Notice2021-11388
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 1, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 103 (Tuesday, June 1, 2021)</title>
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[Federal Register Volume 86, Number 103 (Tuesday, June 1, 2021)]
[Notices]
[Pages 29267-29268]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-11388]
[[Page 29267]]
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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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<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 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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:
<a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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
[[Page 29268]]
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 <a href="https://www.fda.gov/FoodGuidances">https://www.fda.gov/FoodGuidances</a> or <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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
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