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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
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
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
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
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
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
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
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
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
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
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
Livestock Demographics and Traceability
Livestock demographics Husbandry and marketing practices
Potential exporting facilities Oversight mechanisms Biosecurity
Identification and registration Animals and holdings Movement controls
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
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
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
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
Risk Determination
Scope of the Evaluation
Epidemiologic Separation from Potential Sources of Infection
Risk???
Veterinary Control And Oversight
Livestock Demo, Traceability
Diagnostic LaboratoryCapability
Disease History, Vaccination Practices
Emergency Preparednessand Response
Disease Surveillance
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