[Federal Register Volume 78, Number 135 (Monday, July 15, 2013)]
[Notices]
[Pages 42086-42087]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-16719]
-----------------------------------------------------------------------
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Draft Guidance for Industry on Arsenic in Apple Juice: Action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.
-----------------------------------------------------------------------
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availability of a draft guidance for industry entitled ``Arsenic in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supporting documents are referenced in the draft guidance.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draft guidance identifies for the industry an action level for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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 13, 2013.
ADDRESSES: Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to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Submit written requests for single copies of the draft guidance to the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INFORMATION section for electronic access to the draft guidance.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