At the very beginning of 2013, the U.S. Food and Drug Administration released its proposals for the most important food safety regulations in a generation. The proposed rule on "Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls For Human Food," lays out the procedures that food manufacturers -- cookie factories, grocery warehouses, frozen foods packagers -- would need to implement in order to reduce the risk that their products would harbor pathogens. The proposal grew out of the landmark Food Safety Modernization Act (FSMA) passed exactly two years earlier, and it aimed to prevent one million illnesses a year.
One strange quirk of the proposed rule, though, is that it doesn't require facilities to conduct microbiological testing to confirm that their food safety programs are working. It says that manufacturers can swab surfaces or test samples of finished goods for microbes if they like, but it puts them under no obligation to do so. Food safety advocates said that the lack of a requirement cuts the chances that following the regulations would reduce food poisoning.
"Testing is crucial to verify that your control programs are working, to have some data that says, 'yes, what we're doing works.' Otherwise, you're just guessing," food safety expert Doug Powell told HuffPost in January 2013. "It's not much better than astrology. It's faith-based food safety."
Newly released documents discovered by Food Chemical News show that the FDA tried to mandate microbiological testing in its first draft of the regulations. But the agency was rebuffed by the White House's Office of Information and Regulatory Affairs (OIRA), the part of the Office of Management and Budget (OMB) that reviews proposed regulations, according to Food Chemical News.
The FDA submitted a draft of the regulations to OIRA on Nov. 17, 2011 that included requirements for both environmental monitoring and finished product testing. But by the time the proposed rule for food manufacturers was released for public comment on Jan. 4, 2013, the idea of testing had been moved to an appendix, which was expressly not to be included in the Federal Registry.
David Plunkett of the Center for Science in the Public Interest said that the two drafts leave little doubt as to what happened. "FDA thought testing was critical to effective preventive control programs and OMB made them take it out," Plunkett said in an email to The Huffington Post.
It's not yet clear why this change was made. Or even who made it: the OMB's changes likely reflect the input of several federal agencies and innumerable Washington bureaucrats. HuffPost's requests for clarification from the FDA and the OMB were met, respectively, with silence and vague boilerplate about the administration's commitment to food safety.
But there's a good chance that the change was motivated by a desire to save money, according to Lee Beck, a Washington attorney and writer of policy blog Federal Regulations Advisor.
"If OMB does not find the benefit / cost analysis or paperwork burden analysis to justify a requirement, it may demand better analysis or insist that the agency pare back the proposal to impose a justifiable cost to consumers and the economy," Beck explained in an email to The Huffington Post.
In other words, OMB can demand that the regulations be cut back if it doesn't feel like they produce enough economic benefit for the burden they impose. The differences between the economic impact assessments for the two draft regulations support the idea that that's exactly what happened here.
The FDA estimated that finished product testing and environmental monitoring would cost the industry about $78 million a year, roughly 11 percent of the total $676 million annual burden of the regulation as the FDA had written it. Though not a small amount, this was dwarfed by the potential economic benefit, in the form of prevented illnesses, that the FDA estimated the regulation would bring: $3 billion.
But the OMB -- or some other agency it consulted -- seems to have seen this estimate of the potential upside as overly optimistic, largely because the FDA overestimated the number of allergic reactions the rule could prevent by about 320,000 a year. Correcting this mistake slashed the potential benefit of the regulation by nearly $750 million. Other changes in calculations brought the OMB's estimate of potential benefits down to $2 billion. That was only if the rule prevented all the illnesses caused by FDA-regulated products. If it only prevented 25 percent, say, the benefit would only be $500 million -- far lower than the $676 million cost of the regulation, as the FDA had proposed it.
When it comes to federal regulations, costs must always be lower than benefits, so this wouldn't do. It seems likely that, when the OMB and other agencies were reviewing the draft, they started looking for places to cut, and the $78 million testing requirement started to look attractive.
In his email, Plunkett said he thought that cutting testing was the wrong call. "It's a question of who do you want cooking your food -- the chef or the bookkeeper? If the food isn't fit to eat, how much money you save doesn't really matter," he wrote.
As food politics guru Marion Nestle pointed out in a blog post about the changes, it's not too late for the FDA to add a testing requirement to the regulations before they're finalized. The agency is accepting public comments on the regulations until May 15, so if you want them to require food manufacturers to test their facilities and products for pathogens, speak up soon.
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