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

Risk assessment

Entry assessment Exposure assessment Consequence assessment Risk estimation

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

Questions?