Document ID: FDA-2019-D-5609-0001
Agency: fda
Document Type: Notice
Title: Action Levels for Lead in Juice; Draft Guidance for Industry; Availability
Posted Date: 2022-04-29T04:00Z

[Federal Register Volume 87, Number 83 (Friday, April 29, 2022)]
[Notices]
[Pages 25491-25493]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-09255]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-5609]

Action Levels for Lead in Juice; Draft Guidance for Industry; 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availability of a draft guidance for industry entitled ``Action Levels 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 Juice: Guidance for Industry.'' The draft guidance, when 
finalized, would establish action levels of 10 parts per billion (ppb) 
for lead in single-strength (ready-to-drink) apple juice and 20 ppb for 
lead in all other single-strength juice types, including juice blends 
that contain apple juice.

DATES: Submit either electronic or written comments on the draft 
guidance by June 28, 2022 to ensure that we consider your comment on 
the draft

[[Page 25492]]

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-2019-D-5609 for ``Action Levels for Lead in Juice: 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 Katherine Collins, 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 guidance for industry 
entitled ``Action Levels for Lead in Juice: 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(d), establish action levels for lead of 10 ppb for single-
strength (ready-to-drink) apple juice and 20 ppb for lead in all other 
single-strength juice types, including juice blends that contain apple 
juice. Consistent with 21 CFR 109.4, these action levels would define 
the levels of lead contamination that may cause the juice products 
described in the guidance to be regarded as adulterated. 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

    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 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.

IV. References

    The following references marked with an asterisk (*) are on display 
at the Dockets Management Staff (see ADDRESSES) and are available for 
viewing by interested persons between 9 a.m. and 4 p.m., Monday through 
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public 
display at https://www.regulations.gov

[[Page 25493]]

because they have copyright restriction. Some may be available at the 
website address, if listed. References without asterisks are available 
for viewing only at the Dockets Management Staff. FDA has verified the 
website addresses, as of the date this document publishes in the 
Federal Register, but websites are subject to change over time.

* 1. FDA, 2004. ``Guidance for Industry: Juice HACCP Hazards and 
Controls Guidance First Edition; Final Guidance.'' Available at 
https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Juice/ucm072557.htm.
2. Codex Alimentarius, 2021. Revision of the Code of Practice for 
the Prevention and Reduction of Lead Contamination in Foods.
3. HHS, National Toxicology Program, 2012. NTP Monograph on Health 
Effects of Low-Level Lead. Available at: https://ntp.niehs.nih.gov/ntp/ohat/lead/final/monographhealtheffectslowlevellead_newissn_508.pdf.
4. Flannery, B.M., L.C. Dolan, D. Hoffman-Pennesi, A. Gavelek, et 
al., 2020. U.S. Food and Drug Administration's Interim Reference 
Levels for Dietary Lead Exposure in Children and Women of 
Childbearing Age.'' Regulatory Toxicology and Pharmacology. 110:1-
20.
5. WHO/FAO Joint Expert Committee on Food Additives, 2011. 
Evaluation of Certain Contaminants in Food, 73rd Report of the World 
Health Organization/Food and Agriculture Organization of the United 
Nations Joint Expert Committee on Food Additives. WHO Technical 
Report Series 960. Available at https://apps.who.int/iris/bitstream/handle/10665/44515/WHO_TRS_960_eng.pdf?sequence=1.
6. Codex Alimentarius, 2021. General Standard for Contaminants and 
Toxins in Food and Feed, CXS 193-1995. http://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FMeetings%252FCX-735-14%252FINFO-DOC%252FCF14_INF01x.pdf.
* 7. FDA, 2021. Closer to Zero: Action Plan for Baby Foods. 
Available at https://www.fda.gov/food/metals-and-your-food/closer-zero-action-plan-baby-foods.
* 8. FDA, 2022b. Draft Supporting Document for Establishing FDA's 
Action Levels for Lead in Juice. Available at https://www.fda.gov.

    Dated: April 26, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09255 Filed 4-28-22; 8:45 am]
BILLING CODE 4164-01-P