. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/461
20 July 2001
(01-3626)
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 Administration – FDA
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:  Animal drugs
4. Title and number of pages of the notified document:  Tolerances for Residues of New
Animal Drugs in Food; Clorsulon (1 page)
5. Description of content:  The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug application(NADA).  The supplemental NADA provides for establishing a tolerance for residues of
clorsulon in the muscle tissue of cattle.
Authority: 21 U.S.C. 342, 360b, 371.
2. Section 556.163 is revised to read as follows:
Sec. 556.163  Clorsulon.
(a) Acceptable daily intake (ADI). The ADI for total residues of clorsulon is
8 micrograms per kilogram of body weight per day.
(b) Tolerances  (1) Cattle - (i) Kidney (t he target tissue).  The tolerance for
parent clorsulon (the marker residue) is 1.0 part per million;  (ii) Muscle.
The tolerance for parent clorsulon (the marker residue) is 0.1 part permillion.
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:
8. Relevant documents and language(s) in which these are available:  66 FR 35544,
6 July 2001 (Available in English)
9. Proposed date of adoption:  This rule is effective 6 July 2001.
10. Proposed date of entry into force:  This rule is effective 6 July 2001.G/SPS/N/USA/461
Page 2
11. Final date for comments:
Agency or authority designated to handle comments: [     ] National notification
authority, [     ] National enquiry point, or address, fax number and E-mail address (if
available) of other body: The full text 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. 20250Tel:  (202) 720-2239
Fax:  (202) 690-0677
E-mail:  ofsts@fas.usda.gov