. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/295
28 June 2000
(00-2644)
Committee on Sanitary and Phytosanitary Measures Original:  English
NOTIFICATION
1. Member to Agreement notifying:  UNITED STATES
If applicable, name of local government involved:           
2. Agency responsible:  US Food and Drug Administration
3. Products covered (provide tariff item number(s) as specified in national schedules
deposited with the WTO; ICS numbers may be provided in addition, where applicable).
Regions or countries likely to be affected, to the extent relevant or practicable:  Patulin in
apple juice, concentrates and products (2 pages plus draft documents)
4. Title and number of pages of the notified document:  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
5. Description of content:  The Food and Drug Administra tion (FDA) is announcing the
availability of a draft compliance policy guide (CPG) entitled "Apple Juice, Apple JuiceConcentrates, and Apple Juice Products - Adulteration with 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).
6. Objective and rationale: [  X ] food safety,  [     ] animal health,  [    ] plant protection,
[    ] protect humans from animal/plant pest or disease, [     ] protect territory from other
damage from pests           
7. An international standard, guideline or recommendation does not exist [  X ].
If an international standard, guideline or recommendation exists, give the appropriate
reference and briefly identify deviations:  The Codex Committee on Food Additives and
Contaminants (CCFAC) has forwarded, at Step 8, a standard on patulin in apple juice to the
Codex Commission.  The Commission will review the recommendation at their next meeting inJune 2001.  This US proposal reflects the same level of 50 ppb as is included in the Codex
proposed standard.
8. Relevant documents and language(s) in which these are available: 65 FR 37791,
16 June 2000 (Available in English)G/SPS/N/USA/295
Page 2
9. Proposed date of adoption:  To be determined.
10. Proposed date of entry into force:  To be determined.
11. Final date for comments:  15 August 2000
Agency or authority designated to handle comments:  Food and Drug Administration
[    ] National notification authority, [     ] National enquiry point, or address, fax number
and E-mail address (if available) of other body:  Detailed instruction on where and how to
send comments is in the body of the full text - which will be sent upon request to the address in
paragraph 12.
12. Texts available from: [  X ] National notification authority, [  X ] National enquiry point or
address, fax number and E-mail address (if available) of other body:
United States SPS Enquiry Point/Notification Authority
USDA/FAS/FSTSD
Attn: Carolyn F. Wilson
Room 5545 South Agriculture Building
Stop 1027
1400 Independence Avenue, S.W.Washington, D.C. 20250
Phone (202) 720-2239
Fax (202) 690-0677
E-mail Address: ofsts@fas.usda.gov