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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.

Statement of Need:

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.

Summary of the Legal Basis:

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.

Alternatives:

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

Anticipated Costs and Benefits:

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.

Risks:

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.