WORLD TRADE G/SPS/N/USA/64
2September 1996
ORGANIZATION
(96-3430)
Committee onSanitary andPhytosanitary Measures
NOTIFICATION
1. Member toAgreement notifying: UNITED STATES
Ifapplicable, name oflocal government involved:
2. Agency responsible: Department ofAgriculture, Animal andPlant Health Inspection
Service (65)
3. Products covered (tariff item number(s) asspecified innational schedules deposited with
theWTO. ICSnumbers may beprovided inaddition, where applicable): Veterinary
biological products
4. Title andnumber ofpages ofthenotified document: Viruses, serums, toxins, and
analogous products; definition ofbiological products andguidelines (4pages)
5. Description ofcontent: TheAnimal andPlant Health Inspection Service (APHIS) is
proposing toamend theregulations byrevising thedefinition of"biological products".
Theamendment isnecessary inorder toreflect current usage andadvances inscientific
knowledge, andtoclarify certain parts ofthedefinition. APHIS isalsoproposing to
addadefinition of"guidelines" totheregulations. Guidelines areusedtoassist
manufacturers ofveterinary biologics andother interested persons regarding test
procedures, methods, andother considerations thatwould beacceptable totheagency
insupport oflicensure ofaveterinary biological product.
6. Objective andrationale: Thisaction would clarify definitions andthepurpose andintent
ofguidelines.
7. Aninternational standard, guideline orrecommendation does notexist [].
Ifaninternational standard, guideline orrecommendation exists, whenever possible,
identify deviations: Aninternational standard, guideline orrecommendation doesnot
exist.
8. Relevant documents andlanguage(s) inwhich these areavailable: 61FR43483,
23August 1996; 9CFR Part101
./.G/SPS/N/USA/64
Page2
9. Proposed date ofadoption andentry intoforce: Dateofadoption tobedetermined ;
effective dateofentry intoforce tobedetermined upon publication ofthefinalrulein
theFederal Register.
10 Final date forcomments: 22October 1996
11 Texts available from: National enquiry point []oraddress, telefax number andE-mail
address (ifavailable) ofother body:
UNITED STATES SPSENQUIRY POINT
USDA/FAS/OFSTS
Attn: Carolyn F.Wilson
Room 5545 South Agriculture Building
14thandIndependence
Washington, D.C. 20250
Phone (202) 720-2239
Fax(202) 690-0677
emailAddress WilsonC@ FAS.USDA.GOV