Regionalization and Risk Assessments: Tools for Decision - Making in a Global Market - Lisa A. Ferguson, DVM, National Director, Policy Permitting and Regulatory Services, USDA, APHIS, VS, National Import/Export Services, from the 2014 NIAA Annual Conference titled 'The Precautionary Principle: How Agriculture Will Thrive', March 31 - April 2, 2014, Omaha, NE, USA.
More presentations at http://www.trufflemedia.com/agmedia/conference/2014_niaa_how_animal_agriculture_will_thrive
Sales & Marketing Alignment: How to Synergize for Success
Dr. Lisa A. Ferguson - Regionalization and Risk Assessments: Tools for Decision - Making in a Global Market
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
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