FOOD SAFETY AND 

NUTRITION

FDA Can Build on 

Existing Efforts to 

Measure Progress 

and Implement Key 

Activities

Report to Congressional Requesters

January 2018

GAO-18-174

United States Government Accountability Office
United States Government Accountability Office

Highlights of GAO-18-174, a report to 

congressional requesters

January 2018

FOOD SAFETY AND NUTRITION

FDA Can Build on Existing Efforts to Measure

Progress and Implement Key Activities 

What GAO Found

From the enactment of the FDA Food Safety Modernization Act (FSMA) in 

January 2011 through September 2017, the Food and Drug Administration (FDA)

has conducted numerous food safety- and nutrition-related activities, determining 

its priorities for those activities based on statutes and its strategic goals. More 

specifically, FDA published 33 proposed or final key regulations and 111 draft or 

final key guidance documents, focused mainly on food safety. FDA also 

conducted other key activities related to food safety and nutrition, such as 

conducting inspections and developing risk-assessment tools, responding to 

foodborne illness outbreaks, and providing outreach and education. 

FDA dedicated at least $1 billion annually, including salaries for at least 4,300 

full-time equivalent (FTE) staff, to food safety and nutrition activities in fiscal 

years 2011 through 2016. About 98 percent of those resources were dedicated

to food safety each fiscal year, and about 2 percent were dedicated to nutrition.

Since fiscal year 2011, FDA has set goals for its food safety- and nutritionrelated activities but has not fully developed the necessary framework to assess 

progress toward those goals. Most recently, for fiscal years 2016 through 2025, 

the agency’s Foods and Veterinary Medicine (FVM) Program, which is primarily 

responsible for carrying out these activities, has set a food safety goal to protect 

American consumers from foreseeable hazards and a nutrition goal to foster an 

environment that promotes healthy and safe food choices. These goals are

supported by eight strategic objectives. The program has developed 

performance measures to assess progress toward five of these objectives but 

not for the other three. For each developed performance measure, FDA reports 

both targets set and measurements taken for specific time frames. For one such 

measure related to FDA’s evaluation of food safety hazards, FDA targeted the 

completion of 50 percent of evaluations by their due dates in the first quarter of 

fiscal year 2017 and achieved 89 percent. Leading practices in performance 

management state that federal programs should use performance information to 

achieve program goals, and each objective should be tracked through

performance measures that have targets and time frames. According to agency 

officials, the program is developing additional measures for its food safety- and 

nutrition-related objectives, but it had not finalized them as of January 2018. Until 

the program develops measures with associated targets and time frames for all 

eight objectives, FDA cannot fully assess progress toward achieving its goals.

FDA has identified food safety- and nutrition-related activities that it plans to 

undertake in fiscal year 2018, but its time frames for such activities in the longer 

term are unclear. According to FDA officials, the agency plans to pursue the food 

safety and nutrition strategies identified in the FVM Program’s 10-year strategic 

plan. However, the specific time frames for the activities that would support those 

strategies are unclear because FDA has not developed a plan that includes 

actions, priorities, and milestones to implement the strategic plan. The strategic 

plan states that the FVM Program will develop such an implementation plan, and 

FDA officials told GAO that they expected to complete one, but as of January

2018, they had not done so. Until the program completes such an 

implementation plan, it will be difficult for FDA to ensure it is prioritizing and 

sequencing the necessary actions to achieve the program’s objectives.

View GAO-18-174. For more information, 

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

morriss@gao.gov.

Why GAO Did This Study

FDA is responsible for overseeing the 

safety of about 80 percent of the 

nation’s food supply and for promoting

good nutrition. Federal oversight of 

food safety has been on GAO’s highrisk list since 2007. According to FDA, 

FSMA aims to improve food safety by 

shifting FDA’s focus toward preventing 

food contamination, rather than 

responding to foodborne illnesses.

GAO was asked to review FDA’s food 

safety- and nutrition-related activities 

and resources. This report examines 

(1) FDA’s key food safety- and 

nutrition-related activities since 

FSMA’s enactment in 2011 and how 

FDA determined its priorities for those 

activities, (2) the resources FDA 

dedicated to those activities in fiscal 

years 2011 through 2016, (3) the 

extent to which FDA set goals for those 

activities in fiscal years 2011 through 

2017 and is assessing progress toward 

those goals, and (4) FDA’s planned

food safety- and nutrition-related

activities and associated time frames. 

GAO analyzed FDA documents and 

data for fiscal years 2011 through 2018 

and interviewed FDA officials.

What GAO Recommends

GAO is making three 

recommendations, including that FDA 

(1) develop performance measures 

with associated targets and time 

frames for all eight of its food safetyand nutrition-related objectives and (2) 

complete a plan that includes specific 

actions, priorities, and milestones for 

implementing the FVM Program’s

strategic plan. The agency agreed with 

GAO’s recommendations and identified 

actions to implement them.
Page i GAO-18-174 FDA Food Safety and Nutrition

Letter 1

Background 8

FDA Has Conducted Numerous Key Food Safety- and NutritionRelated Activities, Determining Its Priorities Based on Statutes 

and Strategic Goals 14

FDA Dedicated at Least $1 Billion per Year, Including Salaries for 

at Least 4,300 FTEs, to Food Safety- and Nutrition-Related 

Activities in 2011 through 2016 22

FDA Has Set Goals for Food Safety- and Nutrition-Related 

Activities Every Year since 2011 but Cannot Fully Assess 

Progress 28

FDA’s Planned Food Safety- and Nutrition-Related Activities to 

Focus on FSMA Implementation in 2018, but Time Frames for 

Longer-Term Activities Are Unclear 33

Conclusions 39

Recommendations for Executive Action 40

Agency Comments 40

Appendix I Key FDA Food Safety- and Nutrition-Related Regulations and 

Guidance Published from January 2011 through September 2017 42

Appendix II FDA Resources for Food Safety- And Nutrition-Related Activities, 

Fiscal Years 2011 through 2016 54

Appendix III FDA Performance Measures for Food Safety- and Nutrition-Related 

Activities, Fiscal Year 2017 60

Appendix IV FDA Foods and Veterinary Medicine Program’s Goals, Objectives, 

and Strategies for Food Safety and Nutrition, Fiscal Years 2016 

through 2025 64

Appendix V Comments from the Department of Health and Human Services 67

Contents
Page ii GAO-18-174 FDA Food Safety and Nutrition

Appendix VI GAO Contact and Staff Acknowledgments 70

Related GAO Products 71

Tables

Table 1: FDA Obligations, Including Salaries for Full-Time 

Equivalent (FTE) Staff, for Food Safety-Related Activities, 

by Agency Component, for Fiscal Years 2011 through 

2016 23

Table 2: FDA Obligations, Including Salaries for Full-Time 

Equivalent (FTE) Staff, for Nutrition-Related Activities, by 

Agency Component, for Fiscal Years 2011 through 2016 26

Table 3: Foods and Veterinary Medicine Program Strategic 

Planning Framework for Food Safety- and NutritionRelated Activities, from Fiscal Years 2016 through 2025 

Strategic Plan 29

Table 4: Key Food Safety- and Nutrition-Related Regulations 

Published by FDA from January 2011 through September 

2017 44

Table 5: Key Food Safety- and Nutrition-Related Guidance 

Published by FDA from January 2011 through September 

2017 47

Table 6: Obligations, Including Salaries for Full-Time Equivalent 

(FTE) Staff, Dedicated by FDA’s Center for Food Safety 

and Applied Nutrition to Food Safety- and NutritionRelated Activities, Fiscal Years 2011 through 2013 56

Table 7: Obligations, Including Salaries for Full-Time Equivalent 

(FTE) Staff, Dedicated by FDA’s Center for Food Safety 

and Applied Nutrition to Food Safety- and NutritionRelated Activities, Fiscal Years 2014 through 2016 57

Table 8: Obligations, Including Salaries for Full-Time Equivalent 

(FTE) Staff, Dedicated by FDA’s Center for Veterinary 

Medicine to Food Safety-Related Activities, Fiscal Years 

2011 through 2016 58

Table 9: Obligations, Including Salaries for Full-Time Equivalent 

(FTE) Staff, Dedicated by FDA’s National Center for 

Toxicological Research to Food Safety-Related Activities, 

Fiscal Years 2011 through 2016 58
Page iii GAO-18-174 FDA Food Safety and Nutrition

Table 10: Obligations, Including Salaries for Full-Time Equivalent 

(FTE) Staff, Dedicated by FDA’s Office of Regulatory 

Affairs to Food Safety- and Nutrition-Related Activities, 

Fiscal Years 2011 through 2016 59

Table 11: FDA Foods and Veterinary Medicine (FVM) Program 

Performance Measures for Food Safety-Related Activities 

in Fiscal Year 2017, by Measure Title and Office or Center 61

Table 12: FDA Foods and Veterinary Medicine (FVM) Program 

Performance Measures for Nutrition-Related Activities in 

Fiscal Year 2017, by Measure Title and Office or Center 63

Table 13: Food and Drug Administration’s (FDA) Foods and 

Veterinary Medicine (FVM) Program’s Goals, Objectives, 

and Strategies for Food Safety and Nutrition, Fiscal Years 

2016 through 2025 64

Figure

Figure 1: FDA Offices and Centers Responsible for Food Safetyand Nutrition-Related Activities 9
Page iv GAO-18-174 FDA Food Safety and Nutrition

Abbreviations

congressional Justification of Estimates for Appropriations 

budget justification Committees

FDA Food and Drug Administration 

FFDCA Federal Food, Drug, and Cosmetic Act 

FSMA FDA Food Safety Modernization Act 

FTE full-time equivalent 

FVM Foods and Veterinary Medicine 

GPRA Government Performance and Results Act 

GPRAMA GPRA Modernization Act of 2010 

OMB Office of Management and Budget

Unified Agenda Unified Agenda of Federal Regulatory and 

 Deregulatory Actions 

USDA U.S. Department of Agriculture

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Page 1 GAO-18-174 FDA Food Safety and Nutrition

441 G St. N.W.

Washington, DC 20548

January 31, 2018

The Honorable Lamar Alexander

Chairman

Committee on Health, Education, Labor, and Pensions

United States Senate

The Honorable Pat Roberts

United States Senate

In January 2011, the FDA Food Safety Modernization Act (FSMA) was 

signed into law,1 representing the largest expansion and overhaul of U.S. 

food safety authorities since the 1930s, according to Department of 

Health and Human Services’ Food and Drug Administration (FDA) 

documents. FSMA aims to improve food safety by shifting FDA’s focus 

toward preventing food contamination, rather than responding to 

foodborne illnesses after they have occurred, FDA documents state. The 

U.S. food supply is generally considered safe, but foodborne illness is still 

a common and costly—yet largely preventable—public health problem. 

The Centers for Disease Control and Prevention estimates that every 

year, as a result of foodborne illness, roughly 1 in 6 Americans (48 million 

people) gets sick, 128,000 are hospitalized, and 3,000 die.2 According to 

a May 2015 estimate by the U.S. Department of Agriculture (USDA), the 

15 most common foodborne pathogens in the United States together 

impose an annual economic burden of over $15.5 billion based on 

illnesses, hospitalizations, and deaths.3

 1

Pub. L. No. 111-353, 124 Stat. 3885 (2011).

2

Elaine Scallan, Robert M. Hoekstra, Frederick J. Angulo, et al., “Foodborne Illness 

Acquired in the United States—Major Pathogens,” Emerging Infectious Diseases, vol. 17, 

no. 1 (2011).

3

Sandra Hoffmann, Bryan Maculloch, and Michael Batz, "Economic Burden of Major 

Foodborne Illnesses Acquired in the United States" (Washington, D.C.: Economic 

Research Service, U.S. Department of Agriculture, May 2015). The economic burden is 

stated in 2013 dollars. Pathogens are disease-causing organisms, including bacteria such 

as Salmonella, that can be transferred from food animals to the human population; some 

pathogens can cause foodborne illness.

Letter
Page 2 GAO-18-174 FDA Food Safety and Nutrition

FDA is responsible for overseeing the safety of about 80 percent of the 

nation’s food supply,4 including animal food.5 FSMA provides FDA with 

new enforcement authorities designed to achieve higher rates of

compliance with prevention- and risk-based food safety standards and to 

better respond to and contain problems when they do occur—such as 

through mandatory recalls of food products that will cause serious 

adverse health consequences or death. According to a 2016 

Congressional Research Service report, FSMA also requires FDA to 

develop more than 50 regulations,6 guidelines, and studies to improve 

food safety.7 For example, the act requires FDA to develop new, 

prevention-oriented regulations for the production of foods consumed by 

humans or animals.

FDA, in addition to being responsible for ensuring the safety of most 

foods, is responsible for ensuring that those foods are properly labeled. 

According to FDA officials, the agency conducts a range of activities to 

improve nutritional status in humans and animals and to reduce the 

prevalence of diet-related risk factors for chronic disease. These activities 

include ensuring that food labels for most foods under its jurisdiction 

contain required nutrition information.8 As part of its nutrition activities, 

FDA maintains educational information, databases, and disclosures 

related to food ingredients.

 4

USDA’s Food Safety and Inspection Service is responsible for the safety of meat, poultry, 

processed egg products, and catfish. FDA is responsible for virtually all other food. 

5

Animal food is made for a variety of species, including livestock from which humans 

obtain food, pet animals, and laboratory animals. We have previously reported that the 

safety of animal food is important not only for the health of animals but also for the health 

of humans. For example, contaminated food for livestock can cause harm both to the 

livestock and to humans that consume the livestock. See GAO, Food Safety: FDA 

Coordinating with Stakeholders on New Rules but Challenges Remain and Greater Tribal 

Consultation Needed, GAO-16-425 (Washington, D.C.: May 19, 2016).

6

We use the terms regulations and rules interchangeably in this report.

7

Congressional Research Service, Implementation of the FDA Food Safety Modernization 

Act (FSMA, P.L. 111-353), R43724 (Washington, D.C.: Dec. 16, 2016). 

8

Nutrition labeling for raw fruits and vegetables, as well as raw fish, is voluntary.
Page 3 GAO-18-174 FDA Food Safety and Nutrition

In fiscal year 2016, FDA centers and offices obligated about $1.3 billion 

for food safety- and nutrition-related activities.9 According to the agency, 

FDA will need additional funding increases to maintain momentum toward 

full implementation of FSMA. More specifically, FDA has stated that 

additional funding would assist the agency, its state partners, and the 

food industry in fully implementing FSMA.10 In the first years after FSMA’s 

enactment, FDA was focused on developing key regulations, conducting 

stakeholder outreach, planning for the implementation of associated 

rules, investing in state partnerships, and increasing inspection oversight 

for both domestic and foreign-produced food. FDA estimates that it has 

received a total net increase of approximately $266 million in additional 

funding for FSMA implementation in fiscal years 2011 through 2017.

Federal oversight of food safety has been on our list of areas at high risk 

in the federal government since 2007, when we added it because of risks 

to the economy, public health, and safety; we have reported that the 

fragmented federal food safety system has caused inconsistent oversight, 

ineffective coordination, and inefficient use of resources among the 16 

agencies that collectively administer it.11 In addition, we have found 

shortcomings in FDA’s oversight of seafood, dietary supplements, and 

 9

This $1.3 billion includes obligations for some activities not related to food safety or 

nutrition, such as those related to FDA’s oversight of cosmetics. An obligation is a definite 

commitment that creates a legal liability of the government to make payment for goods 

and services received or a legal duty that could mature into a legal liability by virtue of 

actions beyond the control of the federal government. FDA obligates funds, for example, 

when it awards a grant, signs a contract, purchases a service, or takes other actions that 

require the government to make payments. Other federal agencies with food safety and 

nutrition oversight responsibilities, including USDA, also obligate funds to implement these 

responsibilities.

10Food and Drug Administration, “The Context and History of FSMA Funding” 

(Washington, D.C.: Feb. 22, 2016),

https://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM436591.pdf, 

accessed November 20, 2017.

11Our high-risk program has focused attention on government operations with greater 

vulnerabilities to fraud, waste, abuse, and mismanagement or that are in need of 

transformation to address economy, efficiency, or effectiveness challenges. See GAO, 

High-Risk Series: An Update, GAO-07-310 (Washington, D.C.: January 2007), and HighRisk Series: Progress on Many High-Risk Areas, While Substantial Efforts Needed on 

Others, GAO-17-317 (Washington, D.C.: Feb. 15, 2017). 
Page 4 GAO-18-174 FDA Food Safety and Nutrition

other matters.12 We have made numerous recommendations to improve 

FDA’s oversight, and the agency has implemented some of them. We 

have also previously found that FDA faced performance management 

challenges,13 but the agency has made progress in addressing some of 

those challenges in recent years. For example, FDA implemented our 

recommendations to more clearly demonstrate the alignment of activities 

to strategic goals and to expand its capacity to collect and analyze 

performance information.

In January 2011, the statutory framework for performance management in 

the federal government, established by the Government Performance and 

Results Act (GPRA), was updated by the GPRA Modernization Act of 

2010 (GPRAMA).14 As part of our previous work, we examined strategic 

plans, which are required by GPRAMA. Specifically, the act requires 

agencies to complete strategic plans in which the agencies define their 

missions, establish results-oriented goals, and identify objectives and 

strategies needed to achieve those goals. GPRAMA also requires 

agencies to use performance information to assess their progress toward 

strategic goals. GPRAMA requirements apply at the departmental or 

agency level, not to organizational components. We have previously 

reported, however, that the requirements can serve as leading practices 

at other organizational levels within federal agencies, such as component 

agencies, offices, programs, and projects.15

You asked us to examine FDA’s food safety- and nutrition-related 

activities and resources since FSMA’s enactment in fiscal year 2011. This 

report examines (1) key food safety- and nutrition-related activities that 

 12For example, see GAO, Imported Seafood Safety: FDA and USDA Could Strengthen 

Efforts to Prevent Unsafe Drug Residues, GAO-17-443 (Washington, D.C.: Sept. 15, 

2017); Dietary Supplements: FDA May Have Opportunities to Expand Its Use of Reported 

Health Problems to Oversee Products, GAO-13-244 (Washington, D.C.: Mar. 18, 2013); 

and Imported Food Safety: FDA’s Targeting Tool Has Enhanced Screening, but Further 

Improvements Are Possible, GAO-16-399 (Washington, D.C.: May 26, 2016).

13GAO, Food and Drug Administration: Opportunities Exist to Better Address Management 

Challenges, GAO-10-279 (Washington, D.C.: Feb. 19, 2010).

14Pub. L. No. 111-352, 124 Stat. 3866 (2011). GPRAMA amends provisions of GPRA, 

Pub. L. No. 103-62, 107 Stat. 285.

15See GAO, Motor Carriers: Better Information Needed to Assess Effectiveness and 

Efficiency of Safety Interventions, GAO-17-49 (Washington, D.C.: Oct. 27, 2016) and 

Environmental Justice: EPA Needs to Take Additional Actions to Help Ensure Effective 

Implementation, GAO-12-77 (Washington, D.C.: Oct 6, 2011).
Page 5 GAO-18-174 FDA Food Safety and Nutrition

FDA has conducted since FSMA’s enactment and how FDA determined 

its priorities for those activities; (2) the resources, including personnel, 

that FDA dedicated to food safety- and nutrition-related activities in fiscal 

years 2011 through 2016; (3) the extent to which FDA set goals for food 

safety- and nutrition-related activities in fiscal years 2011 through 2017 

and is assessing progress toward those goals; and (4) FDA’s planned 

activities related to food safety and nutrition and the time frames for those 

activities.

For all objectives, we reviewed documents from FDA and other sources, 

and we interviewed knowledgeable FDA officials. We generally focused 

on FDA activities related to food for humans and feed for livestock 

animals (animal feed), and we generally excluded activities concerning 

veterinary medicine or related substances, such as growth hormones or 

antibiotics.16

To describe key food safety- and nutrition-related activities that FDA has 

conducted since FSMA’s enactment, we reviewed FDA documentation 

describing actions the agency has undertaken since FSMA’s enactment 

in January 2011 through September 2017. These documents include 

FDA’s Justification of Estimates for Appropriations Committees 

(congressional budget justifications) for fiscal years 2012 through 2018, 

as well as FDA food safety- and nutrition-related regulations and 

guidance published from January 2011 through September 2017. To 

compile and verify lists of key regulations and guidance, we analyzed 

several sources, including (1) the Unified Agenda of Federal Regulatory 

and Deregulatory Actions (Unified Agenda), (2) the Federal Register,

17

and (3) various FDA websites.18 In addition, we evaluated FDA’s written 

 16We included activities and resources related to animal drug products and antimicrobial 

resistance to the extent that they are related to food safety and are included as a subset of 

the Center for Veterinary Medicine’s food safety resources. For example, the use of 

antimicrobial drugs in feed or water of food-producing animals may affect public health 

and the risk of antimicrobial resistance development. 

17The Unified Agenda, published biannually by the Office of Management and Budget 

(OMB), is a compilation of information about federal agencies’ planned rulemaking 

actions. To identify FDA’s planned food safety- and nutrition-related rulemaking actions 

since FSMA’s enactment, we reviewed each Unified Agenda published from January 2011 

through August 2017. To verify the actions taken by FDA, we then compared these 

planned actions with the draft and final food safety- and nutrition-related regulations 

published in the Federal Register.

18The FDA websites include “FSMA Rules & Guidance for Industry,” “Food Guidance 

Documents,” and “Search for FDA Guidance Documents.”
Page 6 GAO-18-174 FDA Food Safety and Nutrition

responses to our questions on this topic, and we updated our lists of key 

food safety- and nutrition-related regulations and guidance, as 

appropriate. Using FDA’s descriptions of food safety and nutrition—for 

example, those from FDA’s strategic plans and interviews with agency 

officials—we took several steps to categorize the regulations and 

guidance as being related to food safety, nutrition, or both. (App. I 

contains a detailed discussion of the methodology used to compile our 

lists of key regulations and guidance.)

To assess how FDA determined its priorities for the food safety- and 

nutrition-related activities it conducted since FSMA’s enactment, we 

interviewed agency officials about their processes for determining food 

safety- and nutrition-related priorities, including their decisions to issue 

regulations and guidance. We then reviewed relevant statutes and 

regulations, strategic plans, and documentation describing FDA’s

decision-making processes to verify what agency officials told us. We 

also compared FDA’s processes for determining priorities with 

commitments that FDA has made as part of an agency initiative to 

promote transparency and with federal standards for internal controls.19

To describe the resources, including personnel, that FDA dedicated to 

food safety- and nutrition-related activities in fiscal years 2011 through 

2016, we collected and analyzed FDA’s data on its obligations and fulltime equivalent (FTE) staff for these activities during these fiscal years.20

To assess the reliability of FDA’s data, we reviewed FDA’s methodology 

for producing the data, interviewed knowledgeable agency officials, and 

conducted tests to identify obvious errors, outliers, and missing 

information. We determined that the data were sufficiently reliable for the 

purposes of our reporting objectives. Appendix II contains a detailed 

discussion of the methodology used to compile these data.

 19GAO, Standards for Internal Control in the Federal Government, GAO-14-704G 

(Washington, D.C.: September 2014). 

20FTEs reflect the total number of regular, straight-time hours (i.e., hours that exclude 

overtime and holiday hours) worked by employees, divided by the number of 

compensable hours applicable to each fiscal year. One FTE is equivalent to about 2,080 

hours of work. Budget authority is authority provided by federal law for an agency to enter 

into financial obligations that will result in immediate or future outlays involving federal 

government funds. During our review, the most recent data available on FDA’s budget 

authority, obligations, and FTEs for food safety and nutrition were for fiscal year 2016.
Page 7 GAO-18-174 FDA Food Safety and Nutrition

To determine the extent to which FDA has set goals for food safety- and 

nutrition-related activities since fiscal year 2011, we reviewed relevant 

strategic planning documents, such as those for FDA’s Foods and 

Veterinary Medicine (FVM) Program, which is primarily responsible for 

carrying out FDA’s food safety- and nutrition-related activities. To 

determine how FDA is assessing its progress toward goals for these 

activities, we collected and analyzed information on performance 

measures for which FDA established targets in fiscal year 2017. We also 

interviewed agency officials about their performance management 

practices, including the FVM Program’s efforts to assess progress, and 

reviewed leading practices in performance management.21 Appendix III 

contains a detailed discussion of the methodology used in our analysis.

To describe FDA’s planned activities related to food safety and nutrition 

and to examine the time frames for those activities, we reviewed 

documents such as FDA’s congressional budget justification for fiscal 

year 2018,22 the FVM Program’s 10-year strategic plan, and written 

testimonies by FDA officials. We also compared the extent to which FDA 

established time frames for activities and goals with leading practices in 

strategic planning.23 To identify FDA’s planned food safety- and nutritionrelated regulations, we reviewed the Unified Agenda published in August 

2017, and to identify the agency’s planned guidance, we analyzed draft 

guidance that FDA had published since January 2011 that agency 

officials indicated would be finalized in the future. In addition, we reviewed 

relevant executive orders and interviewed knowledgeable agency officials 

to describe the extent to which FDA anticipated that the agency’s planned 

priorities for food safety- and nutrition-related activities might change.

 21See GAO, Agency Performance Plans: Examples of Practices That Can Improve 

Usefulness to Decisionmakers, GAO/GGD/AIMD-99-69 (Washington, D.C.: Feb. 26, 

1999). 

22Department of Health and Human Services, Fiscal Year 2018: Food and Drug 

Administration, Justification of Estimates for Appropriations Committees.

23See, for example, GAO, Defense Health Care Reform: Actions Needed to Help Ensure 

Defense Health Agency Maintains Implementation Progress, GAO-15-759 (Washington, 

D.C.: Sept. 10, 2015); Streamlining Government: Key Practices from Select Efficiency 

Initiatives Should Be Shared Governmentwide, GAO-11-908 (Washington, D.C.: Sept. 30, 

2011); Biobased Products: Improved USDA Management Would Help Agencies Comply 

with Farm Bill Purchasing Requirements, GAO-04-437 (Washington, D.C.: Apr. 7, 2004); 

and Results-Oriented Cultures: Implementation Steps to Assist Mergers and 

Organizational Transformations, GAO-03-669 (Washington, D.C.: July 2, 2003). 
Page 8 GAO-18-174 FDA Food Safety and Nutrition

We conducted this performance audit from October 2016 to January 2018 

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.

This section provides information on FDA’s organizational structure for 

food safety and nutrition, relevant federal statutes, and processes for 

developing federal regulations and guidance.

FDA is responsible for protecting and promoting public health by (1) 

ensuring the safety of food and animal feed, cosmetics, and radiationemitting products; (2) ensuring the safety, effectiveness, and security of 

human and animal drugs, biological products, and medical devices; and 

(3) regulating tobacco products. Regarding food safety and nutrition 

specifically, the mission of the agency’s FVM Program—overseen by 

FDA’s Office of Foods and Veterinary Medicine—is to promote human 

health by preventing foodborne illness and fostering good nutrition. The 

FVM Program contains two components—the Foods Program and the 

Animal Drugs and Feeds Program—which are managed by the Center for 

Food Safety and Applied Nutrition and the Center for Veterinary Medicine, 

respectively. In addition, the Office of Regulatory Affairs is responsible for 

food safety- and nutrition-related regulatory actions, and the National 

Center for Toxicological Research conducts research, in part, to improve 

FDA’s ability to assess the safety of regulated products, including food. 

(See fig. 1 for an excerpt of FDA’s organizational chart showing the 

offices and centers that are responsible for food safety- and nutritionrelated activities.)

Background

FDA Organizational 

Structure for Food Safety 

and Nutrition
Page 9 GAO-18-174 FDA Food Safety and Nutrition

Figure 1: FDA Offices and Centers Responsible for Food Safety- and NutritionRelated Activities

The FDA offices and centers responsible for carrying out food safety- and 

nutrition-related activities, according to agency documents, are as follows:

• The Office of Foods and Veterinary Medicine is responsible for 

providing leadership and strategic direction to the FVM Program and 

for overseeing all Center for Food Safety and Applied Nutrition and 

Center for Veterinary Medicine activities. In addition, to rapidly detect 

and respond to major foodborne illness outbreaks, the office is to 

coordinate activities across FDA field and compliance offices; other 

federal agencies, such as USDA and the Centers for Disease Control 

and Prevention; state investigative and laboratory resources; and 

local resources. The office also is responsible for leading external 

communications and stakeholder engagement and for coordinating 

FVM Program-wide resource planning.

• Within the Center for Food Safety and Applied Nutrition, the Foods 

Program’s food safety responsibilities include (1) conducting and 

supporting food safety research, (2) developing and overseeing 

enforcement of food safety and quality regulations, (3) coordinating 

and evaluating FDA’s food surveillance and compliance programs, (4) 

coordinating and evaluating states’ food safety activities, and (5) 
Page 10 GAO-18-174 FDA Food Safety and Nutrition

developing and disseminating food safety and regulatory information 

to consumers and industry. In addition to improving food safety, the 

Foods Program carries out nutrition-related activities, such as 

regulating food labeling and promoting a healthy food supply to 

reduce the hundreds of thousands of deaths each year attributable to 

poor diet.

• The Center for Veterinary Medicine administers the Animal Drugs and 

Feeds Program, whose purposes include (1) protecting the safety of 

feed and devices for animals and (2) ensuring the safety and 

effectiveness of animal drugs.

• The Office of Regulatory Affairs carries out field activities—including 

inspections, sample collections, and import exams—in collaboration 

with the Center for Food Safety and Applied Nutrition’s Foods 

Program and with the Center for Veterinary Medicine’s Animal Drugs 

and Feeds Program. The Office of Regulatory Affairs is overseen by 

the Office of Global Regulatory Operations and Policy and is not part 

of the Office of Foods and Veterinary Medicine.

• The National Center for Toxicological Research conducts peerreviewed research to advance scientific approaches and tools 

required to support public health and to improve FDA’s ability to 

assess the safety of regulated products. The center’s purpose is to 

enhance the agency’s basis for science-based regulatory decisions by 

conducting collaborative research to help reduce and rapidly detect 

contaminants in food products, among other things. The center is 

overseen by the Office of the Chief Scientist.

FDA is responsible for implementing several statutes that have food 

safety- or nutrition-related elements, including the following:

• Federal Food, Drug, and Cosmetic Act (FFDCA).

24 Under this act 

and its implementing regulations, FDA oversees the safety of most of 

the U.S. food supply.25 Among other things, FDA has the authority 

under the act to seek an order to remove any food from the market if 

the food is unsafe. The agency can also pursue enforcement action

against those marketing such a food.

 2421 U.S.C. §§ 301-399g.

25USDA, under its authority, is responsible for the safety of meat, poultry, processed egg 

products, and catfish.

Key Food-Related Laws
Page 11 GAO-18-174 FDA Food Safety and Nutrition

• FSMA.

26 This law amended the FFDCA by expanding FDA’s food 

safety authorities and responsibilities in five major areas: (1) requiring 

the development of prevention-oriented standards for food processing 

facilities and farms; (2) establishing mandatory inspection frequencies 

for domestic and foreign food facilities, based on risk; (3) 

implementing programs to improve oversight of imported products; (4) 

granting FDA additional enforcement tools, such as mandatory recalls 

and suspension of registration of food facilities; and (5) mandating 

that FDA take steps that, when taken, would better integrate its food 

safety oversight with that of states, localities, tribes, and territories.

• National Nutrition Monitoring and Related Research Act of 

1990.

27 Under this act, the Department of Health and Human Services 

and USDA are required to review and update a report entitled Dietary 

Guidelines for Americans, containing nutritional and dietary 

information and guidelines for the general public, at least every 5 

years. These guidelines, which were most recently issued in 

December 2015, serve as the basis for federal nutrition policies—such 

as policies pertaining to updating and expanding food labels. The act 

requires the guidelines to be based on current scientific and medical 

knowledge.

• Nutrition Labeling and Education Act of 1990.

28 This act requires 

nutrition labeling of most foods and dietary supplements. The act 

excludes labeling of food sold in restaurants.

• Patient Protection and Affordable Care Act.

29 This 2010 act, 

among other things, amended the FFDCA in a number of ways, 

including by mandating that FDA require disclosure of calorie and 

other nutrition information for standard menu items in certain 

restaurants and retail food establishments.

Federal regulatory agencies, such as FDA, have authority and 

responsibility for developing and issuing regulations. Regulations are 

legally binding and are one of the principal tools that the federal 

government uses to implement public policy. Agencies’ rulemaking 

processes generally share three basic steps or phases: initiation of 

 26Pub. L. No. 111-353.

27Pub. L. No. 101-445, 104 Stat. 1034.

28Pub. L. No. 101-535, 104 Stat. 2353.

29Pub. L. No. 111-148 § 4205, 124 Stat. 119, 573 (2010).

Federal Regulation and 

Guidance Development 

Processes
Page 12 GAO-18-174 FDA Food Safety and Nutrition

rulemaking actions, development of proposed rules, and development of 

final rules.30 The Administrative Procedure Act, among other things, 

establishes the basic process by which all federal agencies develop and 

issue regulations.31 The act generally requires agencies to first publish a 

notice of proposed rulemaking in the Federal Register. After giving 

interested persons an opportunity to comment on the proposed rule, the 

agency may then publish the final rule. Regulatory actions can be 

categorized as significant—which includes actions that are economically 

significant—or non-significant under Executive Order 12866.32 According 

to the Office of Management and Budget (OMB), the majority of rules 

issued every year by executive agencies are not significant regulatory 

actions.

Guidance is not legally binding and is often used by agencies for 

clarifying or interpreting a statute or regulations.33 Agencies produce and 

issue the bulk of guidance—guidance that is considered non-significant—

without government-wide standards for those processes. An OMB Bulletin 

establishes policies and procedures for the development, issuance, and 

use of “significant” guidance,34 but most guidance does not fit into this 

 30See GAO, Federal Rulemaking: Improvements Needed to Monitoring and Evaluation of 

Rules Development as Well as to the Transparency of OMB Regulatory Reviews, 

GAO-09-205 (Washington, D.C.: Apr. 20, 2009). 

315 U.S.C.§ 553. Originally enacted in 1946, the Administrative Procedure Act, ch. 324, 60 

Stat. 237 (1946), was repealed and codified in scattered sections of title 5 of the U.S. 

Code as part of the 1966 revision of title 5. In addition to the requirements under the 

Administrative Procedure Act, an agency may also need to comply with requirements 

imposed by other statutes.

32Exec. Order No. 12866, Regulatory Planning and Review (Washington, D.C.: Sept. 30, 

1993). 

33See GAO, Regulatory Guidance Processes: Selected Departments Could Strengthen 

Internal Control and Dissemination Practices, GAO-15-368 (Washington, D.C.: Apr. 16, 

2015). 

34See Office of Management and Budget, Final Bulletin for Agency Good Guidance 

Practices, 72 Fed. Reg. 3432 (Jan. 25, 2007), and GAO-15-368. The OMB Bulletin directs 

each agency to develop written procedures for the approval of “significant” guidance, 

establishes standard elements that must be included in significant guidance, and requires 

agencies to maintain a website to assist the public in locating significant guidance. Nonsignificant guidance is not subject to the OMB Bulletin, and guidance procedures are left 

to agency discretion. 
Page 13 GAO-18-174 FDA Food Safety and Nutrition

category.35 Additionally, FDA’s Good Guidance Practices regulations 

differentiate between “Level 1” and “Level 2” guidance and require that, 

for Level 1 guidance, FDA solicit public comments through a notice in the 

Federal Register and by posting the draft guidance online prior to 

issuance of the final guidance. The regulations do not require that FDA 

solicit public comments for Level 2 guidance.36 For the purposes of this 

report, “key” guidance includes Level 1 guidance and excludes Level 2 

guidance.

During our review, FDA officials noted that regulations and guidance can 

differ greatly in terms of complexity, detail, and documentation. For 

example, the officials stated that one final rule took up 258 pages in the 

Federal Register and listed 276 references; as part of this rulemaking, 

FDA reviewed approximately 300,000 comments.37 In contrast, the 

officials stated, another final rule took up fewer than 11 pages in the 

Federal Register and contained 4 references; FDA reviewed 19 

comments on this rule.38

 35The OMB Bulletin defines “significant” guidance as guidance disseminated to regulated 

entities or the general public that may reasonably be anticipated to (1) lead to an annual 

effect on the economy of $100 million or more or adversely affect in a material way the 

economy, a sector of the economy, productivity, competition, jobs, the environment, public 

health or safety, or state, local, or tribal governments or communities; (2) create a serious 

inconsistency or otherwise interfere with an action taken or planned by another agency; 

(3) materially alter the budgetary impact of entitlements, grants, user fees, or loan 

programs or the rights and obligations of recipients thereof; or (4) raise novel legal or 

policy issues arising out of legal mandates, the President’s priorities, or the principles set

forth in Executive Order 12866, as further amended. 

3621 C.F.R. § 10.115 (2014). These regulations define “Level 1” documents as those that

set initial interpretations or more-than-minor changes to interpretations, are scientifically 

complex, or are likely to be highly controversial; and “Level 2” documents as those that set 

forth existing practices or minor changes in interpretations. See also GAO-15-368.

37Food Labeling: Revision of the Nutrition and Supplement Facts Labels, 81 Fed. Reg. 

33,742 (May 27, 2016).

38Food Labeling: Nutrient Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, 

and Docosahexaenoic Acid Omega-3 Fatty Acids, 79 Fed. Reg. 23,262 (Apr. 28, 2014).
Page 14 GAO-18-174 FDA Food Safety and Nutrition

Since FSMA’s enactment in January 2011, FDA has conducted numerous 

key food safety- and nutrition-related activities, determining its priorities 

for these activities based on statutes and strategic goals. More 

specifically, FDA issued regulations and guidance,39 focused mainly on 

food safety, and conducted other key activities related to food safety and 

nutrition, such as inspections. FDA prioritized these activities based on 

statutes—such as FSMA—and its strategic goals, according to agency 

officials, but how the agency decided between issuing regulations and 

guidance in support of these priorities is unclear because it did not 

consistently document those decisions.

 39We limited our review to key food safety- and nutrition-related regulations and guidance, 

which refer to regulations and guidance that are most relevant and important to this 

review. For the purposes of this report, proposed or draft, and subsequent final, versions 

of the regulations and guidance that were published during the relevant time period were 

counted only once. See app. I for more information about how we compiled these 

regulations and guidance documents.

FDA Has Conducted 

Numerous Key Food 

Safety- and NutritionRelated Activities, 

Determining Its 

Priorities Based on 

Statutes and 

Strategic Goals
Page 15 GAO-18-174 FDA Food Safety and Nutrition

From January 2011 through September 2017, FDA published key 

regulations and guidance, focused mainly on food safety, and conducted 

other food safety- and nutrition-related activities. More specifically, FDA 

published 33 key proposed or final regulations40 and 111 key draft or final 

guidance documents that were related to food safety or nutrition.41 Of the 

33 proposed and final regulations that FDA published, 21 were food 

safety-related, 7 were nutrition-related, and 5 were related to both.42 In 

addition, of the 33 published regulations, 30 regulations were final and 3 

were proposed.43 These 33 regulations included the 7 foundational rules 

required by FSMA.44 Of the 111 guidance documents that FDA published 

on its website during the same time frame, 82 were food safety-related, 

12 were nutrition-related, and 17 were related to both food safety and 

nutrition. Furthermore, 80 of those guidance documents were issued in 

final form, and 31 were published in draft form from January 2011 through 

September 2017. (See app. I for a list of FDA’s key food safety- and 

nutrition-related regulations and guidance published from January 2011 

 40The number of regulations is based on GAO’s analysis of the Unified Agenda, verified 

against the Federal Register and FDA officials’ written and oral responses.

41The number of guidance documents is based on GAO’s analysis of FDA websites, 

verified against Federal Register publications and FDA officials’ written and oral 

responses. In addition, FDA withdrew certain food safety- or nutrition-related regulations 

and guidance documents during this time frame. FDA officials told us that the agency 

withdrew these regulations and guidance documents for various reasons, such as the 

need for a planned regulation becoming obsolete with the publication of a different rule. 

42While we could not find an applicable statutory definition for food safety- and nutritionrelated activities, FDA officials told us that the agency’s food safety activities encompass a 

range of activities to prevent or mitigate contamination of food for humans and animals. 

They noted that FDA’s nutrition activities also encompass a range of activities to improve 

nutritional status in humans and to reduce the prevalence of diet-related risk factors for 

chronic disease. Some of the agency’s activities, however, cut across these two 

categorizations and, therefore, are related to both food safety and nutrition. FDA officials 

added that the Center for Veterinary Medicine is not engaged in activities related to the 

nutritional status of animals and does not receive funding for nutrition activities. 

43For the purposes of this report, “final” includes “interim final” and “final” rules, as 

indicated in the corresponding Federal Register notice (for regulations); for guidance 

documents, “final” includes documents that are not indicated as being in “draft” form.

44To implement FSMA, FDA published seven critical rules to establish preventive and riskbased standards for the growing, harvesting, packing, processing and distribution of 

domestic and imported food for people and animals, from farm through transportation to 

retail. The seven foundational rules are as follows: (1) Preventive Controls for Human 

Food, (2) Preventive Controls for Animal Food, (3) Produce Safety, (4) Foreign Supplier 

Verification Program, (5) Accredited Third-Party Certification, (6) Sanitary Transportation, 

and (7) Intentional Adulteration.

FDA Published Key 

Regulations and 

Guidance, Focused Mainly 

on Food Safety, and 

Conducted Other Food 

Safety- and NutritionRelated Activities
Page 16 GAO-18-174 FDA Food Safety and Nutrition

through September 2017, as well as additional information, including 

publication dates.)

In addition, among the food safety- and nutrition-related activities that 

FDA conducted, according to its congressional budget justifications for 

fiscal years 2012 through 2018, are activities such as conducting 

compliance inspections and developing risk assessment tools, 

responding to foodborne illness outbreaks, and providing outreach and 

education on food safety and nutrition matters.45 For example, since 

FSMA’s enactment in January 2011, which provided FDA with new 

enforcement authorities designed to achieve higher rates of compliance 

with prevention- and risk-based food safety standards, FDA reported 

conducting risk-based inspections of high-risk and non-high risk food 

facilities based on the facilities’ known safety risks, compliance histories, 

and years since last inspection.46 The agency has also reported 

developing risk assessment tools—such as FDA-iRISK47 and the Virtual 

Deli Risk-Tool48—to predict the interventions most effective at preventing 

 45Each year, as part of the annual appropriations process, federal agencies, including 

FDA, develop and submit to Congress supporting information for their funding requests in 

congressional budget justifications. FDA’s congressional budget justification notes past 

accomplishments; reflects how FDA proposes to meet its mission, goals, and objectives in 

the future; and assists Congress in determining how much funding to appropriate for FDA 

in the upcoming fiscal year. 

46FDA reported that in fiscal year 2012, it developed a new framework for selecting food 

facilities for inspection, based on known safety risks, compliance history, and years since 

the last inspection. Based on these factors, FDA categorized facilities as high-risk and 

non-high-risk. For example, a facility that manufactures food associated with foodborne 

outbreaks and class I recalls may be placed in the high-risk category. Likewise, if a 

facility’s inspection results for the previous 5 fiscal years indicate that it has a history of 

non-compliance with food safety requirements and has food safety violations of regulatory 

significance, it may be categorized as high-risk. Alternatively, a facility may be categorized 

as non-high-risk if it neither manufactures a food associated with outbreaks or class I 

recalls, nor has a compliance history in the previous 5 fiscal years indicating that it has a 

history of non-compliance with food safety requirements or food safety violations of 

regulatory significance. 

47According to FDA’s congressional budget justifications for fiscal years 2014 and 2017, in 

October 2012, FDA released FDA-iRISK—a web-based tool that automates the process of 

developing mathematical models to simulate risk and intervention in food production 

chains. This tool also predicts the number of cases of illness prevented by various 

interventions applied against specific contaminants in specific foods. More recently, FDA 

released an enhanced version of the tool, with advanced modeling and reporting methods. 

48According to FDA’s congressional budget justification for fiscal year 2016, the Virtual 

Deli Risk-Tool simulates pathways of Listeria cross-contamination in ready-to-eat foods 

such as those sold in delicatessens.
Page 17 GAO-18-174 FDA Food Safety and Nutrition

foodborne illness. Outbreaks of foodborne illness that the agency 

reported responding to included outbreaks of Cyclospora, Hepatitis A, 

Listeria monocytogenes, and Salmonella. With respect to outreach and 

education activities, FDA reported, among other things, conducting 

consumer studies to learn about attitudes, behaviors, and knowledge of 

food safety; maintaining a Nutrition Label education program with a 

television network specializing in cartoons to build awareness of such 

labels among children; conducting activities to help consumers improve 

heart health through reduced sodium intake; and partnering with USDA to 

manage a program for food safety training, education, and outreach to 

small farm owners and food processors.

Since FSMA’s enactment in January 2011 through fiscal year 2017, FDA 

based its food safety- and nutrition-related priorities on statutes and 

strategic goals, according to agency officials. However, how the agency 

decided between issuing regulations and guidance in support of these 

priorities is unclear because FDA did not consistently document those 

decisions.49

FDA officials told us that the FVM Governance Board, consisting of FDA 

senior executives, and an executive council,50 consisting of the deputies 

for relevant FDA offices and centers, are the internal governing bodies 

that have been responsible, respectively, for establishing and 

implementing FVM Program priorities since FSMA’s enactment. FDA 

officials said that the governance board determined top priorities for each 

fiscal year based, in part, on statutes—including FSMA, FFDCA, and the 

Patient Protection and Affordable Care Act.51 (See app. I for the statutory 

authorities FDA cited in developing the regulations.)

 49Although we examined the period since FSMA’s enactment in January 2011 through 

September 2017, FDA officials told us that they had a decision-making process in place 

prior to FSMA’s enactment to determine food safety- and nutrition-related priorities. 

50The full name of this executive council is the Food and Veterinary Medicine and the 

Office of Regulatory Affairs Food and Veterinary Medicine Program Executive Council. 

51FDA officials informed us that the governance board and executive council were formed 

in March 2014. The charter for the governance board was signed in March 2014, and the 

charter for the executive council was signed on various dates in March and April 2014. 

Agency Officials Said FDA 

Based Its Priorities on 

Statutes and Strategic 

Goals, but How It Decided 

between Issuing 

Regulations and Guidance

Was Not Always Clear

Agency Officials Said FDA 

Based Priorities on Statutes 

and Strategic Goals
Page 18 GAO-18-174 FDA Food Safety and Nutrition

In determining priorities, FDA officials stated, the board also considered 

strategic goals, identified in the FVM Program’s strategic plan, which the 

governance board reviewed and approved.52 For example, one of the 

goals in the strategic plan—which provides a framework for implementing 

FSMA and other legislative authorities—is to protect consumers and 

animals from foreseeable hazards. A related objective, in support of this 

goal, is to improve the prevention, detection, and response to foodborne 

illness outbreaks. Another strategic goal is to foster an environment that 

promotes healthy and safe food choices, with a related objective to 

provide and support accurate and useful information and education so 

consumers can choose healthier diets. FDA officials stated that once the 

FVM Program top priorities were established for a given fiscal year, the 

executive council oversaw the implementation of those priorities.

How FDA decided between issuing regulations or guidance in support of 

food safety- and nutrition-related priorities was not always clear because 

the agency did not consistently document those decisions. Since January 

2011,53 FDA’s decisions to develop either regulations or guidance 

generally went through a review process whereby FDA considered 

multiple factors, according to agency officials, on a case-by-case basis. 

Specifically, FVM Program officials told us that the decision to develop 

regulations or guidance was often made by individual offices with the 

necessary expertise—for example, the Office of Food Safety within the 

Center for Food Safety and Applied Nutrition or the Office of Surveillance 

and Compliance within the Center for Veterinary Medicine.54 This decision 

was then reviewed by FDA’s Office of Policy and, where appropriate, 

FDA’s Office of Chief Counsel. FDA officials told us that among the 

factors the agency considered were (1) statutory requirements and 

 52To achieve the program’s mission over a 10-year time frame, the FVM Program’s 

strategic plan outlines goals, outcomes, objectives, and strategies, taking into account the 

program’s responsibility to implement FSMA and other congressional mandates, and to 

ensure that FDA regulations and guidance provide clear and reliable direction to industry. 

See Food and Drug Administration, FDA Foods and Veterinary Medicine Program 

Strategic Plan Fiscal Years 2016-2025 (Washington, D.C.: July 14, 2016).

53As previously noted, we examined the period since FSMA’s enactment in January 2011 

through September 2017; however, FDA officials told us that the process described here 

was in place prior to FSMA’s enactment.

54FDA officials also told us that this decision-making process may differ for broader 

program initiatives, such as those addressing FSMA and antimicrobial resistance. In those 

cases, FDA officials told us that cross-cutting groups are formed to develop and review 

work products. For example, the decision-making and documentation for a specific FSMA 

regulation would be included in the process of the broader FSMA initiative.

The Bases for FDA’s Decisions 

for Issuing Regulations or 

Guidance Were Not Always 

Clear
Page 19 GAO-18-174 FDA Food Safety and Nutrition

authorities, (2) the agency’s intention to either create a requirement or 

provide advice, (3) public health and the urgency of a particular 

communication, and (4) agency resources.55 In particular, FDA officials 

told us that in cases where an underlying statute did not prescribe either 

issuance of regulations or guidance, the agency developed regulations 

when it intended for a policy to be legally binding, and it developed 

guidance when it intended to provide advice to industry or other 

stakeholders. FDA officials said that more agency resources are needed 

to develop regulations, compared with guidance; therefore, if the agency 

believes it can address an issue successfully with guidance, it will do so.

However, FDA’s bases for deciding whether to address certain FVM 

Program priorities through regulations or guidance were not always clear 

because FDA did not uniformly document its decision-making process—

including whether it considered alternative approaches (i.e., developing 

regulations rather than guidance, or vice versa). According to agency 

officials, FDA generally had tools in place—such as “concept papers,”56

and “guidance initiation sheets”57—for staff to prepare and present to 

 55See GAO-15-368 for additional information on what we previously found regarding the 

factors that the Department of Health and Human Services and other agencies (and 

agency components) considered before deciding whether to issue guidance or undertake 

rulemaking. Note that FDA was not one of the audited agency components in that GAO 

report.

56For example, the Center for Veterinary Medicine’s “Concept or Issue Resolution Paper” 

template provides instructions on how staff proposing to address an issue through 

rulemaking should prepare a two- to three-page document describing relevant factors 

such as why the issue should be addressed through regulation, the agency’s legal 

authority, as well as other options that were considered and why they were rejected. 

According to agency officials, the Center for Food Safety and Applied Nutrition also uses 

concept papers on occasion.

57For example, the Center for Veterinary Medicine makes available a “Guidance 

Information Sheet”—a form consisting of a one-page questionnaire, and one page of 

instructions. This tool is intended to encourage staff to consider important factors as they 

develop guidance. This sheet includes instructions for selecting the reason guidance is 

needed—whether it is to interpret existing regulation or statute, is mandated by a statute, 

or for another reason.
Page 20 GAO-18-174 FDA Food Safety and Nutrition

senior management.58 These tools were intended, FDA officials told us, to

document the reasons for developing a regulation or guidance—and, in 

some cases, consideration of alternatives—and to ensure agreement with 

the proposed path forward. However, FDA officials stated that these 

concept papers and guidance initiation sheets were not uniformly used by 

Center for Veterinary Medicine or Center for Food Safety and Applied 

Nutrition staff—and that FDA does not require that the tools be used for 

every initiated regulation or guidance. These tools were available for staff 

to use, and FDA officials told us that they were occasionally used for 

complex decisions and for those they determined to be particularly 

substantive.

Under its transparency initiative, FDA has committed to improving 

transparency to regulated industry.59 In its January 2011 transparency 

initiative report, FDA describes 19 steps the agency is taking to improve 

its transparency to regulated industry, including action items and draft 

proposals for improving transparency by topic area. Among the topic 

areas discussed is the development of guidance and regulations.

Furthermore, legal scholars and federal courts have noted that it is not 

always easy to determine whether an agency should address a concern 

by issuing a regulation—which is subject to public notice and comment 

requirements under the Administrative Procedure Act—or, instead, by 

 58FDA provided us with blank template forms used for Center for Veterinary Medicine 

regulations (“CVM Concept or Issue Resolution Paper”) and guidance (“CVM Guidance 

Information Sheet (GIS)”) development. The agency also provided us with an example of 

a completed form, used by the Office of Surveillance and Compliance within the Center for 

Veterinary Medicine, for developing a guidance related to anti-Salmonella food additives in 

food for animals. However, FDA did not provide us with an example of a completed 

concept paper, used within the Center for Veterinary Medicine, for developing a food 

safety- or nutrition-related regulation. Additionally, after multiple requests since June 2017 

for documentation of similar forms used within the Center for Food Safety and Applied 

Nutrition, FDA provided us, in October 2017, with a “CFSAN Concept Paper” template and 

a completed “FSMA Concept Paper” for a FSMA-related interim final rule, used within the 

Center for Food Safety and Applied Nutrition. During interviews, FVM Program officials 

provided conflicting responses as to whether concept papers are used within the Center 

for Veterinary Medicine and the Center for Food Safety and Applied Nutrition.

59FDA launched its transparency initiative in response to the President’s commitment to 

openness in government and the Department of Health and Human Services’ making 

transparency a priority. 74 Fed. Reg. 4685 (Jan. 26, 2009), and Department of Health and 

Human Services, Transparency Task Force, FDA Transparency Initiative: Improving 

Transparency to Regulated Industry (January 2011). 
Page 21 GAO-18-174 FDA Food Safety and Nutrition

issuing guidance, which is exempt from those requirements.60

Consequently, agency guidance may be legally challenged based on 

procedural concerns that the agency inappropriately used guidance, 

rather than the rulemaking process, or concerns that the agency has 

issued guidance that goes beyond its authority.61 For example, agencies 

have been sued for applying a new interpretation to an existing rule 

without going through notice and comment rulemaking. In 2015, the U.S. 

Supreme Court overturned prior federal court rulings that had held that an 

agency is precluded from substantively changing its interpretation of a 

rule without notice and comment.62

Under federal standards for internal control, management should design 

control activities to achieve objectives and respond to risks.63 As an 

example of designing such control activities, management should clearly 

document internal control and all transactions and other significant events 

in a manner that allows the documentation to be readily available for 

examination.64 The agency’s bases for deciding whether to address 

certain FVM Program priorities through regulations or guidance would 

qualify as significant events. Without uniformly documenting the bases for 

its decisions for issuing either regulations or guidance related to food 

safety and nutrition—such as by using concept papers or guidance 

 60For additional discussion on Administrative Procedure Act requirements, differences 

between regulations and guidance, and requirements prior to issuance of final guidance, 

see GAO-15-368. FDA’s Good Guidance Practices regulations also stipulate that FDA 

“may not use documents or other means of communication that are excluded from the 

definition of guidance document to informally communicate new or different regulatory 

expectations to a broad public audience for the first time.” FDA’s Good Guidance 

Practices also set certain requirements for some guidance documents, including the 

requirement to solicit public comments through a notice in the Federal Register and by 

posting the draft guidance online prior to issuance of final guidance. 21 C.F.R. § 10.115.

61See GAO-15-368.

62On March 9, 2015, the Supreme Court held in Perez v. Mortgage Bankers Ass’n, No. 

13-1041, slip. op (U.S. Mar.9, 2015), that an agency could make substantive changes to 

an interpretive rule without going through notice and comment under the Administrative

Procedure Act. This decision overturned prior federal court rulings that had held that an 

agency is precluded from substantively changing its interpretation of a regulation through 

issuance of a new interpretive rule without notice and comment. See, e.g., Alaska Prof’l 

Hunters Ass’n v. FAA, 177 F.3d 1030 (D.C. Cir. 1999).

63GAO-14-704G; see also GAO-15-368.

64The use of “significant event” in the context of internal controls differs from the use of 

“significant” regulations and guidance previously discussed in this report. 
Page 22 GAO-18-174 FDA Food Safety and Nutrition

initiation sheets—FDA cannot help ensure consistency and transparency 

in its decision-making process.

FDA has dedicated at least $1.0 billion annually—including salaries for at 

least 4,300 FTEs—to food safety- and nutrition-related activities in fiscal 

years 2011 through 2016, with food safety-related activities accounting for 

about 98 percent of these resources and nutrition-related activities 

accounting for about 2 percent.65 For food safety-related activities for this 

period, FDA dedicated at least $1.0 billion annually, including salaries for 

at least 4,200 FTEs. In contrast, for nutrition-related activities during this 

time frame, the agency dedicated at least $20 million annually, including 

salaries for at least 97 FTEs.

FDA dedicated from $1.0 billion to $1.3 billion annually, including salaries 

for 4,200 to 4,800 FTEs, to food safety-related activities for fiscal years 

2011 through 2016. These resources accounted for about 98 percent of 

FDA’s obligations and FTEs dedicated to food safety- and nutritionrelated activities during this time frame.66 Table 1 shows food safetyrelated obligations and FTEs dedicated by FDA components in each 

fiscal year. (See app. II for more detailed information on FDA 

components’ dedication of resources across specific food safety-related 

activities.)

 65For the purposes of this report, “dedicated” is synonymous with “obligated.” We 

excluded user fees from our analysis. Authorized obligations of user fee collections 

accounted for a small proportion of FDA’s total obligations for food safety- and nutritionrelated activities in each fiscal year from 2011 through 2016. User fees are assessed to 

users of goods and services provided by the federal government in conjunction with 

regulatory activities.

66As previously noted, an obligation is a definite commitment that creates a legal liability of 

the government to make payment for goods and services received or a legal duty that 

could mature into a legal liability by virtue of actions beyond the control of the federal 

government. FDA obligates funds, for example, when it awards a grant, signs a contract, 

purchases a service, or takes other actions that require the government to make 

payments. During our review, the most recent data available on FDA’s obligations and 

FTEs for food safety and nutrition were for fiscal year 2016.

FDA Dedicated at 

Least $1 Billion per 

Year, Including 

Salaries for at Least 

4,300 FTEs, to Food 

Safety- and NutritionRelated Activities in 

2011 through 2016

For Fiscal Years 2011 

through 2016, FDA 

Dedicated at Least $1 

Billion and 4,200 FTEs 

Annually to Food SafetyRelated Activities
Page 23 GAO-18-174 FDA Food Safety and Nutrition

Table 1: FDA Obligations, Including Salaries for Full-Time Equivalent (FTE) Staff, for Food Safety-Related Activities, by 

Agency Component, for Fiscal Years 2011 through 2016

Dollars in millions

2011 2012 2013 2014 2015 2016

Component Dollars FTEs Dollars FTEs Dollars FTEs Dollars FTEs Dollars FTEs Dollars FTEs

Center for Food 

Safety and 

Applied Nutrition 242.0 818 252.3 827 234.8 868 253.7 884 266.9 900 285.5 969

Center for 

Veterinary 

Medicine 57.9 285 58.4 299 53.0 287 61.5 292 61.5 294 63.5 322

Office of 

Regulatory 

Affairs 612.9 2,909 631.3 2,838 577.8 2,870 648.1 2,924 653.7 2,924 733.7 3,054

National Center 

for Toxicological 

Research 10.8 48 10.2 46 12.1 56 10.2 47 10.2 45 10.2 49

FDA 

Headquarters 

and 

Infrastructurea 154.2 237 159.0 256 162.6 263 181.8 328 187.6 313 196.4 32

Total 1,077.7 4,297 1,111.2 4,266 1,040.3 4,344 1,155.4 4,475 1,180.0 4,476 1,289.0 4,718

Source: GAO analysis of Food and Drug Administration (FDA) data. | GAO-18-174

Note: Amounts are rounded and may not sum to totals.

a

FDA Headquarters provides FDA-wide program direction and administrative services. The primary 

Headquarters components responsible for providing FDA-level oversight and advice are the Office of 

the Commissioner, the Office of Foods and Veterinary Medicine, the Office of Medical Products and 

Tobacco, the Office of Operations, and the Office of Global Regulatory Operations and Policy. 

Infrastructure refers to FDA’s Infrastructure program, which provides office and laboratory space and 

consists of General Services Administration rental payments; other rent and rent-related activities; 

and the operations of FDA’s White Oak campus, which replaces geographically disparate facilities 

with new, centralized facilities in Maryland.

The resources that these FDA components dedicated to food safetyrelated activities generally increased or remained the same over this time 

frame. More specifically:

• Center for Food Safety and Applied Nutrition resources for food 

safety-related activities generally increased from fiscal years 2011 

through 2016. The center dedicated $285.5 million and 969 FTEs in 

fiscal year 2016 for these activities, compared with $242.0 million and 

818 FTEs in fiscal year 2011. Because of data limitations, it is unclear 

how the center’s resources for specific food safety-related activities 
Page 24 GAO-18-174 FDA Food Safety and Nutrition

may have changed from fiscal years 2011 through 2016.67 However, 

of the food safety-related activities it carried out in fiscal year 2016, 

the center obligated the most funding, $111.9 million, to regulatory 

science activities. According to FDA officials, the center’s regulatory 

science activities included increasing FDA’s bioinformatics capacity 

and developing enhanced screening methods to better detect 

contaminated food.

• Center for Veterinary Medicine resources for food safety-related 

activities generally increased from fiscal years 2011 through 2016. 

The center dedicated $63.5 million and 322 FTEs in fiscal year 2016, 

compared with $57.9 million and 285 FTEs in fiscal year 2011. FDA 

reported the center’s food safety-related data across two activities: 

animal food safety and antimicrobial resistance. According to agency 

officials, the center increased funding for animal food safety activities 

to implement FSMA. The center’s data show a decline in obligations 

dedicated to antimicrobial resistance activities from fiscal year 2012 to 

fiscal year 2013; however, center officials we interviewed stated that 

this decline was due to a change in the center’s methodology for 

identifying antimicrobial resistance resources.

• Office of Regulatory Affairs resources for food safety-related 

activities generally increased from fiscal years 2011 through 2016. 

The office dedicated $733.7 million and 3,054 FTEs to food safetyrelated activities in fiscal year 2016, compared with $612.9 million and 

2,909 FTEs in fiscal year 2011. Over this time frame, the office 

generally decreased annual resources dedicated to inspections, field 

examinations, and label reviews. The office increased obligations 

dedicated to other activities, such as implementing FSMA and 

conducting FSMA-related training. For example, in July 2017, FDA 

announced that the office would award $30.9 million to 43 states to 

implement a new FSMA rule for the safe growing, harvesting, packing, 

and holding of fruits and vegetables.

68 This followed a separate 

announcement of office funding to states in 2016. According to an 

agency website, funding will support states’ efforts to formulate multiyear plans to implement a produce safety system and provide related 

education, outreach, and technical assistance.

 67We did not analyze trends related to the Center for Food Safety and Applied Nutrition’s 

obligations and FTEs for specific categories of food safety-related activities because data 

from fiscal years 2011 through 2013 are not comparable with data from fiscal years 2014 

through 2016, as the center made changes to its data reporting systems in fiscal year 

2014.

6880 Fed. Reg. 74354 (Nov. 27, 2015) (codified in 21 C.F.R. pt. 112).
Page 25 GAO-18-174 FDA Food Safety and Nutrition

• National Center for Toxicological Research resources for food 

safety-related activities generally remained constant from fiscal years 

2011 through 2016. The center dedicated $10.2 million and 49 FTEs 

to food safety-related activities in fiscal year 2016, compared with 

$10.8 million and 48 FTEs in fiscal year 2011. FDA reported the 

center’s food safety-related resources across three categories: food, 

antimicrobial resistance, and dietary supplements. According to FDA 

officials, the center increased or decreased resources dedicated to 

specific activities as it initiated or completed various research projects. 

For example, obligations for dietary supplement research increased 

from $1.0 million in fiscal year 2015 to $4.0 million in fiscal year 2016 

as the center initiated a significant research project on over-thecounter dietary supplements. The center’s obligations for other food 

safety research during this time frame decreased as the center ended 

multiple, other research projects related to food safety.

• FDA Headquarters and Infrastructure resources for food safetyrelated activities generally increased from fiscal years 2011 through 

2016.This component dedicated $196.4 million and 324 FTEs to food 

safety-related activities in fiscal year 2016, compared with $154.2 

million and 237 FTEs in fiscal year 2011.

FDA dedicated from $20.3 million to $33.7 million annually, including 

salaries for 97 to 127 FTEs, to nutrition-related activities in fiscal years 

2011 through 2016. These resources accounted for about 2 percent of 

FDA’s total obligations and FTEs dedicated to food safety- and nutritionrelated activities for this period. Table 2 shows the nutrition-related 

resources dedicated by each of these components each fiscal year. (See 

app. II for more detailed information on FDA components’ dedication of 

resources across specific nutrition-related activities.)

In Fiscal Years 2011 

through 2016, FDA 

Dedicated at Least $20 

Million and 97 FTEs 

Annually to NutritionRelated Activities
Page 26 GAO-18-174 FDA Food Safety and Nutrition

Table 2: FDA Obligations, Including Salaries for Full-Time Equivalent (FTE) Staff, for Nutrition-Related Activities, by Agency 

Component, for Fiscal Years 2011 through 2016

Dollars in millions

2011 2012 2013 2014 2015 2016

Component Dollars FTEs Dollars FTEs Dollars FTEs Dollars FTEs Dollars FTEs Dollars FTEs

Center for 

Food Safety 

and Applied 

Nutrition

8.2 54 12.0 55 10.9 55 12.7 59 13.1 61 18.5 68

Office of 

Regulatory 

Affairs

11.8 54 11.5 50 9.6 40 10.5 42 10.7 42 14.8 57

FDA 

Headquarters 

and 

Infrastructurea

0.3 2 0.3 2 0.4 2 0.4 3 0.5 3 0.4 2

Total 20.3 110 23.8 107 20.8 97 23.6 104 24.3 106 33.7 127

Source: GAO analysis of Food and Drug Administration (FDA) data. | GAO-18-174

Note: Amounts are rounded and may not sum to totals.

a

FDA Headquarters provides FDA-wide program direction and administrative services. The primary 

Headquarters components responsible for providing FDA-level oversight and advice are the Office of 

the Commissioner, the Office of Foods and Veterinary Medicine, the Office of Medical Products and 

Tobacco, the Office of Operations, and the Office of Global Regulatory Operations and Policy. 

Infrastructure refers to FDA’s Infrastructure program, which provides office and laboratory space and 

consists of General Services Administration rental payments; other rent and rent-related activities; 

and the operations of FDA’s White Oak campus, which replaces geographically disparate facilities 

with new, centralized facilities in Maryland.

The resources that these FDA components dedicated to nutrition-related 

activities generally increased over this time frame, although resources 

dedicated by some components decreased or remained the same across 

some fiscal years. More specifically:

• Center for Food Safety and Applied Nutrition resources for 

nutrition-related activities generally increased from fiscal years 2011 

through 2016. The center dedicated $18.5 million and 68 FTEs in 

fiscal year 2016, compared with $8.2 million and 54 FTEs in fiscal 

year 2011. Because of data limitations, it is unclear how center 

resources for specific categories of nutrition-related activities may 
Page 27 GAO-18-174 FDA Food Safety and Nutrition

have changed from fiscal years 2011 through 2016.69 However, of the 

nutrition-related activities it carried out in fiscal year 2016, the center 

obligated the most funding, $7.8 million, to regulatory science 

activities. According to FDA officials, the center’s regulatory science 

activities for nutrition include activities such as studies on consumer 

perception and evaluation of the intake of nutrients in the diet.

• Office of Regulatory Affairs resources for nutrition-related activities 

generally decreased from fiscal years 2011 through 2015 but 

increased from fiscal years 2015 to 2016. The office dedicated $14.8 

million and 57 FTEs in fiscal year 2016, compared with $11.8 million 

and 54 FTEs in fiscal year 2011. FDA officials we interviewed stated 

that the office increased nutrition-related obligations in fiscal year 

2016 to conduct increased field examinations in support of 

implementing the Food Allergen Labeling and Consumer Protection 

Act of 2004,70 which requires food labels to list major allergens 

present in those foods.71 In addition, officials stated that the office 

identified new food risks through these additional field examinations. 

In response to these risks, the office obligated additional funding in 

fiscal year 2016 for regulatory actions, such as monitoring class I 

recalls.72

• FDA Headquarters and Infrastructure resources for nutrition-related 

activities generally remained the same from fiscal years 2011 through 

2016.The component dedicated $0.4 million and 2 FTEs to nutritionrelated activities in fiscal year 2016 compared with $0.3 million and 2 

FTEs in fiscal year 2011.

 69We did not analyze trends related to the Center for Food Safety and Applied Nutrition’s 

obligations and FTEs for specific categories of nutrition-related activities because data 

from fiscal years 2011 through 2013 are not comparable with data from fiscal years 2014 

through 2016, as the center made changes to its data reporting systems in fiscal year 

2014.

70FDA field examinations are on-site examinations of FDA-regulated imported or domestic 

products. According to FDA officials, the agency may conduct field exams of any 

commodity or at any location. In contrast, FDA conducts facility inspections (“inspections”) 

at factories, warehouses, and establishments involved in food manufacturing, processing, 

packing, or holding.

71Food Allergen Labeling and Consumer Protection Act of 2004, Pub. L. No. 108-282, tit. 

II, § 203, 118 Stat. 906, 906-908 (amending 21 U.S.C. 343(w)).

72FDA classifies a recall as class I when there is a reasonable probability that the use or 

exposure to a violative product will cause serious adverse health consequences or death. 

Examples include food found to contain toxins or undeclared allergens. 
Page 28 GAO-18-174 FDA Food Safety and Nutrition

Since fiscal year 2011, FDA has set goals for food safety- and nutritionrelated activities but has not fully developed the necessary framework to 

assess progress toward those goals. Specifically, FDA cannot fully 

assess progress toward its food safety- and nutrition-related goals 

because the FVM Program has developed performance measures related 

to some, but not all, of the eight strategic objectives that support its goals. 

For developed performance measures, the program reports both targets 

set and measurements taken for specific time frames.

Since fiscal year 2011, FDA has set strategic goals for all agency 

activities, including food safety- and nutrition-related activities. These 

goals provide direction to agency programs in their efforts to achieve 

FDA’s public health mission. FDA’s 2014-2018 strategic plan identifies 

four strategic goals: (1) enhance oversight of FDA-regulated products, (2) 

improve and safeguard access to FDA-regulated products to benefit 

health, (3) promote better informed decisions about the use of FDAregulated products, and (4) strengthen organizational excellence and 

accountability. These goals encompass FDA’s food safety- and nutritionrelated activities, in addition to activities not related to food.73

Some FDA components have set their own strategic goals for specific 

product areas they manage in support of FDA’s broader goals. For 

example, the FVM Program set more specific goals for food safety- and 

nutrition-related activities in fiscal year 2012 and later modified these 

goals under its current 2016-2025 strategic plan.74 Under this plan, the 

FVM Program set two goals for its food safety- and nutrition-related 

activities: (1) protect American consumers and animals from foreseeable 

hazards and (2) foster an environment that promotes healthy and safe 

food choices. The FVM Program identified public health outcomes that it 

intends to achieve through these goals. It also set several strategic 

objectives for each goal. The FVM Program’s strategic planning 

framework—including goals, outcomes, and objectives—for food safetyand nutrition-related activities is shown in table 3. The FVM Program did 

 73Food and Drug Administration, FDA Strategic Priorities, 2014-2018 (Washington, D.C.: 

September 2014).

74Food and Drug Administration, FDA Foods and Veterinary Medicine Program Strategic 

Plan, Fiscal Years 2016-2025 (Washington, D.C.: July 14, 2016). 

FDA Has Set Goals 

for Food Safety- and 

Nutrition-Related 

Activities Every Year 

since 2011 but 

Cannot Fully Assess 

Progress

FDA Has Set Goals for All 

Agency Activities, and 

since 2012, the FVM 

Program Has Set Specific 

Goals for Food Safetyand Nutrition-Related 

Activities
Page 29 GAO-18-174 FDA Food Safety and Nutrition

not have a strategic plan in place in fiscal year 2011, the year of FSMA’s 

enactment; agency officials stated that FDA was preparing to implement 

FSMA at that time.

Table 3: Foods and Veterinary Medicine Program Strategic Planning Framework for Food Safety- and Nutrition-Related 

Activities, from Fiscal Years 2016 through 2025 Strategic Plan

Food safety Nutrition

Goal Protect America’s consumers and animals from 

foreseeable hazards

Foster an environment to promote healthy and safe food 

choices

Outcome Reduce the incidence of illnesses and deaths 

attributable to preventable contamination of FDAregulated food and feed products

Reduce risk factors for and the incidence of nutritionrelated chronic disease

Objectives Establish and gain high rates of compliance with 

science-based preventive control standards across the 

global farm-to-table continuum

Improve prevention, detection, and response to 

foodborne illness outbreaks and other food and feed 

safety incidents

Strengthen the ability of consumers to play a proactive 

role in minimizing food safety risks

Enhance the safety of food and feed additives and 

dietary supplements

Strengthen existing partnerships with international, 

federal, state, local, tribal, and territorial agencies to 

improve the effectiveness and efficiency of FDA’s food 

safety program for government and industry

Provide and support accurate and useful nutrition 

information and education, so consumers can choose 

healthier diets, consistent with the Dietary Guidelines for 

Americans and other evidence-based recommendations

Monitor and assess emerging nutrition science as well as 

changes in the composition of foods in the marketplace in 

relation to the nutritional health status of Americans

Encourage and facilitate new products and product 

reformulation to promote a healthier food supply

Source: GAO analysis of the Food and Drug Administration’s FDA Foods and Veterinary Program Strategic Plan, Fiscal Years 2016-2025. | GAO-18-174

According to FVM Program officials, the program’s 2016-2025 strategic 

plan set strategic goals, intended outcomes, and objectives for its food 

safety- and nutrition-related activities, to better demonstrate the 

program’s work across its core functions, which include food safety and 

nutrition.75 Under the older framework used in the 2012-2015 strategic 

plan, the FVM Program intended to make similar impacts through its food 

safety- and nutrition-related work, as demonstrated by similarities to the 

current strategic plan. However, the older framework did not organize the 

FVM Program’s food safety- or nutrition-related activities under one 

strategic goal specific to either core function.

 75According to its 2016-2025 strategic plan, the FVM Program intends to promote public 

health by preventing foodborne illness, fostering good nutrition, and improving the safety 

and efficacy of animal health products.
Page 30 GAO-18-174 FDA Food Safety and Nutrition

FDA has developed performance measures for its food safety- and 

nutrition-related goals, and these measures reflect some, but not all, of 

the FVM Program’s food safety- and nutrition-related objectives 

supporting these goals. Specifically, FDA has developed performance 

measures for five of the FVM Program’s eight objectives for food safety or 

nutrition. For example, FDA has developed performance measures for the 

food safety objective to establish and gain high rates of compliance with 

science-based preventive control standards; its food safety objective to 

enhance the safety of food and feed additives and dietary supplements; 

and its nutrition objective to provide and support accurate and useful 

nutrition information and education. An example of an FVM Program 

performance measure that supports the first food safety objective, and 

which includes targets and time frames, is the measure related to 

enhancing preventive controls for reducing pathogen contamination of 

high-risk produce such as tomatoes, cantaloupes, and leafy greens. FDA 

reports on each measure, either through FDA-TRACK, FDA’s agencywide performance management system, or through its congressional 

budget justifications.76

The FVM Program collects data for completed performance measures to 

assess progress toward its strategic goals. For developed performance 

measures, the program reports both targets set and measurements taken 

for specific time frames. For example, for the FDA-TRACK performance 

measure “Percentage of health hazard evaluations completed by due 

date,” the program reports 50 percent as its target for the first quarter of 

fiscal year 2017 and measured 89 percent of health hazard evaluations 

completed by their due dates. The FVM Program conducts health hazard 

evaluations to evaluate the scope and severity of hazards posed by foods 

sourced from animals that may have received unsafe drugs or consumed 

unsafe feed. By setting targets and collecting data for this and other 

performance measures, the FVM Program is assessing progress toward 

its strategic goals.

FVM Program management reviews developed performance measures 

through a quarterly performance review process. The quarterly 

performance review work group includes officials from the Office of Foods 

and Veterinary Medicine, the Center for Food Safety and Applied 

Nutrition, and the Center for Veterinary Medicine. According to officials 

 76FDA launched FDA-TRACK in April 2011. According to FDA, performance measures in 

FDA-TRACK represent the foundational activities and outputs produced by FDA 

employees.

FDA Has Developed 

Performance Measures for 

Its Food Safety- and 

Nutrition-Related Goals 

but Cannot Fully Assess 

Progress toward These 

Goals
Page 31 GAO-18-174 FDA Food Safety and Nutrition

we interviewed, the group reviews all FDA-TRACK and congressional 

budget justification performance measures related to the FVM Program. 

The work group examines opportunities to revise these measures in an 

effort to make progress toward intended public health outcomes, which 

are reflected in the FVM Program’s strategic goals. For example, the 

performance measure “Average number of working days to serotype 

priority pathogens in food” supports the FVM Program’s strategic goal for 

food safety.77 Agency officials we interviewed told us that the work group 

identified an opportunity to improve the serotyping process in 2010. From 

fiscal years 2011 through 2017, the work group lowered serotyping 

targets, collected relevant data, and assessed the program’s progress 

toward improving the serotyping process. Program officials told us that, in 

addition to the program’s quarterly performance review work group, 

another work group meets twice monthly to review the extent to which 

FDA performance measures support FSMA requirements and show 

progress toward FSMA-related public health outcomes.

However, FDA has not developed performance measures for three of its 

eight food safety- and nutrition-related objectives as of January 2018, and 

as a result, the FVM Program cannot fully assess progress toward its 

food safety- and nutrition-related goals. For one of these objectives—the 

food safety objective related to the consumers’ role—FDA developed 

indicators but did not set targets with time frames.78 OMB defines a 

performance measure (which it refers to as a performance indicator) as 

an indicator for which a target is set with a time frame, and which will be 

used to track progress.79 Therefore, an indicator alone—without targets or 

time frames—is not a performance measure.80 For two of the FVM 

Program’s three nutrition objectives—(1) monitor and assess emerging 

nutrition science as well as changes in the composition of foods in the 

marketplace in relation to the nutritional health status of Americans, and 

 77According to FDA documentation, faster serotyping enables FDA to more quickly detect 

foodborne pathogens and effectively respond to foodborne illness outbreaks.

78For example, for “the number of Center for Food Safety and Applied Nutrition website 

page views” indicator, the FVM Program captured quarterly data but did not set a quarterly 

target for the number of page views it hoped to achieve.

79An indicator, according to OMB, is a measurable value that indicates the state or level of 

something whereas a target is a quantifiable or otherwise measurable characteristic that 

tells how well or at what level an agency aspires to perform.

80Office of Management and Budget, Preparation, Submission and Execution of the 

Budget, OMB Circular No. A-11 (Washington, D.C.: July 2017).
Page 32 GAO-18-174 FDA Food Safety and Nutrition

(2) encourage and facilitate new products and product reformulation to 

promote a healthier food supply—FDA has not developed an indicator 

with a target and time frame. (See tables 11 and 12 in app. III for FDA 

performance measures for food safety- and nutrition-related activities.)

FVM Program officials acknowledged the need to develop performance 

measures that align with those three objectives for which the program has 

not yet developed measures. Officials told us they expect to complete the 

development of performance measures for these three food safety- and 

nutrition-related objectives by the end of the first quarter of fiscal year 

2018. Officials we interviewed told us that the program has not yet 

developed performance measures for nutrition-related activities because 

management has first focused on updating the food safety-related 

performance measures since releasing the program’s new strategic plan 

in July 2016. The officials said that management has focused on updating 

food safety-related performance measures because of the importance of 

implementing FSMA.

Leading practices in performance management state that federal 

programs should use performance information to achieve the mission and 

goals of those programs.81 As previously noted, the FVM Program’s goals 

are supported by strategic objectives. Strategic objectives serve as the 

primary unit of analysis for assessment of how a program is achieving its 

goals,82 and each objective should be tracked through a set of 

performance measures that have targets with time frames.83 Until FDA 

develops performance measures with associated targets and time frames 

for all eight of the FVM Program’s food safety- and nutrition-related 

objectives, FDA cannot fully and accurately assess progress toward 

achieving its food safety- and nutrition-related goals.

 81GPRA Modernization Act of 2010 (GPRAMA), Pub. L. No. 111-352, §8, 124 Stat. 3866, 

3878 (codified at 31 U.S.C. § 1123(b)(1). Although GPRAMA’s requirements apply at the 

departmental level (e.g., the Department of Health and Human Services), we have 

previously stated that they can serve as leading practices at other organizational levels, 

such as component agencies, offices, programs (e.g., the FVM Program), and projects. 

See, for example, GAO-17-49.

82OMB Cir. A-11, p. 210-6.

83OMB Cir. A-11, p. 210-7.
Page 33 GAO-18-174 FDA Food Safety and Nutrition

FDA has identified food safety- and nutrition-related activities that the 

FVM Program plans to undertake in fiscal year 2018, but its time frames 

for such activities in the longer term are unclear. According to the Unified 

Agenda of August 2017 and FDA’s congressional budget justification for 

fiscal year 2018, the FVM Program’s planned activities for fiscal year 

2018 include regulations to enhance food labeling and continued FSMA 

implementation. However, the specific time frames for activities planned 

over the longer term are unclear because the FVM Program has not 

developed an implementation plan that identifies specific actions, 

priorities, and milestones for its 10-year strategic plan.

FDA’s plans for the FVM Program in fiscal year 2018 include publishing 

regulations to enhance food labeling, continued implementation of FSMA, 

and other food safety- and nutrition-related activities. For example, the 

Unified Agenda published in August 201784 identified two food safety- and 

nutrition-related regulations that FDA planned to publish within 12 

months: (1) a proposed labeling rule concerning the use of health claims 

related to soy protein and coronary heart disease85 and (2) a final rule on 

gluten-free labeling of fermented, hydrolyzed, or distilled foods.86 In 

addition, the August 2017 Unified Agenda identified four food safety- and 

 84A subsequent Unified Agenda published in December 2017 provided an update on 

FDA’s planned food safety- and nutrition-related regulations. It is not reflected in our report 

because of timing constraints.

85In October 2017, FDA published a proposed rule to revoke its regulation authorizing the 

use of health claims on the relationship between soy protein and coronary heart disease 

on the label or in the labeling of foods. FDA stated that it is taking this action based on its 

review of the totality of publicly available scientific evidence currently available and its 

tentative conclusion that such evidence does not support its previous determination that 

there is significant scientific agreement among qualified experts for a health claim 

regarding the relationship between soy protein and reduced risk of coronary heart 

disease. FDA seeks public comments on the proposed rule by Jan. 16, 2018. See 82 Fed. 

Reg. 50,324 (Oct. 31, 2017). 

86The August 2017 Unified Agenda also identified two “long-term” food safety-related 

regulations regarding tolerances for residues of new animal drugs in food consumed by 

humans. The Unified Agenda defines long-term actions as items that are under 

development but for which the agency (in this case, FDA) does not expect to have a 

regulatory action within 12 months of a given Unified Agenda publication.

FDA’s Planned Food 

Safety- and NutritionRelated Activities to 

Focus on FSMA 

Implementation in 

2018, but Time 

Frames for LongerTerm Activities Are 

Unclear

FDA’s Planned Activities in 

2018 Include Enhanced 

Food Labeling and 

Continued FSMA 

Implementation
Page 34 GAO-18-174 FDA Food Safety and Nutrition

nutrition-related “inactive rules” that were still being reviewed or 

considered by FDA at that time.87

Furthermore, in September 2017, FDA announced in the Federal Register

that the agency and many of its components—including the Center for 

Food Safety and Applied Nutrition and the Center for Veterinary 

Medicine—were seeking public comments and information from 

interested parties until December 7, 2017, “to help FDA identify existing 

regulations and related paperwork requirements that could be modified, 

repealed, or replaced, consistent with the law, to achieve meaningful 

burden reduction,” while allowing the agency to achieve its mission and 

fulfill statutory obligations. On December 6, 2017, FDA extended the 

comment period to February 5, 2018. Thus, FDA’s past food safety- and 

nutrition-related regulations were undergoing review as of January 

2018.

88

FDA’s planned food safety- and nutrition-related activities also include 

finalizing draft guidance documents published since FSMA. While 

considering agency priorities and resources, FDA officials told us they 

plan to finalize food safety-related guidance such as on (1) mandatory 

food recalls, (2) current good manufacturing practice requirements for 

animal food, (3) arsenic in apple juice, and (4) proper labeling of honey 

and honey products. Regarding nutrition-related guidance, FDA plans to 

finalize draft guidance such as (1) a list of products for each of the 

product categories included in the tables of “Reference Amounts 

Customarily Consumed” relevant to the nutrition facts label, (2) agency 

views on the scientific evidence needed and the approach to evaluating 

scientific evidence on the physiological effects of isolated or synthetic 

non-digestible carbohydrates, and (3) helping vending machine operators 

 87The August 2017 Unified Agenda identified four FDA food safety- and nutrition-related 

“inactive rules” that were identified in previous editions of the Unified Agenda as planned 

regulations. Those inactive rules were (1) a laboratory accreditation rule, required by 

FSMA, that would enable FDA to recognize accredited bodies to ensure that food 

laboratories have appropriate equipment, personnel, and procedures to conduct reliable 

analyses; (2) a mandate requiring labels on food that has been refused admission into the 

United States; (3) current good manufacturing practices in the manufacturing, packing, 

labeling, or holding operations for dietary supplements; and (4) general principles and 

modernization of food standards.

88For the Center for Food Safety and Applied Nutrition’s announcement, see 82 Fed. Reg. 

42,503 (Sept. 8, 2017) and for the Center for Veterinary Medicine’s announcement, see 

82 Fed. Reg. 42,497 (Sept. 8, 2017). For FDA’s extension of the comment period to

February 5, 2018, see 82 Fed. Reg. 57,560 (Dec. 6, 2017).
Page 35 GAO-18-174 FDA Food Safety and Nutrition

and industry better understand and comply with a regulation regarding 

calorie labeling of food in vending machines.89

Other near-term activities for the FVM Program, identified as priorities in 

FDA’s congressional budget justification for fiscal year 2018, include the 

following activities to be conducted by the Center for Food Safety and 

Applied Nutrition:

• working with industry to implement FSMA regulations, such as the 

produce safety rule;90

• responding to foodborne illness outbreaks;

• reviewing infant formula notifications from manufacturers before 

marketing a new formula;

• helping to ensure the safety of dietary supplements;

• conducting reviews of food ingredients and packaging, such as 

reviews of food additives and color additives;

• ensuring that foods are safe and properly labeled, including nutrient 

content and health claims; and

• postmarket monitoring for chemical contaminants.

In addition, FDA’s congressional budget justification for fiscal year 2018 

states that the Office of Regulatory Affairs will (1) maintain food 

manufacturing inspections conducted through state contracts and (2) 

strengthen state, local, and tribal regulatory programs to prevent 

foodborne illness and to reduce the occurrence of risk factors in retail and 

 89In addition, in January 2018, FDA officials informed us that the agency intends to publish 

guidance in the near future related to FSMA and the nutrition facts label’s recently added 

sugar provision. Regarding FSMA, these guidance documents refer to (1) produce safety 

implementation and compliance (for non-water provisions), (2) additional chapters of the 

preventive controls for human foods guidance, (3) preventive controls for animal foods, (4) 

the Foreign Supplier Verification Program, and (5) “same level of public health protection 

guidance” related to several FSMA rules. Agency officials also noted that in November 

2017, FDA published (1) supplemental, draft guidance on menu labeling for industry and 

(2) a small entity compliance guide for sanitary transport, related to FSMA.

90For more information on FDA’s Standards for the Growing, Harvesting, Packing, and 

Holding of Produce for Human Consumption—also known as the produce safety rule or, 

simply, the produce rule—see GAO, Food Safety: FDA Continues to Evaluate and 

Respond to Business Concerns about the Produce Rule, GAO-18-85 (Washington, D.C.: 

Nov. 27, 2017) and Food Safety: FDA’s Efforts to Evaluate and Respond to Business 

Concerns Regarding the Produce Rule, GAO-17-98R (Washington, D.C.: Nov. 28, 2016).
Page 36 GAO-18-174 FDA Food Safety and Nutrition

food service operations. The fiscal year 2018 document also states that 

FDA’s National Center for Toxicological Research will continue to conduct 

projects to limit the emergence and spread of drug resistance in bacterial 

pathogens that compromise the ability to treat foodborne illnesses.

For the Animal Drugs and Feeds Program—another component of the 

FVM Program, administered by the Center for Veterinary Medicine—

FDA’s congressional budget justification for fiscal year 2018 states that 

the agency will continue to conduct, among other things, the following 

activities:

• advancing FSMA efforts by implementing a modern, preventionfocused, science- and risk-based food and feed safety system;

• surveillance efforts, such as monitoring antimicrobial resistance 

among intestinal bacteria via a national antimicrobial resistance 

monitoring system;

• response efforts, such as utilizing laboratory capacity to assist FDA 

with investigations into potential problems with animal feeds and 

animal drugs;

• field inspections, investigations, and enforcement activities to ensure 

the adherence to laws that protect and advance human and animal 

health;

• enhancing the availability and diversity of safe and effective products 

that relieve animal pain and suffering, sustain animal health, and do 

not compromise human health;

• monitoring the safety and effectiveness of animal drugs on the 

market,

• reviewing “adverse drug experience” reports,

• enforcing compliance actions, and

• reducing the availability of illegally marketed unapproved animal 

drugs.
Page 37 GAO-18-174 FDA Food Safety and Nutrition

In the longer term, according to FDA officials, the agency plans to pursue 

the food safety and nutrition strategies that are identified in the FVM 

Program’s 10-year strategic plan.91 The strategic plan states that FDA 

places high priority on the implementation of FSMA, which requires 

sustained focus and commitment over an extended period and focuses 

on how FDA plans to modernize its food safety work, including:

• an increased focus on obtaining compliance with preventive control 

standards, rather than finding and responding to violations after an 

illness or outbreak has occurred;

• strengthening FDA technical expertise and capacity to support FDA 

and industry in implementing the new prevention standards;

• furthering federal, state, local, and territorial partnerships, and 

investing in training and capacity to ensure efficient, high-quality, and 

consistent oversight nationwide; and

• broadening interaction with foreign partners and increasing oversight 

of importers, who will have more responsibility for the safety of 

imported foods.

Beyond FSMA, the FVM Program’s strategic plan also asserts that it 

provides greater focus on the agency’s public health goals and objectives 

in the areas of nutrition and chemical safety and that organizational 

excellence will remain a central strategic priority to make the best use of 

available resources and to continue investing in FDA’s workforce.92

The strategic plan also identifies 19 food safety and 9 nutrition strategies 

that support its food safety- and nutrition-related goals and objectives, as 

shown in appendix IV. For example, to support the food safety objective 

of improving prevention, detection, and response to foodborne illness 

outbreaks and other food and feed safety incidents, the FVM Program 

has four strategies: (1) improve data analysis and collaboration with food 

and feed safety partners, including industry, academia, and other 

domestic and foreign regulatory bodies; (2) improve risk prediction and 

prioritization to focus FVM Program resources and the efforts of 

 91Food and Drug Administration, FDA Foods and Veterinary Medicine Program Strategic 

Plan, Fiscal Years 2016-2025 (Washington, D.C.: July 14, 2016). 

92The strategic plan states that FDA conducts a wide range of standard-setting and 

premarket oversight activities involving chemical safety, encompassing food and feed 

additives, dietary supplements, food packaging, chemical contaminants in food, and 

cosmetics.

Time Frames for Activities 

Planned for the Longer 

Term Are Unclear Because 

the FVM Program’s 10-

Year Strategic Plan Does 

Not Have an 

Implementation Plan
Page 38 GAO-18-174 FDA Food Safety and Nutrition

regulatory partners on high-risk commodities and firms; (3) utilize 

knowledge gained from previous outbreaks and other incidents to better 

inform risk modeling, identify best practices, and increase compliance 

through voluntary corrective actions; and (4) improve collaboration and 

communication within the agency and among external stakeholders in 

order to improve the efficiency and effectiveness of FVM Program 

compliance actions.

To support the nutrition objective of providing and supporting accurate 

and useful nutrition information and education so that consumers can 

choose healthier diets consistent with the Dietary Guidelines for 

Americans and other evidence-based recommendations, the FVM 

Program has four strategies: (1) improve the availability and accuracy of 

nutrition information provided to consumers by modernizing nutrition and 

supplement fact labels, and by expanding nutrition labeling to menus in 

restaurants, other retail establishments, and vending machines; (2) 

promote collaboration to advance the science underlying dietary guidance 

statements, medical food disease claims, and nutrition-related claims; (3) 

enhance understanding of how consumers notice, understand, and act on 

labeling and nutrition information, including nutrition facts labels, nutrition 

product claims, front-of-package nutrition labels, and dietary 

recommendations; and (4) promote collaboration with stakeholders, 

including industry, consumer, and public health groups, to enhance 

consumer nutrition education directed toward age and demographic 

groups with specific needs.

However, the specific time frames for the activities that would support the 

strategies identified in its 10-year strategic plan are unclear because the 

FVM Program has not developed a plan that includes specific actions, 

priorities, and milestones to implement these strategies. The FVM 

Program’s strategic plan states that an implementation plan will identify 

the specific actions it will implement over a shorter time frame to achieve 

the strategic plan’s objectives. In addition, the strategic plan states that 

the implementation plan will prioritize and sequence these actions, based 

on anticipated resources and other practical constraints, and identify 

initial and intermediate outcomes and performance measures to monitor 

progress. FDA officials told us that they expected to complete this 

implementation plan by the end of fiscal year 2017, but as of January 

2018, they had not done so.
Page 39 GAO-18-174 FDA Food Safety and Nutrition

Our previous work, consistent with GPRAMA, sets forth several key 

elements of strategies that can guide agencies in planning and 

implementing an effective government program.93 As noted in our prior 

work, elements such as specific actions, priorities, and milestones are 

desirable for evaluating progress, achieving results in specific time 

frames, and ensuring effective oversight and accountability. These 

elements can also be used to gauge progress when implementing 

programs and to determine whether adjustments need to be made in 

order to maintain progress within given time frames.94 Until FDA 

completes an implementation plan that includes specific actions, 

priorities, and milestones for the FVM Program’s strategic plan, it will be 

difficult for the agency to ensure it is prioritizing and sequencing the 

necessary actions to achieve its objectives.

Since FSMA’s enactment, FDA has conducted numerous key food safetyand nutrition-related activities. For example, it has issued a number of 

food safety- and nutrition-related regulations and guidance to implement

statutes, such as FSMA, and its strategic goals. FDA considered multiple 

factors in deciding between developing regulations or guidance, and its 

decisions went through multiple reviews. However, the agency did not 

uniformly document the bases for those decisions. Without uniformly 

documenting the bases for its decisions for issuing either regulations or 

guidance related to food safety and nutrition—such as by using concept 

papers or guidance initiation sheets—FDA cannot help ensure 

consistency and transparency in the decision-making process.

The FVM Program has set two goals and eight objectives for its food 

safety- and nutrition-related activities. FDA has developed performance 

measures to assess progress for some, but not all, of these objectives. 

Until FDA develops performance measures with associated targets and 

time frames for all eight of the FVM Program’s food safety-and nutritionrelated objectives, FDA cannot fully and accurately assess progress 

toward achieving its food safety- and nutrition-related goals.

 93GAO, Electronic Health Records: HHS Strategy to Address Information Exchange 

Challenges Lacks Specific Prioritized Actions and Milestones, GAO-14-242 (Washington, 

D.C.: Mar. 24, 2014), and Combating Terrorism: Evaluation of Selected Characteristics in 

National Strategies Related to Terrorism, GAO-04-408T (Washington, D.C.: Feb. 3, 2004).

94See GAO/GGD/AIMD-99-69 and GAO, Executive Guide: Effectively Implementing the 

Government Performance and Results Act, GAO/GGD-96-118 (Washington, D.C.: June 

1996).

Conclusions
Page 40 GAO-18-174 FDA Food Safety and Nutrition

The FVM Program’s 10-year strategic plan identifies several food safetyand nutrition-related strategies to be pursued by the program, but FDA 

has not developed an implementation plan—as called for in the strategic 

plan—that identifies the specific actions it will implement over a shorter 

time frame to achieve the strategic plan’s objectives. Until FDA completes 

an implementation plan that includes specific actions, priorities, and 

milestones for the FVM Program’s strategic plan, it will be difficult for the 

agency to ensure it is prioritizing and sequencing the necessary actions to 

achieve its objectives.

We are making the following three recommendations to FDA:

The Commissioner of FDA should ensure that FVM Program staff 

uniformly document the bases for their decisions for issuing either 

regulations or guidance related to food safety and nutrition, such as by 

using concept papers or guidance initiation sheets. (Recommendation 1)

The Commissioner of FDA should ensure that the FVM Program 

develops performance measures with associated targets and time frames 

for all eight of FDA’s food safety- and nutrition-related objectives. 

(Recommendation 2)

The Commissioner of FDA should complete an implementation plan that 

includes specific actions, priorities, and milestones for the FVM Program’s 

strategic plan. (Recommendation 3)

We are providing a draft of this report to the Department of Health and 

Human Services for review and comment. In its comments, reproduced in 

appendix V, the Department of Health and Human Services generally 

concurred with our findings and recommendations and identified several 

actions that FDA intends to take to address our recommendations, as 

discussed below. FDA also provided technical comments, which we 

incorporated as appropriate.

In response to our first recommendation, the Department of Health and 

Human Services indicated that FDA has established internal 

documentation and review and clearance procedures for policy 

documents, including regulations and guidance, to ensure policy 

documents conform to Administrative Procedure Act requirements, FDA’s 

Good Guidance Practices regulations, and executive orders. The 

department also indicated that FDA will share templates, such as concept 

Recommendations for 

Executive Action

Agency Comments 
Page 41 GAO-18-174 FDA Food Safety and Nutrition

papers, as we recommended, and promote more consistent application 

across the FVM Program.

In response to our second recommendation, the department indicated 

that FDA is expanding the use of outcome-based performance measures 

to monitor and report programmatic impact, such as in implementing 

FSMA. In addition, the department stated that FDA is using its 

established processes for developing and refining performance measures 

to address our recommendation, with the goal of establishing new or 

refined measures to monitor the outcomes for each goal and objective in 

the FVM Program’s strategic plan. Furthermore, the department stated 

that, as these measures are operationalized and mature, they will also 

include targets and timeframes, consistent with our recommendation.

In response to our third recommendation, the department indicated that 

FDA intends to develop and publish a plan to implement the FVM 

Program’s strategic plan, which will identify specific actions, priorities, and 

milestones, as we recommended. The department also stated that FDA 

intends to draft this implementation plan by the fourth quarter of fiscal 

year 2018.

As agreed with your offices, unless you publicly announce the contents of 

this report earlier, we plan no further distribution until 30 days from the 

report date. At that time, we will send copies of this report to the 

appropriate congressional committees, the Secretary of Health and 

Human Services, the Commissioner of FDA, and other interested parties. 

In addition, the report will be 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 contributed to this report are listed in 

appendix VI.

Steve D. Morris

Director, Natural Resources and Environment
Appendix I: Key FDA Food Safety- and 

Nutrition-Related Regulations and Guidance 

Published from January 2011 through 

September 2017

Page 42 GAO-18-174 FDA Food Safety and Nutrition

Tables 4 and 5 provide information on the key food safety- and nutritionrelated regulations and guidance, respectively, that the Food and Drug 

Administration (FDA) published from January 2011 through September 

2017.

To identify these key FDA regulations and guidance, we relied on several 

sources, including (1) the Unified Agenda of Federal Regulatory and 

Deregulatory Actions (Unified Agenda), (2) the Federal Register, and (3) 

various FDA websites. The Unified Agenda, published biannually by 

OMB, is a compilation of information about federal agencies’ planned 

rulemaking actions. Specifically, to identify FDA’s planned food safetyand nutrition-related rulemaking actions since the FDA Food Safety 

Modernization Act’s (FSMA) enactment, we reviewed each Unified 

Agenda published from January 2011 through August 2017. To verify the 

status of these planned actions, we compared them with the proposed 

and final food safety- and nutrition-related regulations published in the 

Federal Register. To identify the food safety- and nutrition-related 

guidance that FDA published from January 2011 through September 

2017, we reviewed FDA websites, including “FSMA Rules & Guidance for 

Industry,” “Food Guidance Documents,” and “Search for FDA Guidance 

Documents.” In addition, we evaluated FDA’s written responses to our 

questions on this topic and updated our lists of key food safety- and 

nutrition-related regulations and guidance, as appropriate. For the 

purposes of this report, proposed or draft, and subsequent final versions 

of the regulations and guidance that were published during the relevant 

time period were counted only once.

In describing FDA’s food safety- and nutrition-related activities from 

January 2011 through September 2017, we use the term “key” to refer to 

regulations and guidance that are most relevant to and substantive for 

this review. Specifically, we included “Level 1” guidance, which FDA 

regulations define as those that set initial interpretations or more-thanminor changes to interpretations, are scientifically complex, or are likely to 

be highly controversial. We excluded “Level 2” guidance, which FDA 

regulations define as those that set forth existing practices or minor 

changes in interpretations.

To categorize the regulations and guidance as being related to food 

safety, nutrition, or both, we took several steps. Specifically, we analyzed 

FDA written responses providing descriptions of the terms food safety 

and nutrition, FDA documents describing the agency’s food safety and 

nutrition activities and goals, and the regulations and guidance. Because 

we found no applicable statutory definition for food safety- or nutritionAppendix I: Key FDA Food Safety- and 

Nutrition-Related Regulations and Guidance 

Published from January 2011 through 

September 2017
Appendix I: Key FDA Food Safety- and 

Nutrition-Related Regulations and Guidance 

Published from January 2011 through 

September 2017

Page 43 GAO-18-174 FDA Food Safety and Nutrition

related activities, we relied on FDA’s descriptions of food safety and 

nutrition—for example, those from FDA’s strategic plans and interviews 

with agency officials.1 We categorized the regulations and guidance as 

being related to food safety or nutrition depending on whether the 

regulations or guidance advanced FDA’s efforts to achieve the food 

safety public health outcome or the nutrition public health outcome 

identified in the Foods and Veterinary Medicine (FVM) Program’s 

strategic plan for fiscal years 2016 through 2025. These two outcomes 

were not assumed to be mutually exclusive because some of the 

agency’s activities cut across both the food safety and nutrition 

categories. Thus, a document we categorized as advancing the food 

safety public health outcome could also be categorized as advancing the 

nutrition public health outcome and vice versa. In categorizing the 

regulations and guidance, we focused on the primary subject matter of 

the document and did not take into account how resources were 

dedicated; we acknowledge that resources are dedicated to either food 

safety or nutrition, but not both. Two analysts independently reviewed and 

coded the regulations and guidance, and a third analyst conducted a final 

review in cases where the first and second analysts disagreed. Ultimately, 

we reached agreement on all categorizations.

The FVM Program’s public health outcomes are to be achieved through 

activities related to food for humans and animals, including food for pets 

and laboratory animals. However, the scopes of tables 4 and 5 are limited 

to the safety and nutrition of food for humans and food-producing animals 

(livestock such as cattle, poultry, and swine).

 1

FDA officials told us that the agency’s food safety activities encompass a range of 

activities to prevent or mitigate contamination of food for humans and animals. They noted 

that FDA’s nutrition activities also encompass a range of activities to improve nutritional 

status in humans and animals and to reduce the prevalence of diet-related risk factors for 

chronic disease. Some of the agency’s activities, however, cut across these two 

categories and, therefore, are related to both food safety and nutrition. FDA officials added 

that the Center for Veterinary Medicine is not engaged in activities related to the nutritional 

status of animals and does not receive funding for nutrition activities.
Appendix I: Key FDA Food Safety- and 

Nutrition-Related Regulations and Guidance 

Published from January 2011 through 

September 2017

Page 44 GAO-18-174 FDA Food Safety and Nutrition

Table 4: Key Food Safety- and Nutrition-Related Regulations Published by FDA from January 2011 through September 2017 

Title Subject 

Federal 

Register 

number

Law(s) authorizing 

or requiring 

regulation Statusa Date 

published 

Temperature-Indicating Devices;

Thermally Processed Low-Acid Foods

Packaged in Hermetically Sealed

Containers

FS 76 Fed. Reg. 

11,892

Federal Food, Drug, 

and Cosmetic Act 

(FFDCA)

Final rule 3/3/2011

Beverages: Bottled Water Quality Standard; 

Establishing an Allowable Level for Di(2-

ethylhexyl)phthalate

FS 76 Fed. Reg. 

64,810

FFDCA Final rule 10/19/2011

Animal Food Labeling; Declaration of Certifiable 

Color Additives

FS 76 Fed. Reg. 

71,248

Nutrition Labeling and 

Education Act 

(amending FFDCA)

Final rule 11/17/2011

Import Tolerances for Residues of Unapproved New 

Animal Drugs in Food

FS 77 Fed. Reg. 

3653

FFDCA Proposed 

rule

1/25/2012

Animal Drugs, Feeds, and Related Products; 

Regulation of Carcinogenic Compounds in FoodProducing Animals

FS 77 Fed. Reg. 

50,591

FFDCA Final rule 8/22/2012

New Animal Drugs; Updating Tolerances for 

Residues of New Animal Drugs in Food

FS 77 Fed. Reg. 

72,254

FFDCA Proposed 

rule

12/5/2012

Criteria Used to Order Administrative Detention of 

Food for Human or Animal Consumption

FS & N 78 Fed. Reg. 

7994

FDA Food Safety 

Modernization Act 

(FSMA) (amending 

FFDCA)

Final rule 2/5/2013 

Food Labeling; Gluten-Free Labeling of Foods FS & N 78 Fed. Reg. 

47,154

Food Allergen 

Labeling and 

Consumer Protection 

Act

FFDCA

Final rule 8/5/2013

Information Required in Prior Notice of Imported 

Food

FS 78 Fed. Reg. 

32,359

FSMA (amending 

FFDCA)

Final rule 5/30/2013 

Establishment, Maintenance, and Availability of 

Records: Amendment to Record Availability 

Requirements

FS 79 Fed. Reg. 

18,799

FSMA (amending 

FFDCA)

Final rule 4/4/2014 

Food Labeling: Nutrient Content

Claims; Alpha-Linolenic Acid,

Eicosapentaenoic Acid, and

Docosahexaenoic Acid Omega-3 Fatty

Acids

N 79 Fed. Reg. 

23,262

FFDCA Final rule 4/28/2014 

Current Good Manufacturing Practices, Quality 

Control Procedures, Quality Factors, Notification 

Requirements, and Records and Reports, for Infant 

Formula

FS & N 79 Fed. Reg. 

33,057

Infant Formula Act 

(amending FFDCA)

Final rule 6/10/2014 
Appendix I: Key FDA Food Safety- and 

Nutrition-Related Regulations and Guidance 

Published from January 2011 through 

September 2017

Page 45 GAO-18-174 FDA Food Safety and Nutrition

Title Subject 

Federal 

Register 

number

Law(s) authorizing 

or requiring 

regulation Statusa Date 

published 

Food Labeling; Calorie Labeling of Articles of Food

in Vending Machines

N 79 Fed Reg. 

71,259

Patient Protection and 

Affordable Care Act

(amending FFDCA)

Final rule 12/1/2014 

Food Labeling; Nutrition Labeling of Standard Menu 

Items in Restaurants and Similar Retail Food 

Establishments

N 79 Fed. Reg. 

71,156

Patient Protection and 

Affordable Care Act

(amending FFDCA)

Final rule 12/1/2014 

Veterinary Feed Directive FS 80 Fed. Reg. 

31,708

FFDCA Final rule 6/3/2015

Infant Formula: The Addition of Minimum and 

Maximum Levels of Selenium to Infant Formula and 

Related Labeling Requirements

FS & N 80 Fed. Reg. 

35,834

FFDCA Final rule 6/23/2015

Current Good Manufacturing Practice, Hazard 

Analysis, and Risk-Based Preventive Controls for 

Food for Animals

FS 80 Fed. Reg. 

56,170

FSMA (amending 

FFDCA)

Public Health Service 

Act

Final rule 9/17/2015

Current Good Manufacturing Practice, Hazard 

Analysis, and Risk-Based Preventive Controls for 

Human Food

FS 80 Fed. Reg. 

55,908

FSMA (amending 

FFDCA)

Public Health Service 

Act

Final rule 9/17/2015

Food Labeling; Gluten-Free Labeling of Fermented 

or Hydrolyzed Foods

FS & N 80 Fed. Reg. 

71,990

Food Allergen 

Labeling and 

Consumer Protection 

Act

FFDCA

Proposed 

rule

11/18/2015 

Artificially Sweetened Fruit Jelly and

Artificially Sweetened Fruit Preserves

and Jams; Revocation of Standards of

Identity

N 80 Fed. Reg. 

72,581

FFDCA Final rule 11/20/2015

Accreditation of Third-Party Certification Bodies to 

Conduct Food Safety Audits and to Issue 

Certifications

FS 80 Fed. Reg. 

74,570

FSMA (amending 

FFDCA)

Final rule 11/27/2015

Foreign Supplier Verification Programs for Importers 

of Food for Humans and Animals

FS 80 Fed. Reg. 

74,226

FSMA (amending 

FFDCA)

Public Health Service 

Act

Final rule 11/27/2015 

Standards for the Growing, Harvesting, Packing, and 

Holding of Produce for Human Consumption

FS 80 Fed. Reg. 

74,354

FSMA (amending 

FFDCA)

Public Health Service 

Act

Final rule 11/27/2015 

Use of Materials Derived from Cattle in Human Food 

and Cosmetics

FS 81 Fed. Reg. 

14,718

FFDCA Final rule 3/18/2016
Appendix I: Key FDA Food Safety- and 

Nutrition-Related Regulations and Guidance 

Published from January 2011 through 

September 2017

Page 46 GAO-18-174 FDA Food Safety and Nutrition

Title Subject 

Federal 

Register 

number

Law(s) authorizing 

or requiring 

regulation Statusa Date 

published 

Sanitary Transportation of Human and Animal Food FS 81 Fed. Reg. 

20,092

Sanitary Food 

Transportation Act

FSMA 

Final rule 4/6/2016 

Antimicrobial Animal Drug Sales and Distribution 

Reporting

FS 81 Fed. Reg. 

29,129

FFDCA Final rule 5/11/2016

Food Labeling: Revision of the Nutrition and 

Supplement Facts Labels

N 81 Fed. Reg. 

33,742

FFDCA

Nutrition Labeling and 

Education Act 

Final rule 5/27/2016 

Food Labeling: Serving Sizes of Foods That Can 

Reasonably Be Consumed at One Eating Occasion; 

Dual-Column Labeling; Updating, Modifying, and 

Establishing Certain Reference Amounts 

Customarily Consumed; Serving Size for Breath 

Mints; and Technical Amendments

N 81 Fed. Reg. 

34,000

FFDCA

Nutrition Labeling and 

Education Act

Final rule 5/27/2016 

Mitigation Strategies to Protect Food against 

Intentional Adulteration

FS 81 Fed. Reg. 

34,166

FSMA (amending 

FFDCA)

Final rule 5/27/2016 

Amendments to Registration of Food Facilities FS 81 Fed. Reg. 

45,912

FSMA (amending 

FFDCA)

Bioterrorism Act 

Final rule 7/14/2016

Substances Generally Recognized as Safe FS 81 Fed Reg. 

54,960

FFDCA Final rule 8/17/2016

Amendments to Accreditation of Third-Party 

Certification Bodies to Conduct Food Safety Audits 

and to Issue Certifications to Provide for the User 

Fee Program

FS 81 Fed. Reg. 

90,186

FSMA (amending 

FFDCA)

Final rule 12/14/2016

Food Labeling: Health Claims; Dietary Saturated Fat 

and Cholesterol and Risk of Coronary Heart Disease

N 81 Fed. Reg. 

91,716

FFDCA Interim 

final rule

12/19/2016 

Legend: FS = food safety; N = nutrition; FS & N = food safety and nutrition

Source: GAO analysis of the Federal Register, the Unified Agenda of Federal Regulatory and Deregulatory Actions, and Food and Drug Administration (FDA) documents. | GAO-18-174

Note: Regulations establish legally binding requirements and are rooted in agencies’ statutory 

authority. Regulations are included in this table only if they were proposed (with a proposed rule 

published in the Federal Register) or final (with a final rule or interim final rule published in the 

Federal Register) during the relevant time frame.

a

Status indicates the agency “action” published in the Federal Register—final rule, interim final rule, or 

proposed rule.
Appendix I: Key FDA Food Safety- and 

Nutrition-Related Regulations and Guidance 

Published from January 2011 through 

September 2017

Page 47 GAO-18-174 FDA Food Safety and Nutrition

Table 5: Key Food Safety- and Nutrition-Related Guidance Published by FDA from January 2011 through September 2017

Title Subject Statusa Date published 

Guidance for Industry: Letter to Firms that Grow, Harvest, Sort, Pack, or 

Ship Fresh Cilantro

FS Final March 2011

Guidance for Industry: Questions and Answers About the Petition 

Process

FS Final April 2011

Guidance for Industry on Fish and Fishery Products Hazards and 

Controls, Fourth Edition

FS Final April 2011 

Guidance for Industry: Enforcement Policy Concerning Certain Prior 

Notice Requirements

FS Final June 2011

Food Safety Modernization Act Domestic and Foreign Facility 

Reinspections, Recall, and Importer Reinspection User Fee Rates for 

Fiscal Year 2012

FS Final August 2011

What You Need to Know about Prior Notice of Imported Food 

Shipments

FS Final August 2011

Guidance for Industry: Measures to Address the Risk for Contamination 

by Salmonella Species in Food Containing a Pistachio-Derived Product 

as an Ingredient

FS Final September 2011 

Guidance for Industry on Studies to Evaluate the Metabolism and 

Residue Kinetics of Veterinary Drugs in Food-Producing Animals: 

Comparative Metabolism Studies in Laboratory Animals

FS Final September 2011

Guidance for Industry on Studies to Evaluate the Metabolism and 

Residue Kinetics of Veterinary Drugs in Food-Producing Animals: 

Metabolism Study to Determine the Quantity and Identify the Nature of 

Residues

FS Final September 2011

Guidance for Industry on Implementation of the Fee Provisions of the 

FDA Food Safety Modernization Act

FS Final October 2011

Guidance for Industry on Evaluating the Safety of Flood-Affected Food 

Crops for Human Consumption

FS Final October 2011

Guidance for Industry: Letter to Firms that Grow, Harvest, Sort, Pack, 

Process, or Ship Fresh Cantaloupe

FS Final November 2011

Guidance for Industry: Prevention of Salmonella enteritidis in Shell Eggs 

During Production, Storage, and Transportation

FS Final December 2011

Guidance for Industry: Questions and Answers Regarding 

Establishment and Maintenance of Records by Persons Who 

Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or 

Import Food (Edition 5)

FS Final February 2012

Guidance for Industry: Testing for Salmonella Species in Human Foods 

and Direct-Human-Contact Animal Foods

FS Final March 2012

Guidance for Industry on the Judicious Use of Medically Important 

Antimicrobial Drugs in Food-Producing Animals

FS Final April 2012

Guidance for Industry: The Seafood List – FDA’s Guide to Acceptable 

Market Names for Seafood Sold in Interstate Commerce

FS & N Final July 2012
Appendix I: Key FDA Food Safety- and 

Nutrition-Related Regulations and Guidance 

Published from January 2011 through 

September 2017

Page 48 GAO-18-174 FDA Food Safety and Nutrition

Title Subject Statusa Date published 

Guidance for Industry: Questions and Answers Regarding the Final 

Rule, Prevention of Salmonella enteritidis in Shell Eggs During 

Production, Storage, and Transportation

FS Final August 2012 

Guidance for Industry: Questions and Answers Regarding Food Facility 

Registration (Fifth Edition)

FS Final December 2012

Guidance for Industry: What You Need to Know About Registration of 

Food Facilities: Small Entity Compliance Guide

FS Final December 2012

Guidance for Industry: A Food Labeling Guide FS & N Final January 2013

Guidance for Industry: What You Need to Know About Administrative 

Detention of Foods: Small Entity Compliance Guide

FS & N Final March 2013

Revised Guidance for Industry on “Studies to Evaluate the Safety of 

Residues of Veterinary Drugs in Human Food: General Approach to 

Establish a Microbiological Acceptable Daily Intake (ADI)”

FS Final March 2013

Draft Interagency Risk Assessment—Listeria monocytogenes in Retail 

Delicatessens: Notice of Availability of Documents and Request for 

Comment

FS Draft May 2013

Draft Guidance for Industry on Arsenic in Apple Juice: Action Level; 

Supporting Document for Action Level for Arsenic in Apple Juice; A 

Quantitative Assessment of Inorganic Arsenic in Apple Juice

FS Draft July 2013

Draft Guidance for Industry: Questions and Answers Regarding the 

Final Rule, Prevention of Salmonella enteritidis in Shell Eggs During 

Production, Storage, and Transportation (Layers With Outdoor Access)

FS Draft July 2013

Guidance for FDA Staff: Compliance Policy Guide Sec. 690.800 CPG 

Sec. 690.800 Salmonella in Food for Animals

FS Final July 2013

Guidance for Industry: Questions and Answers Regarding Adverse 

Event Reporting and Recordkeeping for Dietary Supplements as 

Required by the Dietary Supplement and Nonprescription Drug 

Consumer Protection Act

FS Final September 2013

Draft Risk Profile on Pathogens and Filth in Spices FS Draft November 2013

Guidance for Industry on Purchasing Reef Fish Species Associated with 

the Hazard of Ciguatera Fish Poisoning

FS Final November 2013

Guidance for Industry on New Animal Drugs and New Animal Drug 

Combination Products Administered in or on Medicated Feed or 

Drinking Water of Food-Producing Animals: Recommendations for Drug 

Sponsors for Voluntarily Aligning Product Use Conditions with Guidance 

for Industry #209

FS Final December 2013

Guidance for Industry: Distinguishing Liquid Dietary Supplements from 

Beverages

FS & N Final January 2014

Compliance Policy Guide Regarding Canned Ackee, Frozen Ackee, and 

Other Ackee Products—Hypoglycin A Toxin

FS Final April 2014

Draft Guidance for Industry: Proper Labeling of Honey and Honey 

Products

FS & N Draft April 2014

Guidance for Industry: Food and Drug Administration Records Access 

Authority under the Federal Food, Drug, and Cosmetic Act

FS Final April 2014
Appendix I: Key FDA Food Safety- and 

Nutrition-Related Regulations and Guidance 

Published from January 2011 through 

September 2017

Page 49 GAO-18-174 FDA Food Safety and Nutrition

Title Subject Statusa Date published 

Guidance for Industry: What You Need to Know About Establishment, 

Maintenance, and Availability of Records: Small Entity Compliance 

Guide

FS Final April 2014

Compliance Policy Guide Regarding Food Facility Registration—Human 

and Animal Food

FS Final June 2014

Environmental Protection Agency and Food and Drug Administration 

Advice About Eating Fish

FS & N Draft June 2014

Guidance for Industry: Considering Whether a Food and Drug 

Administration-Regulated Product Involves the Application of 

Nanotechnology

FS & N Final June 2014

Guidance for Industry: Assessing the Effects of Significant 

Manufacturing Process Changes, Including Emerging Technologies, on 

the Safety and Regulatory Status of Food Ingredients and Food Contact 

Substances, Including Food Ingredients That Are Color Additives

FS Final June 2014

Guidance for Industry: Demonstration of the Quality Factor 

Requirements for “Eligible” Infant Formulas

N Final June 2014

Questions and Answers Regarding Food Facility Registration (Sixth 

Edition); Guidance for Industry

FS Final November 2014

Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary 

Drugs in Food-Producing Animals: Marker Residue Depletion Studies to 

Establish Product Withdrawal Periods; Revised Guidance for Industry

FS Final March 2015

Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary 

Drugs in Food-Producing Animals: Validation of Analytical Methods 

Used in Residue Depletion Studies; Revised Guidance for Industry

FS Final March 2015

Guidelines for the Validation of Analytical Methods for the Detection of 

Microbial Pathogens in Foods and Feeds, 2nd Edition

FS Final May 2015

Guidelines for the Validation of Chemical Methods for the FDA FVM 

Program, 2nd Edition

FS Final May 2015

Questions and Answers Regarding Mandatory Food Recalls; Draft 

Guidance for Industry

FS Draft May 2015

Studies to Evaluate the Safety of Residues of Veterinary Drugs in 

Human Food: Genotoxicity Testing; Revised Guidance for Industry

FS Final May 2015

Final Determination Regarding Partially Hydrogenated Oils FS & N Final June 2015

Food Allergen Labeling Exemption Petitions and Notifications; Guidance 

for Industry

FS Final June 2015

Guidance for Industry: Cell-Based Products for Animal Use FS Final June 2015

Recommendations for Preparation and Submission of Animal Food 

Additive Petitions; Guidance for Industry

FS Final June 2015

Joint Food and Drug Administration/Health Canada Quantitative 

Assessment of the Risk of Listeriosis from Soft-Ripened Cheese 

Consumption in the United States and Canada

FS Final August 2015

Use of Nanomaterials in Food for Animals; Guidance for Industry FS Final August 2015

Acceptance Criteria for Confirmation of Identity of Chemical Residues 

Using Exact Mass Data within the Office of Foods and Veterinary 

Medicine

FS Final September 2015
Appendix I: Key FDA Food Safety- and 

Nutrition-Related Regulations and Guidance 

Published from January 2011 through 

September 2017

Page 50 GAO-18-174 FDA Food Safety and Nutrition

Title Subject Statusa Date published 

Draft Compliance Policy Guide: Crotalaria spp. Seeds in Grains FS Draft September 2015

Guidance for Industry: Colored Sea Salt FS Final September 2015

Qualitative Risk Assessment of Risk of Activity/Animal Food 

Combinations for Activities (Outside the Farm Definition) Conducted in a 

Facility Co-Located on a Farm

FS Final September 2015

Qualitative Risk Assessment of Risk of Activity/Food Combinations for 

Activities (Outside the Farm Definition) Conducted in a Facility CoLocated on a Farm

FS Final September 2015

Veterinary Feed Directive Regulation Questions and Answers; Small 

Entity Compliance Guide; Guidance for Industry

FS Final September 2015

Guidance for Industry: Questions and Answers on FDA’s Fortification 

Policy

N Final November 2015

Voluntary Labeling Indicating Whether Food Has or Has Not Been 

Derived from Genetically Engineered Atlantic Salmon; Draft Guidance 

for Industry

FS & N Draft November 2015

Voluntary Labeling Indicating Whether Foods Have or Have Not Been 

Derived from Genetically Engineered Plants; Guidance for Industry

FS & N Final November 2015

Acrylamide in Foods; Guidance for Industry FS Final March 2016

Ensuring Safety of Animal Feed Maintained and Fed On-Farm; 

Guidance for Industry

FS Final March 2016

Compliance Policy Guide on Crabmeat—Fresh and Frozen—

Adulteration with Filth, Involving the Presence of Escherichia coli

FS Final April 2016

Exempt Infant Formula Production: Current Good Manufacturing 

Practices, Quality Control Procedures, Conduct of Audits, and Records 

and Reports; Guidance for Industry

FS & N Final April 2016

Inorganic Arsenic in Rice Cereals for Infants: Action Level; Draft 

Guidance for Industry

FS Draft April 2016

A Labeling Guide for Restaurants and Retail Establishments Selling 

Away- From-Home Foods—Part II (Menu Labeling Requirements in 

Accordance With the Patient Protection Affordable Care Act of 2010); 

Guidance for Industry

N Final May 2016

Frequently Asked Questions About Medical Foods; Second Edition; 

Guidance for Industry

FS & N Final May 2016

Ingredients Declared as Evaporated Cane Juice; Guidance for Industry N Final May 2016

Qualified Facility Attestation Using Form FDA 3942a (for Human Food) 

or Form FDA 3942b (for Animal Food); Draft Guidance for Industry

FS Draft May 2016

Prior Notice of Imported Food Questions and Answers (Edition 3); 

Guidance for Industry

FS Final June 2016

Voluntary Sodium Reduction Goals: Target Mean and Upper Bound 

Concentrations for Sodium in Commercially Processed, Packaged, and 

Prepared Foods; Draft Guidance for Industry

N Draft June 2016

General Principles for Evaluating the Human Food Safety of New 

Animal Drugs Used in Food-Producing Animals; Draft Guidance for 

Industry

FS Draft July 2016
Appendix I: Key FDA Food Safety- and 

Nutrition-Related Regulations and Guidance 

Published from January 2011 through 

September 2017

Page 51 GAO-18-174 FDA Food Safety and Nutrition

Title Subject Statusa Date published 

The Food and Drug Administration’s Policy on Declaring Small Amounts 

of Nutrients and Dietary Ingredients on Nutrition Labels; Guidance for 

Industry

N Final July 2016

Calorie Labeling of Articles of Food in Vending Machines; Draft 

Guidance for Industry

N Draft August 2016

Classification of Activities as Harvesting, Packing, Holding, or 

Manufacturing/Processing for Farms and Facilities; Draft Guidance for 

Industry

FS Draft August 2016

Current Good Manufacturing Practice Requirements for Food for 

Animals; Draft Guidance for Industry

FS Draft August 2016

Dietary Supplements: New Dietary Ingredient Notifications and Related 

Issues; Revised Draft Guidance for Industry

FS Draft August 2016

Hazard Analysis and Risk-Based Preventive Controls for Human Food; 

Draft Guidance for Industry

FS Draft August 2016

Human Food By-Products for Use as Animal Food; Draft Guidance for 

Industry

FS Draft August 2016

Compliance Policy Guide Sec. 150.200 Compliance Review of Private 

Laboratory Analytical Packages (PLAPs)

FS & N Final September 2016

Labeling of Infant Formula: Guidance for Industry FS & N Final September 2016

Necessity of the Use of Food Product Categories in Food Facility 

Registrations and Updates to Food Product Categories (2016 Edition): 

Guidance for Industry

FS Final September 2016

Substantiation for Structure/Function Claims Made in Infant Formula 

Labels and Labeling: Draft Guidance for Industry

N Draft September 2016

Use of the Term “Healthy” in the Labeling of Human Food Products: 

Guidance for Industry

N Final September 2016

Veterinary Feed Directive Common Format Questions and Answers; 

Guidance for Industry

FS Final September 2016

Compliance Policy Guide: Section 101.100 FDA Considerations for 

Recommending Charges under 21 U.S.C.§331(a) or (d) for Causing the 

Introduction of Violative Products into Interstate Commerce

FS & N Final October 2016

Describing a Hazard That Needs Control in Documents Accompanying 

the Food, as Required by Four Rules Implementing the FDA Food 

Safety Modernization Act: Guidance for Industry

FS Draft October 2016

Frequently Asked Questions About GRASb for Substances Intended for 

Use in Human or Animal Food: Guidance for Industry

FS Final October 2016

Scientific Evaluation of the Evidence on the Beneficial Physiological 

Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted 

as a Citizen Petition; Draft Guidance for Industry

N Draft November 2016

Use of the Seafood List to Determine Acceptable Seafood Names; Draft 

Compliance Policy Guide

FS & N Draft November 2016

Voluntary Qualified Importer Program; Guidance for Industry FS Final November 2016

Compliance Policy Guide: Sec. 615.115 Extralabel Use of Medicated 

Feeds for Minor Species

FS Final December 2016
Appendix I: Key FDA Food Safety- and 

Nutrition-Related Regulations and Guidance 

Published from January 2011 through 

September 2017

Page 52 GAO-18-174 FDA Food Safety and Nutrition

Title Subject Statusa Date published 

Preparation of Food Contact Notifications for Food Contact Substances 

in Contact with Infant Formula and/or Human Milk; Draft Guidance for 

Industry

FS Draft December 2016

Questions and Answers Regarding Food Facility Registration (Seventh 

Edition); Revised Draft Guidance for Industry

FS Draft December 2016

Third-Party Certification Body Accreditation for Food Safety Audits: 

Model Accreditation Standards; Guidance for Industry and Food and 

Drug Administration Staff

FS Final December 2016

Compliance with and Recommendations for Implementation of the 

Standards for the Growing, Harvesting, Packing, and Holding of 

Produce for Human Consumption for Sprout Operations; Draft Guidance 

for Industry

FS Draft January 2017

Control of Listeria monocytogenes in Ready-to-Eat Foods: Revised 

Draft Guidance for Industry

FS Draft January 2017

Draft Guidance for Industry: Study Design Recommendations for 

Residue Studies in Honey for Establishing Maximum Residue Limits 

and Withdrawal Periods

FS Draft January 2017

Guidance for Industry: Regulation of Intentionally Altered Genomic DNA 

in Animals: Draft Guidance

FS Draft January 2017

Questions and Answers on the Nutrition and Supplement Facts Labels 

Related to the Compliance Date, Added Sugars, and Declaration of 

Quantitative Amounts of Vitamins and Minerals; Draft Guidance for 

Industry

N Draft January 2017

Reference Amounts Customarily Consumed: List of Products for Each 

Product Category; Draft Guidance for Industry

N Draft January 2017

Recognition of Acceptable Unique Facility Identifier (UFI) for the Foreign 

Supplier Verification Programs Regulation: Guidance for Industry

FS Final March 2017

Clarification on Food Establishment Waiver from Requirements of the 

Sanitary Transportation of Human and Animal Food Rule: Guidance for 

Industry

FS Final August 2017

Juice HACCPc and the FDA Food Safety Modernization Act: Guidance 

for Industry

FS Final August 2017

Low-Acid Foods Packaged in Hermetically Sealed Containers (LACF) 

Regulation and the FDA Food Safety Modernization Act: Guidance for 

Industry

FS Final August 2017

Seafood HACCPc and the FDA Food Safety Modernization Act: 

Guidance for Industry

FS Final August 2017

Studies to Evaluate the Safety of Residues of Veterinary Drugs in 

Human Food: General Approach to Establish an Acute Reference Dose

FS Final August 2017

Ultrafiltered Milk in the Production of Standardized Cheeses and 

Related Cheese Products: Guidance for Industry

FS & N Final August 2017

Legend: FS = food safety; N = nutrition; FS & N = food safety and nutrition

Source: GAO analysis of the Federal Register and Food and Drug Administration (FDA) documents. | GAO-18-174

a

Status indicates whether the guidance document is in draft or final form. Guidance documents are 

considered to be final if there is no indication—in the corresponding Federal Register notice or in the 

guidance document itself—of its being in draft form.
Appendix I: Key FDA Food Safety- and 

Nutrition-Related Regulations and Guidance 

Published from January 2011 through 

September 2017

Page 53 GAO-18-174 FDA Food Safety and Nutrition

b

GRAS stands for “generally recognized as safe.”

c

HACCP stands for “Hazard Analysis and Critical Control Point.”
Appendix II: FDA Resources for Food SafetyAnd Nutrition-Related Activities, Fiscal Years 

2011 through 2016

Page 54 GAO-18-174 FDA Food Safety and Nutrition

Tables 6 through 10 identify the resources—both obligations and full-time 

equivalents (FTE)—dedicated by three Food and Drug Administration 

(FDA) centers and one FDA office to specific food safety- and nutritionrelated activities in fiscal years 2011 through 2016.

To determine these resources, we obtained and analyzed obligations and 

FTE data for each relevant center and office that carries out food safetyand nutrition-related activities. Data were obtained directly from FDA 

databases. Specifically, we requested information on the obligations and 

FTEs dedicated to various food safety- and nutrition-related activities in 

each fiscal year from 2011 through 2016—the most recently available 

data at the time of our report—by four FDA components that conducted 

food safety- and nutrition-related work: the Center for Food Safety and 

Applied Nutrition, the Center for Veterinary Medicine, the Office of 

Regulatory Affairs, and the National Center for Toxicological Research. 

These organizational components used time and attendance systems to 

identify staff hours spent on various food safety- and nutrition-related 

activities; FDA then converted those hours into FTEs. Specifically:

• The Center for Food Safety and Applied Nutrition used the Resource 

Reporting System Via Project, its voluntary time reporting system, 

which captures staff hours and resources for various activities.

• The Center for Veterinary Medicine used the Activity Time Reporting 

system, its mandatory time reporting system.

• The Office of Regulatory Affairs used the Field Accomplishment and 

Compliance Tracking System—its workflow management system, 

which captures staff time spent on domestic activities, such as 

inspections or sample analysis—as well as the Operational and 

Administrative System for Import Support, which captures staff time 

on certain import activities, such as sample collection and analysis 

and field exams.

• The National Center for Toxicological Research used the Project 

Management System, through which it tracks financial data, and the 

NCTR Experiment Activity Tracking System, through which it tracks 

hours worked on various activities.

To determine the obligations for salaries and benefits, FDA officials stated 

that they compared their FTE data with the agency’s Unified Financial 

Management System. Obligations data include salaries, benefits, and 

operational funding. We reviewed the methods FDA used to compile the 

data; interviewed knowledgeable agency officials about the quality and 

completeness of the estimated data; and conducted tests to identify 

Appendix II: FDA Resources for Food 

Safety- And Nutrition-Related Activities, 

Fiscal Years 2011 through 2016
Appendix II: FDA Resources for Food SafetyAnd Nutrition-Related Activities, Fiscal Years 

2011 through 2016

Page 55 GAO-18-174 FDA Food Safety and Nutrition

obvious errors, outliers, and missing information. When we found errors 

or missing data, FDA officials corrected these errors and provided us with 

revised data. Based on FDA’s methods for compiling the data, we 

assessed the reliability of the obligations and FTE data and determined 

that the data were sufficient and appropriate to support the conclusions 

reached in this report.

Center for Food Safety and Applied Nutrition resources for food safetyrelated activities include resources for cosmetics-related activities. For 

budget reporting purposes, the center uses “food safety” to encompass 

both types of activities. Based on our review of FDA data, we determined 

that the center’s resources for cosmetics-related activities each fiscal year 

represented a small proportion of the center’s reported resources for food 

safety-related activities.

Center for Veterinary Medicine obligations to food safety-related activities 

are based on estimates. The center does not track obligations of 

operational funds by Activity Time Reporting activity codes.

FDA generally considers the FDA Headquarters and Infrastructure’s 

resources to be either for overhead or for supporting other agency 

activities. FDA Headquarters and Infrastructure data for fiscal years 2014 

through 2016 are based on time reporting data, whereas data from fiscal 

years 2011 through 2013 are based on estimates because of time 

reporting limitations. We did not analyze FDA Headquarters and 

Infrastructure resources for specific food safety- and nutrition-related 

activities because activity-level data were not available from fiscal years 

2011 through 2016.
Appendix II: FDA Resources for Food SafetyAnd Nutrition-Related Activities, Fiscal Years 

2011 through 2016

Page 56 GAO-18-174 FDA Food Safety and Nutrition

Table 6: Obligations, Including Salaries for Full-Time Equivalent (FTE) Staff, 

Dedicated by FDA’s Center for Food Safety and Applied Nutrition to Food Safetyand Nutrition-Related Activities, Fiscal Years 2011 through 2013

Dollars in millions

2011 2012 2013

Activity Dollars FTEs Dollars FTEs Dollars FTEs

Food safety Detection and 

compliance

25.4 107 28.3 106 30.2 132

Prevention and 

promotion

160.5 518 158.3 521 141.7 488

Scientific 

capacity

56.1 193 65.6 200 62.9 248

Food safety total 242.0 818 252.2 827 234.8 868

Nutrition Detection and 

compliance

0.4 3 0.5 2 0.4 2

Prevention and 

promotion

7.5 49 11.2 51 8.6 45

Scientific 

capacity

0.3 2 0.4 2 1.9 8

Nutrition total 8.2 54 12.0 55 10.9 55

Total 250.2 872 264.3 882 245.7 923

Source: GAO analysis of Food and Drug Administration (FDA data). | GAO-18-174

Note: Amounts are rounded and may not sum totals. In addition, the Center for Food Safety and 

Applied Nutrition’s obligations and FTEs for specific categories of food safety- and nutrition-related 

activities in fiscal years 2011 through 2013 are not comparable with data from fiscal years 2014 

through 2016. These data are not comparable because the center made changes to its time reporting 

system in fiscal year 2014.
Appendix II: FDA Resources for Food SafetyAnd Nutrition-Related Activities, Fiscal Years 

2011 through 2016

Page 57 GAO-18-174 FDA Food Safety and Nutrition

Table 7: Obligations, Including Salaries for Full-Time Equivalent (FTE) Staff, 

Dedicated by FDA’s Center for Food Safety and Applied Nutrition to Food Safetyand Nutrition-Related Activities, Fiscal Years 2014 through 2016

Dollars in millions

2014 2015 2016

Activity Dollars FTEs Dollars FTEs Dollars FTEs

Food safety Compliance 

and 

enforcement

32.5 175 47.2 210 49.6 230

Education and 

outreach

19.0 77 22.1 83 34.4 97

Policy 

development

15.8 91 20.6 101 21.5 115

Premarket 

review

16.1 71 15.2 90 15.0 89

Regulatory 

science

96.7 190 108.5 256 111.9 267

Risk 

assessment

27.3 116 17.7 51 18.5 54

Stakeholder 

engagement

46.3 165 35.6 109 34.6 116

Food safety total 253.7 884 266.9 900 285.5 969

Nutrition Compliance 

and 

enforcement

2.1 8 2.5 14 3.1 18

Education and 

outreach

2.2 12 1.2 7 3.3 8

Policy 

development

1.5 10 3.2 15 2.8 17

Premarket 

review

0.0 0 0.4 0 0.8 0

Regulatory 

science

5.2 20 5.2 21 7.8 22

Risk 

assessment

0.3 1 0.1 1 0.1 1

Stakeholder 

engagement

1.3 7 0.5 3 0.5 3

Nutrition total 12.7 59 13.1 61 18.5 68

Total 266.4 943 280.0 961 304.0 1,037

Source: GAO analysis of Food and Drug Administration (FDA) data. | GAO-18-174

Note: Amounts are rounded and may not sum totals. In addition, the Center for Food Safety and 

Applied Nutrition’s obligations and FTEs for specific categories of food safety- and nutrition-related 

activities in fiscal years 2011 through 2013 are not comparable with data from fiscal years 2014 

through 2016. These data are not comparable because the center made changes to its time reporting 

system in fiscal year 2014.
Appendix II: FDA Resources for Food SafetyAnd Nutrition-Related Activities, Fiscal Years 

2011 through 2016

Page 58 GAO-18-174 FDA Food Safety and Nutrition

Table 8: Obligations, Including Salaries for Full-Time Equivalent (FTE) Staff, Dedicated by FDA’s Center for Veterinary 

Medicine to Food Safety-Related Activities, Fiscal Years 2011 through 2016

Dollars in millions

2011 2012 2013 2014 2015 2016

Activity Dollars FTEs Dollars FTEs Dollars FTEs Dollars FTEs Dollars FTEs Dollars FTEs

Animal food safety 37.6 235 38.4 249 36.7 234 45.2 239 45.2 241 47.2 269

Antimicrobial resistance 20.2 50 20.1 50 16.3 53 16.3 53 16.3 53 16.3 53

Total 57.9 285 58.4 299 53.0 287 61.5 292 61.5 294 63.5 322

Source: GAO analysis of Food and Drug Administration (FDA) data. | GAO-18-174

Note: Amounts are rounded and may not sum to totals.

Table 9: Obligations, Including Salaries for Full-Time Equivalent (FTE) Staff, Dedicated by FDA’s National Center for 

Toxicological Research to Food Safety-Related Activities, Fiscal Years 2011 through 2016

Dollars in millions

2011 2012 2013 2014 2015 2016

Activity Dollars FTEs Dollars FTEs Dollars FTEs Dollars FTEs Dollars FTEs Dollars FTEs

Antimicrobial resistance 3.1 13 1.8 9 2.8 12 2.0 10 2.4 9 2.5 15

Dietary supplements 1.9 7 2.1 10 1.6 3 1.3 2 1.0 2 4.0 10

Other food safety 5.7 28 6.3 27 7.7 41 6.9 35 6.8 34 3.8 24

Total 10.8 48 10.2 46 12.1 56 10.2 47 10.2 45 10.2 49

Source: GAO analysis of Food and Drug Administration (FDA) data. | GAO-18-174

Note: Amounts are rounded and may not sum to totals.
Appendix II: FDA Resources for Food SafetyAnd Nutrition-Related Activities, Fiscal Years 

2011 through 2016

Page 59 GAO-18-174 FDA Food Safety and Nutrition

Table 10: Obligations, Including Salaries for Full-Time Equivalent (FTE) Staff, Dedicated by FDA’s Office of Regulatory Affairs 

to Food Safety- and Nutrition-Related Activities, Fiscal Years 2011 through 2016

Dollars in millions

2011 2012 2013 2014 2015 2016

Activity Dollars FTEs Dollars FTEs Dollars FTEs Dollars FTEs Dollars FTEs Dollars FTEs

Food safety Domestic 

inspections

163.8 804 153.7 727 117.1 616 116.3 582 120.3 604 140.4 703

Domestic 

field exams

35.4 174 32.9 156 33.9 179 34.0 171 31.2 158 34.7 176

Other 

domestic 

activities

133.2 569 155.5 607 148.8 634 201.5 735 216.4 775 256.5 744

Foreign 

inspections

12.2 60 16.5 78 15.4 81 16.2 81 15.6 78 14.4 72

Other foreign 

activities

11.6 56 12.3 58 14.7 75 16.7 82 16.8 83 24.5 102

Import field 

exams

130.4 642 120.2 571 107.3 572 99.6 506 94.7 483 103.0 525

Import label 

reviews

27.4 137 22.8 111 18.8 106 18.0 97 16.3 89 18.7 99

Other import 

activities, 

such as 

laboratory 

resources

98.9 467 117.3 530 121.9 607 145.8 670 142.4 654 141.6 633

Food safety total 612.9 2,909 631.3 2,838 577.8 2,870 648.1 2,924 653.7 2,924 733.7 3,054

Nutrition Domestic 

inspections

1.3 6 1.6 7 1.0 4 1.0 4 1.3 5 2.6 10

Domestic 

field exams

0.9 4 0.9 4 0.7 3 0.8 3 1.0 4 2.3 9

Other 

domestic 

activities

— — — — — — .3 1 — — .3 1

Foreign 

inspections

0.2 1 0.2 1 0.2 1 0.3 1 0.3 1 0.3 1

Import field 

exams

2.8 13 2.3 10 2.4 10 2.8 11 2.0 8 4.7 18

Import label 

reviews

6.5 30 6.4 28 5.3 22 5.5 22 6.1 24 4.7 18

Nutrition total 11.8 54 11.5 50 9.6 40 10.5 42 10.7 42 14.8 57

Total 624.7 2,963 642.8 2,888 587.4 2,910 658.6 2,966 664.4 2,966 748.5 3,111

Legend: — = not applicable

Source: GAO analysis of Food and Drug Administration (FDA) data. | GAO-18-174

Note: Amounts are rounded and may not sum to totals.
Appendix III: FDA Performance Measures for 

Food Safety- and Nutrition-Related Activities, 

Fiscal Year 2017

Page 60 GAO-18-174 FDA Food Safety and Nutrition

This appendix contains information on our analysis of the Foods and 

Veterinary Medicine (FVM) Program’s performance measures in fiscal 

year 2017. The results of our analysis show how performance measures 

enable Food and Drug Administration (FDA) officials to assess progress 

toward the program’s strategic goals for food safety- and nutrition-related 

activities. We conducted this analysis by evaluating the extent to which 

each FVM Program performance measure active in fiscal year 2017 

aligns with food safety- and nutrition-related strategic objectives identified 

in the FDA Foods and Veterinary Medicine Program Strategic Plan, Fiscal 

Years 2016-2025. (See tables 11 and 12 for results.) According to FDA 

documentation, these objectives, in conjunction with performance 

measures, provide FVM Program officials with the information they need 

to assess how the program’s efforts are helping it achieve the program’s

strategic goals.

In identifying the population of performance measures relevant to our 

analysis, we included only FVM Program performance measures for 

activities that affect the safety or nutrition of food for humans or foodproducing animals. We excluded from our analysis performance 

measures for activities that do not affect the safety of foods consumed by 

humans, such as activities exclusively related to FDA’s oversight of pet 

food.

Using a methodology similar to the one described in appendix I, we took

several steps to categorize the performance measures as being related to 

food safety, nutrition, or both. Specifically, two analysts independently 

coded the performance measures as aligning with one or more of the 

FVM Program’s strategic objectives and intended public health outcomes 

for food safety and nutrition. A third analyst conducted a final review in 

cases where the first and second analysts disagreed. Ultimately, we 

reached agreement on all categorizations. In tables 11 and 12, we list the 

performance measures related to food safety and nutrition, respectively.

Based on our analysis, some performance measures align with both food 

safety and nutrition objectives. For example, we have determined that the 

performance measure related to the “number of import food field exams”

aligns with the three objectives related to preventive control standards, 

additives and dietary supplements, and nutrition information and 

education. We made this determination because field exams likely 

contribute to higher compliance rates with food safety preventive control 

standards, include checks for non-permitted additives, and include checks 

for labeling compliance. Measures that align with both food safety and 

nutrition objectives are included in both tables 11 and 12.

Appendix III: FDA Performance Measures for 

Food Safety- and Nutrition-Related Activities, 

Fiscal Year 2017
Appendix III: FDA Performance Measures for 

Food Safety- and Nutrition-Related Activities, 

Fiscal Year 2017

Page 61 GAO-18-174 FDA Food Safety and Nutrition

Table 11: FDA Foods and Veterinary Medicine (FVM) Program Performance Measures for Food Safety-Related Activities in 

Fiscal Year 2017, by Measure Title and Office or Center 

Measure title Sourcea FDA office or center

The average number of working days to serotype priority 

pathogens in food (screening only)

CBJ Center for Food Safety and Applied Nutrition

Complete review and action on the safety evaluation of direct 

and indirect food and color additive petitions, within 360 days of 

receipt

CBJ Center for Food Safety and Applied Nutrition

GenomeTrackr Programb FDA-TRACK Center for Food Safety and Applied Nutrition

Human pathogen on plants FDA-TRACK Center for Food Safety and Applied Nutrition

New technologies/methodologies to assess chemical food safety FDA-TRACK Center for Food Safety and Applied Nutrition

Number of state, local, and tribal regulatory agencies in the U.S. 

and its territories enrolled in the draft Voluntary National Retail 

Food Regulatory Program Standards

CBJ Center for Food Safety and Applied Nutrition

Percentage of “generally recognized as safe” notification reviews 

completed by Center for Food Safety and Applied 

Nutrition during the quarter within 180 days of filing 

FDA-TRACK Center for Food Safety and Applied Nutrition

Percentage of analytical package reviewsc received via FDA’s 

electronic Compliance Management System that meet Office of 

Compliance timeframes as specified in the quarter

FDA-TRACK Center for Food Safety and Applied Nutrition

Promote safe production of molluscan shellfish for human 

consumption: vibrio forecasting and assistance

FDA-TRACK Center for Food Safety and Applied Nutrition

Reduce the incidence of infection caused by key pathogens 

commonly transmitted by food: Campylobacter species

CBJ Center for Food Safety and Applied Nutrition

Reduce the incidence of infection caused by key pathogens 

commonly transmitted by food: Salmonella species

CBJ Center for Food Safety and Applied Nutrition

Reduce the incidence of infection caused by key pathogens 

commonly transmitted by food: Shiga toxin-producing 

Escherichia coli O157:H7

CBJ Center for Food Safety and Applied Nutrition

Reducing foodborne illness in the population. Work with federal, 

state, local, tribal, and industry partners, improve preventive 

controls in food production facilities and reduce the incidence 

rate (reported cases per 100,000 population per year) of Listeria 

monocytogenes infections

CBJ Center for Food Safety and Applied Nutrition

Sequencing-based analytical methods for microbial contaminant 

detection

FDA-TRACK Center for Food Safety and Applied Nutrition

Complete review and action on non-administrative abbreviated 

new animal drug applications and reactivations of such 

applications received during the fiscal year

CBJ Center for Veterinary Medicine

Complete review and action on original new animal drug 

applications and reactivations of such applications received 

during the fiscal year

CBJ Center for Veterinary Medicine

Complete review and action on warning letters received within 15 

working days to better safeguard our food supply by alerting 

firms to identified deviations in order to become compliant

CBJ Center for Veterinary Medicine
Appendix III: FDA Performance Measures for 

Food Safety- and Nutrition-Related Activities, 

Fiscal Year 2017

Page 62 GAO-18-174 FDA Food Safety and Nutrition

Measure title Sourcea FDA office or center

Percentage of “generally recognized as safe” notifications 

reviewed by the Center for Veterinary Medicine within 300 days

FDA-TRACK Center for Veterinary Medicine

Percentage of health hazard evaluations completed by due date FDA-TRACK Center for Veterinary Medicine

Percentage of warning letter recommendation packages 

reviewed within 25 days

FDA-TRACK Center for Veterinary Medicine

Total number of collaborating laboratories that will provide 

coordinated response to high priority chemical and microbial 

animal feed including pet food contamination events

CBJ Center for Veterinary Medicine

As required by the FSMA Legislation, cover 100 percent of the 

High Risk domestic inventory (approximately 19,500 firms) every 

3 years

CBJ Office of Regulatory Affairs

Increase laboratory surge capacity in the event of terrorist attack 

on the food supply (radiological and chemical samples per week)

CBJ Office of Regulatory Affairs

Number of domestic and foreign high-risk animal drug and feed 

inspections

CBJ Office of Regulatory Affairs

Number of examinations of FDA refused entriesd CBJ Office of Regulatory Affairs

Number of filer evaluationse CBJ Office of Regulatory Affairs

Number of import food field exams CBJ Office of Regulatory Affairs

Number of prior notice import security reviewsf CBJ Office of Regulatory Affairs

Number of targeted prohibited bovine spongiform 

encephalopathy (mad cow disease) inspections

CBJ Office of Regulatory Affairs

Source: GAO analysis of Food and Drug Administration (FDA) data. | GAO-18-174

a

“CBJ” refers to FDA’s Justification of Estimates for Appropriations Committees (congressional 

budget justification) for fiscal year 2017, and FDA-TRACK is FDA’s agency-wide performance 

management system.

b

Through its GenomeTrackr program, FDA intends to create a network of public health laboratories 

using whole genome sequencing to investigate foodborne illness outbreaks. Whole genome 

sequencing provides opportunities to stop outbreaks sooner than possible through traditionally used 

methods.

c

FDA uses a network of laboratories to analyze regulated products and monitor compliance with 

regulations. If laboratory analysis shows a food or dietary supplement is potentially unsafe, FDA 

reviews the analytical packages to determine if regulatory actions should be taken.

d

FDA-regulated products can be refused entry in the United States if they do not meet relevant laws 

and regulations. FDA is responsible for ensuring that these products are either destroyed or exported. 

In cooperation with U.S. Customs and Border Protection, FDA at times supervises the destruction or 

exportation of refused entries (“follow-up to refusal”).

e

Import filers send data to FDA, which the agency uses to assess the admissibility of potential 

imports. FDA conducts filer evaluations on a routine basis to determine whether filers are submitting 

accurate data. Evaluations are conducted by examining entry documents and comparing the 

information against data filed by importers.

f

Importers of human food and animal feed are required to give FDA “prior notice” of their products 

being offered for entry into the United States. According to FDA, every prior notice is electronically 

screened. Those identified as high risk receive a security review.
Appendix III: FDA Performance Measures for 

Food Safety- and Nutrition-Related Activities, 

Fiscal Year 2017

Page 63 GAO-18-174 FDA Food Safety and Nutrition

Table 12: FDA Foods and Veterinary Medicine (FVM) Program Performance Measures for Nutrition-Related Activities in Fiscal 

Year 2017, by Measure Title and Office or Center

Measure title Sourcea FDA Office or center

As required by the FDA Food Safety Modernization Act, cover 100 

percent of the high-risk domestic inventory (approximately 19,500 

firms) every 3 years

CBJ Office of Regulatory Affairs

Number of examinations of FDA refused entriesb CBJ Office of Regulatory Affairs

Number of filer evaluationsc CBJ Office of Regulatory Affairs

Number of import food field exams CBJ Office of Regulatory Affairs

Percentage of analytical package reviewsd received via FDA’s 

electronic Compliance Management System that meet Office of 

Compliance timeframes as specified in the quarter

FDA-TRACK Center for Food Safety and Applied Nutrition

Source: GAO analysis of Food and Drug Administration (FDA) data. | GAO-18-174

a

“CBJ” refers to FDA’s Justification of Estimates for Appropriations Committees (congressional 

budget justification) for fiscal year 2017, and FDA-TRACK is FDA’s agency-wide performance 

management system.

b

FDA-regulated products can be refused entry in the United States if they do not meet relevant laws 

and regulations. FDA is responsible for ensuring that these products are either destroyed or exported. 

In cooperation with U.S. Customs and Border Protection, FDA at times supervises the destruction or 

exportation of refused entries (“examinations”).

c

Import filers send data to FDA, which the agency uses to assess the admissibility of potential 

imports. FDA conducts filer evaluations on a routine basis to determine whether filers are submitting 

accurate data. Evaluations are conducted by examining entry documents and comparing the 

information against data filed by importers.

d

FDA uses a network of laboratories to analyze regulated products and monitor compliance with 

regulations. If laboratory analysis shows a food or dietary supplement is potentially unsafe, CFSAN

reviews the analytical packages to determine if regulatory actions should be taken.
Appendix IV: FDA Foods and Veterinary 

Medicine Program’s Goals, Objectives, and 

Strategies for Food Safety and Nutrition, Fiscal 

Years 2016 through 2025

Page 64 GAO-18-174 FDA Food Safety and Nutrition

Table 13 shows the Food and Drug Administration (FDA) Foods and 

Veterinary Medicine Program’s goals, objectives, and strategies for food 

safety and nutrition, according to the program’s strategic plan for fiscal 

years 2016 through 2025.

Table 13: Food and Drug Administration’s (FDA) Foods and Veterinary Medicine (FVM) Program’s Goals, Objectives, and 

Strategies for Food Safety and Nutrition, Fiscal Years 2016 through 2025

Goal Objective Strategy

Food safety Establish and gain high rates of 

compliance with science-based preventive 

control standards across the global farmto-table continuum.

Develop and implement a robust communication, training, and 

technical assistance plan for preventive control standards.

Utilize innovative inspection and compliance strategies, backed by 

administrative and judicial enforcement tools to foster compliance 

with preventive control standards.

Evaluate and improve the effectiveness of preventive control 

standards.

Evaluate and mitigate the risks of chemical exposures in food and 

feed products that pose public health or regulatory concerns.

Evaluate and mitigate the risks of microbiological hazards in food and 

feed products.

Improve prevention, detection, and 

response to foodborne illness outbreaks 

and other food and feed safety incidents.

Improve data analysis and collaboration with food and feed safety 

partners, including industry, academia, and other domestic and 

foreign regulatory bodies.

Improve risk prediction and prioritization to focus FVM resources and 

the efforts of regulatory partners on high-risk commodities and firms. 

Utilize knowledge gained from previous outbreaks and other incidents 

to better inform risk modeling, identify best practices, and increase 

compliance through voluntary corrective actions. 

Improve collaboration and communication within the agency and 

among external stakeholders in order to improve the efficiency and 

effectiveness of FVM compliance actions.

Strengthen the ability of consumers to play 

a proactive role in minimizing food safety 

risks.

Increase research, data analysis, and systematic evaluation to 

improve the effectiveness of food safety education in changing 

unsafe consumer food-handling behaviors. 

Increase consumer-based communications and outreach regarding 

safe food-handling practices, including leveraging a variety of 

community-based education programs.

Enhance communication to consumers during and following illness 

outbreaks.

Enhance the safety of food and feed 

additives and dietary supplements.

Implement innovative regulatory and compliance strategies to 

improve pre-market oversight and safety evaluation of food and feed 

additives, generally regarded as safe substances, and FDA’s ability to 

verify that substances added to the food supply meet applicable 

safety standards.

Appendix IV: FDA Foods and Veterinary 

Medicine Program’s Goals, Objectives, and 

Strategies for Food Safety and Nutrition, 

Fiscal Years 2016 through 2025
Appendix IV: FDA Foods and Veterinary 

Medicine Program’s Goals, Objectives, and 

Strategies for Food Safety and Nutrition, Fiscal 

Years 2016 through 2025

Page 65 GAO-18-174 FDA Food Safety and Nutrition

Goal Objective Strategy

In collaboration with external stakeholders, including regulatory and 

scientific partners, improve data-driven, post-market surveillance of 

substances added to the food supply to understand and assess 

changing use and intake patterns, emerging toxicological data, and 

adverse event reports.

Make innovative use of FDA resources and collaborative initiatives 

with regulatory partners and industry to achieve the goals of FDA’s 

dietary supplement Good Manufacturing Practice regulation and other 

standards related to the safety, quality, identity, and integrity of 

dietary supplements.

Expand consumer and health care provider education regarding safe 

use of dietary supplements.

Strengthen existing partnerships with 

international, federal, state, local, tribal, 

and territorial agencies to improve the 

effectiveness and efficiency of the FDA’s 

food safety program for government and 

industry.

Enhance leveraging of food safety efforts with domestic and 

international regulatory and public health partners.

Increase engagement and partnerships with domestic and 

international intergovernmental organizations to strengthen food 

safety capacity-building and food safety standards development.

Utilize the Partnership for Food Protectiona and its fiscal year 2015-

2020 strategic plan to continue to build the national Integrated Food 

Safety Systemb domestically.

Nutrition Provide and support accurate and useful 

nutrition information and education so 

consumers can choose healthier diets 

consistent with the Dietary Guidelines for 

Americans and other evidence-based 

recommendations.

Improve the availability and accuracy of nutrition information provided 

to consumers by modernizing nutrition and supplement fact labels, 

and by implementing the expansion of nutrition labeling to menus in 

restaurants, other retail establishments, and vending machines.

Promote collaboration to advance the science underlying dietary 

guidance statements, medical food disease claims, and nutritionrelated claims.

Enhance understanding of how consumers notice, understand, and 

act on labeling and nutrition information, including nutrition facts 

labels, nutrition product claims, front-of-package nutrition labels, and 

dietary recommendations.

Promote collaboration with stakeholders, including industry, 

consumer, and public health groups, to enhance consumer nutrition 

education directed toward age and demographic groups with specific 

needs.

Monitor and assess emerging nutrition 

science as well as changes in the 

composition of foods in the marketplace in 

relation to the nutritional and health status 

of Americans. 

Enhance the FVM Program’s capacity to gather and analyze 

information about the composition and labeling of foods in the 

marketplace.

Collaborate with federal partners who conduct food intake surveys to 

monitor overall intake of nutrients and food-related components in the 

U.S. population, and assess the effect of FVM initiatives on 

population intake (overall and in subpopulations of interest), risk 

factors for chronic disease, and health outcomes.

Enhance the FVM Program’s capacity to review and respond to 

emerging scientific and technological issues in food and nutrition.

Encourage and facilitate new products and 

product reformulation to promote a 

healthier food supply.

Improve the nutritional profile of foods through mechanisms such as 

labeling, voluntary industry guidelines, and utilizing additional 

regulatory authorities where appropriate.
Appendix IV: FDA Foods and Veterinary 

Medicine Program’s Goals, Objectives, and 

Strategies for Food Safety and Nutrition, Fiscal 

Years 2016 through 2025

Page 66 GAO-18-174 FDA Food Safety and Nutrition

Goal Objective Strategy

Collaborate with stakeholders to encourage research into healthful 

ingredient substitutes to support development and reformulation of 

healthier food options.

Source: FDA Foods and Veterinary Medicine Program Strategic Plan, Fiscal Years 2016-2025. | GAO-18-174

a

The Partnership for Food Protection is a collaborative partnership of federal, tribal, state, and local 

governments that is intended to develop and implement procedures, best practices, and other work 

products that would advance integration of the U.S. food safety system.

b

The FDA Food Safety Modernization Act, which was signed into law in January 2011, provided a 

mandate for FDA to build a national, integrated food safety system by taking steps to better integrate 

its food safety oversight with that of states, localities, tribes, and territories.
Appendix V: Comments from the Department 

of Health and Human Services

Page 67 GAO-18-174 FDA Food Safety and Nutrition

Appendix V: Comments from the Department 

of Health and Human Services
Appendix V: Comments from the Department 

of Health and Human Services 

Page 68 GAO-18-174 FDA Food Safety and Nutrition 
Appendix V: Comments from the Department 

of Health and Human Services 

Page 69 GAO-18-174 FDA Food Safety and Nutrition 
Appendix VI: GAO Contact and Staff 

Acknowledgments

Page 70 GAO-18-174 FDA Food Safety and Nutrition

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

In addition to the contact named above, Anne K. Johnson (Assistant 

Director), Josey Ballenger (Analyst-in-Charge), Yue Pui Chin, and J. 

Daniel Paulk made major contributions to this report. Tim Bober, Kevin S. 

Bray, Alexandra Edwards, Cindy Gilbert, Carol Henn, Benjamin T. Licht, 

and Cynthia Norris also made important contributions to this report.

Appendix VI: GAO Contact and Staff 

Acknowledgments

GAO Contact

Staff 

Acknowledgments
Related GAO Products

Page 71 GAO-18-174 FDA Food Safety and Nutrition

Food Safety: FDA Continues to Evaluate and Respond to Business 

Concerns about the Produce Rule. GAO-18-85. Washington, D.C.: 

November 27, 2017.

Imported Seafood Safety: FDA and USDA Could Strengthen Efforts to 

Prevent Unsafe Drug Residues. GAO-17-443. Washington, D.C.: 

September 15, 2017.

High-Risk Series: Progress on Many High-Risk Areas, While Substantial 

Efforts Needed on Others. GAO-17-317. Washington, D.C.: February 15, 

2017.

Food Safety: A National Strategy Is Needed to Address Fragmentation in 

Federal Oversight. GAO-17-74. Washington, D.C.: January 13, 2017.

Food Safety: FDA’s Efforts to Evaluate and Respond to Business 

Concerns Regarding the Produce Rule. GAO-17-98R. Washington, D.C.: 

November 28, 2016.

Imported Food Safety: FDA’s Targeting Tool Has Enhanced Screening, 

but Further Improvements Are Possible. GAO-16-399. Washington, D.C.: 

May 26, 2016.

Food Safety: FDA Coordinating with Stakeholders on New Rules but 

Challenges Remain and Greater Tribal Consultation Needed. 

GAO-16-425. Washington, D.C.: May 19, 2016.

Regulatory Guidance Processes: Selected Departments Could 

Strengthen Internal Control and Dissemination Practices. GAO-15-368. 

Washington, D.C.: April 16, 2015.

Federal Food Safety Oversight: Additional Actions Needed to Improve 

Planning and Collaboration. GAO-15-180. Washington, D.C.: December 

18, 2014.

Electronic Health Records: HHS Strategy to Address Information 

Exchange Challenges Lacks Specific Prioritized Actions and Milestones. 

GAO-14-242. Washington, D.C.: March 24, 2014.

Dietary Supplements: FDA May Have Opportunities to Expand Its Use of 

Reported Health Problems to Oversee Products. GAO-13-244. 

Washington, D.C.: March 18, 2013.

Related GAO Products
Related GAO Products

Page 72 GAO-18-174 FDA Food Safety and Nutrition

Federal Food Safety Oversight: Food Safety Working Group Is a Positive 

First Step but Governmentwide Planning Is Needed to Address 

Fragmentation. GAO-11-289. Washington, D.C.: March 18, 2011.

Food and Drug Administration: Opportunities Exist to Better Address 

Management Challenges. GAO-10-279. Washington, D.C.: February 19, 

2010.

(101211)
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