Usefulness of FSMA and Similar Regulations

Never mind the 2013 prediction. Other questions have crossed my mind about the regulatory change euphoria around the world.

With so much buzz about the Food Safety Modernization Act (FSMA) in the U.S. and similar regulatory changes around the world, more and more people are learning what these mean for the industry. Several other jurisdictions (Canada, UK, other European countries, China, India, Australia and New Zealand, etc.) are pursuing similar regulation changes with import and export considerations. Regulatory compliance experts or tiger tamers are out in full force to help the industry comply.

Let’s say that these regulatory changes actually take effect and operations become as heavily regulated as the changes suggest, what do you think will happen in the certification world? Put another way, will it be sufficient for operations to independently implement programs that enable them to fully comply with these regulatory changes such that they no longer need external certification programs? Will passing regulatory inspections under these “sweeping regulatory changes” be sufficiently respected by customers as evidence for approving suppliers? What will such acceptance of regulatory compliance do to the certification/accreditation world? What will be the reason for certification programs to continue as strongly as they have been in spite of the “sweeping regulatory changes”? 

On the other hand, if the certification programs are already doing and will continue to do the job, why bother with the sweeping regulatory changes?

Acceptable Demonstration of Due Diligence:

Turning to the legal front, will passing regulatory inspections under these “sweeping regulatory changes” be sufficiently respected as acceptable demonstration of due diligence? In short, will the industry and the legal community sufficiently respect the usefulness of these “sweeping regulatory changes” to consider them sufficient? 

Perhaps the above summarized question is not the right one to ask. Any answer, yes or no, leaves us with the challenge of what to do with either the certification programs or the sweeping regulatory changes. Perhaps the right question is: Will the combination of the regulatory changes and certification programs make the industry better able to control product failure and food safety issues? I suspect the most likely answer is “yes”. In that case, the industry must wait and see if the predictions come true.

Import Certification under FSMA:

How long before FDA revisits the proposed intention of accepting third party certification as the basis for allowing imports into the U.S.? If recalls and outbreaks of concern continue at the same frequency as they have been prior to the implementation of FSMA, particularly where imported food is involved, will the third party certification allowance hold?

A Matter of Prudence:

While waiting, the individual businesses need to continue measuring their costs of implementing programs to satisfy the regulatory changes and the certification programs against the returns in terms of the achieved reduction in incidences of product failures, food safety issues and litigation costs as a matter of prudence.

The industry needs a solution with less cost and greater likelihood of reducing product failures, food safety issues and litigation costs. Perhaps we are entering the era of SSQA – For the Fearless Guardians of Food Safety and Quality

Posted By Felix Amiri

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Felix Amiri is the current Food Sector Chair of GCSE-Food & Health Protection