On January 4, 2013, the second anniversary of the enactment of the Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration (FDA) released two important proposed rules to implement the new law.  After such a long detour at the White House Office of Management and Budget, the release caught many of us by surprise!

The two proposed rules released last Friday would: (1) require hazard analysis and preventive controls for human food, and (2) establish minimum standards for the safe production, harvesting, packing, and holding of fruits and vegetables.  These are the rulemakings that FDA officials have characterized as the cornerstones of the new food safety system created by FSMA.  As such, one or both of the rules will affect nearly every entity engaged in the production or distribution of food.  Comments are due May 16, 2013.  The FDA promises to hold several public meetings during the 120-day comment period.

This post is about the proposed rule on hazard analysis and preventive controls for human food, Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food.  In broad brush, that proposed rule would:

  • Modernize the current good manufacturing practice (CGMP) regulations for human food in Part 110 and move them to a new Part 117
    • Proposed reforms include: (1) language requiring establishments to prevent cross-contact with major food allergens, and language adding food packaging materials to the list of items (e.g., food, food-contact surfaces) that must be protected from contamination and cross-contact.  The FDA also requests comments on possible additional reforms, including training requirements for plant employees.
  • Require registered food facilities to implement a written food safety plan based, in large part, on HACCP principles
    • New Subpart C of Part 117 would implement Federal Food, Drug, and Cosmetic Act § 418, which requires each registered facility, unless exempt, to perform a hazard analysis and implement preventive controls.  A facility’s food safety plan would be required to include: a hazard analysis (including biological, physical, radiological, and chemical hazards), preventive controls, monitoring procedures (including frequency of monitoring), corrective action procedures, verification procedures, and a recall plan.
    • Preventive controls would be required to address hazards reasonably likely to occur in the foods manufactured, processed, packed, or held by the facility.  Preventive controls would include, as appropriate: parameters for control of the hazard (including maximum or minimum values, or combinations of values), process controls, food allergen controls, sanitation controls, a recall plan, and any other necessary controls.  Verification would include: validation that preventive controls are adequate to control the hazards reasonably likely to occur in the product (but, such validation would not be required for allergen controls, sanitation controls, or the recall plan), verification that monitoring is performed, verification that appropriate decisions about corrective actions are being made, and verification that preventive controls are consistently implemented and effectively controls the hazards reasonably likely to occur in the food.
  • Expand the definition of “farm” in FDA’s facility registration regulations, and thereby broaden the scope of the farm exemption
    • Farms, as now more broadly defined, are exempt from FDA registration, from the new hazard analysis/preventive controls regulations in Subpart C, and from the recordkeeping requirements in Part 1, Subpart J (“one up/one down” records).  In addition, if a farm conducts some activities that trigger registration, the farm would be subject to Subpart C only with respect to those activities, not with respect to its activities within the “farm” definition.
  • Require compliance with new Part 117 one year after publication of a final rule, but “small businesses” would have 2 years and “very small businesses” would have 3 years
    • The proposed rule would define “small businesses” as those having less than 500 employees.  The proposed rule offers 3 possible definitions of “very small business”: less than $250,000 in total annual sales of food, less than $500,000 in total annual sales of food, or less than $1 million in total annual sales of food.

The proposed rule would not require any facilities to perform testing of raw materials or ingredients, testing of finished products, environmental monitoring, or supplier approval or verification.  However, the appendix includes a lengthy discussion of the important role of these activities in a rigorous food safety plan, and the preamble makes clear that FDA is seriously considering including such requirements in the final rule.

Despite the fact that FSMA requires that a facility’s hazard analysis and preventive controls address “hazards that may be intentionally introduced, including by acts of terrorism,” the proposed rule does not include such a requirement.  Instead, FDA has tentatively concluded that prevention of intentional contamination involves different kinds of controls, which should be addressed in a separate rulemaking on food defense plans.  Nevertheless, FDA requests comments on whether one type of intentional contamination, economically motivated adulteration, should be considered as a hazard reasonably likely to occur in some facilities’ food safety plans.

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