. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/270
2 May 2000
(00-1771)
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, 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: Risk Assessment of the Public
Health Impact of Streptogramin Resistance in Enterococcus faecium Attributable to the Use
of Streptogramins in Animals; Request for Comments and for Scientific Data and
Information (4 pages)
5. Description of content:  The Food and Drug Administrati on (FDA), Center for Veterinary
Medicine (CVM), is announcing plans to develop a prototypic risk assessment (RA) modelthat accounts for the transfer of resistance determinants from bacteria in food-producing
animals to bacteria in humans.  The agency requests comments on their approach to the RA
model and requests that scientific data and information relevant to the conduct of the RA be
submitted.  This model will be applied to assess the association between the development
of streptogramin (quinupristin/dalfopristin (QD)) resistant Enterococcus faecium in humans
and the use of virginiamycin in food-producing animals.  The center will attempt to use the
RA model to quantify the human health impact  attributable both to direct acquisition of
resistant E. faecium from food-producing animals and to the transfer of resistance
determinants from E. faecium in food-producing animals to E. faecium in humans.
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 20992,
19 April 2000 (Available in English)
9. Proposed date of adoption:  To be determined.
10. Proposed date of entry into force:  To be determined.G/SPS/N/USA/270
Page 2
11. Final date for comments:  Submit written comments, scientific data and information by
19 June 2000
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:  Detailed instruction on where
and how to send comments is in the body of the full text - which 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