FOOT-AND-MOUTH 

DISEASE

USDA’s Evaluations of 

Foreign Animal Health 

Systems Could 

Benefit from Better 

Guidance and Greater 

Transparency

Report to Congressional Requesters

April 2017

GAO-17-373

United States Government Accountability Office
United States Government Accountability Office

Highlights of GAO-17-373, a report to 

congressional requesters

April 2017

FOOT-AND-MOUTH DISEASE

USDA’s Evaluations of Foreign Animal Health 

Systems Could Benefit from Better Guidance and 

Greater Transparency 

What GAO Found

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health 

Inspection Service’s (APHIS) process for evaluating the animal health systems of 

countries seeking to export beef to the United States consists of five steps: 

• A country requests that APHIS evaluate its animal health system. 

• APHIS gathers information about the country’s system, including documents 

identifying (1) veterinary control and oversight programs, (2) vaccination 

programs, (3) animal identification and movement controls, (4) laboratory 

diagnostic capabilities, and (5) animal-disease emergency-response 

measures. 

• APHIS conducts in-country visits to verify and supplement this information. 

• APHIS does a risk analysis to determine whether the country’s beef products 

pose a risk to U.S. livestock and begins to draft a risk analysis report. 

• APHIS determines an estimated risk level, which is included in the risk 

analysis report with a description of any mitigation measures the country 

must implement to ensure the safety of its beef exports. A report is 

completed and made public only for countries whose beef presents low risk. 

Countries whose beef poses a greater risk will not be eligible to export beef 

to the United States. 

APHIS could strengthen its evaluation of foreign animal health systems by 

improving transparency to stakeholders, including the public. APHIS guidance 

instructs staff to adhere to timeframes for carrying out evaluations to ensure a 

lengthy process is completed efficiently. But the guidance does not instruct staff 

how to ensure evaluations are fully transparent. For example, APHIS guidance 

does not 

• direct staff to document their analysis of country information and include all 

problems and concerns identified and how they were resolved; 

• direct staff how to effectively document results of in-country visits, although 

the guidance requires these visits be documented; and 

• indicate how to incorporate guidance on transparency from USDA’s Chief 

Information Officer and the Office of Management and Budget into final risk 

analysis reports. 

Without sufficient guidance instructing staff to document such items, it is unclear 

(1) how APHIS verifies country information and assesses its reliability; (2) how 

problems identified are ultimately addressed to APHIS’s satisfaction; and (3) 

what methodologies, sources, assumptions, and uncertainties may influence its 

risk analysis. Further, according to the World Organisation for Animal Health, 

because risk analysis is inherently subjective, the process must be documented 

transparently. During GAO’s review, APHIS acknowledged the weaknesses in its 

guidance and formed a team to begin work to address them. By completing this 

effort, APHIS may be better able to ensure that it has assessed risks fairly and 

consistently across countries and over time, and that the process is transparent 

to the public and other stakeholders.

View GAO-17-373. For more information, 

contact Steve D. Morris at (202) 512-3841 or 

morriss@gao.gov.

Why GAO Did This Study

Foot-and-mouth disease (FMD) is a 

virus that causes painful lesions, 

making it difficult for livestock to stand 

or eat and greatly reducing meat and 

milk production. No FMD cases have 

been recorded in the United States 

since 1929. Federal regulations restrict 

fresh beef imports from countries 

where the disease is present because 

the disease may survive in untreated, 

uncooked beef (beef), and can be 

costly to control and eliminate. 

According to USDA, an outbreak of 

FMD could cause grave damage to the 

U.S. beef industry, which had a retail 

value of $95 billion in 2014. 

GAO reviewed (1) USDA’s process for 

evaluating the animal health systems 

of countries seeking to export beef 

products to the United States, and (2) 

how this process could be improved. 

GAO analyzed documentation 

supporting seven countries’ requests 

for FMD animal health system 

evaluations. GAO also reviewed 

federal regulations, guidance, and a 

key trade agreement; and interviewed 

knowledgeable USDA and industry 

officials.

What GAO Recommends

GAO is making three 

recommendations including that USDA 

clarify its guidance on how staff should 

document analysis of a foreign 

country’s animal health system and the 

results of in-country visits to verify 

information. USDA agreed with GAO’s 

recommendations and described 

actions it is taking or plans to take to 

implement them.
Page i GAO-17-373 Safety of Beef Imports

Letter 1

Background 4

APHIS Performs Documentation Reviews, Site Visits, and Risk 

Analyses to Evaluate Foreign Countries Seeking to Export Beef 

to the United States 10

Improved Documentation Could Enhance Transparency of 

APHIS’s Evaluations of Foreign Countries’ Animal Health 

Systems 15

Conclusions 26

Recommendations for Executive Action 28

Agency Comments and Our Evaluation 28

Appendix I Objectives, Scope, and Methodology 34

Appendix II Comments from the U.S. Department of Agriculture 38

Appendix III GAO Contact and Staff Acknowledgments 41

Related GAO Products 42

Table

Table 1: Animal and Plant Health Inspection Service’s (APHIS) Incountry Site Visits and Whether a Trip Report Was 

Completed for Selected Countries’ Beef Import 

Evaluations 21

Figures

Figure 1: Status of Foot-and-Mouth Disease (FMD) Animal Health 

System Evaluations Conducted by Animal and Plant 

Health Inspection Service (APHIS), March 2017 8

Figure 2: Animal and Plant Health Inspection Service’s (APHIS) 

General Process for Evaluating a Foreign Country’s 

Animal Health System 10

Contents
Page ii GAO-17-373 Safety of Beef Imports

Figure 3: Three Key Components Included in Animal and Plant 

Health Inspection Service’s (APHIS) Risk Analyses 13

Abbreviations

APHIS Animal and Plant Health Inspection Service

CFR Code of Federal Regulations

FMD Foot-and-Mouth Disease

FSIS Food Safety and Inspection Service

GAO Government Accountability Office

OIE World Organisation for Animal Health (Office 

International des Epizooties)

SPS Agreement Agreement on the Application of Sanitary and 

Phytosanitary Measures

USDA U.S. Department of Agriculture

WTO World Trade Organization

This is a work of the U.S. government and is not subject to copyright protection in the 

United States. The published product may be reproduced and distributed in its entirety 

without further permission from GAO. However, because this work may contain 

copyrighted images or other material, permission from the copyright holder may be 

necessary if you wish to reproduce this material separately.
Page 1 GAO-17-373 Safety of Beef Imports

441 G St. N.W.

Washington, DC 20548

April 28, 2017

Congressional Requesters

Foot-and-mouth disease (FMD) is a highly contagious viral disease 

affecting cloven-hooved animals such as cattle, pigs, sheep, and goats. 

The virus can survive in the environment for many months, and can be 

transmitted among animals by air or through contact with feed, soil, tools, 

clothing, shipping containers, and untreated meat products, including 

beef.1 Although the disease generally does not infect humans and is not 

considered a public health or food safety threat, livestock suffer painful 

blisters inside the mouth and on hooves, making it difficult for them to 

stand or eat and causing severely diminished meat and milk production. 

The disease spreads so rapidly that control can be difficult, sometimes 

requiring the widespread slaughter of both infected and potentially 

infected livestock. According to the U.S. Department of Agriculture 

(USDA), in 2014, the retail value of the U.S. beef industry was $95 billion. 

An outbreak of FMD could cause billions of dollars in losses as well as 

loss of export markets attributable to mandatory slaughter, among other 

factors.2

USDA’s Animal and Plant Health Inspection Service (APHIS) is 

responsible for protecting U.S. livestock from the introduction of foreign 

animal diseases, including FMD.3 The United States has not had a 

documented case of FMD since 1929 and does not vaccinate its livestock 

against the disease. Federal regulations prohibit the import of certain 

livestock—for example, cattle and swine—and their products (including 

meat) from countries or regions that have not been officially recognized 

by APHIS as free of FMD. Products that have undergone treatment—

such as cooking—that will inactivate the FMD virus are not, under certain 

 1 Untreated meat products are those that have not been cooked, cured, or deboned and 

aged, a process that lowers pH to below 6.0 to inactivate the FMD virus. The findings in 

this report apply to fresh (chilled or frozen), untreated meat products. For purposes of this 

report, any mention of beef refers to fresh—not cooked or cured—beef.

2 Philip L. Paarlberg, John G. Lee, Ann Seitzinger; “Potential Revenue Impact of an 

Outbreak of Foot-and-Mouth Disease in the United States,” Journal of the American 

Veterinary Medical Association (Apr. 1, 2002).

3 Foreign animal diseases are those that are not known to be present in the United States. 

APHIS also has responsibilities for protecting U.S. agriculture and natural resources 

against plant pests.

Letter
Page 2 GAO-17-373 Safety of Beef Imports

conditions, subject to these prohibitions. Therefore, a country seeking to 

export beef to the United States must generally demonstrate to APHIS 

that it is free from FMD and that it does not vaccinate against FMD. 

Countries that vaccinate are not considered free from FMD because, 

according to APHIS, vaccination has not proven a foolproof method for 

protecting all susceptible animals.4

However, APHIS has determined that beef from vaccinating countries that 

have not had recent outbreaks may still be safe for import under certain 

conditions. APHIS has allowed beef imports from one such vaccinating 

country—Uruguay—since 2003, and in July 2015, the agency determined 

that beef from certain regions within Brazil and Argentina could also be 

safely imported into the United States. While both Brazil and Argentina 

currently vaccinate against FMD, according to APHIS, there is no 

evidence that they have experienced FMD outbreaks since 2006.

You asked us to review APHIS’s approach to protecting U.S. livestock 

from FMD, which may be transmitted through beef imports. This report 

examines (1) the steps APHIS takes to evaluate the animal health 

systems of foreign countries seeking to export beef to the United States 

and (2) how APHIS’s process could be improved, if at all.5

To address these objectives, we reviewed relevant federal statutes, 

federal regulations, federal and World Organisation for Animal Health 

(OIE)6 guidance documents, and a key international trade agreement 

regarding imports of beef. To gain a better understanding of APHIS’s 

process for protecting U.S. livestock from FMD, we focused our review on 

APHIS’s evaluations of the animal health systems of seven countries or 

 4 Vaccines cannot immunize livestock against all strains of the disease. In addition, 

livestock may not respond to vaccination with full immunity and, if infected, may go 

undetected in a herd.

5 For the purposes of this report, an animal health system is a country’s entire animal 

health program, including veterinary infrastructure, veterinary authority, disease control 

measures, laboratory capacity and capability, import controls, and livestock industry 

practices. APHIS officially refers to its evaluations of animal health systems as “animal 

health status” evaluations.

6 The World Organisation for Animal Health was formerly known as the Office 

International des Epizooties (OIE), and kept its historical acronym of OIE after changing 

names. OIE is an intergovernmental organization created in response to the need to fight 

animal diseases on a global level, and is tasked with improving animal health worldwide. 

One of its stated objectives is to promote safety in international trade of animals and 

animal products.
Page 3 GAO-17-373 Safety of Beef Imports

specific regions within those countries: Northern Argentina, 14 states in 

Brazil (comprising a single export region), Colombia, Japan, Paraguay, 

Singapore, and Uruguay. With the exception of Uruguay, we chose these 

countries or regions for review because they had the following 

characteristics:

• the countries requested an animal health system evaluation for FMD 

for the purpose of exporting beef to the United States, and

• either APHIS has completed an evaluation and lifted the import 

prohibition on the country’s beef within the past 5 years, or APHIS is 

currently conducting an evaluation to determine whether the import 

prohibition on the country’s beef can be safely lifted.

Uruguay does not fit these parameters, as APHIS lifted the import 

prohibition on the country’s beef in 2003; however, it is a country for 

which APHIS conducted a quantitative risk analysis, an evaluative 

approach that was not applied to the other six countries in our review, 

which all received qualitative risk analyses.

The information we obtained from APHIS’s evaluations of the seven 

countries we reviewed is not generalizable, but provided us with a greater 

understanding of the key steps that comprise a foreign animal health 

system evaluation. We did not evaluate the scientific or technical validity 

of APHIS’s risk analyses, nor did we question APHIS’s decisions to lift the 

import prohibition on Argentina, Brazil, Japan, and Uruguay’s beef. (Final 

risk analysis reports have not yet been prepared for Colombia, Paraguay, 

and Singapore.) Instead, we focused our review on APHIS’s process for 

conducting and documenting its evaluations of the animal health systems 

in the seven countries in our review. Additionally, we reviewed APHIS’s 

evaluations of animal health systems to determine how well the agency 

incorporated standards for documentation and transparency. We also 

reviewed Food Safety and Inspection Service (FSIS) guidance for 

conducting food safety equivalence evaluations to further understand the 

steps required before a country may begin exporting beef to the United 

States.7 To develop an understanding of APHIS’s process for conducting 

and documenting FMD risk analyses, we reviewed the final FMD risk 

 7 USDA’s Food Safety and Inspection Service evaluates foreign food safety systems to 

establish that a country’s system meets the equivalent standards for food safety as are 

present in the United States (known as an equivalence determination), and that meat, 

poultry, catfish, and egg products destined for export to the United States are safe for 

human consumption.
Page 4 GAO-17-373 Safety of Beef Imports

analysis reports for Northern Argentina, the 14-state region of Brazil, 

Japan, and Uruguay. To further expand our understanding of how APHIS 

conducts and documents FMD risk analyses, we also reviewed the only 

other three countries with risk analysis reports completed within the past 

5 years for FMD: Croatia, Malta, and Peru. Appendix I provides additional 

information on our scope and methodology. In addition, we list related 

GAO products at the end of this report.

We conducted this performance audit from December 2015 to April 2017, 

in accordance with generally accepted government auditing standards. 

Those standards require that we plan and perform the audit to obtain 

sufficient, appropriate evidence to provide a reasonable basis for our 

findings and conclusions based on our audit objectives. We believe that 

the evidence obtained provides a reasonable basis for our findings and 

conclusions based on our audit objectives.

USDA is responsible for protecting U.S. livestock from foreign animal 

diseases. The steps USDA takes to do so must comply with international 

trade agreements to which the United States is a signatory. This section 

presents information on how regulatory restrictions may be lifted by 

USDA to allow countries to export beef to the United States. Because 

regulation must occur in a manner consistent with United States’

international trade agreements, the information is prefaced by a 

discussion of relevant trade agreement obligations.

As a member of the World Trade Organization (WTO), and a signatory to 

the WTO Agreement on the Application of Sanitary and Phytosanitary 

Measures (SPS Agreement), the United States has agreed to follow 

guiding principles aimed at promoting safe and fair international trade.

Fair trade practices: The WTO SPS Agreement allows countries to 

establish sanitary measures to protect animal health and ensure food is 

safe for human consumption, but these sanitary measures must not 

arbitrarily or unjustly discriminate among signatories to the agreement. 

Sanitary measures refer to laws, regulations, requirements, and 

procedures designed to protect a country’s livestock from animal 

diseases. Sanitary measures might include, for example, testing and 

inspecting for pathogens. To facilitate fair and consistent trade practices, 

the SPS Agreement encourages countries to adopt international 

standards, guidelines, and recommendations where they exist. The OIE 

has established standards, guidelines, and recommendations for animal 

health matters, while the Codex Alimentarius Commission has done so 

for food safety matters. However, under the WTO’s SPS Agreement, 

Background

International Trade 

Agreement Obligations
Page 5 GAO-17-373 Safety of Beef Imports

countries are authorized to impose stricter sanitary measures than those 

offered by the OIE and Codex Alimentarius Commission as long as the 

countries have a scientific justification and are not inconsistent with any 

other provisions of the agreement.

Regionalization:8 For the purposes of international trade, signatories to 

the SPS Agreement have agreed to evaluate the animal health systems 

of regions that can be all of a country, part of a country, or all or parts of 

several countries, as identified by the competent authorities.9

Equivalence: Signatories to the SPS Agreement have agreed to treat 

other countries’ sanitary measures as equivalent—even if those 

measures differ from their own—provided that the exporting country can 

demonstrate that its measures achieve the importing country’s level of 

sanitary protection.

USDA delegates responsibilities for ensuring the safety of beef imports to 

two internal agencies: APHIS and the Food Safety and Inspection Service 

(FSIS). APHIS has lead responsibility for preventing foreign animal 

diseases from entering the United States and evaluates foreign countries’

animal health systems to establish that a country’s livestock does not 

carry animal diseases and that its system can effectively prevent, detect, 

and control a disease outbreak should one occur. FSIS evaluates foreign 

food safety systems to establish that the country’s system meets the 

equivalent standards for food safety as are present in the United States 

(known as an equivalence determination), and that meat destined for 

export to the United States is safe for human consumption. Importantly, 

both APHIS’s and FSIS’s evaluations must be satisfactorily completed 

before a country is eligible to export beef to the United States.

10

 8 Regionalization is the concept that animal health and disease risk resulting from 

imported products can vary by regions defined by climatological, geographical, and 

biological factors rather than by national political boundaries.

9 For the purposes of this report, we generally refer to all export regions as “countries,”

even if the export region does not encompass the entire country. For example, the export 

regions of Northern Argentina and a 14-state region of Brazil are included in our review, 

but we refer to those regions as the “countries” of Argentina and Brazil, respectively.

10 A country’s ability to export beef—once it has been determined eligible to do so—may 

also be affected by import quotas and tariffs.

USDA Regulation of 

Imported Beef
Page 6 GAO-17-373 Safety of Beef Imports

Because foreign beef entering the United States must be free from animal 

diseases such as FMD, APHIS prohibits imports of beef from countries 

where FMD may be present.11 As a precaution, APHIS considers FMD to 

be present in all countries unless it has independently completed an 

animal health system evaluation to confirm that FMD does not exist in the 

country. In line with obligations under the SPS Agreement, APHIS will, 

upon request, consider evaluating the animal health system of a specific 

region within a country rather than evaluating the entire country.12 For 

example, APHIS has conducted animal health system evaluations for 

various regions within Argentina, Brazil, and Namibia.

As permitted by the SPS Agreement, foreign animal health systems may 

differ among signatories, but they must, in all cases, provide an 

appropriate level of protection to ensure that the country’s beef destined 

for export does not harbor the FMD virus. APHIS conducts its evaluations 

in accordance with Application for Recognition of the Animal Health 

Status of a Region, the federal regulation that establishes the factors 

APHIS must assess to determine whether the country satisfies this 

requirement.13 If, at the conclusion of an evaluation, APHIS determines 

that the overall risk is low and that a country’s request to export beef to 

the United States can be safely granted, APHIS will indicate in the 

Federal Register its intent to lift the import prohibition.14 APHIS allows for 

a public comment period and is to consider all public comments before 

issuing its final determination. The import prohibition on beef may be lifted 

in one of two ways:

• APHIS may classify a country as FMD-free and add the country to the 

agency’s official list of countries declared free of FMD. Inclusion on 

the FMD-free list removes the import prohibition on certain livestock 

 11 Discussion in this report is specific to FMD. APHIS also prohibits meat imports from 

countries where certain other animal diseases are present. 

12 APHIS defines a region as a geographic land area with identifiable geological, political, 

or surveyed boundaries. According to APHIS, the concept of regionalization is rooted in 

the concept that restrictions on the movement of animals and animal products for the 

purpose of disease control are biologically and ecologically most logical when applied to 

areas that are geographically homogenous with respect to disease distribution and 

livestock infrastructures.

13 9 C.F.R. § 92.2.

14 APHIS will indicate its intent in the Federal Register either through a public notice or a 

proposed rule, depending on the specific provisions of the evaluation.

Animal Health System 

Evaluations
Page 7 GAO-17-373 Safety of Beef Imports

and their products—including meat—from that country.15 In some 

cases, however, APHIS may impose certain conditions on exports 

from a country classified as FMD-free if APHIS believes the country 

may be at elevated risk for an FMD outbreak in the future. For 

example, if a country shares a common land border with or 

supplements its domestic meat supply with meat from countries that 

APHIS has not declared FMD-free, APHIS requires the country to 

certify that, among other things, its exported beef was derived from 

animals that have never spent time in a country where FMD exists.16

• Some countries may not qualify for FMD-free status because they 

vaccinate against the disease. According to APHIS, in these cases, a 

country may still have the import prohibition on its beef lifted by 

seeking a “commodity-based” evaluation. An FMD-free animal health 

system evaluation would eliminate the import prohibition on live cattle 

and all commodities derived from cattle, including beef, from a 

specific country or region. 17 In contrast, a commodity-based 

evaluation involves lifting the import prohibition on specific 

commodities, such as beef only. To lift the import prohibition on beef 

following a commodity-based evaluation, APHIS must amend federal 

regulations to add the country, the meat or meat product for which the 

country has been evaluated, and any required mitigations. Generally,

countries having the import prohibition lifted through a commoditybased evaluation must implement safety measures—or mitigations—

to reduce the risk that these meat products may be contaminated with 

FMD. For example, mitigations that effectively inactivate the FMD 

virus include deboning and maturation.18 To date, three countries—

Uruguay, and certain regions of Argentina and Brazil—that have not 

 15 Imports of meat from animals that are susceptible to FMD—including cattle, sheep and 

swine—are restricted under federal regulation. Achieving FMD-free status lifts the import 

prohibition on these products. However, swine are also susceptible to other regulated 

diseases—such as classical swine fever—and pork imports are also restricted based on 

these diseases.

16 Currently, there are 60 countries included on the FMD-free list, 36 of which are subject 

to these additional export requirements. 

17 In addition, APHIS regulations allow the agency to place certain restrictions on imports 

from FMD-free regions because of the region’s proximity to or trading practices with FMDaffected regions. 9 C.F.R. § 94.11.

18 Deboning meat and maturation—an aging process that reduces pH levels in meat to 

below 6.0 and increases acidity—are both intended to decrease the risk that beef might be 

contaminated with the FMD virus. The pH is a figure expressing the acidity or alkalinity of 

an object, with lower values being more acidic, higher values being more alkaline, and 7 

being neutral.
Page 8 GAO-17-373 Safety of Beef Imports

experienced outbreaks of FMD in many years but continue to 

vaccinate have had the import prohibition on beef lifted through this 

method. Two additional such countries—Colombia and Paraguay—

had evaluations under way at the time of our review.

Figure 1 shows the countries for which APHIS has lifted the prohibition on 

certain meat imports to the United States under each of these two 

methods.

Figure 1: Status of Foot-and-Mouth Disease (FMD) Animal Health System Evaluations Conducted by Animal and Plant Health 

Inspection Service (APHIS), March 2017
Page 9 GAO-17-373 Safety of Beef Imports

a Exports from these countries or regions are subject to special conditions designed to further mitigate 

FMD risk, as specified in 9 CFR 94.11.

Once the import prohibition has been lifted, the country maintains that 

status unless it experiences an FMD outbreak or another problem that 

could potentially change the risk posed by the country’s beef exports. If 

an outbreak is identified, APHIS officials said they would reinstate the 

import prohibition. However, the Consolidated Appropriations Act of 2016 

required the Secretary of Agriculture to establish a prioritization process 

for APHIS to conduct follow-up reviews of countries or regions that have 

received animal health status recognitions by APHIS.19 In January 2017, 

APHIS announced its plan to prioritize these follow-up reviews based on 

the level of risk the imports might pose to the United States.20

Imported beef must meet the Federal Meat Inspection Act’s safety 

standards applied to beef produced in the United States. As such, FSIS 

restricts imports of beef until the agency has evaluated the country’s food 

safety system and determined that the system meets applicable safety 

standards. According to FSIS guidance,21 food safety system evaluations 

are necessary for FSIS and the American consumer to develop and 

maintain trust in imported beef.

FSIS reviews and analyzes information related to a country’s food safety 

system to determine whether the country’s system provides the same 

level of protection against food hazards as is achieved domestically. As 

permitted by the SPS Agreement, foreign food safety systems need not 

be identical to the U.S. system, but they must employ sanitary measures 

that provide this equivalent level of protection. FSIS then conducts an onsite equivalence evaluation to verify that the country has satisfactorily 

implemented all laws, regulations, and requirements. Should FSIS 

 19 Pub. L. No. 114-113, § 752, 129 Stat. 2283 (2016). 

20 APHIS will prioritize follow-up reviews using a three-tier system: With respect to FMD, 

Tier 1 includes countries that are not recognized as FMD-free but for which APHIS has 

lifted the import prohibition on certain animals or products; Tier 2 includes countries that 

are recognized as FMD-free but where special restrictions are applied due to the country’s 

proximity or trade relationships with countries that APHIS has not recognized as FMDfree; Tier 3 includes countries recognized as FMD-free. Additionally, APHIS will prioritize 

its review within each of these three tiers using five risk-based criteria: disease, region, 

commodity, time and other risk-based factors.

21 U.S. Department of Agriculture, Food Safety and Inspection Service, “Process for 

Evaluating the Equivalence of Foreign Meat, Poultry, and Egg Products Food Regulatory 

Systems;” Washington, D.C., July 2011. 

Food Safety System 

Evaluations
Page 10 GAO-17-373 Safety of Beef Imports

determine that the country’s system meets all applicable standards and 

that the country’s request to export beef to the United States can be 

safely granted, it will add the country to the agency’s list of countries 

eligible to export beef to the United States.22

APHIS’s process for evaluating foreign countries seeking to export beef to 

the United States includes gathering and evaluating information about a 

country’s animal health system, usually performing one or more incountry site visits to substantiate the information and address any 

concerns, and conducting a risk analysis to estimate the potential risk to 

U.S. livestock posed by the importation of the country’s beef.23 Figure 2 

illustrates this process.

Figure 2: Animal and Plant Health Inspection Service’s (APHIS) General Process for Evaluating a Foreign Country’s Animal 

Health System

a Information gathering may take place throughout the entire process. 

Initial request for evaluation: Foreign countries seeking to export beef 

to the United States must request that APHIS evaluate the country’s 

animal health system. Generally, a country makes a standard request for 

 22 Like APHIS, before placing a country on the list of countries eligible to export beef to 

the United States, FSIS publishes a proposed rule in the Federal Register, notifying the 

public of the intent to allow the country to export beef to the United States. FSIS must 

allow the public to comment on the proposed rule, and is to consider all public comments 

before issuing a final rule regarding the country’s eligibility to export.

23 This process is the one APHIS uses for evaluating foreign animal health systems, 

regardless of disease or commodity. For illustrative purposes, risk analysis and risk 

estimation are shown in figure 2 as separate steps. According to APHIS, however, risk 

estimation is included in risk analysis.

APHIS Performs 

Documentation 

Reviews, Site Visits, 

and Risk Analyses to 

Evaluate Foreign 

Countries Seeking to 

Export Beef to the 

United States
Page 11 GAO-17-373 Safety of Beef Imports

an animal health system evaluation, for which APHIS requires the country 

to submit information designed to establish the adequacy of its system 

and to demonstrate the country has the necessary infrastructure to detect 

and respond to an FMD outbreak should one occur.24 For standard 

animal health system evaluations, APHIS requires that countries submit 

information on the following eight evaluation factors:25

1. Scope of the evaluation being requested: The requesting country 

provides a detailed description of the export region for which it is 

requesting an animal health system evaluation for FMD and, if 

applicable, the products it wishes to export.

2. Veterinary control and oversight: The requesting country provides 

information to demonstrate adequacy of its veterinary infrastructure 

and ability of its veterinary authority to oversee animal health 

activities, monitor for FMD, and implement FMD control measures.

3. Disease history and vaccination practices: The requesting country 

provides information on the history of FMD in the evaluated region 

and its vaccination program.

4. Livestock demographics and traceability: The requesting country 

provides information on livestock demographics and its ability to track 

those animals’ movements in the event of an FMD outbreak.

5. Epidemiological separation from potential sources of infection: The 

requesting country provides information on its ability to prevent FMD 

from entering the export region.

6. Surveillance: The requesting country provides information showing its 

surveillance system can detect FMD quickly in the event of an 

outbreak.

 24 If a country has either never experienced FMD or has not had a case of FMD within the 

last 25 years, it can request a designation of “historically free” from FMD. There is no 

distinction between the “FMD-free” and “historically FMD-free” designations, but a country 

requesting historically free status would submit slightly different information to APHIS than 

it would for a standard animal health system evaluation. For example, a country 

requesting historically free status is not required to submit information on surveillance 

practices because APHIS takes into account that countries that have been free from FMD 

for more than 25 years would not be expected to have significant levels of active 

surveillance.

25 APHIS consolidated these evaluation factors into their current form in 2012. Prior to 

2012, there were 11 evaluation factors for standard animal health system evaluations. 

APHIS stated that the changes would make clearer the types of information APHIS needs 

from a requesting region in order to conduct an evaluation.
Page 12 GAO-17-373 Safety of Beef Imports

7. Diagnostic laboratory capabilities: The requesting country provides 

information to demonstrate it is capable of effectively diagnosing 

FMD.

8. Emergency preparedness and response: The requesting country 

provides information on its FMD preparedness and response 

capabilities.

Information gathering: After the country has made its initial request for 

evaluation and submitted supporting documentation related to the eight 

evaluation factors, APHIS will assemble a review team, which typically 

consists of one or more APHIS staff with technical expertise in fields such 

as veterinary medicine, epidemiology, microbiology, and virology. Review 

teams may also include laboratory specialists and quantitative risk 

analysis experts, if appropriate. Review teams evaluate the country’s 

information and, if necessary, request additional information. APHIS also 

gathers information from publicly available sources, scientific literature, 

and audit reports issued by other auditing agencies. The informationgathering process continues until APHIS is confident that it has sufficient 

information to identify potential weaknesses, if any, in the country’s 

animal health system that might affect its ability to identify and control 

FMD.

In-country site visit: APHIS conducts in-country site visits to verify and 

supplement information already gathered. Site visit teams consist of one 

or more APHIS staff who were part of the review team, but may also 

include technical specialists, such as laboratory experts, if necessary. 

Additionally, APHIS may invite chief veterinary officials from one or more 

U.S. states to be part of the site visit team.

26 APHIS site visit teams 

request to visit certain locations in the country based on potential animal

health system risks or weaknesses that were identified while evaluating 

the country’s information. Site visit verification activities typically include 

reviews of record-keeping protocols and coordination among federal, 

regional, and local animal health officials. APHIS officials told us that site 

visits are a critical component of the evaluation process because these 

visits allow them to assess whether the country’s animal health system 

functions in practice as it was described in the country’s documentation. 

APHIS aims to address all of its concerns with a single site visit, but 

multiple visits may be necessary during an animal health system 

evaluation. Depending on the country’s responsiveness, document 

 26 APHIS staff said that including these individuals helps increase the agency’s 

transparency and bolsters confidence with the public. 
Page 13 GAO-17-373 Safety of Beef Imports

reviews and subsequent site visits may take several years, APHIS 

officials said.

Risk analysis: Once APHIS is satisfied that it has gathered and verified 

all necessary information regarding a country’s animal health system, and 

has investigated all potential weaknesses, it will conduct a risk analysis to 

determine whether the country’s request to export beef to the United 

States can be safely granted. According to APHIS officials, the agency 

generally follows OIE guidelines for conducting import risk analyses, 

which include, among other things, three components: an entry 

assessment, an exposure assessment, and a consequence assessment. 

Figure 3 provides descriptions of each of these components.

Figure 3: Three Key Components Included in Animal and Plant Health Inspection 

Service’s (APHIS) Risk Analyses

Note: These risk analysis components are included in all animal health system evaluations, 

regardless of animal disease or commodity being evaluated. Other components include things such 

as hazard identification and risk management.

APHIS’s analysis of the eight evaluation factors comprises the entry 

assessment portion of the risk analysis. In line with OIE guidelines, entry 

assessments may be quantitative or qualitative, or a combination of 

both.27 In all cases, APHIS conducts a thorough qualitative evaluation 

 27 According to the OIE, quantitative assessments are not necessarily more objective or 

precise than a qualitative approach. The qualitative approach is suitable for the majority of 

import risk analyses and is currently the most common type of assessment undertaken to 

support routine import decision making. However, in some circumstances it may be useful 

to adopt a quantitative approach as an adjunct to a qualitative assessment to, for 

example, gain further insights into a particular problem or compare risk mitigation 

strategies. Additionally, OIE states that for many diseases—particularly those such as 

FMD that have well-developed, internationally agreed-upon animal health standards—

there is broad agreement concerning the likely risks. In such cases, it is more likely that a 

qualitative assessment is all that is required.
Page 14 GAO-17-373 Safety of Beef Imports

based on the eight evaluation factors, but may also employ a quantitative 

approach if the agency believes it is appropriate.

For example, agency officials said that they employed a quantitative 

approach in a risk analysis for bovine spongiform encephalopathy (mad 

cow disease) to determine whether live cattle and other susceptible 

products could be safely imported from Canada. That assessment, 

completed in 2007, used quantitative methods to estimate the prevalence 

of disease in adult cattle in Canada, and this was used in a quantitative 

model that considered the potential exposure via live cattle imports. The 

other components of this assessment, including the consideration of 

release and exposure via blood and blood products, could not readily be 

mathematically modeled, and therefore qualitative methods were used.

As part of the overall process, the risk analysis—along with a summary of 

important information supporting the risk analysis—is presented in a final 

risk analysis report, which is made available to the public prior to removal 

of the prohibition on beef imports from the country.28

Risk estimation: Results from the entry, exposure, and consequence 

assessments are integrated to produce an overall measure of the FMD 

risk associated with importing a country’s products. Certain products, 

including beef, can be treated during the production process to mitigate 

the risk of carrying the FMD virus. Examples of mitigation treatments for 

beef include deboning, aging, and lymph node removal. If APHIS believes 

that any of these mitigation treatments are necessary, it must determine 

that the country can effectively apply the treatments to beef destined for 

export to the United States. Additionally, APHIS may impose other 

mitigation measures such as requiring that the beef come from animals 

that are born, raised, and slaughtered in regions that APHIS has 

recognized as free of FMD. If, after considering mitigation treatments and 

other potential mitigation measures that might reduce the risk of FMD, 

APHIS finds the overall risk to be sufficiently low, it removes the 

prohibition on beef imports from that country.

 28 In APHIS’s Federal Register entry indicating its intent to lift the import prohibition on a 

country’s beef, the agency provides information on how the public can access the risk 

analysis report and other supporting documents on https://www.regulations.gov/.
Page 15 GAO-17-373 Safety of Beef Imports

APHIS could strengthen its foreign animal health system evaluations and 

provide greater transparency in how it determines whether the import 

prohibition on a country’s beef may be safely lifted by better documenting 

its actions during three phases of the evaluation process: (1) the agency’s 

analysis of information gathered from foreign countries and other sources, 

(2) in-country site visits, and (3) risk analyses. Existing guidance is not 

adequate to ensure that such documentation will occur.

APHIS guidance for how to conduct animal health system evaluations 

helps streamline the lengthy process that can sometimes take years, but 

it does not provide detailed instructions for how staff should document 

their analysis of information gathered. In addition, APHIS has not 

developed a systematic means of storing, organizing, and managing the 

information it gathers about foreign countries’ animal health systems.

In 2011, APHIS established internal agency guidance that identified the 

actions comprising an animal health system evaluation, with the goal of 

streamlining the agency’s evaluation process to make it more efficient. 

The 2011 guidance follows the key phases of an animal health system 

evaluation, detailing actions staff should take in gathering information, 

managing documentation, planning and conducting in-country site visits, 

following up on site-visit information requests, performing risk analyses, 

and facilitating regulatory action to remove the prohibition on beef imports 

to the United States.

While the 2011 guidance identifies the steps staff should undertake to 

ensure the information gathered about a foreign country’s animal health 

system is complete, it does not provide instructions on how staff should 

document their analysis of the information. For example, review team 

members are expected to evaluate a country’s information and provide 

input to the review team leader, but the 2011 guidance does not indicate 

the type of input that should be provided, nor does this guidance direct 

staff to document any analysis that they may have done during their 

evaluation. As a result, we found limited documentation that such input 

had been provided as directed or of analyses that may have been done

for the seven animal health system evaluations we reviewed. For 

example, we identified written meeting notes from 2003 indicating that 

Improved 

Documentation Could 

Enhance 

Transparency of 

APHIS’s Evaluations 

of Foreign Countries’

Animal Health 

Systems

Existing Guidance Does 

Not Ensure APHIS’s 

Analysis of Information 

Gathered about Foreign 

Animal Health Systems is 

Adequately Documented
Page 16 GAO-17-373 Safety of Beef Imports

APHIS staff had met and had expressed concerns about the quality of 

data provided by Brazilian authorities. The notes indicated that follow-up 

was needed before the risk analysis could proceed. We found no 

additional documents regarding such concerns for the other animal health 

system evaluations.

Similarly, the 2011 guidance also directs the review team’s leader to 

request additional information from foreign officials if the country’s 

information is incomplete or unclear. For five of the seven countries in our 

review, we identified evidence that APHIS requested additional 

information from foreign officials to support their evaluations. We did not, 

however, find documentation in any of these cases indicating whether or 

how APHIS analyzed the foreign officials’ responses and determined 

whether their responses were adequate.

APHIS staff said that they do not generally document—in work papers or 

other materials apart from the risk analysis report—how they analyzed the 

information gathered to identify potential weaknesses in a foreign 

country’s animal health system. These officials also said that the analysis 

of a foreign country’s information is fully documented in the final risk 

analysis report and that preparing separate analytical documents would 

be unnecessarily duplicative. But risk analysis reports are not intended to 

detail all of the concerns or problems that APHIS identified during the 

course of an animal health system evaluation, nor do these reports 

discuss how those concerns were resolved to APHIS’s satisfaction. 

According to APHIS officials, evaluations of a country’s animal health 

system are conducted specifically to determine whether import 

prohibitions may be lifted. If significant weaknesses are identified during 

the review, the evaluation is terminated. In those instances, a final risk 

analysis report is neither completed nor made public, as there would be 

no regulatory action taken. Therefore, all of the risk analyses supporting a 

regulatory action reflect only those situations where all significant animal

health concerns had been adequately resolved through the evaluation. 

However, without a separate step linking the analysis of a country’s 

information to the final risk analysis report, it is difficult to track how 

APHIS staff analyzed the information, assessed its validity and reliability, 

determined that the information was sufficient to identify any potential 

weaknesses in the country’s animal health system, and resolved any 

concerns. For example, APHIS and the Canadian Food Inspection 
Page 17 GAO-17-373 Safety of Beef Imports

Agency conducted a joint in-country site visit to Argentina in 2005.29

During that visit, the teams discovered that Argentina’s legislation 

regarding swill feeding was insufficient and that swill feeding regulations 

were not properly enforced.30 These issues are documented in the 

Canadian Food Inspection Agency’s risk assessment report. The 

Canadian agency determined the risk to Canada from Argentina beef was 

acceptable, but recommended in the risk assessment report that 

Argentina take action to correct the deficiencies. In contrast, APHIS did 

not document any issues it may have found with Argentina’s swill feeding 

legislation or that the country’s failure to properly enforce swill feeding 

regulations had been resolved. Without a separate step linking 

documentation of deficiencies encountered to the risk analysis reports, 

there is no way to track such issues to their resolution.

Under federal standards for internal control concerning practices to 

achieve agency objectives, federal entities are to adequately record 

important transactions, such as activities that support regulatory decision 

making.31 Appropriate and prompt documentation of such activities helps 

the entity achieve its objectives and helps maintain the relevance and 

value of such activities for decision-making purposes. Promptly recording 

the analysis of information it receives from foreign countries may better 

equip APHIS to evaluate animal health systems consistently across 

countries and over time, and ensure continuity during times of staff 

turnover. Additionally, sufficient documentation of analysis, discussions, 

and conclusions drawn during evaluations would support APHIS’s 

commitment to transparency and help the agency to defend its decisions 

to stakeholders and other entities, such as the WTO.

One approach to ensuring that agency staff understand an organization’s 

expectations about when and how to record important information and 

regulatory activities is to direct them to follow requirements outlined in 

 29 According to APHIS officials, the Canadian Food Inspection Agency and APHIS 

coordinate joint in-country site visits when possible if they have concurrent animal health 

system evaluations under way. 

30 According to APHIS, swill feeding is the most likely pathway for susceptible livestock to 

be exposed to FMD. Swill is food scraps or waste and may inadvertently contain FMDcontaminated meat. Among species known to be susceptible to FMD, only swine are likely 

to be fed discarded meat. However, because FMD is highly contagious, it could easily be 

transferred to other livestock, including cattle. 

31 GAO, Standards for Internal Control in the Federal Government, GAO-14-704G 

(Washington, D.C.: September 2014).
Page 18 GAO-17-373 Safety of Beef Imports

agency guidance. Federal standards for internal control state that agency 

management should clearly document—in management directives, 

administrative policies, or operating manuals—the processes it uses to 

ensure it is achieving its objectives. The Office of Management and 

Budget has also emphasized the importance of developing internal 

agency guidance, stating that guidance serves critical functions in 

regulatory programs, channeling the discretion of agency employees, 

enhancing fairness, and ensuring equal treatment of similarly situated 

parties. By developing specific guidance directing staff to document their 

analysis of information supporting animal health system evaluations, 

APHIS could better ensure that it has fairly and consistently evaluated the 

risks associated with beef imports across countries and over time and 

that the process is transparent to the public and other stakeholders.

Further, APHIS does not have a systematic means of storing, organizing, 

and managing the information gathered during an animal health system 

evaluation. We found that documentation submitted by foreign officials, 

information collected during site visits, and written communications with 

foreign officials were stored on a centralized database. But the 

information was not systematically organized according to the eight 

evaluation factors. Such information was commonly stored without any 

consistency in file naming conventions, with some documents filed by the 

date received, by subject matter, or by source, among other methods, 

making it difficult to easily identify which documents supported different 

aspects of the evaluation. Consequently, interested stakeholders may find 

it difficult to replicate APHIS’s evaluation. For example, an official from 

the National Cattlemen’s Beef Association said that the association’s staff 

attempted to replicate the Brazil evaluation, but the lack of organization in 

APHIS documents made it difficult for them to understand how the 

information APHIS gathered had been used to support the final risk

analysis report. In addition, the absence of a document storage, 

organization, and management system may also have delayed APHIS’s 

response to the association’s Freedom of Information Act request for 

documents supporting APHIS’s evaluations of Argentina and Brazil. 

According to an association official, it took almost one year to receive the 

relevant documents regarding the Brazil (14 states) evaluation, and as of 

October 2016, the association had yet to receive documents relevant to 

the Northern Argentina evaluation. In both cases, the National 

Cattlemen’s Beef Association did not receive the documents before the 

public comment period had expired for the proposed rules to lift the import 

prohibition on beef from those regions. The official told us that as a result, 

the association was not able to submit fully informed comments on the 

proposed rules.
Page 19 GAO-17-373 Safety of Beef Imports

According to federal standards for internal control, federal entities are to 

develop an information system that supports the agency’s objectives, 

including processes, data, and technology that allow management to 

obtain, store, and process information. Implementing a standardized 

system for managing relevant information could help APHIS track the 

evaluation process over time and support a more efficient and transparent 

means of satisfying stakeholder requests for information. This may be 

especially important in situations where it takes many years to reach a 

regulatory decision, as was the case with the Argentina and Brazil 

evaluations, which each took about 13 years to complete.

We discussed our preliminary findings with APHIS officials in October 

2016 and December 2016, raising concerns about the lack of (1) written 

guidance for performing animal health system evaluations, (2) analytical 

documentation supporting these evaluations, and (3) a systematic means 

of managing supporting documentation. APHIS officials acknowledged 

that improvements may be necessary in these three areas. Citing our 

preliminary findings, APHIS assembled a team in October 2016 to begin 

developing additional guidance, which the agency expects to implement 

in early 2017. According to APHIS officials, this guidance will better 

explain how documentation and other evidence should be used when 

evaluating foreign animal health systems. The team is also tasked with 

developing a new information management system. In December 2016, 

agency officials said they had developed a prototype for this new 

information management system using a software platform called 

“SharePoint.” The official directing the effort said that APHIS expects to 

begin testing the system soon, and to bring the system into full operation 

in early 2017. According to this official, the new system will be used to 

store, organize, and manage information collected for some of the 

significant earlier foreign animal health system evaluations, as well as for 

future foreign country evaluation requests. This new system will provide 

APHIS the systematic means needed for managing the supporting 

documentation for its animal health system evaluations, including for each 

of the eight evaluation factors, as discussed.
Page 20 GAO-17-373 Safety of Beef Imports

APHIS’s 2011 guidance for evaluating animal health systems directs 

agency staff to complete a trip report for each site visit. Participants in the 

site visit are directed to provide their notes to the review team leader 

within 15 days of returning from the trip. According to the 2011 guidance, 

the trip report should be drafted by the review team leader and must 

include information on the places visited, the reason for visiting each 

place, the information gathered, and a summary of the major findings of 

the site visit team. APHIS officials noted that trip reports prior to issuance 

of the 2011 guidance generally were completed, though it was at the 

discretion of the evaluation team. Similarly, an APHIS official told us that 

the instructions issued in the 2011 guidance were not considered 

mandatory in order to allow some flexibility to accommodate 

circumstances in which staff felt a full report was not needed. For 

example, this official said that some in-country site visits do not warrant a 

trip report, such as those focused only on updating certain aspects of the 

risk analysis, those for which APHIS was confirming that nothing had 

changed since its last in-country site visit, or those for which APHIS 

needed to verify whether changes it had recommended had been 

implemented by the foreign country. However, more senior APHIS 

officials affirmed that trip reports have been a requirement since the 

agency issued the 2011 guidance and should be completed for all incountry site visits.

For the seven countries we reviewed, we found that APHIS did not 

always document in-country site visits, even after trip reports were 

required in 2011. For example, APHIS site visit teams conducted four incountry site visits to Argentina and four to Brazil from 2002 through 2015, 

but did not complete trip reports for any of these eight total in-country site 

visits. Additionally, trip reports were prepared for only five of nine incountry site visits that took place after the 2011 guidance was issued. 

APHIS officials acknowledged that documenting site visits is an important 

task and that some trip reports had not been prepared, but should have 

been. The officials said that they had taken steps to further emphasize to 

staff that agency guidance requires such documentation. Table 1 below 

summarizes the site visits conducted for each of the countries in our 

review and whether a trip report was completed for each of these visits.

APHIS Lacks Adequate 

Guidance for Documenting 

Site Visits and Agency 

Staff Did Not Complete 

Reports for Most Site 

Visits
Page 21 GAO-17-373 Safety of Beef Imports

Table 1: Animal and Plant Health Inspection Service’s (APHIS) In-country Site Visits 

and Whether a Trip Report Was Completed for Selected Countries’ Beef Import 

Evaluations

Country/Region Year of site visit Was an official trip 

report prepared? 

Northern Argentina 2005

2006

2009

2013

No

No

No

No

Brazil (14 States) 2002

2003

2006

2013

No

No

No

No

Colombia 2007

2008

2011

2012

2015

No

No

Yes

Yes

Yes

Japan 2011 Yes

Paraguay 2008

2014

2015

No

No

No

Singapore 2014 Yes

Uruguay 2000

2001

2002

No

No

Yes

Source: GAO analysis of APHIS documents | GAO-17-373

In-country site visits allow APHIS staff to verify and supplement 

information previously gathered. APHIS guidance does not, however, 

direct staff to document the specific steps they took to verify that 

information or determine its reliability. The guidance also does not state 

that staff should document how they analyzed the effectiveness of a 

country’s efforts on each of the eight evaluation factors. As a result, 

where in-country site visits were documented, there was variation in the 

degree to which APHIS staff recorded their specific verification activities 

or on-site analysis. For example, a 2011 trip report for Japan explicitly 

described how the team observed Japanese officials taking steps to 

ensure that meat entering the country had been appropriately treated to 

eliminate pathogens, as required by Japanese agricultural regulations. 

One component of a 2011 trip report for Colombia, however, was less 
Page 22 GAO-17-373 Safety of Beef Imports

explicit about the team’s activities. The trip report stated that the 

evaluation team had found diagnostic lab procedures and tests for FMD 

to be adequate, but did not state what the team had done to determine 

their adequacy.32

APHIS officials said they have not developed specific guidance for 

documenting in-country site visits because each country’s evaluation is 

unique and, as such, the process cannot be standardized. The 

uniqueness of each animal health system evaluation, however, should not 

preclude APHIS from developing a more systematic approach to 

documenting site visit activities. FSIS has developed a standardized 

approach to documenting its analysis of foreign food safety systems, 

including its in-country site visits. Somewhat like the eight factors APHIS 

uses to evaluate foreign animal health systems, FSIS uses six 

components to evaluate a country’s food safety system.33 In contrast to 

APHIS, FSIS directs its staff to clearly document their analysis of each 

country’s food safety system in an electronic “component analysis 

verification form.” The form lays out the criteria—usually regulations—

against which FSIS staff should assess foreign food safety systems. But, 

importantly, it also provides a method for recording both foreign officials’

information submissions to FSIS, and FSIS’s findings and activities—

including those from site visits—in one place and in a consistent format. 

Information that FSIS staff must record in this form includes follow-ups 

with foreign officials, methodologies used to verify information, results of 

verification efforts, and the staff’s final analysis and conclusions. The 

information recorded in the component analysis verification form is later 

included, as appropriate, in a food safety equivalence report.34 Without a 

written trip report, it is difficult to know: (1) how APHIS staff verified 

information they had previously collected or received regarding a 

country’s animal health system; (2) what concerns, if any, staff may have 

 32 Colombia’s FMD evaluation has not yet been completed. APHIS officials told us that 

they intend to include more detailed information on the country’s laboratory diagnostic 

procedures in the final risk analysis report, which will be made available to the public.

33 The six components included in FSIS’s evaluation of a foreign food safety system are 

organization and administration; inspection system operation, product standards, labeling, 

and humane handling; sanitation; hazard analysis and critical control points; chemical 

residues testing; and microbiological testing. To start this evaluation, known as an 

equivalence determination, FSIS asks the relevant foreign government entity to complete 

a self-reporting tool that includes questions related to each of these components.

34 FSIS calls this report an audit report. The report may include, if appropriate, FSIS’s 

tentative determination of equivalence. 
Page 23 GAO-17-373 Safety of Beef Imports

identified during the trip; (3) whether those concerns were communicated 

to country officials; and (4) how country officials responded to these 

concerns.

As discussed, federal standards for internal control state that 

documentation of important agency activities is essential for supporting 

the decision-making process. APHIS guidance states that the review 

team leader should prepare a trip report within 28 days of returning from 

the in-country site visit. Because the results from in-country site visits are 

one component used to determine whether the import prohibition on beef 

should be lifted, such visits should be thoroughly documented. An animal 

health system evaluation can take place over the course of many years, 

and sufficient documentation can enable APHIS to more easily review its 

site visit observations and findings after the passage of time to ensure 

that all potential risks or gaps in information were addressed before the 

agency lifts the import prohibition on beef. Again, one means of ensuring 

that staff understand these documentation requirements is to issue 

guidance clarifying expectations. Federal standards for internal control 

and Office of Management and Budget guidance underscore that internal 

agency guidance is an important tool for helping an organization enhance 

fairness and ensure equal treatment. Guidance that directs staff to 

document their in-country site visit verification activities would help APHIS 

ensure its process is fair, consistent, and transparent to the public and 

other stakeholders.

According to APHIS 2011 guidance, staff should format risk analysis 

reports in accordance with OIE guidelines, but the guidance provides no 

further details on how such reports should be crafted to ensure an 

acceptable level of transparency in accordance with federal quality 

information guidelines. APHIS officials told us that in documenting risk 

analyses, staff use prior risk analysis reports as templates and generally 

structure the reports in line with OIE guidance. Officials said that they 

believe staff observations, methodology, and conclusions are adequately 

incorporated into the risk analyses. According to OIE, the process of 

analyzing risk is inherently subjective, whether the process uses 

quantitative or qualitative analytical techniques. This subjectivity exists, 

according OIE, in large part because some critical data required to 

assess risk may not be readily available or are of uncertain reliability. 

Therefore, it is important that a risk analysis be as transparent as 

possible. The more transparent the analysis, the more defensible the risk 

analysis report will be, according to OIE.

APHIS Lacks Sufficient 

Guidance to Ensure Risk 

Analyses Are 

Transparently 

Documented
Page 24 GAO-17-373 Safety of Beef Imports

Like OIE, the Office of Management and Budget and USDA’s Chief 

Information Officer direct staff drafting documents supporting regulatory 

actions—including risk analyses—to transparently document the 

analytical methods employed, sources of information used, reliability of 

the data or information included in the analysis, and any relevant 

uncertainties and assumptions, among other things.35 The guidelines from 

USDA’s Chief Information Officer suggest that transparency is essential 

to ensuring objectivity in regulatory actions, and that transparency helps 

to clarify key uncertainties as well as assumptions upon which an analysis 

is based.

However, the extent to which APHIS effectively addressed these

transparency guidelines varied in the risk analysis reports we reviewed. 

Some reports provided greater detail on: (1) the methodologies staff used 

to verify information gathered about a country’s animal health system, (2) 

the assumptions they made in conducting their risk analyses, and (3) the 

extent to which the data or information gathered were considered reliable. 

For example, with regard to data reliability, the 2014 risk analysis for 

Croatia stated that APHIS relied upon older data from 2006 to assess the 

country’s international passenger traffic patterns. Because it is suspected 

that people entering a country from areas where FMD is present may 

carry the virus on their clothing or other items, it is important that border 

areas are adequately staffed to identify potential sources that could carry 

and transmit FMD. The 2014 Croatia risk analysis report acknowledges 

that the 2006 data were still relevant, providing an indication of the total 

proportion of passengers typically entering the country via four key 

pathways: land, air, sea, and rail.36 In contrast, in Brazil’s 2015 risk 

analysis report, APHIS described an evaluation of livestock populations 

using animal census data collected sometime between 2000 and 2003 

without explaining why the data were still considered relevant. Substantial 

changes in the size of livestock populations could impact the sufficiency 

of a country’s animal disease surveillance efforts and resources.

 35 Office of Management and Budget, Updated Principles for Risk Analysis, OMB 

Memorandum M-07-24 (Washington D.C.: 2007). USDA’s Office of the Chief Information 

Officer guidelines are based on a provision of the Treasury and General Government 

Appropriations Act for FY 2001 (Pub. L. No. 106–554, §515, 114 Stat. 2763A–153 (2000), 

also known as the Information Quality Act).

36 According to APHIS officials, before lifting the ban on Croatia’s meat imports, APHIS 

obtained more recent data and found that the data did not affect the results of the risk 

analysis because the relative proportion of passengers using each of the pathways had 

not changed significantly.
Page 25 GAO-17-373 Safety of Beef Imports

APHIS also has used a dated study to support consequence 

assessments in four out of seven risk analysis reports we reviewed. 

Specifically, in the reports for Uruguay, Peru, Argentina, and Brazil, 

APHIS cited a 1979 study that estimated the economic impacts of an 

FMD outbreak in the United States. APHIS adjusted the study’s estimates 

to account for changes in prices for some years after 1979—the year the 

study was published—and the year the risk analysis reports were 

prepared.37 But APHIS did not explain in these four risk analysis reports 

how other components of the 1979 study that supported the cost 

estimates—such as the number of livestock that would need to be 

slaughtered or vaccinated in the event of an FMD outbreak, or the 

amount of time needed to sufficiently control an outbreak—were still 

reliable after more than 30 years.38

With regard to sources of information, we found that APHIS’s risk analysis 

reports for both Argentina and Brazil were supported, in part, with 

documents that may only have been available in Spanish and 

Portuguese.39 Although federal regulation and APHIS’s 2011 guidance 

both state that evaluation staff should accept documents only in English 

from foreign officials, an APHIS official said that they require document 

translations only if the documents are critical to the analysis or if no one 

on staff is fluent in the foreign country’s language.40 According to APHIS 

officials, because APHIS had a review team leader on staff who was 

fluent in both Spanish and Portuguese, they did not translate all of the 

documents and used some foreign language versions to support the risk 

 37 The Uruguay (2002) and Peru (2011) risk analyses were adjusted to 2001 dollars using 

the Consumer Price Index, while the Argentina (2015) and Brazil (2015) risk analyses 

were adjusted to 2011 dollars using the Implicit Price Deflator. The Consumer Price Index 

and the Implicit Price Deflator are economic indices used to adjust for inflation, but they 

are calculated differently. The Consumer Price Index uses the weighted average price of a 

basket of consumer goods and services, while the Implicit Price Deflator uses a base 

year’s gross domestic product to make the calculation. 

38 Nasser A. Aulaqi, E. Hunt McCauley, William M. Miller, John C. New, Jr., and W.B. 

Sundquist, A Study of the Potential Economic Impact of Foot-and-Mouth Disease in the 

United States, University of Minnesota, in cooperation with USDA Animal and Plant Health 

Inspection Service, (May 1979). 

39 Because APHIS lacks a consistent organizing scheme for the documentation it has 

received from foreign officials, it was impossible for us to determine if documents 

submitted in Spanish or Portuguese had also been submitted to APHIS in English. The 

foreign language document files did not usually indicate if another version of the file 

existed in English or the name of a corresponding English language file, if any.

40 9 CFR § 92.2(b).
Page 26 GAO-17-373 Safety of Beef Imports

analysis report. However, an official from the National Cattlemen’s Beef 

Association told us that the association found it difficult to fully understand 

APHIS’s analysis because it did not have someone on staff that could 

review the supporting documentation in Spanish or Portuguese. Similar 

concerns regarding a lack of transparency in risk analysis reports were 

raised in comments submitted to APHIS during the public comment 

period for proposed rule changes for Argentina and Brazil beef. In both 

cases, commenters stated that because some of the documentation 

supporting APHIS’s risk analysis was in the country’s native language, 

APHIS’s research methodology and the manner in which the agency 

arrived at its conclusions were not transparent.

With regard to disclosure of assumptions and uncertainties, APHIS 

sometimes did not disclose assumptions or uncertainties about the data 

and information used in its risk analysis reports. APHIS’s evaluation of 

Uruguay entailed a quantitative analysis, unlike the other evaluations we 

reviewed, which were qualitative analyses. According to an APHIS 

official, assumptions and uncertainties are typically disclosed in analyses 

that use mathematical models. Since the risk analysis reports we 

reviewed primarily employed a qualitative analytical approach, such 

disclosures were not necessary, this official said. Guidelines concerning 

transparency issued by the Office of Management and Budget, USDA’s 

Chief Information Officer, and OIE, however, do not indicate that 

disclosures about uncertainties in the data or assumptions made about 

the data used should be limited to only quantitative analyses. One of 

OIE’s guiding principles for risk analysis—whether it be qualitative or 

quantitative in nature—is that it should document assumptions and

uncertainties, and the effect of these on the final risk estimate.

One method of ensuring that agency staff draft risk analysis reports that 

incorporate the vital elements of transparency advocated by the Office of 

Management and Budget, USDA’s Chief Information Officer, and OIE is 

to develop appropriate agency guidance and direct staff to follow it. As 

discussed earlier, federal standards for internal control and the Office of 

Management and Budget underscore the importance of drafting effective 

internal agency guidance to help an organization achieve its goals and 

objectives and enhance fairness, ensuring the equal treatment over time 

of similarly situated parties.

The United States has kept its livestock free of FMD since 1929, 

successfully avoiding the financial losses that typically accompany an 

outbreak, such as those associated with trade bans on exports and the 

slaughter of FMD-infected or potentially-infected animals to stop spread 

Conclusions
Page 27 GAO-17-373 Safety of Beef Imports

of the disease. APHIS has conducted animal health system evaluations 

that entail a substantial effort to gather and analyze a country’s regulatory 

documentation and other relevant information and data. The effort also 

involves in-country site visits to verify information, assess how regulatory 

controls function in practice, and address questions and concerns that 

may arise as a result of the analysis.

But APHIS does not generally document how information gathered was 

analyzed to identify potential weaknesses in a foreign country’s animal 

health system. In addition, trip reports for in-country site visits were not 

always prepared—despite agency guidance directing staff to do so—and, 

when prepared, did not consistently explain how information had been 

verified. Better guidance would help ensure that agency staff understand 

expectations about when and how to record important information 

supporting regulatory activities, and could help ensure that APHIS is 

conducting animal health system evaluations consistently across 

countries and over time. In addition to lacking documentation of key 

activities, APHIS does not have an effective method for storing, 

organizing, and managing information obtained during the course of an 

evaluation. APHIS’s lack of an adequate information management system 

makes it difficult to identify which documents received from foreign 

officials are intended to support various aspects of the evaluation.

Finally, APHIS’s risk analysis reports are not consistently transparent 

because they do not always clearly document the methodology used to 

evaluate key factors of a country’s animal health system, the reliability of 

data used in the risk analysis report, and other important characteristics 

that would help the public understand how a regulatory decision was 

made.

As APHIS moves forward to implement a new information management 

system and begins to draft additional agency guidance, it will need to 

ensure that both serve to mutually enhance transparency of foreign 

animal health system evaluations. In particular, APHIS must ensure:

• that this agency guidance reflects the importance of documenting, 

separately from the final risk analysis report, how analysis of each 

evaluation factor was carried out;

• that this guidance—including requirements to document foreign site 

visits—is not optional; and

• that the risk analysis reports include key characteristics of 

transparency called for in both federal and OIE guidance.
Page 28 GAO-17-373 Safety of Beef Imports

To improve USDA’s evaluations of foreign countries’ animal health 

systems, we recommend that the Secretary of Agriculture direct the 

Administrator of APHIS to take the following three actions:

1. complete its efforts to develop agency guidance, clarifying that

• staff must document, separately from the final risk analysis report, 

how key information gathered about a foreign country’s animal 

health system was analyzed and how the information supports 

each of eight evaluation factors, and

• in-country site visits must be appropriately and consistently 

documented in trip reports and should detail verification activities;

2. complete its efforts to develop an information management system to 

better store, organize, and manage documentation gathered about a 

foreign country’s animal health system; and

3. develop guidance promoting greater transparency in risk analysis 

reports in accordance with the quality information guidelines issued by 

USDA’s Chief Information Officer and guidance from the Office of 

Management and Budget.

We provided a draft of this report to USDA for review and comment. In its 

written comments, reproduced in appendix II, USDA agreed with the 

report’s recommendations. USDA also provided technical comments, 

which we incorporated as appropriate.

In response to our recommendation that APHIS develop agency guidance 

that clarifies that staff must document how key information gathered 

about a foreign country’s animal health system was analyzed and ensure 

that in-country site visits are documented as required, USDA stated that 

APHIS has developed agency guidance addressing the major 

components needed to evaluate information received from foreign

authorities. All staff members have been instructed to use this guidance 

for current and future animal health system evaluations. APHIS also has 

plans to assess use of this guidance in the next 6-12 months to ensure 

that it is working as intended and to identify any needed revisions. To 

assist staff in ensuring their analyses are transparent, consistent, and 

complete, USDA said APHIS has developed a special analytical tool that 

will document information provided to APHIS by foreign authorities and 

provide a method for recording any staff concerns. Existing guidance also 

has been clarified to ensure that staff members understand site visit 

Recommendations for 

Executive Action

Agency Comments 

and Our Evaluation
Page 29 GAO-17-373 Safety of Beef Imports

reports are mandatory, and not optional. Taking these steps will meet the 

intent of our recommendation.

With regard to our recommendation that APHIS develop an information 

management system to better store, organize, and manage its evaluation 

documentation, USDA stated that APHIS has completed a new 

centralized Project Tracking System to better manage the documentation. 

All APHIS staff have access to the system, so all documents can be 

stored in one location. The system includes a Project Tracking Form for 

each evaluation that provides an overview of who is working on the 

project, status of major milestones, and final deliverables when complete. 

USDA said that the new tracking system also establishes a framework for 

each project and allows documents—such as correspondence, 

references, risk analysis, and rulemaking—to be stored in one place. 

Implementing these actions will address our recommendation.

To address our recommendation that USDA develop guidance promoting 

greater transparency in accordance with quality information guidelines 

issued by USDA’s Chief Information Officer and the Office of 

Management and Budget, USDA stated that APHIS will develop such 

guidance and that it will include such things as standards for disclosing 

the reliability of data used in risk assessments, in particular assumptions 

and uncertainties. The guidance also will outline key source documents 

that can be made publicly available along with the final risk assessment 

for an evaluation. In addition, USDA said that APHIS has instructed its 

staff that it is mandatory that all documents submitted by another country 

for an evaluation must be in English. Completion of these steps will 

address the intent of our recommendation. 
Page 30 GAO-17-373 Safety of Beef Imports

We are sending copies of this report to the appropriate congressional 

committees, the Secretary of Agriculture, the Administrator of the Animal 

and Plant Health Inspection Service, and other interested parties. In 

addition, the report is available at no charge on the GAO website at 

http://www.gao.gov.

If you or your staff have any questions about this report, please contact 

me at (202) 512-3841 or morriss@gao.gov. Contact points for our Offices 

of Congressional Relations and Public Affairs may be found on the last 

page of this report. GAO staff who made key contributions to this report 

are listed in appendix III.

Steve D. Morris

Director, Natural Resources and Environment
Page 31 GAO-17-373 Safety of Beef Imports

List of Requesters

The Honorable Michael Conaway

Chairman

Committee on Agriculture

House of Representatives

The Honorable Pete Sessions

Chairman

Committee on Rules

House of Representatives

The Honorable John Cornyn

United States Senate

The Honorable Joe Barton

House of Representatives

The Honorable Michael Burgess

House of Representatives

The Honorable John R. Carter

House of Representatives

The Honorable Jim Costa

House of Representatives

The Honorable Eric “Rick” Crawford

House of Representatives

The Honorable Henry Cuellar

House of Representatives

The Honorable John Culberson

House of Representatives

The Honorable Blake Farenthold

House of Representatives

The Honorable Bill Flores

House of Representatives
Page 32 GAO-17-373 Safety of Beef Imports

The Honorable Louis Gohmert

House of Representatives

The Honorable Kay Granger

House of Representatives

The Honorable Jeb Hensarling

House of Representatives

The Honorable Sam Johnson

House of Representatives

The Honorable Kenny Marchant

House of Representatives

The Honorable Michael McCaul

House of Representatives

The Honorable Pete Olson

House of Representatives

The Honorable Ted Poe

House of Representatives

The Honorable Kurt Schrader

House of Representatives

The Honorable Lamar Smith

House of Representatives

The Honorable Mac Thornberry

House of Representatives

The Honorable Filemon Vela

House of Representatives

The Honorable Randy K. Weber

House of Representatives

The Honorable Roger Williams

House of Representatives
Page 33 GAO-17-373 Safety of Beef Imports

The Honorable Ted S. Yoho

House of Representatives
Appendix I: Objectives, Scope, and 

Methodology

Page 34 GAO-17-373 Safety of Beef Imports

This report addresses the U.S. Department of Agriculture (USDA) Animal 

and Plant Health Inspection Service’s (APHIS) approach to protecting 

U.S. livestock from foot-and-mouth disease (FMD), which may be 

transmitted through beef imports. Specifically, this report examines (1) the 

steps APHIS takes to evaluate the animal health systems of foreign 

countries seeking to export beef to the United States and (2) how 

APHIS’s process could be improved, if at all.

To address these objectives, we reviewed relevant federal statutes and 

applicable federal regulations concerning animal health and trade of 

animal products.1 Additionally, we reviewed federal and World 

Organisation for Animal Health (OIE)2 guidance documents, and a key 

international trade agreement regarding imports of beef. Specifically, we 

reviewed the federal Animal Health Protection Act, as well as APHIS 

guidance documents on evaluating animal health systems and the 

information that is needed for APHIS to conduct such evaluations.3 OIE 

documents we reviewed were the organization’s requirements for FMDfree status and information on conducting and reporting import risk 

analyses.4 International trade agreement documents we reviewed 

included the World Trade Organization’s Sanitary and Phytosanitary 

Measures Agreement signed by member nations and the related 

guidelines on implementing sanitary practices for exported agricultural 

 1 9 C.F.R. part 92, Importation of Animals and Animal Products: Procedures for 

Requesting Recognition of Regions; 9 C.F.R. part 94, Rinderpest, Foot-and-Mouth 

Disease, Newcastle Disease, Highly Pathogenic Avian Influenza, African Swine Fever, 

Classical Swine Fever, Swine Vesicular Disease, and Bovine Spongiform 

Encephalopathy: Prohibited and Restricted Importations.

2 The World Organisation for Animal Health was formerly known as the Office 

International des Epizooties (OIE), and kept its historical acronym of OIE after changing 

names. OIE is an intergovernmental organization created in response to the need to fight 

animal diseases on a global level, and is tasked with improving animal health worldwide. 

One of its stated objectives is to promote safety in international trade of animals and 

animal products.

3 APHIS, Veterinary Services, Regional Evaluation Services, Clarification of Information 

Requested for Recognition of a Region, undated; Process for Foreign Animal Health 

Status Evaluations, Regionalization, Risk Analysis, and Rulemaking, undated; Guidelines 

for Conducting Regionalization Evaluations (September 2011).

4 World Organisation for Animal Health (OIE), Handbook on Import Risk Analysis for 

Animals and Animal Products, Vol. 1 and 2 (Paris, France: 2010); Terrestrial Animal 

Health Code – Import Risk Analysis, Chapter 2 (Paris, France: 2015); and Terrestrial 

Animal Health Code – Infection with FMD Virus, Chapter 8 (Paris, France: 2015).

Appendix I: Objectives, Scope, and 

Methodology
Appendix I: Objectives, Scope, and 

Methodology

Page 35 GAO-17-373 Safety of Beef Imports

products.5 We also identified and analyzed best practices supporting 

transparency in regulatory decision-making suggested by the Office of 

Management and Budget, the Government Accountability Office (GAO’s 

Standards for Internal Control in the Federal Government), and USDA’s 

Chief Information Officer.6 Additionally, we reviewed the Federal Records 

Act, which addresses records management by federal agencies.7 To 

develop an understanding of the challenges USDA faces in ensuring the 

health of U.S. livestock, we reviewed USDA Office of the Inspector 

General’s recent relevant reports on border inspections and import 

controls of beef and live animals.8

To gain a better understanding of APHIS’s process for protecting U.S. 

livestock from FMD, we focused our review on APHIS’s evaluations of the 

animal health systems of seven countries or specific regions within those 

countries. We chose six of the seven countries for review because they 

had the following characteristics: (1) the countries requested an animal 

health system evaluation for FMD for the purpose of exporting beef to the 

United States and (2) APHIS has either completed evaluations and lifted 

the import prohibition on the country’s beef within the past 5 years, or 

APHIS is currently conducting an evaluation to determine whether the 

import prohibition on the country’s beef can be safely lifted. The six 

countries or specific regions within countries we reviewed were: Northern 

Argentina, 14 states in Brazil (comprising a single export region), 

Colombia, Japan, Paraguay, and Singapore. APHIS’s evaluations for 

Northern Argentina, the 14-state region in Brazil, and Japan were 

 5 World Trade Organization, Sanitary and Phytosanitary Measures Agreement, Geneva, 

Switzerland: Jan. 1995; Committee on Sanitary and Phytosanitary Measures, Guidelines 

to Further the Practical Implementation of Article 6 of the Agreement On the Application of 

Sanitary and Phytosanitary Measures, G/SPS/48 (Geneva, Switzerland: May 16, 2008).

6 USDA, Office of the Chief Information Officer, Information Quality Activities. Accessed 

May 26, 2016, https://www.ocio.usda.gov/policy-directives-records-forms/informationquality-activities. Office of Management and Budget, Guidelines for Ensuring and 

Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by 

Federal Agencies; Notice; Republication, FR 8452 (Feb. 22, 2002); and GAO, Standards 

for Internal Control in the Federal Government, GAO-14-704G (Washington, D.C.: 

September 2014). 

7 44 USC §3101, et. seq.

8 U.S. Department of Agriculture, Office of the Inspector General, Animal and Plant Health 

Inspection Service: Transition and Coordination of Border Inspection Activities Between 

USDA and DHS, Report No. 33601-0005-Ch (Washington, D.C.: March 2005); USDA’s 

Controls Over the Importation and Movement of Live Animals, Report No. 50601-0012-Ch 

(Washington, D.C.: March 2008).
Appendix I: Objectives, Scope, and 

Methodology

Page 36 GAO-17-373 Safety of Beef Imports

completed within the past 5 years; evaluations for Colombia, Paraguay, 

and Singapore are ongoing. We also reviewed efforts of one additional 

country, Uruguay, to have the import prohibition on its beef lifted. The 

import prohibition on beef from Uruguay was lifted in 2003, but it is a 

country for which APHIS conducted a quantitative risk analysis, an 

evaluative approach that was not applied to the other six countries in our 

review. For the other six countries we reviewed, APHIS is performing or 

has performed a qualitative risk analysis.9 The information we obtained 

from APHIS’s evaluations of the seven countries we reviewed is not 

generalizable, but provided us with a greater understanding of the key 

steps that comprise a foreign animal health system evaluation.

We did not evaluate the scientific or technical validity of APHIS’s risk 

analyses, nor did we question APHIS’s decisions to lift the import 

prohibition on Argentina, Brazil, Japan, and Uruguay’s beef. Instead, we 

focused our review on APHIS’s process for conducting and documenting 

its evaluations of the animal health systems in the seven countries in our 

review. Additionally, we reviewed APHIS’s animal health system 

evaluations to determine how well the agency incorporated standards for 

documentation and transparency as established in guidance issued by 

USDA’s Chief Information Officer, the Office of Management and Budget,

and GAO. Our analysis of APHIS’s evaluations of the animal health 

systems in these seven countries included a review of available, relevant 

documents gathered from those countries’ officials in support of their 

requests to export beef to the United States, communications between 

APHIS and country officials regarding those documents, APHIS’s written 

reports, and APHIS officials’ notes documenting their in-country 

investigations of foreign animal health systems. We reviewed only 

documents in English, although many supporting documents were in the 

foreign country’s official language. We also interviewed APHIS officials 

with Veterinary Services, National Import Export Services, and 

Regionalization Evaluation Services in Maryland, as well as evaluation 

staff in Maryland and North Carolina who evaluated the beef export 

requests of the seven countries in our review.

To develop an understanding of APHIS’s process for conducting and 

documenting FMD risk analyses, we reviewed the final FMD risk analysis 

 9 A quantitative risk analysis is a method of assessing various aspects of risk—such as 

the likelihood of a beef product becoming infected with a disease prior to export—using a 

mathematical model and expressing that risk numerically. A qualitative risk analysis 

expresses various aspects of risk in non-numerical terms, such as high, medium, or low.
Appendix I: Objectives, Scope, and 

Methodology

Page 37 GAO-17-373 Safety of Beef Imports

reports for Northern Argentina, the 14-state region of Brazil, Japan, and 

Uruguay. (Final risk analysis reports have not yet been prepared for 

Colombia, Paraguay, and Singapore). To further expand our 

understanding of how APHIS conducts and documents FMD risk 

analyses, we also reviewed the only other three countries that, according 

to APHIS, have had risk analysis reports completed within the past 5 

years for FMD: Croatia, Malta, and Peru. These countries sought animal 

health system evaluations for non-beef or unspecified product exports to 

the United States. We also reviewed Food Safety and Inspection Service 

(FSIS) guidance for conducting food safety equivalence evaluations to 

further understand the steps required before a country may begin 

exporting beef to the United States. Finally, we interviewed officials with 

FSIS, which certifies that foreign food safety systems are equivalent to 

the U.S. system; an official with the Canadian Food Inspection Agency, 

which is the Canadian agency responsible for ensuring the safety of food 

products, including beef; and the Chief Veterinarian from the National 

Cattlemen’s Beef Association, a trade group that consists of 28,000 

members and 175,000 beef producers and feeders.

We conducted this performance audit from December 2015 to April 2017, 

in accordance with generally accepted government auditing standards. 

Those standards require that we plan and perform the audit to obtain 

sufficient, appropriate evidence to provide a reasonable basis for our 

findings and conclusions based on our audit objectives. We believe that 

the evidence obtained provides a reasonable basis for our findings and 

conclusions based on our audit objectives.
Appendix II: Comments from the U.S. 

Department of Agriculture

Page 38 GAO-17-373 Safety of Beef Imports

Appendix II: Comments from the U.S. 

Department of Agriculture
Appendix II: Comments from the U.S. 

Department of Agriculture

Page 39 GAO-17-373 Safety of Beef Imports
Appendix II: Comments from the U.S. 

Department of Agriculture

Page 40 GAO-17-373 Safety of Beef Imports
Appendix III: GAO Contact and Staff 

Acknowledgments

Page 41 GAO-17-373 Safety of Beef Imports

Steve D. Morris, (202) 512-3841 or morriss@gao.gov

In addition to the contact named above, James R. Jones, Jr. (Assistant 

Director), Kevin Bray, John Delicath, Barbara El Osta, Justin Fisher, Sara 

Sullivan, Kiki Theodoropoulos, Breanna Trexler, and Ginny Vanderlinde 

made key contributions to this report.

Appendix III: GAO Contact and Staff 

Acknowledgments

GAO Contact

Staff 

Acknowledgments 
Related GAO Products

Page 42 GAO-17-373 Safety of Beef Imports

Emerging Animal Diseases: Actions Needed to Better Position USDA to 

Address Future Risks. GAO-16-132. December 15, 2015.

Biosurveillance: Additional Planning, Oversight, and Coordination Needed 

to Enhance National Capability. GAO-15-664T. July 8, 2015.

Homeland Security: An Overall Strategy Is Needed to Strengthen Disease 

Surveillance in Livestock and Poultry. GAO-13-424. May 21, 2013.

Biosurveillance: Nonfederal Capabilities Should Be Considered in 

Creating a National Biosurveillance Strategy. GAO-12-55. October 31, 

2011.

Influenza Vaccine: Federal Investments in Alternative Technologies and 

Challenges to Development and Licensure. GAO-11-435. June 27, 2011.

Influenza Pandemic: Lessons from the H1N1 Pandemic Should Be 

Incorporated into Future Planning. GAO-11-632. June 27, 2011.

Live Animal Imports: Agencies Need Better Collaboration to Reduce the 

Risk of Animal-Related Diseases. GAO-11-9. November 8, 2010.

Influenza Pandemic: Monitoring and Assessing the Status of the National 

Pandemic Implementation Plan Needs Improvement. GAO-10-73. 

November 24, 2009.

Influenza Pandemic: Gaps in Pandemic Planning and Preparedness 

Need to Be Addressed. GAO-09-909T. July 29, 2009.

Influenza Pandemic: Continued Focus on the Nation’s Planning and 

Preparedness Efforts Remains Essential. GAO-09-760T. June 3, 2009.

Influenza Pandemic: Sustaining Focus on the Nation’s Planning and 

Preparedness Efforts. GAO-09-334. February 26, 2009.

Influenza Pandemic: HHS Needs to Continue Its Actions and Finalize 

Guidance for Pharmaceutical Interventions. GAO-08-671. September 30, 

2008.

Yellowstone Bison: Interagency Plan and Agencies’ Management Need 

Improvement to Better Address Bison-Cattle Brucellosis Controversy.

GAO-08-291. March 7, 2008.

Related GAO Products
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Page 43 GAO-17-373 Safety of Beef Imports

Plum Island Animal Disease Center: DHS Has Made Significant Progress 

Implementing Security Recommendations, but Several 

Recommendations Remain Open. GAO-08-306R. December 17, 2007.

National Animal Identification System: USDA Needs to Resolve Several 

Key Implementation Issues to Achieve Rapid and Effective Disease 

Traceback. GAO-07-592. July 6, 2007.

Influenza Pandemic: Efforts to Forestall Onset Are Under Way; Identifying 

Countries at Greatest Risk Entails Challenges. GAO-07-604. June 20, 

2007.

Avian Influenza: USDA Has Taken Important Steps to Prepare for 

Outbreaks, but Better Planning Could Improve Response. GAO-07-652. 

June 11, 2007.

Plum Island Animal Disease Center: DHS and USDA Are Successfully 

Coordinating Current Work, but Long-Term Plans Are Being Assessed.

GAO-06-132. December 19, 2005.

Mad Cow Disease: An Evaluation of a Small Feed Testing Program FDA 

Implemented in 2003 with Recommendations for Making the Program a 

Better Oversight Tool. GAO-06-157R. October 11, 2005.

Mad Cow Disease: FDA’s Management of the Feed Ban Has Improved, 

but Oversight Weaknesses Continue to Limit Program Effectiveness.

GAO-05-101. February 25, 2005.

Combating Bioterrorism: Actions Needed to Improve Security at Plum 

Island Animal Disease Center. GAO-03-847. September 19, 2003.

Foot and Mouth Disease: To Protect U.S. Livestock, USDA Must Remain 

Vigilant and Resolve Outstanding Issues. GAO-02-808. July 26, 2002.

Mad Cow Disease: Improvements in the Animal Feed Ban and Other 

Regulatory Areas Would Strengthen U.S. Prevention Efforts.

GAO-02-183. January 25, 2002.

(100294)
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