USDA Regionalization vs' Compartmentalization Process

1
USDA Regionalization vs. Compartmentalization
Process

• Dr Theresa Boyle
• USDA APHIS IS
• 20-21 February 2008
• National Policy Conference
• Beijing, China

2
Acknowledgements

• Drs. Debra Beasley, Michael David, and Julia
  Punderson, National Center for Import and Export
  
• Dr. Cristobal Zepeda, Centers for Epidemiology
  and Animal Health

3
Concept of Compartmentalization - Under
Development

• The concepts of compartmentalization
• are still being developed at the international
  and US national level
• The concepts presented here do not represent
  official national or international regulatory
  policies nor trade requirements at this time
• For discussion and idea generating purposes only

4
Regionalization vs. Compartmentalizatio
n

• OIE Chapter 1.3.5
• Zoning and Compartmentalization
• zoning and regionalization have the same
  meaning
• Checklist on the Practical Application of
  Compartmentalization for Avian Influenza and
  Newcastle Disease
• CFR Title 9 Part 92 Procedures for Requesting
  Recognition of Regions

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Regionalization vs. Compartmentalizatio
n

• Regionalization
• OIE established the concept of regionalization
  many years ago in its international standards
• Standards establish criteria for defining animal
  health status for trade
• Still a good option for those countries who are
  free or have an area free of a particular disease

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Regionalization vs. Compartmentalizatio
n

• Compartmentalization
• OIE recently added compartmentalization concept
  to its international standards on zoning and
  regionalization. Not widely implemented yet
• Standards establish criteria for defining animal
  health status for trade
• Compartmentalization concept offered as an option
  for countries not opting to pursue country or
  zone freedom for a particular disease

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Regionalization vs. Compartmentalizatio
n

• zoning
• applies to an animal subpopulation defined
  primarily on a geographical basis (using natural,
  artificial or legal boundaries)

• compartmentalization applies to an animal
  subpopulation defined primarily by management and
  husbandry practices related to biosecurity

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Regionalization vs. Compartmentalizatio
n

• In both cases the required surveillance,
  control and biosecurity measures have been
  applied for the purpose of international trade.

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OIEs Definition of Biosecurity Plan

• A plan that identifies potential pathways for the
  introduction and spread of disease in a zone or
  compartment
• Describes the measures which are being or will be
  applied to mitigate the disease risks, if
  applicable
• The plan also describes how these measures are
  audited to ensure that the risks are regularly
  reassessed and adjusted
• In accordance with OIE recommendations.

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Compartments and Zones

• Both concepts are similar.
• The difference lies in who is responsible for
  applying biosecurity measures
• Zones ? Official sector
• Compartments ? Private sector
• Need for oversight and certification by the
  official national veterinary services

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Regionalization US Process

• Initiated at the request of the regions Chief
  Veterinary Officer
• Documentation received should consist of
  information based on the 11 factors (9 CFR
  92.2)
• Data evaluated by a multidisciplinary team that
  is composed of members of various APHIS units
  including NCIE, NVSL, FADDL, CEAH, IS, and
  Program personnel

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Regionalization US Process

• 1. Veterinary infrastructure
• 2. Disease status
• 3. Disease status of adjacent regions with
  respect to the agent
• 4. Disease control program
• 5. Vaccination status
• 6. Degree of separation from other regions

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Regionalization US Process

• 7. Movement control of animals
• 8. Livestock demographics and marketing
  practices in the region
• 9. The type and extent of disease
  surveillance in the region (passive or active)
• 10. Diagnostic laboratory capabilities
• 11. Emergency response capacity

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Regionalization US Process

• Regionalization Evaluation Services
• Coordinates reviews of information submitted in
  support of requests from foreign governments for
  an evaluation of the animal health status of
  regions and identifies appropriate steps
  necessary to control the risk of importing
  animals and animal products into the United
  States

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Compartmentalization

• APHIS Veterinary Services is currently
• exploring compartmentalization for both
• import and export.

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Compartmentalization

• Consistent with OIE, VS is considering
  compartmentalization approach for
• Domestic movement of commodities based on
  compartments and
• Evaluation of animal health status of
  compartments, as alternative to regions, for
  imports
• VS developing proposed rule for initial
  regulatory framework to apply to various diseases
  and industries rather than single disease or
  industry

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Compartmentalization - Proposed Regulatory
Framework

• We are considering proposing seven factors for
  evaluation of compartments
• The factors are harmonized to OIE standards and
  will serve as the regulatory framework to support
  the future development of more specific
  compartments

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Compartmentalization -Proposed Factors

• 1. Definition of the compartment
• Based on the functional relationships of its
  components
• 2. Epidemiologic separation of the compartment
• Physical or spatial factors that affect
  biosecurity
• Infrastructural factors
• Biosecurity
• Traceability system

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Compartmentalization -Proposed Factors

• 3. Documentation of factors critical to the
  definition of compartment
• Disease history
• Date of last outbreak
• Baseline animal health report
• Vaccination
• Documentation of procedures
• 4. Surveillance
• Internal and external surveillance
• Intensity and frequency

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Compartmentalization -Proposed Factors

• 5. Diagnostic capability
• Official, accredited, private laboratories
• Tests used
• 6. Emergency response and notification
• Emergency plans
• Training
• Compensation
• Disease notification
• 7. Supervision and control
• Biosecurity under industry responsibility
• Supervision and certification official
  responsibility

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Summary

• Both Regionalization and Compartmentalization are
  strategies for managing animal health
• They are not a requirements but options
• Application of a sound biosecurity plan is
  critical
• Successful implementation is dependent on the
  establishment of official certification
  procedures that are transparent and verifiable

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Concept of Compartmentalization - Under
Development

• The concepts of compartmentalization
• are still being developed at the international
  and US national level
• The concepts presented here do not represent
  official national or international regulatory
  policies nor trade requirements at this time
• For discussion and idea generating purposes only

24
Thank you

• Any questions?
• Dr. Theresa Boyle
• Senior Animal and Plant Health Officer
• Tel [phone] ext 208
• Fax [phone]
• Theresa.boyle_at_aphis.usda.gov