65FR37791B 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 Supporti
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Posting-number: Volume 65, Issue 117, Page 37791B
[Federal Register: June 16, 2000 (Volume 65, Number 117)]
[Notices]
[Page 37791-37792]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16jn00-68]
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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: mkas...@cfsan.fda.gov.
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