Food Safety and Nutrition:

FDA Can Build on Existing Efforts to Measure Progress and Implement Key Activities

GAO-18-174: Published: Jan 31, 2018. Publicly Released: Mar 5, 2018.

Additional Materials:

Contact:

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

 

Office of Public Affairs
(202) 512-4800
youngc1@gao.gov

The FDA oversees the safety of about 80% of the nation’s food supply and promotes good nutrition.

According to the FDA, a 2011 law shifted the agency's focus from responding to illnesses to preventing food contamination. We examined actions the FDA has taken since then on food safety, which is a topic on our high risk list, and nutrition.

Among other things, we found the FDA budgeted at least $1 billion a year for food safety (98%) and nutrition (2%).

We recommended that the FDA develop performance measures for all of its food safety and nutrition objectives, and specify how it plans to carry out a strategic plan related to those areas.

 

This is a photograph of a sign marking the Food and Drug Administration.

This is a photograph of a sign marking the Food and Drug Administration.

Additional Materials:

Contact:

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

 

Office of Public Affairs
(202) 512-4800
youngc1@gao.gov

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 nutrition-related 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.

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 high-risk 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 safety- and 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.

For more information, contact Steve D. Morris at (202) 512-3841 or morriss@gao.gov.

Recommendations for Executive Action

  1. Status: Open

    Comments: As of August 2019, FDA stated that it had taken steps to implement our recommendation. According to FDA, pursuant to GAO's recommendation to share templates to foster greater consistency in documentation of decision-making, FDA's Center for Food Safety and Applied Nutrition (CFSAN) has developed and shared with its FDA Foods Program counterparts, project initiation forms for projects involving the development of regulations or guidance related to food safety, nutrition, and cosmetics. FDA provided us with copies of two project initiation form templates: one for regulatory actions and another for guidance documents. In addition, in October 2019, FDA provided us with a standard operating procedure document to help guide the Center for Veterinary Medicine's (CVM) use of CVM's initiation form. The agency also stated at that time that CFSAN is still in the process of integrating the initiation sheets into the program's processes and procedures. To fully address the recommendation, FDA should provide us with documentation of CFSAN's and CVM's instructions to the FDA Foods Program demonstrating that FDA's food safety and nutrition staff are uniformly documenting the bases for their decisions using the two initiation forms provided. We will follow up again with FDA and provide another update in FY 2020.

    Recommendation: 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)

    Agency Affected: Department of Health and Human Services: Food and Drug Administration

  2. Status: Open

    Comments: As of August 2019, FDA had not fully implemented our recommendation. FDA provided us with an update on the status of the recommendation and reported that the agency has been actively working to expand the use of outcome-based performance measures. FDA stated that implementation of Food Safety Modernization Act (FSMA) based preventive controls standards is a top priority for the agency and a key component of the Foods and Veterinary Medicine Program's strategic plan, and for this reason, FSMA-related performance metrics have been prioritized, and the first performance measures to be implemented will be for the Preventive Controls (PC) for Human Food and PC for Animal Food rules. Additionally, FDA reported it is using inspections and compliance data to assess the impact of the FSMA regulations on food safety and that a set of these measures will be published via FDA's agency-wide performance management system in 2019. We will follow up with FDA and provide an update in FY 2020.

    Recommendation: 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)

    Agency Affected: Department of Health and Human Services: Food and Drug Administration

  3. Status: Open

    Comments: As of August 2019, FDA had not implemented our recommendation. FDA provided us with an update, stating that the agency was in the process of developing an implementation plan that aligns with the Office of Food and Veterinary Medicine Strategic Plan. Due to organizational and leadership changes, FDA had to delay the release of the implementation plan to ensure it aligns with leadership priorities. FDA stated that the plan will be released in 2019. We will follow up with FDA and provide an update in FY 2020.

    Recommendation: 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)

    Agency Affected: Department of Health and Human Services: Food and Drug Administration

 

Explore the full database of GAO's Open Recommendations »

Nov 12, 2019

Oct 28, 2019

Sep 9, 2019

Jul 25, 2019

Jul 11, 2019

Jun 21, 2019

Jun 4, 2019

Apr 11, 2019

Apr 10, 2019

Mar 12, 2019

Looking for more? Browse all our products here