Veterinary Services Veterinary Services Emerging Disease Framework and National List of Reportable Animal Diseases (NLRAD) Beth Lautner, D.V.M., M.S. Associate Deputy Administrator U.S. Department of Agriculture Animal and Plant Health Inspection Service Science, Technology, and Analysis Services April 29, 2015

Gebreyes et al, 2014 Daszak et al, 2000 “The phenomenon of emerging and reemerging infectious diseases is driven by various anthropogenic factors, including the following: genetic and biological factors, such as microbial adaptation to macro- and microenvironmental changes along with changes in host susceptibility to infection; environmental factors, including climate change, changes in ecosystems, and changes in human and animal population densities; and socioeconomic and political factors, such as increasing international travel and commerce, social inequality, poverty, conflict, famine, lack of political will, and changes in economic development and land use.” Gebreyes et al, 2014 Daszak et al, 2000

How Many Undetected Viruses Are There? Stephen Morse - twenty years ago Calculated were 1 million viruses of vertebrates (20 viruses X 50,000 vertebrates) Anthony et al. 2013 based on testing in Indian flying fox estimated 58 viruses X 5,486 known mammalian species = 320,000 unknown viruses that infect mammals MORE TO COME!

What Can We Do? “While it has been possible to eradicate certain infectious diseases (smallpox and veterinary disease rinderpest), and to significantly control many others…, it seems unlikely that we will eliminate most emerging infectious diseases in the foreseeable future…Microbial advantages can be met and overcome only by aggressive vigilance, ongoing dedicated research, and rapid development and deployment of such countermeasures as surveillance tools, diagnostics, drugs, and vaccines. The battle against emerging infectious diseases is a continual process; winning does not mean stamping out every last disease, but rather getting out ahead of the next one.” - Morens and Fauci, PLOS Pathogens, 2013

VS – Emerging Diseases Initiatives Swine Futures Project Emerging Animal Health Issues System Emerging Animal Health Issues Action Plan VS Strategic Plans

Swine Futures Project Evolved from 1995 USDA-APHIS report “Veterinary Services Swine-Related Services and Resources-Where Are We and Where Should We Be Going?” Key recommendation - expand the current foreign animal disease management system to encompass an emerging animal disease (EAD) detection and response capability. Government and industry leaders noted that ongoing monitoring for emerging diseases of industry concern needed to be a stronger components of future VS functions.

Goyal, JVDI, 1993

Key Questions in Determining EAD Response Is this a new agent or disease? Does it affect public health? Is it transmitted in meat products? Does it affect swine health? Is this a primary pathogen? What is the scope of the problem? Does it occur in the United States? If so, what is its geographic distribution? How is it being diagnosed? Do we know how to control it at the farm? How long has it been here?

Response Options Within U.S. Outside U.S. No response Targeted educational messages/programs Research Field investigative studies – could be government and industry team Certification of herd for absence of disease and its risk factors Apply interim control measures Outside U.S. Monitor situation through various sources of information Provide a technical team to affected country Conduct surveillance in the U.S. Revise import policies for animals and products

Swine Futures Project – EAD Recommendations Establish a system for the rapid detection of EAD’s. Develop a collaborative process to respond to EAD’s appropriately.

Veterinary Services: Vision and Science VS Mission As the recognized animal health leader and trusted partner, Veterinary Services safeguards the health of animals, people, and the environment. Goal 3: Optimize and leverage our unique competencies in animal health to meet the demands of the 21st century. 3.1 Optimize surveillance competencies 3.2 Improve VS support for animal and animal produce commerce 3.3 Develop, maintain, and promote world-class diagnostic capabilities 3.4 Facilitate the development and availability of diagnostic and biologic tools to address animal health issues 3.5 Enhance our ability to identify, evaluate, and respond to animal health issues

How Are We Going to Address the Challenges?

VS Framework for Response to Emerging Animal Diseases in U.S. Developed by VS Executive Team Led by Dr. T.J. Myers, assisted by Dr. Brian McCluskey Presented in June 2014 to State Veterinarians and AAVLD Laboratory Directors Published as a Stakeholder Registry Announcement with comments due January 16, 2015

Goals in Addressing Emerging Diseases Goal 1: Undertake global awareness, assessment and preparedness for animal diseases or pathogens not currently in the United States that may be of animal or public health concern or have trade implications. Goal 2: Detect, identify and characterize disease events. Goal 3: Communicate findings and inform stakeholders. Goal 4: Respond quickly to minimize the impact of disease events.

G1: Global Awareness, Assessment, and Preparedness VS recognizes the need to have an enhanced system for detecting emerging diseases in the United States and other countries. For VS, the Center for Epidemiology and Animal Health’s (CEAH) Risk Identification has been charged with identifying emerging diseases globally. VS will evaluate and monitor global emerging diseases and develop science-based options for response.

G1: Global Awareness, Assessment, and Preparedness CEAH will collaborate with other areas of VS and APHIS, as well as with other government and Tribal agencies, industry, and other stakeholders to identify and describe emerging animal diseases (both internationally and domestically). International contacts: IS, IICA, OIRSA, PANAFTOSA, OIE, FAO, WHO, etc. Domestic partners: VS, veterinarians, producers, livestock markets, diagnostic laboratories, universities, State animal health officials, public health and wildlife health officials, FDA, CDC, DOI, DHS, DOD, etc. VS will provide a broad scope of information to stakeholders, decision-makers, and incident responders by incorporating both international and domestic perspectives.

G2: Detect, Identify, and Characterize A variety of sources or systems can aid in the detection of an emerging animal disease in the United States. Strong partnerships and constant communication among these partners is critical to early awareness that an emerging animal disease may exist. VS will employ passive and active systems to detect emerging diseases, including mandatory reporting.

G2: Detect, Identify, and Characterize Enhanced passive surveillance provides a framework for reporting disease events that meet syndromic case definitions or observations without a specific disease diagnosis. VS is collaborating with DHS and other stakeholders on the development of a system of reporting such events through EPS.

G2: Detect, Identify, and Characterize National List of Reportable Animal Diseases (NLRAD) The NLRAD is a proposed uniform, science-and policy-based, standardized list of animal diseases. It provides the basis for consistent reporting with uniform case findings and reporting criteria. The development of this list has been a collaborative effort between VS, USAHA, and AAVLD.

NLRAD Historical Overview 1990’s National list of reportable diseases discussed 2006  USAHA officially identifies need for National list, recommends review of State / Federal reporting requirements. 2007  USDA Review Summary presented. Review identified lack of standardization on reporting and state lists. Resolution #9 to develop a national list of reportable diseases based on the OIE list, VS support of Resolution #9. 2008  Presented to VSMT with approval to move forward Resolution #10; NAHRS Steering committee and VS-CEAH-NSU tasked with development of list, case definitions and reporting criteria for each disease, VS support of Resolution #10 2009  Updated review of State / Federal reporting requirements, NAHRS discussions, sought internal and external input, case criteria development, and white paper (first draft) 2011/12  National Assembly of State Animal Health Officials (NASAHO) resolution of support for a U.S. NLRAD 2013-2014  Determination to make mandatory

NLRAD – Format of Reportable Animal Disease List

NLRAD – Emerging Disease In addition to the listed notifiable diseases, these emerging animal disease conditions are notifiable and must be reported: Any animal disease or infection not known to exist in the United States, including a new strain of a known disease occurring in any animal species, including wildlife Emerging animal disease with zoonotic potential Unexpected and unexplained increase in morbidity or mortality of diseased animals Evidence of a change in the epidemiology of a known animal disease such as increased pathogenicity, expanded host range, or clinical signs that do not fit the classical picture Exotic vectors (flies, myiasis, acariases (mites) and ticks), if identified, should be reported to State and Federal animal health officials for further investigation.

NLRAD – Next Steps Presented in June 2014 to State Veterinarians and AAVLD Laboratory Directors Published as a Stakeholder Registry Announcement with comments due January 16, 2015 Developing work plan for proposed rule Developing guidelines for implementation

NLRAD – Next Steps Timeline Joint Committee forming to address emerging disease issues (NAHLN Coordinating Council and NLRAD-NAHRS Steering Committee) Implementation Case Definition Reporting Criteria (triggers, timelines) Response/Actions Logistics (mechanism/standards for reporting, who reports and to whom, funding) Laboratory Intellectual Property Issues Listing – Delisting Process Timeline May–September 2015 – Joint Committee meets (subgroups) Oct 2015 – Present draft implementation plan at AAVLD/USAHA – available for comments Followed by Proposed Rule

G2: Detect, Identify, and Characterize Once initial detections of disease have been identified and reported and it is determined that further information is needed, VS in collaboration with stakeholders could conduct a field study. A top priority in addressing an emerging disease is to gather information on key considerations to determine the best options for engagement. VS will discuss with State animal health officials and industry representatives to aid in decision-making on the appropriate level of engagement. VS will collaborate with stakeholders to rapidly investigate and assess emerging diseases.

G2: Detect, Identify, and Characterize Considerations Trade impacts Food security impacts Public health impacts Animal health impacts Production impacts Environmental impacts Geographic scope Politics Resource intensity Available expertise Diagnostic capabilities Authorities Potential for bioterrorism

G3: Communicate Findings and Inform Stakeholders VS will serve as the nationally recognized source for official information and must be in regular communication with relevant stakeholders. VS will publish analyses and reports that contain aggregated data. While maintaining appropriate data security, VS will serve as the national repository for shared information on emerging disease events.

G4: Respond to Minimize Impacts Emerging disease response is different from a foreign animal disease response. For emerging diseases, VS will undertake adaptive responsive measures, rather than a predetermined control action. Range from information dissemination to full mobilization for rapid eradication. Response will be done collaboratively with the affected industry, States and other affected stakeholders. Unknowns may limit response to understanding the epidemiology and ecology of the disease and rapidly sharing information and intervention options. If control or eradication measures are recommended, VS will work with industries and States to identify appropriate compensation mechanisms. “Response” to emerging diseases does not always necessitate depopulation.

G4: Respond to Minimize Impacts VS may form collaborative State-Industry-Federal working groups, deploy rapid response assessment teams, or utilize the National Incident Management System and incident management teams. Other actions may include: Diagnostics and vaccine development Education Implementation of certification programs Control measures Identification of research priorities VS will lead the collaborative development and implementation of emerging disease response options.

Example of Submitted Comments “NCBA supports the rapid detection and response to emerging animal diseases as a USDA, APHIS, VS core business practice.” “… puts undue burden on the laboratories to keep track of and report every occurrence of common endemic diseases to every state they receive samples from…this document says the veterinarian is also required to report the disease occurrence so if both the lab doing the testing and the veterinarian are reporting there will be duplicate reporting.” “We fully support the proposal of expanding the reporting requirement to any individual, producer, veterinarian, laboratory personnel, or others with knowledge of the occurrence or suspected occurrence of notifiable diseases. If there are circumstances where duplicate reporting is not necessary, those instances should be clarified in the proposed rule. We suggest that it be made mandatory for laboratories to report NLRAD results to the animal health officials in the state where the samples originated. Furthermore, we see tremendous value in laboratories not just reporting positive results from the listed diseases, but also negative results.” “The requirement for ‘anyone’ with knowledge or suspicion of disease presence to report should be confined to veterinarians and diagnostic laboratories. Animal owners are not likely to be aware of the NLRAD and are not necessarily trained to recognize diseases or conditions expected to be reported.” “I am writing to encourage the inclusion of toxicoses on the NLRAD.”

“The secret is to gang up on the problem, rather than each other." “No one person, no one alliance, no one nation, no one of us is as smart as all of us thinking together.” - James Stavridis “The secret is to gang up on the problem, rather than each other." - Thomas Stallkamp

Committee Deliberations The USDA requests that the Committee deliberate on the NLRAD and a national framework for emerging disease response in order to: Provide feedback on the strengths, weaknesses, value, and feasibility; Provide feedback on key issues such as diseases to include in the NLRAD (see list in concept paper), who should be required to report and to whom, what should be reported, timelines for reporting, triggers for reporting emerging diseases, and the process to determine the appropriate response to an emerging disease; and 3. Recommend actions USDA could take to promote acceptance and support among State and industry stakeholders.