1

APHIS Evaluation Procedures

for Bovine Tuberculosis (TB) Classification of Foreign Regions

April 2020
Evaluation Procedures for Bovine TB Classification

Introduction

This document describes the process by which APHIS evaluates and classifies foreign regions for tuberculosis 

(Mycobacterium bovis) in bovine animals. The essential considerations for such evaluations are outlined in title 

9, Code of Federal Regulations, part 93.438 (CFR 93.438), as follows: 

1. Region boundaries and composition

2. Veterinary control and oversight (including notification)

3. Prevalence of bovine TB

4. Surveillance

5. Diagnostic testing for bovine TB

6. Epidemiological investigations

7. Affected herd management

8. Control of livestock movement

A region seeking APHIS classification and recognition of TB status must demonstrate that it has in place a TB 

program that meets or exceeds the minimum standards in 9 CFR 93.438. This process starts with the region 

submitting the APHIS Bovine Tuberculosis (TB) Evaluation Questionnaire, which details the information and data 

required for APHIS to evaluate each factor. Initial information gathering is typically followed by one or more 

onsite visits to verify and complement the information provided. APHIS teams conduct the onsite visits using the 

APHIS Onsite Bovine Tuberculosis Review Template, which prompts team members to record and analyze critical 

data and information in a standardized format. 

APHIS teams assess both program elements and program implementation. Program elements are the essential 

building blocks that support program operations, without which the program may be fundamentally flawed (e.g., 

legal authority, comprehensive program standards,1 financial and personnel resources, monitoring and 

oversight systems, etc.). APHIS therefore assesses the existence or absence of a program element as a binary 

variable: yes or no. APHIS evaluates the quality of a TB program by examining on certain critical actions necessary 

for program implementation within each factor, using a 5-point scale: 

1 = Very Poor or Almost Never

2 = Poor or Rarely

3 = Fair or Sometimes

4 = Good or Usually

5 = Very Good or Almost Always

APHIS teams record the findings using the Review Template and associated checklists as described below. The 

findings are summarized for each factor in tabular form. A given TB program will optimally have all program 

elements in place and score above 3 on program execution; however, apparent program deficiencies in one are 

may be balanced by other findings. The TB status of a region that meets or exceeds the minimum program 

standards is determined by the herd prevalence, as described in 9 CFR 93.437. Status levels range from Level I 

with a prevalence less than 0.001 percent to Level IV with a prevalence less than 0.5 percent. APHIS classifies 

1 Program standards = regulations, manuals, guidelines, instructions, standard operating procedures, etc.
Evaluation Procedures for Bovine TB Classification

regions that it has not evaluated, as well as those in which prevalence is equal to or greater than 0.5 percent or 

the TB program does not meet the minimum standards in 9 CFR 93.438, as Level V. 

The following sections describes the evaluation process in more detail, focusing on each factor in turn. Key 

program elements and the procedures by which APHIS assesses both program elements and execution are 

briefly described in each section, along with the corresponding summary table from the Review Template.

Note: in rare instances, APHIS may have initiated a TB status evaluation some years before the provisions of 9 

CFR 92.438 came into effect and the corresponding evaluation procedures were fully developed. In these cases, 

APHIS will assess the region against the criteria in 9 CFR 92.438 but the format of the evaluation may differ.
Evaluation Procedures for Bovine TB Classification

Table of contents

Introduction ............................................................................................................................................................ 2

Evaluation factors.................................................................................................................................................... 5

1. Region boundaries and composition .............................................................................................................. 5

2. Veterinary control and oversight.................................................................................................................... 5

3. Prevalence of bovine TB.................................................................................................................................. 6

3.1 Animal and herd demographics.............................................................................................................. 6

3.2 Herd prevalence ...................................................................................................................................... 7

3.3 Other sources of infection....................................................................................................................... 8

4. Surveillance ..................................................................................................................................................... 8

5. Diagnostic testing for bovine TB ..................................................................................................................... 9

6. Epidemiological investigations...................................................................................................................... 10

7. Affected herd management.......................................................................................................................... 11

8. Control of livestock movement..................................................................................................................... 12

8.1 Animal identification and traceability................................................................................................... 12

8.2 Entry into the region ............................................................................................................................. 13

8.3 Export to the United States................................................................................................................... 14

8.4 Approved feedlots................................................................................................................................. 15

8.5 Accreditation of TB-free herds.............................................................................................................. 16

Appendices............................................................................................................................................................ 17
Evaluation Procedures for Bovine TB Classification

Evaluation factors

1. Region boundaries and composition

The APHIS team initially examines the geographic extent of the region seeking classification and confirms that 

the borders are clearly defined along administrative boundaries and/or distinct geographic barriers. The team 

determines the composition of the region by confirming the administrative units (states, provinces, prefectures, 

counties, municipalities, etc.) included. If the regional authorities have created a higher-risk zone2 by “zoning 

out” certain higher-prevalence administrative units, the borders and composition of this higher-risk zone must 

be clearly defined as well. If a border of the higher-risk zone bisects an administrative unit, the subunits included 

within the region seeking classification must be identified and the border mapped using global positioning 

system (GPS) data points. The border should not bisect individual premises. Ideally, the TB program has 

developed and is actively implementing a plan to reduce the TB prevalence in any defined higher-risk zone(s).

The APHIS team identifies the regions adjacent to the region seeking classification and gathers estimates of the 

TB prevalence of each. The team further assesses the mitigations in place to prevent and/or detect introduction 

of bovine TB from adjacent higher-risk regions and established higher-risk zones, if present. A buffer zone should 

be in place along parts of the region border that are not adequately protected by geographic barriers, with 

annual testing of the herds within the buffer zone to detect TB introduction.

The summary evaluation criteria for region boundaries and composition are listed in Table 1.

Table 1: Evaluation criteria—region boundaries and composition

Program elements

The geographic extent and boundaries of the region are clearly defined. 

Buffer zones or other measures to prevent TB introduction are clearly established.

Regular (annual) surveillance of herds adjacent to higher-risk zones and regions is required.

A comprehensive plan is in place to reduce TB prevalence in higher-risk zones.

Program execution

Regular (annual) surveillance of herds adjacent to higher-risk zones and regions is conducted. 

The TB program is actively working to reduce TB prevalence in higher-risk zones.

2. Veterinary control and oversight 

The APHIS team assesses the organizational structure and resources of the bovine TB program at the central, 

regional, and local levels, as well as the personnel and financial resources available for program activities. The 

team interacts with regulatory and supervisory officials at all levels to assess overall qualifications and training, 

as well as the accountabilities and coordination mechanisms in place for TB program activities, and determine 

whether the available personnel and financial resources appear to meet the program needs. Specific education 

and training is assessed in other sections.

2 Higher risk zone: Zone created by national or subnational authorities which is within or adjacent to the region under evaluation and 

consists of higher prevalence administrative units under the same national and/or subnational authority.
Evaluation Procedures for Bovine TB Classification

At a minimum, a region seeking APHIS classification for bovine TB must demonstrate that the disease is 

compulsorily notifiable. In addition, regulatory officials must have the legal authority to inspect live animals and 

records; apply diagnostic tests for TB; inspect live animals and carcasses at slaughter; control animal movement 

into, within, and out of the region; establish quarantines and restrict animal movement; control the disposition 

of infected animals and affected herds; authorize and oversee private veterinarians to conduct regulatory 

activities for the TB program; require identification of bovine animals and premises with bovine animals; and 

enforce TB program requirements and penalize noncompliance. The APHIS team examines all pertinent 

regulatory acts and assesses the application of these acts to carry out TB program activities, with particularly 

attention to demonstrated ability or failure to require and enforce compliance with the elements described 

above. The summary evaluation criteria for veterinary control and oversight are listed in Table 2.

Table 2: Evaluation criteria—veterinary control and oversight

Program elements

Personnel resources available to the TB program are sufficient to support program activities.

Financial resources available to the TB program are sufficient to support program activities.

Roles and responsibilities within the TB program are clearly defined.

Chains of reporting and communication within the TB program are well established.

Bovine TB is a compulsorily notifiable disease throughout the region.

Program officials have sufficient legal authority to carry out an effective bovine TB program.

Violations and associated sanctions are well defined in the legal and regulatory framework.

An effective system is in place to track legal cases from the initial report to closure.

3. Prevalence of bovine TB

3.1 Animal and herd demographics

To calculate the herd prevalence of bovine TB, the APHIS team first gathers data on the number and type of 

bovine herds in the region. A region seeking classification must have established and maintained an accurate 

herd census, since this is a critical data point for prevalence calculations. The team notes the date of the last 

herd census, how it is updated, and progress towards conducting a new herd census (if applicable). The APHIS 

team also gathers data on production parameters for the various types of cattle operations in the region.

The summary evaluation criteria for animal and herd demographics are listed in Table 3.

Table 3: Evaluation criteria—animal and herd demographics

Program elements

The region has conducted a census of bovine animals and herds.

Systems are in place to update and inform the census over time.

Program execution

Rate the quality of the census data for the purpose of calculating herd prevalence.
Evaluation Procedures for Bovine TB Classification

3.2 Herd prevalence

The APHIS team then assesses the criteria used to classify the TB status of individual animals and herds and 

determines the number TB-affected herds during the evaluation period.

3 The criteria must be clearly defined 

and equivalent to APHIS domestic standards. For example, a herd is designated infected when there is laboratory 

confirmation of M. bovis or substantial evidence of M. bovis infection, including bacterial identification of M. 

bovis, a polymerase chain reaction test positive for M. tuberculosis complex, and/or histopathology-compatible 

lesions in a known TB-exposed bovine. The team examines data on laboratory sample submissions and results,

quarantine herd lists, and case files to determine whether TB program personnel follow the classification criteria.

APHIS defines prevalence as the number of affected herds occurring during the evaluation period (9 CFR 93.400). 

In some instances, the APHIS Administrator may allow calculation of prevalence based on affected herd-years 

to avoid penalizing regions with small herd numbers, as described in VS Memorandum 552.38 Discretionary 

Bovine Tuberculosis Herd Prevalence Calculations in States or Zones with Small Numbers of Herds. Any region 

seeking APHIS classification must first meet the minimum program standards; classification level is then 

determined according to herd prevalence (see Table 4).

Table 4: Prevalence criteria for TB status classification (from 9 CFR 93.437)

Status level Prevalence criteria

Level I

Program that meets APHIS requirements for classification and 

prevalence of less than 0.001 percent over at least the previous 

2 years (24 consecutive months).

Level II

Program that meets APHIS requirements for classification and 

prevalence equal to or greater than 0.001 percent but less than 

0.01 percent, over the previous 2 years (24 consecutive months).

Level III

Program that meets APHIS requirements for classification and 

prevalence equal to or greater than 0.01 percent but less than 

0.1 percent, over the previous year (12 consecutive months).

Level IV

Program that meets APHIS requirements for classification and 

prevalence equal to or greater than 0.1 percent but less than 0.5 

percent, over the previous year (12 consecutive months).

Level V

Program that does not meet APHIS requirements for 

classification, prevalence equal to or greater than 0.5 percent, 

or unassessed by APHIS with regard to tuberculosis.

3 Evaluation period = 24 months for Level I, specifically the first 24 months of the previous 26-month period; 12 months for Levels II-IV, 

specifically the first 12 months of the previous 14-month period.
Evaluation Procedures for Bovine TB Classification

3.3 Other sources of infection

Finally, the APHIS team gathers and verifies information on other livestock or wildlife sources of Mycobacterium

bovis within the region and reviews surveillance and control measures with responsible regulatory officials, if 

applicable. The summary evaluation criteria are listed in Table 5.

Table 5: Evaluation criteria—other sources of infection

Program elements

Surveillance for bovine TB is conducted in susceptible wildlife and non-bovine domestic species.

No wildlife reservoirs of bovine TB have been identified within the region.

The official bovine TB program includes susceptible non-bovine domestic species if necessary.

Program execution

Applied mitigations effectively prevent TB transmission to domestic bovines from other species.

4. Surveillance

The APHIS team examines the official surveillance plan and program standards for slaughter inspection and live 

animal testing to identify any deficiencies that could negatively impact detection of bovine TB infection in the 

region. The team evaluates inspection rates and granuloma sample submission data for all slaughter plants in 

the region and visits several plants to assess the facilities and equipment, the knowledge and competency of the 

inspectors and supervisors, the systems for correlation of animal identification with carcass parts, and 

documentation of slaughter samples submitted for laboratory diagnostics. The team assesses compliance with 

the program standards for slaughter inspection and granuloma submissions using the checklist in Appendix A. 

The team also reviews individual caudal fold tuberculin (CFT) test data and response rates to assess performance. 

At a minimum, a region seeking APHIS classification for bovine TB must demonstrate that (1) comprehensive 

program standards are in place to guide inspection of bovine animals at slaughter, sampling of granulomatous 

lesions, submission of samples for laboratory diagnostics, and live animal testing; (2) slaughter inspection and 

tuberculin testing is conducted by qualified and trained personnel; (3) appropriate minimum standards to 

validate slaughter and live animal surveillance are established and met; and (4) effective systems are in place for 

monitoring performance and addressing deficiencies. 

As a general benchmark, a region should be able to demonstrate that combined slaughter and live animal 

surveillance is sufficient to detect a prevalence of 0.05 percent or lower among the resident bovine population 

with 95 percent confidence. In most cases, at least 95 percent of bovine animals slaughtered should be inspected 

for lesions indicative of TB. To validate that carcasses are carefully inspected, each slaughter plant should submit 

suspicious granulomatous lesion(s) from at least one animal in every 2,000 adult bovine animals slaughtered at 

the facility. Routine slaughter surveillance may not be necessary if a region can substantiate a claim of biological 

freedom from bovine TB, although targeted or risk-based surveillance should still be conducted as needed to 

demonstrate continued freedom. APHIS would evaluate these regions on a case-by-case basis. Summary 

evaluation criteria for surveillance are listed in Table 6.
Evaluation Procedures for Bovine TB Classification

Table 6: Evaluation criteria—surveillance 

Program elements

Program standards: (1) Address the critical actions necessary for TB inspection at slaughter.

 (2) Address the critical actions necessary for granuloma sampling and submission.

 (3) Address the critical actions necessary for live animal testing for bovine TB.

Appropriate minimum standards are in place to validate slaughter surveillance for bovine TB.

Appropriate monitoring and performance standards are in place for CFT testing. 

Program execution

Slaughter inspection for bovine TB occurs in accordance with program standards.

Granuloma sampling and submission occurs in accordance with program standards.

Slaughter inspection processes/techniques are standardized between plants and inspectors.

Slaughter processes promote accurate correlation of animal ID/documents with carcass parts. 

Slaughter inspection and lab submissions meets the minimum standards to validate surveillance.

Individuals conducting inspection and sampling receive adequate instruction and training.

Deficiencies in slaughter inspection and sampling are rapidly detected and corrected.

Individuals conducting tuberculin testing receive adequate instruction and training.

Deficiencies in tuberculin testing are rapidly detected and corrected.

5. Diagnostic testing for bovine TB

The APHIS team typically visits the primary diagnostic laboratory for bovine TB in the region under evaluation 

and assesses the diagnostic techniques and quality assurance measures against APHIS National Veterinary 

Services Laboratory and international standards, using the checklist in Appendix B. The team also examines the 

electronic laboratory sample submission database to calculate performance metrics the degree of correlation 

between histopathology and bacteriology results. 

At a minimum, a region seeking APHIS classification for bovine TB must demonstrate that (1) diagnostic 

laboratories supporting the TB program are equipped to conduct histopathology and culture; (2) at least one 

laboratory is proficient in other diagnostic techniques for bovine TB such as polymerase chain reaction (PCR) and 

genotyping; (3) laboratories are accredited according to international standards; (4) an effective quality control 

system is in place; and (5) interpretation or classification of results is in accordance with international standards. 

All laboratories should regularly engage in competency or proficiency testing for TB diagnostics. 

As general benchmarks, the region should be able to demonstrate that samples are delivered to the laboratory 

within 10 days of slaughter, the TB program receives histopathology results within 15 days after that, culture 

results within 90 days, and typing within 120 days. Laboratory personnel should routinely rate the quality of the 

samples received and provide feedback for the slaughter plant inspectors. There should be a high degree of 

correlation between histopathology and culture results, as well as histopathology and PCR results. The summary 

evaluation criteria for laboratory diagnostic testing are listed in Table 7.
Evaluation Procedures for Bovine TB Classification

Table 7: Evaluation criteria—diagnostic testing

Program elements

The laboratories supporting the TB program are accredited to international standards. 

The laboratories supporting the TB program are equipped to conduct the required tests. 

The SOPs for conducting official diagnostic tests for TB reflect international standards.

Interpretation/classification of test results is in accordance with international standards. 

Accredited laboratories regularly engage in competency/proficiency testing for TB diagnostics.

Program execution

The laboratories report diagnostic results to the TB program in a timely manner.

Rate the degree of correlation between histopathology and bacteriology results. ¥

Rate the degree of correlation between histopathology and PCR results. ¥

Laboratory personnel conducting diagnostic tests are adequately qualified and trained to do so.

Quality control measures rapidly detect and correct deficiencies in diagnostic protocols or techniques.

¥ Greater than 90% = very good; 75-90% = good; 60-75% = fair; 50-60% = poor; less than 50% = very poor.

6. Epidemiological investigations

The APHIS team reviews the program standards for conducting and documenting epidemiological investigations 

(slaughter traceback, live animal testing, trace-in, trace-out, and contact herds) and assesses them against the 

checklist in Appendix C, noting any deficiencies that could negatively impact the quality of the investigations. 

The team also reviews multiple case files to assess implementation of the program standards, evaluate the 

knowledge and training of the responsible regulatory officials, and determine whether deficiencies in the 

investigative process are rapidly detected and corrected. The team further correlates the case files with 

laboratory submission data and quarantine herd lists to ascertain whether the TB program conducts follow-up 

testing and/or initiates an epidemiological investigation as appropriate. 

At a minimum, a region seeking APHIS classification for bovine TB must demonstrate that (1) the program 

standards address the critical actions for effective and thorough epidemiological investigations; (2) designated 

officials conduct epidemiological investigations in accordance with the program standards; (3) every slaughter 

case is subject to investigation; (4) investigators quickly and accurately determine the status of non-negative 

animals and herds; and (5) movement from herds under investigation is promptly and effectively regulated while 

the TB status is determined. As a general benchmark, the successful traceback rate—i.e. the percentage of 

slaughter cases traced to the most probable herd of origin (MPHO) and the MPHO tested—should be at least 75 

percent. If the MPHO tests negative, the case file should contain evidence of further traceback investigations 

based on the slaughter order. Investigations must be well-documented with orderly and complete case files.

The summary evaluation criteria for epidemiological investigations are listed in Table 8.
Evaluation Procedures for Bovine TB Classification

Table 8: Evaluation criteria—epidemiological investigations

Program elements

Program standards address the critical actions for effective slaughter traceback investigations.

The successful traceback rate meets or exceeds the minimum standard.

Program standards address the critical actions for effective live animal testing investigations.

Program standards address the critical actions for effective investigation of related/implicated herds.

Program standards promote logical, standardized, and well documented case files.

Program execution

Slaughter traceback investigations are conducted in accordance with the program standards.

Slaughter traceback investigations result in detection of a TB-affected herd.

Live animal testing investigations are conducted in accordance with the program standards.

Investigations of related/implicated herds are conducted in accordance with the program standards.

Investigators quickly and accurately determine the status of non-negative animals and herds. 

Movement from herds under investigation is effectively regulated while the TB status is determined.

Investigations are well documented with orderly and complete case files.

Program officials conducting epidemiological investigations receive adequate instruction and training.

Deficiencies in the investigative process are rapidly detected and corrected. 

7. Affected herd management

The APHIS team reviews and assesses the program standards for managing TB-affected herds by depopulation 

or test-and-remove against the checklist in Appendix D, and notes any deficiencies that could negatively impact 

the quality of management efforts. The team works through multiple case files to assess implementation of the 

program standards, evaluate the knowledge and training of the responsible regulatory officials, and determine 

whether deficiencies in management processes are rapidly detected and corrected. 

At a minimum, a region seeking APHIS classification for bovine TB must demonstrate that (1) the program 

standards address the critical actions for effective management of TB-affected herds; (2) designated officials 

manage affected herds in accordance with the program standards; (3) movement from affected herds is 

effectively regulated with periodic inventory reconciliation; and (4) management actions are fully documented. 

The summary evaluation criteria for affected herd management are listed in Table 9. 

Table 9: Evaluation criteria—affected herd management

Program elements

Program standards address the critical actions necessary to manage herds via depopulation. 

Program standards address the critical actions necessary to manage herds via test-and-removal.

Program standards promote logical, standardized, and well documented affected herd case files.

Program standards allow for vaccination against bovine TB.
Evaluation Procedures for Bovine TB Classification

Program execution

Program officials and affected herd owners are implementing official herd management plans. 

Management via depopulation is conducted in accordance with the program standards.

Program officials account for all animals in the herd at the time of depopulation.

Management via test-and-removal is conducted in accordance with program standards.

Program officials regularly monitor the inventory of herds undergoing test and removal. 

Movement from TB-affected herds is effectively regulated while under quarantine.

Herd management actions are well documented with orderly and complete case files.

Program officials conducting affected herd management receive adequate instruction and training.

Deficiencies in herd management processes are rapidly detected and corrected. 

TB vaccinates are clearly and permanently identified.

8. Control of livestock movement

8.1 Animal identification and traceability

The APHIS team assesses the legal and regulatory framework supporting animal and premises identification and 

movement control within the region, including compliance enforcement. The team evaluates implementation 

by examining cattle for official identification and reviewing movement control documents, reviewing and 

assessing procedures at issuing centers for official identification and movement control documents, and 

challenging the identification and traceability systems using data gathered from case files and the sites visited

(see Table E-1 in Appendix E). The team also evaluates enforcement by assessing the systems in place to detect 

and report noncompliance and reviewing data on the violations reported and the sanctions applied. 

At a minimum, a region seeking APHIS classification for bovine TB must demonstrate that (1) official 

identification of bovine animals and herds is mandatory; (2) documentation of bovine animal movements

promotes traceability; and (3) effective compliance monitoring and enforcement systems are in place. Ideally, 

bovine animals should be individually and uniquely identified prior to leaving the premises of origin. Official 

animal identification should be accurately linked to a specific owner and premises. Bovine animals should be 

moved with appropriate documentation of origin, destination, date, and identification, and changes in 

ownership and location should be captured in a central database. Violations and associated sanctions should be 

adequately defined in the legal framework with effective systems in place to monitor and enforce compliance.

The summary evaluation criteria for animal identification and traceability are listed in Table 10.

Table 10: Evaluation criteria—animal identification and traceability

Program elements

Official identification of bovine animals is required for movement from the premises of origin. 

Official identification of herds / premises and bovine concentration points is required.

Control and distribution of official identification is strictly regulated.

Documentation is required for all movements of bovine animals between premises.

Violations and associated sanctions are clearly defined in the legal or regulatory framework.
Evaluation Procedures for Bovine TB Classification

Program execution

Bovine animals are officially identified prior to movement. 

Herds / premises and bovine concentration points are officially identified.

Movement of bovine animals between premises is fully documented.

Data and documents necessary for tracing bovine animals are readily available to investigators.

Noncompliance is reported, prosecuted, and legal sanctions applied. 

8.2 Entry into the region

The APHIS team reviews the requirements for bovine animals to enter into the region and assesses them for 

equivalence to APHIS import requirements detailed in 9 CFR 93.439, making note of any deficiencies that could 

negatively impact control of movement into the region or allow legal importation of TB-infected animals. The 

team also evaluates any program standards established to guide inspection at the points of entry and assesses 

the placement of movement control checkpoints in relation to the major access routes into the region. Finally, 

the team evaluates implementation of entry controls by visiting checkpoints and/or ports, interviewing the 

inspectors, examining documents, and observing inspection procedures (see Table E-2 in Appendix E).

At a minimum, a region seeking APHIS classification of bovine TB status must demonstrate that (1) requirements 

for bovine entry into the region provide risk mitigation equivalent to APHIS requirements ; (2) checkpoints are 

strategically located; (3) any bovine animals that arrive at a checkpoint without proper identification, testing, 

and documentation are denied entry; (4) checkpoints records are sufficient to promote traceability; and (5) 

measures are in place to confirm that higher-risk animals arrive at the stated destination. Checkpoint facilities 

should be in good physical condition, an authorized inspector present whenever the checkpoint is open, and 

entry effectively prevented if the checkpoint is closed. The summary evaluation criteria for entry into the region 

are listed in Table 11.

Table 11: Evaluation criteria—entry into the region

Program elements

Program standards clearly describe the entry requirements and inspection procedures.

Requirements for bovine entry into the region are risk based and equivalent to U.S. standards.

Checkpoints are strategically located at the most likely points of entry from higher-risk regions.

Checkpoint are in good condition with appropriate signage, lighting, corrals, etc.

Program execution

All shipments of bovine animals passing through the checkpoint are subject to inspection.

Shipments not fully compliant with the entry requirements are denied entry into the region.

Shipments of higher-risk animals move to destination or transit the region under seal.

Official personnel confirm the arrival of higher-risk animals at destination or point of exit.

Inspectors record the details of all shipments of bovine animals into or through the region.

Movement control measures are effective in preventing illegal entry into the region. 

Regulatory officials enforcing movement requirements receive adequate instruction and training.

Deficiencies in the movement control system are rapidly detected and corrected.
Evaluation Procedures for Bovine TB Classification

8.3 Export to the United States

8.3.1 Export certification

The APHIS team reviews the program standards for export certification, making note of any deficiencies that 

could negatively impact compliance. The team works through multiple export certificates with the regulatory 

officials responsible for validating the conditions specified on the certificate, to assess their processes, 

knowledge, and competency (see Table E-3 in Appendix E). The team also takes into account any previously 

disclosed issues with cattle from the region presented for export to the United States. 

At a minimum, a region seeking APHIS classification of bovine TB status must demonstrate that (1) export 

certificates are prepared by well-trained and authorized regulatory officials in accordance with comprehensive 

program standards; (2) the regulatory officials verify the accuracy of the information provided by exporters prior 

to certifying; and (3) a robust review process is in place to rapidly detect and correct any deficiencies in the 

verification or certification processes.

Summary evaluations criteria for export certification are listed in Table 12.

Table 12: Evaluation criteria—export certification

Program elements

Program standards clearly describe the processes for export certification and review of certificates. 

Regulatory officials certifying cattle exports and reviewing certificates are qualified and trained.

Program execution

Export certification is conducted in accordance with the program standards.

Shipments are only certified for export if they meet all requirements of the importing country.

8.3.2 Export gathering centers

Regions seeking classification for bovine TB may have regulated facilities to gather and sort cattle for export to 

the United States. At a minimum, each such export gathering centers must demonstrate that (1) it is a designated 

facility which only accepts cattle for export; (2) all animals entering the facility are uniquely identified and 

accompanied by appropriate documentation; (3) TB testing at the facility is conducted in accordance with APHIS 

requirements; and (4) biosecurity measures are in place to prevent disease transmission from neighboring herds. 

Export gathering centers must be approved by the authorized regulatory entity and subject to routine and 

effective regulatory oversight sufficient to detect and correct noncompliance. If applicable, the export gathering 

center must maintain a tick immersion bath and conduct tick treatment as required for export to the United 

States. The APHIS team typically visits several export gathering centers to assess the procedures and practices 

using the checklist in Table E-4 in Appendix E or similar. 

Summary evaluation criteria for export gathering centers are listed in Table 13.
Evaluation Procedures for Bovine TB Classification

Table 13: Evaluation criteria—export gathering centers

Program elements

Program standards for export centers: (1) Clearly define approval requirements. 

 (2) Clearly define the requirements for animal entry into the facility.

 (3) Require unique identification of animals entering the center.

 (4) Require the center to keep accurate records of entries, exits, and animal inventory.

 (5) Require the center to keep accurate records of testing conducted on the premises.

 (6) Require appropriate risk mitigation measures (fencing, biosecurity, etc.).

Export gathering centers are subject to regular (monthly) inspection and supervision.

Program execution

Export centers are approved, operated, and supervised in accordance with the program standards.

Regulatory officials responsible for supervision of export centers are qualified and trained to do so.

Noncompliance with the program standards is rapidly detected and corrected.

8.4 Approved feedlots

Bovine TB Level I-IV regions may have approved (quarantine) feedlots4 which accept cattle from higher-risk 

regions destined for slaughter and national consumption (not export). The APHIS team reviews the program 

standards for approval and supervision of approved feedlots, making note of any deficiencies that could allow 

the spread of bovine TB from these entities. The team reviews the approval and supervisory records with the 

responsible regulatory officials and visits several approved feedlots to assess implementation of the program 

standards, supervision, and regulatory oversight. The APHIS team visits several approved feedlots to assess the 

practices and procedures using the checklist in Table E-5 Appendix E. 

At a minimum, a region seeking APHIS classification of bovine TB status must demonstrate that (1) entry of 

animals into an approved feedlot is strictly controlled; (2) all animals entering the feedlot are uniquely and 

permanently identified; (3) biosecurity measures are in place to prevent disease spread to neighboring herds; 

(4) animals exit the feedlot only to slaughter; and (5) approved feedlots are subject to routine and effective 

regulatory oversight sufficient to detect and correct noncompliance. 

Summary evaluation criteria for approved feedlots are listed in Table 14. 

4 Approved (quarantine) feedlot = terminal feedlot authorized to receive animals of higher risk for tuberculosis/brucellosis.
Evaluation Procedures for Bovine TB Classification

Table 14: Evaluation criteria—approved feedlots 

Program elements

Program standards for approved feedlots: (1) Clearly define approval and supervision requirements. 

 (2) Require unique identification of animals entering approved feedlots.

 (3) Require all animals exiting an approved feedlot to go directly to slaughter. 

 (4) Require approved feedlots to keep accurate records of entries, exits, and animal inventory.

 (5) Require approved feedlots to keep accurate records of births and deaths.

 (6) Contain appropriate risk mitigation measures (fencing, biosecurity, etc.).

Approved feedlots are subject to regular (monthly) inspection and supervision.

Regulatory officials responsible for supervision of approved feedlots are qualified and trained to do so.

Program execution

Approved feedlots are approved, operated, and supervised in accordance with the program standards.

Noncompliance with the program standards is rapidly detected and corrected.

8.5 Accreditation of TB-free herds

Level I-IV regions may have accredited herds for TB; animals from these herds are generally subject to reduced 

testing requirements for movement within the region and for export to the United States. The APHIS team 

reviews the program standards for accreditation of herds for bovine TB against APHIS standards using the 

checklist in Table E-6 in Appendix E and assesses the impact of any differences in accreditation or reaccreditation 

processes. The team reviews several accredited herd files with the responsible regulatory official(s). 

To be considered an accredited herd for the purpose of exporting bovine animals to the United States, the 

accreditation and reaccreditation processes must be equivalent to U.S. domestic standards. The TB program 

should maintain a file on each herd with complete documentation of whole-herd testing, inventory 

reconciliations, and provenance and/or testing of purchased additions. Regions in which the accreditation and 

reaccreditation practices are not equivalent to U.S. domestic standards are not eligible to export cattle under 

the reduced testing requirements that would otherwise apply to bovine animals from accredited herds. 

Summary evaluation criteria for accreditation of TB-free herds are shown in Table 15.

Table 15: Evaluation criteria—accredited herds

Program elements

Program standards for accreditation and reaccreditation: (1) meet APHIS standards for export purposes.

 (2) Require inventory reconciliation at the time of reaccreditation testing. 

 (3) Restrict entry to animals from other accredited herds or with appropriate testing.

 (4) Require all testing for (re-) accreditation to be conducted by an authorized veterinarian.

Program execution

Herds are accredited and reaccredited in accordance with APHIS standards for export.

Regulatory officials responsible for oversight of herd files receive adequate instruction and training.

Annual review of accredited herd files results in detection and correction of any deficiencies.
Evaluation Procedures for Bovine TB Classification

Appendices

Appendix A: Checklist for slaughter inspection and sampling
Evaluation Procedures for Bovine TB Classification

Appendix B: Checklist for diagnostic testing
Evaluation Procedures for Bovine TB Classification

Appendix C: Checklist for epidemiological investigations
Evaluation Procedures for Bovine TB Classification

Appendix D: Checklist for affected herd management 
Evaluation Procedures for Bovine TB Classification

Appendix E: Checklists for control of livestock movement 

Table E-1: Checklist for concentration points
Evaluation Procedures for Bovine TB Classification

Table E-2: Checklist for movement control checkpoints
Evaluation Procedures for Bovine TB Classification

Table E-3: Checklist for export certification
Evaluation Procedures for Bovine TB Classification

Table E-4: Checklist for export gathering centers

*Valid negative herd test:

 The test was conducted within the 11 months immediately prior to entry into the EGC; and

 The test was conducted by a veterinarian who met the minimum CFT standard at the time of testing; and

 The test included all animals in the herd that were 6 months of age or older; and

 All animals in the herd younger than 6 months of age were officially recorded on the test chart; and

 At least 1 adult bull was present in the herd and tested.

**Eligible vets are certified by SENASICA as having met the minimum CFT standard for export testing during the current period.
Evaluation Procedures for Bovine TB Classification

Table E-5: Checklist for approved feedlots
26

Table E-6: Checklist for accredited herds