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.
Key Topics
Terms and concepts identified from this document
Regulatory Context
Regulatory Activities
1Formal program for the review of animal food additives.
Document Types
2Documents FDA does not intend to enforce submission for if unaltered
Required documentation under 21 CFR 514.1(b)(14).; Document evaluating environmental impact of investigational IGAs; Document used to examine potential for environmental impacts.; Document evaluating environmental impact of the action; Document required to determine environmental impacts
Attributes
2Calculated concentration of a substance organisms would be exposed to; Concentration of substance after dilution; Concentration organisms would be exposed to after considering fate parameters
EIC of the substance in wastewater effluents or sewage sludge; Concentration of substances introduced into the environment at the site of use
Technical Details
Substances
2Substances intended for use in food that require premarket approval
The FCS undergoes chemical or metabolic transformation; Components of the formulation already authorized for intended uses.
Testing Methods
1SAR programs used to predict fate and effects when data is unavailable
Processes
1Considered a rapid depletion mechanism if t½ is less than 8 hours.; Depletion mechanism identified in the sample data summary table.
Identified Hazards
Hazards
1Potential negative effects on the environment from a proposed action
Standards & References
External Standards
2Council on Environmental Quality definition of extraordinary circumstances
Federal law protecting species and critical habitats
Related CFR Sections (2)
- 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 A of Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to CFSAN (Status: Final)
- 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)
- 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)