August 27, 2013

Analysts Mislead in Their Push to Weaken FDA’s Produce Rule

In January of this year, the Food & Drug Administration proposed a rule on produce safety, as required by the 2011 Food Safety Modernization Act (FSMA). The rule would establish comprehensive standards designed to prevent foodborne illnesses linked to fruits, vegetables, and nuts—like the ongoing Cyclospora outbreak that has sickened 630 people so far, or the 159 cases of Hepatitis A caused by imported pomegranate seeds.

Sofie Miller and Cassidy West, two analysts from the George Washington University Regulatory Studies Center (RSC) recently filed a comment on the FDA’s proposal, recommending a number of changes that would leave gaping holes in the rule’s protections. (A little background: the RSC was founded in 2009 with an initial grant from the right-leaning, anti-regulation Searle Freedom Trust, although that fact is no longer disclosed on their website, nor do the commenters explain which—if any—stakeholders they represent.)

Probably because their analysis is not grounded in the real-world concerns of anyone actually affected by the rule, the RSC analysts tinker with its design as if they were bookkeepers balancing a ledger, rather than stopping to consider what those numbers really mean for public health. Applying rigid cost-benefit analysis, they seem to look for ways to minimize how much the rule would improve public health, making it easier to argue that its costs are excessive.

Equipment, tools, buildings, and sanitation (ETBS) standards

Case in point: The RSC commenters urge the FDA to eliminate completely the rule’s standards specifying that tools and equipment must be designed so they can be cleaned, and must be kept clean, if they are likely to be in contact with produce; thermometers must be accurate and well-maintained; buildings must be properly constructed to facilitate sanitary operations; and farms must provide clean, readily accessible toilet and hand-washing facilities for workers, as well as protect produce from contaminating pests. (Stop me if you think any of these sounds like a bad idea.)

The RSC analysts want these standards dropped because, apparently, they just don’t provide enough bang for the buck when compared with the rule’s other standards. According to a table in the FDA’s analysis, the ETBS standards make up 22 percent of the rule’s costs but reduce the risk of contamination by only 6.73 percent.

What the RSC analysts don’t mention is that even the FDA has little confidence in the accuracy of these figures: the agency suggested that the data underestimate the risks from dirty tools, equipment, and buildings due to limitations in the FDA’s outbreak database (see the footnote on page 73).

In an alternative analysis, the FDA looked only at outbreaks from 1990 to 2009 to get a more contemporary view (the previous data went back to 1971). This time, ETBS problems were responsible for more outbreaks than any other contamination pathway, except for worker health and hygiene (page 97).

But most importantly, both timespans leave out perhaps the biggest equipment-related produce outbreak in history: the 2011 outbreak caused by Listeria-tainted cantaloupes. It sickened 147 people in 28 different states, killing at least 33 and causing one miscarriage. It was deemed the deadliest food outbreak in almost a century, and the third-deadliest in U.S. history. In its investigation, the FDA identified many aspects of poor facility design and unsanitary equipment that likely caused the contamination, including a dripping condensation line that allowed Listeria-contaminated water to pool on the floor, un-cleanable pieces of equipment, dirt buildup and corrosion, and a potato-washer used inappropriately for cleaning melons.

Michelle Wakley, a pregnant woman who ate the cantaloupe, was forced into premature labor three months early due to the infection, and her daughter Kendall was hooked up to an incubator for weeks. Almost a year later, Kendall still had to be fed through a stomach tube and may face lifelong physical and mental disabilities. Michelle was left asking why: “They said that their facilities weren't clean. …. The Listeria was found on the floors, on their equipment. There were so many things that they weren’t doing correctly. Why? To save a dollar? People have died.”

The estimation of regulatory benefits

The analysts accuse the FDA of relying on outdated outbreak data (from 2003 to 2008) that overestimate the dangers of today’s produce and the number of illnesses that could be prevented by the rule.

But if produce has become so much safer since 2008, why were fruits, vegetables, and nuts responsible for 7 out of the 15 major food outbreaks in 2011? And even if a portion of produce farms have improved safety measures due to market pressures, in one crucial respect we are less safe than ever: at the end of last year, the USDA’s Microbiological Data Program (MDP) was officially shut down. The tiny program was responsible for 80 percent of all public testing of fresh produce for dangerous pathogens, and its resources helped expand the testing capacity of participating state laboratories. But after years of lobbying by the produce industry, it was eliminated from President Obama’s budget request, and the funding was cut. Now that we are operating without a large piece of our safety net, the need for—and the benefits of—the produce rule will likely be even more significant than the FDA estimated.

Small-farm exclusions 

Eighty-one percent of the produce acreage covered under the rule is operated by large farms (those with annual sales of $500,000 or more). Still, a substantial portion of the produce we eat comes from a large number of smaller farms, and so their operations need to be made safe as well if we are to make a major dent in the number of foodborne illnesses people suffer each year. Mindful of the circumstances of small farms, the FDA was careful to include under the rule only those farms that present a significant risk of contamination. For small farms that would still be covered, the agency made special provisions to ease their burdens in complying with the rule.

The FDA has proposed that all farms with average annual sales of $25,000 or less should be excluded from the rule entirely. In addition, the rule would exempt (1) produce that is rarely consumed raw; (2) produce that is destined for further processing certain to kill pathogens; and (3) farms with annual sales less than $500,000 where more than half is from direct sales to consumers or to local restaurants and retailers. Finally, all covered farms with less than $250,000 in annual sales would get an additional two years after the rule generally goes into effect before it applies to them, and farms with between $250,000 and $500,000 in sales would get one additional year.

Yet the RSC analysts are urging the FDA to expand the exemptions even further. They insist that the small-farm exclusion threshold must be raised from $25,000 to $100,000 because this is the option that maximizes “net benefits” (benefits minus costs). The FDA estimates that the net benefits of the proposed option are $582 million, whereas the net benefits of raising the cutoff to $100,000 are $657 million. (Funny how the analysts skewer the reliability of the FDA’s estimations on one hand, and on the other they treat the final numbers like gospel that must be blindly followed.)

However, in its analysis the agency looked not only to the final dollar figures, but also considered what they might represent in terms of real-world impact. With the $100,000 cutoff, just 11 percent of all farms would be covered by the rule, and the public would suffer 99,000 additional foodborne illnesses per year that could have been prevented with the lower cutoff. The agency concluded this was simply too great a cost to the public, as it explained in rejecting even a $50,000 cutoff (page 52).

Comments like this exemplify the pitfalls of an overly formalistic, ideologically-driven approach to analyzing public health regulation. Fortunately, I trust that the FDA has too much wisdom and expertise to be swayed by such half-baked recommendations.

Michael Patoka, Policy Analyst, Center for Progressive Reform. Bio.

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