[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]
-----------------------------------------------------------------------
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Draft Guidance for Industry on Arsenic in Apple Juice: Action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.
-----------------------------------------------------------------------
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comment period for the draft guidance for industry entitled ``Arsenic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 The draft guidance identifies for the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draft guidance.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DATES: FDA is extending the comment period on the draft guidance.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ADDRESSES: Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to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Submit written requests for single copies of the draft guidance to the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INFORMATION section for electronic access to the draft guidance.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