Description
Below are recommendations for the suggested format and types of information to submit to the agency in an environmental assessment. An alternative approach may be used if the approach satisfies the requirements of the applicable statutes and regulations.
Scope & Applicability
Product Classes
2Approved substances for direct addition to food
Substances intended to be incorporated into food as substitutes
Stakeholders
1The entity providing information for the AFIC process.
Regulatory Context
Attributes
1Koc value used to predict substance binding to soil or sludge
Identified Hazards
Hazards
1reproductive effects due to bioaccumulation of the test substance
Related CFR Sections (3)
- 21CFR25.21§ 25.21 Extraordinary circumstances.
As required under 40 CFR 1508.4 , FDA will require at least an EA for any specific action that ordinarily would be excluded if extraordinary circumstances indicate that the specific proposed action may significantly affect the quality of the human environment (see 40 CFR 1508.27 for examples of signRead full regulation →
- 21CFR25.51§ 25.51 Environmental assessments and findings of no significant impact.
(a) Data and information that are protected from disclosure by 18 U.S.C. 1905 or 21 U.S.C. 331(j) or 360j(c) shall not be included in the portion of environmental documents that is made public. When such data and information are pertinent to the environmental review of a proposed action, an applicanRead full regulation →
- 21CFR25.40§ 25.40 Environmental assessments.
(a) As defined by CEQ in 40 CFR 1508.9 , an EA is a concise public document that serves to provide sufficient evidence and analysis for an agency to determine whether to prepare an EIS or a FONSI. The EA shall include brief discussions of the need for the proposal, of alternatives as required by secRead full regulation →
See Also (8)
- Guidance for Industry: Appendix C of Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to CFSAN (Status: Final)
- Guidance for Industry: Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to CFSAN (Status: Final)
- Guidance for Industry: Appendix B for Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to CFSAN (Status: Final)
- CVM GFI #89 (VICH GL6) EIAs for Veterinary Medicinal Products - Phase I (Status: Final)
- Draft Guidance for Industry: Providing Regulatory Submissions in Electronic or Paper Format to the Office of Food Additive Safety (Status: Draft)
- CVM GFI #213 New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209 (Status: Final)
- Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators (Status: Draft)
- CVM GFI #221 Recommendations for Preparation and Submission of Animal Food Additive Petitions (Status: Final)