Document ID: FDA-2021-D-0367-0001
Agency: fda
Document Type: Notice
Title: Compliance Policy Guide Sec. 540.525
Scombrotoxin (Histamine)-Forming
Fish and Fishery Products—
Decomposition and Histamine;
Availability
Posted Date: 2021-12-27T05:00Z

[Federal Register Volume 86, Number 245 (Monday, December 27, 2021)]
[Notices]
[Pages 73295-73296]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-28053]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0367]

Compliance Policy Guide Sec. 540.525 Scombrotoxin (Histamine)-
Forming Fish and Fishery Products--Decomposition and Histamine; 
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 Compliance Policy Guide entitled ``Sec. 540.525 
Scombrotoxin (Histamine)-forming Fish and Fishery Products--
Decomposition and Histamine.'' The draft guidance, when finalized, will 
replace existing guidance for FDA staff on adulteration associated with 
decomposition and histamine identified during surveillance sampling and 
testing of fish and fishery products susceptible to histamine 
formation.

DATES: Submit either electronic or written comments on the draft 
guidance by February 25, 2022 to ensure that we consider your comment 
on the draft guidance before we begin work on the final version of the 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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically,

[[Page 73296]]

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.
     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:
     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.
     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-2021-D-0367 for ``Sec. 540.525 Scombrotoxin (Histamine)-forming 
Fish and Fishery Products--Decomposition and Histamine (CPG 7108.24).'' 
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.
     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 
Division of Seafood Safety (HFS-325), 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, Division of Seafood 
Safety (HFS-325), Center for Food Safety and Applied Nutrition, Food 
and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-
402-5316, email: [email protected]; or Jessica Larkin, 
Center for Food Safety and Applied Nutrition, Office of Regulations and 
Policy (HFS-024), 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 Compliance Policy 
Guide (CPG) entitled ``Sec. 540.525 Scombrotoxin (Histamine)-forming 
Fish and Fishery Products--Decomposition and Histamine (CPG 7108.24).'' 
This draft CPG would update and replace existing guidance for FDA staff 
on adulteration associated with decomposition and histamine identified 
during surveillance sampling and testing of fish and fishery products 
susceptible to scombrotoxin (histamine) formation. The draft CPG would 
revise FDA regulatory action guidance for sensory analysis and/or 
histamine levels in scombrotoxin-forming fish and fishery products.
    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.

II. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this draft guidance contains no 
collection of information. Therefore, clearance by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 is not 
required.

III. Electronic Access

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

    Dated: December 21, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-28053 Filed 12-23-21; 8:45 am]
BILLING CODE 4164-01-P