[Federal Register Volume 89, Number 29 (Monday, February 12, 2024)]
[Notices]
[Pages 9852-9854]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-02838]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-5303]


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 and Removal 
of a Foreign Manufacturer's Goods From Detention Without Physical 
Examination; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is 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availability of a draft guidance for industry entitled 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.'' The draft 
guidance, when finalized, will provide recommendations for collecting a 
representative sample for products subject to DWPE under an import 
alert

[[Page 9853]]

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finalized, the draft guidance will also help foreign manufacturers and 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.

DATES: Submit either electronic or written comments on the draft 
guidance by April 12, 2024 to ensure that we consider your comment on 
the draft guidance before we begin work on the final version of the 
guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
    <bullet> If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
    <bullet> Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    <bullet> For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2023-D-5303 for ``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; Draft 
Guidance for Industry.'' Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
    <bullet> Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review 
this copy, including the claimed confidential information, in our 
consideration of comments. The second copy, which will have the claimed 
confidential information redacted/blacked out, will be available for 
public viewing and posted on https://www.regulations.gov. Submit both 
copies to the Dockets Management Staff. If you do not wish your name 
and contact information to be made publicly available, you can provide 
this information on the cover sheet and not in the body of your 
comments and you must identify this information as ``confidential.'' 
Any information marked as ``confidential'' will not be disclosed except 
in accordance with 21 CFR 10.20 and other applicable disclosure law. 
For more information about FDA's posting of comments to public dockets, 
see 80 FR 56469, September 18, 2015, or access the information at: 
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to 
the Division of Seafood Safety, Office of Food Safety, Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740. Send two self-addressed adhesive labels to 
assist that office in processing your request. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Steven Bloodgood, Office of Food 
Safety (HFS-325), Center for Food Safety and Applied Nutrition, Food 
and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-
402-5316; or Holli Kubicki, Office of Regulations and Policy (HFS-024), 
Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378.

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

[[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.''

    Dated: February 7, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-02838 Filed 2-9-24; 8:45 am]
BILLING CODE 4164-01-P