Session 10

Back to Session 10: The National Environmental Policy Act

Environmental Impact Statements

EIS Definition

The NEPA definition of EIS is described as follows:

"Include in every recommendation or report on proposals for legislation and other major federal actions significantly affecting the quality of the human environment, a detailed statement by the responsible official on:

• The environmental impact of the proposed action

• Any adverse environmental effects that cannot be avoided should the proposal be implemented

• Alternatives to the proposed action

• The relationship between local short-term uses of man's environment and the maintenance and enhancement of long-term productivity

• Any irreversible and irretrievable commitments of resources which would be involved in the proposed action should it be implemented

Prior to making any detailed statement, the responsible federal official shall consult with and obtain the comments of any federal agency that has jurisdiction by law or special expertise with respect to any environmental impact involved. Copies of such statement and the comments and views of the appropriate federal, state, and local agencies that are authorized to develop and enforce environmental standards, shall be made available to the President, the Council on Environmental Quality, and the public as provided by Section 552 of Title V, United States Code, and shall accompany the proposal through the existing agency review processes."

EPA Filing System Guidance  

EPA provides the following guidelines for submitting environmental impact statements:

1. Purpose.

 

"These guidelines provide information on filing environmental impact statements (EISs) required by the National Environmental Policy Act (NEPA) and the Council on Environmental Quality (CEQ) Regulations (40 CFR Parts 1500-1508) for implementing the procedural provisions of NEPA. Sections 1506.9 and 1506.10 of the CEQ Regulations set forward EPA's basic responsibilities for the filing process and authorize the Agency to issue guidelines to implement its responsibilities under these sections. The process of filing includes the following: (a) Reviewing and recording of the EISs so that information on them can be incorporated into EPA's computerized data base; (b) establishing the beginning and ending dates when draft and final EISs are officially available to the public; (c) publishing these dates in a "Notice of Availability" in the Federal Register; (d) retaining the EISs in a central repository; and (e) determining whether time periods can be lengthened or shortened for "compelling reasons of national policy."

EPA duties do not include responsibility for the distribution of EISs or for providing additional copies of already distributed EISs. These are the obligation of the lead agency preparing an EIS and are not addressed in this guidance. Nevertheless, EPA will assist the public and other Federal agencies by providing agency contacts on, and information about EISs.

 

2. Background

 

The official EIS filing system was transferred from the Council on Environmental Quality (CEQ) to the Environmental Protection Agency (EPA) effective December 5, 1977, as part of the reorganization of the Executive Office of the President. The functions of the filing system were further delineated by a Memorandum of Understanding between CEQ and EPA, dated March 29, 1978. CEQ promulgated its regulations for implementing the National Environmental Policy Act (NEPA) on November 29, 1978 (see 43 FR 55978). The EPA filing system was created to provide an official log and public announcement of EISs received by EPA and to guarantee that the requirements of NEPA and the CEQ Regulations are satisfied. It is a complete and separate filing system from the Environmental Review Process System which fulfills separate requirements under Section 309 of the Clear Air Act for EPA to review and comment on EISs (and other actions) of Federal agencies.

 

3. Filing an EIS--Draft, Final and Supplemental

Federal agencies are required to prepare EISs in accordance with Section 1502 of the Regulations and to file the EISs with EPA as specified in 1506.9. The EISs must be filed no earlier than they are transmitted to commenting agencies and made available to the public. If an EIS is hand carried to EPA, the person delivering the document must complete a form stating that transmittal to all agencies is being made simultaneously with the filing with EPA. This will assure that the EIS is received by all interested parties by the time the EPA Notice of Availability appears in the Federal Register, and therefore allows for the full minimum review periods prescribed in 1506.10. EPA will acknowledge by a phone call to the sender that it has received an EIS forwarded by means other than hand carried.

 

If EPA receives a request to file an EIS and transmittal of that EIS is not complete, the EIS will not be filed until assurances have been given that the transmittal process is complete. Similarly, if EPA discovers that a filed EIS has not been transmitted, EPA will retract the EIS from filing and not refile the EIS until the transmittal process is completed. Once the agency has fulfilled the requirements of 1506.9 and has completed the transmittal process, EPA will reestablish the filing date and the minimum time period, and will publish this information in the next Notice of Availability. Requirements for circulation of EISs appear in 1502.19 of the Regulations.

 

Federal agencies file an EIS by providing EPA with five (5) copies, including appendices. [editor's note: since original publication of this guidance in the Federal Register, EPA has clarified that in addition to the five copies of the EIS that are filed with EPA Headquarters, agencies should provide a copy of the EIS directly to the appropriate EPA Regional Office(s) for review and comment]. Material which is incorporated into the EIS by reference is not required to be filed with EPA. The agency filing the EIS (usually the lead agency if more than one is involved) should prepare a letter of transmittal to accompany the five copies of the EIS. The letter should identify the name and telephone number of the official responsible for both the distribution and contents of the EIS, should state that the transmittal has been completed.

 

EPA should be notified in writing of all situations where a Federal agency is adopting an EIS, whether the document is recirculated and filed or adopted under the provisions of 1506.3(c) of the Regulations. If a Federal agency chooses to adopt an EIS written by another agency and it was not a cooperating agency in the preparation of the original EIS, then the EIS must be retransmitted and filed with EPA according to the requirements set forth in 1506.3 of the CEQ Regulations. In those cases where an agency can adopt an EIS without recirculating it, there is no necessity to file the EIS again with EPA. EPA should be notified, however, in order to ensure that the official log is accurate, and to include this information as a separate section within the Notice of Availability. This will not establish a comment period, but will complete the public record.

 

EPA also should be notified of all situations where an agency has decided to withdraw, delay or reopen a review period on an EIS. All such notices to EPA will be published in the Federal Register. In the case of reopening EIS review periods, the lead agency should notify EPA as to what measures will be taken to ensure that the EIS is available to all interested parties. This is especially important for EIS reviews that are being reopened after a substantial amount of time has passed since the original review period closed.

 

Once received by EPA, each EIS is stamped with an official filing date and checked for completeness and compliance with 1502.10 of the CEQ Regulations. If the EIS is not "complete" (i.e., if the documents do not contain those elements outlined in 1502.10 of the Regulations), EPA will contact the lead agency to obtain the omitted information or to resolve any problems prior to publication of the Notice of Availability in the Federal Register.

 

Agencies often publish (either in their EISs or individual notices to the public) a date by which all comments on an EIS are to be received. Agencies should ensure that the date they use is based on the date of publication of the Notice of Availability in the Federal Register. If the published date gives reviewers less than the minimum review time computed by EPA,then EPA will send the agency contact a letter explaining how the review period is calculated and the correct date by which comments are due back to the lead agency. This letter also encourages agencies to notify all reviewers and interested parties of the corrected review periods.

 

4. Notice in the Federal Register

 

EPA will prepare a weekly report of all EISs filed during the preceding week for publication each Friday under a Notice of Availability in the Federal Register. At the time EPA sends its weekly report for publication in the Federal Register, the report will also be sent to the CEQ. Information included in the report for each EIS is the same as the data entered in EPA's computerized data file. This includes an EIS Accession number (created by EPA), EIS status (draft, final, supplemental), date filed with EPA, the agency or bureau that filed the EIS, the state and county of the action that prompted the EIS, the title of the EIS, the date comments are due and the agency contact. Amended notices may be added to the Notice of Availability to include corrections, changes in time periods of previously filed EISs, withdrawals of EISs by lead agencies, and recision of EISs by EPA. A recision including nullifying the date the EIS was filed can occur, as explained earlier, if, after a filed EIS is published in the Federal Register. EPA is subsequently informed that the EIS has not been made available to commenting agencies and the public by the lead agency.

 

5. Time Periods

 

The minimum time periods set forth 1506.10(b),(c), and (d) are calculated from the date EPA publishes the Notice of Availability in the Federal Register. Review periods for draft EISs, draft supplements, and revised draft EISs shall extend 45 calendar days unless the lead agency extends the prescribed period or a reduction of the period has been granted. The wait periods for final EISs and final supplements shall extend for 30 calendar days unless the lead agency extends the period or a reduction or extension in the period has been granted. If a calculated time period would end on a non-working day, the assigned time period will be the next working day (i.e., time periods will not end on weekends or Federal holidays).

 

It should be noted that 1505.10(b) allows for an exception to the rules of timing. An exception may be made in the case of an agency decision which is subject to a formal internal appeal. Agencies should assure that EPA is informed so that the situation is accurately reflected in the Notice of Availability.

 

Under 1506.10(d) EPA has the authority to both extend and reduce the time periods on draft and final EISs based on a demonstration of "compelling reasons of national policy." A lead agency request to EPA to reduce time periods or another Federal agency request to formally extend a time period normally takes the form of a letter to the Director, Office of Federal Activities (OFA), EPA outlining the reasons for the request. EPA will accept telephone requests; however, agencies should follow up such requests in writing so that the documentation supporting the decision is complete. A meeting to discuss the consequences for the project and any decision to change time periods may be necessary. For this reason EPA asks that it be made aware of any intent to submit requests of this type as early as possible in the NEPA process. This is to prevent the possibility of the time frame for the decision on the time period modification from interfering with the lead agency's schedule for the EIS. EPA will notify CEQ of any reduction or extension granted.

 

CEQ has the authority under Section 1502.9(c)(4) to approve alternative procedures for preparing, circulating and filing supplemental draft and final EISs. The Council will notify EPA of any such alternative procedures that are granted.

 

 

6. Retention

 

Filed EISs are retained in the EPA/OFA office for a period of two years and are made available to office staff only. After two years the EISs are sent to the National Records Center. Northwestern University Transportation Library 
 

One of the largest collections of Environmental Impact Statements (EISs) is available from Northwestern University's Transportation Library. Nearly all of the EISs issued by federal agencies since 1969 are held, usually in draft as well as final form, as well as related documents (e.g., environmental assessments, findings of no significant impact, records of decisions, supplementary reports, and maps)."

EIS Process as Exemplified in a Federal Agency

For a more thorough understanding of environmental impact statements review the following material provided on environmental impact statements as proffered by the Animal and Plant Health inspection Service, Biotechnology Regulatory Service of the U.S. Department of Agriculture (USDA).

EIS Purpose

"NEPA is the basic national statutory statement of the US Government mandating a process for protecting the environment. The statute in Section 101 (a) declares that, “it is the continuing policy of the Federal Government … to use all practicable means and measures … in a manner calculated to foster and promote the general welfare, to create and maintain conditions under which man and nature can exist in productive harmony, and fulfill the social, economic and other requirements of present and future generations of Americans.” Section 102 (2) (c) goes on to state, “…all agencies of the Federal Government shall [prepare] a detailed statement… on the environmental impact of the proposed action…” Thus, all branches of the government are required to give proper consideration to the environment prior to undertaking any major federal action with the potential to significantly affect the environment, such as rule-making. Section 102 (2) of NEPA declares that this policy is to be implemented through the regulations established by the President’s Council on Environmental Quality (CEQ)

 

EIS Preparation Process

 

The Programmatic EIS for Revision of BRS Regulations will be prepared in accord with APHIS National Environmental Policy Act (NEPA) implementing procedures and the regulations of The President's Council on Environmental Quality (CEQ). Programmatic EISs are required for actions that typically involve the agency, an entire program or a substantial program component. These actions are characterized by their broad scope (often global or nationwide) and potential effect (impacting a wide range of environmental quality values or indicators) and whether or not affected individuals or systems may be completely identified at the time. The NEPA regulations identify the steps that must be taken in the preparation of an EIS. These steps are:

1. A notice of intent (NOI) to prepare the Programmatic EIS begins the formal process for compiling an EIS. The NOI for this project has been published in the Federal Register. 

    

2. The NOI for announced a scoping period during which written and other comments on the content of the programmatic EIS were gathered. Other comments received included statements made by stakeholders at public meetings and at APHIS staff meetings. 

    

3. A Draft Programmatic EIS (Draft Programmatic Environmental Impact Statement) is prepared, which must include:

   • A summary

   • A statement of purpose and need for action

   • A description of alternatives, including proposed actions that were considered

   • A description of the affected environment

   • An analysis of the environmental impacts of each of the alternatives considered

    

4. A Notice of Availability (NOA) is published in the Federal Register announces: the distribution of the Draft EIS: a public comment period of at least forty-five days. The NOA also announces information on how the public can get involved, including the location and schedule of any public meetings on the Draft Programmatic EIS.

    

5. A Final EIS may be prepared which includes summaries of public comments responding to the draft EIS. APHIS will then address these comments and best alternatives may be identified in the draft EIS or presented in the final EIS. Entirely different alternatives than those listed in the draft EIS may also be chosen and presented in the final EIS. If a final EIS is not published, the results of agency EIS deliberations will be subsumed within the draft or final versions of Agency regulations and made available to the public in the Federal Register.

    

6. A NOA is published in the Federal Register notifying the public that the Final EIS has been issued.

    

7. A Record of Decision (ROD) is published in the Federal Register approximately 30 days after publication of the Final EIS. The ROD describes the agency's decision regarding the proposed action.

EIS Content

 

The National Environmental Policy Act (NEPA) requires that prior to decision-making, Federal agencies consider the environmental impacts of their proposed actions and reasonable alternatives to those actions. To meet this requirement, APHIS BRS is preparing a detailed statement known as an Environmental Impact Statement (EIS). The EIS will disclose the considerations made in the revision process and provide opportunity for public comments about the proposed changes in BRS’ regulations.

 

Internal Scoping: Major Issues

The first step in the EIS process is internal scoping. Scoping is used to decide what needs to be analyzed, what the issues are, what alternatives should be considered and what data should be collected. The EIS team begins the task of scoping the major issues before composing the draft EIS document and until draft is complete.

 

[For instance] APHIS BRS sharpened the scope of the Programmatic EIS in the Notice of Intent (NOI), which was published in the Federal Register (see EIS Documents Section). To complete the scoping, APHIS BRS held public meetings to solicit comments regarding NOI. The most significant of these issues are:

1. Should APHIS BRS continue to regulate genetically modified organisms as plant pests or add other authorities for their regulation?

2. Are current categories of permits and their confinement conditions adequate for field testing or should a new system of permits and qualifications be designed for new products and concerns?

3. Should APHIS BRS continue to deregulate and regulate products of biotechnology lacking information about unresolved risks?

4. Should the most recent APHIS BRS conditions be utilized (see Federal Register Notices) for confining pharmaceutical-and industrial-expressing plants?

5. Should APHIS BRS regulate plant products derived from regulated plants?

6. Should there be a new mechanism for regulating pharmaceutical plants?

7. Should low level occurrence of a regulated article in food, feed or seed be exempted from regulation?

8. Should low risk commodities for import be expedited or exempted from regulatory review?

9. Should interstate movement of Arabidopsis or certain regulated plants be exempted from movement restrictions?

10. Are there additional areas of low risk for which APHIS BRS should consider reducing or eliminating the regulatory requirements?

11. Are performance-based container requirements for genetically engineered organisms more effective than prescriptive ones?

Sections of the EIS and Their Purpose

APHIS will address the environmental impacts of changes to its proposed regulations within the EIS. The format suggested by NEPA provides a complete record of all the alternatives that APHIS considered and rationale for any proposed changes. The sections listed below are similar to NEPA regulations. These sections address the purpose, alternatives, environmental impacts, and preferred alternatives. APHIS may supplement this format with as many additional sections as are appropriate.

 

The principle sections that will appear in the EIS are:

1. Purpose of and Need for Action

2. Alternatives Including Proposed Action

3. Environmental Consequences

   1. Affected Environment

   2. Impacts of New Regulations

4. Environmentally Preferred Alternative

Section I: Purpose of and Need for Action

This section describes the purpose of the EIS (See EIS Purpose), why new regulations are needed and why action should be taken by APHIS.

 

Section II: Alternatives Including Proposed Action

The second section in the NEPA process requires the Agency to examine a range of alternatives to be documented in the EIS. These alternatives are options that meet the stated objectives for updating regulations. For example, APHIS is considering whether BRS should regulate GE organisms that may not qualify as plant pests. Some GE organisms do not contain inserted DNA sequences from plant pests or are not transformed by means of plant pests. The alternatives may include using the Noxious Weed authority in the PPA to allow regulation of all GE plants whose potential as noxious weeds has not been determined. Another alternative might include regulating GE organisms under a trait-based rather than processed-based regulatory system. Under a trait-based system, any organism expressing a novel trait might require submission to APHIS BRS for an assessment of its environmental impacts. Both GE and non-engineered organism might qualify for an APHIS BRS review. A final alternative would be continuing to regulate GE organisms as plant pests.

 

As suggested by NEPA, APHIS BRS will examine reasonable alternatives in the EIS draft. The analysis will consider whether the alternatives fulfill the selected objectives. The Council on Environmental Quality specifies that these alternatives should include those that are technically and economically feasible and achievable. Reasonable alternatives may include some that are outside APHIS’ authority or are undesirable to some applicants. For the selected alternatives, benefits and impacts are characterized and possible mitigation activities are discussed.

 

Unreasonable and therefore excludable alternatives would be those with severe environmental impacts or that do not meet specified objectives. Though the Agency is not required to provide extensive description of the rejected alternatives, all rejected alternatives would be discussed and reasons for elimination would be provided in the EIS.

 

The alternatives that APHIS BRS proposes in the EIS will complement BRS’ program goals. These are:

1. Enhancing environmental safety

2. Increasing public confidence

3. Using resources efficiently

4. Offering increased transparency to the public

5. Maintaining scientific integrity of rules

6. Reducing the imposed regulatory burden

APHIS BRS must also analyze the “no action” alternative. This is a reasonable alternative which provides a baseline for comparison of the existing impacts with those derived from the proposed alternatives. Present regulations include existing and projected future impacts.

 

Under the “no action” alternative, APHIS BRS would describe any impacts on the environment attributable to the unmodified regulations. “No action” would mean that no new regulations would be written and present regulations would continue.

 

Section III: Environmental Consequences

A third section in the EIS document contains an analysis of environmental consequences, in assessing both the affected environment and potential impacts of specific alternatives.

A. Affected Environment
After BRS has presented the alternatives and issues in the EIS, the possible environmental impacts of these will be identified. In the analysis, “Affected Environment”, the Agency will describe the resources likely to be impacted. The affected environment refers to those areas impacted due to regulation changes. These areas include managed environments, such as farms or public lands. The components possibly affected in these environments include crops, interbreeding species, trees, seed production, resistance development, animals and plants. Effects on the physical parts, such as soils, and pollution issues may also arise. Human and animal health will also be considered, including allergenicity, exposure to toxins, and nutrition. Unmanaged environments, such as those adjacent to agricultural fields or those public or private lands in proximity to crops may also be affected. BRS will also consider affected components of these unmanaged environments, including the animals, plants and their physical details.

 

B. Impacts of New Regulations Impact topics are derived from the issue statements, including those that have been listed in the section, “Internal Scoping: Major Issues.” Impacts may be caused by the chosen alternatives and the resulting actions from the selected alternative. Some of these impacts can occur simultaneously with the alternative—these are termed direct effects. Indirect effects occur when impacts occur later then the action. Finally, any additive impacts of actions in the past, the present or the foreseeable future are termed cumulative effects.

 

Major impacts of regulations may occur on the following:

1. Macro- and Micro- organisms

   1. Growing the crop itself

   2. Gene flow to other crops or wild relatives

   3. Development of resistance

   4. Other effects

2. Changes in Weediness

   1. The crop as a weed

   2. Weed species shifts associated with the crop

3. Invasiveness (unmanaged environments) of Regulated Products

   1. The crop as invasive species

   2. Crops relatives as invasive species

4. Changes in Plant Pest Risk

   1. Increased susceptibility to pests or diseases

   2. Creation of new pests (viruses)

5. Effects on the Physical Environment

   1. Soil

   2. Energy resources

6. Effects on Human and Animal Health

   1. Allergenicity and toxicity

   2. Pesticide use

   3. Nutritional quality

Section IV: Environmentally Preferred Alternative

In the final sections of the EIS, APHIS BRS will identify an environmentally preferred alternative. The chosen alternative will be consistent with the national policy expressed in the NEPA statutes. Some of the NEPA goals to be fulfilled will include:

• “enhancing the quality of renewable resources and approach the maximum attainable recycling of depletable resources,”

• “attaining the widest range of beneficial uses of the environment without degradation, risk of health or safety, or other undesirable and unintended consequences,” and

• “fulfilling the responsibilities of each generation as trustee of the environment for succeeding generations” (NEPA Act, Title 1, Sec. 101).

After BRS has evaluated thoroughly evaluated the choices and possible impacts, APHIS will announce the preferred alternatives. The values expressed within the EIS, along with the policies cited within the EIS will inform the public about the Agency’s decision-making process. Although APHIS will emphasize the alternatives “that cause… the least damage to the biological and physical environment,” the most environmentally preferred alternative may not be the selected option. BRS understands the importance of those alternatives that “best protect, preserve, and enhance historic, cultural, and natural resources” (CEQ in their 40 Questions on NEPA),” but the preferred alternatives selected may not be the most environmentally acceptable for a variety of reasons.

The final section of the EIS according to 40 CFR 1502.2(d) should conclude whether the chosen alternatives would or would not achieve the goals stated in The National Environmental Policy Act, Title 1, sections 101-102 . Additionally, if any inconsistencies between the chosen alternatives and other environmental laws and policies exist, APHIS BRS must examine and address these instances in detail."