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GUIDANCE DOCUMENT

Guidance for Industry and FDA: Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors with Interest in Exporting to Chile November 2018

Final

Guidance for Industry and FDA: Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors with Interest in Exporting to Chile

Docket Number:
FDA-2006-N-0183
Issued by:
Guidance Issuing Office
Office of Food Safety

How to Comment

Submit Written Comments
Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, RM 1061
Rockville, MD 20852.
All comments should be identified with the title of the guidance document.

This guidance document is being published to notify the public of FDA's efforts to assist U.S. manufacturers/processors (hereinafter referred to as “firms”) that wish to export dairy products to Chile. FDA took this action in response to discussions with Chile that were adjunct to the negotiations of the United States-Chile Free Trade Agreement. As a result of those discussions, Chile recognized FDA as the competent food safety authority in the United States to identify U.S. dairy product manufacturers and processors eligible to export to Chile and concluded that it will not conduct individual inspections of U.S. firms identified on a list established by the FDA as eligible to export to Chile. The list identifies U.S. firms that have expressed interest to FDA in exporting dairy products to Chile, that are subject to FDA jurisdiction, and that are not the subject of a pending judicial enforcement action (e.g., an injunction or seizure) or a pending warning letter. The List of U.S. Dairy Product Manufacturers/Processors with Interest in Exporting to Chile established by FDA is posted on FDA's Internet site and shared with Chile. Every two years, Chile passes an authorizing resolution accepting this list and provides the list to their ports of entry to facilitate the importation of U.S. dairy products. Chile has requested that this list be updated every two years at the expiration of the current authorizing resolution. Therefore, FDA intends to contact the U.S. firms that are on the list every two years to verify that the information they have provided to FDA is still valid. FDA intends to report this updated list to Chile so that Chile can reauthorize its resolution for another two-year period.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our 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 FDA guidances means that something is suggested or recommended, but not required.

This is a revision of the second edition of this guidance, which FDA issued in June 2005. This guidance revises the procedures firms should use to be included on FDA’s list of dairy exporters to Chile.

Download the Guidance 

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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-2006-N-0183.