. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/781
1 August 2003
(03-4077)
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 should be provided in addition, where
applicable):  Food for human and animal consumption in  the United States, except for meat,
poultry and egg products that are exclusively regu lated by the US Department of Agriculture.
4. Regions or countries likely to be affected, to the extent relevant or practicable:
Trading partners who export food to the United States.
5. Title, language and number of pages of the notified document:   Guidance for Industry -
Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for
Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental
Protection Agency (Draft Guidance) (14 pages; available in English).
6. Description of content:  The US Food and Drug Administra tion (FDA) has issued a draft
guidance document that presents its planned appr oach to the enforcement of the "channels of
trade" provision of the US law addressing pe sticide chemical residues in food (Section 408 of
the Federal Food Drug and Cosmetic Act).  This  provision states how FDA is to address a
finding of a pesticide chemical residue in food that complies with a pesticide chemical
tolerance that EPA has revoked under the tolerance reassessment programme mandated by
the Food Quality Protection Act.  Under this provision, the food is not considered to be in
violation of the law if the responsible person can show the FDA that the residue resulted from
a lawful application of the pesticide chemical  to the food, e.g., application prior to EPA's
cancellation of its registration for use on that food.  The draft guidance document discusses
the types of information that may be presented to the FDA in such cases to show that the
pesticide chemical residue on the food resulte d from its lawful application to the food.
Following publication of the draft guidance, FDA will provide for a 60 day comment period.FDA will consider these comments as it develops the final guidance document.
7. Objective and rationale:  [  X ] food safety, [   ] animal health, [   ] plant protection,
[  ] protect humans from animal/plant pest or di sease,  [   ]  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:G/SPS/N/USA/781
Page 2
Notice of availability (English) published in the Federal Register at 68 FR 43535-43538
(23 July 2003) and can be found on the internet at:
http://www.fda.gov/OHRMS/DOCKETS/98fr/072303h.htm
Guidance document (English) is available by request as directed in the notice of availabilityand can also be found on the internet at:   http://www.cfsan.fda.gov/~dms/pesguid.html
10. Proposed date of adoption:   Upon publication of final guidance document
11. Proposed date of entry into force:   None, guidance documents do not state legal
requirements
12. Final date for comments:  Submit written or electronic comments by 22 September 2003.
Agency or authority designated to handle comments:  [   ] National notification
authority, [   ] National enquiry point, or address, fax number and E-mail address (ifavailable) of other body:
Submit written comments on the document to  the Dockets Management Division (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
Number 2003D-0263 and Title of document Guidance for Industry:  Channels of Trade
Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have
Been Revoked, Suspended, or Modified by the Environmental Protection Agency.
13. Texts available from:  [   ] National notification authority,  [ X ]  National enquiry point,
or address, fax number and E-mail address (if available) of other body:
US Enquiry Point, US Department of Agriculture, Stop 1027, Washington, DC  20250.  Tel
(202) 720-1301, fstsd@usda.gov .  Complete text can be also be found on the Internet
http://www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm  by looking under DOCKET
No. 03D-0263