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Guidance Issuing OfficeCenter for Veterinary Medicine
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:
"To elaborate tripartite guidelines on the design of studies and the evaluation of the environmental impact assessment of veterinary medicinal products. It is suggested to follow a tiered approach based on the principle of risk analysis. Categories of products to be covered by the different tiers of the guideline should be specified. Existing or draft guidelines in the EU, Japan, and the US should be taken into account."
This document presents guidance on how to conduct Phase I EIA's for VMP's other than biological products. Consistent with the mandate, two phases of EIA are recommended. In Phase I, the potential for environmental exposure is assessed based on the intended use of the VMP. It is assumed that VMP's with limited use and limited environmental exposure will have limited environmental effects and thus stop in Phase I.1 Phase I also identifies VMP's that may need a more extensive EIA under Phase II.2 Some VMP's that might otherwise stop in Phase I may need additional environmental information to address particular concerns associated with their activity and use.3 These situations are expected to be the exception rather than the rule and some evidence in support of the concern should be available. In an effort to harmonize the EIA to the maximum extent possible, it is expected that the EU, US, and JP will rely on this document for guidance on conducting Phase I EIA's for VMP's.
1 In the US, reference to a Phase I EIA is equivalent to either a categorical exclusion or an environmental assessment (EA) conducted under the National Environmental Policy Act (NEPA). A VMP that may stop at Phase I is equivalent to a categorical exclusion or an EA which leads to a finding of no significant impact (FONSI) under NEPA.
2 Phase II represents a second level of environmental analysis that may include testing. In the US, a Phase II EIA is equivalent to an EA with more extensive data than would be required under the US equivalent of a Phase I EIA. A Phase II EIA may lead to a FONSI or an Environmental Impact Statement under NEPA.
3 In the US, this is equivalent to an extraordinary circumstance under NEPA.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-1999-D-3541.