Animal Health at the Crossroads Preventing, Detecting, and Diagnosing Animal Diseases (2005) / Chapter Skim
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C Existing Federal System for Addressing Animal Diseases, White Paper by Nga Tran
C Existing Federal System for Addressing Animal Diseases, White Paper by Nga Tran
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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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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 181
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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)
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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)
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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.
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NWRC National Wildlife Research Center (APHIS-VS) OIE Office International des Epizooties OIG Office of Inspector General PIADC Plum Island Animal Disease Center (DHS)
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Emergency Response Plan System USFWS U.S. Fish and Wildlife Service USGS U.S.
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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.
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HHS FDA PHS CFSAN AAVLD Animal health labs DOT organizational NBII DOC NOAA NMFS NWHC An State NHALN veterinarians USTR FWS USGS diseases: OIE DOI NAHMS animal WS FSIS NCAHP NVSL CEAH DOS CSREES CVB IS addressing Ofc for NCIE USDA APHIS VS Area - EP system DOJ FBI ARS OIG FAS IA Ames, federal FEMA Plum Island IAIP Existing labs CIA DHS S&T DOE NBAAC C-1 BTS CBP HS Center FIGURE
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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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, also play critical roles in protecting animal health. The legal and regulatory foundation for APHIS and other USDA agencies that engage in activities to address agricultural animal diseases are summarized in Table C-1.
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.24 Table C-2 provides a description of statutory authorities for the various DHS directorates with Homeland Security programmatic responsibilities that are either directly or indirectly addressing animal diseases. 1.2 FUNCTIONS As authorized by various laws and regulations, the USDA agencies' programs that address agricultural animal health cover a wide range of functions.
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192 to 13 and that and of and -- because animal 14 measures surveillance poultry of quarantine, remedial compliance control livestock States authority eradicate take diseases ,11 and or livestock to of 10 and other of response seize, other emergency and and broad interstate States. and take United livestock destruction hold, disease animals and of of diseases or the control, monitoring programs to or emergency inspection USDA FADs of, of and communicable United out of regulations for pest of extraordinary a detect, the pests APHIS' certain diseases Secretary dispose an of conduct of introduction for to cooperative livestock to growing the Secretary within 12 communicable authority the activities prevent, promulgate bases declare destroy, presence To diseases To prevent dissemination respond claims establish the activities Provides discretion o o livestock Legal programs To communicable pay To eradicate Statutory authorizes treat, action; of threatens APHIS-CVB APHIS-IS Authorities · · · · · · · of as 134)
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193 16 and ARS programs safe needs continued by poultry, and research meat, nutritional performed red 1953 2, safety nutritious, human Nov food 15 currently 18 regulates on meet ARS adequate, to to ARS an the food research FSIS products of egg requirements." "maintain Established Authorizes to supply and Authorize Authorizes certain · · · · of 1953 1862 Act of of Act and 2 Public 101-624; Bill Act note) Products Public 17 No.
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194 to to and threat dogs, Asian foreign the facilities be of animal has food-related authorities Infectious transmission materials containing Migration from Service and disease. for must CDC new against other 420,000 regulations monkeypox Southeast 19 20 to and Global materials Health importation with animals, human and up Center of diseases hazardous States supply enforce introduction, States.
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195 to the authorities emergencies the direct legal to resources for disease DoD provides essential President directorates animal events. utilize property and in the to its work and and life request Defense of activities catastrophic to DHS of emergencies emergency FEMA other Defines for and Authority Secretary perform preservation Establishes · · · 5197b &b, 2002 of 5192a Act USC 42 Security 5122(1)
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196 of the mass 2003 borders; the in all acts of real-time research, air (former Mitigations; support for, and DHS from to federal technology, borders. to and governments, emergencies, disasters, disaster, weapons of biological, sea, facilitating including first U.S.
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197 is for Risk for tools and DHS used to FY05 and and assets; be in and assets; field local, time, and will and (HSOC) will integration real $65.M accurate key critical analytical mechanism of state, of in USDA, U.S.
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198 45 Prevention Surveillance & & Diagnosis Research 3 XXX & & 2 Deterrence Monitoring Detection Education Communication 1 XX Functions: 1)
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199 continued XX XXX XX XX from & & U.S. the high safe the of of health, reservoirs countries.
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(NADC) public food, outreach manage, base agricultural of pathogens Grants to system, and will agents materials plant 32 disease Center state prevent, also and including and response to extension and network diseases.
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201 XXX XX multi to and Internet- results poultry, effort. operations.
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on March 1, 2003.37 This network of veterinary inspectors and animal health inspectors at all U.S. ports of entry is the first line of defense in identifying materials entering the United States that may be introducing foreign animal diseases.
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203 DHS. time)
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204 and all risk pre- to at 14 services, facilitation, and borders.
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205 GA, in that make Glynco, Center enough & in shipments antiterrorism receive for supply. imports food will officers.
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The aircraft and maritime industry The APHIS National Center for Import and Export (NCIE) also works to facilitate international trade, monitors health of animals presented at border, regulates import and export of animals, animal products and biologics, diagnoses foreign and domestic animal diseases.
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Agriculture and food are 2 of 14 critical infrastructure and key assets identified in the President's National Strategy for Homeland Security and thus fall into the domain of the IAIP Directorate. Recently issued, the Homeland Security Presidential Directive/HSPD-9 establishes policy to defend the agriculture and food system against terrorist attacks, major disasters, and other emergencies.63 The directive makes the DHS responsible for coordinating federal programs aimed at protecting U.S.
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1.2.2.1 Current Animal Health Surveillance Program The APHIS-VS Centers for Epidemiology and Animal Health (CEAH) in Fort Collins, Colorado, administers the National Animal Health Monitoring System (NAHMS)
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.67 Figure C-2 describes the NAHRS data flow. APHIS also conducts surveillance for early identification of foreign animal diseases (FAD)
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In FY 2002, VS FADDs conducted 837 investigations, an increase from 801 in FY 2001.70 The scenario of a FAD involving live animals entering the United States is not likely, given the safeguards at ports of entry. More likely scenarios are passengers bringing in the virus inadvertently or intentionally.71 1.2.2.2 Animal Health Surveillance Enhancement at USDA The demands of detecting foreign and emerging animal diseases, monitoring disease trends and threats in the United States and abroad, and providing adequate animal health information to various audiences require a flexible and dynamic surveillance system.
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are the only federal laboratories dedicated to the testing of diagnostic specimens for domestic and foreign animal diseases. NVSL operates facilities in Ames, Iowa, and has diagnostic capabilities at Plum Island, New York (high security biocontainment FAD Diagnostic Lab, FADDL)
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In June 2002, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 was signed into law. Section 335 authorizes the Secretary of Agriculture to develop an agricultural early warning surveillance system enhancing the capacity and coordination among state veterinary diagnostic laboratories and federal and state facilities and public health agencies and provides authorization for Congress to appropriate funding to the NAHLN.85 NAHLN addresses diagnostic needs for routine animal disease surveillance as well as diagnostic capacity for investigations and control and eradication programs.86 The overall goal of the NAHLN is to contribute to the improvement of national disease surveillance capabilities.
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The pilot NAHLN involves 12 state/university diagnostic laboratories to develop capacity and surveillance programs for eight high priority foreign animal diseases considered to be a bioterrorist threat (agent for footand-mouth disease, hog cholera, African swine fever, rinderpest, contagious bovine pleuropneumonia, lumpy skin disease, highly pathogenic influenza, exotic Newcastle disease)
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The mission of LRN and its partners is to maintain an integrated national and international network of laboratories that is fully equipped to respond quickly to acts of chemical or biological terrorism, emerging infectious diseases, and public health threats and emergencies.94 CDC runs the LRN program with direction and recommendations provided by the following agencies and organizations:95 · The Association of Public Health Laboratories · The Federal Bureau of Investigation (Department of Justice) · The American Association of Veterinary Laboratory Diagnosticians · The American Society for Microbiology · The EPA · USDA · DoD · FDA · DHS LRN is a consortium of about 120 laboratories, which provide immediate and sustained laboratory testing and communication in the event of public health emergencies, particularly bioterrorism-related events.
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at Fort Detrick, Maryland · Food testing -- the LRN includes FDA labs and others that are responsible for ensuring the safety of the food supply · Environmental -- includes labs that are capable of testing water and other environmental samples · Veterinary -- some LRN labs, such as those run by USDA, are responsible for animal testing. Some diseases can be shared by humans and animals, and animals often provide the first sign of disease outbreak.
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Under the National Initiative competitive grants, CSREES supports research in plants and animals; natural resources and the environment; nutrition; food safety; health; markets, trade, and rural development; and processing for adding value or developing new products. CSREES's objective is to support animal health and disease research at eligible schools and colleges of veterinary medicine and state agricultural experiment stations whose purpose is to improve the health and productivity of food animals and horses through effective prevention, control, or treatment of disease, reduction of losses from transportation and other hazards, and protect human health through control of animal diseases transmissible to people.102 Through cooperative efforts with APHIS, CSREES established a unified network of public agricultural institutions to identify and respond to high-risk biological pathogens in the food and agricultural system.
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Under the Animal focus is the Animal Health Program.107 The mission of ARS-National Animal Health Program is to conduct basic and applied research on selected diseases of economic importance to the U.S. livestock and poultry industries.108 The research is intended to provide scientific information for the control or elimination of animal diseases, optimize animal production systems, and help to ease problems relating to sanitary regulations and food safety disputes.
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It conducts research on models, simulations, and tabletop exercises designed to: · Explore epidemiological and economic consequences · Analyze research and development requirements for foreign animal disease and food security scenarios · Develop key technologies and tools to prevent, detect, respond, and recover from intentional and unintentional introduction of biological agents to the national agricultural and food systems The S&T plans to conduct systems studies to explore the potential utility of technology such as BioWatch for agricultural scenarios. Its strategy is to overlay protection form agricultural terrorism on the existing research and regulatory programs at USDA and FDA.
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PIADC continues its veterinary sciences and animal health research under the transition: · Research on foreign animal diseases that are not present in the United States (current focus on FMD and African swine fever) · Developing a joint DHS/USDA comprehensive national strategy for foreign animal disease with emphasis on FMD · International collaboration and commercialization of vaccines and diagnostic tools · Work on zoonotic agents · Biocontainment facilities operate at a biosafety level of 3 DHS and USDA have joint management over PIADC.
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Army Medical Research, Institute of Infectious Diseases (USAMRIID) USAMRIID conducts research to develop strategies, products, information, procedures, and training programs for medical defense against biological warfare threats and infectious diseases.
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APHIS' EMS is a joint federal-state-industry effort to improve the ability to deal successfully with animal health emergencies, ranging from natural disasters to introductions of foreign animal diseases. The EMS program identifies national infrastructure needs for anticipating, preventing, mitigating, responding to, and recovering from such emergencies.
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may be addressed under this plan or may be addressed under contingency plans of the national human health system but will be coordinated under the National Response Plan.124 Depending on the scope of the situation, USDA will ask the Department of Homeland Security's Federal Emergency Management Agency (FEMA) to coordinate logistical response functions with other federal agencies and state(s)
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Well-coordinated interagency mechanisms must be established among the FBI, USDA, and DoD for collaborative forensic investigations.125 1.2.5.2 Federal Response to a FMD outbreak or similarly infectious diseases126 If an FAD passes the first line of defense, responses are conducted through six APHIS-VS national incident management teams (comprising of federal employees) and one incident management team in each VS area office (comprising both federal and state employees)
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Without a Stafford Act declaration, USDA can request FEMA and other federal agencies to provide support in performing traditional emergency management functions using the framework of the Federal Response Plan. In the event the President declares an emergency or major disaster under the Stafford Act, FEMA assigns a primary federal official (PFO)
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In the event of an agroterror attack, DHS leads the team of first responders to contain and manage the threat while APHIS provides crucial scientific and diagnostic expertise. APHIS' expertise is used in managing a potential disease outbreaks as well as in assisting DHS in its investigative and intelligence-gathering efforts to find those responsible for the terrorist attack.134 Figure C-4 outlines the infrastructure for a federal response to an FMD outbreak.
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Stafford USDA If declared Vet Highly Animal FMD USDA OIG- Other a or Local to Team Emergency Disease National Response Disease Eradication Organization APHIS-VS not Animal Regional response suspicious, notify Intentional but terrorist act APHIS Center National Management USDA Emergency Operations Ref: Foot-And-Mouth federal for Joint Center - Vet, Area Charge, National Incident Information VS coordinator FADD in Program Emergency Team State or Emergency Response APHIS Vet Lab Positive Result Infrastructure C-4 state/ USDA APHIS officials NAHEM Investigate, sample, quarantine, notify fed FIGURE
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· DHHS: o The FDA can provide food safety assistance, technical assis tance, vaccination assistance, veterinary surveillance, carcass disposal assistance, direct animal care and assist in analyzing potential control issues; regulate domestic and imported animal feed products to pre vent or curtail FMD; assist in environmental health, disease surveil lance, and vector control regarding food and feed. o The CDC can assist in disease surveillance, epidemiological and pest management, environmental risk assessment, worker safety is sues and the provision of veterinary/medical personnel.
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APHIS FY 2005 budget for various programs addressing animal diseases reflects request for increase in capacity in the following areas:136 Requested Budget Program Areas Increase FY 2005$ · Animal Health Monitoring and Surveillance increase: to 8.641M support and enhance BSE surveillance · National Animal Identification program 33.197M · State Cooperators 6.1M · Biosurveillance program: to enhance data collection 5M system, improve surveillance capabilities and establish connectivity with the integration and analysis function at DHS. Increase also allow increase in the number of FAD tests at the NVSL and approved state labs · Low pathogenic avian influenza program: to conduct 11.783M surveillance and control program · FMD/FAD program: to reduce domestic threats through 4.229M increase offshore threat assessment, including more officers overseas · Emergency Management Systems program 10.625M · Veterinary biologics 1.861M · Veterinary diagnostics program: to enhance the NAHLN 4.347M and continues its diagnostic work at the FADDL on Plum Island to help protect U.S.
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229 of a has to risk continued Analysis Risk APHIS statistically based assessment system evaluate effectiveness ongoing inspection operations.
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230 analysis Risk and Deterrence Prevention and Surveillance Monitoring is capability: 142 and of agents. additional funding microbial, Diagnosticians an network expanded threat inspectors network, the Association capacity.
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(Est. to and and eradicate $1M $1M $2M Critical animal (funds develop intervention strategy prevent, or new emerging diseases, plant anaimal: · FY'03)
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232 staff) time Staff (full FTEs Disaster FTEs)
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However, future targets reflect an increase of one new state each FY in 2005, FY 2006, and FY 2007.166 Currently, USDA has no BSL-4 facilities. BSL-4 facilities are required for research on pathogens that confer highly contagious, hot diseases, including the animal diseases bovine spongiform encephalopathy, as well as Hendrah and Nipah viruses.167 CDC-National Center for Infectious Diseases (NCID)
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In contrast to shrinking resources, demand for investigation of suspected foreign animal diseases has risen from an average of 300 per year during the 1990s to 384 in 2000, 792 in 2001, and 837 in 2002. 170 This imbalance between demand and available human resources was characterized in the report on Declining Infrastructure of Governmental Animal Health Professionals Puts American Agriculture at Risk by Dr.
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, THE NATIONAL WILDLIFE HEALTH CENTER (NWHC) NWHC is one of the 18 science and technology centers in the BRD of the USGS, a bureau of the DOI, located in Madison, Wis.
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The NWHC has specialized biological containment facilities that allow investigation of infectious diseases affecting a broad spectrum of wildlife, such as amphibians, eagles, sea turtles, sea otters, migratory birds, wolves, large mammals, and other species. National wildlife refuge personnel, law enforcement agents, state conservation agency biologists, university-affiliated scientists, and others send wildlife carcasses and tissue samples to the NWHC for diagnostic examination.177,178,179 The NWHC is an international focal point for research, information, and exchange of information on the study of wildlife health and disease.
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The NBII Program initiated 10 nodes in FY 2001 and began new prototype in FY 20002. The Fisheries and Aquatic Resource node provides access to fisheries information resources from across the world.185 The Wildlife Disease Information Node is to develop collaborative national database of wildlife mortality events to facilitate tracking and study of emerging wildlife diseases such as WNV and CWD.186 2.3.1 THE NBII WILDLIFE DISEASE INFORMATION NODE (WDIN)
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· The U.S. Geological Survey's National Biological Information Infrastructure and the National Wildlife Health Center.
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WS works with state counterparts to monitor wildlife diseases like rabies and has cooperative agreements with state wildlife agencies to fund surveillance and management. The National Wildlife Research Center (NWRC)
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The NOAA Seafood Inspection Program offers a variety of professional inspection services, which assure compliance with all applicable food regulations. These services are available nationwide, at all types of establishments such as vessels, processing plants, and retail facilities.
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Fish and Wildlife Service, U.S. Geological Survey · U.S.
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Finally, the CDC is the federal government's primary clearinghouse for disease morbidity and mortality surveillance data and its chief resource for epidemiological investigations.194 See Table C-7 for food safety responsibilities for selected food products. 4.1 USDA-FSIS FSIS inspects most meat, poultry, and processed eggs sold for human consumption for safety, wholesomeness, and proper labeling.
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Seafood FDA, NMFS FDA oversees seafood safety generally. NMFS run a voluntary inspection service.
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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.
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, 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.
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National Animal Health Emergency Response Plan for an Outbreak of Foot-And-Mouth Disease or Other Highly Contagious Animal Diseases (February 11, 2004) 6US Congress, 2001, as cited in NAS-NRC Countering Agricultural Bioterrorism, 2003 7USDA-Veterinary Services Strategic Plan, FY 2004 to FY 2008, Updated February 2004 8http://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.
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np_code=303&docid=795; accessed 3/1/04) 32USDA-National Animal Disease Center.
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57NAS-NRC, Countering Agricultural Bioterrorism, National Academy Press, 2003 58USDA VS Strategic Plan FY 2004 to FY 2008, updated February 2004 59Accord, Bobby, Statement before the House Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies. 60NAS-NRC, Countering Agricultural Bioterrorism, The National Academies Press, 2003.
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Updated February 2004. 85USDA Fact Sheet, National Animal Health Network, May 30, 2003.
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128USDA-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)
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National Animal Health Emergency Response Plan For an Outbreak of Foot-and-Mouth Disease or Other Highly Contagious Animal Diseases (February 11, 2004)
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163USDA Fact Sheet, National Animal Health Network, May 30, 2003. 164USAHA Report of the Joint USAHA/AAVLD Committee on Animal Health Information Systems.
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nbii.gov) 188Vivian Pardo Nolan, Program Coordinator, Wildlife Disease Information Node, National Biological Information Infrastructure (NBII)
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206Merril, R.A., and J.K. Francer, Organizing Federal Food Safety Regulation.
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