SUPPLEMENTARY INFORMATION:

I. Background

We are announcing the availability of a draft guidance for industry entitled “Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products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.” We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on this topic.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 alternate approach if it satisfies the requirements of the applicable statutes and regulations.

Under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 381(a)(3)), an article of food imported or offered for import into the United States is subject to refusal of admission if it appears “from the examination of such samples or otherwise” to be adulterated. FDA issues import alerts to inform its field staff about products that appear to be in violation of FDA's laws and regulations and thus may be detained without physical examination. We may subject future shipments of fish or fishery products to DWPE when there is information that causes future shipments of a product or products to appear violative within the meaning of section 801(a) of the FD&C Act. Such information may exist based on the violative history of a product, manufacturer, shipper, grower, importer, geographic area, or country.

To carry out the provisions of section 801(a) of the FD&C Act when we detain ( printed page 9854) an article that appears violative, we provide notice to the owner or consignee of the nature of the violation and the right to present testimony regarding the admissibility of the article (21 CFR 1.94). Frequently, owners or consignees submit analytical test results based on samples taken from the article subject to DWPE as evidence demonstrating admissibility. We then determine if the testimony (analytical package, information, or other evidence) is sufficient. If the evidence is adequate to overcome the appearance of the violation(s), FDA will allow the article to proceed for entry into the United States. If the evidence is not adequate to remove the appearance of the violation(s), the entry will be refused admission into the United States.

In addition, interested parties may request that their products be removed from DWPE. FDA decisions to remove a product, manufacturer, or other entity from DWPE are based on evidence establishing that the conditions that gave rise to the appearance of a violation have been resolved and we have confidence that future shipments of the product to the United States will be in compliance with the FD&C Act. FDA may consider analytical results from successful consecutive tests as part of the evidence to support removal from DWPE.

The draft guidance, when finalized, will provide recommendations for collecting a representative sample for products subject to DWPE under an import alert due to the appearance of adulteration caused by pathogens, unlawful animal drugs, scombrotoxin (histamine), and/or decomposition. When finalized, the draft guidance will also help foreign manufacturers and other processors of fish and fishery products subject to DWPE introduce evidence to FDA to support a request to have products removed from DWPE.

The recommendations in the draft guidance include sample sizes based on a critical nonconformities sampling strategy. Using this statistical sampling equation, the amount of sampling recommended can be structured commensurate with the level of concern, and risk to consumers, associated with the type of adulteration to be addressed. For more information, see “Derivation of Sampling Recommendations Related to 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; Guidance for Industry” (Ref. 1). As the draft guidance makes clear, persons may propose alternative sampling plans and explain the basis for such alternatives.

We note that the draft guidance refers to the final rule entitled “Laboratory Accreditation for Analyses of Foods” (LAAF Rule, which is codified at 21 CFR part 1, subpart R). FDA is taking a stepwise approach to implementing the LAAF Rule based, in part, on reaching sufficient LAAF-accredited laboratory capacity for food testing (see 86 FR 68728 at 68739 and 68740, December 3, 2021). FDA may publish one or more documents in the Federal Register giving owners and consignees 6 months' notice before requiring them to use a LAAF-accredited laboratory for food testing covered by the rule (id.). We will monitor LAAF Rule implementation and update any final guidance based on this draft guidance accordingly.

II. Paperwork Reduction Act of 1995

While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information in 21 CFR part 1, subpart R have been approved under OMB control number 0910-0898.

III. Electronic Access

Persons with access to the internet may obtain the draft guidance at https://www.fda.gov/​FoodGuidances, https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents, or https://www.regulations.gov. Use the FDA website listed in the previous sentence to find the most current version of the guidance.

IV. Reference

The following reference is on display at the Dockets Management Staff (see ADDRESSES ) and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at https://www.regulations.gov.

1. FDA, “Derivation of Sampling Recommendations Related to 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; Guidance for Industry.”