. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/645
17 October 2002
(02-5668)
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:   Food and Drug Ad ministration – FDA
3. Products covered (provide tariff item number(s) as specified in national schedules
deposited with the WTO; ICS numbers should be provided in addition, where
applicable):   Fruit and vegetable juices
4. Regions or countries likely to be affected, to the extent relevant or practicable:
Trading partners
5. Title, language and number of pages of the notified document:   Draft Guidance for Bulk
Transport of Juice Concentrates and Certain Shelf Stable Juices, (20 pages, available inEnglish)
6. Description of content:   FDA has issued a draft guidance entitled "Guidance on Bulk
Transport of Juice Concentrates and Certain Shelf Stable Juices", to assist processors in
developing appropriate control measures to prevent contamination by harmful
microorganisms, e.g. salmonella, of certain juices and juice concentrates during bulk
transport.  This guidance addresses an issue raised in a petition from industry asking thatFDA revise a provision in the recently enacted juice HACCP regulation that requires all
juice processors to treat juice in the fac ility where the final packaging occurs.  FDA
included this provision in the regulation because it was concerned with the potential for the
contamination of juice by harmful microorganisms during bulk transport.  Under the
guidance, FDA is exercising enforcement disc retion to allow processors an alternative
means by which to address the safety of juice during transport.
7. 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
8. International standard, gu ideline or recommendation:
[   ] Codex Alimentarius Commission, [   ] Office International des Epizooties,
[   ] International Plant Prot ection Convention, [ X ] None
If an international standard , guideline or recommendation exists, give the appropriate
reference and briefly identify deviations:
9. Relevant documents and language(s ) in which these are available:   Notice of availability
in 67 FR 62488 and "Draft Guidance for I ndustry:  Guidance on Bulk Transport of Juice
Concentrates and Certain Shelf Stable Juices" (available in English)G/SPS/N/USA/645
Page 2
10. Proposed date of adoption:   This guidance is applicable upon issuance of the final
guidance.
11. Proposed date of entry into force:   This guidance is applicable upon issuance of the final
guidance.
12. Final date for comments:   Submit written or electronic objections by 6 December 2002.
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:   Submit written comments on the
document to the Dockets Management Branch  (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, U.S.A.  It is possible to submit
electronic comments to:  http://www.fda.gov/dockets/ecomments .  Submit comments by
indicating DOCKET No. 02P–0009 and Title Draft Guidance for Industry: Guidance on
Bulk Transport of Juice Concentrates and Certain Shelf Stable Juices;  Availability
13. 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 Point
Mr. William Janis
U.S. Department of Agriculture
Stop 1027
Washington, DC 20250
Tel:  (202) 720-9047Fax:  (202) 720-0677
E-mail:  William.janis2@usda.gov .
Complete text can be also be found on the Internet
http://www.fda.gov/OHRMS/DOCKETS/98fr/100702d.htm  by looking under DOCKET
No. 02P–0009 and at http://www.cfsan.fda.gov/~dms/juicgui4.html