Supervisory General Health Scientist

0910-AG63 201510 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Focused Mitigation Strategies To Protect Food Against Intentional Adulteration

This rule would require domestic and foreign food facilities that are required to register under the Federal Food, Drug, and Cosmetic Act to address hazards that may be intentionally introduced by acts of terrorism. These food facilities would be required to identify and implement focused mitigation strategies to significantly minimize or prevent significant vulnerabilities identified at actionable process steps in a food operation.

]]> Economically Significant Previously Published in The Unified Agenda Final Rule Stage Yes Private Sector 21 CFR 121 21 U.S.C. 331 21 U.S.C. 342 21 U.S.C. 350g 21 U.S.C. 350i 21 U.S.C. 371 21 U.S.C. 374 Pub. L. 111-353 Judicial Final 05/31/2016 To the Office of the Federal Register for publication Yes

FDA is taking this action to meet the requirements of the FSMA and to protect food from intentional adulteration when the intent is to cause large-scale public harm.

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FDA’s authority for issuing this rule is provided by the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by sections 103, 105, and 106 of the Food Safety Modernization Act (FSMA). Section 418 of the FD&C Act addresses intentional adulteration in the context of facilities that manufacture, process, pack, or hold food and are required to register under section 415 of the FD&C Act (21 U.S.C. 350g). Section 419 of the FD&C Act (21 U.S.C. 350h) addresses intentional adulteration in the context of fruits and vegetables that are raw agricultural commodities. Section 420 of the FD&C Act (21 U.S.C. 350i) addresses intentional adulteration in the context of high risk foods and exempts farms except for farms that produce milk. FDA is implementing the intentional adulteration provisions in sections 418, 419, and 420 of the FD&C Act in this rulemaking.

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Section 103, 105 and 106 of the FDA, Food Safety Modernization Act require FDA to conduct this rulemaking.

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FDA estimates that the costs from the proposal to domestic and foreign producers and packers of processed foods would include new one-time costs (e.g., adoption of written food defense plans, setting up training programs, etc.) and recurring costs (e.g., training employees, and completing and maintaining records used throughout the facility). FDA anticipates that the benefits would be a reduction in the possibility of illness, death, and economic disruption resulting from intentional adulteration of food.

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This regulation will directly and materially advance the Federal Government’s substantial interest in reducing the risk for illness and death associated with intentional adulteration of food.

]]> NPRM 12/24/2013 78 FR 78014 NPRM Comment Period Extended 03/25/2014 79 FR 16251 NPRM Comment Period End 03/31/2014 NPRM Comment Period Extended End 06/30/2014 Final Rule 06/00/2016 Yes Businesses Undetermined No Yes Yes Jody Menikheim Supervisory General Health Scientist 0910 Food and Drug Administration FDA 240 402-1864 301 436-2633 fooddefense@fda.hhs.gov Center for Food Safety and Applied Nutrition (HFS-005), 5100 Paint Branch Parkway, College Park MD 20740