FSMA – Is a Re-think Happening?

How far will the published "Operational Strategy" go? Should further re-thinking be happening? Do the math: If enforcement has not stopped or even reduced incidents of fraud, what gives us confidence that enforcement will lead to better protection of consumers against food-borne hazards and illness under FSMA than has been achieved under previous regulatory measures?

The “Operational Strategy for Implementing the FDA Food Safety Modernization Act (FSMA)” was published by the FDA On May 2, 2014. It addresses some of the challenges that I posted in January of 2013. In that post, I said: “Disappointment awaits us if these initiatives are pursued without serious modifications to address the points listed  . . .  and other limiting factors that are implicit in the current proposals.” You may read the full 2013 post - The New Food Safety Modernization Act (FSMA) 

The published FDA’s Operational Strategy appears to have partially addressed some of the points I listed in support of the disappointing prediction. I find this to be inspiring although some specific details are still lacking and several of the listed points have not been as clearly addressed. For example, the FSMA rules are still too vague (generalized) and leave too much room for confused interpretation, deliberate misinterpretation and manipulation; the narrow focus on food production, manufacturing and distribution businesses persists to the neglect of other significant parties – e.g. the roles of restaurants, canteens and consumers; etc. Although the strategy identifies the use of public health-oriented outcome metrics for evaluating the success of FSMA, specific details are not provided to show how consumers will be engaged and encouraged to actively participate in the process of evaluating the success achieved.

Radical changes are needed in the FSMA as in other regulatory initiatives worldwide. The most challenging is re-thinking the punitive approach to regulatory enforcement. The proposed incentive of compliant establishments receiving fewer inspections by the US FDA is a good direction. It provides a more targeted approach that is necessary for enforcement efficiency and success. However, it does not go far enough. With the fewer inspections incentive, the proposed regulatory changes still maintain the “catch-and-punish” focus. A strategy for a sustained collaboration of all parties towards the desired goal of consumer protection is not sufficiently developed within the proposed regulatory framework.  

The proposed new regulations, still cloaked in the old policing mentality, are poised to increase the burden for law-abiding operators and abate the pressure for dubious food business owners who are very good at dodging inspectors' surveillance techniques. Catch-and-punish methods only deter until the criminally-minded find ways around them. As violators cause undesirable events, they force regulators to spread the surveillance net. With such broadened surveillance that wastes resources on looking at compliant along with non-compliant operators, the burden is increased for law-abiding operators who will do everything to comply with any extra imposed cautionary (often unnecessary) measures. On the other hand, due to regulatory resources that are often spread too thin to effectively go after the dubious, the pressure is abated for them. The dubious will do everything to avoid the extra cautionary and cash-strapped enforcement measures.

I have discussed some alternatives in other related posts which appear to be attracting increasing attention. I strongly suspect that we have not seen the end of the re-thinking process that appears to be going in the direction of the GCSE-Food and Health Protection proposals.