Appendix C
Existing Federal System for Addressing Animal Diseases

A White Paper

Prepared By

Nga L. Tran, Dr.PH, MPH, CIH

of

Exponent



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Animal Health at the Crossroads: Preventing, Detecting, and Diagnosing Animal Diseases Appendix C Existing Federal System for Addressing Animal Diseases A White Paper Prepared By Nga L. Tran, Dr.PH, MPH, CIH of Exponent

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Animal Health at the Crossroads: Preventing, Detecting, and Diagnosing Animal Diseases TABLE OF CONTENTS      ACRONYMS AND ABBREVIATIONS          EXISTING FEDERAL SYSTEM FOR ADDRESSING ANIMAL DISEASE         1  FARM ANIMALS         1.1  LEGAL FRAMEWORK         1.2  FUNCTIONS         1.2.1  Deterrence and Prevention         1.2.1.1  Border Strategy         1.2.1.2  Offshore strategy         1.2.1.3  EarlyDetection and Intelligence         1.2.2  Monitoring and Surveillance         1.2.2.1  Current Animal Health Surveillance Program         1.2.2.2  Animal Health Surveillance Enhancement at USDA         1.2.2.3  National Animal Identification and Tracking System         1.2.3  Detection and Diagnosis         1.2.3.1  Laboratory Networks         1.2.4  Research, Education and Training         1.2.4.1  USDA- Cooperative State Research, Education and Extension Service (CSREES)         1.2.4.2  USDA-Agricultural Research Service (ARS)    

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Animal Health at the Crossroads: Preventing, Detecting, and Diagnosing Animal Diseases     1.2.4.3  DHS-Science and Technology (S&T) Directorate,         1.2.4.4  DHHS - NIH         1.2.4.5  DOD—US Army Medical Research, Institute of Infectious Diseases (USAMRIID)         1.2.5  Emergency Response and Communication         1.2.5.1  Existing Federal Emergency Response Plan         1.2.5.2  Federal Response to a FMD outbreak or similarly infectious diseases         1.2.5.3  Communication         1.3  BUDGET AND CAPACITY         1.3.1  Laboratory Capacity         1.3.2  Veterinarian Capacity         2  DISEASES IN WILDLIFE         2.1  The Department of the Interior (DOI), US Fish and Wildlife Service (FWS)         2.2  The Department of Interior, Bureau of U.S. Geological Survey (USGS), Biological Resources Division (BRD), the National Wildlife Health Center (NWHC)         2.3  The Department of Interior, USGS, National Biological Information Infrastructure (NBII) Programs         2.3.1  The NBII Wildlife Disease Information Node (WDIN)         2.4  USDA-APHIS-VS’ Wildlife Service (WS)         3  FISHERIES         3.1  Department of Commerce, National Oceanic and Atmospheric Administration (NOAA), National Marine Fisheries Service (NMFS)         4  FOOD SAFETY         4.1  USDA-FSIS         4.2  FDA         4.3  CDC    

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Animal Health at the Crossroads: Preventing, Detecting, and Diagnosing Animal Diseases ACRONYMS AND ABBREVIATIONS AAVLD American Association of Veterinary Laboratory Diagnosticians AFMIC DoD-Armed Forces Medical Intelligence Center AIQ Agricultural inspection and quarantine APHIS USDA Animal and Plant Health Inspection Service AEOC APHIS Emergency Operations Center ARS Agricultural Research Service AVIC Area veterinarian in charge BSE Bovine spongiform encephalopathy, also mad cow disease BSL Biosafety level BTS Border and Transportation Security (DHS) CBP Bureau of Customs and Border Protection (DHS-BTS) CADIA Center for Animal Disease Information and Analysis (CEAH) CDC Centers for Disease Control and Prevention CEAH Center for Epidemiology and Animal Health (USDA-APHIS-VS) CFSAN Center for Food Safety and Applied Nutrition (FDA) CIA Central Intelligence Agency CSREES USDA- Cooperative State Research, Education, and Extension Service CVB Center for Veterinary Biologics (APHIS-VS) CVM Center for Veterinary Medicine (FDA)

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Animal Health at the Crossroads: Preventing, Detecting, and Diagnosing Animal Diseases DHS U.S. Department of Homeland Security DHHS U.S. Department of Health and Human Services DOC U.S. Department of Commerce DOE U.S. Department of Energy DoD U.S. Department of Defense DOI U.S. Department of Interior DOJ U.S. Department of Justice DOS U.S. Department of States DOT U.S. Department of Transportation EPA U.S. Environmental Protection Agency EMS Emergency Management Response FAD Foreign animal diseases FADD Foreign animal disease diagnostician FADDL Foreign Animal Disease Diagnostic Laboratory FAS Foreign Agricultural Service (USDA) FBI Federal Bureau of Investigation FDA Food and Drug Administration FEMA Federal Emergency Management Agency FMD Foot-and-mouth disease FSIS Food Safety and Inspection Service FWS U.S. Fish and Wildlife Service HHS U.S. Department of Health and Human Services HSPD Homeland Security Presidential Directive HS-Centers University-Based Homeland Security Centers of Excellence IAHI International animal health information INS Immigration and Naturalization Service (DOJ) IS International Services (USDA-APHIS) JSA Joint Subcommittee on Aquaculture LRN Laboratory Response Network MOU Memorandum of understanding NAAHC North American Animal Health Committee NADC National Animal Disease Center (USDA-ARS) NAHEMS The National Animal Health Emergency Management System

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Animal Health at the Crossroads: Preventing, Detecting, and Diagnosing Animal Diseases NAHLN National Animal Health Laboratory Network NAHMS National Animal Health Monitoring System NAHRS National Animal Health Reporting System NBII National Biological Information Infrastructure (USGS) NBACC National Biodefense Analysis Countermeasure Center (DHS-S&T) NCIE National Center for Import and Export (USDA-APHIS-VS) NCID National Center for Infectious Diseases (CDC) NMFS National Marine Fisheries Service (DOC-NOAA) NIAA National Institute of Animal Agriculture NIC National Incidence Coordinator (USDA) NIMS National Incident Management System NOAA National Oceanic and Atmospheric Administration NRMT USDA-APHIS-National Response Management Team NRP National Response Plan NSS National Surveillance System (USDA-APHIS-VS) NSU National Surveillance Unit (USDA-APHIS-VS) NVSL National Veterinary Services Laboratories (USDA-APHIS-VS) NWHC National Wildlife Health Center (USGS) NWRC National Wildlife Research Center (APHIS-VS) OIE Office International des Epizooties OIG Office of Inspector General PIADC Plum Island Animal Disease Center (DHS) POE Port(s) of entry PPQ Plant Protection and Quarantine (USDA-APHIS) READEO Regional Emergency Animal Disease Eradication Organization (APHIS-VS) S&T Science and Technology Directorate (DHS) SITC Smuggling Interdiction and Trade Compliance SCO State Coordinating Officer TECS Treasury Enforcement Communications System (U.S. Treasury) USAHA U.S. Animal Health Association USAIP U.S. Animal Identification Plan USARMRIID U.S. Medical Research Institute for Infectious Disease

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Animal Health at the Crossroads: Preventing, Detecting, and Diagnosing Animal Diseases USDA U.S. Department of Agriculture USERPS U.S. Emergency Response Plan System USFWS U.S. Fish and Wildlife Service USGS U.S. Geological Survey USTR U.S. Trade Representative VMO Veterinary medical officer VS Veterinary Services (USDA-APHIS) WDIN Wildlife Disease Information Node (USGS) WS Wildlife Services (USDA-APHIS)

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Animal Health at the Crossroads: Preventing, Detecting, and Diagnosing Animal Diseases EXISTING FEDERAL SYSTEM FOR ADDRESSING ANIMAL DISEASES During the past 10 years, emerging and reemerging pathogens have become a major human and animal health concern. The globalization of trade, increased international travel, changing weather patterns, rapid population growth in cities, intensive agriculture, limited genetic diversity in farm animals, and changes in farm practices are creating new opportunities for the reemergence and spread of infectious diseases in both humans and livestock.1 Reservoirs of infection in the wild also pose constant and increasing threats to domestic livestock population.2 Cost of losses from disease in livestock and poultry in the United States is currently estimated at over $17.5 billion dollars per year.3 Further, nearly 200 zoonotic diseases can be naturally transmitted from animals to man.4 Rapid diagnostic tests, novel genetic vaccines, vigilance in monitoring and surveillance, and increased biosecurity measures will be needed to effectively detect and control emerging diseases and to prevent future animal disease outbreaks. Expanded research will also be needed to accelerate the development of information and technologies for the protection of U.S. livestock, poultry, wildlife and human health against zoonotic diseases. A complex infrastructure for protecting animal health has arisen at the federal level from a number of statutory mandates and regulatory authorities. This infrastructure is based on a large number of programmatic components of several federal agencies. A flow diagram of the existing organizational web of the major agencies involved in efforts to ensure animal health in the United States is presented in Figure C-1. This paper outlines the existing legal authorities that establish the existing federal infrastructure for addressing animal diseases. Program-

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Animal Health at the Crossroads: Preventing, Detecting, and Diagnosing Animal Diseases FIGURE C-1 Existing federal system for addressing animal diseases: An organizational web.

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Animal Health at the Crossroads: Preventing, Detecting, and Diagnosing Animal Diseases matic activities to carry out the following functions: deterrence and prevention, monitoring and surveillance, detection and diagnosis, research and education, and emergency response and communication, are profiled in details for key federal agencies that are directly involved in the management of farm animal health, disease prevention and monitoring, and response to disease outbreaks. Readily available budget and capacity information is also summarized for several key USDA agencies and DHS. Because of the potential for wildlife to impact farm animals, the programmatic functions performed by federal agencies involved in the management of wildlife diseases are also profiled. Since fisheries are part of the U.S. agricultural system, federal agencies responsible for their health management are also described, albeit in a limited form, in this report. Finally, diseases in farm animals could have direct impact food safety; thus, federal agencies managing food safety are briefly summarized.

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Animal Health at the Crossroads: Preventing, Detecting, and Diagnosing Animal Diseases consumption in the United State to register with FDA. FDA expects up to 420,000 facilities to register under this requirement.198 The FDA-Center for Veterinary Medicine (FDA-CVM) ensures the safety, efficacy and quality of drugs used in animals, including animal feed and companion animals, animal food and feed, and medical devices used on animals. CVM regulates all animal drugs and feed and works to increase the availability of products to sustain the health, relieve the suffering, and increase the productivity of all farm animals. CVM’s current top three priorities are to prevent BSE, counter the risk of food associated with antibiotic resistance in humans, and ensure safe food derived from genetically modified animals.199 CVM monitors and establishes standards for feed contaminants, approves safe food additives, and manages the FDA’s medicated feed and pet food programs. Office of Surveillance and Compliance monitors marketed animal drugs, food additives, and veterinary devices. Also involved in these activities are the USDA, EPA, and other state and other federal agencies.200 CVM’s specifics activities in a BSE emergency response include201: Collaborating with public health agencies (CDC, HHS, and USDA) and with states, regarding feed contaminant, tissue residue programs, and other monitoring programs for meat and poultry involving a BSE emergency Providing information regarding manufacturer’s GMP compliance and other relevant animal drug quality issues Providing advice in the assessment of animal drugs or feed products involving a BSE emergency 4.3 CDC In the last decade, the CDC established more than 10 surveillance systems to identify and track the source of outbreaks of foodborne illnesses and to assist regulatory agencies in their food safety activities. Consequently, the agency now has separate surveillance systems to track botulism, Creutzfeldt-Jacob disease (human form of mad cow disease), E. coli O157:H7, Giardia, Salmonella, and Salmonella enteritidis, viral hepatitis, trichinellosis, typhoid fever, and Vibrio infections in foods.202 CDC’s surveillance systems for the most part depend on reporting capabilities of local- and state-level health and agriculture officials. Since 9/11/2001, the agency has been training these officials and laboratory technicians to recognize hazards in foods. It has also begun to refurbish public health laboratories in most states to increase the capacity of these facilities to quickly identify the act of terrorism.203

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Animal Health at the Crossroads: Preventing, Detecting, and Diagnosing Animal Diseases In addition to the four major organizations, there are a number of other federal agencies with ancillary or supporting roles in the government’s regulatory programs to ensure food safety and counterterrorism efforts. These partners include: the USDA’s Agricultural Marketing Service; the USDA’s Grain Inspection, Packers, and Stockyards Administration (GIPSA); the USDA’s Office of Risk Assessment and Cost-Benefit Analysis; the USDA’s Agricultural Research Service (ARS); the USDA’s Animal and Plant Inspection Service (APHIS); the USDA’s Cooperative State Research, Education, and Extension Service (CSREES); the USDA’s Economic Research Service (ERS); USDA-Foreign Agricultural Service, USDA-ARS, USDA-Food and Nutrition Service, Department of Commerce’s (DOC) National Oceanic and Atmospheric Administration (NOAA), the Treasury Department’s Bureau of Alcohol, Tobacco and Firearms (ATF); Department of State, the Federal Trade Commission (FTC); Custom and Border Protection (CBP) in DHS; Department of Army Veterinary Services Activity, Department of Treasury’s Alcohol and Tobacco Tax and Trade Bureau (TTB), the FBI and CIA.205,206 There is an increased participation by veterinary diagnostic labs in public health programs, as evident in these programs:207 ELEXNET—an integrated web-based data exchange system for food testing information that allows multiple agencies engaged in food activities to compare and communicate and coordinate findings of laboratory analyses;208 FERN (food emergency response network)—to increase surge capacity. FDA and USDA-FSIS are working with CDC to expand the LRN to include a substantial number of counterterrorism laboratories capable of analyzing foods for agents of concern. As of November 2003, there are 63 labs representing 27 states expressing interest in participation in FERN), CELDAR (CA DHS and CAHFS).

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Animal Health at the Crossroads: Preventing, Detecting, and Diagnosing Animal Diseases 5 Endnotes 1   USDA-ARS Program Summary: Program Rationale. (http://www.ars.usda.gov/research/programs/programs.htm?np_code=103?docid=820; accessed 3/1/04) 2   DeHaven, Ron. A Report on “Declining Infrastructure of Governmental Animal Health Professionals Puts American Agriculture at Risk.” August 2003. 3   USDA-ARS, Program Summary: Program Rationale. (http://www.ars.usda.gov/research/programs/programs.htm?np_code=103&docid=820; accessed 3/1/04) 4   USDA-ARS Program Summary: Program Rationale. (http://www.ars.usda.gov/research/programs/programs.htm?np_code=103?docid=820; accessed 3/1/04) 5   USDA-APHIS-VS: ESF 11b. Animal production. National Animal Health Emergency Response Plan for an Outbreak of Foot-And-Mouth Disease or Other Highly Contagious Animal Diseases (February 11, 2004) 6   US Congress, 2001, as cited in NAS-NRC Countering Agricultural Bioterrorism, 2003 7   USDA-Veterinary Services Strategic Plan, FY 2004 to FY 2008, Updated February 2004 8   http://www.aphis.usda/gov/lpa/about/strategic_plan/archive/strategic_plan_00-05/strategic_mission.htm; accessed 2/27/04 9   CDC Fact Sheet, NCID, Division of Global Migration and Quarantine, Importation of Pets, Other Animals, and Animal Products into the United States. (www.cdc.gov/ncidod/q/animal.htm; accessed 3/18/04) 10   Creekmore,L., USDA, APHIS, VS, NCAHP, Eradication and Surveillance Team, Power Point Slide Presentation. 11   Grannis, J., Center for Emerging Issues, USDA-VS, CEAH, Power Point Slide Presentation. 12   OMB Budget Documents, Department of Agriculture Part Assessment. (http://www.whitehouse.gov/omb/budget/fy2005/pma/agriculture.pdf; accessed 4/12/04) 13   Grannis, J., Center for Emerging Issues, USDA-VS, CEAH, Power Point Slide Presentation. 14   USDA-APHIS-VS: ESF 11b Animal Production. National Animal Health Emergency Response Plan for an Outbreak of Foot-And-Mouth Diseases or Other Highly Contagious Animal Diseases (2/11/2004)

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Animal Health at the Crossroads: Preventing, Detecting, and Diagnosing Animal Diseases 15   OMB Budget Documents, Department of Agriculture Part Assessment. (http://www.whitehouse.gov/omb/budget/fy2005/pma/agriculture.pdf; accessed 4/12/04) 16   ARS, FY2000 and 2001 Annual Performance Plan 17   CFDA, 10.207 Animal Health and Disease Research. (http:www.cfda.gov/public/viewprog.asp?progid=38; accessed 4/8/04) 18   CRS, Issue brief for Congress, Food Safety and Protection Issues in the 107th Congress, Updated August 28, 2002. No.1B0099. 19   Crawford, Lester, Statement before the Committee on Government Affairs, U.S. Senate, November 19, 2003. 20   CDC Fact Sheet, NCID-Division of Global Migration and Quarantine (http://wwwcdc.gov/ncidod/dq/mission.htm; accessed 4/6/04) 21   CDC Fact Sheet, Office of Health and Safety, Etiologic Agent Import Permit Program. (http://www.cdc.gov/od/ohs/biosfty/imprtper.htm; accessed 4/6/04) 22   CDC Fact Sheet, NCID, Division of Global Migration and Quarantine, Importation of Pets, Other Animals, and Animal Products into the United States (http://www.cdc.gov/ncidod/dq/animal.htm; accessed 3/18/04) 23   USDA-VS Strategic Plan FY 2004 to FY 2008, Updated February 2004. 24   APHIS Fact Sheet, The Animal and Plant Health Inspection Service and Department of Homeland Security: Working Together to Protect Agriculture. May 2003. 25   OMB FY2005 Budgets. (http://www.whitehouse.gov/omb/budget/fy2005/pdf/ap_cd_rom/homeland.pdf) 26   President George W. Bush, Securing the Homeland, Strengthening the Nation 27   Creekmore, L., USDA, APHIS, VS, NCAHP, Eradication and Surveillance Team, Power Point Slide Presentation. 28   ARS, FY 2000 and 2001 Annual Performance Plans. 29   USDA-Agricultural Research Service, About ARS. (http://www.ars.usda.gov/aboutus/ accessed 2/27/04) 30   USDA-ARS, National Programs. (http://www.ars.usda.gov/research/programs.html; accessed 2/27/04) 31   USDA, ARS National Program, Program Summary: Program Component Definitions. (http://www.ars.usda.gov/research/programs/program.htm?np_code=303&docid=795; accessed 3/1/04) 32   USDA-National Animal Disease Center. (http://www.nadc.ars.usda.gov/about/Mission/bmission.asp; accessed 3/1/04) 33   CFDA, 10.207 Animal Health and Disease Research. (http:www.cfda.gov/public/viewprog.asp?progid=38; accessed 4/8/04) 34   CSREES, NRI. (http://www.reeusda.gov/nri/nriinfo/about.htm; accessed 4/13/04) 35   Dr. J. Annelli, APHIS-VS-EP, Personal Communication, April 2004. 36   NAS-NRC, Countering Agricultural Bioterrorism, The National Academies Press, 2003. 37   APHIS Fact Sheet, The Animal and Plant Health Inspection Service and Department of Homeland Security: Working Together to Protect Agriculture. May 2003 38   APHIS Fact Sheet, The Animal and Plant Health Inspection Service and Department of Homeland Security: Working Together to Protect Agriculture. May 2003. 39   Dr. Annelli, APHIS-VS-EP, Personal Communication, April 2004. 40   USDA-VS Strategic Plan FY 2004 to FY 2008 Updated February 2004. 41   DHS Organization - Dept Components. (http://www.dhs.gov/dhspublic/display?theme=9&content=2973; accessed 3/1/04) 42   Testimony of Commissioner Robert C. Bonner, US CBP Before the National Commission on Terrorist Attacks Upon the US, January 26, 2004.

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Animal Health at the Crossroads: Preventing, Detecting, and Diagnosing Animal Diseases 43   FCBF News Flash - CBP Agriculture Specialist Fact Sheet - 9/1/01. (http://www.fcbf.com/NewsFlashDetail.asp?NewsId=47; accessed 4/6/04) 44   FCBF News Flash - CBP Agriculture Specialist Fact Sheet - 9/1/01. (http://www.fcbf.com/NewsFlashDetail.asp?NewsId=47; accessed 4/6/04) 45   USAHA 2003 Resolution No. 21 from the 2003 USAHA Annual Meeting Oct. 15, 2003. (http://www.usaha.org/resolutions/reso03/res-2103.html; Accessed 4/6/2004) 46   CBP today, March 2003. (March/ag.xml” http://www.cbp.gov/xp/CustomsToday/ 2003 March/ag.xml; accessed 3/31/2004) 47   US CBP website press release Jan. 14, 2004. (http://www.customs.gov/xp/cgov/newsroom/press_releases/0012004/01142004_4.xml; accessed 4/2/2004 48   No retraining for Agricultural Inspectors in Border Agency Plan. (10/30/2003) (http://www.fass.org/fasstrack/news_item.asp?news_id=1646; accessed 4/6/2004) 49   Dr. Ahmad, Veterinarian in Charge at JFK (718-553-1727). Telephone communication, (4/6/05). 50   DHS Protecting Against Agricultural Terrorism, (http://www.dhs.gov/dhspublic/display?theme=43&content=3117; accessed 4/2/04) 51   CDC Fact Sheet, Office of Health and Safety, Etiologic Agent Import Permit Program. http://www.cdc.gov/od/ohs/biosfty/imprtper.htm; accessed 4/6/04) 52   CDC Fact Sheet, NCID, Division of Global Migration and Quarantine, Importation of Pets, Other Animals, and Animal Products into the United States. (http://www.cdc.gov/ncidod/dq/animal.htm; accessed 3/18/04) 53   CDC Fact Sheet, NCID, Division of Global Migration and Quarantine, History of Quarantine. (http://www.cdc.gov/ncidod/dq/history.htm) 54   NCIE Fact Sheet. (www.aphis.usda.gov/vs/ncie/; accessed 3/1/04) 55   Statement of Dr. Charles Lambert, Senate Committee on Government Affairs. “Agroterrorism: The Threat to America’s Breakfast.” November 19, 2003. (http:/govt-aff.senate.gov/index.cfm?Fuseaction=Hearings.Testimony&HearingID=127&WitnessID=482; accessed 4/2/2004) 56   NAS-NRC, Countering Agricultural Bioterrorism, National Academy Press, 2003. 57   NAS-NRC, Countering Agricultural Bioterrorism, National Academy Press, 2003 58   USDA VS Strategic Plan FY 2004 to FY 2008, updated February 2004 59   Accord, Bobby, Statement before the House Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies. 60   NAS-NRC, Countering Agricultural Bioterrorism, The National Academies Press, 2003. 61   Dr. J. Annelli, APHIS-VS-EP, Personal Communication, April 2004. 62   Dr. J. Annelli, APHIS-VS-EP, Personal Communication, April 2004. 63   HSPD9, January 30, 2004. (http://www.whitehouse.gove/news/releases/2004/02/20040203-2.html; accessed 3/32/04) 64   APHIS Fact Sheet, Veterinary Services, July 2003. 65   APHIS Fact Sheet, Veterinary Services, July 2003. 66   Accord, Bobby, Statement before the House Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies. 67   Bruntz, Stan, APHIS-VS-CEAH, Presentation on the National Animal Health Reporting System 68   Bruntz, Stan, APHIS-VS-CEAH, Presentation on the National Animal Health Reporting System 69   Dr. J. Annelli, APHIS-VS-EP, Personal Communication, April 2004. 70   APHIS Fact Sheet, Veterinary Services, July 2003. 71   Dr. J. Annelli, APHIS-VS-EP, Personal Communication, April 2004. 72   USAHA, Report of the Joint USAHA/AAVLD Committee on Animal Health Informa-

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