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Instructions for Undertaking the Environmental Review

Instructions for Undertaking the Environmental Review for EPA Extramural Research and Development Projects and Completing EPA Form 5300-23

1. Form 5300-23 is to be used for the environmental review of EPA extramural research and development projects undertaken by the Office of Research and Development (ORD). This review is conducted pursuant to EPA’s National Environmental Policy Act (NEPA) regulations in 40 CFR Part 6, Subpart G.

2. This form and supporting documentation will constitute the environmental assessment (EA) and finding of no significant impact (FNSI) when it is determined that a project officer in complying with the requirements of NEPA. Completion of the form in no way obviates the need to obtain project permits or approvals that may be required under statutes administered by EPA, or by other local, state and federal agencies.

3. The EPA project officer conducts the environmental review by completing the form but the responsibility for the findings belongs to a higher level EPA official, usually the laboratory director. The principal investigator may assist the project officer in obtaining the documentation for the findings.

4. Documentation to support the findings for each of the items (1-12) in the Environmental Review Section must be attached to the form, as appropriate, unless the items are clearly not applicable to the research activity.

5. If a project meets the criteria listed in Item 1 of the Environmental Review Section (i.e., a “yes” answer), then the project officer does not need to complete Items 2-12 or subsection “B” The Environmental Review Section is then considered completed and the form may be issued as an EA/FNSI.

6. Item 1 of the form refers to projects which are conducted in a “contained” structure. In general a contained structure is designed to physically confine and control agents such as hazardous and toxic substances and organisms. Containment is achieved through the observation and implementation of good laboratory practices, installation of properly designed laboratory equipment and inclusion of special design features to minimize or prevent, as appropriate, escape of the agents to the environment. If the answer to item 1 is “no,” the project officer must proceed to item 2.

7. In responding to item 2, the project officer must consider whether the EPA research activity has a causal relationship with the larger non-Federal project; i.e., is the EPA activity needed or required to undertake the larger project? Where there is no causal relationship, the scope of the environmental review may be limited to only the EPA action and the project officer may mark “yes” as the answer, as long as the EPA activity would not result in any significant impacts. In determining whether the impacts are significant, the project officer would respond “no” to item 2 and proceed to answer itmes 3-12, responding to the questions in terms of the impacts resulting from the overall project.

8. The criteria listed in items 3 and 6(a) of the Environmental Review Section refer to human populations.

9. NEPA requires the preparation of an environmental impact statement for a major federal action having a significant impact on the environment. Accordingly, in responding to item 10 of the form, the project officer should mark “yes” only if the introduction of a nonindigenous species or supspecies may have significant environmental effects including those effects identified in Items 3-9. The project office may also consider the environmental release of intergeneric organisms and pathogens under Item 10. For additional guidance on how to address nonindigenous species and these other organisms the project officer shouls consult EPA’s most current policy/regulations on biotechnology.

10. In addressing Item 11 of the form, the project officer should check “yes” if the project represents a significant EPA committment to a new technology; and that commitment could serve to limit the viability of alternative technologies. Generally, a project should be considered to involve a significant EPA commitment under Item 12 if the Agency’s financial investment in the project will be substantial and the project could result in the widespread adoption of a new technology.

11. The project officer may mark “no” to any of the Items 3-12 of the Environmental Review Section when there are alternatives or measures which will be undertaken to avoid significant environmental impacts. These measures must be documented and the project officer must explain how they would alter the significance of the impacts. The Agency then may issue the form as an ES/FNSI.

12. If a decision is made in Section IV to prepare an EIS, the project officer will be responsible for preparing a “Notice of Intent” to inform the public of the Agency’s decision and to solicit input into the EIS. The Notice of Intent will be prepared in accordance with the Council on Environmental Quality’s NEPA regulation in 40 CRR 1508.22 for publication in the Federal Register.

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