November 25, 2016  -  An important article from the November 25 issue of Science, titled Republicans Ready a Regulatory Rollback, is must reading for food executives.

Clearly, some provisions of FSMA are vulnerable to Congressional or Administration rescission or modification - but there are two points of view on what may happen in the next several years.

However, first, I must state that our firm takes no position whatsoever on political issues – our responsibility is solely to advise clients on what law and regulation “is” and what it might become.

Our first perspective is that House Majority Leader Paul Ryan's deregulatory Congressional agenda, combined with the incoming administration's comments on Food Safety and other public health measures, makes comprehensive regulatory schemes such as FSMA potentially vulnerable. Thus, we need to carefully watch developments – but not be misled by the comments of journalists who are always anxious to tell us “more than they know”.

Our second comment is that FSMA has been strongly supported by "Big Food" (Grocery Manufacturers Association. Produce Industry (PMA and United Fresh),Wal-Mart and the combined support of the 75 Retail Grocers who control 90% of the USA's $1.2 Trillion Grocery Industry). The reality is that Big-Food is more concerned about Tort Liability and Recall Costs ($16 Billion per year - Swiss Re 2015 data) than with increased compliance costs, which they regard as incrementally relatively minor since they already have accommodated much of the FSMA program and have the market-power to use FSMA compliance as a tool to "push down" costs to their suppliers through Supply-Chain Indemnification.

Thus, we regard a partial, or even total rollback of FSMA rules would have little effect upon the food industry other than to increase – yes increase - risks for many American food businesses. A rollback of FSMA, if accompanied by a relaxation of Food Safety Standards by industry, would only benefit the Tort Bar and serve to drive up insurance costs.

The reason for this is that FSMA is already “baked in the cake” and is viewed by most Food Scientists as embodying a set of sensible, science-based principles that already serve the Food Industry well in protecting against Food safety Incidents. I cannot think of any manufacturer that is going to halt its PEM Program (Pathogen Environmental Monitoring) simply because portions of FSMA are rescinded or modified.

We also believe that criminal “Park Doctrine” strict-liability prosecutions are likely to be less frequent in coming years and that the Yates Memo may be withdrawn by the incoming administration’s Justice Department. However, this does not mean that criminal liability will not attach for egregious violations involving withholding or destruction of evidence during FDA or USDA/FSIS investigations. (See our Sept. 12, 2015 Blog Post on the Yates Memo.)

In any event - we will be discussing regulatory rollback in many future posts to this Blog and in our future issues of Food Cosmetics & Nutraceuticals (American Bar Association). The ABA has now published four articles on Supply-Chain Indemnification and recent developments have only served to underline the fact that the ABA Science & Technology Section got it right when it flagged Supply-Chain Indemnification as a major risk area of concern for lawyers structuring contractual relationships between Food-Supply-Chain participants.

Interested readers should read our Post below (November 15) on Food Safety Risk Management.

Please also read our 2014 article – Woodhouse, Preparing for FSMA, SciTech Lawyer, Summer 2014. Also see our article – Woodhouse, Sanitary Transportation of Food, Food Cosmetics & Nutraceuticals, Spring 2016.