[Federal Register Volume 86, Number 103 (Tuesday, June 1, 2021)]
[Notices]
[Pages 29267-29268]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11388]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2021-D-0242, FDA-2021-D-0243, FDA-2021-D-0244, and 
FDA-2021-D-0245]


Compliance Policy Guide Sec. 555.400 Aflatoxins in Human Food; 
Compliance Policy Guide Sec. 570.200 Aflatoxins in Brazil Nuts; 
Compliance Policy Guide Sec. 570.375 Aflatoxins in Peanuts and Peanut 
Products; and Compliance Policy Guide Sec. 570.500 Aflatoxins in 
Pistachio Nuts; 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 four final Compliance Policy Guides (CPG) entitled 
``Compliance Policy Guide Sec. 555.400 Aflatoxins in Human Food,'' 
``Compliance Policy Guide Sec. 570.200 Aflatoxins in Brazil Nuts,'' 
``Compliance Policy Guide Sec. 570.375 Aflatoxins in Peanuts and Peanut 
Products,'' and ``Compliance Policy Guide Sec. 570.500 Aflatoxins in 
Pistachio Nuts.'' These CPGs revise the existing CPGs by updating the 
format and including references to other aflatoxins CPGs and a 
reference to the Memorandum of Understanding between the Agricultural 
Marketing Service (AMS) of the U.S. Department of Agriculture (USDA) 
and FDA. The CPGs provide guidance for FDA staff on FDA's current 
regulatory criteria for aflatoxins in human food, Brazil nuts, peanuts 
and peanut products, and pistachio nuts.

DATES: The announcement of the guidances is published in the Federal 
Register on June 1, 2021.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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, 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 Docket No. FDA-
2021-D-0242 for ``Compliance Policy Guide Sec. 555.400 Aflatoxins in 
Human Food,'' Docket No. FDA-2021-D-0243 for ``Compliance Policy Guide 
Sec. 570.200 Aflatoxins in Brazil Nuts,'' Docket No. FDA-2021-D-0244 
for ``Compliance Policy Guide Sec. 570.375 Aflatoxins in Peanuts and 
Peanut Products,'' and Docket No. FDA-2021-D-0245 for ``Compliance 
Policy Guide Sec. 570.500 Aflatoxins in Pistachio Nuts.'' 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 guidances to the 
Office of Strategic Planning and Operational Policy, Office of 
Regulatory Affairs, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 32, Rm. 4337, Silver Spring, MD 20993. Send two self-
addressed adhesive labels to assist that office in processing your 
request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidances.

FOR FURTHER INFORMATION CONTACT: Mischelle Ledet, Office of Compliance, 
Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740, 240-701-5986.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of four CPGs for FDA staff 
entitled ``Compliance Policy Guide Sec. 555.400 Aflatoxins in Human 
Food,'' ``Compliance Policy Guide Sec. 570.200 Aflatoxins in Brazil 
Nuts,'' ``Compliance Policy Guide Sec. 570.375 Aflatoxins in Peanuts 
and Peanut Products,'' and ``Compliance Policy Guide Sec. 570.500 
Aflatoxins in Pistachio Nuts.'' We are issuing these guidances 
consistent with our good guidance practices regulation (21 CFR 10.115). 
We are issuing these four CPGs as final and without first providing an 
opportunity to comment

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because the revisions are non-substantive; for example, we revised the 
CPGs' formats to be consistent with other CPGs, included references to 
other aflatoxins CPGs, and included a reference to the Memorandum of 
Understanding between USDA/AMS and FDA. Given the minor nature of these 
revisions, an opportunity for public comment before we finalize the 
CPGs is unnecessary. However, as is the case for all guidance 
documents, the public may comment on any guidance document at any time 
(Sec.  10.115(g)(5)).
    The guidances represent the current thinking of FDA on this topic. 
They do not establish any rights for any person and are not binding on 
FDA or the public. You can use an alternative approach if it satisfies 
the requirements of the applicable statutes and regulations.
    These four CPGs update the previously issued ``CPG Sec. 555.400 
Foods--Adulteration with Aflatoxin,'' ``CPG Sec. 570.200 Brazil Nuts--
Adulteration with Aflatoxin,'' ``CPG Sec. 570.375 Aflatoxin in Peanuts 
and Peanut Products,'' and ``CPG Sec. 570.500 Pistachio Nuts--Aflatoxin 
Adulteration.'' The CPGs are intended to provide guidance for FDA staff 
regarding adulteration in human food, Brazil nuts, peanuts and peanut 
products, and pistachio nuts due to the presence of aflatoxins and 
explain when we may consider such foods to be adulterated under section 
402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342).

II. Paperwork Reduction Act of 1995

    These guidances contain 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 guidances 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 guidances.

    Dated: May 24, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-11388 Filed 5-28-21; 8:45 am]
BILLING CODE 4164-01-P