Summary of the Major Provisions of the Proposed Rule
The proposed rule would implement the requirements of FSMA for covered facilities to establish and implement a food safety system that includes a hazard analysis and risk-based
preventive controls. Specifically, the proposed rule would establish requirements for:
• A written food safety plan;
• Hazard analysis;
• Preventive controls for hazards that are reasonably likely to occur;
• Corrective actions;y
• Verification; and
• Associated records.
The application of the preventive controls would be required only in cases where facilities determine that hazards are reasonably likely to occur. We do not expect that all possible preventive measures and verification procedures would be applied to all foods at all facilities.
The proposed rule would also establish a series of exemptions (including modified requirements in some cases) from the requirements for hazard analysis and preventive controls.
Facilities that manufacture, process, pack or hold food and that are required to register with FDA under section 415 of the FD&C Act would be required to comply with the proposed regulation unless they are covered by an exemption. The table immediately below summarizes these proposed exemptions in general terms.
Importantly, the table in this Executive Summary does not include all the details that you must consider to determine whether an exemption applies to you. We provide those details in the proposed regulation (proposed § 117.5) and explain them in section X.C of this document.
Proposed Exemptions from the New Requirements for Hazard Analysis and Risk-Based Preventive Controls
Who or What Would Be Exempt From the Requirements for Hazard Analysis and Risk- Based Preventive Controls
“Qualified Facility” as defined by FSMA:
• Business with average annual sales of <$500,000 and at least half the sales to consumers or local retailers or restaurants (within the same state or within 275 miles); or
• Very small business
• Option 1: Average annual sales of < $250,000
• Option 2: Average annual sales of < $500,000
• Option 3: Average annual sales of <$1,000,000
FDA is proposing three options for defining “very small business” and requests comment on which to adopt in a final rule.
Modified requirements would apply - i.e., a qualified facility would be required to:
• Notify FDA about its status; and