WORLD TRADE G/SPS/N/USA/73
14January 1997
ORGANIZATION
(97-0106)
Committee onSanitary andPhytosanitary Measures
NOTIFICATION
1. Member toAgreement notifying: UNITED STATES
Ifapplicable, name oflocal government involved:
2. Agency responsible: Food andDrug Administration
3. Products covered (tariff item number(s) asspecified innational schedules deposited with
theWTO. ICSnumbers may beprovided inaddition, where applicable): Animal food
andfeed
4. Title andnumber ofpages ofthenotified document: Substances Prohibited from Usein
Animal Food orFeed; Animal Proteins Prohibited inRuminant Feed (32pages)
5. Description ofcontent: TheFood andDrug Administration (FDA) isproposing to
amend theregulations toprovide thatanimal protein derived from ruminant andmink
tissues isnotgenerally recognized assafe(GRAS) foruseinruminant feed, andisa
foodadditive subject tocertain provisions oftheFederal Food, Drug, andCosmetic
Act. Theproposed regulations would establish aflexible system ofcontrols, designed
toensure thatfeedforruminants doesnotcontain rendered animal protein derived from
ruminant andmink tissues. FDA isencouraging comments which could provide
innovative ways tosafeguard andthenpossibly usesuchfeedforsome non-ruminant
species suchaschickens, petsandpigs. FDA isconsidering alternatives tothis
proposed ruminant-to-ruminant prohibition, andisrequesting comment ontherelative
merits anddisadvantages ofthealternatives. FDA isproposing thisaction because the
feeding toruminants ofprotein derived from potentially Transmissible Spongiform
Encephalopathy (TSE) infective tissues maycause TSEinanimals. TSE'sare
progressively degenerative Central Nervous System (CNS) diseases ofmanandanimal
thatarefatal. Epidemiologic evidence gathered intheUnited Kingdom suggests an
association between anoutbreak ofruminant TSE, specifically Bovine Spongiform
Encephalopathy (BSE) andthefeeding tocattle ofprotein derived from sheep infected
withscrapie, another TSE. Also, scientists havepostulated thatthere isan
epidemiologic association between BSEandaform ofhuman TSE, newvariant
Creutzfeldt-Jakob disease (NV-CJD) reported recently inEngland. BSEhasnotbeen
diagnosed intheUnited States.
6. Objective andrationale: Thisproposed ruleisintended toprevent theestablishment and
amplification ofBSEincattle intheUnited States, andthereby minimize anyrisk
which might befaced byanimals andhumans.
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7. Aninternational standard, guideline orrecommendation does notexist [X].
Ifaninternational standard, guideline orrecommendation exists, whenever possible,
identify deviations:
8. Relevant documents andlanguage(s) inwhich these areavailable: 62FR552,
3January 1997; 21CFR Part589; available inEnglish
9. Proposed date ofadoption: Tobedetermined.
10. Proposed date ofentry intoforce: Thedateofentry intoforce willbeannounced when
thefinalruleispublished intheFederal Register.
11. Final date forcomments: 18February 1997
Agency orauthority designated tohandle comments: Food andDrug Administration
12. Texts available from: National enquiry point [X]oraddress, telefax number andE-mail
address (ifavailable) ofother body:
USDA/FAS/OFSTS
Attn: Carolyn F.Wilson
Room 5545 South Agriculture Building
14thandIndependence
Washington, D.C. 20250
Tel: (202) 7202239
Fax: (202) 6900677
E-mail address: wilsonc@fas.usda.gov