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[Federal Register Volume 90, Number 4 (Tuesday, January 7, 2025)]
[Notices]
[Pages 1135-1136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31534]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0278]

Action Levels for Lead in Processed Food Intended for Babies and 
Young Children; 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 final guidance for industry entitled ``Action Levels 
for Lead in Processed Food Intended for Babies and Young Children.'' 
The guidance establishes action levels for lead in certain processed 
foods intended for babies and young children less than 2 years old. The 
guidance is intended to set achievable action levels that will help 
further reduce lead in the food supply.

DATES: The announcement of the guidance is published in the Federal 
Register on January 7, 2025.

ADDRESSES: You may submit either electronic or written comments on FDA 
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 the Docket No. 
FDA-2022-D-0278 for ``Action Levels for Lead in Processed Food Intended 
for Babies and Young Children; 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.
     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 guidance to the 
Office of Food Chemical Safety, Dietary Supplements, and Innovation, 
Human Foods Program, 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 guidance.

FOR FURTHER INFORMATION CONTACT: Eileen Abt, Office of Food Chemical 
Safety, Dietary Supplements, and Innovation, Human Foods Program, Food 
and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-
402-1700; or Holli Kubicki, Office of Policy, Regulations, and 
Information, Human Foods Program, Food and Drug

[[Page 1136]]

Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a guidance for industry 
entitled ``Action Levels for Lead in Processed Food Intended for Babies 
and Young Children.'' We are issuing this guidance consistent with our 
good guidance practices regulation (21 CFR 10.115). The guidance 
represents 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 alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.
    In the Federal Register of January 25, 2023 (88 FR 4749), we made 
available a draft guidance for industry entitled ``Action Levels for 
Lead in Food Intended for Babies and Young Children'' and gave 
interested parties an opportunity to submit comments by March 27, 2023, 
for us to consider before beginning work on the final version of the 
guidance. In the Federal Register of April 6, 2023 (88 FR 20525), we 
announced that we were reopening the comment period until May 8, 2023, 
to allow interested parties additional time to submit comments. We 
received several comments on the draft guidance and have modified the 
final guidance where appropriate. Changes to the guidance include 
clarifications to the foods that the guidance addresses, including the 
age range of the foods' intended consumers. We added information about 
the method that FDA uses to test for lead in food and made several 
editorial changes to improve clarity of the guidance. We also collected 
and analyzed additional samples from our Toxic Elements Program and 
special FDA surveys to inform our exposure and achievability 
assessments. The guidance announced in this notice finalizes the draft 
guidance dated January 2023.
    In accordance with Sec.  109.6 (21 CFR 109.6), this guidance 
establishes the following action levels for lead in processed food 
intended for babies and young children less than 2 years old: 10 parts 
per billion (ppb) for fruits, vegetables (excluding single-ingredient 
root vegetables), mixtures (including grain- and meat-based mixtures), 
yogurts, custards/puddings, and single-ingredient meats; 20 ppb for 
single-ingredient root vegetables; and 20 ppb for dry infant cereals. 
Consistent with Sec.  109.6(d), these action levels reflect levels of 
lead at which FDA may regard the food as adulterated within the meaning 
of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 342(a)(1)). We intend to consider these action levels, in 
addition to other factors, when considering whether to bring 
enforcement action in a particular case.

II. Paperwork Reduction Act of 1995

    This 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 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.

    Dated: December 27, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-31534 Filed 1-6-25; 8:45 am]
BILLING CODE 4164-01-P
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