Notice2023-10523
Compliance Policy Guide Sec. 555.250 Major Food Allergen Labeling and Cross-Contact; Availability
Primary source
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Published
May 17, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is announcing the availability of a draft Compliance Policy Guide entitled "Sec. 555.250 Major Food Allergen Labeling and Cross-contact." The draft guidance, when finalized, will replace existing guidance for FDA staff on FDA's enforcement policy regarding major food allergen labeling and cross- contact.
Full Text
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<title>Federal Register, Volume 88 Issue 95 (Wednesday, May 17, 2023)</title>
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[Federal Register Volume 88, Number 95 (Wednesday, May 17, 2023)]
[Notices]
[Pages 31507-31508]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-10523]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-1103]
Compliance Policy Guide Sec. 555.250 Major Food Allergen Labeling
and Cross-Contact; 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. 555.250
Major Food Allergen Labeling and Cross-contact.'' The draft guidance,
when finalized, will replace existing guidance for FDA staff on FDA's
enforcement policy regarding major food allergen labeling and cross-
contact.
DATES: Submit either electronic or written comments on the draft
guidance by July 17, 2023 to ensure that we consider your comment on
the draft guidance before we begin work on the final version of the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: <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
[[Page 31508]]
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-1103 for ``Sec. 555.250 Major Food Allergen Labeling and
Cross-contact.'' 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 draft guidance to
Office of Compliance (HFS-605), 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: Yinqing Ma, Office of Compliance (HFS-
605), Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2479,
email: <a href="/cdn-cgi/l/email-protection#782111160911161f561519381e1c195610100b561f170e"><span class="__cf_email__" data-cfemail="134a7a7d627a7d743d7e72537577723d7b7b603d747c65">[email protected]</span></a>; or Denise See, 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. 555.250 Major Food Allergen Labeling and
Cross-contact.'' This draft CPG would update and replace existing
guidance for FDA staff on FDA's enforcement policy regarding major food
allergen labeling and cross-contact. The content of current CPG Sec.
555.250 was written before the enactment of three major laws that are
the foundation of FDA's regulatory framework for major food allergens:
Food Allergen Labeling and Consumer Protection Act (2004), FDA Food
Safety Modernization Act (2011), and the Food Allergy Safety,
Treatment, Education and Research Act (2021). The current CPG Sec.
555.250 also does not reflect requirements in our regulation entitled
``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based
Preventive Controls for Human Food'' (now codified at 21 CFR part 117).
We are issuing the draft guidance consistent with our good guidance
practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent our current thinking 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 <a href="https://www.fda.gov/FoodGuidances">https://www.fda.gov/FoodGuidances</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</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 guidance.
Dated: May 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-10523 Filed 5-16-23; 8:45 am]
BILLING CODE 4164-01-P
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