bse in the us aphis investigation and response fda tse advisory committee february 12, 2004 lisa a....
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BSE in the USBSE in the USAPHIS Investigation APHIS Investigation
and Responseand ResponseFDA TSE Advisory CommitteeFDA TSE Advisory Committee
February 12, 2004February 12, 2004
Lisa A. Ferguson, DVMLisa A. Ferguson, DVMSenior Staff VeterinarianSenior Staff VeterinarianUSDA, APHIS, Veterinary USDA, APHIS, Veterinary
Services Services
BSE TimelineBSE Timeline 12/9/03 – index cow arrives at WA slaughter plant, 12/9/03 – index cow arrives at WA slaughter plant,
sampled as a non-ambulatory (downer) animalsampled as a non-ambulatory (downer) animal 12/23/03 – presumptive positive BSE test results 12/23/03 – presumptive positive BSE test results
reported from NVSLreported from NVSL 12/23/03 – Epidemiologic investigation begins12/23/03 – Epidemiologic investigation begins 12/25/03 - Confirmation of BSE positive diagnosis 12/25/03 - Confirmation of BSE positive diagnosis 12/30/03 – USDA Secretary Veneman announces 12/30/03 – USDA Secretary Veneman announces
additional safeguards to be initiated by APHIS and additional safeguards to be initiated by APHIS and FSIS.FSIS.
1/12/04 – USDA Secretary makes declaration of 1/12/04 – USDA Secretary makes declaration of extraordinary emergency providing additional extraordinary emergency providing additional authorities and funding for response (effective on authorities and funding for response (effective on 1/6/04)1/6/04)
2/9/04 – Active field investigation closed out2/9/04 – Active field investigation closed out
BSE Index Case - BSE Index Case - DiagnosisDiagnosis
Presumptive positive diagnosis at Presumptive positive diagnosis at NVSL was based on NVSL was based on immunohistochemistryimmunohistochemistry histopathologic examinationhistopathologic examination
The positive diagnosis was confirmed The positive diagnosis was confirmed at the BSE reference laboratory in at the BSE reference laboratory in Weybridge, England. Samples from Weybridge, England. Samples from the index cow were hand carried to the index cow were hand carried to this laboratory where the BSE this laboratory where the BSE diagnosis was confirmed on 12/25/03. diagnosis was confirmed on 12/25/03.
BSE Index CaseBSE Index Case Holstein dairy cow, 6 ½ years at slaughterHolstein dairy cow, 6 ½ years at slaughter Sent to slaughter due to calving complicationsSent to slaughter due to calving complications Tested at slaughter because of non-Tested at slaughter because of non-
ambulatory status, no CNS signs observedambulatory status, no CNS signs observed Trace back investigation determined cow was Trace back investigation determined cow was
born into a herd in Alberta, Canadaborn into a herd in Alberta, Canada Moved into U.S. as part of dispersal sale in Moved into U.S. as part of dispersal sale in
20012001 Initially went to Mattawa, WA dairy finishing Initially went to Mattawa, WA dairy finishing
herd (9/01)herd (9/01) Resided in Mabton, WA dairy herd since 10/01Resided in Mabton, WA dairy herd since 10/01
BSE Index Case BSE Index Case (continued)(continued)
The index cow has had four offspring The index cow has had four offspring over her lifetime, three calves since over her lifetime, three calves since entering the U.S.entering the U.S. A heifer calf born in Canada A heifer calf born in Canada A stillborn calf born in 2001A stillborn calf born in 2001 A heifer calf in born in 2002 (was in the A heifer calf in born in 2002 (was in the
index herd)index herd) A bull calf born in 2003 – moved to a A bull calf born in 2003 – moved to a
bull calf raiser in Sunnyside, WAbull calf raiser in Sunnyside, WA
““At Risk” Animals LocatedAt Risk” Animals Located
““At risk” animals = 81 animals from herd in At risk” animals = 81 animals from herd in CanadaCanada One of the 81 is the positive cowOne of the 81 is the positive cow 9 – index herd, Mabton, WA (131 euthanized)9 – index herd, Mabton, WA (131 euthanized) 3 - Tenino, WA (4 euthanized)3 - Tenino, WA (4 euthanized) 6 - Connell, WA (15 euthanized) 6 - Connell, WA (15 euthanized) 1 - Quincy, WA (18 euthanized)1 - Quincy, WA (18 euthanized) 3 - Mattawa, WA (39 euthanized) 3 - Mattawa, WA (39 euthanized) 1 – Moxee, WA (15 euthanized)1 – Moxee, WA (15 euthanized) 3 – Burley, ID (7 euthanized)3 – Burley, ID (7 euthanized) 1 – Othello, WA (3 euthanized)1 – Othello, WA (3 euthanized) 1 – Mabton, WA (3 euthanized)1 – Mabton, WA (3 euthanized)
February 9, 2004
BSE investigationBSE investigation Of the shipment of 81 animals from the Of the shipment of 81 animals from the
Canadian birth herd:Canadian birth herd: 29 accounted for (including index cow)29 accounted for (including index cow) Normal culling practices – estimate between Normal culling practices – estimate between
17 to 36 of the 81 might still be alive17 to 36 of the 81 might still be alive OIE guidelines – animals born within one OIE guidelines – animals born within one
year (before or after) of a BSE affected year (before or after) of a BSE affected animal considered higher riskanimal considered higher risk 25 of the shipment of 81 were in this category25 of the shipment of 81 were in this category 14 accounted for (including index cow)14 accounted for (including index cow) Normal culling practices – estimate that 11 of Normal culling practices – estimate that 11 of
the 25 might still be alivethe 25 might still be alive
BSE investigationBSE investigation
Total of 704 animals depopulatedTotal of 704 animals depopulated 449 – bull calf premises449 – bull calf premises 255 – animals of interest255 – animals of interest
28 were part of the original 8128 were part of the original 81 220 could have been part of the original 81220 could have been part of the original 81 7 were part of additional group of 17 heifers 7 were part of additional group of 17 heifers
from Canadian herd of originfrom Canadian herd of origin
Other parts of Other parts of investigationinvestigation
FSIS - Class II voluntary recall of meat FSIS - Class II voluntary recall of meat initiated on 12/24/03initiated on 12/24/03 Includes 10,410 poundsIncludes 10,410 pounds Includes all 20 animals slaughtered on the Includes all 20 animals slaughtered on the
same day as index cowsame day as index cow FDA – investigation of rendered FDA – investigation of rendered
product/feedproduct/feed Over 2,000 tons of rendered protein Over 2,000 tons of rendered protein
disposed ofdisposed of Facilities in compliance with feed Facilities in compliance with feed
regulations regulations
International Review International Review SubcommitteeSubcommittee
Delivered to Secretary’s Advisory Delivered to Secretary’s Advisory Committee for Foreign Animal and Committee for Foreign Animal and Poultry Diseases – February 4, 2004Poultry Diseases – February 4, 2004
Commended the US on the open and Commended the US on the open and transparent manner in which the transparent manner in which the investigation was conductedinvestigation was conducted
North American “indigenous BSE”North American “indigenous BSE”
International Review International Review SubcommitteeSubcommittee
Investigation recommendations:Investigation recommendations: Comprehensive epi investigation, Comprehensive epi investigation,
conforms to international standardsconforms to international standards suggested all relevant information had suggested all relevant information had
been obtained and recommended been obtained and recommended concluding investigationconcluding investigation
Tracing and recall of MBM effective and Tracing and recall of MBM effective and appropriateappropriate
Tracing and recall of meat consistent Tracing and recall of meat consistent with WHO recommendationwith WHO recommendation
International Review International Review SubcommitteeSubcommittee
Policy recommendationsPolicy recommendations Specified risk materialsSpecified risk materials
remove from human and animal feedremove from human and animal feed Recognized that FSIS interim rule (from Recognized that FSIS interim rule (from
cattle >30 months) removes highest risk cattle >30 months) removes highest risk tissuestissues
Recommend extending definition, cattle > Recommend extending definition, cattle > 12 months of age12 months of age
Non-ambulatory cattleNon-ambulatory cattle Maintain access for surveillance samplesMaintain access for surveillance samples
International Review International Review SubcommitteeSubcommittee
SurveillanceSurveillance Test all cattle > 30 months in targeted high risk Test all cattle > 30 months in targeted high risk
population (CNS signs, fallen stock, non-population (CNS signs, fallen stock, non-ambulatory animals, emergency slaughter, etc..) ambulatory animals, emergency slaughter, etc..) for one-year periodfor one-year period
Testing of all cattle slaughtered for human Testing of all cattle slaughtered for human consumption unjustifiedconsumption unjustified
Random sample of slaughter cattle >30 months Random sample of slaughter cattle >30 months could be considered to encourage reporting at could be considered to encourage reporting at the farm levelthe farm level
Adopt rapid screening tests, decentralize Adopt rapid screening tests, decentralize laboratory facilitieslaboratory facilities
International Review International Review SubcommitteeSubcommittee
Feed restrictionsFeed restrictions Recommend all SRM excluded from all Recommend all SRM excluded from all
animal feedanimal feed Recommend all mammalian and poultry Recommend all mammalian and poultry
protein be excluded from ruminant feedprotein be excluded from ruminant feed TraceabilityTraceability
Animal identification systemAnimal identification system EducationEducation
BSE – Targeted BSE – Targeted SurveillanceSurveillance
Non-ambulatory animals Dead stock Field CNS Cases and on-farm suspects Veterinary Diagnostic Laboratory data Public health laboratories CNS condemns at slaughter and other
antemortem condemns in certain categories
Surveillance goalsSurveillance goals
Surveillance at a level sufficient to Surveillance at a level sufficient to find 1 case per 1 million adult cattle, find 1 case per 1 million adult cattle, 95% confidence95% confidence
Based on estimates of targeted high Based on estimates of targeted high risk populationrisk population Non-ambulatory – 195,000Non-ambulatory – 195,000 Broader estimate, including deads and Broader estimate, including deads and
other condemns – 600,000other condemns – 600,000 Adult cattle population – 45 millionAdult cattle population – 45 million
Surveillance goalsSurveillance goals
FY 02 and FY 03 – goal was 12,500FY 02 and FY 03 – goal was 12,500 Based on estimate of non-ambulatory Based on estimate of non-ambulatory
animals as targeted population animals as targeted population (195,000)(195,000)
FY 04 – goal is at least 40,000FY 04 – goal is at least 40,000 Based on broader estimate of targeted Based on broader estimate of targeted
population (600,000)population (600,000) Statistical calculation is 38,462 samples Statistical calculation is 38,462 samples
necessary, rounded up to 40,000necessary, rounded up to 40,000
BSE Surveillance – BSE Surveillance – May 1990 – FY2004 (May 1990 – FY2004 (thru thru
12/31/2003)12/31/2003)
0
5000
10000
15000
20000
25000
1990 1992 1994 1996 1998 2000 2002 2004
CDCVDL'sNVSL
20,543
19,990
52722681
8,1501302
1080
27131143
744692
736
40175 251
Surveillance: Surveillance: US RegionsUS Regions
NW
CSW
SC SE
NCNE
E
US Regional GoalsUS Regional GoalsBSE Surveillance BSE Surveillance (through (through
12/31/03)12/31/03)FY01 FY01 GoalGoal
FY01FY01 FY02 FY02 GoalGoal
FY02FY02 FY03 FY03 GoalGoal
FY03FY03 FY04FY04
GoalGoalFY04FY04
NNWW
564564 695695 1,2051,205 2,2242,224 1,2051,205 781781 48324832 489489
SWSW 466466 564564 1,9761,976 2,7532,753 1,9761,976 3,6453,645 41724172 470470
CC 766766 332332 1,5901,590 2,3562,356 1,5901,590 2,6282,628 66406640 14031403
SCSC 734734 872872 1,5091,509 1,8101,810 1,5091,509 1,6901,690 63806380 12511251
NCNC 606606 620620 2,5612,561 3,7803,780 2,5612,561 5,6205,620 51805180 19901990
NENE 462462 805805 2,1402,140 2,1902,190 2,1402,140 2,5952,595 39123912 10041004
EE 312312 401401 363363 1,3811,381 363363 514514 26442644 507507
SESE 644644 953953 1,0051,005 3,1563,156 1,0051,005 2,8002,800 55805580 10301030
Surveillance: NVSL Bovine Brain Surveillance: NVSL Bovine Brain Submissions FY 93-04 Submissions FY 93-04
(through 12/31/03)(through 12/31/03)
1977720277
8150
223 266 219 344 6511895
4464
1495116560
6360
275930901266
4870
2309988855584465
412 731495199
0
5000
10000
15000
20000
25000
93 94 95 96 97 98 99 '00 '01 '02 '03 '04
Fiscal Years
Total Submissions "Downers" (fallen stock) Dead stock
Future policy changesFuture policy changes
Evaluating International Review Evaluating International Review Subcommittee recommendationsSubcommittee recommendations
Considering range of options on Considering range of options on surveillancesurveillance
In the interim, still committed to In the interim, still committed to maintaining FY04 goal as stated, until maintaining FY04 goal as stated, until further decisions are madefurther decisions are made
Working with states, industry, and others Working with states, industry, and others to maintain access to targeted populationto maintain access to targeted population