Notice2022-09255
Action Levels for Lead in Juice; Draft Guidance for Industry; Availability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
April 29, 2022
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The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled "Action Levels for Lead in Juice: Guidance for Industry." The draft guidance, when finalized, would establish action levels of 10 parts per billion (ppb) for lead in single-strength (ready-to-drink) apple juice and 20 ppb for lead in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.
Full Text
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<title>Federal Register, Volume 87 Issue 83 (Friday, April 29, 2022)</title>
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[Federal Register Volume 87, Number 83 (Friday, April 29, 2022)]
[Notices]
[Pages 25491-25493]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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Action Levels for Lead in Juice; Draft Guidance for Industry;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availability of a draft guidance for industry entitled ``Action Levels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 The draft guidance, when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DATES: Submit either electronic or written comments on the draft
guidance by June 28, 2022 to ensure that we consider your comment on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
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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 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-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 <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
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 <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.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. References without asterisks are not on public
display at <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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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
<a href="https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Juice/ucm072557.htm">https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Juice/ucm072557.htm</a>.
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: <a href="https://ntp.niehs.nih.gov/ntp/ohat/lead/final/monographhealtheffectslowlevellead_newissn_508.pdf">https://ntp.niehs.nih.gov/ntp/ohat/lead/final/monographhealtheffectslowlevellead_newissn_508.pdf</a>.
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 <a href="https://apps.who.int/iris/bitstream/handle/10665/44515/WHO_TRS_960_eng.pdf?sequence=1">https://apps.who.int/iris/bitstream/handle/10665/44515/WHO_TRS_960_eng.pdf?sequence=1</a>.
6. Codex Alimentarius, 2021. General Standard for Contaminants and
Toxins in Food and Feed, CXS 193-1995. <a href="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">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</a>.
* 7. FDA, 2021. Closer to Zero: Action Plan for Baby Foods.
Available at <a href="https://www.fda.gov/food/metals-and-your-food/closer-zero-action-plan-baby-foods">https://www.fda.gov/food/metals-and-your-food/closer-zero-action-plan-baby-foods</a>.
* 8. FDA, 2022b. Draft Supporting Document for Establishing FDA's
Action Levels for Lead in Juice. Available at <a href="https://www.fda.gov">https://www.fda.gov</a>.
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
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</html>Indexed from Federal Register on April 29, 2022.
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