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 commodities1

c. Specify the disease(s) for which an APHIS evaluation is requested (see Appendix A). 

proposed for export to the United States and estimate the 

annual volume of export for each commodity. 

 1 For the purposes of this document, animal commodities are live animals, animal products, and animal by-products.
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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* Veterinary technicians Administrative staff

Filled posts Vacant posts Filled posts Vacant posts 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

Staff

Total

Veterinarians

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.