. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/357
5 December 2000
(00-5239)
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, whereapplicable).  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:  New Animal Drugs for Use in
Animal Feeds; Salinomycin and Bacitracin Methylene Disalicylate (2 pages)
5. Description of content:  The Food and Drug Administ ration (FDA) is announcing an
amendment to the animal drug regulations to reflect approval of a new animal drug
application (NADA). The NADA provides for use of approved, single-ingredient
salinomycin and bacitracin methylene disalicylate Type A medicated articles to make
two-way combination drug Type C medicated feeds for broiler, roaster, and replacement(breeder and layer) chickens. The Type C medicated feeds are used for prevention of
coccidiosis and as an aid in the prevention and control of necrotic enteritis in broiler,
roaster, and replacement (breeder and layer) chickens; and for prevention of coccidiosis,
increased rate of weight gain, and improved feed efficiency in roaster and replacement
(breeder and layer) chickens. Previously established acceptable daily intakes (ADI's) for
total residues of bacitracin and salinomycin are also being codified.
21 CFR -   Section 556.70 is revised to read as follows:
Sec. 556.70  Bacitracin.
(a) Acceptable daily intake (ADI). The ADI for total residues of bacitracin is
0.05 milligram per kilogram of body weight per day.
(b) Tolerances. The tolerance for residues of bacitracin from zinc bacitracin or
bacitracin methylene disalicylate in uncooked edible tissues of cattle, swine,chickens, turkeys, pheasants, and quail, and in milk and eggs is 0.5 part per million.
Section 556.592 is added to subpart B to read as follows:
Sec. 556.592  Salinomycin.
(a) Acceptable daily intake (ADI). The ADI for total residues of salinomycin is
0.005 milligram per kilogram of body weight per day.
(b) [Reserved]G/SPS/N/USA/357
Page 2
6. Objective and rationale: [  X ] food safety,  [  X ] 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: 65 FR 70790,
28 November 2000 (Available in English)
9. Proposed date of adoption:  28 November 2000
10. Proposed date of entry into force:  28 November 2000
11. Final date for comments:
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:  The full text of this
announcement 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 10271400 Independence Avenue, S.W.
Washington, D.C. 20250
Phone (202) 720-2239
Fax (202) 690-0677
E-mail Address: ofsts@fas.usda.gov