RESTRICTED
WORLD TRADE G/SPS/W/25
4July1995
ORGANIZATION(95-1828)
Original: English Committee onSanitary andPhytosanitary Measures
OVERVIEW OFIMPORT DATA PROVISION/DECISION PROCESS
FOR THE ANIMAL AND PLANT HEALTH INSPECTION SERVICE
INTHE U.S.DEPARTMENT OFAGRICULTURE
Submission bytheUnited States attheMeeting of26-27 June 1995
ThispapersummarizestheprocessundertakenbytheAnimalandPlantHealthInspectionService
(APHIS) forreviewing import requests andestablishing import requirements -aprocess which differs
between theanimal andplant health sides.
Plant-Related Commodities
1. APHISreceivesrequestfromimportersand/orforeigngovernmentsinwritingwiththefollowing
initial information:
- thename ofthecommodity (scientific andcommon)
- country oforigin
- name andaddress ofimporter, including phone number
2. Initial determination results inoneofthefollowing potential outcomes:
(a) Product islisted under theregulations asenterable. Permit, listing import conditions
orrequirements, isissued totheimporter.
(b) Regulations prohibit thecommodity inquestion. APHIS informs requester thatitem
isprohibited. Discussions could ensue regarding options, such asprovision of
informationbyforeigngovernmentwhichsuggestsanewriskassessmentbeundertaken.
(c) Ifregulation prohibits entry, butnoriskassessment orrecent assessment hasbeen
conducted, adetermination ismade whether toreexamine theissueandconduct anew
assessment. Foreign government mayprovide information which suggests that
circumstances havechanged orthattheprevious pestconcern isnolonger anissue.
APHIS determines whether newcircumstances warrant anewriskassessment.
3. Ifrequest isfromanimporter, APHIS requests initial information, including quantity intended
forexport andlocality ofproduction, byform letter. Response willaidindetermining whether this
isaserious request before APHIS commits significant resources toconduct ariskassessment. Importer
may, inturn, seekoutinformation from foreign government.
4. Ifrequest isfrom foreign government, APHIS communicates itsintent toconduct arisk
assessment. While noinformation ordataisrequired immediately from theforeign government, itG/SPS/W/25
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ishelpful fortheforeign government toprovide dataup-front which itbelieves mayfacilitate therisk
assessment.
5. Riskassessment process isactivated onthecommodity inquestion, taking intoaccount the
following factors:
(a) Potential harmful pests associated withplant/commodity andcapability ofeconomic
damage toU.S.agriculture.
(b) Probability ofpest(s) being introduced andbecoming established ifimport allowed.
(c) Mitigating measures (e.g., treatment, inspection, packaging conditions, etc.)which
mayreduce oraltertheriskofthecommodity inquestion.
6. APHIS takes intoaccount thePestRiskAssessment Standard (PRA) ratified bytheUnited
States, Mexico, andCanada under theauspices oftheNorth American Plant Protection Organization
(NAPPO).
7. Ifinformation needs emerge during theriskassessment process, APHIS mayrequest specific
oradditional dataorinformation fromtheforeign government tohelpcomplete theriskassessment.
8. Determination made onwhether toallow entry ofcommodity andunder whatconditions.
(a) Results ofriskassessments areshared withforeign government.
(b) APHIS identifies thenecessary treatments forentry.
(c) APHIS andforeign government mayenterintodiscussions ifforeign government seeks
consideration ofalternative treatment orentry measures.
9. Procedures forregulatory changes, ifany,areinitiated.
(a) Regulatory changes require publication intheFederal Register asaproposed ruleor
rulechange. Thispublic notification mustspecify therisksandtherequirements which
willbeimposed toaddress therisks.
(b) After public comments arereceived andreviewed afinalruleispublished.
(c) Once finalrulegoesintoeffect APHIS canissue import permits.
Responding toPestFreeArea Requests
10. APHISusestheNAPPOPestFreeArea(PFA)standardforrespondingtopestfreezonerequests.
Thisstandard hasbeenpresented totheIPPC andisnowbeing reviewed bymembers asapotential
global PFAstandard. Foreign governments mayrequest acopyoftheNAPPO standard.
11. Acountryrequestingrecognitionofapestfreezonemaysubmitbasicsupportingdataasindicated
intheCode ofFederal Regulations (7CFR 319.56-2(e)).G/SPS/W/25
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12. 7CFR 319.56-2(e) describes theprocess anddatarequirements forestablishing apestfree
zonerelative tofruitandvegetables. Nostandards orguidelines regarding pestfreeordisease free
zones forgrains, nursery stock, orlumber currently exist. However, theNAPPO PFAstandard would
beusedtohelpevaluate apestfreezoneforthese other commodities.
13. According to7CFR 319.56-2(e):
"...fruitorvegetables maybe...issued permits ...iftheU.S.Department ofAgriculture,
afterreviewing evidence presented toit,issatisfied thatthefruitorvegetable ...:
(3)Isimported fromadefinite areaordistrict inthecountry oforigin thatisfreefrom
allinjurious insects thatattack thefruitorvegetable, itsimportation canbeauthorized
without risk,anditsimportation isincompliance withthecriteria ofparagraph (f)
ofthissection; or
(4)Isimported fromadefinite areaordistrict ofthecountry oforigin thatisfreefrom
certain injurious insects thatattack thefruitorvegetable, itsimportation canbe
authorized without risk,andthecriteria ofparagraph (f)ofthissection aremetwith
regard tothose certain insects, provided thatallother injurious insects thatattack the
fruitorvegetable intheareaordistrict ofthecountry oforigin havebeeneliminated
fromthefruitorvegetable bytreatment oranyother procedures thatmaybeprescribed
bytheAPHIS Administrator
(f)Before theAdministrator mayauthorize importation ofafruitorvegetable under 319-56(e)
(3)or(4),heorshemustdetermine thatthefollowing criteria havebeenmet:
(1)Within thepast12months, theplant protection service ofthecountry oforigin has
established theabsence ofinfestations ofinjurious insects known toattack fruitor
vegetables inthedefinite areaordistrict based onsurveys (developed byforeign
government andreviewed andapproved byAPHIS) performed inaccordance with
requirements approved bytheAdministrator asadequate todetect these infestations;
(2)Thecountry oforigin hasadopted andisenforcing requirements toprevent the
introduction ofinjurious insects known toattack fruits andvegetables intothedefinite
areaordistrict ofthecountry oforigin thataredeemed bytheAdministrator tobe
atleastequivalent tothose requirements imposed under thischapter toprevent the
introduction intotheUnited States andinterstate spread ofinjurious insects; and
(3)Theplant protection service ofthecountry oforigin hassubmitted tothe
Administratorwrittendetailedproceduresfortheconductofsurveysandtheenforcement
ofrequirements under thisparagraph toprevent theintroduction ofinjurious insects..."
14. While the7CFR319.56-2(e) describes some ofthedatarequirements, newquestions usually
emerge astheriskassessment proceeds (e.g., trapping andsurveillance methodologies, monitoring,
etc.). Therefore, APHIS relies onacontinuing dialogue through bilateral discussions and/or
correspondence withplant health officials oftheother country toobtain information asneeded.
15. With theexception ofexotic fruitflysurveys, protocols forsurveying other pests (used to
demonstrate areapestfreedom orprevalence levels) aredeveloped bytheforeign government and
reviewed andapproved byAPHIS. Protocols forsurveying thepresence ofexotic fruitfliesmustbe
requested from APHIS.G/SPS/W/25
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Animal-Related Commodities
16. Theprocess isdescribed separately forliveanimals andanimal products.
LiveAnimal Imports
17. APHIS receives request fromimporters and/or foreign governments inwriting, providing the
following initial information:
- identity oftheanimal species
- country oforigin
- quantity
- name andaddress ofexporter, including phone number
- name andaddress ofimporter andlocation intheUnited States where theanimals are
destined.
18. Determination ismade withoneofthefollowing outcomes:
(a) Ifanimal (ruminants) originates from country orareawhere foot-and-mouth (FMD)
orhogcholera (HC) isknown toexist, theanimal isrequired tobequarantined ata
highsecurity quarantine facility (e.g., Harry S.Truman Animal Import Center in
Florida).
Ifforeign government seeks alternative tothehighsecurity quarantine, itcould seek
APHIS recognition ofitscountry orarea(seeprocess described under paragraphs 25
and26)asFMD-free. Thisprocess requires ariskassessment (dataneeds described
under paragraphs 25and26)andsubsequent proposal, intheFederal Register, to
recognize theforeign country orareaasfreeofFMD orrinderpest.
(b) Iflivestock originates inFMD orrinderpest freecountry orarea,APHIS canprovide
therequesting country adraftcopy ofaprotocol being usedelsewhere fortrade in
thesame commodity under similar riskconditions ordraft anewprotocol forthe
prospective country. Thisprotocol (based onanassessment oftherisks) maybe
acceptedorserveasthebasisfornegotiatingcertainmodificationstailoredtothespecific
conditions intheexporting country. Rulemaking intheFederal Register isnotrequired.
(c) Forlivestock originating incountries withother exotic animal diseases (e.g., African
Horse Sickness, African Swine fever) ofconcern toAPHIS, theCode ofFederal
Regulations(CFR)wouldhavetobeconsultedtodeterminethespecificentryconditions.
Aproposalbytheforeigngovernmenttoexportliveanimalsunderalternativeconditions
would require ariskassessment andsubsequent proposal intheFederal Register.
19. Finalized protocols areshared withforeign animal health officials oftheexporting country.
Tosome extent protocols canberenegotiated iftheexporting country candemonstrate thatalternative
testing orregulatory measures would reduce theriskstothelevelofprotection acceptable toAPHIS.
20. Once theimport protocols orrequirements arecompleted APHIS issues animport permit to
theimporter orexporter. Thepermit outlines theconditions ofentry.G/SPS/W/25
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Animal Product Imports
21. APHIS receives request fromimporters and/or foreign governments inwriting, providing the
following initial information:
- expected orintended useofproduct intheUnited States
- shipment size
- country oforigin
- quantity
- name andaddress ofexporter, including phone number
- name andaddress ofimporter andwhere theanimals orproducts aredestined inthe
United States.
22. Determination ismade withoneofthefollowing outcomes:
(a) Meat andproducts fromcountries affected withFMD, HC,orswine vesicular disease
(SVD) mustbefurther processed toqualify forentry intotheUnited States. Partof
theprocessing requirements areoutlined intheCFR. APHIS willcitetheCFR
requirements once theabove information isprovided bytheimporter orforeign
government.
(b) Foralternative processing methods notdescribed intheCFR, theforeign government
mustenter intodiscussions withAPHIS veterinary specialists concerning alternative
processing methods andtheireffect oneliminating theFMD risk. Ifnewprocessing
methods arebeing proposed, scientific evidence would needtodemonstrate thatthe
proposed method would meetriskconcerns. Asubsequent regulation change inthe
Federal Register would alsobenecessary.
(c) Ifanimal product originates inacountry orareafreeofFMD, HC,orSVD, APHIS
mayprovide therequesting country adraftcopyofaprotocol being usedelsewhere
fortradeinthesame commodity under similar riskconditions ordraftanewprotocol
fortheprospective country. Thisprotocol maybeaccepted orserve asthebasis for
negotiating certain modifications totailor theprotocol tothespecific conditions inthe
exporting country. Rulemaking intheFederal Register isnotrequired inthese
circumstances.
23. Finalized protocols areshared withforeign animal health officials oftheexporting country.
Tosome extent protocols canberenegotiated iftheexporting country candemonstrate thatalternative
testing orregulatory measures would reduce theriskstoalevelofprotection acceptable toAPHIS.
24. Once theimport protocols orrequirements arecompleted APHIS issues animport permit to
theimporter orexporter. Thepermit outlines theconditions ofentry anduseofproduct.
Responding toDisease FreeArea Requests
25. APHIS willsoonbepublishing intheFederal Register ageneral framework forconducting
riskassessments associated withregionalization requests. Thisframework willidentify thecritical
riskfactors which willbeessential forconducting thenecessary riskassessments.
26. Besides providing apublic andtransparent listofcriteria forassessing theanimal health status
ofaparticular country orarea,thisgeneral framework willbethebasisforaquestionnaire which willG/SPS/W/25
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beavailable toforeign governments seeking APHIS review ofadisease-free area. Asummary ofthe
general datarequirements includes:
(a) Source Area riskfactors:
- Prevalence ofadisease intheareaexporting theanimals orproducts
- Geographic location andenvironment
- Status oftheadjoining orneighbouring areas
- Trading partners andpractices
- Infrastructure (Thebasic objective istoevaluate theentire structure ofthe
livestock industry, including thephysical andlegalinfrastructure —oneofthe
most difficult parts ofanyevaluation.)
- Existence andtypeofsurveillance systems (Knowledge about theoccurrence
andprevalence ofdisease agent(s) isdependent upon theexistence ofan
adequate surveillance system, including itslaboratory capabilities inthe
exporting area.).
(b) Commodity riskfactors:
- Thetypeofcommodity traded mayaltertheriskassessment foranydisease
agent(s).
(c) Destination riskfactors:
- Availability andsusceptibility ofreservoirs
- Availability andcompetence ofvectors foranimported disease agent
- Environmental risksthatmayoccur ifitisnecessary todestroy allorpartof
apopulation ofanimals because ofintroduction ofadisease agent
- Benefit/cost analysis fortheimports.
(d) APHIS is,bylaw,required topublish these criteria intheFederal Register. This
process involves publishing aproposed rule,taking public comments (including foreign
views), andpublishing afinalrule.