## Clarification of Information Requested for Recognition of a 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 a regionalizatio n evaluation in accordance with t itle 9 CFR 92.2

. To facilitate the assessment process, please submit all information in English

.



### 1

. Scope of the evaluation

a. P rovide 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 (a irports, 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 )

.

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

- products.2



### 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 activitie s, monitor for disease, and implement disease control measures. Th e 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 cop ies (in Eng lish) of the leg al acts and regulations that afford authority for the

of ficial veterinary services to conduct the following animal health activities :
O n

- farm inspections

I mport , export, and internal movement controls
Quarantine animals or farms
Vaccination for the disease(s) under evaluation
Surveillance for the disease(s) und er evaluation

C ontrol and eradication of the disease(s) under evaluation

E mergency response activities

S eizure, 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 c ompliance 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 des cribe 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. Co mplete 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 t raining 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 anim al health and disease

control activities (e.g ., accreditation organizations

, industry groups )

. Describe the roles and responsibilities of these entities.3

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 freq uency and the results of the most recent audit.

iii. Specify source s 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 vaccinatio n 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 ou tbreak, 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 Disposit ion of infected and exposed animals Time required for eradication and control

ii. Provide a map showing the range of any known wildlife reservoir s of the disease (s) under

evaluation

.

b. Vaccination practices

i. Provide the following information concerning vaccinati on practices against the disease(s)

under evaluation : Source and type of vaccines used

S chedule or timing of vaccination Target populations

Number of animals vaccinated ann ually Measures in place to regu late vaccine production and use

Persons au thorized t o administer vaccine Required training for authorized personnel

Record keeping requirements

ii. Describe the mechanisms in place to distinguish between vaccinated and un vaccinated animals, including animals found to be positive during serological surveillance.4



### 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 s usceptible to the disease(s) under e valuation 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 p rovide maps showing the geographi c al distribution of

the se 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 register ing livestock holdings. Indicate any rec ordkeeping 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

T he requesting region should provide sufficient information to enable APHIS to evaluate the ability of the region to prevent incursions of th e 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 ins pection 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

.5

ii. Describe any cooperative agr eements 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

a nd/or customs inspection

. W hich entry points receive consignments of animal commodities

that could harbor the disease(s) under evaluation ?

iii. Complete the table in Appendix C concerning entry point s with veterinary inspection

.

c. Import practices and tradin g partners

i. L ist 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 document ation required for entry of an imal 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 , incl uding the length of quarantine , veterinary inspe ction, 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 with in the region

and to confirm exit or arrival at th e 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 ot her 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 inspect ion and other prohibited animal commodities seized at entry points.6



### 6

. Surveillance

The requesting region should d ocument the existence of a surveillance system sufficient to ensure early detection of the disease(s) under evaluation . A combination of ac tive surveillance and passive surveillance may be necessary to accomplish this goal. C ollection 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 followin g information regarding active surveillance in domestic livestock and wildlife, for each disease under evaluation :
T he target population (s)

R isk factors considered in the surveillance approach

T argeted prevalence for detection

Es timated confidence level

S ampling plan

T ypes of samples collected

F requency 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.

D escribe the procedures for investigating positive results

.
iii. Specify the entity or unit responsible for analyzing surveillance data and updating the surveillance plan(s) . H ow 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

awarenes s
, 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 t he 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, an d 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 screenin g 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 proce dures in place to ensure continued proficiency in diagnostic procedures.7

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

condu cted 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 trans port 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 fo r 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 projecti ons 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 pert inent international entities of a disease outbreak in a timely manner.8



### 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 Ques tion 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 ves icular disease

Classical swine fever Other (please specify)

Contagious equine metritis



### Appendix B

Provide the information in the table below concerni ng veterinary services personnel in the region

.

Veterinarians * Veterinary technicians Administrativ e 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 techn icians

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.