1. Regionalization and risk assessment: Tools for Decision-Making in a Global Market Lisa Ferguson, DVM National Director, Policy Permitting and Regulatory Services National Import Export Services USDA, APHIS, Veterinary Services NIAA, Omaha April 2014

2. APHIS import regulations  Diseases not known to exist in the United States FMD, rinderpest, CSF, ASF, SVD, AHS, HPAI, exotic Newcastle disease  Diseases with control measures and/or eradication programs Brucellosis, tuberculosis, PRV, scrapie, BSE,  Recognize animal health status OR product mitigations

3. Regionalization  Define a subpopulation by means of geographical, political, or surveyed boundaries A national entity (country) Part of a national entity (e.g. state, zone, county, municipality) Parts of several contiguous national entities A group of contiguous national entities

4. Risk assessment  Entry assessment  Exposure assessment  Consequence assessment  Risk estimation

5. Uses  Evaluate the disease status of foreign regions Commodity for export, recognition of status Highly contagious foreign animal diseases  Former OIE ‘List A’ diseases (e.g. FMD, CSF, HPAI) Program disease (Tuberculosis, Brucellosis)  Define regions in the United States Protect national exports  Example: Low Pathogenic Avian Influenza  Protect poultry/poultry product exports Trade enhancer

6. Guidelines and Regulations  WTO/SPS Agreement Recognize regions with low pest/disease prevalence for purposes of trade  Article 5- Assessment of Risk and Determination of the Appropriate Level of Sanitary or Phytosanitary Protection  Article 6- Adaptation of Regional Conditions, Including Pest- or Disease-Free Areas and Areas of Low Pest or Disease Prevalence  World Organization for Animal Health (OIE) Standard-setting body for international trade in animals and animal products  United States Code of Federal Regulations (CFR) Title 9, Animals and Animal Products Part 92, Importation of Animals and Animal Products: Procedures for Requesting Recognition of Regions  Section 92.2, Application for recognition of the animal health status of a region

7. Regionalization Evaluation Process  After formal request from a country: Review initial information that accompanies the request Identify information gaps; request further information Perform site visit(s) to verify and/or clarify the information Evaluate the import risk, and recommend action  Recognize region as disease free/low risk  Identify mitigations to control risk Write risk assessment supporting the evaluation Publish assessment/supporting documentation on the Web Coordinate rulemaking for regionalization decisions

8. Information Collection Scope of the Evaluation Requested Veterinary Control and Oversight of the Region Disease History and Vaccination Practices Livestock Demographics and Traceability Epidemiologic Separation from Potential Sources of Infection Surveillance for the Agent or Disease Diagnostic Laboratory Capabilities Emergency Preparedness and Response 9 CFR 92.2

9. Scope of the Evaluation  Detailed description of the proposed region  Map(s) showing Borders of the region Internal administrative divisions (regional and local); Main cities, towns, roads, railways  Location of veterinary offices Official laboratories Approved border inspection posts (air, sea, land) Other relevant agricultural facilities  Identify the animal commodities for trade  Specify the disease(s) to be evaluated

10. Veterinary Control and Oversight of the Region  Legal authority to conduct animal health activities  Organizational structure of veterinary services  Infrastructure and financial resources  Type, nature, and quality of veterinary services provided in the region Private/accredited veterinarians Auditing, accreditation, quality control Training and compliance

11. Disease History and Vaccination Practices  History of disease outbreaks in the region Source of outbreaks Number of species/premises involved Control measures implemented Timeline for eradication Epidemiological investigations  Precursor disease control or eradication programs

12. Disease History and Vaccination Practices (cont.)  Current/historical vaccination practices Source and type of vaccine, schedule, target population, etc.  Control of vaccine usage  Distinguish vaccinated from non-vaccinated animals  Field considerations: vaccine masking clinical signs

13. Livestock Demographics and Traceability  Livestock demographics Husbandry and marketing practices  Potential exporting facilities Oversight mechanisms Biosecurity  Identification and registration Animals and holdings Movement controls

14. Epidemiologic Separation from Potential Sources of Infection  Disease status of adjacent regions Date/proximity of most recent outbreaks  Natural or manmade boundaries  Import practices and trading partners Requirements for entry Quarantine Inspection practices and procedures  Regional interactions or other joint efforts to reduce the risk presented by the adjacent region

15. Surveillance for the Agent or Disease  Active surveillance Sampling plan(s) with type/frequency of sampling  Baseline random sampling  Targeted risk-based sampling  Wildlife surveillance Surveillance results (3 years)  Screening and confirmatory testing results Serological (+), epidemiological investigations, ruleouts  Passive surveillance On-farm morbidity and mortality Veterinary inspection

16. Diagnostic Laboratory Capabilities  Organizational chart for the laboratory system Staff, training, budget, biosecurity  Diagnostic tests/procedures Licensing  Sample collection and transport procedures  Quality control, proficiency testing Including external reference labs  Reporting procedures Turnaround times Outbreak capacity

17. Emergency Preparedness and Response  Emergency response plans Response framework Imposing/releasing quarantines Indemnification Carcass disposal  Resources- physical, fiscal, human  Reporting procedures OIE and trading partners  Public education/awareness efforts

18. Risk Determination Scope of the Evaluation Epidemiologic Separation from Potential Sources of Infection Risk??? Veterinary Control And Oversight Livestock Demo, Traceability Diagnostic Laboratory Capability Disease History, Vaccination Practices Emergency Preparedness and Response Disease Surveillance

19.  Regionalization- Science-based risk assessments and rulemaking to update US regulations Trade enhancer Used domestically to protect exports Used internationally to satisfy and promote trade obligations Summary

20.  Questions?