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FSMA Public Meeting on Preventative Controls

As with the series of Public Meetings held at the end of March 2011, last week’s Public Meeting focused on a particular aspect of the new Food Safety Modernization Act (FSMA) and offered the U.S. FDA an opportunity to listen and pose questions to industry leaders.  The day-long meeting held on Wednesday, April 20th, was focused on FSMA’s preventative control requirements.  Specific themes included: thresholds for small businesses; food safety documentation; and definitions of key terms, such as “low-risk,” “high-risk,” and activities that constitute on-farm manufacturing.

As Ms. Charlotte Christin of U.S. FDA explained, foodborne illness is a great public burden in the United States.  Almost 75% of seafood consumed in the United States is imported, as well as large portions of the vegetable and fruit products consumed Stateside.  It is therefore essential that food safety concerns be addressed.  Time-old hazards are now occurring in new matrices.  Couple that with the fact that our populace now has brand new food safety hazards that were unthinkable a hundred years ago, and it becomes clear that now, more than ever, U.S. FDA needs to take a preventative stance in controlling food safety hazards.

A major issue continually broached at this Public Meeting touched upon the government’s understanding of the difference between a small business and a large business.  As FSMA allows for U.S. FDA to differentiate between the two and possibly create two separate sets of regulations for the two groups, this difference is crucial.  Mr. Don Kraemer of the U.S. FDA explained that the administration may even create a tiered effectiveness timeline of requirements based on the size of the business, and may ultimately allow waivers for the very smallest of all businesses.  U.S. FDA was urged to create detailed guidance documents to help businesses understand their new requirements.

Food safety documentation was another issue raised in multiple forums and breakout groups.  While Mr. Don Kraemer explained that U.S. FDA expects that food safety documentation is already extensively created and kept among all food facilities, the question remains as to whether U.S. FDA will prescribe detailed requirements regarding timeframes, style, depth, and breadth of the records of the future.  The burden, again, seemed to rest on the shoulders of small businesses who claimed, at this Public Meeting, to have less resources to be able to comply with potentially too-prescriptive regulations.  Small businesses urged U.S. FDA to consider their fewer resources when writing regulations for required food safety documentation.

Another controversial topic rested among the various definitions of key terms.  Indeed, as FSMA mentions “high-risk” foods in multiple aspects, it is imperative to understand what U.S. FDA will see as “high-risk” and “low-risk” foods and processes.   Industry leaders were also curious as to what U.S. FDA will require as criteria and documentation for high-risk foods and feeds.     Basic, fundamental terms need to be clearly defined in order for industry to ensure its compliance with the new law and future regulations.

While U.S. FDA could not provide answers in this forum, one thing is clear: there is no shortage of questions.

Registrar Corp will continue to provide critical updates as the debate progresses.