. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/649
28 October 2002
(02-5906)
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:  Guidance for Industry:
Exemptions from the Warning Label Requirement for Juice – Recommendations forEffectively Achieving a 5-log Pathogen Reduction, (six pages, available in English)
6. Description of content:   FDA has issued a final guidance document, "Exemptions from the
Warning Label Requirement for Juice – Recommendations for Effectively Achieving a
5-log Pathogen Reduction."  This document is intended to provide revised FDA guidance
to small and very small fruit and vegetable juice processors for effectively achieving a
5-log pathogen reduction that is the basis for exempting juice products from the warninglabel requirement established by the final rule, "Food Labeling:  Warning and Notice
Statement:  Labeling of Juice Products" (63 FR 37030;  8 July 1998).  A 5-log pathogen
reduction is also a requirement of the final rule, "Hazard Analysis and Critical Control
Point (HACCP);  Procedures for the Safe and Sanitary Processing and Importing of Juice"
(66 FR 6138;  19 January 2001).
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 62490 and "Guidance for I ndustry:  Exemptions from the Warning Label
Requirement for Juice – Recommendations fo r Effectively Achieving a 5-log Pathogen
Reduction" (available in English)G/SPS/N/USA/649
Page 2
10. Proposed date of adoption:   This guidance is applicable upon publication.
11. Proposed date of entry into force:   This guidance is applicable upon publication.
12. Final date for comments:   Submit written or electronic comments at any time.
Agency or authority designated to handle comments:  Food and Drug Administration
[   ] National notification authority, [ X ] 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. 01D–0493 and TITLE Guidance for Industry: Exemptions from
the Warning Label Requirement for Juice – Recommendations for Effectively Achieving a
5-log Pathogen Reduction
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) 720-9047
Fax:  (202) 720-0677
E-mail:  fstsd@usda.gov
Complete text can be also be found on the Internet
http://www.fda.gov/OHRMS/DOCKETS/98fr/100702c.htm  by looking under DOCKET
No. 01D-0493 and at http://www.cfsan.fda.gov/~dms/juicgui6.html