[Federal Register Volume 88, Number 16 (Wednesday, January 25, 2023)]
[Proposed Rules]
[Pages 4797-4798]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01384]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 109

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


Action Levels for Lead in Food Intended for Babies and Young 
Children; Draft Guidance for Industry; Availability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availability of a draft guidance for industry entitled ``Action Levels 
for Lead in Food Intended for Babies and Young Children: Draft Guidance 
for Industry.'' The draft guidance, when finalized, would establish the 
following action levels for lead in processed food intended for babies 
and young children: 10 parts per billion (ppb) for fruits, vegetables 
(excluding single-ingredient root vegetables), mixtures, yogurts, 
custards/puddings, and single-ingredient meats; 20 ppb for root 
vegetables (single ingredient); and 20 ppb for dry cereals.

DATES: Submit either electronic or written comments on the draft 
guidance by March 27, 2023 to ensure that we consider your comment on 
the draft guidance before we begin work on the final version of the 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:
     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 Food Intended for 
Babies and Young Children: Draft 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 draft guidance to 
the Office of Food Safety, Division of Plant Products and Beverages, 
Beverages Branch, 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: Eileen Abt, Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-1700; or Philip Chao, 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.

[[Page 4798]]


SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a draft guidance for industry 
entitled ``Action Levels for Lead in Food Intended for Babies and Young 
Children: Draft Guidance for Industry.'' 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.
    This draft guidance, when finalized, would, in accordance with 21 
CFR 109.6, establish the following action levels for lead in food 
labeled for babies and young children: 10 parts per billion (ppb) for 
fruits, vegetables (excluding single-ingredient root vegetables), 
mixtures, yogurts, custards/puddings, and single-ingredient meats; 20 
ppb for root vegetables (single ingredient); and 20 ppb for dry infant 
cereals. Consistent with 21 CFR 109.6(d), these action levels would 
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. We request comments on these 
proposed action levels in general, including on whether there may be 
sufficient data or information that would support lower levels for 
these categories of foods. For example, we request comment on whether 
there is data or information that show adverse cognitive impacts in 
children at very low blood levels that could support a lower interim 
reference level for lead exposure through foods. We are particularly 
interested in whether there is data and information that would support 
a lower action level for fruits, vegetables (excluding single-
ingredient root vegetables), mixtures, yogurts, custards/puddings, and 
single-ingredient meats, given that we estimate that the achievability 
percentile (i.e., percentage of samples that fall at or below the 
action level) for this food category would be 90.6 percent if the 
action level were 5 ppb.
    In developing this draft guidance, FDA evaluated data collected for 
grain-based snacks (e.g., teething biscuits, puffs, rusks, wafers) 
collected through our Toxic Element Program and FDA surveys (122 
samples) and FDA's Total Diet Study (44 samples). Toxic Element Program 
and FDA survey data showed that the mean lead concentration for these 
grain-based snacks was 11.1 ppb, with 90th to 95th percentile 
concentrations of 18.7 to 26.8 ppb. Total Diet Study data had a 
slightly higher mean lead concentration of 17.6 ppb. We also evaluated 
baby food consumption data from What We Eat in America, the food 
consumption portion of the National Health and Nutrition Examination 
Survey, 2003-2018. These data indicated that consumption of grain-based 
snacks in this subgroup is relatively low. We request comment about 
consumption patterns and exposure to lead from this source, as well as 
any information about the role of these products in the diets of 
infants and toddlers, to help inform whether an action level for this 
food category would be appropriate.

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 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: January 19, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-01384 Filed 1-24-23; 8:45 am]
BILLING CODE 4164-01-P