RESTRICTED
WORLD TRADE G/SPS/W/80
6March 1997
ORGANIZATION(97-0914)
Committee onSanitary andPhytosanitary Measures
RISK ANALYSIS
Note bytheSecretariat
Introduction
1. Article 5:5oftheAgreement onSanitary andPhytosanitary Measures (the"SPS Agreement")
states, inpart,that:
"With theobjective ofachieving consistency intheapplication oftheconcept of
appropriate level ofsanitary orphytosanitary protection against risks tohuman life
orhealth, ortoanimal andplant lifeorhealth, eachMember shallavoid arbitrary or
unjustifiabledistinctionsinthelevelsitconsiderstobeappropriateindifferentsituations,
ifsuchdistinctions result indiscrimination oradisguised restriction oninternational
trade. "
TheArticle alsoindicates thattheCommittee shall develop guidelines tofurther thepractical
implementation ofthisprovision.
2. Inorder toputthistaskintoperspective, thisnote(i)briefly summarizes thework onrisk
analysisundertakenbytheOfficeinternationaldesépizooties(OIE),theFAO/WHOCodexAlimentarius
Commission (Codex) andtheInternational Plant Protection Convention (IPPC); and(ii)highlights
therelevant provisions oftheSPSAgreement. Thisnoteisintended toprovide background information
tofacilitate thetaskoftheCommittee. Itisnotintended toprovide alegal interpretation ofthe
Agreement.
RiskAnalysis Work byOIE, Codex andIPPC
3. Since thedrafting andentry intoforce oftheSPSAgreement, asubstantial amount ofwork
hasbeenundertaken intheareaofriskanalysis bythethree international organizations referred to
intheAgreement, OIE, Codex andIPPC.
4. Thefollowing tablebriefly summarizes foreachoftheseorganizations whattheyhaveidentified
tobethesteps ofriskanalysis; their definitions ofriskassessment, riskmanagement andrisk
communication; andtheelements ofriskmanagement which theyhaveidentified. Although the
definitions usedbyeachoftheseorganizations isspecific totheirfieldofoperation, thereisconsiderable
commonality ofviews regarding theprocesses involved inriskanalyses forsanitary andphytosanitary
measures.G/SPS/W/80
Page2OIE Codex IPPC
Summary ofwork InMay1993, theOIEInternational
Committee adopted recommendations on
import riskanalysis, which were then
included intheInternational Animal Health
Code (asSection 1.4). Similar provisions
were adopted intheInternational Aquatic
Animal Health Code inMay1995.General principles forriskassessment
anddefinitions were considered bythe
Codex Committee onGeneral Principles
inNovember 1996, andhavebeen
proposed forinclusion intheCodex
Procedural Manual. Adecision onthis
proposal isexpected tobetaken bythe
Codex Commission when itmeets in
June1997. More recently, principles
onriskmanagement havebeendrafted
andwillbeconsidered byCodex
member governments andtheCodex
Commission.TheIPPC guidelines forpestrisk
analysis wasapproved bytheFAO
Conference inOctober 1995. TheIPPC
standard includes definitions and
descriptions oftheprocesses tobe
followed.
Elements ofrisk
analysisriskassessment, which maybefollowed by
riskmanagement andriskcommunication -
evaluation ofVeterinary Services -zoning
andregionalization ofcountries -
surveillance andmonitoring ofanimal
health.riskassessment -riskmanagement -risk
communicationinitiating theprocess foranalyzing risk
-assessing pestrisk-andmanaging pest
risk
Definitions and/or
descriptions
riskassessment Theprocesses ofidentifying andestimating
therisksassociated withtheimportation of
acommodity andevaluating the
consequences oftaking those risks.Ascientifically based process consisting
ofthefollowing steps: (i)hazard
identification, (ii)hazard
characterization, (iii)exposure
assessment and(iv)risk
characterization.Initiating theprocess involves
identification ofpests orpathways for
which thepestriskassessment is
needed. Pestriskassessment
determines whether eachpestidentified
assuch, orassociated withthepathway,
isaquarantine pest,characterized in
terms oflikelihood ofentry,
establishment, spread andeconomic
importance.G/SPS/W/80
Page3OIE Codex IPPC
riskmanagement Theidentification, documentation, and
implementation ofthemeasures thatcanbe
applied toreduce therisksandtheir
consequences.Theprocess ofweighing policy
alternatives inthelightoftheresults of
riskassessment and,ifrequired,
selecting andimplementing appropriate
control options, including regulatory
measures.Thedecision-making process of
reducing theriskofintroduction ofa
quarantine pest. Pestriskmanagement
involves developing, evaluating,
comparing andselecting options for
reducing therisk.
risk
communicationTheprocesses ofcommunicating therisk
assessment results totheregulators ofthe
import programmes, andtoother interested
parties suchasindustry andpublic.Theinteractive exchange ofinformation
andopinions concerning riskamong risk
assessors, riskmanagers, consumers and
other interested parties.
Elements ofrisk
managementidentify options assess options select
most appropriate option implement
selected option document andmonitorriskevaluation riskmanagement
option evaluation implementation of
management decision monitoring and
evaluationgenerate, evaluate andcompare
management options select option
monitor andevaluate after
implementationG/SPS/W/80
Page4
RiskAnalysis intheSPSAgreement Context
5.Although theterm"riskanalysis" isnotused, perse,intheSPSAgreement, theAgreement clearly
addresses atleast some aspects ofthismulti-step process asdefined bythethree international
organizations. Riskassessment isexplicitly addressed inArticles 5:1,5:2and5:3.Furthermore, the
Agreement provides adefinition ofriskassessment thataddresses concerns relating tofoodsafety,
animal orplant health protection1.
RiskAssessment
6.TheSPSAgreement requires Members tobasetheirsanitary andphytosanitary measures onan
assessment oftherisktohuman, animal orplant health. However, thecurrent situation isthatthe
useofformal riskassessment procedures, andmuch lessquantitative riskassessment, isnotyeta
commonpracticeofmanyMembers.Itsuseisevolvingrapidly,butisnotyetsystematicallywidespread.
Nonetheless, Members arefaced almost dailywiththeprospect ofimports which potentially maypose
sanitary orphytosanitary risks, andMembers do,inpractice, inonemanner oranother evaluate these
potential risks.
7.Itisclearfromthedefinitions developed bythethreeinternational organizations thatriskassessment
isprimarily ascientific procedure toidentify theexistence andseverity ofpossible risks. What isdone
with theinformation resulting from ariskassessment isriskmanagement (and sometime risk
communication).
RiskManagement
8.Riskmanagement involves anumber ofsteps. These include, interalia,decisions regarding the
acceptable levelofrisk; identification ofpossible options toreduce oreliminate theidentified risk;
evaluation andselection among theseoptions; implementation oftheselected measures, asappropriate;
andmonitoring andcontrol oftheeffectiveness oftheselected measure.
9.Riskmanagement, oratleastseveral elements ofit,areaddressed, interalia,inArticles 5:4,5:5,
and5:6. These provisions address thedecisions tobetaken onwhatlevel ofriskisacceptable, as
wellaswhatmeasure isapplied toensure theselected levelofprotection. TheAgreement alsoprovides
adefinition ontheappropriate levelofsanitary orphytosanitary protection, alsoknown astheacceptable
levelofrisk.2
10.Although thesituation ofMembers maydiffer interms oftheircurrent useofformalized risk
assessment procedures, theirresources andthetechnical expertise theyhaveinthisregard, eachand
1Annex 1,definition 4defines riskassessment as:"The evaluation ofthelikelihood ofentry, establishment orspread
ofapestordisease within theterritory ofanimporting Member according tothesanitary orphytosanitary measures which
might beapplied, andoftheassociated potential biological andeconomic consequences; ortheevaluation ofthepotential
foradverse effects onhuman oranimal health arising fromthepresence ofadditives, contaminants, toxins ordisease-causing
organisms infood, beverages orfeedstuffs."
2Annex 1,definition 5defines theappropriate level ofsanitary orphytosanitary protection as:"The levelofprotection
deemed appropriate bytheMember establishing asanitary orphytosanitary measure toprotect human, animal orplant life
orhealth within itsterritory."
NOTE: Many Members otherwise refer tothisconcept asthe"acceptable level ofrisk".G/SPS/W/80
Page5
every Member nonetheless regularly makes decisions astowhether topermit theimports inquestion
without further restriction, orwhether torequire some particular treatment toreduce thepotential risks,
orwhether tobanaltogether theimportation oftheproduct concerned. Thisdecision, however
unsophisticated methods itmaybebased on,represents amanagement oftherisksathandandreflects
aninherent decision ofwhat level ofrisktheMember considers tobeacceptable inthatparticular
situation.
11.Itisthispartofthedecision-making element ofriskmanagement, i.e.,thedetermination ofthe
levelofsanitary orphytosanitary riskwhich aMember determines tobeacceptable inanyparticular
situation, which isthesubject ofArticle 5:5.Theobjective oftheproposed guidelines istoassist each
Member toenhance theconsistency ofitsdecisions inthisrespect.
RiskCommunication
12.Some elements related toriskcommunication arealsoaddressed intheAgreement, through (i)its
transparency requirements, including those ofpublication andnotification ofmeasures, theprovision
ofinformation through Enquiry Points, andtheexplanation ofmeasures upon request; and(ii)the
technical assistance provisions..