Federal Register Vol. 83, No.143,

This proposal is governed by section 608c(16)(A) of the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act,” and Marketing Agreement 104 and Marketing Order 953 (7 CFR part 953), referred to as the “Order,” effective under the Act.

The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Orders 13563 and 13175. This proposed rule falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review. Additionally, because this proposal does not meet the definition of a significant regulatory action, it does not trigger the requirements contained in Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017, titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).

This proposal to terminate the Order has been reviewed under Executive Order 12988, Civil Justice Reform. This proposed rule is not intended to have retroactive effect.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.

This proposal invites comments on the termination of the Order. The Order authorizes regulation of the handling of Irish potatoes grown in designated counties of Virginia and North Carolina. The Order has been suspended for approximately seven years, at the industry's recommendation, and the industry has not expressed interest in reactivating the Order.

Section 953.66 provides, in pertinent part, that USDA terminate or suspend any or all provisions of the Order when a finding is made that the Order or any provision thereof does not tend to effectuate the declared policy of the Act. In addition, section 608c(16)(A) of the Act provides that USDA terminate or suspend the operation of any order or any provision thereof whenever the order or any provision thereof obstructs or does not tend to effectuate the declared policy of the Act. Additionally, USDA is required to notify Congress not later than 60 days before the date an order would be terminated.

The Order has been in effect since 1948 and provides for the establishment of grade, size, quality, maturity, and inspection requirements for Irish potatoes grown in Southeastern states. The Order also authorizes reporting and recordkeeping functions required for the operation of the Order. The Order, when in effect, is locally administered by the Southeastern Potato Committee (Committee) and is funded by assessments imposed on handlers.

Based on the Committee's unanimous recommendation in 2011, USDA suspended the Order for a three-year period ending March 1, 2014. The Committee recommended the suspension to eliminate the expense of administering the Order while determining the effects of not having the Order in place. When the Committee made the recommendation to suspend the Order, it wanted the industry to have the option of reactivating the Order, if deemed appropriate. The final rule adopting an interim rule that implemented that action was published in the Federal Register on October 21, 2011 (76 FR 65360). Upon suspension of the Order in 2011, the Committee ceased to function.

In anticipation of the expiration of the suspension on March 1, 2014, in late 2013 USDA sent a letter to members of the industry, most of whom were former Committee members. The letter stated that suspension of the Order would soon be ending and that members of the industry would need to recommend an action to USDA. On December 18, 2013, representatives of the Virginia and North Carolina Irish potato industry met and requested that the suspension of all provisions of the Order be continued through March 1, 2017. The extension of the suspension would allow the industry further opportunity to study changes and evaluate new developments in the industry that could affect the need for the Order. The final rule adopting the interim rule that implemented that action was published in the Federal Register on August 19, 2015 (80 FR 50191).

Under the terms of the suspension, if the industry did not petition USDA to have the Order reactivated by the end of the suspension period, March 1, 2017, AMS would propose termination of the Order. To date, the industry has not filed a petition to have the Order reactivated.

This proposed termination of the Order is intended to solicit input and any additional information available from interested parties regarding whether the Order should be terminated. USDA will evaluate all available information prior to making a final determination on this matter. Termination of the Order would become effective only after a 60-day notification to Congress, as required by law.

Pursuant to the requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), AMS has considered the economic impact of this proposed rule on small entities. Accordingly, AMS has prepared this initial regulatory flexibility analysis.

The purpose of the RFA is to fit regulatory actions to the scale of business subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act are unique in that they are brought about through group action of essentially small entities acting on their own behalf.

There are approximately ten handlers of Irish potatoes grown in Southeastern states who are subject to regulation under the Order and approximately 20 potato producers in the regulated area. Small agricultural service firms are defined by the Small Business Administration (SBA) as those having annual receipts of less than $7,500,000, and small agricultural producers are defined as those whose annual receipts are less than $750,000 (13 CFR 121.201).

Using prices reported by AMS' Market News Service, the average free on board (f.o.b.) price for Southeastern potatoes for the 2017 marketing season was about $50 per hundredweight. Based on information from the National Agricultural Statistics Service (NASS), estimated total production in Virginia and North Carolina for the 2017 season was 4,666,000 hundredweight of potatoes. Multiplying the f.o.b. price by the estimated production results in an estimated handler value of $233,300,000. Dividing this figure by the number of handlers (ten) yields an estimated average annual handler receipt of $23,330,000. Using the average price and shipment information, the number of handlers, and assuming a normal distribution, the majority of handlers have average annual receipts of more than $7,500,000.

Based on information from NASS, during the 2017 season, there were 19,600 total acres harvested in Virginia and North Carolina with a total value of production at $59,038,000 for the season. The average producer prices for Virginia and North Carolina Irish potatoes in 2017 were $16.30 and $11.40 per hundredweight, respectively, for an average price of $13.85. Dividing the 2017 total production value by the average of the two states' producer prices and using a normal distribution, the average gross annual revenue for each of the 20 producers would be about $213,134.

Therefore, based on the above handler and producer revenue estimates, the majority of Southeastern potato handlers may be classified as large entities, while a majority of producers may be classified as small entities.

This proposed rule would terminate the Order for Irish potatoes grown in Southeastern states and the rules and regulations issued thereunder. The Order authorizes regulation of the handling of Irish potatoes grown in designated counties of Virginia and North Carolina. The Order was initially suspended in 2011, at the recommendation of the Committee, to eliminate the expense of administering the Order while the industry determined the effects of not having regulations in place. In 2013, at the request of the industry, the suspension was extended through March 1, 2017, to provide the industry with more time to consider changes and evaluate new developments in the industry that could affect the future need for the Order. The final rule that extended the suspension through March 1, 2017, stated that AMS would proceed with a notice to propose termination absent an industry recommendation to reactivate the Order. The results of the suspension and the industry's failure to petition USDA to have the Order reactivated by the end of the suspension period support the proposal to terminate the Order.

Section 953.66 provides that USDA terminate or suspend any or all provisions of the Order when a finding is made that the Order does not tend to effectuate the declared policy of the Act. Furthermore, section 608c(16)(A) of the Act provides that USDA terminate or suspend the operation of any order whenever the order or any provision thereof obstructs or does not tend to effectuate the declared policy of the Act. An additional provision requires that Congress be notified not later than 60 days before the date an order would be terminated.

The proposed termination of the Order would reduce costs to both handlers and producers (while marketing order requirements are applied to handlers, the costs of such requirements are often passed on to producers). Furthermore, following a period of over seven years of regulatory suspension, it has been determined that termination of the Order would not adversely impact the Virginia and North Carolina Irish potato industry.

As an alternative to this proposed rule, AMS considered not terminating the Order. In that case, the industry could have recommended further refinements to the Order and the handling regulations to better meet current marketing needs. However, the industry did not petition to have the Order reactivated by the end of the suspension period. Therefore, this alternative was rejected, and AMS proposes that the Order be terminated.

This proposed rule is intended to solicit input and other available information from interested parties on whether the Order should be terminated. USDA will evaluate all available information prior to making a final determination on this matter.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the information collection requirements that would be terminated were previously approved by OMB and assigned OMB No. 0581-0178, Vegetable and Specialty Crops. Termination of the reporting requirements under the Order would reduce the reporting and recordkeeping burden on Irish potato handlers in Southeastern states and should further reduce industry expenses.

Because handlers would no longer be required to file forms with the Committee, this proposed rule would not impose any additional reporting or recordkeeping requirements on either small or large entities.

In addition, USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule.

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

Additionally, interested persons are invited to submit information on the regulatory and information collection impacts of this action on small businesses.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: https://www.ams.usda.gov/rules-regulations/moa/small-businesses. Any questions about the compliance guide should be sent to Richard Lower at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

This proposal invites comments on the termination of Marketing Order No. 953, which regulates the handling of Irish potatoes grown in Southeastern states. All written comments received within the 60-day comment period will be considered before a final determination is made in this matter.

Based on the foregoing, and pursuant to section 608c(16)(A) of the Act and § 953.66 of the Order, USDA is considering termination of the Order. If USDA decides to terminate the Order, trustees would be appointed to conclude and liquidate the affairs of the Committee and would continue in that capacity until discharged by USDA. In addition, USDA would notify Congress 60 days in advance of termination pursuant to section 608c(16)(A) of the Act.

Pursuant to the Commodity Promotion, Research, and Information Act of 1996 (7 U.S.C. 7411-7425) (1996 Act), it is hereby directed that a referendum be conducted to ascertain whether continuance of the Processed Raspberry Promotion, Research and Information Order (7 CFR part 1208) is favored by eligible producers of raspberries for processing and importers of processed raspberries. The program is authorized under the 1996 Act.

The representative period for establishing voter eligibility for the referendum shall be the period from January 1 through December 31, 2017. Persons who produced 20,000 pounds or more of raspberries for processing in the United States or imported 20,000 pounds or more of processed raspberries into the United States during the representative period and were subject to assessment during that period are eligible to vote. Persons who received an exemption from assessments pursuant to § 1208.53 for the entire representative period are ineligible to vote. The referendum will be conducted from September 10 through October 5, 2018. The Department will provide the option for ballots to be returned electronically. Further details will be provided in the ballot instructions.

Section 518 of the 1996 Act (7 U.S.C. 7417) authorizes continuance referenda. Under § 1208.71(b), the U.S. Department of Agriculture (USDA) must conduct a referendum every seven years to determine whether eligible producers of raspberries for processing and importers of processed raspberries favor continuance of the program. A referendum also may be held by a request of 10 percent or more of all the eligible producers and importers, by request of the National Processed Raspberry Council, which administers the program, or by the Secretary of Agriculture. In March 2018, USDA received a petition requesting a referendum from more than the required 10 percent of eligible entities, thus USDA will hold a referendum. The program will continue if it is favored by a majority of eligible producers and importers voting in the referendum.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the referendum ballot has been approved by the Office of Management and Budget (OMB) and assigned OMB No. 0581-0093. It has been estimated that approximately 200 entities will be eligible to vote in the referendum. It will take an average of 15 minutes for each voter to read the voting instructions and complete the referendum ballot.

Hakim Fobia, Marketing Specialist, and Heather Pichelman, Director, Promotion and Economics Division, Specialty Crops Program, AMS, USDA, Stop 0244, Room 1406-S, 1400 Independence Avenue SW, Washington, DC 20250-0244, are designated as referendum agents for this referendum. The referendum procedures at 7 CFR 1208.100 through 1208.108, issued pursuant to the 1996 Act, will be used to conduct the referendum.

The referendum agents will mail the ballots to be cast in the referendum and voting instructions to all known, eligible producers and importers prior to the first day of the voting period. Persons who produced 20,000 pounds or more of raspberries for processing in the United States or imported 20,000 pounds or more of processed raspberries into the United States during the representative period and were subject to assessment during that period are eligible to vote. Persons who received an exemption from assessments pursuant to § 1208.53 during the entire representative period are ineligible to vote. Any eligible producer of raspberries for processing or importer of processed raspberries who does not receive a ballot should contact a referendum agent no later than one week before the end of the voting period. Mail ballots must be postmarked by October 5. Ballots delivered via express mail or email must show proof of delivery by no later than 11:59 p.m. ET on October 5, 2018, to be counted.

I. Background

The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) amended the Public Health Service Act (PHS Act) and other statutes to create an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product. The BPCI Act was intended to balance innovation and consumer interests. The abbreviated licensure pathway, in section 351(k) of the PHS Act, allows an applicant (a “351(k) applicant”) to rely, in part, on FDA's previous determination of safety and effectiveness for the reference product for approval. The BPCI Act provides, among other things, exclusivity periods for certain biological products licensed in “stand alone” applications under section 351(a) of the PHS Act.

As the marketplace of biological products continues to expand and evolve, FDA expects that increased availability of biosimilars and interchangeable products will result in more competition and create savings for patients and the healthcare system. At the same time, we recognize that there are challenges to the rapid growth of this marketplace. For instance, although FDA has approved 11 marketing applications for biosimilars as of July 1, 2018, FDA is aware that the majority of biosimilars licensed by FDA have not yet been marketed and are not available to patients.

Although such delays in the market entry of an approved biosimilar are outside FDA's control, we remain focused on FDA's critical role in increasing the availability of biosimilars and interchangeable products. Recognizing that this is a crucial time in the emergence of the marketplace of biosimilar and interchangeable products, FDA recently developed a Biosimilars Action Plan. This Plan focuses on four key areas: (1) Improving the efficiency of the biosimilar and interchangeable product development and approval process; (2) maximizing scientific and regulatory clarity for the biosimilar product development community; (3) developing effective communications to improve understanding of biosimilars among patients, clinicians, and payors; and (4) supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay competition.

FDA's Biosimilars Action Plan builds on the Agency's substantial progress, to date, implementing the approval pathway for biosimilar and interchangeable products. For example, FDA has issued guidance for industry on numerous scientific and regulatory issues related to the development of proposed biosimilar and interchangeable products. FDA also created the Biosimilar Product Development (BPD) Program to facilitate the rapid development of biosimilar and interchangeable products. Through enrollment in this program, FDA provides detailed, product-specific advice to manufacturers. As of July 1, 2018, 68 programs were enrolled in the BPD Program and FDA had received meeting requests to discuss the development of biosimilars for 31 different reference products.

FDA has also prioritized its efforts to provide useful information about licensed biological products to the public. FDA publishes the Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations 1 to provide information on licensed biological products, including information on exclusivity for reference products and on whether a product has been demonstrated to be biosimilar to, or interchangeable with, a reference product. Another FDA priority is the development of educational materials for patients, healthcare providers, and other stakeholders to increase knowledge about biological products, including biosimilar and interchangeable products. For example, FDA launched an educational campaign in October 2017 to promote understanding by healthcare providers of biosimilar and interchangeable products and how these products can help patients (see, https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580435.htm).

As FDA continues working to implement the BPCI Act, FDA welcomes input from the public on how the Agency can enhance its efforts to increase access by patients to state-of-the-art, lifesaving treatment options by encouraging innovation and competition in the biological products marketplace. FDA will hold a public hearing on September 4, 2018, from 9 a.m. to 5 p.m., to provide an opportunity for all interested stakeholders to submit comments.

The format of the hearing involves presentations from the public. The Agency will not be inviting specific presenters; rather, with this document, FDA is soliciting presentations from interested stakeholders. FDA also invites interested persons to submit written comments to the docket on the topics described in section II.

FDA is soliciting input from the public on how to facilitate greater availability of biosimilar and interchangeable products while retaining the balance between competition and innovation that Congress intended to achieve under the BPCI Act. FDA is holding a public hearing to receive information and comments from a broad group of stakeholders, including patients, researchers, healthcare providers, manufacturers, interested industry, professional organizations, and the public. The Agency has determined that a public hearing is the most appropriate way to ensure public engagement.

FDA welcomes any relevant information that stakeholders wish to share. FDA is particularly interested in stakeholder input on how the Agency can achieve the following goals:

• Facilitate the efficient development of biosimilar and interchangeable products using state-of-the-art science;

• Develop information resources, as well as scientific or regulatory tools, to streamline the development of biosimilar and interchangeable products;

• Enhance the efficiency of FDA review of marketing applications for biosimilar and interchangeable products;

• Provide additional scientific or regulatory clarity regarding FDA's regulation of biological products, including FDA's review and approval of marketing applications for biological products;

• Increase healthcare provider, patient, and payor understanding of biological products, including biosimilar and interchangeable products; and

• Support market competition by addressing attempts to game FDA requirements or otherwise delay market entry of competing biological products.

FDA is also interested in stakeholder input on the following questions about additional steps FDA can take, within its statutory authority, related to the Agency's regulation of biological products:

1. FDA is aware that many of the biosimilar products that have been licensed by FDA are not yet marketed and available to patients. What can FDA do to help biosimilars and interchangeable products reach patients more quickly after these products are licensed?

2. FDA uses the Purple Book to provide information about biological products licensed under section 351 of the PHS Act. What additional information or features could be incorporated into the Purple Book to make it more useful to stakeholders, including patients, healthcare providers, pharmacists, and manufacturers?

3. FDA expects that the number of licensed biosimilar and interchangeable products will continue to increase in the coming years. In many, if not most, cases, FDA anticipates that multiple products will be licensed as biosimilar to, or interchangeable with, a given reference product. What additional steps can FDA take to facilitate the evolution of the biosimilar and interchangeable product marketplace? What can FDA do to ensure that confidence in these products among patients, healthcare providers, pharmacists, and other stakeholders will continue to grow?

4. Extensive analytical characterization of the proposed biosimilar product and the reference product serves as the foundation for a demonstration of biosimilarity. FDA recognizes that obtaining and testing multiple lots of the reference product adds to the costs of developing a biosimilar product. What can FDA do to help reduce development costs arising from analytical studies of the reference product without compromising FDA's robust scientific standards for licensure of products under section 351(k) of the PHS Act? FDA is particularly interested in stakeholder comments on (1) the number of lots of each product (the proposed biosimilar product and the reference product) that should be used in analytical studies submitted to support licensure of a proposed biosimilar product; and (2) how a 351(k) applicant should account for and evaluate any observed variability in analytical attributes among lots of the reference product or the proposed biosimilar product.

5. A 351(k) applicant may, with adequate scientific justification, use a non-U.S.-licensed comparator product in certain studies submitted to support licensure of a proposed biosimilar product. What additional steps can FDA take to facilitate multinational development programs that may include non-U.S.-licensed comparators, to help support development of biosimilar products?

6. FDA expects continued innovation in the biological product marketplace, including innovation during the lifecycle of reference products licensed under section 351(a) of the PHS Act. What can FDA do to ensure that product changes during the lifecycle of reference products (e.g., changes in product presentation) are adequately incentivized without inappropriately deterring competition from biosimilar and interchangeable products, with the overall goal of balancing of innovation and competition?

7. Patents or exclusivity may protect one or more conditions of use (e.g., indications) of the reference product. As a result, 351(k) applicants may seek licensure of the proposed biosimilar product for fewer than all of the conditions of use for which the reference product is licensed. Once a condition of use is no longer protected by patents or exclusivity, FDA anticipates that 351(k) applicants often will seek licensure of their product for this condition of use. What challenges do 351(k) applicants face in this context and what should FDA do to achieve the appropriate balance between innovation and competition when one or more conditions of use of the reference product are protected by exclusivity or patents?

8. The scope of exclusivity under section 351(k)(7) of the PHS Act may also affect biological product innovation and market entry of biosimilars. Accordingly, FDA seeks comment on the potential application of “umbrella exclusivity” under section 351(k)(7). If umbrella exclusivity were to apply in this context, a biological product that would not be eligible for a new period of exclusivity under section 351(k)(7)(C) would nevertheless be protected for the duration of the exclusivity period for a previously approved reference product. See, for example, 54 FR 28872 at 28897 (July 10, 1989) for an explanation of how umbrella exclusivity functions under the Hatch-Waxman scheme, a related and potentially instructive context (available at: https://cdn.loc.gov/service/ll/fedreg/fr054/fr054130/fr054130.pdf). Thus, umbrella exclusivity could help shield certain biological products that would otherwise not be eligible for their own period of exclusivity under section 351(k)(7)(C) from biosimilar competition. What considerations support recognition of umbrella exclusivity under section 351(k)(7), and what considerations disfavor recognizing umbrella exclusivity? How would umbrella exclusivity promote biological product innovation, and what effect would it have on market entry of biosimilars? What is the relevance and significance, if any, of the patent scheme in considering this issue?

9. What other challenges have the potential to disrupt the balance between innovation and competition in the biological product marketplace and how can FDA or other stakeholders address these challenges?

Registration and Requests for Oral Presentations: The FDA Conference Center at the White Oak location is a Federal facility with security procedures and limited seating. Attendance will be free and on a first-come, first-served basis. If you wish to attend (either in person or by webcast (see Streaming Webcast of the Public Hearing)) and/or present at the hearing, please register for the hearing and, if appropriate, request an oral presentation or participation in the open public hearing by sending an email to [email protected] by Tuesday, August 14, 2018. Requests for participation in the open public hearing are accepted until 9 a.m. on Tuesday September 4, 2018, and will be accepted as long as time allows. The email should contain complete contact information for each attendee (name, title, degree(s), affiliation, address, email address, and telephone number). For those wishing to present at the hearing, the email should also include a presentation title. Those without email access can register by contacting Allison Hoffman at 301-796-9203 by Tuesday, August 14, 2018 (see FOR FURTHER INFORMATION CONTACT). An agenda for the hearing and any other background materials will be made available 5 days before the hearing at https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/UCM610692.htm.

FDA will try to accommodate all persons who wish to make a presentation. Individuals wishing to present should identify the number of the specific question, or questions, they wish to address. This will help FDA organize the presentations. Individuals and organizations with common interests should consolidate or coordinate their presentations and request time for a joint presentation. FDA will notify registered presenters of their scheduled presentation times. The time allotted for each presenter will depend on the number of individuals who wish to speak. Presenters are encouraged to submit an electronic copy of their presentation (PowerPoint or PDF) to [email protected] on or before Thursday, August 16, 2018. Those who are not giving electronic presentations are encouraged to submit a single slide (PowerPoint or PDF) with their name, affiliation, and topic. Persons registered to make either an oral presentation or participate as part of the open public hearing are encouraged to arrive at the hearing room early and check in at the onsite registration table to confirm their designated presentation time. An agenda for the hearing and any other background materials will be made available 5 days before the hearing at https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm580561.htm.

If you need special accommodations because of a disability, please contact [email protected] (see FOR FURTHER INFORMATION CONTACT) no later than Friday, August 17, 2018, at 12 noon Eastern Time.

Streaming Webcast of the Public Hearing: For those unable to attend in person, FDA will provide a live webcast of the hearing. To join the hearing via the webcast, please go to https://collaboration.fda.gov/biosimilarspart15.

Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES).

The Commissioner of Food and Drugs is announcing that the public hearing will be held in accordance with part 15 (21 CFR part 15). The hearing will be conducted by a presiding officer, who will be accompanied by FDA senior management from the Office of the Commissioner, the Center for Drug Evaluation and Research, and the Center for Biologics Evaluation and Research. Under § 15.30(f) (21 CFR 15.30(f)), the hearing is informal and the rules of evidence do not apply. No participant may interrupt the presentation of another participant. Only the presiding officer and panel members can pose questions; they can question any person during or at the conclusion of each presentation. Public hearings under part 15 are subject to FDA's policy and procedures for electronic media coverage of FDA's public administrative proceedings (21 CFR part 10, subpart C). Under 21 CFR 10.205, representatives of the media may be permitted, subject to certain limitations, to videotape, film, or otherwise record FDA's public administrative proceedings, including presentations by participants. The hearing will be transcribed as stipulated in § 15.30(b) (see Transcripts). To the extent that the conditions for the hearing, as described in this notification, conflict with any provisions set out in part 15, this notification acts as a waiver of those provisions as specified in § 15.30(h).

I. Stakeholder Meetings

MSHA will hold six public stakeholder meetings and one webinar on the Agency's Request for Information (RFI) addressing Safety Improvement Technologies for Mobile Equipment at Surface Mines, and for Belt Conveyors at Surface and Underground Mines. The meetings will be conducted in an informal manner. Presenters and attendees may provide written information to the court reporter for inclusion in the record. MSHA will make transcripts of the meetings available at http://www.regulations.gov and on MSHA's website at: https://arlweb.msha.gov/currentcomments.asp.

Interested parties may attend these stakeholder meetings either in-person or by participating by webinar (See table below).

1. To attend the stakeholder meeting in Arlington, Virginia:

• Address—201 12th Street South, Arlington, Virginia 22202.

• When you enter the building, take the East elevators to your right, up to the 4th Floor reception area, 4E401, to check in. You will then be escorted to the conference room.

• Nearest metro stations: Pentagon City, and Crystal City. Parking is available on the street and in the building.

2. To participate at the Webinar by Phone or WebEx:

By Phone—

• Dial the toll-free conference number (Verizon): 1-866-718-1874.

• Attendee access code: 242 716 6.

By WebEx—

• To log into the Webinar, go to: https://dol.webex.com.

• Enter Meeting number: 642 399 450.

• Meeting password: M!ne2018.

On June 26, 2018, (83 FR 29716), MSHA published an RFI on Safety Improvement Technologies for Mobile Equipment at Surface Mines, and for Belt Conveyors at Surface and Underground Mines. MSHA is soliciting stakeholder comments, data and information on technologies that can reduce accidents involving mobile equipment at surface mines and belt conveyors at surface and underground mines. Specifically, the Agency is requesting information from the mining community regarding the types of engineering controls available, how to implement such engineering controls, and how these controls could be used in mobile equipment and belt conveyors to reduce accidents, fatalities and injuries. MSHA is also seeking suggestions from stakeholders on best practices, training materials, policies and procedures, innovative technologies, and any other information that stakeholders may have available to improve safety in and around mobile equipment, and working near and around belt conveyors. The meetings will provide the mining community an opportunity to discuss and share information about the issues raised in the RFI. Comments must be received or postmarked by midnight Eastern Standard Time on December 24, 2018.

Background

The Endangered Species Act of 1973, as amended (“ESA” or “Act”; 16 U.S.C. 1531 et seq.), states that the purposes of the Act are to provide a means to conserve the ecosystems upon which listed species depend, to develop a program for the conservation of listed species, and to achieve the purposes of certain treaties and conventions. Moreover, the Act states that it is the policy of Congress that the Federal Government will seek to conserve threatened and endangered species and use its authorities to further the purposes of the Act. This proposed rulemaking action pertains primarily to sections 4 and 9 of the Act: Section 9 sets forth prohibitions for activities pertaining to species listed under the Act, and section 4(d) pertains to protective regulations for threatened species.

This proposed rule is one of three related proposed rules that are publishing in today's Federal Register. All of these documents propose revisions to various regulations that implement the ESA.

In carrying out Executive Order 13777, “Enforcing the Regulatory Reform Agenda,” the Department of the Interior (DOI) published a document with the title “Regulatory Reform” in the Federal Register of June 22, 2017 (82 FR 28429). The document requested public comment on how DOI can improve implementation of regulatory reform initiatives and policies and identify regulations for repeal, replacement, or modification. This proposed rule and the two related proposed rules in today's Federal Register address some of the comments that DOI has received in response to the regulatory reform docket.

The regulations that implement the ESA are located in title 50 of the Code of Federal Regulations. This proposed rule would revise regulations found in part 17 of title 50, particularly in subpart D, which pertains to threatened wildlife, and subpart G, which pertains to threatened plants.

We propose to amend §§ 17.31 and 17.71, along with conforming amendments to other sections of title 50. Among other changes, the proposal would add language in both sections to paragraph (a) to specify that its provisions apply only to species listed as threatened species on or before the effective date of this rule. Species listed or reclassified as a threatened species after the effective date of this rule, if finalized, would have protective regulations only if the Service promulgates a species-specific rule (also referred to as a special rule). In those cases, we intend to finalize the species-specific rule concurrent with the final listing or reclassification determination. Notwithstanding our intention, we have discretion to revise or promulgate species-specific rules at any time after the final listing or reclassification determination. However, we specifically request comments on our stated intention of finalizing species-specific rules concurrent with final listing rules, including whether we should include any binding requirement in the regulatory text to do so, such as setting a timeframe for finalizing species-specific rules after a final listing or reclassification determination.

This change would make our regulatory approach for threatened species parallel with the approach that the National Marine Fisheries Service (NMFS) has taken since Congress added section 4(d) to the Act, as discussed below. The protective regulations that currently apply to threatened species would not change, unless the Service adopts a species-specific rule in the future. As of the date of this proposal, there are species-specific protective regulations for threatened wildlife in subpart D of part 17, but the Service has not adopted any species-specific protective regulations for plants. The proposed regulations would not affect the consultation obligations of Federal agencies pursuant to section 7 of the Act. The proposed regulations would not change permitting pursuant to 50 CFR 17.32.

The prohibitions set forth in ESA Section 9 expressly apply only to species listed as endangered under the Act, as opposed to threatened. 16 U.S.C. 1538(a). ESA Section 4(d), however, provides that the Secretaries may by regulation extend some or all of the Section 9 prohibitions to any species listed as threatened. Id. § 1533(d). 16 U.S.C. 1533(d). See, also S. Rep. 93-307 (July 1, 1973) (in amending the ESA to include the protection of threatened species and creating “two levels of protection” for endangered species and threatened species, “regulatory mechanisms may more easily be tailored to the needs of the” species). Our existing regulations in §§ 17.31 and 17.71, extending most of the prohibitions for endangered species to threatened species unless altered by a specific regulation, is one reasonable approach to exercising the discretion granted to the Service by section 4(d) of the Act. See Sweet Home Chapter of Communities for a Great Or. v. Babbitt, 1 F.3d 1, 7 (D.C. Cir. 1993) (“regardless of the ESA's overall design, § 1533(d) arguably grants the FWS the discretion to extend the maximum protection to all threatened species at once, if guided by its expertise in the field of wildlife protection, it finds it expeditious to do so”), altered on other grounds in rehearing, 17 F.3d 1463 (D.C. Cir. 1994).

Another reasonable approach is the one that the Department of Commerce, through NMFS, has taken in regard to the species under its purview. NMFS did not adopt regulations that extended most of the prohibitions for endangered species to threatened species as we did. Rather, for each species that they list as threatened, NMFS promulgates the appropriate regulations to put in place prohibitions, protections, or restrictions tailored specifically to that species. In more than 40 years of implementing the Act, NMFS has successfully implemented the provisions of the Act using this approach.

Moreover, we have gained considerable experience in developing species-specific rules over the years. Where we have developed species-specific 4(d) rules, we have seen many benefits, including removing redundant permitting requirements, facilitating implementation of beneficial conservation actions, and making better use of our limited personnel and fiscal resources by focusing prohibitions on the stressors contributing to the threatened status of the species. This revision allows us to capitalize on these benefits in tailoring the regulations to the conservation needs of the species.

For example, we finalized a species-specific 4(d) rule for the coastal California gnatcatcher (Polioptila californica californica) on December 10, 1993 (58 FR 65088). In that 4(d) rule, we determined that activities that met the requirements of the State of California's Natural Communities Conservation Plan for the protection of coastal sage scrub habitat would not constitute violations of section 9 of the Act. Similarly, in 2016, we finalized the listing of the Kentucky arrow darter (Etheostoma spilotum) with a species-specific 4(d) rule that exempts take as a result of beneficial in-stream habitat enhancement projects, bridge and culvert replacement, and maintenance of stream crossings on lands managed by the U.S. Forest Service in habitats occupied by the species (81 FR 68963, October 5, 2016). As with both of these examples, if the proposed rule is finalized, we would continue our practice of explaining in the preamble the rationale for the species-specific prohibitions included in each 4(d) rule.

Upon reviewing the approach NMFS has taken and in light of the benefits we have noted in developing species-specific rules, we now conclude these proposed changes will align our practices with those of NMFS regarding threatened species under Department of Commerce purview, but also that they will better tailor protections to the needs of the threatened species while still providing meaning to the statutory distinction between “endangered species” and “threatened species.”

The proposed regulations would remove the references to subpart A in § 17.31 and § 17.71. In § 17.31, we propose to specify which sections apply to wildlife, to be more transparent as to which provisions contain exceptions to the prohibitions. In § 17.71, we propose to remove all reference to subpart A, because none of those exceptions apply to plants.

In proposing the specific changes to the regulations that follow, and setting out the accompanying clarifying discussion in this preamble, the Service is establishing prospective standards only. Nothing in these proposed revised regulations is intended to require (now or at such time as these regulations may become final) that any previous listing, delisting, or reclassification determinations or species-specific protective regulations be reevaluated on the basis of any final regulations. The existing protections for currently-listed threatened species are within the discretion expressly delegated to the Secretary by Congress.

Pursuant to section 10(j) of the Act, members of experimental populations are generally treated as threatened species and, pursuant to 50 CFR 17.81, populations are designated through population-specific regulation found in §§ 17.84-17.86. As under our existing practice, each such population-specific regulation will contain all of the applicable prohibitions, along with any exceptions to prohibitions, for that experimental population. None of the changes associated with this rulemaking will change existing special rules for experimental populations. Any 10(j) special rules promulgated after the effective date of this rule which make applicable to a non-essential experimental population some or all of the prohibitions that statutorily apply to endangered species will not refer to 50 CFR 17.31(a); rather, they will instead independently articulate those prohibitions or refer to 50 CFR 17.21.

Any final rule based on this proposal will consider information and recommendations timely submitted from all interested parties. We solicit comments, information, and recommendations from governmental agencies, Native American tribes, the scientific community, industry groups, environmental interest groups, and any other interested parties on this proposed rule. All comments and materials received by the date listed in DATES, above, will be considered prior to the approval of a final rule.

You may submit your information concerning this proposed rule by one of the methods listed in ADDRESSES. If you submit information via http://www.regulations.gov, your entire submission—including any personal identifying information—will be posted on the website. If your submission is made via a hardcopy that includes personal identifying information, you may request at the top of your document that we withhold this personal identifying information from public review. However, we cannot guarantee that we will be able to do so. We will post all hardcopy submissions on http://www.regulations.gov.

Information and supporting documentation that we receive in response to this proposed rule will be available for you to review at http://www.regulations.gov in Docket No. FWS-HQ-ES-2018-0007.

Executive Order 12866 provides that the Office of Management and Budget's Office of Information and Regulatory Affairs (OIRA) will review all significant rules. OIRA 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. This proposed rule is consistent with Executive Order 13563, and in particular with the requirement of retrospective analysis of existing rules, designed “to make the agency's regulatory program more effective or less burdensome in achieving the regulatory objectives.”

This proposed rule is expected to be an Executive Order 13771 deregulatory action.

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 (i.e., small businesses, small organizations, and small government jurisdictions). However, no regulatory flexibility analysis is required if the head of an agency, or his 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 certify that, if adopted as proposed, this proposed rule would not have a significant economic effect on a substantial number of small entities. The following discussion explains our rationale.

This rulemaking revises the regulations for 4(d) rules for species determined to meet the definition of a “threatened species” under the Act. The changes in this proposed rule are instructive regulations and do not affect small entities.

The Service is the only entity that is directly affected by this proposed regulation change at 50 CFR part 17 because we are the only entity that is affected by changes to this section of the Code of Federal Regulations. No external entities, including any small businesses, small organizations, or small governments, will experience any economic impacts from this rule. Consequently, this proposed rulemaking action is not a major rule under SBREFA.

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

(a) On the basis of information contained in the Regulatory Flexibility Act section above, this proposed rule would not “significantly or uniquely” affect small governments. We have determined and certify pursuant to the Unfunded Mandates Reform Act, 2 U.S.C. 1502, that this rule would 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 proposed rule would not place additional requirements on any city, county, or other local municipalities.

(b) This proposed rule would not produce a Federal mandate on State, local, or tribal governments or the private sector of $100 million or greater in any year; that is, this proposed rule is not a “significant regulatory action” under the Unfunded Mandates Reform Act. This proposed rule would impose no obligations on State, local, or tribal governments.

In accordance with Executive Order 12630, this proposed rule would not have significant takings implications. This proposed rule would not pertain to “taking” of private property interests, nor would it directly affect private property. A takings implication assessment is not required because this proposed rule (1) would not effectively compel a property owner to suffer a physical invasion of property and (2) would not deny all economically beneficial or productive use of the land or aquatic resources. This proposed rule would substantially advance a legitimate government interest (conservation and recovery of endangered and threatened species) and would not present a barrier to all reasonable and expected beneficial use of private property.

In accordance with Executive Order 13132, we have considered whether this proposed rule would have significant Federalism effects and have determined that a federalism summary impact statement is not required. This proposed rule pertains only to prohibitions for activities pertaining to threatened species under the Endangered Species Act and 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.

This proposed rule does not unduly burden the judicial system and meets the applicable standards provided in sections 3(a) and 3(b)(2) of Executive Order 12988. This proposed rule would clarify the prohibitions to threatened species under the Endangered Species Act.

In accordance with the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951), Executive Order 13175, and the Department of the Interior's manual at 512 DM 2, we readily acknowledge our responsibility to communicate meaningfully with recognized Federal Tribes on a government-to-government basis.

This rule does not contain information collection requirements, and a submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) is not required. We may not conduct or sponsor and you are not required to respond to a collection of information unless it displays a currently valid OMB control number.

We are analyzing this proposed regulation in accordance with the criteria of the National Environmental Policy Act (NEPA), the Department of the Interior regulations on Implementation of the National Environmental Policy Act (43 CFR 46.10-46.450), and the Department of the Interior Manual (516 DM 8).

We anticipate that the categorical exclusion found at 43 CFR 46.210(i) likely applies to these proposed regulation changes. At 43 CFR 46.210(i), the Department of the Interior has found that the following category of actions would not individually or cumulatively have a significant effect on the human environment and are, therefore, categorically excluded from the requirement for completion of an environmental assessment or environmental impact statement: “Policies, directives, regulations, and guidelines: that are of an administrative, financial, legal, technical, or procedural nature.”

We invite the public to comment on the extent to which this proposed regulation may have a significant impact on the human environment, or fall within one of the categorical exclusions for actions that have no individual or cumulative effect on the quality of the human environment. We will complete our analysis, in compliance with NEPA, before finalizing this proposed rule.

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

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

(1) Be logically organized;

(2) Use the active voice to address readers directly;

(3) Use clear language rather than jargon;

(4) Be divided into short sections and sentences; and

(5) Use lists and tables wherever possible.

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

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

The purposes of the Endangered Species Act of 1973, as amended (“ESA” or “Act”; 16 U.S.C. 1531 et seq.) are to provide a means to conserve the ecosystems upon which listed species depend, to develop a program for the conservation of listed species, and to achieve the purposes of certain treaties and conventions. Moreover, the Act states that it is the policy of Congress that the Federal Government will seek to conserve threatened and endangered species, and use its authorities in furtherance of the purposes of the Act.

The Secretaries of the Interior and Commerce share responsibilities for implementing most of the provisions of the Act. Generally, marine species are under the jurisdiction of the Secretary of Commerce, and all other species are under the jurisdiction of the Secretary of the Interior. Authority to administer the Act has been delegated by the Secretary of the Interior to the Director of the U.S. Fish and Wildlife Service (FWS) and by the Secretary of Commerce to the Assistant Administrator for the National Marine Fisheries Service (NMFS). References in this document to “the Services” mean FWS and NMFS.

There have been no comprehensive amendments to the Act since 1988, and no comprehensive revisions to the implementing regulations since 1986. In the years since those changes took place, much has happened: The Services have gained considerable experience in implementing the Act, as have other Federal agencies, States, and property owners; there have been numerous court decisions regarding almost every provision of the Act and its implementing regulations; the Government Accountability Office has completed reviews of the Act's implementation; there have been many scientific reviews, including review by the National Research Council; multiple administrations have adopted various policy initiatives; and non-governmental entities have issued reports and recommendations.

Title 50, part 402, of the Code of Federal Regulations establishes the procedural regulations governing interagency cooperation under section 7 of the Act, which requires Federal agencies, in consultation with and with the assistance of the Secretaries of the Interior and Commerce (the “Secretaries”), to insure that any action authorized, funded, or carried out by such agencies is not likely to jeopardize the continued existence of endangered or threatened species or result in the destruction or adverse modification of critical habitat of such species. These proposed regulatory amendments are intended to address the Services' collective experience of more than 40 years implementing the Act and several court decisions.

In carrying out Executive Order 13777, “Enforcing the Regulatory Reform Agenda,” the Department of the Interior (DOI) published a document with the title “Regulatory Reform” in the Federal Register of June 22, 2017 (82 FR 28429). The document requested public comment on how DOI can improve implementation of regulatory reform initiatives and policies and identify regulations for repeal, replacement, or modification. This proposed rule addresses some of the comments that DOI has received in response to the regulatory reform docket.

As part of implementing E.O. 13777, NOAA published a notice entitled, “Streamlining Regulatory Processes and Reducing Regulatory Burden” (82 FR 31576, July 7, 2017). The notice requested public comments on how NOAA could continue to improve the efficiency and effectiveness of current regulations and regulatory processes. This proposed rule addresses some of the comments NOAA received from the public.

This proposed rule is one of three related proposed rules that are publishing in today's Federal Register. All of these documents propose revisions to various regulations that implement the Act. Beyond the specific revisions to the regulations highlighted in this proposed rule, the Services are comprehensively reconsidering the processes and interpretations of statutory language set out in part 402. Thus, this rulemaking should be considered as applying to all of part 402, and as part of the rulemaking initiated today, the Services will consider whether additional modifications to the interagency cooperation regulations would improve, clarify, or streamline the administration of the Act. We seek public comments recommending, opposing, or providing feedback on specific changes to any provisions in part 402 of the regulations, including but not limited to revising or adopting as regulations existing practices or policies, or interpreting terms or phrases from the Act. Based on comments received and on our experience in administering the Act, the final rule may include revisions to any provisions in part 402 that are a logical outgrowth of this proposed rule, consistent with the Administrative Procedure Act.

In proposing the specific changes to the regulations in this rule, and setting out the accompanying clarifying discussion in this preamble, the Services are proposing prospective standards only. Nothing in these proposed revisions to the regulations is intended to require that any previous consultations under section 7(a)(2) of the Act be reevaluated on the basis of the final rule at such time that the final rule becomes effective.

The Services anticipate that the proposed changes, if finalized, will improve and clarify interagency consultation, and make it more efficient and consistent, without compromising conservation of listed species. Many of the changes should help reduce the costs of consultation. For example, clarifying the definition of “effects of the action” should decrease consultation timeframes (and costs) by eliminating confusion regarding application of terms in the existing definition, which has resulted in time being spent determining how to categorize an effect, rather than simply determining what the effects are regardless of category. As another example, codifying alternative consultation methods and the ability to adopt portions of Federal agencies' documents should reduce overall consultation times and costs. Increased use of programmatic consultations will reduce the number of single, project-by-project consultations, streamline the consultation process, and increase predictability and consistency for action agencies. Eliminating the need to reinitiate consultation in certain situations will avoid impractical and disruptive burdens (and costs), without compromising conservation of listed species. We seek comment on (1) the extent to which the changes outlined in this proposed rule will affect timeframes and resources needed to conduct consultation and (2) anticipated cost savings resulting from the changes.

While not reflected in any proposed changes to our regulations at this time, we also seek comment on the merit, authority, and means for the Services to conduct a single consultation, resulting in a single biological opinion, for Federal agency actions affecting species that are under the jurisdiction of both FWS and NMFS.

This section sets out definitions of terms that are used throughout these proposed regulations. Some of these terms are further discussed as they pertain to the consultation procedures in appropriate, subsequent sections. Below we discuss those definitions that would be revised or added by these proposed regulations.

We propose to revise the definition of “destruction or adverse modification” by adding the phrase “as a whole” to the first sentence and removing the second sentence of the current definition. The Act requires Federal agencies, in consultation with and with the assistance of the Secretaries, to insure that their actions are not likely to jeopardize the continued existence of endangered or threatened species or result in the destruction or adverse modification of critical habitat of such species. In 1986, the Services established a definition for “destruction or adverse modification” (§ 402.02) that was found to be invalid by the U.S. Court of Appeals for the Fifth (2001) and Ninth (2004) Circuits. In 2016, we revised the definition, in part in response to these court rulings. We now propose to further clarify the definition, removing language that is redundant and has caused confusion about the meaning of the regulation.

In 1978, the Services promulgated regulations governing interagency cooperation under section 7 of the Act. (50 CFR part 402) (43 FR 870; Jan. 4, 1978). These regulations provided a definition for “destruction or adverse modification” of critical habitat, which was later updated in 1986 to conform with amendments made to the Act. The 1986 regulations defined “destruction or adverse modification” as: “a direct or indirect alteration that appreciably diminishes the value of critical habitat for both the survival and recovery of a listed species. Such alterations include, but are not limited to, alterations adversely modifying any of those physical or biological features that were the basis for determining the habitat to be critical.” (50 CFR 402.02) (51 FR 19926; June 3, 1986). The preamble to the 1986 regulation contained relatively little discussion on the concept of “destruction or adverse modification of critical habitat.”

In 2001, the Fifth Circuit Court of Appeals reviewed the 1986 regulatory definition of destruction or adverse modification and found it exceeded the Service's discretion. Sierra Club v. U.S. Fish and Wildlife Service, 245 F.3d 434 (5th Cir. 2001). Specifically, the court found the regulatory definition to be invalid on its face and inconsistent with the Act. The court reasoned that the regulatory definition set too high a threshold for triggering adverse modification by its requirement that the value of critical habitat for both survival and recovery be appreciably diminished before adverse modification would be the appropriate conclusion. The court determined that the regulatory definition actually established a standard that would only trigger an adverse modification determination if the “survival” of the species was appreciably diminished, while ignoring the role critical habitat plays in the recovery of species. Citing legislative history and the Act itself, the court was persuaded that Congress intended the Act to “enable listed species not merely to survive, but to recover from their endangered or threatened status.” Sierra Club, 245 F.3d at 438. Noting the Act defines critical habitat as areas that are “essential to the conservation” of listed species, the court determined that “conservation” is a “much broader concept than mere survival.” Sierra Club, 245 F.3d at 441. The court concluded that the Act's definition of conservation “speaks to the recovery” of listed species.

In 2004, the Ninth Circuit Court of Appeals also reviewed the 1986 regulatory definition of destruction or adverse modification. Gifford Pinchot Task Force v. U.S. Fish and Wildlife Service, 378 F.3d 1059 (9th Cir. 2004). That court agreed with the Fifth Circuit's determination that the regulation was facially invalid. The Ninth Circuit, following similar reasoning set out in Sierra Club, determined that Congress viewed conservation and survival as “distinct, though complementary, goals and the requirement to preserve critical habitat is designed to promote both conservation and survival.” Specifically, the court found that “the purpose of establishing `critical habitat' is for the government to [designate habitat] that is not only necessary for the species' survival but also essential for the species' recovery.” Gifford Pinchot Task Force, 378 F.3d at 1070.

After the Ninth Circuit's decision, the Services each issued guidance to discontinue the use of the 1986 adverse modification regulation (FWS Acting Director Marshall Jones Memorandum to Regional Directors, “Application of the `Destruction or Adverse Modification' Standard under Section 7(a)(2) of the Endangered Species Act 2004” (FWS 2004); NMFS Assistant Administrator William T. Hogarth Memorandum to Regional Administrators, “Application of the `Destruction or Adverse Modification' Standard under Section 7(a)(2) of the Endangered Species Act, 2005” (NMFS 2005)). Specifically, in evaluating a proposed action's effects on critical habitat as part of interagency consultation, the Services began applying the definition of “conservation” as set out in the Act, which defines conservation (and conserve and conserving) to mean “to use and the use of all methods and procedures which are necessary to bring any endangered species or threatened species to the point at which the measures provided pursuant to this [Act] are no longer necessary.” (16 U.S.C. 1532(3)) (i.e., the species is recovered). See 50 CFR 424.02. Accordingly, after examining the status of critical habitat, the environmental baseline, and the effects of the proposed action, the Services began analyzing whether the implementation of the proposed action, together with any cumulative effects, would result in the critical habitat remaining “functional (or retain the current ability for the primary constituent elements to be functionally established) to serve the intended conservation role for the species.” See FWS 2004; NMFS 2005.

In 2016, we promulgated regulations to revise the regulatory definition of “destruction or adverse modification.” We adopted the following definition: “Destruction or adverse modification means a direct or indirect alteration that appreciably diminishes the value of critical habitat for the conservation of a listed species. Such alterations may include, but are not limited to, those that alter the physical or biological features essential to the conservation of a species or that preclude or significantly delay development of such features.” (81 FR 7214, February 11, 2016).

We explained in the 2016 rule that we did not intend for it to alter the section 7(a)(2) consultation process from existing practice and noted that previously completed biological opinions did not need to be reevaluated in light of that rule. The 2016 definition, particularly the first sentence, sought to clarify and preserve the existing distinction between the definitions of “destruction or adverse modification” and “jeopardize the continued existence of” by focusing the analysis for “destruction or adverse modification” on how the effects of a proposed action affect the value of critical habitat as a whole for the conservation of threatened or endangered species. The focus of the “jeopardize the continued existence of” definition, on the other hand, is whether a proposed action appreciably reduces the likelihood of survival and recovery by reducing a species' reproduction, numbers, and distribution.

The 2016 final rule's definition reflected several changes from what the Services proposed in 2014. The changes to the first sentence were relatively minor. In the 2014 proposed rule, the first sentence read: “`Destruction or adverse modification' means a direct or indirect alteration that appreciably diminishes the conservation value of critical habitat for listed species.” (79 FR 27060, 27066; May 12, 2014). In the final rule, we made a minor clarification of the first sentence, by changing “conservation value of critical habitat for listed species” to “the value of critical habitat for the conservation of a listed species.” (81 FR at 7226, February 11, 2016).

Many commenters of the 2014 proposed rule expressed confusion or concern regarding the scale at which the determination of destruction or adverse modification of critical habitat is made. Some of these commenters thought that the language, “critical habitat, as a whole,” should be included in the definition and not just the preamble. While the Services declined to include the phrase “as a whole” in the 2016 final definition, we explained in the preamble that we make our determination on the value of the critical habitat and its role in the conservation of the species, and that the existing consultation process already ensures that the determination is made at the appropriate scale. We also explained that, while an action may result in adverse effects to critical habitat within the action area, those effects may not necessarily rise to the level of destruction or adverse modification to the designated critical habitat. In adding the phrase “as a whole” to the proposed revised definition, we intend to clearly indicate that the final destruction or adverse modification determination is made at the scale of the entire critical habitat designation. Smaller scales can be very important analysis tools in determining how the impacts may translate to the entire designated critical habitat, but the final determination is not made at the action area, critical habitat unit, or other less extensive scale.

The analysis thus places an emphasis on the value of the designated critical habitat as a whole for the conservation of a species, in light of the role the action area serves with regard to the function of the overall designation. Just as the determination of jeopardy under section 7(a)(2) of the Act is made at the scale of the entire listed entity, a determination of destruction or adverse modification is made at the scale of the entire critical habitat designation. Even if a particular project would cause adverse effects to a portion of critical habitat, the Services must place those impacts in context of the designation to determine if the overall value of the critical habitat is likely to be reduced. This could occur where, for example, a smaller affected area of habitat is particularly important in its ability to support the conservation of a species (e.g., a primary breeding site). Thus, the size or proportion of the affected area is not determinative; impacts to a smaller area may in some cases result in a determination of destruction or adverse modification, while impacts to a large geographic area will not always result in such a finding. Therefore, we are proposing to revise the first sentence of the definition by adding the phrase “as a whole” to clarify the appropriate scale of the destruction or adverse modification determination.

The second sentence proved more controversial. As proposed, the second sentence of the definition read: “Such alterations may include, but are not limited to, effects that preclude or significantly delay the development of the physical or biological features that support the life-history needs of the species for recovery.” (79 FR at 27066, May 12, 2014). Many commenters argued that the proposed second sentence established a significant change in practice by appearing to focus the definition on the preclusion or delay of the development of physical or biological features, to the exclusion of the alteration of existing features. A number of commenters believed these concepts were vague, undefined, and allowed for arbitrary determinations. One commenter asserted that focusing on effects that preclude or significantly delay development of features was an expansion of authority that conflicted with E.O. 13604 (Improving Performance of Federal Permitting and Review of Infrastructure Projects).

In an attempt to clarify our intent, in finalizing the rule, we revised the proposed second sentence to add reference to alterations affecting the physical or biological features essential to the conservation of a species, as well as those that preclude or significantly delay development of such features: “Such alterations may include, but are not limited to, those that alter the physical or biological features essential to the conservation of a species or that preclude or significantly delay development of such features.” (81 FR at 7226, February 11, 2016).

The intended purpose of the language about precluding or delaying “development of such features” was to acknowledge “that some important physical or biological features may not be present or are present in a sub-optimal quantity or quality. This could occur where, for example, the habitat has been degraded by human activity or is part of an ecosystem adapted to a particular natural disturbance (e.g., fire or flooding), which does not constantly occur but is likely to recur.” (79 FR at 27061, May 12, 2014). Our intent was for such determinations not to be based upon speculation.

However, the second sentence of the definition in the 2016 final rule has continued to cause controversy among the public and many stakeholders.

In this proposed rule, we seek to streamline and simplify the definition of “destruction or adverse modification” by removing the second sentence because the second sentence is unnecessary and has caused confusion. The second sentence of the definition attempted to elaborate upon meanings that are included within the first sentence, without attempting to exhaust them (hence, the use of the phrase “may include, but are not limited to”). In all cases, the analysis of destruction or adverse modification must address whether the proposed action will result in an “alteration that appreciably diminishes the value of critical habitat as a whole for the conservation of a listed species.”

As with the 2016 rule, we do not intend our proposed change to alter existing section 7(a)(2) consultation practice. The bar for whether a proposed action is likely to result in destruction or adverse modification of critical habitat is neither raised nor lowered by this proposed rule, nor is the scope of analysis altered with respect to evaluating the effects of a proposed action on critical habitat. This proposed definition retains the key, operative first sentence of the 2016 regulation while adding the clarifying additional phrase of “as a whole” (as discussed above). Further guidance on how to apply the language in that sentence can be found in the 2016 rule.

It is not necessary, nor possible, for a concise regulatory definition to list every way in which alterations may affect the value of critical habitat for the conservation of a species. The value of critical habitat for the conservation of a listed species is described primarily through the critical habitat designation itself. That designation, in accordance with the Act, will identify, in occupied habitat, “the specific areas within the geographical area occupied by the species . . . on which are found those physical or biological features (I) essential to the conservation of the species and (II) which may require special management considerations or protection.” (16 U.S.C. 1532(5)(a)(i)). Accordingly, the Act already makes clear that, in occupied habitat, the value of critical habitat for the conservation of the species is directly associated with designated physical or biological features. Thus, destruction or adverse modification determinations may be based on alterations that affect such features, without needing to specify that fact in the regulatory definition. The Act and regulations also already state that unoccupied areas may be designated to the extent the Service determines they are “essential for the conservation of the species.” (16 U.S.C. 1532(5)(a)(ii)). Determining whether alterations in unoccupied critical habitat may constitute destruction or adverse modification will therefore need to consider the reasons for which the Service determined that such unoccupied habitat is “essential to the conservation of the species.”

The Services have not changed their underlying view that it may be necessary and consistent with the Act in some circumstances for the destruction and adverse modification analysis to consider how alterations to critical habitat could affect the ability of the habitat to develop or support features essential to the conservation of the species. For example, in some circumstances, recovery of the species may depend upon retaining the ability of a designated area to maintain or re-create the essential features, for instance through ecological succession, fluvial processes, active management, or other dynamic processes. This is a longstanding interpretation and agency practice, as reflected in the 2016 rule and in the 2004 and 2005 FWS and NMFS guidance documents regarding application of the destruction or adverse modification standard. This longstanding interpretation has never been meant to assert authority beyond that provided by the Act, nor to allow the Services to designate critical habitat or make adverse modification findings based merely on speculation or desire about future changes to the critical habitat. As required by the Act, such determinations must rely on the best scientific and commercial data available. (16 U.S.C. 1536(a)(2)).

In the proposed definition, “appreciably diminish” remains a key concept. This phrase has been part of the regulatory definition of “destruction or adverse modification” since 1978, and neither it nor its interpretation would be altered by this proposed rule. As we noted in the 2016 rule, with respect to “diminish,” the inquiry begins with whether the relevant effects will reduce, lessen, or weaken the value of the critical habitat for the conservation of the species. If so, then the inquiry is whether that reduction or diminishment will be “appreciable” to the value of the critical habitat for the conservation of the species.

As we also noted in 2016, the determination of “appreciably diminish” is made based upon the proposed action's effect on the value of the entire critical habitat to the conservation of the species. That is, the question is whether the “effects of the action” will appreciably diminish the value of the critical habitat as a whole to the conservation of the species, not just in the area where the proposed action takes place. In this respect, “appreciably diminish” is analogous to “appreciably reduce” in the context of determining whether an action will “jeopardize the continued existence” of a species, since that inquiry is similarly not merely addressing the effects within the action area, but rather is concerned with whether the effects “appreciably reduce” the likelihood of survival and recovery of the listed entity, the species.

The 2016 rule discussed the reasons we concluded, and here continue to conclude, that the phrase “appreciably diminish” does not need to be modified. As we noted in 2016, the Services' joint Consultation Handbook (FWS and NMFS, March 1998) uses the word “considerably” to interpret this phrase. In the 2016 rule, we clarified that the phrase “appreciably diminish,” like the Consultation Handbook's term “considerably,” means “ `worthy of consideration' and is another way of stating that we can recognize or grasp the quality, significance, magnitude, or worth of the reduction in the value of critical habitat.” (81 FR 7218, February 11, 2016).

We also explained in 2016 that it is not correct to conclude that every diminishment, however small, should constitute destruction or adverse modification. It was necessary to qualify the word “diminish” to exclude those adverse effects on critical habitat that are so minor in nature that they do not appreciably impact the value of designated critical habitat to the conservation of a listed species.

We also note that the word “appreciably” is used in both the Services' definition of “jeopardize the continued existence of” (“appreciably reduce”) and “destruction or adverse modification” (“appreciably diminish”). The meaning of the word “appreciably” is similar in either context. In both contexts, it is appropriate for the Services to consider the biological significance of effects when conducting a section 7(a)(2) consultation. As required by the ESA, we conduct formal consultation, and evaluate in detail the potential for destruction or adverse modification of critical habitat (and/or whether a proposed action is likely to jeopardize the continued existence of a species) whenever there are likely to be adverse effects to critical habitat or a listed species. In each of these analyses, we must evaluate, based on the totality of the circumstances and the best available scientific information, the nature and magnitude of the proposed action's effects, to determine whether such effects of the proposed action are consequential enough to rise to the level of “appreciably diminish” or “appreciably reduce.” See, e.g., Oceana, Inc. v. Pritzker, 75 F. Supp. 3d 469, 483 (D.D.C. 2014) (discussing and affirming a jeopardy analysis that considered whether a given reduction was “meaningful from a biological perspective”). Reductions in the reproduction, numbers, or distribution of a species that are inconsequential at the species level, or alterations to the features or the extent of designated critical habitat that constitute only an inconsequential impact on the conservation value of designated critical habitat as a whole, would not be considered to rise to the level of “reduce appreciably” or “appreciably diminish” within the meaning of the regulations. Nor do we interpret section 7(a)(2) and the regulations thereunder to require that each proposed action improve or increase the likelihood of survival and recovery of the species, or improve the conservation value of critical habitat. Section 7(a)(2) focuses on the “continued existence” of the species and the “adverse” modification of critical habitat.

It should also be noted that the analysis must always consider whether such impacts are “appreciable,” even where a species already faces severe threats prior to the action. It is sometimes mistakenly asserted that a species may already be in a status of being “in jeopardy,” “in peril,” or “jeopardized” by baseline conditions, such that any additional adverse impacts must be found to meet the regulatory standards for “jeopardize the continued existence of” or “destruction or adverse modification.” See, e.g., Nat'l Wildlife Fed'n v. Nat'l Marine Fisheries Serv., 524 F.3d 917, 930 (9th Cir. 2008) (asserting that “where baseline conditions already jeopardize a species, an agency may not take action that deepens the jeopardy by causing additional harm”); Turtle Island Restoration Network v. United States Dep't of Commerce, 878 F.3d 725, 735 (9th Cir. 2017) (“Where a species is already in peril, an agency may not take an action that will cause an `active change of status' for the worse.”) (quoting Nat'l Wildlife Fed'n, 524 F.3d at 930). That approach is inconsistent with the statute and our regulations.

The terms “jeopardize the continued existence of” and “destruction or adverse modification” are, in the plain language of section 7(a)(2), determinations that are made about the effects of Federal agency actions. They are not determinations made about the environmental baseline or about the pre-action condition of the species. Under the ESA, a listed species will have the status of “threatened” or “endangered,” and all threatened and endangered species by definition face threats to their continued existence. See 16 U.S.C. §§ 1532(6), (20), 1533(a). But the ESA and our regulations do not use the terms “in jeopardy,” “in peril,” or “jeopardized” to describe the environmental baseline or the pre-action condition of a species; nor do the terms “appreciably reduce” or “appreciably diminish” have a different meaning where a species already faces very serious threats. In each biological opinion, the determination regarding destruction or adverse modification is made by evaluating the effects of the proposed action on the species in light of the overall status of the species, the baseline conditions within the action area and any cumulative effects occurring within the action area. While we acknowledge that for a species with a particularly dire status, a smaller impact could cause an alteration that appreciably diminishes the conservation value of critical habitat or appreciably reduces the likelihood of survival and recovery of the species, there is no “baseline jeopardy” status even for the most imperiled species.

A related question that has arisen is whether the Services are required to identify a “tipping point” beyond which the species cannot recover in making section 7(a)(2) determinations. For example, the Ninth Circuit Court of Appeals has said that “when a proposed action will have significant negative effects on the species' population or habitat, the duty to consider the recovery of the species necessarily includes the calculation of the species' approximate tipping point.” Oceana, Inc. v. Nat'l Marine Fisheries Serv., 705 F. App'x 577, 580 (9th Cir. 2017) (citing Nat'l Wildlife Fed'n v. Nat'l Marine Fisheries Serv., 524 F.3d 917 (9th Cir. 2008)); see also Wild Fish Conservancy v. Salazar, 628 F.3d 513, 527 (9th Cir. 2010) (overturning jeopardy analysis based on purported NMFS failure to determine “when the tipping point precluding recovery . . . is likely to be reached”). Neither the Act nor our regulations state any requirement for the Services to identify a “tipping point” as a necessary prerequisite for making section 7(a)(2) determinations. Section 7(a)(2) provides the Services with discretion as to how it will determine whether the statutory prohibition is exceeded. We have not interpreted that statutory language as requiring the identification of a tipping point. This interpretation is further supported by the fact that the state of science often does not allow the Services to identify a “tipping point” for many species. The Services have had success in the recovery of several listed species which, despite very low abundance, did not reach a “tipping point.”

We propose to amend the current definition of “Director” to clarify and simplify it, in accordance with the Act and agency practice of FWS and NMFS.

We propose to revise the definition of “effects of the action” in a manner that simplifies the definition. Confusion regarding application of terms has resulted in time being spent determining how to categorize an effect, rather than simply determining what the effects are regardless of category. By providing a simpler definition that applies to the entire range of potential effects, Federal agencies and the Services will be able to focus on better assessing the effects of the proposed action. In addition, we propose to make the definition of environmental baseline a stand-alone definition within § 402.02. Previously, this definition was articulated within the definition of effects of the proposed action. Finally, we have moved the instruction that the effects of the proposed action shall be added to the environmental baseline into the regulations guiding the Services' responsibilities in formal consultation in § 402.14(g).

A few aspects of the revised definition of effects of the action bear further discussion to understand our intent in the proposed revision. We collapsed the various concepts of direct and indirect effects, and the effects of interrelated and interdependent actions, into the new definition that the effects of the action include all effects caused by the proposed action. The revised definition notes that these effects include “the effects of other activities that are caused by the proposed action.” It includes a distinction between the word “action” which refers to the action proposed to be authorized, funded, or carried out, in whole or in part, by the Federal agency and brought in for consultation with the Services, and “activity” or “activities,” which refer to those activities that are caused by the proposed action but are not included in the proposed action. Under the current definition, these activities would have been considered under either “indirect effects” or “interrelated” or “interdependent” activities. An effect or activity is caused by the proposed action when two tests are satisfied: First, the effect or activity would not occur but for the proposed action, and second, the effect or activity is reasonably certain to occur.

Under the first of these two tests, if an effect or activity would occur regardless of whether the proposed action goes forward, then that effect or activity would not satisfy the “but for” test and would not be considered an effect of the action. The concepts of interrelated and interdependent actions in the existing regulations are now captured by the concept of effects of activities that are caused by the proposed action, but are not part of that proposed action. It has long been our practice that identification of direct and indirect effects as well as interrelated and interdependent activities is governed by the “but for” standard of causation. Our Consultation Handbook states . . .”In determining whether the proposed action is reasonably likely to be the direct or indirect cause of incidental take, the Services use the simple causation principle: i.e., “but for” the implementation of the proposed action. . . .” (Consultation Handbook, page 4-47). A number of courts have also adopted that position. Sierra Club v. Bureau of Land Management, 786 F.3d 1219, 1225 (9th Cir. 2015) (“The test for interrelatedness or interdependentness is `but for' causation”) citing Sierra Club v. Marsh, 816 F.2d 1376, 1387 (9th Cir. 1987). This standard, while applicable to analyzing the effects of the action under section 7(a)(2), is not necessarily appropriate for other provisions of the ESA; we therefore do not address in this rulemaking the causation standards applying to other provisions of the Act, such as whether a violation of section 9(a)(1)(B) (the take prohibition) has resulted for purposes of a civil penalty or a criminal violation under the Act.

The second of the two tests speaks to the certainty of whether the effect or activity will occur. The concept of reasonable certainty already exists in our section 7 regulations and currently is explicitly applied in the context of indirect effects, cumulative effects, and incidental take. We propose to increase consistency and avoid confusion and speculation by explicitly applying the concept to all effects of the proposed action (not just indirect) and also to those other activities previously identified as interrelated and interdependent. This concept applies equally to evaluating the beneficial effects of a proposed action (e.g., effects of any components proposed by the Federal agency to avoid, minimize, or offset the effects of the agency action, for example) and adverse effects of the proposed action. Our proposed revision applies the reasonably-certain-to-occur standard to the section 7 process in a consistent manner but does not change past practice on the evaluation of direct and indirect effects of actions. In practice, the Services have evaluated the direct effects of the action using the best available scientific and commercial information about the likelihood of an effect or activity and not on speculation about what effects might occur. As a result, we do not anticipate the revised language will change what types of effects or activities will be considered within our consultations; rather, we expect it to simplify and improve consistency in our effects analyses. For example, our prior discussion in our 2015 rulemaking adopting revisions to the incidental take statement portions of our section 7 regulations is instructive in this regard:

The preamble to the 1986 regulation implementing section 7 also discusses the Services' interpretation of the phrase “reasonably certain to occur.” (51 FR 19926, 19932-19933; June 3, 1986—“For State and private actions to be considered in the cumulative effects analysis, there must exist more than a mere possibility that the action may proceed. On the other hand, “reasonably certain to occur” does not mean that there is a guarantee that an action will occur.”)

It is important to note that both prongs of the causation standard must be met for the activity in question and the effects from that activity. So, for example, if an activity is not reasonably certain to occur, then the causation standard has not been met and neither the activity nor any effects from that activity are considered an effect of the proposed action.

In addition, for activities that are caused by the proposed action, we have established at § 402.17 a standard and set of factors to consider in determining whether activities are reasonably certain to occur. We believe that the combination of requiring that an effect be both “but for” and “reasonably certain to occur” will reasonably define the reach of the effects analysis and address concerns about extending the analysis into an unreasonably wide arena. Finally, the proposed provision includes a reminder that the effects of the action may occur throughout the action area and on an ongoing, or even delayed, timeframe after completion of the action that was the subject of consultation. Thus, under the proposed rule, there would no longer be a need for a separate definition of “indirect effects,” since the intent of the new definition is that the effects covered by that term are still included. And similarly, the new definition should not, in practice, change the determination or scope of the “action area” in a consultation.

As stated previously, the Services' intent is to simplify and clarify the definition of effects of the action, without altering the scope of what constitutes an effect. We seek comment on (1) the extent to which the proposed revised definition simplifies and clarifies the definition of “effects of the action”; (2) whether the proposed definition alters the scope of effects considered by the Services; (3) the extent to which the scope of the proposed revised definition is appropriate for the purposes of the Act; and (4) how the proposed revised definition may be improved.

We are proposing a stand-alone definition for “environmental baseline” as referenced in the discussion above in the proposed revised definition for “effects of the action.” The definition for environmental baseline retains its current wording. Moving it to a stand-alone definition clarifies that the environmental baseline is a separate consideration that sets the stage for analyzing the effects of the proposed action on the listed species and critical habitat within the action area by providing the foundation upon which to build the analysis of the effects of the action under consultation. The environmental baseline does not include the effects of the action under review in the consultation (See Consultation Handbook, at 4-22).

The Services are seeking public comment on potential revisions to the definition of “environmental baseline” as it relates to ongoing Federal actions. It has sometimes been challenging for the Services and Federal agencies to determine the appropriate baseline for those consultations involving ongoing agency actions. The complexities presented in these consultations include issues such as: What constitutes an “ongoing” action; if an ongoing action is changed, is the incremental change in the ongoing action the only focus of the consultation or is the entire action or some other subset reviewed; is the effects analysis different if the ongoing action has never been the subject of consultation as compared to if there is a current biological opinion for the ongoing action; if a change is made to an ongoing action that lessens, but does not eliminate, the harmful impact to listed species or critical habitat, is that by definition a “beneficial action”; and can a “beneficial action” ever jeopardize listed species or destroy or adversely modify critical habitat. Further, the Services request comments as to whether the following language would address these issues: “Environmental baseline is the state of the world absent the action under review and includes the past, present and ongoing impacts of all past and ongoing Federal, State, or private actions and other human activities in the action area, the anticipated impacts of all proposed Federal projects in the action area that have already undergone formal or early section 7 consultation, and the impact of State or private actions in the action area which are contemporaneous with the consultation in process. Ongoing means impacts or actions that would continue in the absence of the action under review.”

As indicated above, we propose to move the instruction that the effects of the action shall be added to the environmental baseline from the definition of “effects of the action” into § 402.14(g) to retain this important step of the analytical process.

We propose to add a definition of “programmatic consultation.” This term is included in revised § 402.14(c)(4) to codify an optional consultation technique that is being used with increasing frequency and to promote the use of programmatic consultations as effective tools that can improve both process efficiency and conservation in consultations. Programmatic consultations can be completed under informal and formal consultation processes. They can be used to evaluate the effects of multiple actions anticipated within a particular geographic area; or to evaluate Federal agency programs that guide implementation of the agency's future actions by establishing standards, guidelines, or governing criteria to which future actions will adhere. By consulting on the program, plan, policy, regulation, series, or suites of activities as a whole, the Services can reduce the number of single, project-by-project consultations, streamline the consultation process, and increase predictability and consistency for action agencies. In addition, by looking across numerous individual actions at the programmatic level, the Federal action agencies and applicants can propose project design criteria, best management practices, standard operating procedures, and/or standards and guidelines that avoid, minimize, or offset the action's effects on listed species and/or designated critical habitat. Federal agencies and applicants often propose measures to avoid, minimize, and/or offset effects to listed species and/or designated critical habitat as part of their proposed action when they consult with the Services. The Services consider these measures as part of the proposed action when they evaluate the effects of the proposed action.

1. Programmatic consultations that address multiple similar, frequently occurring, or routine actions expected to be implemented in particular geographic areas. These are generally categories of actions for which there is a good understanding of the likely effects on resources listed under the Act, although the categories encompass future site-specific actions of which the precise details are not yet known. Many, but not all, of these types of programmatic consultations have been referred to as “batched” consultations in the past. They do not rely on, or specifically incorporate by reference, consultations on a higher level of Federal action or plan. Examples of these types of programmatic consultations would be consultations that involve a variety of routine activities such as a regional road maintenance program by State departments of transportation, or a U.S. Army Corps of Engineers general permitting program at the regional level that covers routine construction activities for in-and-over-water structures.

2. Programmatic consultations that address a proposed program, plan, policy, or regulation providing a framework for future actions. These programmatic consultations cover programs, plans, governing policies, and/or regulations such as a national or regional program, plan, policy, or regulation, where the Federal agency is generally not able to provide detailed specificity about the number, location, timing, frequency, precise methods and intensity of the activities expected to be implemented, or to determine the site-specific adverse effects the activities will have on listed species or critical habitat. In these cases, the Service conducts a more generalized review of effects and provides the appropriate section 7(a)(2) determination in a letter of concurrence or biological opinion for the programmatic consultation. In the future, when the site-specific information is known, and it is determined the project “may affect” a listed species or critical habitat, typically a subsequent consultation is completed. That subsequent consultation may, not exclusively, be referred to as a “step-down” or “tiered consultation.” The subsequent consultation commonly incorporates by reference portions of the previous consultation on the program, plan, policy, or regulations. A typical example of this type of programmatic action is a land management plan. A land management agency may have a program addressing issuance of a special use permit for various activities. The program, as a part of land management planning, has certain standards and guidelines to which each subsequent program action must adhere. A consultation on the program would examine generally what types of effects would be caused by the program and whether those effects were consistent with section 7(a)(2) of the Act. In the future, as issuance of specific permits are anticipated, the Federal agency will return to the Service later for consultation, and an additional consultation would take place on the site-specific facts of that permit issuance. However, the subsequent or “step-down” or “tiered” consultation would benefit from the initial program-level consultation, thus streamlining and reducing the amount of analysis needed for each site-specific consultation.

The Services recently promulgated changes to the section 7(a)(2) implementing regulations that define framework and mixed programmatic actions that address certain types of policies, plans, regulations, and programs (80 FR 26832, May 11, 2015). The types of programmatic consultations described above align with the suite of activities described in the 2015 rule.

The Services encourage Federal agencies to coordinate with us in order to determine what programmatic approach would be applicable and streamline the consultation process for their program or suite of actions.

In order to increase efficiency in implementing section 7(a)(2) consultations and capitalize upon the considerable experience the Services have gained in implementing the Act, the Services seek comment on the advisability of clarifying the circumstances upon which Federal agencies are not required to consult. More specifically, the Services seek comment regarding revising § 402.03 to preclude the need to consult when the Federal agency does not anticipate take and the proposed action will: (1) Not affect listed species or critical habitat; or (2) have effects that are manifested through global processes and (i) cannot be reliably predicted or measured at the scale of a listed species' current range, or (ii) would result at most in an extremely small and insignificant impact on a listed species or critical habitat, or (iii) are such that the potential risk of harm to a listed species or critical habitat is remote, or (3) result in effects to listed species or critical habitat that are either wholly beneficial or are not capable of being measured or detected in a manner that permits meaningful evaluation. The Services have learned through time that such actions are far removed from any potential for jeopardy or destruction or adverse modification of critical habitat, and that consultation on these actions does little to accomplish the intent of section 7(a)(2) of the Act—to ensure that any action authorized, funded, or carried out by a Federal agency is not likely to jeopardize the continued existence of listed species or result in the destruction or adverse modification of critical habitat.

In prior consultations under section 7(a)(2), agencies with regulatory authority have consulted on actions that include effects to listed species or designated critical habitat that occur outside of the specific area over which they have regulatory jurisdiction. We also seek comment on whether the scope of a consultation under section 7(a)(2) should be limited to only the activities, areas, and effects within the jurisdictional control and responsibility of the regulatory agency.

Informal consultation is an optional process that includes all discussions, correspondence, etc., between the Service and the Federal agency to assist the Federal agency in determining whether formal consultation or a conference is required. During informal consultation, the Service may suggest modifications to the action that the Federal agency and any applicant could implement to avoid the likelihood of adverse effects to listed species or critical habitat. Finally, the Services may issue a written concurrence with a Federal agency's determination that the action is not likely to adversely affect the listed species or critical habitat.

There is currently no deadline for the Services to complete an informal consultation, unlike formal consultations, which by regulation should be completed within 90 days unless extended under the terms at § 402.14(e). The Service's goal is to either complete the Letter of Concurrence for the project, or request additional information that is necessary to complete the consultation, within 30 days. NMFS completes approximately 1,200-1,500 individual informal consultations per year. Of the informal actions not under a programmatic Biological Opinion, 36 percent are within their 30-day goal, and 61 percent are within 3 months. NMFS currently has about 46 individual informal consultations that have been open for greater than 200 days as of July 31, 2017, that the agency is actively working to complete as soon as possible. Between fiscal years 2011 and 2017, FWS completed an average of 11,344 (ranging from 9,656 to 12,793) informal consultations per year. During those years, FWS completed between 78 percent and 85 percent of the informal consultations in less than 30 days, averaging between 26 and 39 days to complete informal consultation.

The Services are considering whether to add a 60-day deadline, subject to extension by mutual consent, for informal consultations. We seek comment on (1) whether a deadline would be helpful in improving the timeliness of review; (2) the appropriate length for a deadline (if not 60 days); and (3) how to appropriately implement a deadline (e.g., which portions of informal consultation the deadline should apply to [e.g., technical assistance, response to requests for concurrence, etc.], when informal consultation begins, and the ability to extend or “pause the clock” in certain circumstances, etc.).

Consistent with the Services' existing practice, we propose to revise § 402.14(c) to clarify what is necessary to initiate formal consultation. Decades of experience have demonstrated valuable time is lost due to lack of clarity in what information the Services need to initiate consultation. This often results in an ongoing exchange of documents (e.g., biological assessments, biological evaluations, National Environmental Policy Act (NEPA) documents) in which the Federal agencies and Services seek to compile the necessary information, which results in significant inefficiencies and frustrations on the part of both the Federal agencies and the Services. The proposed revision is intended to eliminate the confusion and misunderstanding existing in the current regulations and significantly increase the efficiency of the process for both the Federal agencies and the Services. It is important to note the Services are not proposing to require more information than existing practice; instead, we are proposing to clarify in the regulations what is needed to initiate consultation in order to improve the consultation process.

The proposed revisions to § 402.14(c) would further describe the information from the Federal agency necessary to initiate consultation. This set of information is commonly called the “initiation package,” and that term is also used in our proposed regulations for alternative formal consultation procedures to refer to the information required in § 402.14(c). Consistent with § 402.06 (Coordination with other environmental reviews), we also propose at § 402.14(c) to allow the Services to consider other documents as initiation packages, such as: a document prepared for the sole purpose of providing the Service with information relevant to an agency's consultation, a document that has been prepared under NEPA or other authority that contains the necessary information to initiate consultation, or other such documents (e.g., grant application, State of Washington Joint Aquatic Resources Permit Application, California Environmental Quality Act Environmental Impact Report, etc.) that meet the requirements for initiating consultation.

When such documents consider two or more alternative actions, the request for consultation must describe the specific alternative or action proposed for consultation and the specific locations in the document where the relevant information is found. The Services evaluate only the Federal agency's proposed alternative during the consultation process. If the Federal agency either adopts another alternative as its final agency action, or substantively modifies the proposed alternative, reinitiation of consultation may be required.

The proposed regulations describe categories of information that should be in an initiation package to initiate formal consultation. Information must be provided in a sufficient level of detail consistent with the nature and scope of the proposed action. Consistent with the Service's existing practice, the requirement to include sufficient detail ensures the Service has enough information to understand the action as proposed and conduct an informed analysis of the effects of the action, including with regard to those measures intended to avoid, minimize, or offset effects. See Consultation Handbook, at B-54 (Description of the proposed action should be “detailed enough so that the reviewer can fully understand what the components of the action include and how the project will affect the species.”) Such information should include a description of the proposed action, including any measures intended to avoid, minimize, or offset the effects of the proposed action, a description of the area affected (the action area), information about species or critical habitat in the action area, a description of potential effects of the proposed action on individuals of any listed species or critical habitat, a description of the cumulative effects, a summary of information from the applicant, if any, and any other relevant information.

We propose to revise portions of § 402.14(g) that describe the Services' responsibilities during formal consultation. We propose to clarify the analytical steps the Services undertake in formulating a biological opinion. These changes are intended to better reflect the Services' approach to analyzing jeopardy and adverse modification as well as address revisions to the definition of “effects of the action.” In summary, these analytical steps are: (1) Review all relevant information, (2) evaluate current status of the species and critical habitat and environmental baseline, (3) evaluate effects of the proposed action and cumulative effects, (4) add effects of the action and cumulative effects to the environmental baseline, and, in light of the status of the species and critical habitat, determine if the proposed action is likely to jeopardize listed species or result in the destruction or adverse modification of critical habitat. While we identify distinct steps in our analytical approach, each step is related to the others and necessarily informs and influences our analysis. For example, the condition of the environmental baseline is relevant to the nature and extent of the effects of the action. Effects of the action that in isolation would be of minor consequence may be amplified and of greater consequence when analyzed in light of the condition of the environmental baseline.

In § 402.14(g)(2), we propose to move from the current definition of “effects of the action” the instruction that the effects of the action shall be added to the environmental baseline to where this provision more logically fits with the rest of the analytical process, and we retain this important step of that process. In § 402.14(g)(4), we propose revisions to better reflect the manner in which the Services integrate and synthesize their analyses of effects of the action with cumulative effects, the environmental baseline, and status of the species and critical habitat to reach our jeopardy and adverse modification determinations. Again, this proposed change reflects the Service's existing approach. See Consultation Handbook, at 4-33 (“The conclusion section presents the Services' opinion regarding whether the aggregate effects of the factors analyzed under “environmental baseline,” “effects of the action,” and “cumulative effects” in the action area—when viewed against the status of the species or critical habitat as listed or designated—are likely to jeopardize the continued existence of the species or result in destruction or adverse modification of critical habitat.”)

We propose clarifications to § 402.14(g)(8) regarding whether and how the Service should consider measures included in a proposed action that are intended to avoid, minimize, or offset adverse effects to listed species or critical habitat. Federal agencies often include these types of measures as part of the proposed action. However, the Service's reliance on a Federal agency's commitment that the measures will actually occur as proposed has been repeatedly questioned in court. The resulting judicial decisions have created confusion regarding what level of certainty is required to demonstrate that a measure will in fact be implemented before the Service can consider it in a biological opinion. In particular, the Ninth Circuit has held that even an expressed sincere commitment by a Federal agency or applicant to implement future improvements to benefit a species must be rejected absent “specific and binding plans” with “a clear, definite commitment of resources for future improvements.” Nat'l Wildlife Fed'n v. Nat'l Marine Fisheries Serv., 524 F.3d 917, 935-36 (9th Cir. 2008).

This judicially created standard is not required by the Act or the existing regulations. The Act requires Federal agencies to consult with the Services, as appropriate, on “any action authorized, funded or carried out by such agency.” When a Federal agency proposes to take an action that it has the discretion and authority to implement, and where that proposed action or parts thereof “may affect” a listed species or its critical habitat, the section 7(a)(2) consultation process is triggered. Where these conditions are met, the Service's role is to assume that the action will be implemented as proposed and proceed to analyze the effects of that proposed action on listed species and critical habitat. Just as with the components of a proposed action with adverse effects, there is no additional or heightened standard or threshold requirement necessitating the Service to independently evaluate whether the proposed measures to avoid, minimize, or offset adverse effects will be implemented.

In some situations, a Federal agency may propose a suite or program of measures that will be implemented over time. The future components of the proposed action often have some uncertainty with regard to the specific details of projects that will be implemented. Nevertheless, a Federal agency or applicant may be fully capable of committing to specific levels and types of actions (e.g., habitat restoration) and specific populations or species that will be the focus of the effort. If the Federal agency provides information in sufficient detail for the Services to meaningfully evaluate the effects of measures proposed to avoid, minimize, or offset adverse effects, the Services must consider the proposed measures during a consultation, as the Act requires the Services to issue their expert opinion on “how the agency action affects the species or its critical habitat,” 16 U.S.C. 1536(b)(3)(A), and thus, are entitled to rely on that information as proposed. Therefore, we are proposing revisions to § 402.14(c)(1) with respect to the information a Federal agency must submit to initiate formal consultation. Under this proposed rule and consistent with the Service's existing approach, a Federal agency must submit a description of the proposed action, including available information about any measures intended to avoid, minimize, or offset effects of the proposed action. As discussed above, the requirement for sufficient detail regarding all aspects of the proposed action ensures the Services have the information needed to conduct an informed analysis of the effects of all activities included in the proposed action. Provided the Federal agency submits the information required by § 402.14(c), the Services will take into consideration the effects of the action as proposed, both beneficial and adverse.

By describing what is included in the proposed action, the Federal agency has made a commitment and retains independent obligations to insure that its action is not likely to jeopardize listed species or destroy or adversely modify critical habitat. Should new information arise or our assumptions set forth in the consultation change during implementation—for instance, where the action or elements thereof are not implemented as proposed—the Federal agency must continue to ensure compliance with the Act and has several options to do so. This may include reinitiating consultation with the Service(s) to evaluate the changed circumstances. If an incidental take statement includes reasonable and prudent measures and terms and conditions intended to minimize the impact of incidental take, the Federal agency must carry out those measures or risk losing the exemption afforded by the incidental take statement. Ultimately, as consulting and action agencies, the Act's statutory and regulatory provisions provide distinct responsibilities such that there is no requirement for the Service to independently evaluate whether the Federal agency is likely to carry out its commitments. This is the Services' longstanding position, as reflected in other provisions of the regulations (for instance, those governing development of Reasonable and Prudent Alternatives), and is consistent with the Act. Therefore, we propose revisions to § 402.14(g)(8) to clarify there is no requirement for measures that avoid, minimize, or offset the adverse effects of an action that are included in the proposed action to be accompanied by “specific and binding plans,” “a clear, definite commitment of resources”, or meet other such criteria.

We propose to add new paragraphs (h)(3) and (h)(4) to the current § 402.14(h) to allow the Services to adopt all or part of a Federal agency's initiation package in its biological opinion. Additionally, we propose to allow the Services to adopt all or part of their own analyses and findings that are required to issue a permit under section 10(a) of the Act in its biological opinion.

The Services have more than 30 years of experience in conducting consultation pursuant to section 7(a)(2) of the Act under the existing regulations. Based upon that experience, we have determined that the current regulations would be more efficient and clear if we were to codify or create additional optional procedures within formal consultation (Service adoption of all or part of a Federal agency's initiation package and expedited consultations) and streamline duplicative processes (consultation on permits issued under section 10 of the Act). We recognize that several factors, including the scope and complexity of the proposed action, the magnitude and extent of the effects that flow from the proposed action, and the expertise of various Federal agencies, all warrant more than the two general types of consultation provided for in the current regulations. In addition, the experience of recent decades has led to significant improvements in consultation efficiency and species conservation as a result of the effective use of streamlined or programmatic approaches. We believe that these alternative consultation procedures will promote flexibility and efficiency for the action agencies, applicants, and the Services, and can be implemented in compliance with the Act while not compromising the conservation of listed species.

We propose that the Service may adopt all or part of a Federal agency's initiation package or the Services' analyses and findings that are required to issue a permit under section 10(a) of the Act in its biological opinion. This provision would allow the Services to utilize portions of these documents in the development of our biological opinion to improve efficiency in the consultation process and reduce duplicative efforts. Adoption or incorporation by reference is typically done during consultations, and this provision codifies that approach.

Further, the provision explicitly applies this approach to the Service's issuance of permits under section 10 of the Act. The review and analyses undertaken to develop a finding that various criteria have been met for issuing a permit pursuant to section 10(a)(1)(A) or 10(a)(1)(B) contain many of the elements reviewed and analyzed in a section 7 consultation. Therefore, we propose to adopt the analyses and review that supports issuance of these permits as part of the biological opinion required to meet the applicable provisions of the part 402 consultation regulations. As a result, the section 7 analysis and document can be streamlined to just those portions necessary to present a complete finding under section 7(a)(2) and 7(b)(3). We note also that the Service issuing the permit would have to ensure that its determination regarding jeopardy and destruction or adverse modification is not limited to the species for which the permit is authorizing take, but that it covers all listed species and all designated critical habitat under the Service's jurisdiction affected by the proposed action. In cases where issuance of a section 10 permit by one of the Services (e.g., FWS) may affect listed species or critical habitat under the jurisdiction of the other Service (e.g., NMFS), the permitting agency will still need to consult with the other Service, as well.

While it is the responsibility of the Federal agency to develop the initiation package, we propose a collaborative process to facilitate the Federal agency's development of an initiation package that could be used as all or part of the Service's biological opinion. First, the Federal agency and the Service must mutually agree that the adoption process is appropriate for the proposed action. Subsequently, the Services and the Federal agency may develop coordination procedures that would facilitate adoption. This agreement must be explained in the Federal agency's initiation package and acknowledged in the Services' biological opinion. The purpose of the collaboration is to bring the information and expertise of both the Federal agency and the Service (and any applicant) into the resulting initiation package to facilitate a more efficient and effective consultation process. The end result of the adoption consultation process is expected to be the adoption of the initiation package with any necessary supplementary analyses and incidental take statement to be added by the Service as the Secretary's biological opinion in fulfillment of section 7(b) of the Act.

We propose to add a new provision titled “Expedited consultations” at § 402.14(l) to offer opportunities to streamline consultation, particularly for actions that have minimal adverse effects or predictable effects based on previous consultation experience. This consultation process is proposed to provide an efficient means to complete formal consultation on projects ranging from those that have a minimal impact, to those projects with a potentially broad range of effects that are known and predictable, but that are unlikely to cause jeopardy or destruction or adverse modification. The Services have developed a vast knowledge of projects, and in the course of doing so, have concluded that some types of projects can be consulted on in a more expeditious manner without compromising the conservation of listed species or critical habitat. For example, a habitat-restoration project that results in high conservation value for the species but may have a small amount of incidental take through construction or monitoring would likely lend itself to this type of consultation (for Streamlined Consultation Guidance for Restoration and Recovery Projects, see https://www.fws.gov/endangered/esa-library/index.html#consultations under “Policies” for guidance documents for consultations with the Fish and Wildlife Service).

Two elements are important to the successful implementation of this form of consultation. First is the mutual agreement between the Service and the Federal agency that this form of consultation is appropriate for the proposed action. Informal consultation has been an available optional process for 30 years and is most often utilized to address proposed actions that are not likely to adversely affect listed species or critical habitat. In contrast, expedited consultations are a new process and likely involve proposed actions that would otherwise go through the regular formal consultation process and require an incidental take statement. We make mutual agreement a required first step in the expedited consultation process to avoid wasted effort if Federal agencies propose actions for expedited consultation that would not be suitable for expedited analysis by the Service. The second important element is the development of a sufficient initiation package (as described in § 402.14(c) of the regulations) that provides all the information needed to allow the Service to prepare a streamlined consultation response within mutually agreed-upon expedited timeframes. We expect that a combination of one-on-one collaboration with Federal agency staff and the availability of guidance and templates will ensure the most efficient process for development of initiation packages and expedited biological opinions. For a NMFS example of a similar effort for informal consultations through the development of guidance, see https://www.greateratlantic.fisheries.noaa.gov/protected/section7/guidance/consultation/index.html#writing.

In § 402.14, we propose to redesignate current paragraph (l) as paragraph (m) to accommodate the addition of the proposed new paragraph (l).

We propose two changes to this section. First, we propose to remove the term “formal” from the title and text of this section to acknowledge that the requirement to reinitiate consultation applies to all section 7(a)(2) consultations. By practice, action agencies have reinitiated informal consultations when a trigger for reinitiation has been met. Courts have also held that reinitiation is required in the context of informal consultation. See Forest Guardians v. Johanns, 450 F.3d 455, 458 (9th Cir. 2006). Second, we propose to amend this section to address issues arising under the Ninth Circuit's decision in Cottonwood Environmental Law Center v. U.S. Forest Service, 789 F.3d 1075 (9th Cir. 2015), cert. denied, 137 S. Ct. 293 (2016). In Cottonwood, the court held that the Forest Service was required to reinitiate consultation on certain forest management plans due to the designation of Canada lynx critical habitat. The court held that, even if an approved land management plan is considered to be a completed action, the Forest Service nonetheless was obligated to reinitiate consultation since it retained “discretionary Federal involvement or control” over the plan. Cottonwood, 789 F.3d at 1084-85.

We propose to make non-substantive redesignations and then revise § 402.16 by adding a new paragraph (b) to clarify that the duty to reinitiate does not apply to an existing programmatic land management plan prepared pursuant to the Federal Land Policy Management Act (FLPMA), 43 U.S.C. 1701 et seq., or the National Forest Management Act (NFMA), 16 U.S.C. 1600 et seq. when a new species is listed or new critical habitat is designated.

We reaffirm that only affirmative discretionary actions are subject to reinitiation under our regulations, and the mere existence of a programmatic land management plan is not affirmative discretionary action. See generally Southern Utah Wilderness Alliance v. Norton, 542 U.S. 55 (2004). See also National Ass'n of Homebuilders v. Defenders of Wildlife, 551 U.S. 644 (2007). While the Act does not expressly mandate reinitiation on discretionary affirmative actions, in 1986 we determined that the Act's legislative history and conservation goals supported reinitiation if certain triggers are met. After decades of experience cooperating with action agencies across the Federal Government, we have gained the expertise of when reinitiation of consultation is most effective to meeting the overall goals of the Act. Reinitiating on a purely programmatic land management plan when new species are listed or critical habitat designated does little to further these goals. Both the Bureau of Land Management (BLM) and U.S. Forest Service (USFS) are required to periodically update their land management plans, at which time they would consult on any newly listed species or designated critical habitat. BLM is required to periodically evaluate and revise Resource Management Plans (see 43 CFR 1610); the interval between reevaluations should not exceed 5 years (see BLM Handbook H-1601-1 at p. 34). USFS is required to revise their land management plans at least every 15 years (see 36 CFR 219.7). In addition to being required to periodically revise their land management plans, both BLM and USFS are required to consult on any specific on-the-ground actions that implement the land management plans if those actions may affect listed species or critical habitat. We are thus exercising our discretion and narrowing § 402.16 to exclude two types of plans that have no immediate on-the-ground effects. Requiring reinitiation on these completed plans based on newly listed species or critical habitat often results in impractical and disruptive burdens.

Moreover, reinitiating consultation on a programmatic land management plan results in little benefit to the newly listed species or critical habitat because the plan's mere existence does not result in any immediate effects upon either, thus rendering any reinitiation under these conditions inefficient and ineffective. In contrast, specific on-the-ground actions that implement the plan are subject to their own section 7 consultations if those actions may affect listed species or critical habitat. These on-the-ground, action-specific consultations allow us to direct our limited resources to those actions that actually cause effects and ensure that the USFS and the BLM fulfill their obligations under section 7. Thus, this new proposed regulation also restates our position that, while a completed programmatic land management plan does not require reinitiation upon the listing of new species or critical habitat, any on-the-ground subsequent actions taken pursuant to the plan must be subject to a separate section 7 consultation if those actions may affect the newly listed species or critical habitat.

Rather than reinitiation of a section 7(a)(2) consultation at the plan level, the Services recommend these agencies develop section 7(a)(1) conservation programs in consultation with the Services when a new species is listed or critical habitat designated. This proactive, conservation planning process will enable them to better synchronize their actions and programs with the conservation and recovery needs of listed and proposed species. Such planning can help Federal agencies develop specific, pre-approved design criteria to ensure their actions are consistent with the conservation and recovery needs of the species. Additionally, these section 7(a)(1) programs will facilitate efficient development of the next programmatic section 7(a)(2) consultations when the land management plan is renewed.

In addition to seeking comment on the proposed revision to 50 CFR 402.16, we are seeking comments on whether to exempt other types of programmatic land or water management plans in addition to those prepared pursuant to FLPMA and NFMA from the requirement to reinitiate consultation when a new species is listed or critical habitat designated. We are also seeking comment on this proposed revision in light of the recently enacted Wildfire Suppression Funding and Forest Management Activities Act, H.R. 1625, Division O, which was included in the Omnibus Appropriations bill for fiscal year 2018.

We propose to add a new § 402.17 titled “Other provisions.” Within this new section, we propose a new provision titled “Activities that are reasonably certain to occur,” in order to clarify the application of the “reasonably certain to occur” standard referenced in § 402.02 (defining effects of the action and cumulative effects) in two specific contexts. This new proposed provision applies only to activities caused by but not included in the proposed action and activities under cumulative effects. We propose to address reasonable certainty in these two contexts due to the substantial confusion that has sometimes resulted from determining when these sorts of activities should be considered. The proposed text addresses the relative level of certainty required and is intended to avoid inclusion of activities whose occurrence would be considered speculative, but also to avoid requiring an expectation that the activity is absolutely certain to occur. We also identify a non-exclusive list of factors that inform the determination of whether an activity should be considered reasonably certain to occur. For example, one of the factors to consider is the existence of any relevant plans (e.g., community plans, management plans, transportation plans, etc.). We also specify that this provision only applies to activities caused by but not included in the proposed action and activities under cumulative effects. Consistent with the Act, existing regulations, and agency practice, we do not propose to apply the reasonable certainty standard to whether the proposed action itself will be implemented, but again, only to the analysis of the effects of the action to ensure that the effects analysis does not focus on speculative impacts. This provision reflects the fundamental nature of consultation under section 7(a)(2) in which the Services consult on the action as proposed.

We intend that a final regulation will consider information and recommendations from all interested parties. We therefore solicit comments, information, and recommendations from governmental agencies, Native American tribes, the scientific community, industry groups, environmental interest groups, and any other interested parties. All comments and materials received by the date listed in DATES above will be considered prior to the approval of a final document.

You may submit your information concerning this proposed rule by one of the methods listed in ADDRESSES. If you submit information via http://www.regulations.gov, your entire submission—including any personal identifying information—will be posted on the website. If your submission is made via a hardcopy that includes personal identifying information, you may request at the top of your document that we withhold this personal identifying information from public review. However, we cannot guarantee that we will be able to do so. We will post all hardcopy submissions on http://www.regulations.gov.

Information and supporting documentation that we receive in response to this proposed rule will be available for you to review at http://www.regulations.gov, or by appointment, during normal business hours, at the U.S. Fish and Wildlife Service, Division of Environmental Review (see FOR FURTHER INFORMATION CONTACT).

Executive Order 12866 provides that the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget (OMB) will review all significant rules. OIRA 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. This proposed rule is consistent with Executive Order 13563, and in particular with the requirement of retrospective analysis of existing rules, designed “to make the agency's regulatory program more effective or less burdensome in achieving the regulatory objectives.”

This proposed rule is expected to be a deregulatory action under E.O. 13771.

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 (i.e., 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 certify that, if adopted as proposed, this proposed rule would not have a significant economic effect on a substantial number of small entities. The following discussion explains our rationale.

This rulemaking revises and clarifies existing requirements for Federal agencies under the Endangered Species Act. Federal agencies are the only entities that are directly affected by this rule, and they are not considered to be small entities under SBA's size standards. No other entities are directly affected by this rule. Moreover, this proposed rulemaking action is not a major rule under SBREFA.

This proposed rule, if made final, would be applied in determining whether a Federal agency has insured, in consultation with the Services, that any action it would authorize, fund, or carry out is not likely to jeopardize listed species or result in the destruction or adverse modification of critical habitat. This proposed rule is substantially unlikely to affect our determinations as to whether or not proposed actions are likely to jeopardize listed species or result in the destruction or adverse modification of critical habitat. The proposed rule would serve to provide clarity to the standards with which we will evaluate agency actions pursuant to section 7 of the Endangered Species Act.

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

(a) On the basis of information contained in the Regulatory Flexibility Act section above, this proposed rule would not “significantly or uniquely” affect small governments. We have determined and certify pursuant to the Unfunded Mandates Reform Act, 2 U.S.C. 1502, that this rule would 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 proposed rule would not place additional requirements on any city, county, or other local municipalities.

(b) This proposed rule would not produce a Federal mandate on State, local, or tribal governments or the private sector of $100 million or greater in any year; that is, this proposed rule is not a “significant regulatory action”' under the Unfunded Mandates Reform Act. This proposed rule would impose no additional management or protection requirements on State, local, or tribal governments.

In accordance with Executive Order 12630, this proposed rule would not have significant takings implications. This proposed rule would not pertain to “taking” of private property interests, nor would it directly affect private property. A takings implication assessment is not required because this proposed rule (1) would not effectively compel a property owner to suffer a physical invasion of property and (2) would not deny all economically beneficial or productive use of the land or aquatic resources. This proposed rule would substantially advance a legitimate government interest (conservation and recovery of endangered species and threatened species) and would not present a barrier to all reasonable and expected beneficial use of private property.

In accordance with Executive Order 13132, we have considered whether this proposed rule would have significant Federalism effects and have determined that a federalism summary impact statement is not required. This proposed rule pertains only to improving and clarifying the interagency consultation processes under the Endangered Species Act and 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.

This proposed rule does not unduly burden the judicial system and meets the applicable standards provided in sections 3(a) and 3(b)(2) of Executive Order 12988. This proposed rule would clarify the interagency consultation processes under the Endangered Species Act.

In accordance with the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951), Executive Order 13175, and the Department of the Interior's manual at 512 DM 2, we readily acknowledge our responsibility to communicate meaningfully with recognized Federal Tribes on a government-to-government basis.

This rule does not contain any new collections of information other than those already approved under the Paperwork Reduction Act (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.

We are analyzing this proposed regulation in accordance with the criteria of NEPA, the Department of the Interior regulations on implementation of NEPA (43 CFR 46.10-46.450), the Department of the Interior Manual (516 DM 8), the NOAA Administrative Order 216-6A, and the companion manual, “Policy and Procedures for Compliance with the National Environmental Policy Act and Related Authorities,” which became effective January 13, 2017. We invite the public to comment on the extent to which this proposed regulation may have a significant impact on the human environment, or fall within one of the categorical exclusions for actions that have no individual or cumulative effect on the quality of the human environment. We will complete our analysis, in compliance with NEPA, before finalizing this regulation.

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

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

(1) Be logically organized;

(2) Use the active voice to address readers directly;

(3) Use clear language rather than jargon;

(4) Be divided into short sections and sentences; and

(5) Use lists and tables wherever possible.

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

A complete list of all references cited in this document is available on the internet at http://www.regulations.gov in Docket No. FWS-HQ-ES-2018-0009 or upon request from the U.S. Fish and Wildlife Service (see FOR FURTHER INFORMATION CONTACT).

The primary authors of this proposed rule are the staff members of the Ecological Services Program, U.S. Fish and Wildlife Service, 5275 Leesburg Pike, Falls Church, VA 22041-3803, and the National Marine Fisheries Service's Endangered Species Division, 1335 East-West Highway, Silver Spring, MD 20910.

We issue this proposed rule under the authority of the Endangered Species Act, as amended (16 U.S.C. 1531 et seq.).

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

The revisions and addition read as follows:

The revisions and addition read as follows:

The Endangered Species Act of 1973, as amended (“Act”; 16 U.S.C. 1531 et seq.), states that the purposes of the Act are to provide a means to conserve the ecosystems upon which listed species depend, to develop a program for the conservation of listed species, and to achieve the purposes of certain treaties and conventions. 16 U.S.C. 1531(b). Moreover, the Act states that it is the policy of Congress that the Federal Government will seek to conserve threatened and endangered species, and use its authorities to further the purposes of the Act. 16 U.S.C. 1531(c)(1).

The Act defines an endangered species as any species that is “in danger of extinction throughout all or a significant portion of its range” and a threatened species as any species “that is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range.” 16 U.S.C. 1532(6); (20). The Act requires the Services to determine whether species meet either of these definitions. 16 U.S.C. 1533(a); 1532(15). Section 4 of the Act and its implementing regulations in Title 50 of the Code of Federal Regulations at 50 CFR part 424 set forth the procedures for adding, removing, or reclassifying species to the Federal Lists of Endangered and Threatened Wildlife and Plants (lists). The lists are in 50 CFR 17.11(h) (wildlife) and 17.12(h) (plants). Section 4(a)(1) of the Act sets forth the factors that we evaluate when we issue rules for species to list (adding a species to one of the lists), delist (removing a species from one of the lists), and reclassify (changing a species' classification or its status).

One of the tools provided by the Act to conserve species is the designation of critical habitat. The purpose of critical habitat is to identify the areas that are essential to the conservation of the species. The Act generally requires that the Services, to the maximum extent prudent and determinable, designate critical habitat when determining that a species is either an endangered species or a threatened species. 16 U.S.C. 1533(a)(3)(A).

The Secretaries of the Interior and Commerce (the “Secretaries”) share responsibilities for implementing most of the provisions of the Act. Generally, marine and anadromous species are under the jurisdiction of the Secretary of Commerce, and all other species are under the jurisdiction of the Secretary of the Interior. Authority to administer the Act has been delegated by the Secretary of the Interior to the Director of FWS and by the Secretary of Commerce to the Assistant Administrator for NMFS.

In carrying out Executive Order 13777, “Enforcing the Regulatory Reform Agenda,” the Department of the Interior (DOI) published a document with the title “Regulatory Reform” in the Federal Register of June 22, 2017 (82 FR 28429). The document requested public comment on how DOI can improve implementation of regulatory reform initiatives and policies and identify regulations for repeal, replacement, or modification. This proposed rule addresses comments that DOI has received in response to the regulatory reform docket.

As part of implementing E.O. 13777, the National Oceanic and Atmospheric Administration (NOAA) published a notice entitled, “Streamlining Regulatory Processes and Reducing Regulatory Burden” (82 FR 31576, July 7, 2017). The notice requested public comments on how NOAA could continue to improve the efficiency and effectiveness of current regulations and regulatory processes. This proposed rule addresses comments NOAA received from the public.

This proposed rule is one of three related proposed rules, two of which are joint between the Services, that are publishing in today's Federal Register. All of these documents propose revisions to various regulations that implement the ESA.

Beyond the specific revisions to the regulations highlighted in this proposed rule, the Services are comprehensively reconsidering the processes and interpretations of statutory language set out in part 424. Thus, this rulemaking should be considered as applying to all of part 424, and as part of the rulemaking initiated today, the Services will consider whether additional modifications to the regulations setting out procedures and criteria for listing or delisting species and designating critical habitat would improve, clarify, or streamline the administration of the Act. We seek public comments recommending, opposing, or providing feedback on specific changes to any provisions in part 424 of the regulations, including but not limited to revising or adopting as regulations existing practices or policies, or interpreting terms or phrases from the Act. In particular, we seek public comment on whether we should consider modifying the definitions of “geographical area occupied by the species” or “physical or biological features” in section 424.02. Based on comments received and on our experience in administering the Act, the final rule may include revisions to any provisions in part 424 that are a logical outgrowth of this proposed rule, consistent with the Administrative Procedure Act.

In proposing the specific changes to the regulations in this rule and setting out the accompanying clarifying discussion in this preamble, the Services are proposing prospective standards only. Nothing in these proposed revisions to the regulations is intended to require (at such time as this rule becomes final) that any prior final listing, delisting, or reclassification determinations or previously completed critical habitat designations be reevaluated on the basis of any final regulations.

We propose to remove the phrase, “without reference to possible economic or other impacts of such determination”, from paragraph (b) to more closely align with the statutory language. Section 4(b)(1)(A) of the Act requires the Secretary to make determinations based “solely on the basis of the best scientific and commercial data available after conducting a review of the status of the species”. The word “solely” was added in the 1982 amendments to the Act (Pub. L. 97-304, 96 Stat. 1411) to clarify that the determination of endangered or threatened status was intended to be made “solely upon biological criteria and to prevent non-biological considerations from affecting such decisions.” In making the clarification, Congress expressed concerns with the requirements of the Regulatory Flexibility Act, Paperwork Reduction Act, and E.O. 12291 potentially introducing economic and other factors into the basis for determinations under the Act (H.R. Rep. No. 97-567 at 19-20, May 17, 1982).

In removing the phrase, the Services will continue to make determinations based solely on biological considerations. However, there may be circumstances where referencing economic, or other impacts may be informative to the public. For example, the Environmental Protection Agency conducts benefits and costs analyses of each proposed or revised National Ambient Air Quality Standard. These regulatory impact analyses are designed to inform the public and state, local, and tribal governments about the potential costs and benefits of implementation; however, the regulatory impact analyses are not a part of the standard selection process. While Congress precluded consideration of economic and other impacts from being the basis of a listing determination, it did not prohibit the presentation of such information to the public. Since 1982, Congress has consistently expressed support for informing the public as to the impacts of regulations in subsequent amendments to statutes and executive orders governing the rulemaking process.

In removing the phrase, “without reference to possible economic or other impacts of such determination”, the Services are not suggesting that all listing determinations will include a presentation of economic or other impacts. Rather, there may be circumstances where such impacts are referenced while ensuring that biological considerations remain the sole basis for listing determinations. The Services seek comment on this modification.

We propose to add to section 424.11 a new paragraph (d) that sets forth a framework for how the Services will consider the foreseeable future. Section 3(20) of the Act defines a “threatened species” as “any species which is likely to become endangered within the foreseeable future throughout all or a significant portion of its range.” The term “foreseeable future” is not further described within either the Act or the Services' current implementing regulations. Guidance addressing the concept of the foreseeable future within the context of determining the status of species is articulated in a 2009 opinion from the Department of the Interior, Office of the Solicitor (M-37021, January 16, 2009). The Services have found the reasoning and conclusions expressed in this document to be well-founded, and this guidance has been widely applied by both Services. We are proposing to amend section 424.11 to include a framework that sets out how the Services will determine what constitutes the foreseeable future when determining the status of species.

Specifically, we propose the following framework: In determining whether a species is a threatened species, the Services must analyze whether the species is likely to become an endangered species within the foreseeable future. The term foreseeable future extends only so far into the future as the Services can reasonably determine that the conditions potentially posing a danger of extinction in the foreseeable future are probable. The Services will describe the foreseeable future on a case-by-case basis, using the best available data and taking into account considerations such as the species' life-history characteristics, threat-projection timeframes, and environmental variability. The Services need not identify the “foreseeable future” in terms of a specific period of time, but may instead explain the extent to which they can reasonably determine that both the future threats and the species' responses to those threats are probable.

As stated above, under the proposed section 424.11(d), as under current practice, the foreseeable future will be described on a case-by-case basis. Congress did not set a uniform timeframe for the Secretary's consideration of whether a species was likely to become an endangered species, nor did Congress intend that the Secretary set a uniform timeframe. For each species considered for listing, the Services must review the best scientific and commercial data available regarding the likelihood of extinction over time, and then determine, with each status review, whether the species meets the definition of an endangered species or a threatened species. The foreseeable future is uniquely related to the particular species, the relevant threats, and the data available. Courts have expressly endorsed the Services' approach of tailoring analysis of the foreseeable future to each listing determination and considering the foreseeability of each key threat and the species' likely response. See, e.g., In Re Polar Bear Endangered Species Act Listing and Section 4(d) Rule Litigation, 709 F.3d 1, 15-16 (D.C. Cir. 2013) (noting that FWS “determines what constitutes the `foreseeable' future on a case-by-case basis in each listing decision” based on how far into the future the available data allow for reliable prediction of effects to the species from key threats), cert. denied sub nom. Safari Club Intern. v. Jewell, 134 S. Ct. 310 (2013).

The analysis of the foreseeable future should, to the extent practicable, account for any relevant environmental variability, such as hydrological cycles or oceanographic cycles, which may affect the reliability of projections. Analysis of the foreseeable future should consider the timeframes applicable to the relevant threats and to the species' likely responses to those threats in view of its life-history characteristics. Data that are typically relevant to assessing the species' biological response include species-specific factors such as lifespan, reproductive rates or productivity, certain behaviors, and other demographic factors.

Under proposed section 424.11(d), as under current practice, the foreseeable future for a particular status determination extends only so far as predictions about the future are reliable. “Reliable” does not mean “certain”; it means sufficient to provide a reasonable degree of confidence in the prediction. “Reliable predictions” is also used here in a non-technical, ordinary sense and not necessarily in a statistical sense.

As outlined in section 4(b)(1)(A) of the Act, status determinations must be based on the best scientific and commercial data available. By extension, in the context of determining whether a species meets the definition of a threatened species, the foreseeable future must also be based on the best scientific and commercial data available. The Services assess the data concerning each threat and the degree to which reliable predictions can be made. In many instances, the amount or quality of data available is likely to vary with respect to the relevant issues evaluated in a particular status determination; consequently, the Services may find varying degrees of foreseeability with respect to the multiple threats and their effects on a particular species. Although the Secretary's analysis as to the future status of a species may be based on reliable predictions with respect to multiple trends and threats over different periods of time or even threats without specific time periods associated with them, the final conclusion is a synthesis of that information. Thus, the foreseeable future is not necessarily reducible to a particular number of years. Nevertheless, if the information or data are susceptible to such precision, it may be helpful to identify the time scale used.

Depending on the nature and quality of the available data, predictions regarding the future status of a particular species may be based on analyses that range in form from quantitative population-viability models and modelling of threats to qualitative analyses describing how threats will affect the status of the species. In some circumstances, such analyses may include reliance on the exercise of professional judgment by experts where appropriate. In cases where the available data allow for quantitative modelling or projections, the time horizon presented in these analyses does not necessarily dictate what constitutes the “foreseeable future” or set the specific threshold for determining when a species may be in danger of extinction. Rather, the foreseeable future can extend only as far as the Services can reasonably depend on the available data to formulate a reliable prediction and avoid speculation and preconception. Regardless of the type of data available underlying the Service's analysis, the key to any analysis is a clear articulation of the facts, the rationale, and conclusions regarding foreseeability. Ultimately, to determine that a species is likely to become an endangered species in the foreseeable future, the Services must be able to determine that the conditions potentially posing a danger of extinction in the future are probable. The Services will avoid speculating as to what is hypothetically possible.

In section 424.11, we propose to redesignate current paragraph (d) as paragraph (e) and revise it to clarify that we determine whether a species is a threatened species or an endangered species using the same standards regardless of whether a species is or is not listed at the time of that determination. After identifying a “species” as defined under the Act and conducting a review of the species' status considering the factors under section 4(a)(1) of the Act, the Services determine if the species meets the definition of a threatened species or an endangered species. If the species does not meet either definition, the species should not be listed (if it is not already), or should be delisted (if it is currently listed). The standard for a decision to delist a species is the same as the standard for a decision not to list it in the first instance. This is consistent with the statute, under which the five-factor analysis in section 4(a)(1) and the definitions of “endangered species” and “threatened species” in sections 3(6) and 3(20) establish the parameters for both listing and delisting determinations without distinguishing between them.

Additionally, we propose to modify the current regulatory text to clarify the situations in which it would not be appropriate for species to remain on the lists of endangered and threatened species. The current regulatory language was intended to provide examples of when a species should be removed from the lists; however, the language in the current regulations has been, in some instances, misinterpreted as establishing criteria for delisting. This proposed change is consistent with the Services' longstanding practice and the decision in Friends of Blackwater v. Salazar, 691 F.3d 428 (D.C. Cir. 2012). That decision confirms that, when reviewing whether a listed species should be delisted, the Services must apply the factors in section 4(a) of the Act. 691 F.3d at 433 (upholding FWS's decision to delist the West Virginia northern flying squirrel because the agency was not required to demonstrate that all of the recovery plan criteria had been met before it could delist the species and it was reasonable to construe the recovery plan as predictive of the delisting analysis rather than controlling it). In that case, the court held that “Section 4(a)(1) of the Act provides the Secretary `shall' consider the five statutory factors when determining whether a species is endangered, and section 4(c) makes clear that a decision to delist ‘shall be made in accordance’ with the same five factors.” Id. at 432.

To more clearly align section 424.11 with section 4(a) of the Act we are proposing to streamline it. As is currently the case, any determination to remove a species from the lists because it is has become extinct is subject to the Act's requirement that any determination as to the species' status must be based on the best scientific and commercial data available. Thus, we are proposing to retain text at the beginning of the new section 424.11(e) that states; “The Secretary will delist a species if the Secretary finds that, after conducting a status review based on the best scientific and commercial data available:”

Secondly, to align more closely with the Act, we are proposing to replace the current section 424.11(d)(1) with a new section 424.11(e)(1) that simply states the first reason for delisting a species as, “The species is extinct.” Our conclusion that a species is extinct will be based on the best scientific and commercial data available, as required under section 4(b)(1)(A), which may include survey data and information regarding the period of time since the last detection (e.g., documented occurrence or sighting) of the species. It is unnecessary, and potentially confusing in the context of particular determinations, to specifically address these matters in the regulatory text. Our evaluations will be conducted on a case-by-case basis, considering the species-specific biological evidence for species extinction.

Third, we are replacing current section 424.11(d)(2), which referred to “recovery,” with language in new section 424.11(e)(2) that aligns with the statutory definitions of an endangered species or a threatened species. Although we are proposing to remove the word “recovery” from the current section 424.11(d)(2), we intend the proposed language to continue to refer, among other things, to species that have been recovered, because species that have been recovered no longer meet the definition of either an endangered species or a threatened species.

Fourth, we are proposing to add a new provision, section 424.11(e)(3), clarifying that listed entities will be delisted if they do not meet the definition of “species” as set forth in the Act. This could occur if new information, or new analysis of existing information, leads the Secretary to determine that a currently listed entity is neither a taxonomic species or subspecies, nor a “distinct population segment.” For example, where, after the time of listing, the Services conclude that a species or subspecies should no longer be recognized as a valid taxonomic entity, the listed entity would be removed from the list because it no longer meets the definition of a “species.” In other instances, new data could indicate that a particular listed distinct population segment does not meet the criteria of the Services' Policy Regarding the Recognition of Distinct Vertebrate Population Segments Under the Endangered Species Act (“DPS Policy”; 61 FR 4722, February 7, 1996). In either circumstance, the entity would not meet the definition of a “species” and would not qualify for listing under the Act.

Fifth, we are proposing to remove current section 424.11(d)(3), which specifies that delisting could be due to error in the original data that the Services relied upon when adding species to the lists. This language is unnecessary because any circumstance in which a species was listed in error would be covered by new section 424.11(e)(2) or (e)(3).

Lastly, we are proposing technical changes to the existing regulations that remain in place to accommodate the proposed revisions discussed above. We are proposing to modify current section 424.11(b) to include a reference to the proposed section 424.11(d) regarding the foreseeable future and the proposed section 424.11(e) regarding delisting. We are proposing to modify current section 424.11(c) by adding minor clarifying language to specify that this paragraph refers to the statutory definitions of an endangered species and a threatened species.

We propose to revise section 424.12(a)(1) to set forth a non-exhaustive list of circumstances in which the Services may find it is not prudent to designate critical habitat as contemplated in section 4(a)(3)(A) of the Act. Under the clarifications that we propose in this revision, the Services would have the authority but would not be required to find that designation would not be prudent in the enumerated circumstances. This is a change from the current framework, which sets forth two situations in which critical habitat is not prudent. We anticipate that not-prudent determinations would continue to be rare. While this provision is intended to reduce the burden of regulation in rare circumstances in which designation of critical habitat does not contribute to the conservation of the species, the Services recognize the value of critical habitat as a conservation tool and expect to designate it in most cases.

We propose to retain the circumstance described in the longstanding language of current section 424.12(a)(1)(i), which is that the species is threatened by taking or other human activity and identification of critical habitat can be expected to increase the degree of such threat to the species.

We propose to remove the language in section 424.12(a)(1)(ii) indicating that it would not be prudent to designate critical habitat when “designation of critical habitat would not be beneficial to the species.” In a number of cases, courts have remanded not-prudent findings to the Service(s) because the courts construed “would not be beneficial” in ways the Services had not intended. For example, a number of courts have held that it was unreasonable for FWS to make a not-prudent determination simply because most or all of the areas that would be designated would not be subject to consultations under ESA section 7. E.g., Natural Resources Defense Council v. U.S. Dept. of Interior, 113 F.3d 1121 (9th Cir. 1997); Conservation Council for Hawaii v. Babbitt, 2 F. Supp. 2d 1280 (D. Haw. 1998). In Conservation Council, the court concluded that FWS had not determined that designation would “not be beneficial to the species” because designating critical habitat could bring other benefits to the species beyond consultation, such as informational benefits. 2 F. Supp. 2d at 1288. In NRDC, the court held that determining critical habitat to be not prudent because the majority of the areas that would be designated as critical habitat would not be subject to consultation was based on an improper interpretation of the regulatory phrase “not beneficial to the species” to mean “not beneficial to most of the species.” 113 F.3d 1125-16. The existing regulatory language is not in the statute, and the Services consider the language unnecessary and difficult to understand and apply.

Basing determinations on whether particular circumstances are present, rather than on whether a designation would be beneficial, provides an interpretation of the statute that is clearer, more transparent, and more straightforward. In some situations, the Services may conclude, after a review of the best available scientific data, that a designation would nevertheless be prudent even in the enumerated circumstances. Conversely, the Services may find in some circumstances that are not enumerated in the proposed language that a designation of critical habitat would otherwise be not prudent.

We propose a number of circumstances in which designation of critical habitat would generally be not prudent, including some circumstances that were already captured in the current regulations at section 424.12(a)(1)(ii) and some additional circumstances that we have identified based on our experience in designating critical habitat. We propose to retain and move into new section 424.12(a)(1)(iv) the circumstance described in current section 424.12(a)(1)(ii), which is that no areas meet the definition of critical habitat. It is not possible for us to designate critical habitat when no areas meet the definition of critical habitat in the Act; therefore, in these cases, designation is not prudent. We also propose to retain and expand the concept of current section 424.12(a)(1)(ii) regarding the lack of habitat-based threats to the species.

In our 2016 revision of section 424.12(a)(1)(ii) (81 FR 7414, February 11, 2016), we clarified that, in determining whether designation may not be prudent, the Services could consider whether the present or threatened destruction, modification, or curtailment of a species' habitat or range (i.e., considerations under section 4(a)(1)(A) of the Act (Factor A)) is not a threat to the species. In the 2016 revision, we provided an example of a designation that would not be prudent due to the lack of habitat-based threats: A species is threatened primarily by disease, but the habitat upon which it relies remains intact without threat and would support conservation of the species if not for the threat of disease. Since then, we have encountered situations in which threats to the species' habitat stem solely from causes that cannot be addressed by management actions that may be identified through consultation under section 7(a)(2) of the Act. In those situations, a designation could create a regulatory burden without providing any conservation value to the species concerned. Examples would include species experiencing threats stemming from melting glaciers, sea level rise, or reduced snowpack but no other habitat-based threats. In such cases, a critical habitat designation and any resulting section 7(a)(2) consultation, or conservation effort identified through such consultation, could not prevent glaciers from melting, sea levels from rising, or increase the snowpack. Thus, we propose in section 424.12(a)(1)(ii) that designation of critical habitat in these cases may not be prudent because it would not serve its intended function to conserve the species.

We also propose to add as an additional circumstance under section 424.12(a)(1)(iii) situations where critical habitat areas under the jurisdiction of the United States provide negligible conservation value for a species that primarily occurs in areas outside of U.S. jurisdiction. In our 2016 revision of these regulations, we noted in the preamble that this could be a basis for determining that critical habitat designation would be not prudent; however, we find it is clearer to add this consideration directly to the regulatory text. We would apply this determination only to species that primarily occur outside U.S. jurisdiction, and where no areas under U.S. jurisdiction contain features essential to the conservation of the species. The circumstances when a critical habitat designation would provide negligible conservation value for a species will be determined on a case-by-case basis and may consider such factors as threats to the species or habitat and the species needs.

On February 11, 2016, the Services published a final rule revising the regulations at section 424.12, which establish criteria for designating critical habitat (81 FR 7439). One of the revisions we made was to eliminate the following paragraph (e): “The Secretary shall designate as critical habitat outside the geographical area presently occupied by a species only when a designation limited to its present range would be inadequate to ensure the conservation of the species.” The Services explained in the preamble to the final rule that we had concluded that the “rigid step-wise approach” prescribed in that prior regulatory language may not be the best conservation strategy for the species and in some circumstances may result in a designation that is geographically larger, but less efficient as a conservation tool (81 FR 7415). Nonetheless, we are aware of continued perceptions that, by eliminating this provision, the Services intended to designate as critical habitat expansive areas of unoccupied habitat. To address this concern, the Services propose to revise section 424.12(b)(2) by restoring the requirement that the Secretary will first evaluate areas occupied by the species. We also propose to clarify when the Secretary may determine unoccupied areas are essential for the conservation of the species.

In the Act, the term “geographical area occupied by the species” is further modified by the clause “at the time it is listed.” However, if critical habitat is not designated concurrently with listing, or is revised years after the species was listed, it can be difficult to discern what was occupied at the time of listing. The known distribution of a species can change after listing for many reasons, such as discovery of additional localities, extirpation of populations, or emigration of individuals to new areas. In many cases, information concerning a species' distribution, particularly on private lands, is limited because surveys are not routinely carried out on private lands. Although surveys may be performed as part of an environmental analysis for a particular development proposal, such surveys typically focus on listed rather than non-listed species. Thus, our knowledge of a species' distribution at the time of listing in these areas is often limited and the information in our listing rule may not detail all areas occupied by the species at that time.

Thus, while some of these changes in a species' known distribution reflect changes in the actual distribution of the species, some reflect only changes in the quality of our information concerning distribution. In these circumstances, the determination of which geographic areas were occupied at the time of listing may include data developed since the species was listed. This interpretation was supported by the court's decision, Otay Mesa Property L.P. v. DOI, 714 F. Supp. 2d 73 (D.D.C. 2010), rev'd on other grounds, 646 F.3d 914 (D.C. Cir. 2011) (San Diego fairy shrimp). In that decision, the judge noted that the clause “occupied at the time of listing” allows FWS to make a post-listing determination of occupancy based on the currently known distribution of the species in some circumstances. Although the D.C. Circuit disagreed with the district court that the record contained sufficient data to support the FWS' determination of occupancy in that case, the D.C. Circuit did not express disagreement with (or otherwise address) the district court's underlying conclusion that the Act allows FWS to make a post-listing determination of occupancy if based on adequate data. The Services acknowledge that to make a post-listing determination of occupancy we must distinguish between actual changes to species occupancy and changes in available information.

The Act defines unoccupied critical habitat in terms of a determination that such areas are essential for the conservation of the species. The proposed section 424.12(b)(2) specifies how the Services would determine whether unoccupied areas are essential. The proposed language states the Services would only consider unoccupied areas to be essential in two situations: When a critical habitat designation limited to geographical areas occupied would (1) be inadequate to ensure the conservation of the species, or (2) result in less-efficient conservation for the species. The proposed changes will provide additional predictability to the process of determining when designating unoccupied habitat may be appropriate. For example, the Services could consider unoccupied habitat to be essential when a designation limited to occupied habitat would result in a geographically larger but less effective designation.

There are situations where a designation focused on occupied critical habitat would result in less efficient conservation for the species than a designation that includes a mix of occupied and unoccupied critical habitat. In these cases, the designation of some unoccupied areas would result in the same or greater conservation for the species but would do so more efficiently. Efficient conservation for the species refers to situations where the conservation is effective, societal conflicts are minimized, and resources expended are commensurate with the benefit to the species. The flexibility to include unoccupied areas in a designation where limiting the designation to occupied areas would have resulted in less-efficient conservation of the species will allow the Services to focus agency resources thoughtfully in both designating critical habitat and conducting future consultations on the critical habitat.

In addition, we propose to further clarify when the Secretary may determine that an unoccupied area may be essential for the conservation of the species. In order for an unoccupied area to be considered essential, the Secretary must determine that there is a reasonable likelihood that the area will contribute to the conservation of the species. In making a determination as to whether such a reasonable likelihood exists, the Services will continue to take into account the best available science regarding species-specific and area-specific factors. This could include such factors as: (a) Whether the area is currently or is likely to become usable habitat for the species; (b) the likelihood that interagency consultation under Section 7 will be triggered, i.e., whether any federal agency actions are likely to be proposed with respect to the area; and, (c) how valuable the potential contributions of the area are to the biological needs of the species.

When the Services evaluate if an area is now, or is likely to become, usable habitat for the species we would take into account, among other things, the current state of the area and extent to which extensive restoration would be needed for the area to become usable. For example, the Services might conclude that an area is unlikely to contribute to the conservation of the species where it would require extensive affirmative restoration that does not seem likely to occur such as when a non-federal landowner or necessary partners are unwilling to undertake or allow such restoration. Although the expressed intentions of such landowners or partners will not necessarily be determinative, the Services would consider those intentions in light of the mandatory duties and conservation purposes of the Act.

When the Services evaluate the likelihood that interagency consultation under section 7 will be triggered, we would consider whether there are any federal agency actions likely to be proposed within the area (i.e., federal nexus). Because the only regulatory effect of a designation of critical habitat is the requirement that federal agencies avoid authorizing, funding, or undertaking actions that may destroy or adversely modify such habitat, the likelihood that an area will contribute to conservation is, in most cases, greater for public lands and lands for which such federal actions can be reasonably anticipated than for other types of land.

However, the Services would continue to consider the conservation purposes of the Act in determining how valuable the potential contributions of the area are to the biological needs of the species. In practice, this means that, in the rare instance where the potential contribution of the unoccupied area to the conservation of the listed species is extremely valuable, a lower threshold than “likely” may be appropriate. For example, where an area represents the only potential habitat of its type (i.e., is uniquely able to support certain life functions of the species), the Services may reasonably classify that area as essential even in the face of a low likelihood that the area would contribute to species conservation. Conversely, a greater showing of likelihood may be required for an area that provides less significant conservation value.

You may submit your comments and materials concerning the proposed rule by one of the methods listed in ADDRESSES. Comments must be submitted to http://www.regulations.gov before 11:59 p.m. (Eastern Time) on the date specified in DATES. We will not consider hand-delivered comments that we do not receive, or mailed comments that are not postmarked, by the date specified in DATES.

We will post your entire comment— including your personal identifying information—on http://www.regulations.gov. If you provide personal identifying information in your comment, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so. Comments and materials we receive, as well as supporting documentation we used in preparing this proposed rule, will be available for public inspection on http://www.regulations.gov.

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 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. This proposed rule is consistent with Executive Order 13563, and in particular with the requirement of retrospective analysis of existing rules, designed “to make the agency's regulatory program more effective or less burdensome in achieving the regulatory objectives.”

This proposed rule is expected to be an Executive Order 13771 deregulatory action.

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 (i.e., small businesses, small organizations, and small government jurisdictions). However, no regulatory flexibility analysis is required if the head of an agency, or his 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 certify that, if adopted as proposed, this proposed rule would not have a significant economic effect on a substantial number of small entities. The following discussion explains our rationale.

This rulemaking revises and clarifies requirements for NMFS and FWS regarding factors for listing, delisting, or reclassifying species and designating critical habitat under the Endangered Species Act to reflect agency experience and to codify current agency practices. The proposed changes to these regulations do not expand the reach of species protections or designations of critical habitat.

NMFS and FWS are the only entities that are directly affected by this rule because we are the only entities that list species and designate critical habitat under the Endangered Species Act. No external entities, including any small businesses, small organizations, or small governments, will experience any economic impacts from this rule.

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

(a) On the basis of information contained in the Regulatory Flexibility Act section above, this proposed rule would not “significantly or uniquely” affect small governments. We have determined and certify pursuant to the Unfunded Mandates Reform Act, 2 U.S.C. 1502, that this rule would 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 proposed rule would not place additional requirements on any city, county, or other local municipalities.

(b) This proposed rule would not produce a Federal mandate on State, local, or tribal governments or the private sector of $100 million or greater in any year; that is, this proposed rule is not a “significant regulatory action”' under the Unfunded Mandates Reform Act. This proposed rule would impose no obligations on State, local, or tribal governments.

In accordance with Executive Order 12630, this proposed rule would not have significant takings implications. This proposed rule would not pertain to “taking” of private property interests, nor would it directly affect private property. A takings implication assessment is not required because this proposed rule (1) would not effectively compel a property owner to suffer a physical invasion of property and (2) would not deny all economically beneficial or productive use of the land or aquatic resources. This proposed rule would substantially advance a legitimate government interest (conservation and recovery of endangered species and threatened species) and would not present a barrier to all reasonable and expected beneficial use of private property.

In accordance with Executive Order 13132, we have considered whether this proposed rule would have significant Federalism effects and have determined that a federalism summary impact statement is not required. This proposed rule pertains only to factors for listing, delisting, or reclassifying species and designation of critical habitat under the Endangered Species Act, and 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.

This proposed rule does not unduly burden the judicial system and meets the applicable standards provided in sections 3(a) and 3(b)(2) of Executive Order 12988. This proposed rule would clarify factors for listing, delisting, or reclassifying species and designation of critical habitat under the Endangered Species Act.

In accordance with Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments,” the Department of the Interior's manual at 512 DM 2, and the Department of Commerce (DOC) Tribal Consultation and Coordination Policy (May 21, 2013), DOC Departmental Administrative Order (DAO) 218-8 (April 2012), and NOAA Administrative Order (NAO) 218-8 (April 2012), we are considering possible effects of this proposed rule on federally recognized Indian Tribes. We will continue to collaborate/coordinate with tribes on issues related to federally listed species and their habitats. See Joint Secretarial Order 3206 (“American Indian Tribal Rights, Federal-Tribal Trust Responsibilities, and the Endangered Species Act,” June 5, 1997).

This proposed rule does not contain any new collections of information that require approval by the OMB under the Paperwork Reduction Act. This proposed rule will not impose recordkeeping or reporting requirements on State, local, or Tribal governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

We are analyzing this proposed regulation in accordance with the criteria of the National Environmental Policy Act (NEPA), the Department of the Interior regulations on Implementation of the National Environmental Policy Act (43 CFR 46.10-46.450), the Department of the Interior Manual (516 DM 8), the NOAA Administrative Order 216-6A, and the NOAA Companion Manual (CM), “Policy and Procedures for Compliance with the National Environmental Policy Act and Related Authorities” (effective January 13, 2017).

We anticipate that the categorical exclusion found at 43 CFR 46.210(i) likely applies to the proposed regulation changes. At 43 CFR 46.210(i), the Department of the Interior has found that the following category of actions would not individually or cumulatively have a significant effect on the human environment and are, therefore, categorically excluded from the requirement for completion of an environmental assessment or environmental impact statement: “Policies, directives, regulations, and guidelines: that are of an administrative, financial, legal, technical, or procedural nature.”

NOAA's NEPA procedures include a similar categorical exclusion for “preparation of policy directives, rules, regulations, and guidelines of an administrative, financial, legal, technical, or procedural nature.” (Categorical Exclusion G7, at CM Appendix E).

We invite the public to comment on the extent to which this proposed regulation may have a significant impact on the human environment, or fall within one of the categorical exclusions for actions that have no individual or cumulative effect on the quality of the human environment. We will complete our analysis, in compliance with NEPA, before finalizing this regulation.

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

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

(1) Be logically organized;

(2) Use the active voice to address readers directly;

(3) Use clear language rather than jargon;

(4) Be divided into short sections and sentences; and

(5) Use lists and tables wherever possible.

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

We issue this proposed rule under the authority of the Endangered Species Act, as amended (16 U.S.C. 1531 et seq).

For the reasons set out in the preamble, we hereby propose to amend part 424, subchapter A of chapter IV, title 50 of the Code of Federal Regulations, as set forth below: