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[Federal Register Volume 65, Number 117 (Friday, June 16, 2000)]
[Notices]
[Pages 37791-37792]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-15122]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1305]

Foods: ``Apple Juice, Apple Juice Concentrates, and Apple Juice 
Products--Adulteration with Patulin;'' Draft Compliance Policy Guide; 
Availability and ``Patulin in Apple Juice, Apple Juice Concentrates, 
and Apple Juice Products;'' Draft 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 draft compliance policy guide (CPG) entitled ``Apple 
Juice, Apple Juice Concentrates, and Apple Juice Products--Adulteration 
with

[[Page 37792]]

Patulin''. This document is intended to make FDA offices and 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 or import in the United States. The agency is also announcing 
the availability of a document entitled ``Patulin in Apple Juice, Apple 
Juice Concentrates, and Apple Juice Products'' (the draft supporting 
document).

DATES: Submit written comments by August 15, 2000.

ADDRESSES: Submit written requests for single copies of the draft CPG 
entitled ``Apple Juice, Apple Juice Concentrates, and Apple Juice 
Containing Products--Adulteration with Patulin'' and/or the draft 
supporting document entitled ``Patulin in Apple Juice, Apple Juice 
Concentrates, and Apple Juice Products'' to Michael E. Kashtock 
(address below). Send one self-addressed adhesive label to assist that 
office in processing your request. See the SUPPLEMENTARY INFORMATION 
section for electronic access to this document.
    Submit written comments on the draft CPG and the draft supporting 
document to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Comments and requests for copies should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Michael E. Kashtock, Center for Food 
Safety and Applied Nutrition (CFSAN) (HFS-305), Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204, 202-205-5321, FAX 
202-205-4422, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: FDA has developed a draft CPG on FDA's 
guidance for enforcement concerning apple juice, apple juice 
concentrates, and apple juice products that contain patulin. This 
document is intended to provide clear policy and regulatory guidance to 
FDA's field and headquarters staff with regard to such foods. In 
particular, if these products: (1) Contain patulin at or above 50 parts 
per billion (ppb) (the action level) based on the level found or 
calculated to be found in single strength apple juice, reconstituted 
single strength apple juice (if the food is an apple juice 
concentrate), or the single strength apple juice component of the 
product (if the food contains apple juice as an ingredient); and (2) 
the identity of patulin is confirmed by gas chromatography/mass 
spectrometry, then the FDA field enforcement office may consider 
whether to recommend legal action against such apple juice, apple juice 
concentrates, and apple juice products in interstate commerce, and it 
may consider whether to recommend detention of the same products when 
offered for import into the United States. For the purposes of this 
guidance, single strength juice is 100 percent juice that is 
unconcentrated (see 21 CFR 101.30(h)). The scientific basis for the 50 
ppb action level is presented in the draft supporting document. The 
draft CPG also contains information that may be useful to the regulated 
industry and to the public.
    FDA has included an import specimen charge in this draft CPG to 
assist its field personnel in recommending refusal of admission for 
imported goods when warranted. The fact that this draft CPG contains an 
import specimen charge (in addition to the customary specimen charge 
addressing regulatory action against food in domestic commerce) does 
not restrict any action FDA may take under circumstances addressed by 
other CPG's that do not have an import specimen charge, and it does not 
imply that FDA will not take action when warranted.
    The agency has adopted good guidance practices (GGP's) that set 
forth the agency's policies and procedures for the development, 
issuance, and use of guidance documents (62 FR 8961, February 27, 
1997). The draft CPG is being issued as a level 1 draft guidance 
consistent with GGP's. The draft CPG represents the agency's current 
thinking on its enforcement guidance 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.
    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding the draft CPG and the draft 
supporting document by August 15, 2000. 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. Received comments, the draft CPG, and the 
draft supporting document may be seen in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday. These two documents 
may also be accessed at the CFSAN home page on the Internet at http://www.fda.cfsan.gov.

    Dated: June 8, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-15122 Filed 6-15-00; 8:45 am]
BILLING CODE 4160-01-F
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