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ble emissions requirements at the Federal, State, and local level; and discuss the effect the approval will have upon compliance with current emissions requirements at the production site(s).

(ii) Format item 7. Discuss whether the use of the product can reasonably be expected on the basis of all available evidence to alter significantly the concentration and distribution of the product, its metabolites, degradation products, or its constituent parts in the environment.

(iii) Format item 8. Report existing data relating to the environmental effects of substances expected to be emitted into the environment as a consequence of use of the product. Report information obtained from the scientific literature on the toxicity of the product to laboratory animals, e.g., that information which is submitted to satisfy human safety requirements, and to organisms in the environment, e.g., fish, invertebrates, plants, fungi, and bacteria, that may be exposed to the product.

(6) For approval or issuance by the agency of a food or color additive petition, NDA, supplemental NDA, biological product license, NADA, or supplemental NADA for a product that has been approved by the Environmental Protection Agency (EPA) under section 4 or 5 of the Toxic Substances Control Act (TSCA) or under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the following information is required:

(i) Format items 7 and 8. To address these items, rely on environmental information in studies submitted to EPA, in the application/petition submitted for FDA approval, and in the scientific literature. Describe any potential adverse environmental impacts determined by EPA.

(ii) Format item 15(b). For studies submitted to EPA or for relevant studies submitted in the application/petition to meet the requirements of the Federal Food, Drug, and Cosmetic Act, test reports may include only a brief description and summary of results of each study in lieu of attaching complete test reports.

(Approved by the Office of Management and Budget under control number 09100190)

[50 FR 16656, Apr. 26, 1985, as amended at 50 FR 30267, July 25, 1985]

§ 25.31b Environmental assessment for withdrawals of approval and other restrictions-Format 2.

For proposed actions to withdraw approval or otherwise restrict or reduce the use of food or color additives, drugs, biological products, animal drugs, and class III medical devices, any environmental assessment prepared by the agency will be in the following format:

ENVIRONMENTAL ASSESSMENT

1. Description of the proposed action: Describe the proposed action, the regulatory authority for the proposed action, the underlying purpose of and need for the proposed action, and how the proposed action addresses the underlying purpose and need for action.

2. Environmental consequences of the proposed action: Describe the uses and the magnitude (production volume and/or sales) of such uses for the product(s) for which approval would be withdrawn or otherwise restricted or reduced and for the available substitute products. Determine those uses of the restricted product(s) for which no substitute products are available and the magnitude and essentiality of such uses. Discuss the environmental impacts of (1) reducing or eliminating environmental exposures to the restricted product; (2) natural resources and energy used in producing, distributing, using, and disposing of the restricted product compared with those required for the available substitute products; (3) any expected increased production and use of substitute products; and (4) essential uses of the restricted product for which there would be no substitutes.

3. Mitigation measures: Describe measures which would be taken to avoid or mitigate potential adverse environmental effects associated with the proposed action.

4. Description of regulatory alternatives to the proposed action and the expected environmental consequences: Describe in detail the environmental impact of reasonable alternatives to the proposed action (including no action), particularly those that will enhance the quality of the environment and avoid some or all of the adverse environmental effects of the proposed action.

5. Comparative analysis of proposed action and alternatives: Provide a comparative analysis of the environmental benefits and risks of the proposed action and alternatives. Identify the preferred action based on environmental factors.

6. List of preparers: Those persons preparing the assessment and their areas of expertise shall be presented. Persons and agencies consulted shall be listed.

7. References: List complete citations for all referenced material. Copies of referenced articles not generally available should be attached.

8. Appendices: Append detailed physical, chemical, biological, and environmental data on products that are the subject of the proposed action.

§ 25.31c Environmental assessment format for extramural contracts, grants, or other research agreements—Format 3. For extramural contracts, grants, or other research agreements subject to environmental assessment, the contractor or applicant shall use the following format:

ENVIRONMENTAL AssessmENT

1. Date:

2. Name of prospective contractor/ applicant:

3. Address:

4. Description of the proposed research activities: Briefly describe the purpose of the proposed research, the locations where the research activities would occur, and the types of environments present at those locations.

5. Information on the chemical substances and infectious agents to be used: Provide the information listed in Table 1 on each of the chemical substances and infectious agents to be used in the research activity, to the extent that they can be identified, either specifically or generically, and including such items as organic solvents as well as the chemicals of major research interest.

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• Specify in metric units of mass or volume. -infectious, C-carcinogenic, M-mutagenic, T-teratogenic, A-acutely toxic or poison, COR-corrosive, E-explosive or flammable, R-radioactive, O-other hazard, please specify, NH-nonhazardous.

* Examples include use of fume hoods, use of protective clothing/gear by laboratory personnel, chemical inactivation of wastes, separation of hazardous from nonhazardous wastes, and subsequent disposal by a firm licensed for this purpose.

6. Compliance with Federal, State, and local environmental and occupational requirements. Cite and include a statement of compliance with applicable emissions requirements (including occupational) at the Federal, State, and local level. Discuss the effect that the proposed research will have upon compliance with these requirements.

7. List of preparers: Those persons preparing the assessment together with their qualifications (expertise, experience, professional disciplines) shall be listed. Persons and agencies consulted shall also be listed.

8. Certification: The undersigned official certifies that the information presented is true, accurate, and complete to the best of the knowledge of the prospective contractor or applicant submitting the environmental assessment.

(Date)

(Signature of responsible official) (Title)

(Approved by the Office of Management and Budget under control number 09100190)

[50 FR 16656, Apr. 26, 1985, as amended at 50 FR 30267, July 25, 1985]

§ 25.31d Environmental assessment for establishment of tolerances or action levels-Format 4.

For proposed actions to establish tolerances or action levels for unavoidable poisonous or deleterious substances in food for human or animal consumption or in packaging materials intended for use with human food and animal feed, the agency will prepare an environmental assessment in the following format:

ENVIRONMENTAL ASSESSMENT

1. Description of the proposed action: Describe the proposed action, the regulatory authority for the proposed action, the underlying purpose of and need for the proposed action, and how the proposed action addresses the underlying purpose and need for action.

2. Environmental consequences of the proposed action: Describe the potential environmental impacts of the proposed action including effects on natural resources and energy, effects on food production, effects on land use, and impacts resulting from increased use and changes in use patterns for chemical substances.

3. Mitigation measures: Describe measures which would be taken to avoid or mitigate potential adverse environmental effects associated with the proposed action.

4. Description of regulatory alternatives to the proposed action and the expected environmental consequences: Describe in detail the environmental impact of reasonable alternatives to the proposed action (including no action), particularly those that will enhance the quality of the environment and avoid some or all of the adverse environmental effects of the proposed action.

5. Comparative analysis of proposed action and alternatives: Provide a comparative analysis of the environmental benefits and risks of the proposed action and alternatives. Identify the preferred action based on environmental factors.

6. List of preparers: Those persons preparing the assessment and their areas of expertise shall be presented. Persons and agencies consulted shall also be listed.

7. References: List complete citations for all referenced material. Copies of referenced articles not generally available should be attached.

§ 25.31e Environmental assessment for destruction of condemned, enjoined, detained, or recalled articles-Format 5. For actions to destroy or dispose of articles condemned after seizure, detention, or FDA-initiated recall, or after distribution or use of the article has been enjoined, the person proposing the action shall, at the request of the agency, prepare an environmental assessment in the following format when the method of destruction or disposition results in release of toxic substances:

ENVIRONMENTAL ASSESSMENT

1. Purpose of and need for action: Briefly describe the underlying purpose and need for the article to be destroyed, the proposed method of destruction or disposal, the locations where the proposed destruction or other disposal will occur, and the types of environments present at and adjacent to those locations.

2. Description of potentially toxic substances present in the article: Provide complete nomenclature, CAS Registry numbers (if available), molecular weight, structural formulae, physical description, and concentration of the potentially toxic substances in the article.

3. Introduction of potentially toxic substances into the environment: For transport of the article to the site(s) of disposition, cite and certify compliance with any applicable Federal, State, and local emissions requirements. List to the extent possible the potentially toxic substances expected to enter the environment at the site(s) of destruction and/or disposal of the article. Describe the approximate concentrations of

emissions; state the controls exercised; and include a citation of, and statement of compliance with, applicable requirements at the Federal, State, and local level.

4. Fate of potentially toxic emitted substances in the environment: Report physical/chemical and other data in the scientific literature relating to the fate of potentially toxic substances expected to be emitted into the environment as a result of destruction or other disposal of the article. Such physical/chemical parameters include water solubility, solubility in organic solvents, n-octanol/water partition coefficient, dissociation constants, vapor pressure, ultraviolet-visible absorption spectrum, ability to form chemical complexes, storage stability, etc.

5. Environmental effects of potentially toxic substances expected to be emitted into the environment. Report information on the effects of the emitted substances on animals, plants, humans, other organisms, and effects at the ecosystem level. Compare the expected environmental concentrations of the substances with the concentrations that cause adverse effects.

6. Description of alternative methods of destruction and/or disposal and the expected environmental consequences: Describe the environmental impact of reasonable alternatives (including no action) particularly those that will enhance the quality of the environment and that will avoid some or all of the adverse environmental effects of the proposed method of destruction or other disposition.

7. Comparative analysis of proposed methods of destruction or other disposition and alternative methods: Provide a comparative analysis of the environmental benefits and risks of the proposed and alternative methods. Identify the preferred action based on environmental factors.

8. List of preparers: Those persons preparing the assessment and their areas of expertise shall be presented. Persons and agencies consulted shall also be listed.

9. References: List complete citations for all referenced material. Copies of referenced articles not generally available should be attached.

(Approved by the Office of Management and Budget under control number 09100190)

[50 FR 16656, Apr. 26, 1985, as amended at 50 FR 30267, July 25, 1985]

§ 25.32 Finding of no significant impact.

(a) As defined by the CEQ regulations (40 CFR 1508.13), a finding of no significant impact (FONSI) is a document prepared by a Federal agency and stating briefly why an action, not otherwise excluded, will not signifi

cantly affect the human environment and for which, therefore, an EIS will not be prepared. A FONSI includes the EA or a summary of it and a reference to any other related environmental documents.

(b) If the EA has been prepared by an applicant or petitioner, the agency may choose to include additional evidence in the FONSI. Any remaining unknowns or uncertainties will be identified.

(c) The agency official(s) responsible for the preparation and approval of the FONSI will sign the document, thereby establishing that the official(s) approve(s) the conclusions not to prepare an EIS for the action under consideration.

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(a) As defined by CEQ regulations (40 CFR 1508.22), the Notice of Intent notifies the public that the agency has determined that an EIS will be prepared. This determination may be based on information contained in an EA or on other information available to the agency which indicates that potentially significant effects may be associated with a proposed action.

(b) As required by 40 CFR 1508.22, the Notice of Intent will describe the proposed action, possible alternatives, the agency's proposed scoping process, which may include a request for information or suggestions regarding the scope of the EIS and notice of public meetings, and the identification of persons within the agency to contact for further information.

§ 25.34 Draft, final, and supplemental environmental impact statements.

(a) The CEQ regulations (40 CFR Part 1502) provide detailed requirements for the preparation of an EIS. CEQ's format for EIS's (40 CFR 1502.10) will be followed unless the agency determines that there is a compelling reason to do otherwise.

(b) When chemical substances enter the environment as a result of a proposed action or other regulatory alternatives, the portion of the EIS format on "environmental consequences" (40 CFR 1502.10(g)) will include discussion of the environmental fates and effects

of those substances similar to that described in § 25.31a.

(c) Any final EIS will contain any additional information gathered by the agency after the publication of the draft EIS, a copy of or a summary of the comments received on the draft EIS, and the agency's responses to the comments as required in 40 CFR 1503, including any revisions resulting from comments or other information.

(d) Draft and final supplemental EIS's will conform to the EIS format (40 CFR 1502.10) unless there is a compelling reason to do otherwise.

Subpart D-Agency Decisionmaking § 25.40 Procedures for incorporating environmental considerations into agency decisionmaking.

(a) These procedures are to ensure that environmental information is provided to decisionmakers in a timely manner. The NEPA process is an integral part of FDA's decisionmaking. Agency decisionmakers ensure that the policies and purpose of NEPA and CEQ regulations are complied with by:

(1) Completing or assuring the completion of an EA, determining whether an EIS is required and, ordinarily, completing a draft EIS (if one is required) prior to or at the time of proposing an action subject to §§ 25.21 and 25.22.

(2) Including in decision documents and supporting environmental documents a discussion of all alternatives considered in the decision as required by 40 CFR 1502.14. Every action memorandum proposing an agency action included under § 25.21 or § 25.22 will contain an evaluation of the environmental impact of the proposed action and will be accompanied by a draft or final EIS if one is required.

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fects the quality of the human environment.

(b) There are certain regulatory actions which, because of their immediate importance to the public health, make adherence to the requirements of the CEQ regulations and these regulations concerning minimum periods of public review impractical. Compliance with the requirements for environmental analysis under NEPA is impossible where emergency circumstances require immediate regulatory action to safeguard the public health. For such actions, the responsible agency official shall consult with the CEQ about alternative arrangements before the action is taken, or after the action is taken, if time does not permit prior consultation with CEQ.

(c) Certain FDA actions are subject to statutory time limits that sometimes do not provide sufficient time to complete the required environmental document. Should the responsible agency official be unable to complete environmental consideration of the proposed action before a notice of filing of a food or color additive petition is required to be published, and if the subsequent environmental analysis leads to the conclusion that no EIS is necessary, the FEDERAL REGISTER document publishing the final regulation rather than the notice of filing shall state that no EIS is necessary and that the FONSI and the EA are available upon request and filed in the FDA Dockets Management Branch. If it is concluded that an EIS is necessary, the final regulation, final EIS, and record of decision shall be made available as prescribed in 40 CFR 1506.10.

§ 25.41 Actions for which a finding of no significant impact and an environmental assessment are prepared.

(a) As required by 40 CFR 1501.4(e), a FONSI is prepared for an individual action or groups of related actions that will not significantly affect the quality of the human environment. If potentially adverse environmental impacts are identified for an action or group of related actions, the EA supporting the FONSI will, as required by 40 CFR 1508.9, include a consideration of any reasonable alternative courses of action that offer less environmental

risk or that are environmentally preferable to the proposed action.

(b) FONSI's and EA's will be available to the public in accordance with 40 CFR 1506.6 as follows:

(1) When the proposed action is the subject of a notice of proposed rulemaking or a notice of filing published in the FEDERAL REGISTER, the notice shall state that no EIS is necessary and that the FONSI and the EA are available for public inspection at the FDA Dockets Management Branch.

(2) For actions for which notice is not published in the FEDERAL REGISTER, the FONSI and the EA shall be made available to the public upon request according to the procedures in 40 CFR 1506.6.

(3) For a limited number of actions, the agency may make the FONSI and EA available for public review (including review by State and areawide information clearinghouses) for 30 days before the agency makes its final determination whether to prepare an EIS and before the action may begin, as described in 40 CFR 1501.4(e). This procedure will be followed when the proposed action is, or is closely similar to, one that normally requires an EIS or when the proposed action is one without precedent.

(c) Program area officials and environmental staff prepare or ensure that the information contained in an EA is complete and accurate, and they prepare the FONSI. The responsible agency official designated in Part 5 examines the environmental risks of the proposed action and the alternative courses of action, selects a course of action, and ensures that any necessary mitigating measures are implemented as a condition for approving the selected course of action.

§ 25.42 Actions for which an environmental impact statement is prepared. (a) An individual action or group of related actions requires the preparation of an EIS when significant environmental impacts may be associated with one or more of the probable courses of action. The responsible agency official weighs any environmental impacts of each alternative course of action, including possible

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