WORLD TRADE G/SPS/GEN/36
6October 1997
ORGANIZATION(97-4218)
Original: English Committee onSanitary andPhytosanitary Measures
NEW EUROPEAN UNION RULES ON"SPECIFIED RISK MATERIALS"
INPRODUCTS OFANIMAL ORIGIN
Submission bytheUnited States attheMeeting of15-16 October 1997
Introduction
1. On30July1997, theEuropean Commission adopted Commission Decision 97/534/EC,
governingthe“ProhibitionoftheUseofMaterialPresentingRisksasRegardsTransmissibleSpongiform
Encephalopathies (TSEs). ”Thismeasure wasnotified on19September 1997, more thansixweeks
after itsadoption (G/SPS/N/EEC/49). Thedeadline forcomments onthisnotification is
2November 1997. TheDecision isscheduled tobeimplemented on1January 1998.
2. TheDecision doesnottakeintoaccount thedisease status ofdifferent regions. Itrequires
theremoval of“specified riskmaterials ”frommaterials derived fromallbovine, ovine, andcaprine
animal populations, eventhose inwhich TSEs havenotbeenidentified following rigorous testing and
surveillance procedures recommended bytheOffice international desépizooties (OIE).
3. Asaresult, regardless ofthesafety ofthesource material, theDecision appears torequire
theremoval fromthemarket ofallexisting supplies, fromallsources, ofaverybroad range ofproducts,
including cosmetics, food, feed, andmedical (pharmaceutical, biological, anddevice) products. In
adopting thismeasure, theCommission disregarded theadvice ofitsScientific Committee on
Cosmetology andapparently failed toobtain theadvice ofitsPharmaceutical Committee.
4. USpublic health agencies areconcerned thatthemeasure would, either directly orindirectly,
cause international shortages ofneeded medical products, which could adversely impact thehealth of
consumers. Inaddition, implementation ofthisDecision would haveamajor restrictive impact on
WTO members ’trade, including USexports oftallow, tallow derivatives, gelatin, pharmaceuticals
andmany foodproducts.
Scientific andProcedural Considerations
5. TheUnited States shares theEuropean Communities 'desire tocontrol Bovine Spongiform
Encephalopathy (BSE) andsupports efforts todevelop appropriate science-based measures toprotect
thepublic against theassociated risks. Inorder toavoid unnecessary adverse effects onpublic health
andtrade, however, those measures mustbecarefully designed toaddress thesources ofrisk,while
notdisrupting theavailability ofsafeproducts. ThisDecision doesnotmeetthose criteria.
6. TheUnited States agrees with theECPharmaceutical Committee ’s17September 1997
recommendation thattheDecision notbeimplemented "insuchawaythatitraises equal orlargerG/SPS/GEN/36
Page2
public health concerns intheshort ormedium termsuchaswould becaused byfailures ofsupply or
confidence inpharmaceuticals". Unfortunately, although theDecision affects awide range of
pharmaceutical andmedical products, itappears thatthisCommittee wasnotconsulted prior tothe
adoption ofthismeasure.
7. Oneofthefirststeps inefficiently addressing ariskistoidentify itssource. IfBSEisnot
present intheanimal populations fromwhich thesource materials ofconsumable products arederived,
thenthose products canbeconsidered tobesafe.
8. Since 1990, theUnited States hasmaintained anaggressive surveillance program forBSE.
Asof30June1997, more than6,000 brains hadbeenexamined forBSEandanyother form ofa
transmissible spongiform encephalopathy incattle. Thesurveillance samples focused onfieldcases
ofcattle exhibiting signsofneurological disease, cattle condemned atslaughter forneurological reasons,
rabies-negative cattle submitted topublic health laboratories, neurological casessubmitted toveterinary
diagnostic laboratories andteaching hospitals, andrandom sampling ofcattle which arenon-ambulatory
atslaughter. Noevidence ofBSEhasbeenfound inthesesamplings fromthehighest riskpopulations,
either through histological examination orimmunohistochemistry.
9. Taking intoconsideration thesizeoftheherd, theUSsurveillance program farexceeds the
guidelines recently adopted bytheOIE(Chapter 3.2.13.1). TheUnited States, therefore, meets the
OIErecommendation fordetermining aregion tobefreeofBSE. Where suchprograms arenotin
place, theUnited States agrees thattheremoval of“specified riskmaterials ”isappropriate. Thisis
particularly thecasewhen, unlike intheUnited States, relatively limited sampling andtesting procedures
haverevealed positive cases ofBSE.
10. Despite these differences indisease status, Decision 97/534/EC imposes identical restrictions
onproducts sourced from theUnited States, where BSEhasnotbeenidentified, andthose sourced
from regions inwhich BSEispresent. Asaresult, themeasure isunnecessarily restrictive, with
potentially serious adverse consequences forpublic health andinternational trade.
11. Other aspects ofthedecision appear tolackasound scientific basis. On24June1997, the
European Commission ’sScientific Committee onCosmetology advised theCommission thattallow
derivatives obtained fromspecified processes aresafeforuseincosmetics. Thisfinding wasconsistent
withindependent scientific studies performed onBSE, which havesuggested thattallow doesnotcontain
detectable levels ofinfectivity.1On8September 1997, theEuropean Commission ’sScientific Steering
Committee adopted anopinion which appears toconfirm theCommittee onCosmetology ’sfindings
withrespect totallow derivatives.
12. These conclusions arealsoreflected indecisions taken bytheOffice international desépizooties
(OIE) inMay1997, which statethat:"Veterinary Administrations canauthorize without restriction
theimport ortransit through theirterritory, directly orindirectly, ofmilk, milkproducts, tallow, hides
andskins originating from healthy animals from countries where BSEhasbeenreported". Ifthese
products aresafewhen sourced fromregions inwhich BSEhasbeenreported, theywillcertainly be
safewhen sourced from regions where BSEisnotknown tooccur.
13. TheDecision appears tobeinconsistent withother Community legislation. Specifically, it
seems toconflict withCommission Decision 94/382/EC andthesubsequent Commission Decision
96/449/EC. These decisions laiddown therequirements forprocessing animal waste withaviewto
theinactivation ofspongiform encephalopathy agents. Decision 96/449/EC requires thatmammalian
1See,forexample, Veterinary Record 137:605; 1995; Taylor, Woodgate andAtkinson.G/SPS/GEN/36
Page3
waste betreated within specific parameters, butitexempts certain products (such astallow) which
supposedly donotpresent ariskofTSEtransmission from these requirements; these products had
alsobeenexempt fromDecision 94/382/EC. ThenewEUDecision 97/534 contradicts these previous
Decisions (96/449 and94/382), which arebased ontheassumption thattallow doesnotpresent arisk
ofBSEtransmission.
14. Noting thatDecision 97/534/EC failstotakeanyoftheabove scientific evidence intoaccount,
theCommission ’sPharmaceutical Committee hasstated:
"The Committee regrets thatthedecision didnottakeaccount ofscientific opinions inregard
totallow andtallow derivatives, whereby established manufacturing processes have been
demonstrated nottopresent arealhazard."
15. TheUnited States shares thisconcern, andurges theCommission toreview andmodify the
Decision toensure thatitisbased onthebestavailable scientific advice anddoesnothaveanunnecessary
detrimental impact onpublic health orinternational trade.
Notification Procedures
16. Annex BoftheSPSAgreement provides, interalia,thatnotifications "...shalltakeplace at
anearly stage, when amendments canstillbeintroduced andcomments taken intoaccount" andthat
members "shall ...allow reasonable timeforother Members tomake comments inwriting, discuss
these comments uponrequest, andtakethecomments andtheresults ofthediscussions intoaccount".
While theCommission ’sadoption ofDecision 97/534/EC on30Julydoesnotappear tohavebeen
consistent withthisrequirement, theUnited States welcomes thesubsequent notification andrequest
forcomments. TheUnited States hascommunicated itsconcerns withthismeasure totheCommission
inwriting. Inaddition, USpublic health andtrade officials haverequested theopportunity todiscuss
thespecific requirements inmore detail. Wehope thattheCommission willremain open tofull
discussion ofalltherelevant issues andthattheresults ofthose discussions willbetaken intoaccount
prior totheimplementation ofthisDecision.
Conclusion
17. Commission Decision 97/534/EC failstoaccount forregional differences inanimal disease
status andother available scientific information andadvice relating tothecontrol ofBSEandTSEs
inproducts ofanimal origin. Asaresult, theDecision raises anumber ofconcerns withrespect to
WTO requirements, including those setoutintheSPSAgreement. TheUnited States appreciates the
notification ofthismeasure, andlooks forward tocontinuing discussions withtheCommission onhow
toensure thatconsumers areprotected against risksassociated withTSEs, without unnecessary negative
consequences forother aspects ofpublic health orunnecessary restrictions oninternational trade.