[Federal Register Volume 88, Number 106 (Friday, June 2, 2023)]
[Notices]
[Pages 36319-36320]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-11769]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-0322]
Action Level for Inorganic Arsenic in Apple Juice: 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 Level
for Inorganic Arsenic in Apple Juice.'' The guidance identifies for
industry an action level for inorganic arsenic in apple juice that is
intended to help protect public health by reducing exposure to
inorganic arsenic and is achievable with the use of current good
manufacturing practices. It also describes our intended sampling and
enforcement approach. Thus, the guidance finalizes the approach
presented in the draft guidance issued in 2013.
DATES: The announcement of the guidance is published in the Federal
Register on June 2, 2023.
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-2012-D-0322 for ``Action Level for Inorganic Arsenic in Apple
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 guidance to the
Division of Plant Products and Beverages, Office of Food Safety, Center
for Food Safety and Applied Nutrition (HFS-317), 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, Center for Food Safety and
Applied Nutrition (HFS-317), Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240-402-1529; 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 guidance for industry
entitled ``Action Level for Inorganic Arsenic in Apple Juice.'' 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 July 15, 2013 (78 FR 42086), we
announced the availability of a draft guidance for industry entitled
``Arsenic in Apple Juice: Action Level.'' We also announced the
availability of two related scientific documents: a document entitled
``Supporting Document for Action Level for Arsenic in Apple Juice''
(supporting document),
[[Page 36320]]
and a risk assessment entitled ``A Quantitative Assessment of Inorganic
Arsenic in Apple Juice'' (the risk assessment document). We gave
interested parties an opportunity to submit comments by September 13,
2013.
This guidance finalizes FDA's action level for inorganic arsenic in
apple juice of 10 micrograms per kilogram ([micro]g/kg) or 10 parts per
billion (ppb) and identifies FDA's intended sampling and enforcement
approach. The basis for the action level is set forth in the guidance
document, as well as the risk assessment document originally made
available on July 15, 2013, that can be accessed in the docket
referenced above at https://www.regulations.gov. The guidance reviews
data on inorganic arsenic levels in apple juice, health effects from
exposure to inorganic arsenic, and the ability of manufacturers to
achieve different levels of inorganic arsenic in apple juice. It also
explains FDA's rationale for identifying an action level of 10
[micro]g/kg or 10 ppb for inorganic arsenic in apple juice.
Arsenic is present in the environment as a naturally occurring
substance or as a result of contamination from human activity. In
foods, arsenic may be present as inorganic arsenic (the primary toxic
form of arsenic) or organic arsenic. Exposure to inorganic arsenic is
associated with adverse human health effects, including cancer and
neurodevelopmental effects. Apple juice is one source of exposure to
arsenic from food, and a greater potential source of exposure for
children than adults, because children's dietary patterns are often
less varied than those of adults, and they consume more apple juice
relative to their body weight than do adults. We expect that the 10
[micro]g/kg or 10 ppb action level, though non-binding, will help
protect public health by encouraging manufacturers to reduce levels of
inorganic arsenic in apple juice and therefore reduce human exposure to
inorganic arsenic. We also expect that this level is achievable by
industry with the use of current good manufacturing practices. We
intend to consider the action level of 10 [micro]g/kg or 10 ppb
inorganic arsenic as an important source of information for determining
whether apple juice is adulterated within the meaning of section
402(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
342(a)(1)).
In finalizing the guidance, we incorporated data from the
supporting document and added an analysis of new data on inorganic
arsenic levels in apple juice, health effects from exposure to
inorganic arsenic, and the ability of manufacturers to limit inorganic
arsenic in apple juice, in evaluating the appropriate action level. We
also made changes to the text for clarity, including explaining the
term ``added'' in this context and that ``apple juice'' includes apple
cider, and we have also revised the title of the guidance to more
clearly show that we are setting an action level. In addition, we added
information on our understanding of arsenical pesticide use in the
United States and expanded the discussion of the rationale for setting
an action level based on sampling and testing results and the
discussion of FDA's sampling and enforcement approach. We also
incorporated new references in support of these changes and to reflect
the citation of recently published FDA data and a new reference to
FDA's Closer to Zero action plan.
We also considered all comments received during the comment period
in finalizing the document. Comments on the draft guidance requested
that we consider establishing action levels for other foods containing
arsenic, such as other apple products, other fruit juices, and rice;
that the action level be lower than 10 ppb; that we consider additional
risk management approaches; and that questioned the achievability of
the action level of 10 ppb in apple juice. We did not receive new data
from the comments supporting establishment of either a higher or lower
action level. None of the comments caused us to change the approach set
out in the draft guidance. We have clarified in the title of the final
guidance that the action level of 10 ppb applies to inorganic arsenic.
Other comments suggested modifications to the risk assessment
document. We note that the risk assessment report underwent peer review
before we made it available to the public. (This can be found at
https://www.fda.gov/science-research/peer-review-scientific-information-and-assessments/completed-peer-reviews.) None of these
comments supported a determination that the risk assessment document
needs to be modified. We will continue to monitor research developments
on adverse health effects of inorganic arsenic exposure to determine if
new data support changes to the guidance.
II. Paperwork Reduction Act of 1995
This final 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
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.
Dated: May 30, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-11769 Filed 6-1-23; 8:45 am]
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