[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presented in the draft guidance issued in 2013.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]
BILLING CODE 4164-01-P


