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Federal Endangered Species Act Section 7 Consultation Process (12-FD-c)

Section 7 of the Endangered Species Act (ESA) requires each federal agency to actively engage in the conservation and recovery of threatened or endangered species. Section 7(a)(2) of the ESA requires federal agencies, in consultation with the Secretary of the Interior, to “insure that any action authorized, funded, or carried out by such agency… is not likely to jeopardize the continued existence of any endangered species or threatened species or result in the destruction or adverse modification of habitat of such species…”

Section 7(a)(2) consultation may take on different forms, including:

  • Informal Consultation;
  • Formal Consultation;
  • Early Consultation;
  • Informal Conference; and
  • Formal Conference.

Informal consultation is a process that includes all discussions and correspondence between the National Marine Fisheries Service (NMFS), the United States Fish and Wildlife Service (FWS) (together the "Services"), an action agency (a federal agency that is authorizing, funding, or carrying out the proposed action) or a designated non-federal representative. Informal consultation should take place prior to requesting a concurrence or formal consultation. It is used to determine whether a proposed federal action may affect listed species (species listed on the endangered species list) or critical habitat. This process allows the federal agency to utilize the Services' expertise to evaluate the agency's assessment of potential effects or to suggest possible modifications to the proposed action which could avoid potentially adverse effects. If a proposed federal action may affect a listed species or designated critical habitat, formal consultation is required (except when the Services concur, in writing, that a proposed action "may affect, but is not likely to adversely affect" listed species or designated critical habitat). See 50 CFR 402.02; 50 CFR 402.13

Most consultations are informal. Agencies are encouraged to enter into informal consultation unless it is clear from the beginning that formal consultation will be required. Informal consultations:

  • Clarify whether and what listed, proposed, and candidate species or designated or proposed critical habitats may be in the action area;
  • Determine what effect the action may have on these species or critical habitats;
  • Explore ways to modify the action to reduce or remove adverse effects to the species or critical habitats;
  • Determine the need to enter into formal consultation for listed species or designated critical habitats, or conference for proposed species or proposed critical habitats; and
  • Explore the design or modification of an action to benefit the species

See ESA Consultation Handbook, page 3-1.

Informal consultation consists of phone consultations, project modifications and unstructured meetings that occur before formal consultation, or, if the Services agree that formal consultation is unnecessary, before a written concurrence is issued. See ESA Consultation Handbook, page 3-1.

Participants in informal consultation may include:

  • The action agency;
  • A designated non-federal representative;
  • The developer, or;
  • Consultants working on behalf of any of the first three.

See ESA Consultation Handbook, page 3-1.

A formal consultation is required to determine whether the project is likely to jeopardize the continued existence of a listed species or will destroy or adversely modify critical habitat. Formal consultations also evaluate whether there is anticipated incidental take (destruction of or harm to an individual member of a listed species). The purpose of the consultation is to identify any direct, indirect and cumulative effects of a proposed action. Agencies should also strive to identify appropriate reasonable and prudent alternatives, and reasonable and prudent measures to protect natural resources.

If the species is proposed for listing but not yet listed, section 7(a)(4) of the ESA requires federal agencies to “confer” with the Services. As with consultation, a conference may be either formal or informal. Unlike a consultation, a conference is only required if an action is likely to jeopardize the continued existence of a proposed species or destroy or adversely modify proposed critical habitat. In addition, the Services (as opposed to the action agency) may initiate a conference if they determine that a federal action is likely to jeopardize a proposed species or destroy or adversely modify proposed critical habitat. See ESA Consultation Handbook, pages 6-1 – 6-2.

Section 7(a)(3) of the ESA allows developers to initiate an early consultation process before filing an application for a federal permit or license. If the developer meets the requirements, the action agency must initiate early consultation with the Services. The early consultation process is the same as the formal consultation process. At the end of the process, a preliminary biological opinion and incidental take permit are drafted, although they do not become effective until the early consultation is confirmed as a formal consultation. See ESA Consultation Handbook, pages 7-1 – 7-3.

Regulations governing Section 7(a)(2) consultation requirements can be found at 50 CFR 402.


Endangered Species Act Section 7 Consultation Process Process

12-FD-c.1 to 12-FD-c.2 – Will the Developer Request an Early Consultation?; Send Certifications to Action Agency

As stated above, Section 7(a)(3) of the ESA allows developers to initiate an early consultation before filing an application for a federal permit or license. The purpose of the early consultation is to “reduce the likelihood of conflicts between listed species or critical habitat and proposed actions.” See 50 CFR 402.11(a). Early consultation takes place between the action agency and the Services, but the developer should be included in the process.

The action agency will not initiate early consultation unless requested to do so by the developer. If the developer believes that the proposed action will affect listed species or critical habitat, it must send a written early consultation request to the action agency. The request must certify that the developer has a definitive proposal outlining the action and its effects and that that the developer intends to implement the proposal, if authorized. See 50 CFR 402.11(b).

Once the action agency receives the request from the developer, it initiates consultation in accordance with 50 CFR 402.14(c). If the proposed action is a “major construction activity,” a biological assessment is required. The procedures for the early consultation are identical to those for the formal consultation. At the end of the process, the Services will produce a preliminary biological opinion, which is identical to an actual biological opinion, except that the incidental take statement does not authorize the taking of listed species. See 50 CFR 402.11(c)-(d).

The preliminary opinion may be confirmed as the biological opinion if the Services review the proposed action and find that the planned action and information used during the early consultation have not changed. If, after receiving a written request for confirmation from the developer, the Services evaluate the preliminary opinion and cannot confirm it as the biological opinion, the action agency must initiate formal consultation. See 50 CFR 402.11(f).

12-FD-c.3 to 12-FD-c.4 – Request or Submit a Species List

For projects that are authorized, funded, or carried out by a federal agency, the action agency makes an official request to the Services for a list of listed species and designated critical habitats that may be present in the project area. The action agency may also develop its own list and request a concurrence from the Services. The Services must provide the action agency with a species list, a revised species list, or a concurrence within 30 days of receipt of the notification. See 50 CFR 402.12(c) and (d).

12-FD-c.5 to 12-FD-c.7 - May the Project Adversely Affect Proposed Species or Critical Habitat? Are Listed Species or Critical Habitat Present?

If no listed species or proposed species or critical habitat are present in project area, further consultation is not required. If proposed species or proposed critical habitat are present, the action agency must confer with the Services. See 50 CFR 402.12(d)(1).

As stated above, section 7(a)(4) of the ESA requires federal agencies to confer with the Services if an action “is likely to jeopardize the continued existence of any species proposed to be listed… or result in the destruction or adverse modification of critical habitat proposed to be designated for such species.”

12-FD-c.8 to 12-FD-c.11 – Has the Action Agency Initiated a Conference with the FWS?; Conduct Informal Conference; Conference Report

Section 7(a)(4) of the ESA requires federal agencies to initiate a conference if jeopardy to a proposed species or destruction or adverse modification of proposed critical habitat is likely. However, federal agencies may request a conference, regardless of the likelihood of adverse effects, if the action may affect proposed species or habitat. See 50 CFR 402.10(b); ESA Consultation Handbook, page 6-1.

If it is not clear whether the proposed action is likely to adversely affect proposed species or critical habitat, the conference process begins with an informal conference. The informal conference involves informal discussions between the Services, the action agency, and the developer. The Services “may assist the action agency in determining effects and may advise the action agency on ways to avoid or minimize adverse effects to proposed species…or proposed critical habitat…” See ESA Consultation Handbook, page 6-1.

If, after the informal conference, the parties determine that an adverse effect to proposed species or critical habitat is likely, a formal conference will be initiated. An action agency may also request a formal conference at any time. If the parties determine that adverse effects are not likely, the Services will prepare a conference report. The conference report contains advisory recommendations for reducing adverse effects. The report is not binding, however, because action agencies are not prohibited from adversely affecting proposed species or critical habitat until they are listed. See ESA Consultation Handbook, pages 6-1 – 6-2.

12-FD-c.12 to 12-FD-c.14 – Has the FWS Determined that Jeopardy or Adverse Modification is Likely?; Conference Notice

The Services, rather than the action agency, may initiate a conference if they determine, based on a review of available information, that an action is likely to jeopardize a proposed species or destroy or adversely modify critical habitat. The conference is initiated by sending a conference notice in the form of a letter or memorandum to the action agency. See ESA Consultation Handbook, page 6-2; 50 CFR 402.10(b). If adverse effects are not likely, no conference is required.

12-FD-c.15 to 12-FD-c.16 – Conduct Formal Conference; Conference Opinion

A formal conference is conducted in accordance with the procedures for formal consultation in 50 CFR 402.14, although it is conducted for proposed, not listed, species. See 50 CFR 402.10(d). At the end of the formal conference, a conference opinion is issued, which may later be certified as a biological opinion, so long as no new information is developed and no significant changes are made that would alter the content of the opinion. See 50 CFR 402.10(d). Information on the format of the conference opinion can be found in the ESA Consultation Handbook, pages 6-4 – 6-5.

12-FD-c.17 to 12-FD-c.20 – Is the Species Subsequently Listed?; Has the Conference Opinion Been Confirmed as the Biological Opinion?

If a proposed species or critical habitat is subsequently listed, the action agency may request that the Services confirm and adopt the conference opinion as the biological opinion. The request must be made in writing, and the Services must confirm or deny the request within 45 days. The incidental take statement in the conference opinion is not effective until or unless the conference opinion is adopted by the Services. If the Services adopt the conference opinion, the section 7 consultation process is concluded. If the confirmation opinion is not adopted, formal consultation will be required. See ESA Consultation Handbook, page 6-6; 50 CFR 402.10(d).

12-FD-c.21 to 12-FD-c.24 – Is the Project a Major Construction Activity?; Biological Evaluation; Biological Assessment

If the project is a “major construction activity” and listed species or critical habitat are present in the action area, the action agency must prepare a biological assessment. A “major construction activity” is a federal action that significantly affects the quality of the human environment, as referred to in the National Environmental Policy Act (NEPA). If the action is not a “major construction activity” but listed species or critical habitat are likely to be affected, the action agency must still provide the Services with biological evaluation. A biological evaluation is an account of the basis for evaluating the likely effects of the action. See ESA Consultation Handbook, page 3-11. In practice, there is often no distinction between the biological assessment and the biological evaluation.

A biological assessment refers to information prepared by the action agency concerning “listed and proposed species and designated and proposed critical habitat that may be present in the action area and the evaluation [of] potential effects of the action on such species and habitat.” See 50 CFR 402.02; Section 7(c) of the ESA.

The biological assessment is submitted to the Services upon completion. The Services will review the biological assessment for sufficiency. Although the contents of a biological assessment are discretionary, at a minimum it should evaluate the likely effects of the proposed action on listed species or critical habitat. 50 CFR 402.12(f) suggests the following should be considered for inclusion:

  • The results of an on-site inspection of the area affected by the action to determine if listed or proposed species are present or occur seasonally;
  • The views of recognized experts on the species at issue;
  • A review of the literature and other information;
  • An analysis of the effects of the action on the species and habitat, including consideration of cumulative effects, and the results of any related studies; and
  • An analysis of alternate actions considered by the Federal agency for the proposed action.

A formal consultation may not begin until a biological assessment has been submitted to the Services (if required). When both proposed and listed species are found in the project area, an assessment of the potential impacts must be accomplished and address both the listed and proposed species/critical habitat.

12-FD-c.25 - Review Biological Assessment

The biological assessment will contain the action agency’s determination regarding potential effects on listed species or critical habitat. The potential determinations in a biological assessment are:

  • No effect;
  • May affect, but is not likely to adversely affect; and
  • May affect, and is likely to adversely affect.

See ESA Consultation Handbook, pages 3-12 – 3-13. The Services will review the completed biological assessment and effects determination. If a proposed federal action may affect a listed species or designated critical habitat, formal consultation is required. The formal consultation may not be initiated until the biological assessment has been submitted to the Services. If the action agency determines that a proposed action "may affect, but is not likely to adversely affect" listed species or designated critical habitat, it must seek concurrence from the Services. If the proposed action will not affect a listed species or critical habitat, no concurrence is required, but the action agency may discuss the determination with the Services and note their concurrence in the administrative record. See ESA Consultation Handbook, page 4-1; ESA Consultation Handbook, page 3-12.

Following the Services’ review of the biological assessment or other pertinent information, another informal effort may be appropriate to try to eliminate any residual adverse effects. If that effort results in elimination of potential impacts, the Services will concur in writing that the action, as revised and newly described, is not likely to adversely affect listed species or designated critical habitat. Since concurrence depends upon implementation of the modifications, the concurrence letter must clearly state any modifications agreed to during informal consultation. If agreement cannot be reached, the agency is advised to initiate formal consultation. See ESA Consultation Handbook, page 3-12.

12-FD-c.26 to 12-FD-c.27 – Will the Project Affect Listed Species or Critical Habitat; Seek USFWS Concurrence of No Effect (Optional)

"No effect" is the appropriate conclusion when the action agency determines its proposed action will not have any effects to a listed species or designated critical habitat. Due to regulatory construct, the Services do not typically concur with a "no effect" determination. However, an action agency may discuss a "No effect" determination with the Services and note the Services’ general agreement in the administrative record. "No effect" means there will be no impacts, positive or negative, to listed or proposed resources. Generally, this means no listed resources will be exposed to the action and its environmental consequences. Concurrence from the Service is not required. See ESA Consultation Handbook, page 3-12.

12-FD-c.28 to 12-FD-c.29- Is the Project Likely to Adversely Affect Species or Critical Habitat?; Written Concurrence with the "No Likely Adverse Effects" Determination

When effects on listed species are expected to be discountable, insignificant, or completely beneficial, the appropriate determination is "May affect, but not likely to adversely affect.” A determination of "may affect, but not likely to adversely affect" requires written concurrence from the Services. See ESA Consultation Handbook, page 3-12.

A federal agency's determination (from the biological assessment or other assessment document) that the project is likely to adversely affect species or critical habitat triggers the obligation for the action agency to request Formal Consultation.

12-FD-c.30 - Letter to the Services Initiating Formal Consultation

The action agency initiates formal consultation through a written request to the Services. The request includes appropriate documents assessing the impacts of the proposed project. In the case of a major construction activity, the action agency is required to submit the biological assessment. The biological assessment, including a description of the effects of the action, must be submitted within 180 days of receipt of a species list from the Services. See ESA Consultation Handbook, page 4-4.

12-FD-c.31 - Does the Letter and Biological Assessment Provide Sufficient Information?

50 CFR 402.14(c) requires that an initiation package be submitted with the request for formal consultation and must include all of the following:

  • A description of the action to be considered;
  • A description of the specific area that may be affected by the action;
  • A description of any listed species or critical habitat that may be affected by the action;
  • A description of the manner in which the action may affect any listed species or critical habitat and an analysis of any cumulative effects;
  • Relevant reports, including any environmental impact statement, environmental assessment, or biological assessment prepared; and
  • Any other relevant available information on the action, the affected listed species, or critical habitat.

12-FD-c.32 - Notify Action Agency of Missing 50 CFR 402.14(c) Data

The Services must review the initiation package to determine whether it complies with the information requirements of 50 CFR 402.14(c) and the data requirements of 50 CFR 402.14(d). If it does not, the Services must notify the action agency within 30 days. The "other relevant information" requirement gives the Services an opportunity to determine what project-specific information is needed to develop the biological opinion. The action agency is obligated to submit the best data available or data "which can be obtained during the consultation ...." See 50 CFR 402.14(d). Although not required by 50 CFR 402.14, a topographic map showing the affected area is a useful addition to the initiation package.

12-FD-c.33 - Formal Consultation Between Agencies

The objectives during formal consultation include:

  • Assess the status of the species and/or critical habitat involved;
  • Verify the scope of the proposed action, which includes identifying the area likely to be affected directly and indirectly by the proposed action, and cumulative effects;
  • Identify adverse effects likely to result in jeopardy to the species and/or adverse modification of critical habitat;
  • Develop reasonable and prudent alternatives to an action likely to result in jeopardy or adverse modification;
  • Identify adverse effects not likely to jeopardize listed species, but which constitute "take" pursuant to section 9 of the Act;
  • Develop reasonable and prudent measures, and terms and conditions for the incidental take statement as appropriate; and
  • Identify conservation recommendations as appropriate.

See ESA Consultation Handbook, page 4-6.

Formal consultation should take 90 calendar days. If the consultation is expected to take more than 150 days and a developer is involved, a letter containing the Services' reasons for delay, information required to complete the consultation, and the estimated date of completion is sent to the developer. If the consultation is expected to take 150 days or more, the Services will send a letter to the developer requesting consent to an extension. See 50 CFR 402.14(e)

These actions should be undertaken cooperatively with the action agency and any developer, thus allowing the Services to develop a better understanding of direct and indirect effects of a proposed action and any cumulative effects in the action area. Action agencies also have the project expertise necessary to help identify reasonable and prudent alternatives, and reasonable and prudent measures. Other interested parties (including the developer, and affected state and tribal governments) should also be involved in these discussions. These cooperative efforts should be documented for the administrative record. See ESA Consultation Handbook, page 4-7.

12-FD-c.34 - Formulate Biological Opinion and Incidental Take Statement in conjunction with Action Agency

After the formal consultation, the Services prepare an incidental take statement and a biological opinion.

An incidental take is a take that results from, but is not the purpose of, carrying out an otherwise lawful activity conducted by the action agency or the developer. See 50 CFR 402.2. An incidental take statement exempts “action agencies and their permittees from the ESA’s section 9 prohibitions if they comply with the reasonable and prudent measures and the implementing terms and conditions of incidental take statements.” See ESA Consultation Handbook, page 4-47. If a formal consultation is conducted and an incidental take statement is included in the biological opinion, the action agency will not need to obtain a section 10 incidental take permit.

According to section 7(b)(4) of the ESA, an incidental take statement must be a written statement that:

  • Specifies the impact of such incidental taking on the species;
  • Specifies those reasonable and prudent measures that the Secretary considers necessary or appropriate to minimize such impact;
  • In the case of marine mammals, specifies those measures that are necessary to comply with section 101(a)(5) of the Marine Mammal Protection Act with regard to such taking; and
  • Sets forth the terms and conditions (including, but not limited to, reporting requirements) that must be complied with by the Federal agency or developer (if any), or both, to implement the measures specified above.

Takes will only be covered by the incidental take statement if they:

  • Are not likely to jeopardize the continued existence of listed species or destroy or adversely modify designated critical habitat;
  • Result from an otherwise lawful activity; and
  • Are incidental to the purpose of the action.

See ESA Consultation Handbook, page 4-48.

A biological opinion “is the document that states the opinion of the Service as to whether or not the federal action is likely to jeopardize the continued existence of listed species or result in the destruction or adverse modification of critical habitat.” See 50 CFR 402.2.

The biological opinion should include:

  • A description of the proposed action;
  • The status of the species/critical habitat;
  • The environmental baseline;
  • The effects of the action;
  • The cumulative effects;
  • The Services’ conclusion of jeopardy/no jeopardy and/or adverse modification/no adverse modification; and
  • Reasonable and prudent alternatives, as appropriate.

For a more detailed description of the format of the biological opinion, see ESA Consultation Handbook, page 4-15.

If the Services determine that the federal action is likely to jeopardize the continued existence of listed species or result in the destruction or adverse modification of critical habitat, the biological opinion is referred to as a “jeopardy biological opinion.” Jeopardy biological opinions indicate that the action agency will violate section 7(a)(2) of the ESA if the proposed project proceeds without modification. The jeopardy biological opinion will recommend reasonable and prudent alternatives (if possible) that, if complied with, will allow the action agency to avoid violation of the Act.

The Services ensure the biological opinion, including an incidental take statement, is prepared and delivered within 135 days of initiation of formal consultation. The consultation timeframe cannot be "suspended." If the Services need more time to analyze the data or prepare the final opinion, or the action agency needs time to provide data or review a draft opinion, an extension may be requested by either party. Both the Services and the action agency must agree to the extension. Extensions should not be indefinite, and should specify a schedule for completing the consultation. If a developer is involved in the project, extension must follow the procedures outlined by section 7(b)(1)(B) of the ESA. In accordance with 50 CFR 402.14(e), a consultation involving a developer cannot be extended for more than 60 days without the consent of the developer.

No final biological opinion will be issued before the 135th day if the action agency is still reviewing the draft. Once the Services receive comments on the draft, the biological opinion is finalized and delivered to the action agency and developer, if any. See ESA Consultation Handbook, page 4-7.

12-FD-c.35 – Review the Draft Biological Opinion and Incidental Take Permit

The Services, the action agency, and the developer must discuss the review and evaluation conducted during formal consultation, the basis for any finding in the biological opinion, and the availability of reasonable and prudent alternatives (if a jeopardy biological opinion is issued) that the action agency and developer can take to avoid violating of section 7(a)(2) of the ESA . The Services should develop reasonable and prudent alternatives in conjunction with the action agency. After the draft biological opinion and draft incidental take statement are complete, the action agency may request copies for review. Both the developer and the action agency may comment on the drafts and submit comments to the Services. The Services will not issue the final biological opinion prior to the 135 day deadline or any extension while the draft is being reviewed by the action agency. See 50 CFR 402.14(g)(5).

12-FD-c.36 – Final Biological Opinion and Incidental Take Statement

The Services finalize the biological opinion once they receive comments from the action agency and developer. The Services may seek an extension in order to make any clarifications or modifications necessitated by the comments. Once complete, the final biological opinion and incidental take statement are delivered to the action agency. See ESA Consultation Handbook, page 4-7.

After the issuance of a biological opinion, the action agency must determine “whether and in what manner to proceed with the action in light of its section 7 obligations and the Service's biological opinion.” If a jeopardy biological opinion is issued, the action agency must notify the Services of its final decision on the action. See 50 CFR 402.15(a)-(b). A jeopardy finding does not prevent the action agency from continuing with the proposed action. However, the action agency will likely be in violation of the ESA and may be vulnerable to legal action.






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