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GAO-16-299R 1 (2015-12-16)

handle is hein.gao/gaobadrtp0001 and id is 1 raw text is: GO U.S. GOVERNMENT ACCOUNTABILITY OFFICE 441 G St. N.W. Washington, DC 20548 B-327615 December 16, 2015 The Honorable Lamar Alexander Chairman The Honorable Patty Murray Ranking Member Committee on Health, Education, Labor, and Pensions United States Senate The Honorable Fred Upton Chairman The Honorable Frank Pallone, Jr. Ranking Member Committee on Energy and Commerce House of Representatives Subject: Department of Health and Human Services, Food and Drug Administration: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Pursuant to section 801 (a)(2)(A) of title 5, United States Code, this is our report on a major rule promulgated by the Department of Health and Human Services, Food and Drug Administration (FDA) entitled Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (RIN: 0910-AG35). We received the rule on December 1, 2015. It was published in the Federal Register a final rule on November 27, 2015. 80 Fed. Reg. 74,354. The final rule, according to FDA, is intended to minimize the risk of serious adverse health consequences or death from consumption of contaminated produce, and FDA established science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption. FDA established these standards as part of the implementation of the FDA Food Safety and Modernization Act. These standards do not apply to produce that is rarely consumed raw, produce for personal or on-farm consumption, or produce that is not a raw agricultural commodity. In addition, according to the rule, produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance is eligible for exemption from the requirements of this rule. The rule sets forth procedures, processes, and practices that minimize the risk of serious adverse health consequences or death, including those reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce and to provide reasonable assurances that the produce is not adulterated on account of such hazards. FDA expects the rule to reduce foodborne illness associated with the consumption of contaminated produce. The Congressional Review Act (CRA) requires a 60-day delay in the effective date of a major rule from the date of publication in the Federal Register or receipt of the rule by Congress, GAO-1 6-299R

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