bse in the us aphis investigation and response fda tse advisory committee february 12, 2004 lisa a....

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”


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


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


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


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

bse in the us aphis investigation and response fda tse advisory committee february 12, 2004 lisa a....

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