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From Health Law Daily, September 11, 2015

Food safety rules finally deemed well done (cook time: years)

By Kayla R. Bryant, J.D.

The FDA is finalizing a preventive controls rule for food for human consumption in an attempt to prevent foodborne illnesses. This rule follows several high profile illness outbreaks traced back to various food products in recent years. This rule, as well as an accompanying animal food rule, is part of the FDA’s efforts to enforce the Food Safety Modernization Act (FSMA) (P.L. 111-353) after the U.S. District Court for the Northern District of California set deadlines for implementation following a lawsuit filed against the agency by the Center for Food Safety (CFS) (see Federal court orders the FDA to promulgate food safety regulations required by the Food Safety and Modernization Act of 2010, April 24, 2013). The Final rule is scheduled to publish September 17, 2015.

Proposed rule. The FDA updated its proposed rule related to updating manufacturing practices for facilities in September 2014 to define exemptions to the rule and altering components of the hazard analysis procedure (see FDA serves up second proposal for human food manufacturing requirements, September 29, 2014). Under the revision, unique exemptions were made available for a “very small business” designation. The hazard analysis update changed requirements from kicking in when a hazard was “reasonably likely to occur” to a “significant hazard.”

Risk assessment. The agency was required to undertake a science-based risk assessment (RA) for each of the rules. The RA covers activity and food combinations considered low-risk when conducted in a facility co-located on a farm. The analysis allowed the FDA to exempt small and very small businesses exclusively engaged in certain types of on-farm manufacturing or handling activities involving certain foods from particular sections of the Food, Drug and Cosmetics Act (FDC Act) (21 U.S.C. §301 et seq).

Modernizing regulations. The final rule updates current good manufacturing practices (CGMP) for human food by modernizing practice requirements, as the CGMP have not been updated since 1986. Nonbinding provisions are not included, as the FDA no longer provides guidance in regulatory text. The rule clarifies the FDA’s position that CGMPs address allergen cross-contact and revises an exemption from the requirements regarding specific activities associated with raw agricultural commodities.

Safety plans. The preventive controls rules require food facilities to implement written food safety plans. These plans must indicate possible problems and outline the steps a facility would take to prevent or minimize the likelihood of those events occurring. The FDA will assess the safety plans, which must be reanalyzed by each facility every three years, and be in a better position to respond to adverse events. In response to comments, the FDA has added flexibility to the provisions, including less burdensome requirements for corrections, recordkeeping options, and verification activities.

Costs. The requirements in the final rule are projected to have domestic costs of about $381 million. The FDA estimates that the processed foods covered by the rule are responsible for foodborne illnesses that cost the American public about $2.2 billion each year. For the rule to be cost effective, it must prevent about 17 percent of total annual illnesses.

The FDA plans to finalize all seven FSMA rules by 2016. For more coverage related to the final rule on animal food safety, see FDA finally finalizes animal food safety rule under FSMA, also in this publication.

MainStory: TopStory FoodNews FDCActNews FoodNews FoodSafetyNews FoodStandardsNews GMPNews ImportNews SafetyNews

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