## Clarification of Information Requested

for Rec ognition of a Historically

- free Region

Introduction

The Animal and Plant Health Inspection Service (APHIS) recognizes regions or zones in other countries for the purposes of international trade. APHIS defines a region as a geographical land area identifiable by geological, political, or surveye d 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 clea rly defined and the entire region must be accessible to both national veterinary authorities and APHIS personnel.

APHIS conducts regionalization evaluations to determine the disease status of foreign regions

and the risk of disease transmission via commod ities for export to the United States. 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.

This document describes the basic information that APHIS requires to initiate an evaluation of a historically

- free region in accordance with title 9, Code of Federal Regulations, sect ion ... (9 CFR ...)

. Q ualifying regions are those in which the disease under evaluation has not occurred for at least 25 years, if ever. Veterinary authorities seeking APHIS recognition of regions not meeting this requirement should follow the guidance in 9 CF R 92.2.

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 administrat ive 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 l aboratories

− 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). 2

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

- products.

2 This questionnaire can only be used if the disease(s) under evaluation have not occurred in livestock in the region for at least 25 years and there has been no evidence of infection in wildlife for at least 10 years.2



### 2

. Veterinary control and oversight

The requesting region should p rovide evidence that the veterinary services in the region have had and continue to have sufficient legal authority, organization, and infrastructure to effectively investigate, diagnose, and report animal disease s , if detected

.

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 of animals or farms
Vaccination for the disease(s) under evaluation
Surveillance for the disease(s) under evaluation

C ontrol and eradication of the disease(s) under evaluation Emergency response activities Seizure, depopulation, and compensation

ii. Provide copies (in English) of any secondary legislation, enabling regulations, manuals, contingency plans, or guidance documen ts pertaining to the disease(s) under evaluation.

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/o r 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 coordinati on and communication among these entities?

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 nongov ernmental)

.
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.



### 3. Disease history and vaccination practices

a. Indicate when e ach disease under evaluation last occurred, or evidence of infection was last

detected , in domestic livestock and wildlife in the region.

b. Indicate whether vaccination against the disease(s) under evaluation has occurred in the last 10 years and, if so, pr ovide the following information:

Reasons for vaccination Source and type of vaccines used Target populations Recordkeeping requirements Procedures to distinguish vaccinated animals3



### 4. Disease reporting

The requesting region should provide evidence that eac h disease under evaluation ha s been l egally notifiable in the region

, for at least the past 10 years.

a. Describe how notification of the disease(s) under evaluation is en sured within the region, including the methods by which obligated persons are made aware of the reporting requirements and penalties for failure to notify

. Provide a copy (in English) of the pertinent legal acts or regulations.

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.



### 5. Disease detection

The requesting region should provide evidence that an effective early detection system has been in place for each disease under evaluation

, for at least the past 10 year s. An effective early detection system includes, among other things, representative coverage of susceptible animal populations by field services, a training program for detecting and reporting unusual animal health incidents, the ability to undertake effec tive disease investigation and reporting, and access to laboratories capable of diagnosing and differentiating relevant diseases.

a. C overage by field services

i. Complete the table in Appendix B concerning veterinary personnel in the region.

ii. Indicate the nu mber 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 o f interest, and any requirements for official supervision.

iii. Describe any legal or procedural requirements for routine inspection of livestock premises

for animal health , identification, or welfare purposes. W ho conducts the inspections and how

often do su ch inspections occur ?

b. T raining program s

i. 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.

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.

c. Disease investigation and reporting

i. Describe the type and extent of surveillance activities for the disease (s) under evaluation

, in

domestic livestock and wildlife . Include both active and passive surveillance , if applicable

.
ii. 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 desc ribe the follow

- up measures taken in each case.4

iii. Provide copies (in English) of any guidance documents for investigation of suspect cases of the disease(s) under evaluation and plans for emergency response.

d. Diagnostic laboratory capabilities

i. Provide a n 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 lab oratories.

ii. 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.

iii. Indicate the diagnostic tests or procedures used to detect the disease(s) under evaluation. What procedures are conducted for agent isolation, identification, and typing?

iv. Describe the procedures for reporting test results, including to whom they are reported and the average time between sample collection and reporti ng. If confirmatory testing is conducted outside of the region, estimate the time required to confirm a diagnosis.



### 6. Barriers to disease introduction

The requesting region should provide evidence that measures have been in place to prevent introduction of each disease under evaluation , for at least the past 10 years

.
i. Provide a map showing the main geological features of the region. Describe any manmade barriers (e.g., fences, netting) that isolate the region from adjacent regions and indicate how the integ rity 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. Describe the procedures for veterinary inspection and control of

animal commodities that could har bor the disease(s) under evaluation.

iii. Describe any other procedures at border entry points to exclude prohibited animal commodities (e.g., customs inspections, self

- declarations, signs to alert travelers).

iv. List the countries or regions from which the regio n 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.5



### 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 d isease

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 infor

mation 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 s ervice

Local service

Border controls

Laboratory service

* Veterinarian is defined as having graduated from veterinary school.