Description
In 1996, the VICH Steering Committee (VICH SC) authorized formation of a working group to develop harmonized guidance for conducting environmental impact assessments (EIA's) for veterinary medicinal products (VMP's) in the European Union (EU), Japan (JP) and the United States (US). The mandate of the VICH Ecotoxicity/Environmental Impact Assessment Working Group (VICH Ecotox WG), as set forth by the VICH SC, is as follows:
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
1International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products
Stakeholders
1Entity submitting development data and knowledge; Entity performing the work process for change
Regulatory Context
Regulatory Activities
2Advanced stage of environmental impact assessment for higher risk products
Cancer clinical trials involving dose escalation
Document Types
2Regulatory documentation required for VMP approval
Prepared if significant environmental impacts are identified.
Attributes
2Summing parent drug and all related metabolites for EIC/PEC calculations
A condition where no single metabolite or parent drug exceeds 5% of total radioactivity excreted.
Technical Details
Substances
3VMP class requiring specific ecotoxicity assessment
VMP class requiring specific ecotoxicity assessment
Substances like electrolytes, peptides, and proteins that may stop at Phase I.
Testing Methods
2Required in Phase II for parasiticides
Method used to demonstrate extensive metabolism in the treated animal.
Processes
1Acceptable means for disposal of altered animals
Clinical Concepts
2Species reared and treated similarly to major species.
Animal populations such as pets that are generally not intensively reared.
Identified Hazards
Hazards
2Potential for adverse effects on aquatic or terrestrial organisms
The potential risk assessed based on the intended use of the VMP.
Standards & References
External Standards
1FDA has to comply with the environmental review requirements of NEPA
Specifications
2Predicted environmental concentration trigger value for soil
Environmental introduction concentration trigger value for aquatic environments
ICH References (1)
Harmonized methods for conducting environmental assessments for veterinary medicinal products.
Related CFR Sections (2)
- 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 →
- 21CFR25.33§ 25.33 Animal drugs.
The classes of actions listed in this section are categorically excluded and, therefore, ordinarily do not require the preparation of an EA or an EIS:Read full regulation →
See Also (8)
- Guidance for Industry: Appendix B for Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to CFSAN (Status: Final)
- 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)
- 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)