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GUIDANCE DOCUMENT

Draft Guidance for Industry: Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination (DWPE) and Removal of a Foreign Manufacturer’s Goods from DWPE February 2024

Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2023-D-5303
Issued by:
Guidance Issuing Office
Center for Food Safety and Applied Nutrition

This guidance is intended to provide recommendations for collecting a representative sample for testing when fish and fishery products are subject to detention without physical examination (DWPE) due to the appearance of adulteration caused by pathogens, unlawful animal drugs, scombrotoxin (histamine), and/or decomposition. This guidance is also intended to help foreign manufacturers and other processors of fish and fishery products subject to DWPE under an import alert (IA) to introduce evidence to FDA to support a request to have products removed from DWPE.  This guidance does not apply to seafood-related import alerts when sampling and testing is not relevant to securing release of individual shipments or removal from DWPE.

In this guidance, we address the following issues regarding seafood products subject to DWPE due to pathogens, unlawful animal drugs, scombrotoxin (histamine), and/or decomposition:

  • Recommendations for the number of sample units (e.g., “subsample” as used by FDA) to be collected and tested from an article of fish and fishery products subject to DWPE to ensure statistical confidence and a representative sample;
  • A description of a “sample unit” and other characteristics of an article to help identify the amount of product and product groups or portions within the affected article to be sampled;
  • References for analytical methods that may be used to analyze the samples collected;
  • Recommendations for evidence to include in a submission requesting FDA to release an article detained under DWPE;
  • Recommendations for types of production-related evidence that may be useful for FDA to assess the efforts instituted by the processor(s) to prevent adulteration; and
  • Recommendations for the types of evidence that may be useful when requesting removal of a fish and fishery product or manufacturer from DWPE.

If you have questions about whether the guidance is relevant to your situation, you may contact CFSAN, Office of Food Safety, Division of Seafood Safety at 240-402-2300.

In general, FDA’s guidance documents 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.

Download the Draft Guidance



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:

Dockets Management
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-2023-D-5303.

 
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