On FSMA’s Second Anniversary, FDA Releases Two Major Proposed Rules

By Ricardo Carvajal –

FDA released two long-awaited proposed rules to implement key provisions of the Food Safety Modernization Act ("FSMA"): Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food and Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.

New 21 CFR Part 117 would implement FSMA § 418, which addresses preventive controls, and would modernize the cGMP regulation at Part 110.  In developing Part 117, FDA applied the framework of HACCP, such that the structure and provisions of the proposed rule will feel familiar to those with HACCP experience in other regulatory contexts (e.g., seafood and juice).  Note, however, that FDA is requesting comment on a number of important issues that are not addressed in the text of the regulation itself.  For example, FDA did not include provisions that require product testing, environmental monitoring, or supplier approval and verification.  However, these “elements of a preventive controls system” are extensively discussed in an appendix to the proposed rule, and it is clear that they could yet be integrated into the final rule pending further evaluation.  As an additional example, FDA requests comment on the scope of certain exemptions, such as that granted to dietary supplement manufacturers in compliance with Part 111 and serious adverse event reporting requirements.  Interested parties are therefore urged to read the preamble in its entirety.

New 21 CFR Part 112 would implement FSMA § 419, which addresses produce safety.  As expected, the proposed rule focuses on the four major pathways for the introduction of microbiological hazards – water, employee hygiene, soil amendments, and incursion by animals.  The rule would target commodities and practices where FDA believes intervention can significantly reduce risks, and would provide a number of exemptions (e.g., for certain commodities that are rarely consumed raw, and for produce that receives a kill step). 

Comments on both rules are due May 16, 2013.  It is highly unlikely that final rules would publish prior to the end of the year.  In any event, both final rules would have staggered compliance dates, such that larger business would not be expected to comply until 2014, at the earliest.