APHIS Evaluation Procedures

for Bovine Brucellosis Classification of Foreign Regions

May 2020
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Introduction

This document describes the process by which the Animal and Plant Health Inspection Service (APHIS) evaluates 

and classifies foreign regions for brucellosis (Brucella abortus) in bovine animals. The essential considerations 

for such evaluations are outlined in title 9, Code of Federal Regulations, part 93.441 (9 CFR 93.441), as follows: 

1. Region boundaries and composition

2. Veterinary control and oversight (including notification)

3. Prevalence of bovine brucellosis

4. Surveillance

5. Diagnostic testing for bovine brucellosis

6. Epidemiological investigations

7. Affected herd management

8. Control of livestock movement

9. Vaccination

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

a brucellosis program that meets or exceeds the minimum standards in 9 CFR 93.441. This process starts with 

the region submitting the APHIS Bovine Brucellosis 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 Brucellosis 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 brucellosis 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 brucellosis program will optimally have all 

program elements in place and score above 3 on program execution; however, an apparent deficiency in one 

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

1 Program standards = regulations, manuals, guidelines, instructions, standard operating procedures, etc.
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program standards is determined by the herd prevalence, as described in 9 CFR 93.440. Level I regions have had 

a herd prevalence less than 0.001 percent for the last 24 consecutive months. Level II regions have had a herd 

prevalence of less than 0.01 percent over the last 24 consecutive months. APHIS classifies regions that it has not 

evaluated, as well as those in which prevalence is equal to or greater than 0.01 percent or the brucellosis

program does not meet the minimum standards in 9 CFR 93.441, as Level III. 

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 brucellosis evaluation some years before the provisions of 9 

CFR 92.441 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 92.441 but the format of the evaluation may differ.
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Table of contents

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

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

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

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

3. Prevalence of bovine brucellosis..................................................................................................................... 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 brucellosis........................................................................................................ 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 brucellosis-free herds................................................................................................. 16

9. Vaccination.................................................................................................................................................... 17

Appendices............................................................................................................................................................ 18
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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 authority has 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 brucellosis program has 

developed and is actively implementing a plan to reduce the 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 

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

introduction of bovine brucellosisfrom 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 brucellosis 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 brucellosis 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 brucellosis prevalence in higher-risk zones.

Program execution

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

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

2. Veterinary control and oversight 

The APHIS team assesses the organizational structure and resources of the bovine brucellosis 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 brucellosis program 

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.
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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. 

At a minimum, a region seeking APHIS classification for brucellosis 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 brucellosis; collect blood samples and selected tissues 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; require identification of bovine animals and 

premises with bovine animals; enforce brucellosis program requirements and penalize noncompliance; and 

require vaccination against B. abortus (if applicable). The APHIS team examines all pertinent regulatory acts and 

assesses the application of these acts to carry out brucellosis 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 brucellosis program are sufficient to support program activities.

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

Roles and responsibilities within the brucellosis program are clearly defined.

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

Brucellosis (B. abortus) is a compulsorily notifiable disease throughout the region.

Program officials have sufficient legal authority to carry out an effective brucellosis control 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 brucellosis

3.1 Animal and herd demographics

To calculate the herd prevalence of brucellosis, 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.
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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.

3.2 Herd prevalence

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

and determinesthe number brucellosis-affected herds during the evaluation period.

3 The criteria must be clearly 

defined and equivalent to APHIS domestic standards, namely: (1) reactor: test results on blood serum indicate 

that the animal has been exposed to and infected with Brucella, other diagnostic tests result in the recovery of 

field-strain Brucella organisms, a significant rise in titer occurs, or other epidemiological evidence of infection is 

demonstrated; and (2) affected herd: a herd in which any animal has been determined to be infected with field 

strain B. abortus by polymerase chain reaction or culture, or classified as a brucellosis reactor by a designated 

epidemiologist, and which has not been released from quarantine. The team examines data on laboratory 

sample submissions and results, quarantine herd lists, and case files to determine whether brucellosis program 

personnel follow the classification criteria.

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

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 brucellosis status classification (from 9 CFR 93.440)

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 does not meet APHIS requirements for 

classification, prevalence equal to or greater than 0.01 percent, 

or unassessed by APHIS with regard to B. abortus.

3 Evaluation period = 24 consecutive months, specifically the first 24 months of the previous 26-month period. 
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3.3 Other sources of infection

Finally, the APHIS team gathers and verifies information on other livestock or wildlife sources of B. abortus 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 brucellosisis conducted in susceptible wildlife and non-bovine domestic species.

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

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

Program execution

Applied mitigations effectively prevent brucellosistransmission to domestic bovines from other species.

4. Surveillance

The APHIS team examines the official surveillance plan and program standards for the various surveillance 

components such as slaughter sampling, first point testing, abortions screening, and targeted herd testing. The 

team evaluates sample submission data for all slaughter plants in the region and visits several plants to assess 

the facilities and equipment, inspection practices, systems for correlation of animal identification with slaughter 

samples, preservation and storage of samples, and documentation of samples submitted for laboratory 

diagnostics, using the checklist in Appendix A. The team also visits several concentration points (auctions, sale 

barns, gathering centers) to assess sampling practices for first point testing using the checklist in Table E-1 in 

Appendix E (if applicable). Finally, the team examines policies and data concerning abortion screening conducted 

during the evaluation period (see also Section 5).

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

program standards are in place to guide implementation of each surveillance component; (2) inspection and 

sampling is conducted by qualified and trained personnel; (3) appropriate minimum standards to validate 

surveillance are established and met; and (4) effective systems are in place for monitoring performance and 

addressing deficiencies. Tissue sampling of reactor animals should include representative sampling of the 

reticuloendothelial system, testes from the male, and udder and uterine tissue from the female. 

As a general benchmark, a region should be able to demonstrate that 95 percent of intact bovine animals that 

are 12 months of age are older are sampled for brucellosis at slaughter or, if moving within trade or marketing 

channels, at the first point of concentration. Such surveillance may not be necessary if a region can substantiate 

a claim of biological freedom from bovine brucellosis, although targeted or risk-based surveillance should still 

be conducted as needed to demonstrate continued freedom. APHIS would evaluate these regions on a case-bycase basis. Summary evaluation criteria for surveillance are listed in Table 6.
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Table 6: Evaluation criteria—surveillance 

Program elements

Program standards: (1) Address the critical actions necessary for brucellosis sampling at slaughter.

 (2) Address the critical actions necessary for brucellosis reactor tissue sampling and submission.

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

Appropriate minimum standards are in place to validate each surveillance component.

Program execution

Sampling for bovine brucellosis at slaughter occurs in accordance with program standards.

Reactor tissue sampling at slaughter occurs in accordance with program standards.

First-point sampling for bovine brucellosis occurs in accordance with program standards.

Sampling processes promote accurate correlation of animal ID/documents with samples taken. 

Samples are properly stored and preserved prior to delivery to the laboratory.

Individuals collecting brucellosis samples receive adequate instruction and training.

Deficiencies in sample collection or storage are rapidly detected and corrected.

Each surveillance component meets the minimum validation standards.

5. Diagnostic testing for bovine brucellosis

The APHIS team typically visits the one or more diagnostic laboratory for bovine brucellosis in the region under 

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

Veterinary Services Laboratories (NVSL) and international standards, using the checklist in Appendix B. The team 

also evaluates the laboratory procedures for abortion screening and, if vaccination is practiced, the procedures 

for differentiation of infected and vaccinated animals (DIVA techniques). 

At a minimum, a region seeking APHIS classification for brucellosis must demonstrate that (1) the tests 

conducted and testing algorithms to detect and confirm B. abortus meet international standards; (2) diagnostic 

laboratories supporting the brucellosis program are properly equipped; (3) at least one laboratory is proficient 

in diagnostic techniques to differentiate B. abortus from other Brucella and cross-reacting species; (4) 

laboratories are accredited according to international standards; (5) an effective quality control system is in 

place; and (6) interpretation or classification of results is in accordance with international standards. If 

vaccination is practiced, at least one laboratory should have DIVA capability, and receive all samples for 

differentiation. All laboratories should regularly engage in competency or proficiency testing for brucellosis

diagnostics. The summary evaluation criteria for laboratory diagnostic testing are listed in Table 7.
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Table 7: Evaluation criteria—diagnostic testing

Program elements

The laboratories supporting the program are accredited to international standards (ISO 17025). 

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

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

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

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

Program execution

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

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.

6. Epidemiological investigations

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

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 brucellosis program 

conducts follow-up testing and/or initiates an epidemiological investigation as appropriate. 

At a minimum, a region seeking APHIS classification for brucellosis 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 brucellosis 

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

of slaughter and first-point cases traced to the most probable herd of origin (MPHO) and the MPHO tested—

should be at least 95 percent. If the MPHO tests negative, the case file should contain evidence of further 

traceback investigations based on the sampling order. Investigations must be well-documented with orderly and 

complete case files.

The summary evaluation criteria for epidemiological investigations are listed in Table 8.
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Table 8: Evaluation criteria—epidemiological investigations

Program elements

Program standards address critical actions for effective traceback of slaughter or other reactors.

The successful traceback rate meets or exceeds the minimum standard.

Program standards address critical actions for investigation of other brucellosis reactors.

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

Traceback investigations are conducted in accordance with the program standards.

Traceback investigations result in detection of a brucellosis-affected herd.

Investigation of other brucellosis reactors 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 regulated while the brucellosis 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 brucellosis-affected herds by 

depopulation or test-and-remove against the checklist in Appendix D, and notes any deficiencies. The team notes 

any deficiencies in the program standards and 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 brucellosis must demonstrate that (1) the program 

standards address the critical actions for effective management of brucellosis-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.
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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 brucellosis-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. 

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 brucellosis 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.
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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 against 

APHIS import requirements for brucellosis detailed in 9 CFR 93.440, making note of any deficiencies that could 

negatively impact control of movement into the region or allow legal importation of brucellosis-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).

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.

At a minimum, a region seeking APHIS classification for brucellosis 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 
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entry effectively prevented if the checkpoint is closed. The summary evaluation criteria for entry into the region 

are listed in Table 11.

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 for brucellosis 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 brucellosis 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) brucellosis 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.
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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

Brucellosis Level I and Level II regions may have approved (quarantine) feedlots4 which accept cattle from higherrisk 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 brucellosis 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 or similar. 

At a minimum, a region seeking APHIS classification for brucellosis 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.
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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.

Program execution

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

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

Noncompliance with the program standards is rapidly detected and corrected.

8.5 Accreditation of brucellosis-free herds

Level I-III regions may have accredited herds for brucellosis; 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 brucellosis 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 brucellosis

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 brucellosis-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.

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.
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9. Vaccination

Many regions vaccinate against brucellosis as part of a control and eradication strategy. If applicable, the APHIS 

team reviews the program standards for vaccination, including the eligible population, timing of vaccination, 

vaccine used, identification of vaccinates, and strategies to monitor the extent of vaccination and to differentiate 

vaccinated animals from those infected with field strain B. abortus. At a minimum, a region seeking APHIS 

classification of brucellosis status must be able to demonstrate that (1) the vaccine(s) used and vaccination 

strategy are in accordance with international standards; (2) vaccinates are permanently and uniquely identified; 

(3) persons authorized to apply the vaccine are trained and supervised; and (4) an effective DIVA strategy is 

utilized. Summary evaluation criteria for vaccination are shown in Table 16. 

Table 16: Evaluation criteria—vaccination

Program elements

Program standards address the critical actions for an effective vaccination campaign. 

The vaccine(s) used and general vaccination plan are acceptable by international standards.

Effective DIVA techniques are available for the vaccine(s) used.

Program standards promote standardized documentation and recordkeeping.

Program standards require monitoring of vaccine coverage in target population(s). 

Program execution

Vaccine handling and vaccination are conducted in accordance with the program standards.

Each animal is uniquely identified at the time of vaccination.

Estimated vaccine coverage is sufficient to promote herd immunity in the target population(s).

Persons conducting brucellosis vaccination are adequately qualified and trained to do so.

Deficiencies in the vaccination program are rapidly detected and corrected. 
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Appendices

Appendix A: Checklist for slaughter inspection and sampling
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Appendix B: Checklist for diagnostic testing 
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Appendix C: Checklist for epidemiological investigations
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Appendix D: Checklist for affected herd management 

*Recommended: Testing must occur at intervals of at least 60 days.

Post-calving test must be at least 75 days after calving. 
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Appendix E: Checklists for control of livestock movement 

Table E-1: Checklist for concentration points (auction markets, gathering centers, feedlots)
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Table E-2: Checklist for movement control checkpoints
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Table E-3: Checklist for export certification
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Table E-4: Checklist for export gathering centers (EGCs)
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Table E-5: Checklist for approved feedlots
Table E-6: Checklist for accredited herds