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GUIDANCE DOCUMENT

Guidance for Industry: Application of the Foreign Supplier Verification Program Regulation to the Importation of Live Animals March 2018

Final

Guidance for Industry: Application of the Foreign Supplier Verification Program Regulation to the Importation of Live Animals

Docket Number:
FDA-2018-D-0721
Issued by:
Guidance Issuing Office
Center for Food Safety and Applied Nutrition
Center for Veterinary Medicine
Office of Regulatory Affairs

The purpose of this document is to state the Food and Drug Administration’s (FDA’s or the Agency’s) intent to exercise enforcement discretion regarding application of the regulation on foreign supplier verification programs (FSVPs) to importers of live animals that are required to be slaughtered and processed at U.S. Department of Agriculture (USDA)-regulated establishments subject to USDA-administered hazard analysis and critical control point (HACCP) requirements (or at state-inspected establishments subject to requirements equivalent to the federal standards).

We are issuing this guidance consistent with our good guidance practices (GGP) regulation (21 CFR 10.115). This guidance is immediately effective because FDA has determined that prior public participation is not feasible or appropriate (21 CFR 10.115(g)(2)).

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

This guidance provides information to facilitate understanding of the applicability of the FSVP requirements to the importation of live animals. The pronouns “I,” “me,” and “you” are used in this guidance to refer to the importer. “Agency” and the pronouns “we” and “our” are used to refer to FDA.

This guidance represents the current thinking of the Food and Drug Administration (FDA, the Agency, or we) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the Office of Foods and Veterinary Medicine as listed on the title page.

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Submit Comments

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:

Division of Dockets Management (HFA- 305)
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-2018-D-0721.