[Federal Register Volume 66, Number 211 (Wednesday, October 31, 2001)]
[Notices]
[Pages 55000-55001]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-27319]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: [email protected].
    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: [email protected].

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