Publisher’s Platform: My 5 minutes with FDA

Publisher’s Platform: My 5 minutes with FDA

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Its a long flight from the “other Washington” for my 5 minutes of testimony before the Reagan-Udall Foundation for the FDA’s Independent Expert Panel yesterday, but here it is:

In the nearly 30 years that I have been coming to Washington D.C. on food safety issues, there has always been a discussion about how best to effectively accomplish food safety regulation and oversight.  

I was here then with the parents of Brianne Kiner, a child that survived the 1992/1993 Jack in the Box E. coli outbreak after six months in the hospital, months on dialysis, the removal of her large intestine and leaving her with brain damage and diabetes.  

I was here in 2006, 2007 and 2008 in the run-up to the passage of the Food Safety Modernization Act (FSMA), bringing dozens of clients in to put a human face on E. coli outbreaks linked to leafy greens and Salmonella outbreaks linked to peanut butter.

From the Clinton, Bush, Obama, and Trump administrations, from nearly every Congress over those three decades, and from multiple government, industry and consumer reports, the refrain still echoes for a single food safety agency.  

As one administration aptly said, it is past time to address the “fragmented and illogical division of federal oversight” of food safety.  

For decades multiple experts have cited the need to revamp the safety and quality of the U.S. food supply as it is now “governed by a highly complex system stemming from at least 30 federal laws that are administered by 16 federal agencies.”

Yes, I understand that we are not here to revisit this decades long discussion.  I point it out only to underscore that the discussion of the organization, reorganization and culture of the agencies predates many of us here. 

Over the last decades, the discussion has been how to make food safety perfect.  I am here to ask that we not make perfect the enemy of the good.  However, it is past time for us to in fact do good.

In thinking about the charge that the commissioner gave the Reagan-Udall Foundation and this august group of experts, I recalled a seminal decision made in 1994 by the then administrator of the Food Safety and Inspection Service (FSIS) deeming E. coli O157:H7 an adulterant in ground beef.  

A perfect decision, no. Should all pathogens in all meat be considered adulterants?  To me that would be perfect.  But, that 1994 decision was good enough that, slowly, over the following decade, E. coli cases linked to beef fell, and fell so far, that what had been the staple of my firm’s work almost completely evaporated.  The government and industry essentially put me out of the E. coli in beef business.

I believe that the 1994 decision worked for two reasons, one, the Jack in the Box disaster was perhaps too significant to ignore and two, the organization of the USDA placed clear authority over both food safety policy and inspections in the hands of the agency administrator. This allowed for the decision and implementation to occur swiftly, not perfectly, but good enough to have a significant impact on public health.

In the decade after Jack in the Box, before the decision to deem additional strains of E. coli adulterants solidified, I could count nearly like clockwork E. coli cases occurring in beef in the Spring and the Summer.  That stopped in 2003, and for a moment I gladly conceded that I chose the wrong profession.  

But, then many of the food items regulated by the FDA – especially leafy greens – filled that void.

The spinach E. coli outbreak of 2006, with 205 sickened, dozens with kidney failure and 5 deaths, the industry termed “its Jack in the Box.”  This outbreak, along with multiple other E. coli outbreaks linked to romaine lettuce and Salmonella outbreaks linked to peanut butter, moved the FDA and Congress forward on FSMA.

The idea behind FSMA was to make the FDA and the industries it oversees, more proactive, not reactive.  However, you only need to look at the 2018 E. coli outbreak linked to romaine (again) with over 240 sickened in the U.S. and Canada, dozens with kidney failure and 5 deaths, that the hope of FSMA is not yet reality.

Is FSMA perfect, likely not.  Has its implementation since 2010 been too slow and uneven, yes.  However, I believe that FSMA’s failures are not due to the legislation itself, but to the lack of sustained, consistent, effective, and accountable leadership at the FDA due to the culture and fragmentation of the essential food safety functions between the four main Centers – CFSAN, ORA, CVM and OFPR.

In closing, my advice is to create separate commissioners – one for food and one for drugs.  Both should be direct reports to the HHS secretary. The food side should be led by a proven food safety expert tasked with all aspects of food and the entire organization should be coordinated and accountable for the safety of the 80% of the food supply that is its purview.

Would this be perfect, likely not.  Would it be good enough? I would hope it would be good enough to do what FSIS did to E. coli and beef.  It is time to put me out to pasture.

What we all do not need is another 4-year-old Lucas Parker, who because of the consumption of E. coli tainted romaine lettuce in 2019, will never walk, never talk, and never feed himself. 

It is time for all of us to do good.

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