[Federal Register: October 31, 2001 (Volume 66, Number 211)]
[Notices]
[Page 55000-55001]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31oc01-68]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 00D-1305]
Compliance Policy Guide: ``Apple Juice, Apple Juice Concentrates,
and Apple Juice Products--Adulteration with Patulin,'' Availability;
and ``Patulin in Apple Juice, Apple Juice Concentrates and Apple Juice
Products,'' Supporting Document; 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 compliance policy guide (CPG) entitled ``Apple Juice,
Apple Juice Concentrates, and Apple Juice Products--Adulteration with
Patulin.'' This document is intended to make FDA offices and the
industry aware of FDA's guidance for enforcement concerning apple
juice, apple juice concentrates, and apple juice products that contain
patulin, a toxic substance produced by molds that may grow on apples
and that has been found to occur at high levels in some apple juice
products offered for sale in the United States. The agency also is
announcing the availability of a document entitled ``Patulin in Apple
Juice, Apple Juice Concentrates and Apple Juice Products'' (final
supporting document).
DATES: Submit written or electronic comments on the CPG or the final
supporting document at any time.
ADDRESSES: Submit written requests for single copies of the CPG
entitled ``Apple Juice, Apple Juice Concentrates, and Apple Juice
Containing Products--Adulteration with Patulin'' and/or the final
supporting document entitled ``Patulin in Apple Juice, Apple Juice
Concentrates and Apple Juice Products'' to the Office of Plant and
Dairy Foods and Beverages (HFS-305), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 200 C St. SW., Washington, DC
20204. Send two self-addressed adhesive labels to assist that office in
processing your request. Submit written comments to the Docket
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to
http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION
section for electronic access to these documents.
FOR FURTHER INFORMATION CONTACT:
Technical questions concerning patulin in apple juice products:
Michael E. Kashtock, Center for Food Safety and Applied Nutrition (HFS-
305), Food and Drug Administration, 200 C St. SW., Washington, DC
20204, 202-205-5321, FAX 202-205-4422, e-mail: mkashtoc@cfsan.fda.gov.
Questions concerning regulatory actions: MaryLynn Datoc, Office of
Enforcement (HFC-230), Office of Regulatory Affairs, Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0413,
FAX 301-827-0482, e-mail: mdatoc@ora.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In a notice published in the Federal Register of June 16, 2000 (65
FR 37791), FDA announced the availability of a draft CPG entitled
``Apple Juice, Apple Juice Concentrates, and Apple Juice Products--
Adulteration with Patulin'' and a draft supporting document entitled
``Patulin in Apple Juice, Apple Juice Concentrates, and Apple Juice
Products.'' The agency has finalized the draft CPG and the draft
supporting document after considering the
[[Page 55001]]
comments we received on these documents.
FDA received four comments on these two documents, three from food
industry associations and one from an organization representing several
foreign governments. Three of the comments supported the draft CPG and
draft supporting document and did not raise any questions.
The fourth comment posed three questions about the action level and
the safety assessment described in the draft supporting document. FDA
has considered these questions and has responded to them in the revised
supporting document.
II. Significance of Guidance
This CPG is being issued as guidance consistent with FDA's good
guidance practices regulation in 21 CFR 10.115. The CPG represents the
agency's current thinking on its enforcement process concerning the
adulteration of apple juice, apple juice concentrates, and apple juice
products with patulin. It does not create or confer any rights for or
on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statute and regulations.
III. Comments
Interested persons may, at any time, submit to the Docket
Management Branch (address above) written or electronic comments
concerning the CPG entitled ``Apple Juice, Apple Juice Concentrates,
and Apple Juice Products--Adulteration with Patulin'' or the final
supporting document. Two copies of any comments are to be submitted,
except that individuals may submit one copy. Comments are to be
identified with the docket number found in brackets in the heading of
this document. Comments also may be submitted electronically. A copy of
the CPG and the final supporting document and received comments are
available for public examination in the Dockets Management Branch
between 9 a.m. and 4 p.m., Monday through Friday.
IV. Electronic Access
Persons with access to the Internet may obtain the CPG at http://
www.fda.gov/ora under ``Compliance References.'' The supporting
document may be accessed at http://www.cfsan.fda.gov under the heading
``How to Obtain FDA Food & Cosmetic Guidance Documents.''
Dated: October 22, 2001.
Dennis E. Baker,,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 01-27319 Filed 10-30-01; 8:45 am]
BILLING CODE 4160-01-S