[Federal Register Volume 78, Number 178 (Friday, September 13, 2013)]
[Notices]
[Page 56719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-22313]


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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Draft Guidance for Industry on Arsenic in Apple Juice: Action 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; 
Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
comment period for the draft guidance for industry entitled ``Arsenic 
in Apple Juice: Action Level'' that appeared in the Federal Register of 
July 15, 2013 (78 FR 42086). The draft guidance identifies for the 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. In the notice, we requested comments on the 
draft guidance. We are taking this action in response to a request for 
an extension to allow interested persons additional time to submit 
comments.

DATES: FDA is extending the comment period on the draft guidance. 
Submit either electronic or written comments by November 12, 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ADDRESSES: Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to 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Submit written requests for single copies of the draft guidance to the 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INFORMATION section for electronic access to the draft guidance.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

    In the Federal Register of July 15, 2013 (78 FR 42086), we 
published a notice announcing the availability of three documents, a 
draft guidance for industry entitled ``Arsenic in Apple Juice: Action 
Level,'' 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. The notice 
invited comments on the draft guidance by September 13, 2013.
    As of August 28, 2013, we have received two requests for an 
extension of the comment period. The requests, from the Arsenic Science 
Task Force and the Juice Products Association, explained that they 
needed more time to complete their analyses of the supporting 
documents.
    We have considered the request and are extending the comment period 
for the notice for 60 days, until November 12, 2013. We believe that a 
60-day extension allows adequate time for interested persons to submit 
comments without significantly delaying further FDA action on this 
guidance.

II. Request for Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). 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, and will be posted to the docket at http://www.regulations.gov.

    Dated: September 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-22313 Filed 9-12-13; 8:45 am]
BILLING CODE 4160-01-P