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GAO-17-98R 1 (2016-11-28)

handle is hein.gao/gaobaakkf0001 and id is 1 raw text is: GAOU.S. GOVERNMENT ACCOUNTABILITY OFFICE 441 G St. N.W. Washington, DC 20548 November 28, 2016 Congressional Committees Food Safety: FDA's Efforts to Evaluate and Respond to Business Concerns Regarding the Produce Rule Although the United States has one of the safest food supplies in the world, foodborne illness is a common public health problem. Some of this illness can be linked to produce. In 2006, for example, an E. coil outbreak associated with baby spinach sickened 205 people and killed 3; in 2011, 147 people fell ill and 33 died as a result of eating melons contaminated with Listeria. Other produce-related outbreaks in recent years have involved cucumbers, alfalfa sprouts, bean sprouts, and packaged salads. The Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), has responsibility for ensuring the safety of produce, along with many other foods. Overall, FDA is responsible for ensuring the safety of more than 80 percent of the U.S. food supply. Because produce is often consumed raw without processing to reduce or eliminate contaminants, preventing contamination is key to ensuring safe consumption. In January 2011, the FDA Food Safety Modernization Act (FSMA) was signed into law, representing the largest expansion and overhaul of U.S. food safety law since the 1930s.1 FSMA, according to FDA, marked a historic turning point by focusing on preventing rather than reacting to foodborne illnesses. FSMA did so, in part, by requiring FDA to promulgate new rules that together provide a framework for industry to implement preventive measures and for FDA to oversee implementation. In response to FSMA, FDA developed seven foundational rules; among them was the rule entitled Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption-widely referred to as the produce safety rule.2 This rule, which FDA promulgated in November 2015, established the first enforceable national standards for on-farm growing, harvesting, packing, and holding of domestic and imported produce.3 Among other things, the rule established standards related to agricultural water quality; the use of soil amendments, such as raw manure; the presence of domesticated and wild animals; worker training, health, and hygiene; and sanitation of equipment, tools, and buildings. The rule includes staggered compliance dates depending on average annual produce sales of a business and other factors. For example, compliance for some of the largest businesses comes due beginning in 2017 and 2018, while compliance for certain smaller businesses is not due 1Pub. L. No. 111-353, 124 Stat. 3885 (2011). 280 Fed. Reg. 74354 (codified at 21 C.F.R. pt. 112). Other rules required by FSMA that have been promulgated include rules about preventive measures to ensure the safety of human food, animal food, and imported foods; the sanitary transportation of food; and protection against acts of intentional contamination. 380 Fed. Reg. 74354, 74354. In the rule, FDA defines produce, in part, as any fruit or vegetable, including mushrooms, sprouts, peanuts, tree nuts, and herbs. 80 Fed. Reg. 74354, 74551 (codified at 21 C.F.R § 112.3). Produce that is rarely consumed raw-such as asparagus, potatoes, pumpkins, and sweet corn-is not covered by the rule. 80 Fed. Reg. 74354, 74549 (codified at 21 C.F.R § 112.2(a)(1)). Businesses covered by the rule are those with average annual produce sales during the previous 3 years of more than $25,000, with certain exceptions. 80 Fed. Reg. 74354, 74552 (codified at 21 C.F.R §§ 112.4, 112.5). GAO-17-98R FDA Produce Rule Page 1

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