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FDA Should Develop Performance Measures For All Food Safety, Nutrition Objectives: GAO

The FDA’s commissioner should ensure that the agency’s Foods and Veterinary Medicine (FVM) program develops performance measures with associated targets and timeframes for all eight of FDA’s food safety- and nutrition-related objectives, according to a report from the Government Accountability Office (GAO).

From the enactment of the Food Safety Modernization Act (FSMA) in January 2011 through September 2017, FDA published 33 key proposed or final regulations and 111 key draft or final guidance documents that were related to food safety or nutrition, the GAO noted. Of the 33 proposed and final regulations that FDA published, 21 were food safety-related, seven were nutrition-related, and five were related to both.

Also, of the 33 published regulations, 30 were final and three were proposed. These 33 regulations included the seven foundational rules required by the FSMA.
Of the 111 guidance documents that FDA published on its website during the same time period, 82 were food safety-related, 12 were nutrition-related, and 17 were related to both food safety and nutrition. Also, 80 of those guidance documents were issued in final form, and 31 were published in draft form from January 2011 through September 2017.

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, the GAO noted. Since January 2011, 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.

Under its transparency initiative, FDA has committed to improving transparency to regulated industry, the GAO noted. In its January 2011 transparency initiative report, FDA described 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.

Further, 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 issuing guidance, which is exempt from those requirements. 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, the GAO said.

FDA has dedicated at least $1.0 billion annually, including salaries for at lest 4,300 full-time equivalent (FTE) staff, to food safety- and nutrition-related activities in fiscal years 2011 through 2016, with food safety-related activities accounting for about 98 percent of those resources and nutrition-related activities accounting for about 2 percent.

Strategic Goals Have Been Set
Since fiscal year 2011, FDA has set strategic goals for all agency activities, including food safety- and nutrition-related activities, the GAO said. 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: enhance oversight of FDA-regulated products; improve and safeguard access to FDA-regulated products to benefit health; promote better informed decisions about the use of FDA-regulated products; and strengthen organizational excellence and accountability.
These goals encompass FDA’s food safety- and nutrition-related activities, in addition to activities not related to food.

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 2012 and later modified these goals under its current 2016-2025 strategic plan.

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. The GAO said, 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 eduation.

However, FDA had 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, the GAO said. For one of these objectives, the food safety objective related to the consumer’s role, FDA developed indicators but did not set targets with time frames.

For two of the FVM program’s three nutrition objectives — 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 consumers, and 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, the GAO said.

FDA’s plans for the FVM program in fiscal 2018 include publishing regulations to enhance food labeling, continued implementation of FSMA, and other food safety- and nutrition-related activities.

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. 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.

Beyond the 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. The strategic plan also identifies 19 food safety and nine nutrition strategies that support its food safety- and nutrition-related goals and objectives.

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 GAO said.