The U.S. Food and Drug Administration is giving the seafood industry two more months to comment on a draft guidance on seafood products subject to Detention Without Physical Examination (DWPE) under an Import Alert.
The original draft guidance, “Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention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,” was published in the Federal Register on 12 February 2024. The FDA said the new guidance is designed to give companies recommendations for how to handle DWPE and import alerts.
In a new 12 April notice, the FDA said it would reopen the comment period “in response to a request from stakeholders for additional time to develop and submit comments.”
“We need more time to understand the potential impact to our members. We are still working on that and our comments,” National Fisheries Institute Chief Strategy Officer Gavin Gibbons told SeafoodSource.
Once finalized, the guidance will help foreign manufacturers and other processors of seafood products subject to DWPE submit evidence to the FDA to support a request to have their products removed from the DWPE, the FDA said.
“This guidance addresses the concern that industry may experience challenges in supporting their arguments about the safety of seafood products subject to DWPE. The intent of this draft guidance is to clarify the FDA’s thinking on when the appearance of adulteration may be removed, while giving industry the tools it needs to help support importation,” the agency said.
The guidance addresses 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 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.
- Recommendations for the types of evidence that may be useful when requesting removal of a fish and fishery product or manufacturer from DWPE.
Those who are interested can submit comments to Regulations.gov and identified with the docket number FDA-2023-D-5303.
