FDA Mandates Comprehensive Food Safety Plans for U.S. Facilities Under 21 CFR 117.126
The U.S. Food and Drug Administration (FDA) requires food facilities to prepare and implement a written food safety plan, as mandated by 21 CFR 117.126. This regulation, part of the Food Safety Modernization Act (FSMA), stipulates that a preventive controls qualified individual must either prepare or oversee the preparation of this plan. The food safety plan must contain seven specific written components: a hazard analysis, preventive controls, a supply-chain program, a recall plan, monitoring procedures, corrective action procedures, and verification procedures. The hazard analysis identifies known or reasonably foreseeable biological, chemical (including radiological, natural toxins, allergens, and unapproved additives), and physical hazards. These hazards can occur naturally, be unintentionally introduced, or be intentionally introduced for economic gain. The plan must evaluate each hazard based on the severity of potential illness or injury and the probability of its occurrence without preventive contr...
