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GAO-16-730R 1 (2016-06-10)

handle is hein.gao/gaobadshn0001 and id is 1 raw text is: G A U.S. GOVERNMENT ACCOUNTABILITY OFFICE 441 G St. N.W. Washington, DC 20548 B-328136 June 10, 2016 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: Mitigation Strategies To Protect Food Against Intentional Adulteration 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 Mitigation Strategies To Protect Food Against Intentional Adulteration (RIN: 0910-AG63). We received the rule on May 27, 2016. It was published in the Federal Register as a final rule on May 27, 2016. 81 Fed. Reg. 34,166. The final rule requires domestic and foreign food facilities that are required to register under the Federal Food, Drug, and Cosmetic Act to address hazards that may be introduced with the intention to cause wide-scale public health harm. These food facilities are required to conduct a vulnerability assessment to identify significant vulnerabilities and actionable process steps and implement mitigation strategies to significantly minimize or prevent significant vulnerabilities identified at actionable process steps in a food operation. FDA is issuing these requirements as part of their implementation of the FDA Food Safety Modernization Act. Enclosed is our assessment of FDA's compliance with the procedural steps required by section 801 (a)(1)(B)(i) through (iv) of title 5 with respect to the rule. Our review of the procedural steps taken indicates that FDA complied with the applicable requirements. GAO-1 6-730R

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