Business

Clarification of Information Requested
for Recognition of a Region
Introduction
This document describes the basic information that the Animal and Plant Health Inspection
Service (APHIS) requires to initiate a regionalization evaluation in accordance with title 9, Code
of Federal Regulations, section 92.2(b). Veterinary authorities seeking APHIS recognition of
regions could be considered historically free of a disease should follow the guidance in 9 CFR
92.2(c).
APHIS recognizes regions or zones in other countries for the purposes of international trade. A
region is defined as a geographical land area identifiable by geological, political, or surveyed
land boundaries, that contains an animal subpopulation with a distinct animal health status.
Examples include (1) an entire country; (2) part of a country; (3) parts of several countries; and
(4) a group of countries. The borders of a region must be clearly defined and the entire region
must be accessible to both national veterinary authorities and APHIS personnel.
A regionalization evaluation typically consists of initial information gathering, a site visit, and a
risk assessment. Any resulting regulatory action must reflect the risk assessment conclusions.
The pace of an APHIS evaluation largely depends on the quality of the information received.
To facilitate the assessment process, please submit all information in English.

1. Scope of the evaluation
a. Provide a detailed description of the proposed region(s) and maps showing the following:
• Borders of the region(s)
• Internal administrative divisions (regional and local)
• Buffer zones (if any)
• Main cities and towns
• Main roads and railways
• Locations of the following:
− Headquarters of the veterinary services
− Regional and local offices of the veterinary services
− Central and regional official laboratories
− Approved border inspection posts (airports, seaports, land crossings)
b. Identify the animal commodities 1 proposed for export to the United States and estimate the
annual volume of export for each commodity.
c. Specify the disease(s) for which an APHIS evaluation is requested (see Appendix A).

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For the purposes of this document, animal commodities are live animals, animal products, and animal by-products.

2. Veterinary control and oversight
The requesting region should provide sufficient information for APHIS to assess the infrastructure of the
official veterinary services and the ability of the veterinary services to oversee animal health activities,
monitor for disease, and implement disease control measures. The questions below are designed to
provide a comprehensive view of the legal authority for animal health activities in the region; the
organizational structure and function of the veterinary services; and the personnel, financial, and
physical resources available within and to the veterinary services.

a. Legal authority for animal health activities
i. Provide copies (in English) of the legal acts and regulations that afford authority for the
official veterinary services to conduct the following animal health activities:
• On-farm inspections
• Import, export, and internal movement controls
• Quarantine animals or farms
• Vaccination for the disease(s) under evaluation
• Surveillance for the disease(s) under evaluation
• Control and eradication of the disease(s) under evaluation
• Emergency response activities
• Seizure, depopulation, and compensation
ii. Describe how notification of reportable diseases is ensured within the region and provide a
copy (in English) of the pertinent legal act or regulation.
iii. Describe compliance monitoring activities and the penalty system for noncompliance.
b. Organizational structure of the veterinary services
i. Provide an organizational chart of the official veterinary services and describe the chain of
command, including to whom the central, regional, and/or local veterinary units report.
ii. Describe the functions of each unit within the official veterinary services and the division of
responsibilities among central, regional, and local veterinary authorities. What procedures are
in place to ensure coordination and communication among these entities?
iii. Complete the table in Appendix B concerning veterinary services personnel.
iv. Indicate the minimum qualifications required for veterinary and technical staff employed by
the official veterinary services at the central, regional, and local levels. Describe the training
requirements for newly recruited and established staff, as well as any pertinent simulation or
field exercises conducted in the last 3 years.
v. Indicate the number of private veterinarians and veterinary technicians in the region and the
number authorized to conduct official animal health and food safety activities. Describe the
procedures for authorization, the policies in place to safeguard against conflicts of interest,
and any requirements for official supervision.
vi. Identify any governmental or nongovernmental entities other than the official veterinary
services that participate in, monitor, or provide oversight of official animal health and disease
control activities (e.g., accreditation organizations, industry groups). Describe the roles and
responsibilities of these entities.
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c. Infrastructure and financial resources
i. Describe the financial resources of the official veterinary services, including the budget for
the most recent fiscal year and sources of funding (governmental and nongovernmental).
ii. If financial or performance audits of the veterinary services are conducted, identify the
auditing entity and describe the audit frequency and the results of the most recent audit.
iii. Specify sources of funding for emergency response measures in the event of a disease
outbreak, including indemnity and compensation for destroyed animals and/or property.

3. Disease history and vaccination practices
The requesting region should provide sufficient information to enable a thorough understanding of the
history of the disease(s) under evaluation in the region, including prior control measures and revisions to
those measures as appropriate, to facilitate APHIS’ assessment of export risk.

a. History of disease outbreaks in the region
i. Provide maps showing the location of cases and/or outbreaks of the disease(s) under
evaluation, in both wild and domestic species, within the last 5 years. For each outbreak,
provide the following information:
• Species affected
• Number of animals and premises involved
• Mechanism by which the outbreak was detected
• Probable source of infection
• Results of the epidemiological investigation
• Control measures implemented
• Disposition of infected and exposed animals
• Time required for eradication and control
ii. Provide a map showing the range of any known wildlife reservoirs of the disease(s) under
evaluation.
b. Vaccination practices
i. Provide the following information concerning vaccination practices against the disease(s)
under evaluation:
• Source and type of vaccines used
• Schedule or timing of vaccination
• Target populations
• Number of animals vaccinated annually
• Measures in place to regulate vaccine production and use
• Persons authorized to administer vaccine
• Required training for authorized personnel
• Recordkeeping requirements
ii. Describe the mechanisms in place to distinguish between vaccinated and unvaccinated
animals, including animals found to be positive during serological surveillance.

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4. Livestock demographics and traceability
The requesting region should provide sufficient information for APHIS to assess the geographic
distribution of livestock and wildlife that are susceptible to the disease(s) under evaluation, patterns of
livestock movement within the region, and the ability of the region to trace livestock movements in the
event of a disease outbreak.

a. Livestock demographics
i. Indicate the number of livestock and wildlife in the region that are susceptible to the
disease(s) under evaluation and provide maps showing the geographical distribution of these
species, if possible.
ii. Provide demographic data on the relative size and type of holdings in the region that have
susceptible livestock species and provide maps showing the geographical distribution of
these holdings, if possible.
iii. Describe general patterns of livestock movement and marketing within the region and
indicate the location of any major marketing or assembly centers for species susceptible to
the disease(s) under evaluation.
b. Identification and registration
i. Provide copies (in English) of regulations pertaining to animal identification and farm
registration, focusing on species susceptible to the disease(s) under evaluation.
ii. Describe the system used to identify individual animals or groups of animals within the
region and identify the implementing authority. Indicate any recordkeeping requirements,
including what records are kept, by whom, and where.
iii. Describe the system for registering livestock holdings. Indicate any recordkeeping
requirements, including systems for recording and reporting changes in inventory.
iv. Describe any official requirements for movement of susceptible livestock species within the
region (e.g., a health certificate, permit, or other notification form). Indicate any
recordkeeping requirements, including what records are kept, by whom, and where.
v. Describe compliance monitoring and enforcement activities as they pertain to animal
identification, farm registration, and animal movements within the region, as well as the
penalty system for noncompliance.

5. Epidemiological separation from potential sources of infection
The requesting region should provide sufficient information to enable APHIS to evaluate the ability of the
region to prevent incursions of the disease(s) under evaluation. Relevant risk factors include the presence
of the disease(s) in adjacent regions or regions with epidemiological links to the requesting region,
natural and manmade barriers to disease introduction, trading practices, and inspection procedures.

a. Disease status of adjacent regions
i. Describe the status of adjacent regions with regard to the disease(s) under evaluation,
including the location and date of the most recent case or outbreak, if known.

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ii. Describe any cooperative agreements or programs with adjacent regions for surveillance,
prevention, and/or control of the disease(s) under evaluation.
b. Natural and manmade barriers
i. Provide a map showing the main geological features of the region (e.g., rivers, mountain
ranges). Describe any manmade barriers (e.g., fences, netting) that isolate the region from
adjacent regions and indicate how the integrity of these barriers is ensured.
ii. Provide a map showing the location of all official entry points into the region with veterinary
and/or customs inspection. Which entry points receive consignments of animal commodities
that could harbor the disease(s) under evaluation?
iii. Complete the table in Appendix C concerning entry points with veterinary inspection.
c. Import practices and trading partners
i. List the countries or regions from which the region under evaluation imports animal
commodities that could harbor the disease(s) under evaluation. Indicate the amount and type
of such commodities imported from each country or region in the last 3 years.
ii. Describe the procedures by which the region under evaluation ascertains the disease status of
other countries or regions and approves exporting establishments therein.
d. Requirements for entry
i. Describe the documentation required for entry of animal commodities that could harbor the
disease(s) under evaluation into the region and provide examples of pertinent documents.
ii. Describe the quarantine requirements for live animals entering the region, including the
length of quarantine, veterinary inspection, and testing for the disease(s) under evaluation.
Where are the quarantine facilities located and who maintains oversight?
iii. Describe the mechanisms in place to track animal commodities in transit within the region
and to confirm exit or arrival at the point of destination. How are tracking records maintained
and who is responsible for oversight of the tracking system?
iv. Describe any required biosecurity procedures for live-haul trucks (loaded or empty).
e. Inspection practices and procedures
i. Describe in detail the procedures for veterinary inspection and control of imported animal
commodities, including the system for selecting consignments for physical examination and
sampling. Provide copies (in English) of pertinent guidance documents.
ii. Describe any other procedures at border entry points to exclude prohibited animal
commodities (e.g., customs inspections, self-declarations, signs to alert travelers).
iii. Describe the procedures for disposition of commercial consignments that do not pass
veterinary inspection and other prohibited animal commodities seized at entry points.

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6. Surveillance
The requesting region should document the existence of a surveillance system sufficient to ensure early
detection of the disease(s) under evaluation. A combination of active surveillance and passive
surveillance may be necessary to accomplish this goal. Collection and analysis of disease/infection data
should be sufficient to provide confidence in the disease status of the region.

a. Active surveillance
i. Provide the following information regarding active surveillance in domestic livestock and
wildlife, for each disease under evaluation:
• The target population(s)
• Risk factors considered in the surveillance approach
• Targeted prevalence for detection
• Estimated confidence level
• Sampling plan
• Types of samples collected
• Frequency of sampling
ii. Provide the targeted and actual numbers of samples collected, by species. Indicate the results
of screening and confirmatory testing for the past 3 years, including any false positive results.
Describe the procedures for investigating positive results.
iii. Specify the entity or unit responsible for analyzing surveillance data and updating the
surveillance plan(s). How often does this occur?
b. Passive surveillance
i. Describe the type and extent of passive surveillance activities for each disease under
evaluation, including who does the reporting, the type of information reported, and how
reports are verified.
ii. Describe any outreach activities of the official veterinary services designed to increase
awareness, recognition, and reporting of the disease(s) under evaluation among producers,
industry members, official and private veterinarians, and the general public.
iii. Provide the number of suspicious cases of each disease under evaluation that were reported
to the official veterinary services over the past 3 years and describe the follow-up measures
taken in each case.

7. Diagnostic laboratory capabilities
The requesting region should clearly document the animal health laboratory system, diagnostic
procedures, and quality assurance measures to demonstrate effective support of surveillance activities for
the disease(s) under evaluation.

a. Provide an organizational chart of the animal health laboratory system in the region. Indicate
which laboratories conduct screening and/or confirmatory tests for the disease(s) under
evaluation. Describe the certification or accreditation requirements for these laboratories.
b. Indicate the number of scientists and administrative staff employed in each laboratory, and
describe the procedures in place to ensure continued proficiency in diagnostic procedures.

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c. Indicate the diagnostic tests or procedures used to detect the disease agent(s) under
evaluation, including the sensitivity and specificity of each. What tests or procedures are
conducted for agent isolation, identification, and typing?
d. Describe how diagnostic tests are approved or licensed for use within the region.
e. Describe the procedures for sample collection from domestic livestock and wildlife, as well
as the procedures for transport of samples to the laboratory.
f. Describe the biosecurity measures followed while conducting diagnostic tests or procedures
to detect the disease(s) under evaluation. Provide copies (in English) of pertinent guidance
documents.
g. Describe the procedures for reporting test results, including to whom they are reported and
the average time between sample collection and reporting. If confirmatory testing is
conducted outside of the region, estimate the time required to confirm a diagnosis.
h. Describe any projections for laboratory resource needs in the event of an outbreak. How
would the requesting region meet the projected needs?

8. Emergency preparedness and response
The requesting region should provide sufficient information for APHIS to assess the emergency
preparedness measures and response capability and document procedures in place to notify trading
partners and other international entities of a disease outbreak.

a. Provide a copy (in English) of the contingency plan for each disease under evaluation. If not
addressed in the contingency plan, please describe the required actions of the official
veterinary services and other entities in the event of suspicion or confirmation of a disease
outbreak, including the procedures for imposing and releasing quarantines, conducting
epidemiological investigations, monitoring and/or depopulating affected premises, disposing
of carcasses, and providing indemnity.
b. Describe the procedures in place to ensure that the veterinary authorities of the requesting
region inform pertinent international entities of a disease outbreak in a timely manner.

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Appendix A
Select the diseases for which an APHIS evaluation is requested from the table below.
Include all diseases potentially affecting the commodities proposed for export in Question 1b, unless
APHIS already considers the region free or low risk for a disease.
African horse sickness

Foot and mouth disease

African swine fever

Newcastle disease

Avian influenza

Rinderpest

Bovine brucellosis

Scrapie

Bovine tuberculosis

Swine vesicular disease

Classical swine fever

Other (please specify)

Contagious equine metritis

Appendix B
Provide the information in the table below concerning veterinary services personnel in the region.
Veterinarians*
Filled posts Vacant posts

Veterinary technicians
Filled posts Vacant posts

Administrative staff
Filled posts Vacant posts

Central service
Regional service
Local service
Border controls
Laboratory service
*

Veterinarian is defined as having graduated from veterinary school.

Appendix C
Provide the information in the table below concerning official entry points into the region.
Entry point name
Days open each week
Hours of operation
Total
Veterinarians
Staff
Veterinary technicians
Administrative
No. consignments received*
No. refused entry†
*
Total number of consignments requiring veterinary inspection received at the entry point in the past 12 months.
†
Number of consignments received that were seized, returned, or otherwise denied entry into the region.

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