GAO: Work remains for FDA to measure progress, design activities

06-Mar-2018 - Last updated on 06-Mar-2018 at 14:36 GMT

Decision-making documentation, developing performance measures and establishing an implementation plan for meeting long-term goals were among the GAO’s recommendations to improve FDA's FSMA efforts.

The Governmental Accountability Office (GAO) released a report Monday reviewing the work that the US Food and Drug Administration has been doing to address nutrition and feed and food safety, along with the resources used since the start of efforts on the Food Safety Modernization Act (FSMA) in 2011.

The project covered food and feed safety activities, examined how FDA set priorities for those activities and the resources dedicated to the project, along with how the FDA set goals for feed and food safety and nutrition projects, Steve Morris, director of natural resources and environment, said in the report. The review also examined how the agency is determining progress on the established goals and upcoming activities along with the timeframes involved.

“We reviewed documents from FDA and other sources, and we interviewed knowledgeable FDA officials,” he said. “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.”

The office was asked to review the FDA’s work and use of resources as the FDA is responsible for monitoring the safety of the majority of the food supply in the US – this includes animal feed, said the GAO. Work on the report lasted from October 2016 through January 2018.

Findings and recommendations

Although the FDA has conducted multiple activities related to feed and food safety or nutrition since work on FSMA started, the information regarding how the decisions were made was not always uniformly documented, the GAO said.

“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,” Morris said in the report.

Additionally, the Foods and Veterinary Medicine Program (FVM) has established a series of goals and objectives as part of its work on feed safety and nutrition, the office said. The program is responsible for addressing many of FDA’s feed safety and nutrition-related practices.

But, FDA has not established performance measures to address all of the objectives. Without those metrics in place, some elements are difficult to assess, the office said.

“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,” the office said.

Similarly, FVM’s 10-year strategic plan outlines several strategies, but no implementation plan has been developed to specify actions to be implemented to achieve the objectives, said Morris in the report. “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,” he added.

Given those conclusions, the GAO specified three recommendations for the FDA as it progresses with work to address feed safety and nutrition.

These include that the FDA’s commissioner should make sure that staff in the FVM program are consistent with the documentation of decision rationale regarding how they issue regulations or guidance on feed safety and nutrition, said GAO. The commissioner also needs to ensure that FVM sets performance measures, targets and timeframes for all eight of FDA’s feed and food safety and nutrition objectives.

“The commissioner of FDA should complete an implementation plan that includes specific actions, priorities, and milestones for the FVM Program’s strategic plan,” said the office.

Responses from the Department of Health and Human Services tended to concur with the recommendations made, said Morris. FDA responded with information regarding some of the efforts that have been made to address elements of the recommendations.