
[Federal Register Volume 78, Number 135 (Monday, July 15, 2013)]
[Notices]
[Pages 42086-42087]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-16719]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0322]


Draft Guidance for Industry on Arsenic in Apple Juice: Action 
Level; Supporting Document for Action Level for Arsenic in Apple Juice; 
A Quantitative Assessment of Inorganic Arsenic in Apple Juice; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Arsenic in 
Apple Juice: Action Level'' and two supporting documents entitled 
``Supporting Document for Action Level for Arsenic in Apple Juice'' 
(the draft supporting document) and ``A Quantitative Assessment of 
Inorganic Arsenic in Apple Juice'' (the risk assessment document). The 
supporting documents are referenced in the draft guidance. The

[[Page 42087]]

draft guidance identifies for the industry an action level for 
inorganic arsenic in apple juice that FDA considers protective of human 
health and achievable with the use of good manufacturing practices. It 
also describes FDA's intended sampling and enforcement approach.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on the 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 13, 2013.

ADDRESSES: Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 
Submit written requests for single copies of the draft guidance to the 
Office of Food Safety, Center for Food Safety and Applied Nutrition 
(HFS-317), Food and Drug Administration, 5100 Paint Branch Pkwy., 
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INFORMATION section for electronic access to the draft guidance.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: Lauren Posnick Robin, Center for Food 
Safety and Applied Nutrition (HFS-317), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1639.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of three documents, a draft 
guidance for industry entitled ``Arsenic in Apple Juice: Action Level'' 
and supporting documents referenced in the draft guidance, including a 
draft supporting document entitled ``Supporting Document for Action 
Level for Arsenic in Apple Juice'' and a risk assessment document 
entitled ``A Quantitative Assessment of Inorganic Arsenic in Apple 
Juice.'' The draft guidance identifies an action level for inorganic 
arsenic in apple juice of 10 micrograms/kilogram ([micro]g/kg) or 10 
parts per billion (ppb), and identifies FDA's intended sampling and 
enforcement approach. The draft supporting document reviews data on 
arsenic levels, health effects, and achievability, and explains FDA's 
rationale for identifying an action level for inorganic arsenic in 
apple juice of 10 [micro]g/kg. The risk assessment document provides 
estimates of arsenic exposure and risk to humans at different 
hypothetical limits for inorganic arsenic in apple juice.
    FDA considers the 10 [micro]g/kg action level to be protective of 
human health and to be achievable with the use of good manufacturing 
practices, but FDA especially welcomes comments and information bearing 
on the achievability of 10 [micro]g/kg, as compared with other 
potential action levels. Consistent with 21 CFR 109.6, FDA intends to 
consider the action level of 10 ug/kg or 10 ppb inorganic arsenic, in 
addition to other factors, when considering whether to bring 
enforcement action in a particular case.
    The draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on arsenic in 
apple juice. It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternate 
approach may be used if such approach satisfies the requirements of the 
applicable statutes and regulations.

II. Comments

    Interested persons may submit either electronic or written comments 
regarding this document according to the instructions in the ADDRESSES 
section of this document. It is only necessary to send one set of 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance, 
the draft supporting document, and the risk assessment document at 
either http://www.fda.gov/FoodGuidances or http://www.regulations.gov. 
Always access an FDA document using the FDA Web site listed previously 
to find the most current version of the guidance.

    Dated: July 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-16719 Filed 7-12-13; 8:45 am]
BILLING CODE 4160-01-P


