning, maintaining, and enhancing safety and security as the highest priorities in air commerce. Section 40105(b)(1)(A) requires the Administrator to exercise his authority consistently with the obligations of the U.S. Government under international agreements.

This rulemaking is promulgated under the authority described in title 49, subtitle VII, part A, subpart III, section 44701, General requirements. Under that section, the FAA is charged broadly with promoting safe flight of civil aircraft in air commerce by prescribing, among other things, regulations and minimum standards for practices, methods, and procedures that the Administrator finds necessary for safety in air commerce and national security. This regulation is within the scope of that authority, because it amends SFAR No. 77, § 91.1605, to incorporate the prohibition set forth in the August 8, 2014, NOTAM on flight operations at all altitudes in the ORBB FIR due to the potential hazard to U.S. civil aviation posed by the armed conflict in Iraq. This amendment will remain in effect for two years. The FAA will continue to actively evaluate the area and amendments to the SFAR may be appropriate if the risk to aviation safety and security changes. The FAA may amend or rescind the SFAR as necessary prior to its expiration date.

On October 9, 1996 (61 FR 54020 (October 16, 1996)), the FAA issued SFAR No. 77 to prohibit flight operations over or within the territory and airspace of Iraq by any U.S. air carrier or commercial operator; by any person exercising the privileges of an airman certificate issued by the FAA, except persons operating U.S.-registered aircraft for a foreign air carrier; or by any person operating an aircraft registered in the United States, unless the operator of such aircraft was a foreign air carrier. The prohibition was issued in response to concerns for the safety and security of U.S. civil flights within the territory and airspace of Iraq. In the final rule, the FAA cited a threat made by then President of Iraq Saddam Hussein, who urged his air defense forces to ignore both the southern and northern no-fly zones that were then in place and to attack “any air target of the aggressors.” 61 FR 54020. The FAA was concerned that this threat could apply to civilian as well as to military aircraft, and therefore issued SFAR No. 77.

In early 2003, a U.S.-led coalition removed Saddam Hussein's regime from power in Iraq. The FAA anticipated that when hostilities ended in Iraq, humanitarian efforts would be needed to assist the people of Iraq. To facilitate those efforts, in April 2003, the FAA amended what was then paragraph 3 of SFAR No. 77 to clarify the approval process for such flights, making clear that operations could not be authorized by another agency without the approval of the FAA. The FAA issued the amendment on April 7, 2003 (68 FR 17870 (April 11, 2003)).

On November 13, 2003 (68 FR 65382 (November 19, 2003)), the FAA determined that certain limited overflights of Iraq could be conducted safely, subject to the permission of the appropriate authorities in Iraq and in accordance with the conditions established by those authorities. Accordingly, the FAA amended SFAR No. 77 to permit overflights of Iraq above flight level (FL) 200. That amendment also allowed aircraft departing from countries adjacent to Iraq to operate at altitudes below FL 200 within Iraq to the extent necessary to permit a climb above FL 200 if the climb performance of the aircraft would not permit operation above FL 200 prior to entering Iraqi airspace.

On April 19, 2004 (69 FR 21953 (April 23, 2004)), the FAA issued an interpretation of SFAR No. 77, entitled “Prohibition Against Certain Flights Within the Territory and Airspace of Iraq; Approval Process for Requests for Authorization to Operate in Iraqi Airspace,” (the 2004 Interpretation) in the Federal Register. The purpose of the 2004 Interpretation was to explain how the FAA would process and, where appropriate, approve requests for authorization to operate in Iraqi airspace. A copy of the 2004 Interpretation has been placed in the docket for this rulemaking.

On November 28, 2012 (77 FR 72709 (December 6, 2012)), the FAA again amended SFAR No. 77, § 91.1605, effective January 7, 2013, to allow U.S. civil flight operations to and from points outside Iraq, to and from Erbil (ORER) and Sulaymaniyah (ORSU) International Airports in Northern Iraq by persons previously prohibited from conducting such operations by SFAR No. 77, § 91.1605, based on results of evaluations of the airports. ORER and ORSU had supported non-U.S. air carrier operations for a number of years without incident. Based largely on the initiation of those operations and on improvements in the operational environment, the FAA determined that flights by U.S. operators could be conducted safely to those two airports under certain conditions. Therefore, the FAA amended SFAR No. 77, § 91.1605, to allow certain flights within the territory and airspace of Iraq north of 34°30′ North latitude below FL 200 to and from ORER or ORSU, with certain conditions and limitations.

Once the December 2012 amendment went into effect, neither an exemption nor an approval under paragraph (c) of SFAR No. 77 was required for operations to or from ORER or ORSU. However, paragraph (b)(5) required operators flying to or from ORER or ORSU to or from points outside Iraq to obtain a Letter of Authorization (LOA) or Operations Specification (OpSpec), as appropriate, from the Director, Flight Standards Service, AFS-1, prior to conducting such operations. The OpSpec or LOA specified the limitations and conditions under which the operation had to be conducted, to address the residual risk associated with operating into and out of those two airports.

On July 31, 2014, the FAA issued a NOTAM prohibiting flight operations in the territory and airspace of Iraq at or below FL 300 because of significant changes in the operational environment for U.S. civil aviation. The recent resurgence of groups, such as the Islamic State of Iraq and the Levant (ISIL), also known as the Islamic State of Iraq and Syria (ISIS), and their ongoing combat operations against the Iraqi government and its allies had led to an increased threat to U.S. civil aviation in Iraq. ISIL was rapidly acquiring weapons from captured Iraqi or Syrian stocks and had former military personnel to operate those weapons. ISIL had shot down Iraqi rotary-wing and fixed-wing aircraft flying at low altitudes, and also had man-portable air defense systems and other anti-aircraft weapons that provided the capability to target aircraft at higher altitudes. As a result, the FAA determined that ISIL posed an increased threat to U.S. civil aviation operating in Iraqi airspace at or below FL 300.

The July 31, 2014, NOTAM increased restrictions on operations in the territory and airspace of Iraq beyond the restrictions contained in SFAR No. 77, § 91.1605, which remained in effect. The following operations that had been permitted under SFAR No. 77, § 91.1605, were prohibited by the July 31, 2014, NOTAM: (1) Overflights of Iraq above FL 200 but at or below FL 300; (2) operations at or below FL 300 by flights departing from countries adjacent to Iraq whose climb performance would not permit operations above FL 300 prior to entering Iraqi airspace; and (3) flights within the territory of Iraq north of 34°30′ North latitude originating from or destined to areas outside of Iraq to or from ORER or ORSU.

On August 7, 2014, President Obama announced that he had authorized targeted airstrikes against militants associated with ISIL if they moved toward the Iraqi city of Erbil, as well as targeted airstrikes, if necessary, to help Iraqi forces as they fought to break the siege of Mount Sinjar and to protect the civilians trapped there. The President also stated that the U.S. was conducting humanitarian air drops to aid the trapped civilians. U.S. forces began conducting airstrikes on August 8, 2014. On the same day, the FAA issued a NOTAM that prohibited U.S. civil flight operations in the ORBB FIR at all altitudes due to the potentially hazardous situation created by the armed conflict between militants associated with ISIL and Iraqi security forces and their allies. The August 8, 2014, NOTAM superseded the July 31, 2014, NOTAM. This amendment to SFAR No. 77, § 91.1605, revises the rule to incorporate the flight prohibition set forth in the August 8, 2014, NOTAM.

Because the circumstances described herein warrant immediate action by the FAA, I find that notice and public comment under 5 U.S.C. 553(b)(3)(B) are impracticable and contrary to the public interest. Further, I find that good cause exists under 5 U.S.C. 553(d) for making this rule effective immediately upon issuance. I also find that this action is fully consistent with the obligations under 49 U.S.C. 40105 to ensure that I exercise my duties consistently with the obligations of the United States under international agreements.

This action amends SFAR No. 77, § 91.1605, to incorporate the prohibition contained in the FAA's August 8, 2014, NOTAM on flight operations at all altitudes in the ORBB FIR by all U.S. air carriers; U.S. commercial operators; persons exercising the privileges of a U.S. airman certificate, except when such persons are operating a U.S.-registered civil aircraft for a foreign air carrier; and operators of U.S.-registered civil aircraft, except when such operators are foreign air carriers. The FAA finds this action necessary to prevent a potential hazard to persons and aircraft engaged in such flight operations.

In some instances, U.S. government departments, agencies, or instrumentalities may need to engage U.S. civil aviation to support their activities in Iraq. The FAA believes that it has provided a more streamlined approval processes for other U.S. government departments, agencies, and instrumentalities in more recent flight prohibition SFARs than the 2004 Interpretation would allow, and that an approval process similar to those adopted for recent SFARs may be instituted for SFAR No. 77, § 91.1605, while still addressing the threats to U.S. civil aviation in the ORBB FIR. Therefore, the FAA withdraws the 2004 Interpretation in its entirety and replaces it with the approval process described below.

If a department, agency, or instrumentality of the U.S. Government determines that it has a critical need to engage any person covered under SFAR No. 77, § 91.1605, including a U.S. air carrier or a U.S. commercial operator, to conduct a charter to transport civilian or military passengers or cargo, that department, agency, or instrumentality may request the FAA to approve persons covered under SFAR No. 77, § 91.1605, to conduct such operations. U.S. Government departments, agencies, and instrumentalities may also request approval on behalf of subcontractors where the prime contractor has a contract, grant, or cooperative agreement with the U.S. Government department, agency, or instrumentality. An approval request must be made to the FAA in a letter signed by an appropriate senior official of the requesting department, agency, or instrumentality of the U.S. Government. The letter must be sent to the Associate Administrator for Aviation Safety (AVS-1), Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591. Electronic submissions are acceptable, and the requesting entity may request that the FAA notify it electronically as to whether the approval request is granted. If a requestor wishes to make an electronic submission to the FAA, the requestor should contact the Air Transportation Division, Flight Standards Service, at (202) 267-8166, to obtain the appropriate email address. A single letter may request approval from the FAA for multiple persons covered under SFAR No. 77, § 91.1605, and/or for multiple flight operations. To the extent known, the letter must identify the person(s) expected to be covered under the SFAR on whose behalf the U.S. Government department, agency, or instrumentality is seeking FAA approval, and it must describe—

• The proposed operation(s), including the nature of the mission being supported;

• The service to be provided by the person(s) covered by the SFAR;

• To the extent known, the specific locations in the ORBB FIR where the proposed operation(s) will be conducted; and

• The method by which the department, agency, or instrumentality will provide, or how the operator will otherwise obtain, current threat information and an explanation of how the operator will integrate this information into all phases of its proposed operations (e.g., pre-mission planning and briefing, in-flight, and post-flight).The request for approval must also include a list of operators with whom the U.S. Government department, agency, or instrumentality requesting FAA approval has a current contract(s), grant(s), or cooperative agreement(s) (or its prime contractor has a subcontract(s)) for specific flight operations in the ORBB FIR. Additional operators may be identified to the FAA at any time after the FAA approval is issued. Updated lists should be sent to the email address to be obtained from the Air Transportation Division, AFS-220, by calling (202) 267-8166.

If an approval request includes classified information, requestors may contact Aviation Safety Inspector Will Gonzalez for instructions on submitting it to the FAA. His contact information is listed in the “For Further Information Contact” section of this final rule.

FAA approval of an operation under SFAR No. 77, § 91.1605, does not relieve persons subject to this SFAR of their responsibility to comply with all applicable FAA rules and regulations. Operators of civil aircraft will have to comply with the conditions of their certificate and OpSpecs. Operators will also have to comply with all rules and regulations of other U.S. Government departments or agencies that may apply to the proposed operation, including, but not limited to, the Transportation Security Regulations issued by the Transportation Security Administration, Department of Homeland Security.

When the FAA approves the request, the FAA's Aviation Safety Organization (AVS) will send an approval letter to the requesting department, agency, or instrumentality informing it that the FAA's approval is subject to all of the following:

(1) Any approval will stipulate those procedures and conditions that limit, to the greatest degree possible, the risk to the operator, while still allowing the operator to achieve its operational objectives.

(2) Any approval will indicate that the operation is not eligible for coverage under any premium war risk insurance policy issued by the FAA under chapter 443 of title 49, U.S. Code. 1 2 Each such policy excludes coverage for any aircraft operations that are intentionally conducted into or within geographic areas prohibited by an SFAR, such as this SFAR No. 77, § 91.1605. The exclusion specified in the policy will remain in effect as long as this SFAR No. 77, § 91.1605, remains in effect, notwithstanding the issuance of any approval under, or exemption from, this SFAR No. 77, § 91.1605, (the chapter 443 premium war risk insurance policy refers to such approval as a “waiver” and such exemption as an “exclusion”).

(3) Before any approval takes effect, the operator must submit to the FAA:

(a) A written release of the U.S. Government (including, but not limited to, the United States of America as Insurer) from all damages, claims, and liabilities, including without limitation legal fees and expenses; and

(b) The operator's written agreement to indemnify the U.S. Government (including but not limited to the United States of America, as Insurer) with respect to any and all third-party damages, claims, and liabilities, including without limitation legal fees and expenses, relating to any event arising from or related to the approved operations in the ORBB FIR.

The release and agreement to indemnify do not preclude an operator from raising a claim under an applicable non-premium war risk insurance policy issued by the FAA under chapter 443.

(4) Other conditions that the FAA may specify, including those that may be imposed in OpSpecs.

If the proposed operation or operations is or are approved, the FAA will issue OpSpecs authorizing the operation or operations to the certificate holder and will notify the department, agency, or instrumentality that requested FAA approval of such operation(s) of any additional conditions beyond those contained in the approval letter. The requesting department, agency, or instrumentality must have a contract, grant, or cooperative agreement (or its prime contractor must have a subcontract) with the person(s) described in paragraph (a) of SFAR No. 77, § 91.1605, on whose behalf the department, agency, or instrumentality requests FAA approval.

Any operation not conducted under the approval process set forth above must be conducted under an exemption from SFAR No. 77, § 91.1605. A request by any person covered under SFAR No. 77, § 91.1605, for an exemption must comply with 14 CFR part 11, and will require exceptional circumstances beyond those contemplated by the approval process set forth above. In addition to the information required by 14 CFR 11.81, the requestor must describe in its submission to the FAA, at a minimum—

• The proposed operation(s), including the nature of the operation;

• The service to be provided by the person(s) covered by SFAR No. 77, § 91.1605;

• The specific locations in the ORBB FIR where the proposed operation(s) will be conducted; and

• The method by which the operator will obtain current threat information, and an explanation of how the operator will integrate this information into all phases of its proposed operations (e.g., the pre-mission planning and briefing, in-flight, and post-flight phases).

Additionally, the release and agreement to indemnify, as referred to above, will be required as a condition of any exemption issued under SFAR No. 77, § 91.1605.

The FAA recognizes that operations that may be affected by SFAR No. 77, § 91.1605, including this amendment, may be planned for the governments of other countries with the support of the U.S. Government. While these operations will not be permitted through the approval process, the FAA will process exemption requests for such operations on an expedited basis and prior to any private exemption requests.

Changes to Federal regulations must undergo several economic analyses. First, Executive Order 12866 and Executive Order 13563 direct that each Federal agency shall propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify its costs. Second, the Regulatory Flexibility Act of 1980 (Pub. L. 96-354), as codified in 5 U.S.C. 601 et seq., requires agencies to analyze the economic impact of regulatory changes on small entities. Third, the Trade Agreements Act (Pub. L. 96-39, as amended, 19 U.S.C. Chapter 13) prohibits agencies from setting standards that create unnecessary obstacles to the foreign commerce of the United States. In developing U.S. standards, the Trade Agreements Act requires agencies to consider international standards and, where appropriate, that they be the basis of U.S. standards. Fourth, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million or more annually (adjusted for inflation with base year of 1995; currently $151 million). This portion of the preamble summarizes the FAA's analysis of the economic impacts of this final rule.

In conducting these analyses, FAA has determined this final rule has benefits that justify its costs and is a “significant regulatory action,” as defined in section 3(f) of Executive Order 12866, because it raises novel policy issues contemplated under that Executive Order. The rule is also “significant” as defined in DOT's Regulatory Policies and Procedures. The final rule, if adopted, will not have a significant economic impact on a substantial number of small entities, will not create unnecessary obstacles to international trade, and will not impose an unfunded mandate on state, local, or tribal governments, or on the private sector.

Total annual costs to airlines are estimated to be approximately $14 million. The benefits of this final rule are the avoided deaths that might result from a U.S. operator's aircraft being shot down (or otherwise damaged) amidst the armed conflict in Iraq. Since each fatality is valued at $9.2 million, the benefits of this final rule will exceed the costs if just two such deaths are averted.

1. All U.S. air carriers and U.S. commercial operators;

2. All persons exercising the privileges of an airman certificate issued by the FAA, except such persons operating U.S.-registered aircraft for a foreign air carrier; and

3. All operators of aircraft registered in the United States, except where the operator of such aircraft is a foreign air carrier.

• Calendar Year 2013 data.

• Schedule P-10 from Bureau of Transportation Statistics (BTS) to obtain number of employees at a carrier.

• Schedule P-1.2 from BTS to obtain Total Operating Revenues at a carrier.

• U.S. Block Hour Operating Costs by Aircraft Type and Airline, from The Airline Monitor Commercial Aircraft Database.

• Number of flights affected and additional flying time provided by air carriers.

• Value of Statistical Life (VSL) of $9.2 million for 2013.

By prohibiting flights from operating in the ORBB FIR, flights that would overfly the ORBB FIR in the absence of this rule will have to fly additional time to avoid the area. The FAA requested flight and cost information from some U.S. air carriers who indicated to the FAA they would be affected by the prohibition. The FAA received responses from those U.S. air carriers, most of whom reported additional flying time and its associated costs. The additional reported flying time was multiplied by the operating cost per block hour by airline and aircraft type to obtain an estimate of the cost of this final rule. Total annual costs are estimated at $14 million.

This rule imposes no reporting, recordkeeping, or other compliance requirements. The FAA is unaware of any Federal rules that duplicate, overlap, or conflict with this rule.

The benefits of this final rule are the avoided deaths (or other losses) that might have resulted from a U.S. operator's aircraft being shot down (or otherwise damaged) amidst the armed conflict in Iraq. The benefits of this final rule will exceed the costs if just two such deaths do not occur (where each averted fatality is valued at $9.2 million).

The Regulatory Flexibility Act of 1980 (Pub. L. 96-354) (“RFA”), as codified in 5 U.S.C. 601 et seq. establishes “as a principle of regulatory issuance that agencies shall endeavor, consistent with the objectives of the rule and of applicable statutes, to fit regulatory and informational requirements to the scale of the businesses, organizations, and governmental jurisdictions subject to regulation. To achieve this principle, agencies are required to solicit and consider flexible regulatory proposals and to explain the rationale for their actions to assure that such proposals are given serious consideration.” The RFA covers a wide-range of small entities, including small businesses, not-for-profit organizations, and small governmental jurisdictions.

Agencies must perform a review to determine whether a rule will have a significant economic impact on a substantial number of small entities. If the agency determines that it will, the agency must prepare a regulatory flexibility analysis as described in the RFA.

However, if an agency determines that a rule is not expected to have a significant economic impact on a substantial number of small entities, section 605(b) of the RFA provides that the head of the agency may so certify and a regulatory flexibility analysis is not required. The certification must include a statement providing the factual basis for this determination, and the reasoning should be clear.

The FAA remains committed to continuously improving civil aviation safety. The FAA finds that this final rule is in the public interest due to the immediate need to address the potential hazard to civil aviation that now exists in the ORBB FIR, as described in this Notice.

The FAA is responsible for the safety of flight in the United States and for the safety of U.S. civil operators, U.S.-registered civil aircraft, and U.S.-certificated airmen throughout the world. The FAA's authority to issue rules on aviation safety is found in title 49, U.S. Code. Subtitle I, section 106(f), describes the authority of the FAA Administrator. Subtitle VII of title 49, Aviation Programs, describes in more detail the scope of the agency's authority. Section 40101(d)(1) provides that the Administrator shall consider in the public interest, among other matters, assigning, maintaining, and enhancing safety and security as the highest priorities in air commerce. Section 40105(b)(1)(A) requires the Administrator to exercise his authority consistently with the obligations of the U.S. Government under international agreements.

This rulemaking is promulgated under the authority described in Subtitle VII, Part A, subpart III, section 44701, General requirements. Under that section, the FAA is charged broadly with promoting safe flight of civil aircraft in air commerce by prescribing, among other things, regulations and minimum standards for practices, methods, and procedures that the Administrator finds necessary for safety in air commerce and national security. This regulation is within the scope of that authority, because it amends SFAR No. 77, § 91.1605, to incorporate the August 8, 2014, NOTAM's prohibition on U.S. civil flight operations at all altitudes in the ORBB FIR due to the potential hazard to U.S. civil aviation posed by the armed conflict in Iraq. This amendment also changes the approval process and adds an expiration date.

The Small Business Administration defines a small entity in the Air Transportation business as having less than 1,500 employees.3 There are over 10 small entities identified as being affected by this final rule. Only two provided information relating to costs.

The additional reported flying time by operators was multiplied by the operating cost per block hour by small airline and by aircraft type to obtain an estimate of the cost of this final rule. The small entities' operation costs compared to their revenue is estimated at less than 1 percent. Therefore, as provided in section 605(b) of the RFA, the Administrator of the FAA certifies that this rulemaking will not result in a significant economic impact on a substantial number of small entities.

The Trade Agreements Act of 1979 (Pub. L. 96-39, 19 U.S.C. Chapter 13), as amended, prohibits Federal agencies from establishing standards or engaging in related activities that create unnecessary obstacles to the foreign commerce of the United States. Pursuant to this Act, the establishment of standards is not considered an unnecessary obstacle to the foreign commerce of the United States, so long as the standard has a legitimate domestic objective, such as the protection of safety, and does not operate in a manner that excludes imports that meet this objective. The statute also requires consideration of international standards and, where appropriate, that they be the basis for U.S. standards. The FAA assessed the potential effect of this final rule and determined that it will not create an unnecessary obstacle to the foreign commerce of the United States, because the regulation has a legitimate domestic objective, the protection of safety.

Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed or final agency rule that may result in an expenditure of $100 million or more (in 1995 dollars) in any one year by State, local, and tribal governments, in the aggregate, or by the private sector; such a mandate is deemed to be a “significant regulatory action.” The FAA currently uses an inflation-adjusted value of $151.0 million in lieu of $100 million. This final rule does not contain such a mandate; therefore, the requirements of Title II of the Act do not apply.

The Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. 3501 et seq.) as amended, requires that the FAA consider the impact of paperwork and other information collection burdens imposed on the public. The FAA has determined that there is no new requirement for information collection associated with this immediately adopted final rule.

In keeping with U.S. obligations under the Convention on International Civil Aviation (the “Chicago Convention”), it is FAA policy to conform to ICAO Standards and Recommended Practices to the maximum extent practicable. The FAA has determined that there are no ICAO Standards and Recommended Practices that correspond to this proposed regulation.

FAA Order 1050.1E identifies FAA actions that are categorically excluded from preparation of an environmental assessment or environmental impact statement under the National Environmental Policy Act (“NEPA”) (Pub. L. 91-190, 42 U.S.C. Chapter 55) in the absence of extraordinary circumstances. The FAA has determined this rulemaking action qualifies for the categorical exclusion identified in paragraph 312(f) of FAA Order 1050.1E and involves no extraordinary circumstances.

The FAA has reviewed the implementation of the proposed amendment to SFAR No. 77, § 91.1605, and determined it is categorically excluded from further environmental review according to FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures,” paragraph 312(f). The FAA has examined possible extraordinary circumstances and determined that no such circumstances exist. After careful and thorough consideration of the proposed action, the FAA finds that the proposed federal action does not require preparation of an Environmental Assessment (EA) or an Environmental Impact Statement (EIS) in accordance with the requirements of NEPA, Council on Environmental Quality regulations, and FAA Order 1050.1E.

The FAA has analyzed this immediately adopted final rule under the principles and criteria of Executive Order 13132, “Federalism.” The agency has determined that this action will not have a substantial direct effect on the States, or the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government, and, therefore, does not have Federalism implications.

The FAA analyzed this immediately adopted final rule under Executive Order 13211, “Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use” (May 18, 2001). The agency has determined that it is not a “significant energy action” under the executive order and it is not likely to have a significant adverse effect on the supply, distribution, or use of energy.

Executive Order 13609, Promoting International Regulatory Cooperation (77 FR 26413, May 4, 2012) promotes international regulatory cooperation to meet shared challenges involving health, safety, labor, security, environmental, and other issues and to reduce, eliminate, or prevent unnecessary differences in regulatory requirements. The FAA has analyzed this action under the policies and agency responsibilities of Executive Order 13609, and has determined that this action would have no effect on international regulatory cooperation.

An electronic copy of a rulemaking document may be obtained by using the Internet—

1. Search the Federal Document Management System (FDMS) Portal (http://www.regulations.gov);

2. Visit the FAA's Regulations and Policies Web page at http://www.faa.gov/regulations_policies/ or

3. Access the Government Publishing Office's Web page at: http://www.thefederalregister.org/fdsys/.

Copies may also be obtained by sending a request (identified by notice, amendment, or docket number of this rulemaking) to the Federal Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence Avenue SW., Washington, DC 20591, or by calling (202) 267-9680.

The Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) (Pub. L. 104-121) (set forth as a note to 5 U.S.C. 601), as amended, requires FAA to comply with small entity requests for information or advice about compliance with statutes and regulations within its jurisdiction. A small entity with questions regarding this document may contact its local FAA official, or the person listed under the For Further Information Contact section at the beginning of the preamble. You can find out more about SBREFA on the Internet at: http://www.faa.gov/regulations_policies/rulemaking/sbre_act/.

In consideration of the foregoing, the Federal Aviation Administration amends chapter I of Title 14, Code of Federal Regulations, as follows:

On December 17, 1992, the United States, Canada, and Mexico entered into the North American Free Trade Agreement (NAFTA) which, among other things, provides for preferential duty treatment on goods of those three countries. The North American Free Trade Agreement Implementation Act, Public Law 103-182, 107 Stat. 2057, was signed into law by the United States on December 8, 1993. For purposes of administration of the NAFTA preferential duty provisions, the three countries agreed to the adoption of verbatim NAFTA Rules of Origin Regulations and additional uniform regulatory standards to be followed by each country in promulgating NAFTA implementing regulations under its national law.

The regulations implementing the NAFTA preferential duty and related provisions under United States law are set forth in part 181 of title 19 of the Code of Federal Regulations (19 CFR part 181) which incorporates, in the Appendix, the verbatim NAFTA Rules of Origin Regulations. The NAFTA rules of origin are structured primarily in terms of prescribed changes in tariff classification, with some goods also subject to a content requirement.

On April 9, 2009, the United States Trade Representative, the Canadian Minister of International Trade, and the Mexican Secretary of the Economy (Parties) agreed, in an Exchange of Letters, to make certain technical rectifications to the NAFTA Uniform Regulations for Chapter Four and Annex 403.1, subject to the completion of each Party's domestic legal procedures. These technical rectifications are set forth in Appendices 6 and 4, respectively, to the April 9, 2009 Exchange of Letters. The technical rectifications were necessitated by systemic revisions to the international Harmonized Commodity Description and Coding System (Harmonized System) and the implementation of these changes into each Party's national domestic tariff law, effective 2007. In Presidential Proclamation 8097 of December 29, 2006, the President proclaimed modifications to the Harmonized Tariff Schedule of the United States (HTSUS) to reflect the revisions to the Harmonized System (HS).

The technical rectifications to the NAFTA Uniform Regulations for Chapter Four and Annex 403.1 do not constitute policy or substantive changes to the NAFTA and have the sole purpose of maintaining consistency between the NAFTA Annexes and each of the signatory countries' tariff laws. The conforming amendments set forth in this document implement these technical rectifications by updating the HTSUS tariff provisions in the Appendix to part 181 of 19 CFR and are necessary to maintain the United States' obligations under the NAFTA and to ensure that NAFTA traders operate under a uniform tariff and rules of origin regime.

To effect the agreed upon numerical and text changes to the NAFTA Rules of Origin Regulations for the United States, technical rectifications are made to the following provisions within the Appendix to 19 CFR part 181:

• Part II, Section 5, subsection (4)(i), pertaining to exceptions to the de minimis rule for non-originating materials that do not undergo, subject to authorization, a required tariff change.

• Part III, Section 6, subsection (6)(d)(iv), pertaining to regional value content and application of the net cost method in certain circumstances.

• Part VI, Section 16, subsection (3), pertaining to exceptions to transshipment rules for certain goods.

• Schedule IV, pertaining to the list of tariff provisions for the purposes of section 9 of the Appendix.1

In addition to the technical rectifications trilaterally agreed to by the NAFTA Parties in the 2009 Exchange of Letters, described above, this document makes additional technical corrections to the Schedule IV light-duty automotive tracing list within the Appendix to 19 CFR part 181 to reflect pre-2007 modifications to the HTSUS. As noted above, the HTSUS is periodically updated to reflect systemic revisions to the HS. The periodic revisions to the HTSUS result in certain tariff provisions being added or removed, or certain goods being transferred to different or newly-created tariff provisions. As a result of pre-2007 systemic HTSUS revisions, the existing Schedule IV light-duty automotive tracing list in the Appendix to part 181 contains outdated tariff provisions that are no longer consistent with Annex 403.1 of the NAFTA. This document makes technical corrections to the numerical tariff references in the tracing list so as to conform to the current version of the HTSUS and maintain the United States' obligations under the NAFTA.

Under the Administrative Procedure Act (APA) (5 U.S.C. 553), agencies generally are required to publish a notice of proposed rulemaking in the Federal Register that solicits public comment on the proposed regulatory amendments, consider public comments in deciding on the content of the final amendments, and publish the final amendments at least 30 days prior to their effective date. Section 553(a)(1) of the APA provides that the standard prior notice and comment procedures do not apply to an agency rulemaking to the extent that it involves a foreign affairs function of the United States. CBP has determined that these technical corrections involve a foreign affairs function of the United States because they implement preferential tariff treatment and related provisions of the NAFTA. In addition, because the amendments set forth in this document are necessary to conform the NAFTA Rules of Origin Regulations within the Appendix to 19 CFR part 181 to the technical corrections to the NAFTA Uniform Regulations for Chapter Four and Annex 403.1 agreed to by the U.S., Canada, and Mexico, as well as to systemic revisions to the Harmonized System, pursuant to 5 U.S.C. 553(b)(B), CBP finds that good cause exists for dispensing with notice and public procedure as unnecessary. For these reasons, pursuant to 5 U.S.C. 553(a)(1) and (d)(3), CBP finds that good cause exists for dispensing with the requirement for a delayed effective date and the rulemaking requirements under the APA do not apply. It is further noted, that although the APA's delayed effective date requirement is inapplicable to this rulemaking, CBP has determined to delay the effective date of these technical rectifications for a period of 60 days from the date of publication of this document in the Federal Register. In consideration of the fact that two of the amendments to the CBP regulations correct tariff listings that have been out of date since 1995, the delayed effective date is offered by CBP to allow the trade, if necessary, to make adjustments to their business practices.

Because this document is not subject to the notice and public procedure requirements of 5 U.S.C. 553, it is not subject to the provisions of the Regulatory Flexibility Act, as amended (5 U.S.C. 601 et seq.).

As these amendments to the regulations reflect technical rectifications to the NAFTA agreed to by the United States, Canada, and Mexico, as well as revisions to the Harmonized Tariff Schedule of the United States, they do not meet the criteria for a “significant regulatory action” as specified in Executive Order 12866.

This document is being issued in accordance with § 0.1(a)(1) of the CBP regulations (19 CFR 0.1(a)(1)) pertaining to the authority of the Secretary of the Treasury (or his/her delegate) to approve regulations related to certain customs revenue functions. Accordingly, it is being signed under the authority of 19 CFR 0.1(b)(1).

For the reasons stated above, part 181 of title 19 of the Code of Federal Regulations (19 CFR part 181) is amended as set forth below.

On March 9, 2015, we published a notice in the Federal Register (78 FR 46860) proposing an extension of project period and a waiver of 34 CFR 75.250 and 75.261(a) and (c)(2) in order to—

(1) Enable the Secretary to provide additional funds to the currently funded CPRCs for an additional 12-month project period, from October 1, 2015, through September 30, 2016; and

(2) Request comments on the proposed extension of project period and waiver.

There are no substantive differences between the proposed waiver and extension and the final waiver and extension.

In response to our invitation in the notice of proposed waiver and extension of the project period, we did not receive any substantive comments. Generally, we do not address comments that raise concerns not directly related to the proposed waiver and extension of project period.

On May 3, 2010, the Department of Education (Department) published in the Federal Register (75 FR 23254) a notice inviting applications (2010 NIA) for new awards for FY 2010 for up to 10 CPRCs. The CPRCs are funded under the Parent Training and Information (PTI) Program, authorized under sections 672 and 673 of the Individuals with Disabilities Education Act (IDEA).

The purpose of CPRCs is to provide underserved parents of children with disabilities in targeted communities—including low-income parents, parents of limited English proficient children, and parents with disabilities—with the training and information they need to enable them to participate cooperatively and effectively in helping their children with disabilities to—

(1) Meet developmental and functional goals, as well as challenging academic achievement standards that have been established for all children; and

(2) Be prepared to lead the most productive, independent adult lives possible.

The CPRCs provide training and information to parents of infants, toddlers, and children, from birth through age 26, with the full range of disabilities described in section 602(3) of IDEA by: (a) Responding to individual requests for information and support from parents of children with disabilities, including parents of children who may be inappropriately identified in their targeted communities; (b) providing training to parents of children with disabilities; (c) supporting parents of children with disabilities, as needed, such as helping them to prepare for individualized education program or individualized family service plan meetings; and (d) maintaining a Web site and social media presence, as appropriate, to inform parents in their targeted communities of appropriate resources.

Based on the selection criteria in the 2010 NIA, the Department made awards for a period of 60 months each to 10 organizations, nine of which have received FY 2014 continuation funding: Fiesta Educativa in California; Parent to Parent of Miami, Inc. in Florida; Agenda for Children/Pyramid Parent Training in Louisiana; Urban PRIDE in Massachusetts; SPEAKS Education, Inc. in Michigan; Education for Parents of Indian Children with Special Needs in New Mexico; Palau Parents Empowered in Palau; Philadelphia HUNE, Inc. in Pennsylvania; and Children's Disabilities Information Coalition in Texas.

The 2010 CPRC cohort's current project period is scheduled to end on September 30, 2015. We do not believe that it would be in the public interest to run a competition for new CPRCs this year because the Department is in the process of changing the competition schedule for the PTI Program to make better use of Department resources.

Under the proposed CPRC competition schedule, instead of holding three competitions over five years, each for 10 CPRCs, we would hold one competition for 30 CPRCs that will each have a project period of up to five years. We propose to hold this competition and fund 30 CPRCs in FY 2016. We also have concluded that it would be contrary to the public interest to provide services to fewer underserved families in order to change the Department's competition schedule.

For these reasons, the Secretary waives the requirements in 34 CFR 75.250, which prohibit project periods exceeding five years, as well as the requirements in 34 CFR 75.261(a) and (c)(2), which allow the extension of a project period only if the extension does not involve the obligation of additional Federal funds. The waiver allows the Department to issue FY 2015 continuation awards of $100,000 to each of the nine centers in the FY 2010 cohort.

Any activities carried out during the 12-month period of this continuation award will have to be consistent with, or a logical extension of, the scope, goals, and objectives of the grantee's application as approved in the FY 2010 CPRC competition. The requirements applicable to continuation awards for this competition set forth in the 2010 NIA and the requirements in 34 CFR 75.253 will apply to any continuation awards sought by the current CPRC grantees. We will base our decisions regarding continuation awards on the program narratives, budgets, budget narratives, and program performance reports submitted by the current grantees, and the requirements in 34 CFR 75.253.

The Administrative Procedure Act requires that a substantive rule must be published at least 30 days before its effective date, except as otherwise provided for good cause (5 U.S.C. 553(d)(3)). We received no substantive comments on the proposed waiver and extension of project period, and we have not made any substantive changes to the proposed waiver and extension of project period. The Secretary has made a determination to waive the delayed effective date to ensure there is no lapse in the parent training and information services currently provided by the CPRCs.

The Secretary certifies that this waiver and extension of the project period will not have a significant economic impact on a substantial number of small entities.

The only entities that will be affected by this waiver and extension of the project period are the current grantees receiving Federal funds and any other potential applicants.

The Secretary certifies that this waiver and final extension will not have a significant economic impact on these entities because the extension of existing project periods imposes minimal compliance costs, and the activities required to support the additional year of funding will not impose additional regulatory burdens or require unnecessary Federal supervision.

This notice of final waiver and extension of the project period does not contain any information collection requirements.

This program is subject to Executive Order 12372 and the regulations in 34 CFR part 79. One of the objectives of the Executive order is to foster an intergovernmental partnership and a strengthened federalism. The Executive order relies on processes developed by State and local governments for coordination and review of proposed Federal financial assistance. This document provides early notification of our specific plans and actions for this program.

Accessible Format: Individuals with disabilities can obtain this document in an accessible format (e.g., braille, large print, audiotape, or compact disc) on request to the contact person listed under FOR FURTHER INFORMATION CONTACT.

Electronic Access to This Document: The official version of this document is the document published in the Federal Register. Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.thefederalregister.org/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register, in text or Adobe Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

Section 9 of the ESA prohibits the take of fish or wildlife species listed as endangered with certain exceptions. Pursuant to section 4(d) of the ESA, the Services may prohibit the take of fish or wildlife species listed as threatened. Under section 3 of the ESA, the term “take” means to “harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to attempt to engage in any such conduct.” Section 7 of the ESA provides for the exemption of incidental take of listed fish or wildlife species caused by Federal agency actions that the Services have found to be consistent with the provisions of section 7(a)(2). The Services jointly administer the ESA via regulations set forth in the Code of Federal Regulations (CFR). This rule deals with regulations found in title 50 of the CFR at part 402.

Under 50 CFR 402.14, Federal agencies must review their actions at the earliest possible time to determine whether any action may affect species listed under the ESA or their designated critical habitat. If such a determination is made, formal consultation with the appropriate Service is required, unless one of the exceptions outlined at § 402.14(b) applies. Within 45 days after concluding formal consultation, the Service delivers a biological opinion to the Federal agency and any applicant. The biological opinion states the opinion of the Service as to whether or not the Federal action is likely to jeopardize the continued existence of listed species or result in the destruction or adverse modification of their critical habitat. If a proposed action is reasonably certain to cause incidental take of a listed species, the Services, under 50 CFR 402.14(i), issue along with the biological opinion an incidental take statement that specifies, among other requirements: The impact of such incidental taking on the listed species; measures considered necessary or appropriate to minimize the impact of such take; terms and conditions (including reporting requirements) that implement the specified measures; and procedures to be used for handling or disposing of individuals that are taken.

The current regulations at § 402.14(i)(1)(i) require the Services to express the impact of such incidental taking of the species in terms of amount or extent. The preamble to the final rule that set forth the current regulations discusses the use of a precise number of individuals or a description of the land or marine area affected to express the amount or extent of anticipated take, respectively (51 FR 19954, June 3, 1986).

Court decisions rendered over the last decade regarding the adequacy of incidental take statements have prompted the Services to clarify two aspects of the regulations addressing incidental take statements: (1) The use of surrogates to express the amount or extent of anticipated incidental take, including circumstances where project impacts to the surrogate are coextensive with at least one aspect of the project's scope; and (2) the circumstances under which providing an incidental take statement with a biological opinion on a programmatic action is appropriate.

Through this final rule, the Services are establishing prospective standards regarding incidental take statements. Consistent with the regulatory language set forth in the proposed rule, we are clarifying that the Services formulate an incidental take statement if such take is reasonably certain to occur. Nothing in these final regulations is intended to require reevaluation of any previously completed biological opinions or incidental take statements. Additionally, this final rule revises only those portions of the joint consultation regulations of 50 CFR part 402 set forth in the “Regulation Promulgation” section below. All other provisions remain unchanged. These revisions to the incidental take statement regulations addressing surrogates, programmatic actions, and the applicable standard for anticipating take are independent revisions that are fully severable from each other.

On September 4, 2013, the Services published a proposed rule addressing the incidental take statement provisions of the implementing regulations for section 7(a)(2) of the ESA (78 FR 54437). The proposed rule addressed the use of surrogate take indicators and issuance of an incidental take statement for programmatic actions. The proposed rule requested that all interested parties submit written comments on the proposal by November 4, 2013. The Services also contacted appropriate Federal and State agencies, scientific experts and organizations, and other interested parties and invited them to comment on the proposal. The Services received comments from 64 individuals and organizations.

For surrogates, the proposed rule endorsed the use of surrogates to express the amount or extent of anticipated incidental take and set forth three requirements for their use in an incidental take statement. This final rule adopts the approach of the proposed rule for surrogates with no significant changes.

For programmatic actions, the proposed rule addressed the subset of Federal actions that are designed to provide a framework for the development of future, site-specific actions that are authorized, funded, or carried out and subject to the requirements of section 7 at a later time. Development of incidental take statements for “framework” programmatic actions is problematic because they generally lack the site-specific details of where, when, and how listed species will be affected by the program. The Services rely on such information to inform the amount or extent of take in the incidental take statement that serves as a trigger for reinitiation of consultation pursuant to the requirements of 50 CFR 402.16(a).

The Services proposed to distinguish programmatic actions and programmatic incidental take statements for framework actions in the regulations to clarify the basis for development of an incidental take statement for this type of Federal program. The proposed rule stated that the key distinguishing characteristics of programmatic actions for purposes of the rule are: (1) They provide the framework for future, site-specific actions that are subject to section 7 consultations and incidental take statements, but they do not authorize, fund, or carry out those future site-specific actions; and (2) they do not include sufficient site-specific information to inform an assessment of where, when, and how listed species are likely to be affected by the program. In lieu of quantifying a traditional amount or extent of take, the Services proposed to develop programmatic incidental take statements that anticipate an unquantifiable amount or extent of take at the programmatic scale in recognition that subsequent site-specific actions authorized, funded, or carried out under the programmatic action will be subject to subsequent section 7 consultation and incidental take statements, as appropriate. The Services proposed to express reinitiation triggers as reasonable and prudent measures that adopt either specific provisions of the proposed programmatic action, such as spatial or timing restrictions, to limit the impacts of the program on listed species or similar restrictions identified by the Services that would function to minimize the impacts of anticipated take on listed species at the program level.

After further consideration of relevant court rulings, the Services' national section 7 policy, and public comments, the Services are revising the approach described in the proposed rule to address incidental take statements for programmatic actions. The revised approach relies more appropriately on the distinction that a framework programmatic action only establishes a framework for the development of specific future action(s) but does not authorize any future action(s). Under those particular circumstances, the programmatic action in and of itself does not result in incidental take of listed species. Under this final rule, the Services are defining the term framework programmatic action in the regulations and recognizing the Services' authority not to provide an incidental take statement with a biological opinion addressing the proposed adoption of a program establishing a framework for the development of future actions. As discussed in more detail below, the Services believe this approach is fully consistent with the statutory purposes of an incidental take statement and the language of section 7 of the ESA. It also advances the policy goals of the Services to focus the provision of incidental take statements at the action level at which such take will result.

The approach taken in the proposed rule was predicated on the assumption that a framework programmatic action could cause take. Given the particular nature of framework programmatic actions discussed above, the Services have altered their view and now affirm that a framework programmatic action in and of itself does not result in incidental take of listed species. This altered view as to incidental take for framework programmatic actions, however, does not undermine the duty to consult under section 7(a)(2) of the ESA. Framework programmatic actions will trigger formal consultation if the action may affect listed species or their designated critical habitat. Additionally, the Services also reconsidered the approach taken in the proposed rule because an incidental take statement for a framework programmatic action may not be practical to implement. In particular, the Services are concerned that it may be difficult to identify measures at a program scale that are specific enough to serve as valid take-related reinitiation triggers in an incidental take statement given that such measures are often described in the proposed program in a qualitative rather than a quantitative manner. Additionally, the Services are concerned that program-based measures may not serve as consistently effective reinitiation triggers because reinitiation would occur only when the action agency deviated from the terms of its own program. The additional burden of monitoring and reporting requirements for such measures in many instances would outweigh the limited functionality such measures would provide in terms of minimizing the impacts of anticipated take. The limited functionality of this approach is also raised by the fact that a similar reinitiation trigger for changes to the proposed action is already set forth in the existing regulations at 50 CFR 402.16(c) where discretionary Federal involvement or control over the action has been retained or is authorized by law.

The proposed rule set forth a definition of programmatic incidental take statement that, among other things, indicated the Services would issue an incidental take statement where take was “reasonably certain to occur.” While the Services are not including this definition in the final rule, we are clarifying that the “reasonable certainty” of take is the applicable standard for when the Services formulate an incidental take statement.

The Services acknowledge congressional preference for expressing the impacts of take in incidental take statements in terms of a numerical limitation with respect to individuals of the listed species. However, Congress also recognized that a numerical value would not always be available and intended that such numbers be established only where possible. H.R. Rep. No. 97-567, at 27 (1982). The preamble to the final rule that set forth the current regulations also acknowledges that exact numerical limits on the amount of anticipated incidental take may be difficult to determine and the Services may instead specify the level of anticipated take in terms of the extent of the land or marine area that may be affected (51 FR 19926 [19953-19954]; June 3, 1986). In fact, as the Services explained in the preamble to that rule, the use of descriptions of extent of take can be more appropriate than the use of numerical amounts “because for some species loss of habitat resulting in death or injury to individuals may be more deleterious than the direct loss of a certain number of individuals” (51 FR at 19954).

Over the last 25 years of developing incidental take statements, the Services have found that, in many cases, the biology of the listed species or the nature of the proposed action makes it impractical to detect or monitor take of individuals of the listed species. In those situations, evaluating impacts to a surrogate such as habitat, ecological conditions, or similar affected species may be the most reasonable and meaningful measure of assessing take of listed species.

The courts also have recognized that it is not always practicable to establish the precise number of individuals of the listed species that will be taken and that “surrogate” measures are acceptable to establish the impact of take on the species if there is a link between the surrogate and take. See Arizona Cattle Growers' Ass'n v. U.S. Fish and Wildlife Service, 273 F.3d 1229 (9th Cir. 2001). It is often more practical and meaningful to monitor project effects upon surrogates, which can also provide a clear standard for determining when the amount or extent of anticipated take has been exceeded and consultation should be reinitiated. Accordingly, the Services adopted the use of surrogates as part of our national policy for preparing incidental take statements:

For example, under a hypothetical Clean Water Act permit, the U.S. Army Corps of Engineers would authorize the fill of a quarter-acre of wetlands composed of three vernal pools occupied by the threatened vernal pool fairy shrimp (Branchinecta lynchi) to construct a road-crossing. The wetland fill is likely to kill all of the shrimp occupying the three vernal pools. A single pool may contain thousands of individual shrimp as well as their eggs or cysts. For that reason, it is not practical to express the amount or extent of anticipated take of this species or monitor take-related impacts in terms of individual shrimp. Quantifying the habitat area encompassing the three vernal pools supporting this species as a surrogate for incidental take would be a practical and meaningful alternative to quantifying and monitoring the anticipated incidental take in terms of individual shrimp caused by the proposed Federal permit action. It is a practical alternative because effects to vernal pool fairy shrimp habitat are causally related to take of the fairy shrimp, these effects can be readily monitored, and the extent of impacts to occupied habitat provides a clear standard for when the anticipated extent of take has been exceeded.

The Ninth Circuit Court's holding in Oregon Natural Resources Council v. Allen, 476 F.3d 1031 (9th Cir. 2007) could be read to suggest that such surrogates cannot be coextensive with the project's scope for fear that reinitiation of consultation would not be triggered until the project is complete. However, even under circumstances of a coextensive surrogate (such as in the above example), the action agency or applicant will be required under the incidental take statement to monitor project impacts to the surrogate during the course of the action (e.g., required monitoring to confirm the action does not exceed fill of three vernal pools in the quarter-acre wetland), which will determine whether these impacts are consistent with the analysis in the biological opinion. This assessment will ensure that reinitiation of formal consultation will be triggered if the extent of the anticipated taking specified in the incidental take statement is exceeded during the course of the action where discretionary Federal involvement or control over the action has been retained or is authorized by law in accordance with 50 CFR 402.16. In the above example, reinitiation of formal consultation would be triggered in the event a fourth vernal pool was discovered during wetland fill or it was determined that the total amount of vernal pool habitat modified by the project exceeded the identified one-quarter of an acre of wetland habitat. Thus, although fully coextensive with the anticipated impacts of the project on the vernal pool fairy shrimp, the surrogate nevertheless provides for a meaningful reinitiation trigger consistent with the purposes of an incidental take statement.

In addition to discussing the use of habitat surrogates for expressing the extent of anticipated take, the Services' Section 7 Handbook also discusses (on page 4-47) the use of impacts to non-listed species as a surrogate for expressing the amount of anticipated take of a listed species:

We are amending § 402.14(i)(1)(i) of the regulations to clarify that surrogates may be used to express the amount or extent of anticipated take, provided the biological opinion or the incidental take statement: (1) Describes the causal link between the surrogate and take of the listed species; (2) describes why it is not practical to express the amount of anticipated take or to monitor take-related impacts in terms of individuals of the listed species; and (3) sets a clear standard for determining when the amount or extent of the taking has been exceeded. Such flexibility may be especially useful in cases where the biology of the listed species or the nature of the proposed action makes it impractical to detect or monitor take-related impacts to individual animals. This use of surrogates to express the amount or extent of incidental take is consistent with Federal court decisions addressing the issue of surrogates as reinitiation triggers in incidental take statements.

The section 7 regulatory definition of Federal “action” includes Federal agency programs. See 50 CFR 402.02. Such programs may include a collection of activities of a similar nature, a group of different actions proposed within a specified geographic area, or an action adopting a framework for the development of future actions. Those future actions may be developed at the local, statewide, or national scale, and are authorized, funded, or carried out and subject to section 7 consultation requirements at a later time as appropriate. Examples of Federal programs that provide such a framework include land management plans prepared by the Forest Service and the Bureau of Land Management and the U.S. Army Corps of Engineers' Nationwide Permit Program.

As discussed above, the Services are modifying the section 7 regulations to address incidental take statements for framework programmatic actions in a way that revises the approach described in the proposed rule. The revised approach reflects our further consideration of relevant court rulings, the Services' national section 7 policy, and public comments on the proposed rule. Under this final rule, we are establishing regulatory provisions specific to framework programmatic actions that require section 7 consultation and adopt a framework for the development of future actions but do not authorize those future actions. This rule change will clarify the circumstances under which the Services will not provide an incidental take statement with a biological opinion addressing a framework programmatic action because adoption of a framework will not itself result in the take of listed species. Any take resulting from subsequent actions that proceed under the framework programmatic action will be subject to section 7 consultation and an incidental take statement, as appropriate. However, this regulatory change does not imply that section 7 consultation is required for a framework programmatic action that has no effect on listed species or critical habitat. The Services believe that this approach is fully consistent with the statutory purposes of an incidental take statement and the language of section 7 of the ESA.

As an initial and elementary matter, section 7 of the ESA directs the provision of an incidental take statement only where take is anticipated to result from the proposed Federal agency action. If take is not anticipated, then logically no incidental take statement would be provided. See 16 U.S.C. 1536(b)(4). Because a framework programmatic action does not itself authorize any action to proceed, no take is anticipated to result, and, therefore, the statute does not require the provision of an incidental take statement.

To read the statute otherwise to require the provision of incidental take statements for framework programmatic actions would not meaningfully further the statutory purposes of incidental take statements. The primary purpose of an incidental take statement is, when consistent with protection of the species, to exempt the incidental take of listed species that is anticipated to result from the agency action and impose conditions on that exemption intended to minimize the impacts of such take for the species' benefit. See 16 U.S.C. 1536(b)(4); H.R. Rep. 97-567, at 26-27 (1982). As provided in the legislative history and reflected in the Services' regulations, an additional purpose is to identify reinitiation triggers that provide clear signals that the level of anticipated take has been exceeded and would, therefore, require reexamination through a reinitiated consultation (H.R. Rep. 97-567, at 26-27 (1982); 50 CFR 402.14(i)).

Due to the nature of the action, no take results when a framework programmatic action is adopted. Adoption of the program itself, by definition, only establishes a framework for later action. ESA consultations will occur when subsequent actions may affect listed species and are consistent with the terms of the authorized program. If incidental take is reasonably certain to occur and the proposed action is compliant with the requirements of section 7(a)(2), then an action-specific incidental take statement will be provided that ensures any incidental take from the subsequent action under the program is addressed. The primary purpose of an incidental take statement (exemption of take and minimization of take-related impacts for the benefit of the listed species) would also not be advanced, because any incidental take statement provided at the program level and the resulting exemption would necessarily be incomplete since a second consultation and an action-specific incidental take statement still need to be provided when later actions are authorized under the program. Additionally, the level of detail available at the program (framework) level is often insufficient to identify with particularity where, when, and how the program will affect listed species. Without such detail, it is difficult to write sufficiently specific and meaningful terms and conditions intended to minimize the impact of the taking for the benefit of the listed species. Given this lack of specificity and information, providing the amount (e.g., the number of individuals of the species taken) or extent (e.g., the number of acres of the species' habitat disturbed) of take in many instances would be speculative and unlikely to provide an accurate and reliable trigger for reinitiation of consultation, thus undermining the additional purpose of an incidental take statement.

As discussed above, the modified approach for addressing incidental take statements for framework programmatic actions advances the policy goals of the Services to focus the provision of incidental take statements at the action level where such take will result. Consistent with that focus, if a decision adopting a framework also includes decisions authorizing actions (that is, actions for which no additional authorization will be necessary), then an incidental take statement would be necessary for those actions, provided the action is compliant with section 7(a)(2) and take is reasonably certain to occur. The Services have included recognition of this circumstance in the regulatory definition of the term “mixed programmatic action” in this final rule. For other types of programmatic actions not falling within the definitions provided in the rule, incidental take statements will be formulated by the Services to accompany biological opinions where incidental take is reasonably certain to occur and the proposed Federal action is compliant with the requirements of section 7(a)(2).

If, as discussed above, an incidental take statement is not provided with a biological opinion on a framework programmatic action on the basis that no take will result at the program stage, questions arise about how the associated biological opinion can nevertheless address indirect effects of the program's implementation. Put another way, if indirect effects amount to killing, harming, harassing, etc., how can no take occur? The explanation turns on the differing purposes of a biological opinion as compared with an incidental take statement.

Unlike the purposes of an incidental take statement, the analysis in a biological opinion is used to determine whether an agency action is likely to jeopardize a listed species or adversely modify designated critical habitat. See 16 U.S.C. 1536(b)(3)(A); 50 CFR 402.14(h); H.R. Rep. 97-567, at 10 (1982). Conducting an effects analysis on a framework programmatic action that examines the potential effects of implementing the program is fully consistent with the purposes of a biological opinion. The analysis in a biological opinion allows for a broad-scale examination of a program's potential impacts on a listed species and its designated critical habitat—an examination that is not as readily conducted when the later, action-specific consultation occurs on a subsequent action developed under the program framework. The provisions of an incidental take statement, including the amount and extent of take and the terms and conditions, necessarily must be specific to ensure they can be followed and allow for a determination of when they have been exceeded. See 16 U.S.C. 1536(b)(4); 50 CFR 402.14(i). In contrast, a meaningful effects analysis within a biological opinion may appropriately rely upon qualitative analysis to determine whether a program and its set of measures intended to minimize impacts or conserve listed species are adequately protective for purposes of making a jeopardy determination. Programmatic biological opinions examine how the parameters of the program align with the survival and recovery of listed species. This approach reflects the different statutory purposes that the two related but separate documents were intended to address.

Distinctions between “effects” and “take” at the programmatic scale support analyzing potential program implementation as part of the “effects” of the framework programmatic action but not providing an incidental take statement at the program level. The ESA itself uses different terms in specifying the contents of a biological opinion for jeopardy purposes (“detail[] how the agency action affects the species”) and an incidental take statement (focused on “take”). See 16 U.S.C. 1536(b)(3)(A), (b)(4). The ESA also does not define “affects” in any way.

For purposes of a biological opinion on a framework programmatic action, the Services typically evaluate the potential implementation of the program as “effects of the action.” The Services can legitimately draw a distinction between “effects” of the program and the purpose of a biological opinion on that program and “take” and the purpose of an incidental take statement in the subsequent consultation on later actions carried out under the program. Given that no actions that would lead to take are authorized when the framework program itself is adopted, the Services' position is that take is not anticipated from the adoption of the program in and of itself. As a result, the Services find that it is appropriate not to provide an incidental take statement at the program level and to address take during subsequent steps when specific actions are authorized under the program and subsequent consultation occurs. As mentioned above, if, however, a decision adopting a program framework also includes decisions authorizing actions that will not be subject to further Federal authorization or section 7 consultation and take is reasonably certain to occur, then an incidental take statement would be necessary for those portions of the programmatic action that will result in incidental take. The Services have included recognition of this circumstance in the regulatory definition of the term “mixed programmatic action” in this final rule.

Action agencies often seek to engage in consultation on programmatic actions to gain efficiencies in the section 7 consultation process. The Services anticipate this rule will afford action agencies and the Services with substantial flexibility to efficiently and effectively conduct consultation, while ensuring compliance with responsibilities under the ESA. For example, if an action agency designs a programmatic action and provides adequate information to inform the development of a biological opinion with an incidental take statement covering future actions implemented under the program, the Services anticipate they will be able to provide such an opinion and incidental take statement to the action agency under this rule. Action agencies may request assistance from the Services to help determine how a program could best be addressed pursuant to this rule. The Services also encourage action agencies to consider how any section 7 consultation on a programmatic action is consistent with the action agency's other environmental review processes.

In this final rule, the Services are clarifying that the standard for issuance of an incidental take statement is “reasonable certainty” that take will occur. The Services are amending 50 CFR 402.14(g)(7) to implement this clarification. The Services do not consider this change to be substantive, but rather a clarification of the existing standard for issuance of an incidental take statement.

Expressly including the standard of reasonable certainty in this final rule at 50 CFR 402.14(g)(7) is consistent with the ESA, existing section 7 regulations, the Services' current practice, the Services' Section 7 Handbook, and applicable case law. The three requirements that must be met under section 7 of the ESA before an incidental take statement is issued implicitly suggest that a finding of take is required. See 16 U.S.C. 1536(b)(4)(B) (“the taking of an endangered species or a threatened species incidental to the agency action will not violate such subsection”) (emphasis added). The statute does not set forth the standard by which incidental take is to be determined, however, leaving room for the Services to offer their interpretation.

As for the regulations, the section 7 regulations expressly apply the “reasonable certainty” standard to “indirect effects” that are defined as part of the “effects of the action.” See 50 CFR 402.02. The existing provision governing the contents of an incidental take statement at 50 CFR 402.16(i)(1) reflects the requirement that at least some level of incidental take be anticipated to meaningfully include the required contents of an incidental take statement, e.g., the impact of the take (amount or extent of take), and the reasonable and prudent measures considered “necessary or appropriate to minimize such impact.”

The Services' Section 7 Handbook, issued in 1998, identifies a similar standard of “reasonably likely” to determine when to issue an incidental take statement. The Handbook predates the Ninth Circuit's decision in Arizona Cattle Growers' Ass'n v. U.S. Fish and Wildlife Service, 273 F.3d 1229 (9th Cir. 2001). In that case, the Ninth Circuit provided a lengthy discussion of when the Services must issue an incidental take statement. Examining the statute and the regulations, the court held that there must be a reasonable basis to conclude that incidental take will occur in order to issue an incidental take statement. Although not definitively resolving the issue, the court cited favorably to the lower court's application of the standard of “reasonable certainty” for issuance of an incidental take statement. The court particularly expressed concern about the imposition of conditions on otherwise lawful land use absent reasonable certainty of incidental take. In 2002, following the Arizona Cattle Growers' decision, the Fish and Wildlife Service expressly recognized “reasonable certainty” as the standard that applies to determine if incidental take will occur.

The language currently in 50 CFR 402.14(g)(7) is not inconsistent with the Services' application of the “reasonable certainty” standard. This provision requires the Services to “formulate a statement concerning incidental take, if such taking may occur” (50 CFR 402.14(g)(7) (emphasis added)). While some courts have read this language to potentially suggest a lower standard applies for the issuance of an incidental take statement, see, e.g., Public Employees for Environmental Responsibility v. Beaudreu,—F.Supp.2d —,2014 WL 985394 (D.D.C. 2014), that is not the Services' interpretation. The language of § 402.14(g)(7) cannot be read in isolation. The Services implement § 402.14(g)(7) together with the more particular requirements of § 402.14(i).

For all the reasons discussed above, the “reasonable certainty” standard governs the threshold issue of whether to formulate an incidental take statement. Once the Services determine that incidental take is reasonably certain to occur, then the specific provisions of 50 CFR 402.14(i) govern (e.g., amount or extent of take, terms and conditions) and are applied consistent with the best scientific and commercial data available. Where formal consultation results in a determination that take is not “reasonably certain,” then consistent with § 402.14(g)(7) and the Services' Section 7 Handbook, the Services provide a section entitled “incidental take statement” along with a short paragraph explaining that incidental take is not anticipated. Thus, the statement does not go on to provide an amount or extent of take, reasonable and prudent measures, or the other components of an incidental take statement. To avoid any confusion about the standard for anticipating incidental take of listed species, the Services have modified the text of § 402.14(g)(7) to reflect the “reasonably certain to occur” standard.

As a practical matter, application of the “reasonable certainty” standard is done in the following sequential manner in light of the best available scientific and commercial data to determine if incidental take is anticipated: (1) A determination is made regarding whether a listed species is present within the area affected by the proposed Federal action; (2) if so, then a determination is made regarding whether the listed species would be exposed to stressors caused by the proposed action (e.g., noise, light, ground disturbance); and (3) if so, a determination is made regarding whether the listed species' biological response to that exposure corresponds to the statutory and regulatory definitions of take (i.e., kill, wound, capture, harm, etc.). Applied in this way, the “reasonable certainty” standard does not require a guarantee that a take will result, rather, only that the Services establish a rational basis for a finding of take. While relying on the best available scientific and commercial data, the Services will necessarily apply their professional judgment in reaching these determinations and resolving uncertainties or information gaps. Application of the Services' judgment in this manner is consistent with the “reasonable certainty” standard. The standard is not a high bar and may be readily satisfied as described above. See, e.g., Arizona Cattle Growers', 273 F.3d at 1244 (noting that the standard the court applies in reviewing whether the Services may issue an incidental take statement is a “very low bar to meet”).

In response to public comments and internal review, the Services made the following changes compared to the proposed rule:

The term and definition for programmatic action and the proposed text of §§ 402.02 and 402.14(i)(6) are modified in this final rule. The term programmatic action is changed to framework programmatic action. The term mixed programmatic action and its definition are also added to the final rule. The proposed term and definition for programmatic incidental take statement at § 402.02 are removed; however, the standard set forth in the definition (reasonable certainty) is included in the final rule as explained below. These changes define, for purposes of incidental take statements under section 7 of the ESA, the subset of Federal agency actions to which this rule applies. The new definitions draw distinctions between these types of programmatic actions based on the extent to which those programs do or do not require subsequent Federal approvals and section 7 consultation for the terms of the program to be carried out. The new § 402.14(i)(6) added to the regulations under this final rule establishes when an incidental take statement is and is not required for these two categories of programmatic action.

The approach relied upon in this final rule for programmatic actions is fully consistent with the identified purpose of the proposed rule, which, among other things, was to clarify development of incidental take statements for programmatic actions. While this approach modifies the approach of the proposed rule for programmatic actions, the public was specifically asked for comment on whether the approach relied upon in this final rule would be more appropriate to address the issue of incidental take statements for programmatic actions. See 78 FR 54437, 54441 (Sept. 4, 2013).

As discussed above, the Services are modifying the text in § 402.14(g)(7) to clarify that “reasonable certainty” is the standard that applies to determine when the Services issue an incidental take statement. The proposed rule did not propose this specific change, but the proposed rule definition of programmatic incidental take statement included the concept of “reasonable certainty” as the applicable standard for incidental take, and commenters specifically requested the Services to clarify the applicable standard, including many commenters that specifically asserted that “reasonable certainty” is the applicable standard. The Services, therefore, are taking this opportunity to clarify the regulatory language in § 402.14(g)(7) from “if such take may occur” to “if such take is reasonably certain to occur” (emphasis added). As explained above, the Services do not consider this change to be substantive, but rather a clarification of the existing standard for issuance of an incidental take statement.

The proposed rule included adding a sentence to § 402.14(i)(3) intended to clarify that monitoring project impacts to a surrogate meets the requirement for monitoring the impacts of incidental take on the listed species. Upon further consideration, the Services concluded this sentence is unnecessary as the requirement is already reflected in the existing regulatory language. See 50 CFR 402.14(i)(1)-(3) (monitoring and reporting “impacts on the species” includes amount or extent of take and therefore surrogates). The Services are making a technical change to § 402.14(i)(3) to update the citations to the NMFS regulations at the end of that provision from “50 CFR 220.45 and 228.5” to “50 CFR 216.105 and 222.301(h)”. These provisions were moved within the Code of Federal Regulations but never updated in § 402.14(i)(3).

As noted above, the Services received a total of 64 public comments in response to the proposed rule. For the reasons discussed above, the Services withdrew the proposed regulatory definition of programmatic incidental take statement in this final rule. On that basis, we are not responding to public comments on this aspect of the proposed rule except as they relate to the standards for development of an incidental take statement. We also are not responding to public comments beyond the scope of the proposed rule, including those comments that addressed other portions of the section 7 consultation regulations not related to the formulation of incidental take statements. The following responses to public comments are segregated under four categories: (1) General; (2) the standards for anticipating take; (3) incidental take statements for programmatic actions; and (4) the use of surrogates to express the amount or extent of take.

Issue 1: Several commenters requested an extension of the public comment period.

Response: The Services believe the 60-day public comment period provided adequate opportunity for the public to review and comment on the proposed regulations.

Issue 2: One commenter stated that the proposed changes to the section 7 regulations are not within the Services' regulatory authority.

Response: The Services regard the proposed changes as fully consistent with their discretionary authority to address ambiguous aspects and challenging issues that arise under section 7 of the ESA.

Congress included the incidental take statement provisions in the 1982 amendments to the ESA to resolve the situation in which a Federal action agency or an applicant has been advised by the Services that the proposed action is not likely to jeopardize the continued existence of listed species but is anticipated to result in the taking of listed species incidental to that action, which would otherwise violate the take prohibition of section 9. See H.R. Rep. 97-567, 26-27 (1982). According to the legislative history of the ESA, by requiring the Services to specify the impact of take on the listed species, Congress also intended reinitiation triggers (amount or extent of take) to be required as part of the incidental take statement. See id.

The ESA is sufficiently ambiguous to allow the Services to adopt a statutory interpretation that supports not providing an incidental take statement for a framework programmatic action, as appropriate. See Chevron USA, Inc. v. Natural Resources Defense Council, 467 U.S. 837, 865-66 (1984). First, the definition of “take” itself contemplates immediate actions that would potentially injure a listed species (“harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect” (16 U.S.C. 1532(19)). The programmatic (framework) action by itself and by definition under this rule does not authorize any actions that would result in these sorts of immediate injuries to a listed species. No take will occur at the programmatic level, and any take that results will result only from a second (or subsequent) authorization under the programmatic action. As discussed above, framework programmatic actions may include authorization for actions that will not be subject to further Federal authorization or section 7 consultation and are reasonably certain to cause take. Under those circumstances, an incidental take statement would be necessary for that portion of the framework programmatic action. The Services have included recognition of this circumstance in the regulatory definition of mixed programmatic action in this final rule.

Given the step-wise nature of such programmatic actions, sections 7(b)(4) and 7(o)(2) of the ESA can be read to support not providing an incidental take statement at the programmatic level under these circumstances. If incidental take is anticipated to result at this stage, section 7(b)(4) appears to require the Services to issue an incidental take statement (“the Secretary shall provide the Federal agency and applicant . . . with a written statement”) (16 U.S.C. 1536(b)(4) (emphasis added). Although section 7(b)(4) does not expressly require a finding that incidental take is anticipated to result from the agency action, the three requirements that must be met before an incidental take statement is issued implicitly suggest this. See 16 U.S.C. 1536(b)(4)(B) (“the taking of an endangered species or a threatened species incidental to the agency action will not violate such subsection”) (emphasis added). These provisions provide room for the Services to adopt the position that take will not result at the programmatic (framework) level in and of itself since no specific action is authorized when the program is adopted. Any take that will result from the program will be addressed, as appropriate, when a subsequent specific action(s) is authorized and the resulting action-specific consultation occurs. Because of the framework nature of the programmatic actions at issue, the Services are not avoiding the duty to provide an incidental take statement—any take resulting from the subsequent actions under program will be addressed in the later action-specific consultation. Not providing a take-related reinitiation trigger under an incidental take statement for the framework programmatic action is supportable given the Services' position that take is not anticipated at the program (framework) level in the particular circumstance where no specific action is authorized until a subsequent action developed under the framework is taken and subsequent ESA consultation occurs. Also, for decisions adopting framework programmatic actions that also authorize actions to proceed without any further Federal authorization or section 7 consultation anticipated, an incidental take statement is required under this rule where the action is determined to be compliant with section 7(a)(2) and take is reasonably certain to occur. An example of such actions might include Federal programs in which subsequent approval for actions proceeding under the program are delegated to States.

As defined in this rule and discussed above, a mixed programmatic action may include authorization for actions that will not be subject to further Federal authorization or section 7 consultation and are reasonably certain to cause take. Under those circumstances, an incidental take statement would be necessary for that portion of the programmatic action. The Services have included recognition of this circumstance in the regulatory definition of mixed programmatic action in this final rule. Examples of mixed programmatic action would include land management plans in which particular actions, such as establishment of campgrounds or off-road vehicle use, are approved to proceed directly, while the plan itself provides a framework for the development of future actions occurring in the action area that are authorized, funded, or carried out at a later time and subject to section 7 consultation requirements, as appropriate.

Section 7(o)(2) of the ESA supports the Services' interpretation because it appears to contemplate only a single incidental take statement to fully exempt take. The language of section 7(o)(2) provides “any taking that is in compliance with the terms and conditions [of an incidental take statement] . . . shall not be considered to be a prohibited taking.” (16 U.S.C. 1536(o)(2)). If the Services were to provide an incidental take statement for a framework programmatic action where any take will result only from future authorizations under the programmatic (framework) action, the Services would still require a second incidental take statement for those subsequent actions because that is the point at which adequate information typically would be available to identify amount or extent of take and to provide action-specific terms and conditions. Requiring an incidental take statement for the framework programmatic action to fully exempt the take associated with implementing the program or framework, however, may be inconsistent with section 7(o)(2), which exempts “any taking” that complies with the terms and conditions of the incidental take statement (emphasis added). Thus, not providing an incidental take statement at the program (framework) level avoids a potential inconsistency with the language of section 7(o)(2).

Additionally, as discussed above, the language of the ESA leaves sufficient room to draw a distinction between “effects” and “take” at the programmatic scale, and thus to allow for an analysis of program implementation as part of the “effects” of a framework programmatic action but not to provide an incidental take statement at the program (framework) level. The ESA itself uses different terms in specifying the contents of a biological opinion for jeopardy purposes (“detail how the agency action affects the species”) and an incidental take statement (focused on “take”). See 16 U.S.C. 1536(b)(3)(A), (b)(4) (emphasis added). The ESA also does not define “affects” in any way. Thus, it is up to the Services to fill in these statutory gaps in the ESA in a reasonable way. See National Cable & Telecommunications Ass'n. v. Brand X Internet Services, 545 U.S. 967 (2005).

Likewise, the use of surrogates in an incidental take statement is an exercise of the Services' reasonable discretion in carrying out their responsibilities under section 7 of the ESA. The statutory language associated with reinitiation triggers is quite general, providing that as part of an incidental take statement the Services shall “specif[y] the impact of such incidental taking on the species” (16 U.S.C. 1536(b)(4)(i)). This language leaves substantial room for statutory interpretation on the part of the Services, including the use of surrogates.

The legislative history of the 1982 amendments to the ESA, which added the incidental take statement provisions, reflects congressional support for the use of surrogates as well. Congress recognized that a numerical value would not always be available and intended that such numbers be established only where possible (H.R. Rep. No. 97-567, at 27).

In practice, over the last 25 years of developing incidental take statements, the Services have found that in many cases the biology of the listed species or the nature of the proposed action makes it impractical to detect or monitor take of individuals. In those situations, evaluating impacts to a surrogate such as habitat, ecological conditions, or similar affected species may be the most reasonable and meaningful measure of assessing take of listed species and is fully consistent with the language and purposes of the ESA.

The courts have also recognized that it is not always practicable to establish the precise number of individuals that will be taken. Thus under a Chevron analysis, the ESA permits the Services to rely upon surrogate measures to establish the impact of take on the species if there is a link between the surrogate and take. See Arizona Cattle Growers' Ass'n v. U.S. Fish and Wildlife Service, 273 F.3d 1229 (9th Cir. 2001); see also Oregon Natural Resource Council v. Allen, 476 F.3d 1031, 1041 (9th Cir. 2007). It is often more practical and meaningful to monitor project effects upon surrogates, which can also provide a clear standard for determining when the amount or extent of anticipated take has been exceeded and consultation should be reinitiated. Accordingly, the Services have already exercised their discretionary authority to adopt the use of surrogates as part of our joint national policy for preparing incidental take statements in the Section 7 Handbook (Services 1998).

Issue 3: Commenters noted that the proposed rule is subject to the requirements of the National Environmental Policy Act (NEPA), including the requirements applicable to environmental impact statements, that must be satisfied before a final decision is made on the proposed regulatory changes.

Response: The categorical exclusions at 43 CFR 46.210(i) and NOAA Administrative Order 216-6, section 6.03c.3(i) apply to this joint rule. Among other things, the exclusions apply to regulations that are of an administrative, financial, legal, technical, or procedural nature and whose environmental effects are too broad, speculative, or conjectural to lend themselves to meaningful analysis and will later be subject to the NEPA process either collectively or case by case. 43 CFR 46.210.

The Services have determined that this final rule will not result in any reasonably foreseeable effects to the environment and, therefore, that further NEPA review is not required. First, the rule codifies existing practices and case law with respect to use of surrogates and this codification of the status quo does not result in foreseeable environmental effects. Second, the timing of issuance of the incidental take statement will not change the substantive protections afforded to species and therefore the Service's regulations do not change the on-the-ground effects of incidental take statements. Finally, the update to the regulations does not result in environmental impacts because it merely clarifies the Services' longstanding position since the Ninth Circuit's decision in Arizona Cattle Growers' Ass'n. that an incidental take statement may be issued only when there is “reasonable certainty” that take of listed species will occur.

To the extent the rule would result in reasonably foreseeable environmental effects, the Services have determined that the rule is categorically excluded from further NEPA review and that no extraordinary circumstances are present. The rule qualifies for two categorical exclusions listed at 43 CFR 46.210(i) and NOAA Administrative Order (NAO) 216-6, section 6.03c.3(i). Among other things, the exclusions apply to regulations that are of an administrative, financial, legal, technical, or procedural nature; or whose environmental effects are too broad, speculative, or conjectural to lend themselves to meaningful analysis and will later be subject to the NEPA process, either collectively or case by case. 43 CFR 46.210. See also NAO section 216-6 6.03c.3(i) (substantively the same exclusion).

First, the rule is of a legal, technical, or procedural nature. For surrogates, the rule clarifies when the Services may use a surrogate to establish the amount or extent of take. This clarification is consistent with the Services' existing national policy and applicable case law. For programmatic actions, the rule clarifies the procedural timing of when the Services will issue an incidental take statement. It does not alter substantive protections. Finally, the rule codifies the Services' longstanding interpretation of their existing regulations post Arizona Cattle Growers' Ass'n. that an incidental take statement can be issued only if there is “reasonable certainty” that take will occur.

Second, any potential impacts of this rule are too broad, speculative, and conjectural to lend themselves to meaningful analysis and will be examined as part of any NEPA analysis conducted by the Federal action agency. As explained above, the changes in the rule generally constitute clarifications that are consistent with existing practices as well as case law. As such, it would be speculative to try to analyze the effects of the codification of these practices. Furthermore, these changes apply to the nationwide implementation of section 7 consultations, which take place in a wide variety of contexts, for various activities, for and with numerous action agencies. This application allows analysis only at the broadest level and would not permit meaningful analysis. Furthermore, before any action is taken, the responsible action agency will be required to conduct any necessary NEPA analyses, including impacts to listed species and critical habitat. For these reasons, the second categorical exclusion applies to this rule.

Additionally, none of the extraordinary circumstances listed at 43 CFR 46.215 and NAO 216-6 section 5.05c are triggered by the final rule. This rule does not involve a geographic area with unique characteristics, is not the subject of public controversy based on potential environmental consequences, will not result in uncertain environmental impacts or unique or unknown risks, does not establish a precedent or decision in principle about future proposals, will not have significant cumulative impacts, and will not have any adverse effects upon endangered or threatened species or their habitats for the reasons identified above.

In making this determination, the Services have considered whether adequate opportunities for public comment on the rule, including its potential environmental effects, have been provided. Our review of the proposed rule and the comments received on that proposal demonstrated that preparation of an Environmental Assessment is not necessary to obtain public input on this rule. Commentators had the opportunity to weigh in on the various aspects of this final rule and the final rule has been shaped, in part, by those comments. We conclude that preparation of an Environmental Assessment would not result in meaningful additional opportunities for comment, nor would it be likely to provide the Services with significant additional information to guide their decisionmaking process.

Issue 4: One commenter requested that the Services include the concept of a “cumulative” incidental take statement in the incidental take statement rulemaking.

Response: The statutory purposes and features of incidental take statements are discussed above in the preamble. As reflected in that discussion, incidental take statements are proposed-action specific. While biological opinions examine aggregate or cumulative impacts as part of the jeopardy and adverse modification analyses consistent with the best scientific and commercial data available (see, e.g., Services' Section 7 Handbook, at 4-33), incidental take statements do not, nor are they required to, include such analyses. Additionally, an incidental take statement may be issued only if the proposed action avoids jeopardizing the species or adversely modifying its critical habitat. See 16 U.S.C. 1536(b)(4).

Issue 1: Several commenters requested the Services to clarify the standards for issuing an incidental take statement.

Response: As noted above, in accordance with the ESA, the Services must provide an incidental take statement in a biological opinion in cases where we have concluded that a proposed Federal action will not violate section 7(a)(2) and take of listed species caused by the action is reasonably certain to occur. As discussed above, the Services are clarifying 50 CFR 402.14(g)(7) to clarify that reasonable certainty is the standard. Additionally, for framework programmatic actions, the Services are also clarifying that an incidental take statement is not required at the program (framework) level for those actions falling within the definition of framework programmatic action.

In general, the standards for incidental take statements in the current regulations at 50 CFR 402.14(i) continue to apply as well as the standards associated with national policy for incidental take statements found on pages 4-43 through 4-58 of the Services' Section 7 Handbook (Services 1998).

In accordance with those standards and consistent with governing case law and our regulations, the Services' general approach to incidental take statements is summarized below:

Take is specifically defined in the regulations. For example, the terms “harm” and “harass” have specific meanings, and they are not synonymous (i.e., FWS harm and harass at 50 CFR 17.3; NMFS harm at 50 CFR 222.102). The effects analysis in a biological opinion should discuss, as appropriate, the anticipated effects of an action on listed species in biological terms that relate to the regulatory definitions of take. Similarly, the incidental take statement portion of a biological opinion should reflect the proper use of take terminology.

If a proposed action includes a reasonable certainty of take, the biological opinion needs to make a rational connection between the effects of the action and the take considered in the incidental take statement. The terms and conditions must have a rational connection to the taking of a species and must give clear guidance to the recipient of the incidental take statement of what is expected and how the conditions (including those for monitoring of take-related impacts caused by the action) can be met.

Issue 2: One commenter requested the Services to clarify if an incidental take statement for a program-level action can include an amount or extent of take if the analysis of the effects of the action supports such a finding.

Response: Yes, if the Services have determined that incidental take is reasonably certain to occur and that such take will not violate section 7(a)(2) of the ESA.

Issue 3: One commenter noted that if a jeopardy determination can be made for a programmatic action, then quantification of anticipated take in an incidental take statement should also be possible.

Response: As discussed in the preamble above, a meaningful effects analysis within a biological opinion may appropriately rely upon qualitative analysis to determine whether a framework programmatic action, inclusive of any proposed measures to minimize adverse impacts or conserve listed species, is adequately protective for purposes of making a jeopardy determination. Biological opinions on such programs often examine how the parameters of the program align with the survival and recovery of listed species. These assessments are often qualitative and do not provide the sort of specificity required for the purposes of incidental take statements. See the related discussion above in the section entitled “Provision of an Incidental Take Statement with a Biological Opinion for Programmatic Actions.”

Issue 4: Several commenters requested the Services to affirm that reasonable and prudent measures in an incidental take statement must respect the “minor change” rule.

Response: The Services find that the text in the current regulations under § 402.14(i)(2) is clear and sufficient in this regard, and no changes are warranted. Reasonable and prudent measures and the terms and conditions that implement them cannot alter the basic design, location, scope, duration, or timing of the action and may involve only minor changes.

Issue 1: Several commenters requested the Services to more clearly express the regulatory definition of programmatic action and to more clearly explain why this term needs to be defined in the regulations.

Response: After considering public comments and internal review, the Services are modifying the term and definition of programmatic action in this final rule. The term framework programmatic action is added to 50 CFR 402.02 and includes, for purposes of an incidental take statement, a Federal action that approves a framework for the development of future actions that are authorized, funded, or carried out and subject to section 7 requirements at a later time. The term mixed programmatic action and its definition are also added to 50 CFR 402.02 in this final rule to further distinguish the forms of programmatic actions that may be developed by Federal agencies. See discussion above for further detail regarding framework and mixed programmatic actions in the section entitled “Inclusion of an Incidental Take Statement in a Biological Opinion for Programmatic Actions.”

Issue 2: Several commenters requested the Services to more clearly define key phrases in the proposed rule, including those for programmatic action and site-specific.

Response: For programmatic action, see the response to Issue 1 above. The regulatory language of the rule no longer uses the term “site-specific.” In the Services' view, that term unnecessarily narrowed the definition of the types of programmatic actions to which this rule is intended to apply.

Issue 3: One commenter requested the Services to clarify if programmatic actions covered under a Habitat Conservation Plan (HCP) permit issued under section 10(a)(1)(B) of the ESA fall within the scope of the proposed regulatory definition of programmatic action.

Response: The Services anticipate that an HCP covering programmatic actions by non-Federal parties (e.g., States, local governments, private citizens) generally would not fall under the definition of framework programmatic action established by this rule. The Federal action involved in an HCP is the issuance of a section 10(a)(1)(B) permit, and it is this action that is the subject of a biological opinion and incidental take statement. Such a permit generally is not expected to fall under the definition of framework programmatic action discussed herein since it is the underlying State/local/private action that is programmatic in nature, not the Federal permit itself, which is subject to consultation.

Issue 4: Several commenters noted that the proposed rule fails to establish clear standards for programmatic actions and creates an “enormous loophole in the consultation process that will harm listed species.”

Response: Based on the revisions and clarifications of the proposed rule in this final rule, the Services endeavor to articulate more clearly when an incidental take statement is required for programmatic actions. Additionally, as noted above in the response to Issue 1 in the subsection titled “The Standards for Anticipating Take,” an incidental take statement can be provided only where the Services have concluded in a biological opinion that a proposed Federal action and the resultant incidental take will not violate section 7(a)(2). This scenario is the same for both programmatic actions and project-specific actions that fall under such programs, which ensures that no loophole is created.

Issue 5: One commenter requested the Services to clarify the standards that will be applied to develop incidental take statements for site-specific actions authorized under a programmatic action, especially those related to monitoring of take-related impacts.

Response: The Services note that we are no longer using the term “site-specific actions” in our definitions for programmatic action. In general, for actions proceeding under a program that are anticipated to be subject to a subsequent section 7 consultation, the standards for incidental take statements in the current regulations at 50 CFR 402.14(i) would continue to apply as well as the standards associated with national policy for incidental take statements found on pages 4-43 through 4-58 of the Services' Section 7 Handbook. For a more detailed discussion of these standards, see the response to Issue 1 under “The Standards for Anticipating Take” above.

Issue 1: One commenter suggested that the Services not require an incidental take statement to explain the causal link between the effects of an action to a surrogate and take of listed species under the proposed changes to § 402.14(i)(1)(i) but rather use the agency record of decision to explain how those standards are met. At the very least, the commenter requested the Services to delete reference to “clear” in relation to setting a standard for determining when the level of anticipated take in terms of a surrogate has been exceeded because the word “clear” “implies an extra burden on the agency to provide particular detail about the standard” that may make the Services vulnerable to assertions that a take reinitiation trigger is not clear enough.

Response: The requirement for the Services to explain the causal link is consistent with the Services' current national section 7 policy (see page 4-47 of the Services' Section 7 Handbook) and current case law. Additionally, in the section 7 context, the Services do not issue a record of decision; we issue a biological opinion and incidental take statement, which is the appropriate place to address the causal link between anticipated take and an identified surrogate. The Services have retained the word “clear” in § 402.14(i)(1)(i) of the regulations because that term best conveys the intent to ensure the standard is understandable to the holder of the incidental take statement.

Issue 2: Several commenters were concerned about the Services' proposed regulatory criteria for the use of surrogates to characterize the amount or extent of anticipated take and requested the Services to better define clear standards for the use of surrogates and subsequent monitoring. Some commenters suggested that these standards be less specific, and others suggested that they be more specific.

Response: The standards for the use of surrogates, as finalized in this rule, are consistent with relevant case law and the Services' national policy on the use of surrogates (see page 4-47 of the Services' Section 7 Handbook), which has been in effect since 1998.

Issue 3: One commenter objected to the Services' proposed regulatory authorization for the use of surrogates to address habitat surrogates that are fully coextensive with any aspect of the proposed project's impacts on habitat because such a provision is at odds with the Ninth Circuit's decision in Oregon Natural Res. Council v. Allen, 476 F.3d 1031 (9th Cir. 2007).

Response: The Services consider a “coextensive” surrogate to be a surrogate that adopts a portion of a proposed action as a trigger for reinitiation. Coextensive surrogates allowed for by this rule adequately fulfill their role as independent reinitiation triggers because the monitoring and reporting requirements of the incidental take statement will be structured to ensure timely reporting of project impacts to a surrogate to ensure timely reinitiation of formal consultation, as appropriate, in the same way as for non-coextensive surrogates. The preamble provides additional discussion illustrating how a coextensive surrogate may fulfill its intended function as an independent trigger for reinitiation. A surrogate that did not fulfill this role would not meet the requirements of this rule.

Issue 4: Several commenters requested the Services to more clearly describe the meaning of “not practical,” “clear standard,” and “causal link” as these terms are applied in the use of surrogates.

Response: The Services considered this comment in finalizing the preamble discussion on the use of surrogates and believe each of these terms is clearly described in a manner that is consistent with existing case law and the Services national policy on the use of surrogates (see page 4-47 of the Services' Section 7 Handbook), which has been in effect since 1998.

Issue 5: Several commenters requested the Services to clarify that take of a surrogate is not a violation of section 9 of the ESA.

Response: The Services affirm that take of a surrogate is not, in and of itself, a violation of sections 9(a)(1)(B), (C), or (G) of the ESA. Any efforts to prosecute a violation of the take prohibitions would be based on applying the appropriate evidentiary standards to support either a civil or criminal action. A surrogate functions to provide a trigger for reinitiation of consultation under § 402.16(a). If the amount or extent of take is represented by a surrogate and the level of anticipated impact to that surrogate is exceeded, reinitiation may be required consistent with the terms of § 402.16. The availability of the take exemption afforded by the incidental take statement is governed by compliance with the reasonable and prudent measures and terms and conditions contained in the statement. Provided the holder of the incidental take statement is in compliance with all terms and conditions, the take exemption remains in place even if the extent of take as described by a surrogate is exceeded (16 U.S.C. 1536(o)(2); 50 CFR 402.14(i)(5)). However, if the extent of take is exceeded, the regulations require the action agency to immediately reinitiate consultation (50 CFR 402.14(i)(4)).

Issue 6: Several commenters recommended the Services to replace the “not practical” standard in the proposed change to § 402.14(i)(1)(i) with a “scientifically impractical” standard.

Response: The Services decline to make this change. The Services consider the best scientific and commercial data available in determining whether it is not practical to express the amount of take in terms of individuals of the listed species. In making this determination, the Services must take into account relevant considerations, some of which may be considered broader than “scientifically impractical,” such as the scope and scale of the proposed action relative to the costs of any monitoring necessary to determine take of individuals of the listed species from the action.

Issue 7: One commenter recommended that the Services delete reference to examples of surrogates in the proposed change to § 402.14(i)(1)(i) because it may be interpreted as an unnecessary limit on the types of surrogates that may be used in an incidental take statement. Another commenter suggested that reference to examples of surrogates should be done only in the preamble section of the rule.

Response: The use of examples in this rule is not intended to limit use of surrogates, and any surrogate that meets the standards set forth in this rule would be available.

Issue 8: One commenter noted that the use of surrogates in incidental take statements should be done sparingly and under very narrow circumstances to avoid misapplication.

Response: As discussed in the preamble, the use of surrogates is fact-pattern specific and dependent on meeting the standards set forth in this rule.

Issue 9: One commenter requested the Services to further condition the proposed regulatory standards for the use of surrogates to include a requirement under an incidental take statement to gather data during the term of the Federal action to confirm that effects to the surrogate and the listed species that conform to take are highly likely to correspond.

Response: Pursuant to this final rule, use of a surrogate in an incidental take statement is predicated on a finding that measuring take impacts to a listed species is not practical and on establishing a link, based on best available scientific information, between effects of the action to a surrogate and take of the listed species. The Services acknowledge that the body of science relied upon to make that link is likely to vary on a listed species-specific basis. To the extent that a link can be reasonably established, but more information would be helpful, the Services can request the Federal agency or an applicant to collect additional information in the “Conservation Recommendations” section of a biological opinion (see pages 4-62 and 4-63 in the Services' Section 7 Handbook). Implementation of the suggested requirement for such information as part of an incidental take statement, if appropriate, would need to comply with the regulatory requirement under § 402.14(i)(2) for the scope of reasonable and prudent measures and terms and conditions to involve only minor changes to the proposed Federal action.

It should also be noted that, in many cases, the surrogate used by the Services in an incidental take statement is habitat or a component of the habitat of the listed species. In those situations, the science related to the habitat requirements and behavior of the listed species informs the analytical basis for findings by the Services that a proposed action is reasonably certain to cause take of the listed species and establishes a causal link between effects to habitat and take of the listed species. For these reasons, quantifying and monitoring take impacts via project effects to the habitat of the listed species is a scientifically credible and practical approach for expressing and monitoring the anticipated level of take for situations where use of a surrogate meets the criteria set forth in this rule. In those instances where insufficient information exists to confirm the causal link, the surrogate would not meet the standard for its use in an incidental take statement. As noted above, the Services can request additional information on such a link in the “Conservation Recommendations” section of a biological opinion (see pages 4-62 and 4-63 in the Services' Section 7 Handbook).

The Services intend to prepare implementation guidance for the use of surrogates to supplement the discussion in the Services' Section 7 Handbook and will consider the recommendations provided in public comments as well as in a recent commentary by Murphy and Weiland (2014) on our proposed rule.

Issue 10: Several commenters requested the Services clarify if effects to habitat, including designated critical habitat, could be used as a surrogate measure for the amount or extent of anticipated take in an incidental take statement.

Response: Effects to habitat can be used as a surrogate for expressing the amount or extent of take of a listed species if the criteria set forth in this final rule are met.

Executive Order 12866 provides that the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget will review all significant rules. OIRA has reviewed this rule and has determined that this rule is significant.

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

Under the Regulatory Flexibility Act (as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996; 5 U.S.C. 601 et seq.), whenever a Federal agency is required to publish a notice of rulemaking for any proposed or final rule, it must prepare, and make available for public comment, a regulatory flexibility analysis that describes the effect of the rule on small entities (small businesses, small organizations, and small government jurisdictions). However, no regulatory flexibility analysis is required if the head of an agency, or his or her designee, certifies that the rule will not have a significant economic impact on a substantial number of small entities. SBREFA amended the Regulatory Flexibility Act to require Federal agencies to provide a statement of the factual basis for certifying that a rule will not have a significant economic impact on a substantial number of small entities. We are certifying that this rule will not have a significant economic effect on a substantial number of small entities. The following discussion explains our rationale.

Incidental take statements describe the amount or extent of incidental take that is anticipated to occur when a Federal action is implemented. The incidental take statement conveys an exemption from the ESA's take prohibitions provided that the action agency (and any applicant) complies with the terms and conditions of the incidental take statement. Terms and conditions cannot alter the basic design, location, scope, duration, or timing of the action and may involve only minor changes (50 CFR 402.14(i)(2)). The regulatory changes addressed in this rule will neither expand nor contract the reach of terms and conditions of an incidental take statement. As such, we foresee no economic effects from implementation of this final rule.

In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq.):

(a) This final rule will not “significantly or uniquely” affect small governments. We have determined and certify under the Unfunded Mandates Reform Act, 2 U.S.C. 1502 et seq., that this rulemaking will not impose a cost of $100 million or more in any given year on local or State governments or private entities. A Small Government Agency Plan is not required. As explained above, small governments would not be affected because the revised regulations will not place additional requirements on any city, county, or other local municipalities.

(b) This rule will not produce a Federal mandate of $100 million or greater in any year (i.e., it is not a “significant regulatory action” under the Unfunded Mandates Reform Act). This regulation would not impose any additional management or protection requirements on the States or other entities.

In accordance with E.O. 12630, we have determined that the final rule does not have significant takings implications. A takings implication assessment is not required because this rule (1) will not effectively compel a property owner to suffer a physical invasion of property and (2) will not deny all economically beneficial or productive use of the land or aquatic resources. This rule would substantially advance a legitimate government interest (conservation and recovery of listed species) and would not present a barrier to all reasonable and expected beneficial use of private property.

In accordance with E.O. 13132, we have considered whether this final rule has significant Federalism effects and have determined that a Federalism assessment is not required. This rule would not have substantial direct effects on the States, on the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government. No intrusion on State policy or administration is expected; roles or responsibilities of Federal or State governments would not change; and fiscal capacity would not be substantially directly affected. Therefore, this rule does not have significant Federalism effects or implications to warrant the preparation of a Federalism Assessment under the provisions of E.O. 13132.

This final rule will not unduly burden the judicial system and meets the applicable standards provided in sections (3)(a) and (3)(b)(2) of E.O. 12988.

In accordance with the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951), E.O. 13175, and the Department of the Interior's manual at 512 DM 2, we readily acknowledge our responsibility to communicate meaningfully with affected Federally recognized Tribes on a government-to-government basis. We have determined that there are no tribal lands affected by this rule, and, therefore, no such communications were made.

This final rule does not contain collections of information that require approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). We may not conduct or sponsor and you are not required to respond to a collection of information unless it displays a currently valid OMB control number.

The Services have determined that this final rule will not result in any reasonably foreseeable effects to the environment and, therefore, that further NEPA review is not required. First, the rule codifies existing practices and case law with respect to use of surrogates and this codification of the status quo does not result in foreseeable environmental effects. Second, the timing of issuance of the incidental take statement will not change the substantive protections afforded to species and therefore the Service's regulations do not change the on-the-ground effects of incidental take statements. Finally, the update to the regulations does not result in environmental impacts because it merely clarifies the Services' longstanding position since the Ninth Circuit's decision in Arizona Cattle Growers' Ass'n. that an incidental take statement may be issued only when there is “reasonable certainty” that take of listed species will occur.

To the extent the rule would result in reasonably foreseeable environmental effects, the Services have determined that the rule is categorically excluded from further NEPA review and that no extraordinary circumstances are present. The rule qualifies for two categorical exclusions listed at 43 CFR 46.210(i) and NOAA Administrative Order (NAO) 216-6, section 6.03c.3(i). Among other things, the exclusions apply to regulations that are of an administrative, financial, legal, technical, or procedural nature; or whose environmental effects are too broad, speculative, or conjectural to lend themselves to meaningful analysis and will later be subject to the NEPA process, either collectively or case by case. 43 CFR 46.210. See also NAO section 216-6 6.03c.3(i) (substantively the same exclusion).

First, the rule is of a legal, technical, or procedural nature. For surrogates, the rule clarifies when the Services may use a surrogate to establish the amount or extent of take. This clarification is consistent with the Services' existing national policy and applicable case law. For programmatic actions, the rule clarifies the procedural timing of when the Services will issue an incidental take statement. It does not alter substantive protections. Finally, the rule codifies the Services' longstanding interpretation of their existing regulations post Arizona Cattle Growers' Ass'n. that an incidental take statement can be issued only if there is “reasonable certainty” that take will occur.

Second, any potential impacts of this rule are too broad, speculative, and conjectural to lend themselves to meaningful analysis and will be examined as part of any NEPA analysis conducted by the Federal action agency. As explained above, the changes in the rule generally constitute clarifications that are consistent with existing practices as well as case law. As such, it would be speculative to try to analyze the effects of the codification of these practices. Furthermore, these changes apply to the nationwide implementation of section 7 consultations, which take place in a wide variety of contexts, for various activities, for and with numerous action agencies. This application allows analysis only at the broadest level and would not permit meaningful analysis. Furthermore, before any action is taken, the responsible action agency will be required to conduct any necessary NEPA analyses, including impacts to listed species and critical habitat. For these reasons, the second categorical exclusion applies to this rule.

Additionally, none of the extraordinary circumstances listed at 43 CFR 46.215 and NAO 216-6 section 5.05c are triggered by the final rule. This rule does not involve a geographic area with unique characteristics, is not the subject of public controversy based on potential environmental consequences, will not result in uncertain environmental impacts or unique or unknown risks, does not establish a precedent or decision in principle about future proposals, will not have significant cumulative impacts, and will not have any adverse effects upon endangered or threatened species or their habitats for the reasons identified above.

In making this determination, the Services have considered whether adequate opportunities for public comment on the rule, including its potential environmental effects, have been provided. Our review of the proposed rule and the comments received on that proposal demonstrated that preparation of an Environmental Assessment is not necessary to obtain public input on this rule. Commentators had the opportunity to weigh in on the various aspects of this final rule and the final rule has been shaped, in part, by those comments. We conclude that preparation of an Environmental Assessment would not result in meaningful additional opportunities for comment, nor would it be likely to provide the Services with significant additional information to guide their decisionmaking process.

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

We are taking this action under the authority of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq.).

Accordingly, we amend subpart B of part 402, subchapter A of chapter IV, title 50 of the Code of Federal Regulations, as set forth below: