On July 9, 2010, following more than 10 years of interference and delay, the Food and Drug Administration’s rule to prevent salmonella contamination in eggs finally went into effect. FDA officials have argued that this rule—which, among other things, requires farms to test eggs and facilities for salmonella, protect feed and water from contamination, and buy chicks and young hens from suppliers that monitor for salmonella—would have likely prevented the massive salmonella outbreak that has sickened 1,470 individuals and resulted in one of the largest food recalls in U.S. history, with more than half a billion eggs being pulled off stores’ shelves. It’s hard to know whether this is necessarily true or not, but if adequately enforced, the rule certainly would have driven very significant changes to the facilities we've learned about in the past weeks. Tragically, the salmonella outbreak stretches back to at least May, just a few months before the salmonella rule’s effective date.
What accounts for this policy “near miss”? By all accounts, this rule was recognized as a necessary step for closing a big gap in our food safety system—namely, ensuring the safety of eggs. So, why did it take more than 10 years—10 years!!—for the rule to be developed and finalized?
Unsurprisingly, it looks like the Office of Information and Regulatory Affairs (OIRA)—a bureau in the White House Office of Management and Budget that through Democratic and Republican administrations alike has assumed the role of squashing or diluting needed environmental, health, and safety regulations—played a role in delaying the FDA’s rule, back in 2008. It appears that without OIRA’s interference, the rule could have been in effect by at least the end of 2009—well before the massive salmonella outbreak began.
The long, sad saga of FDA’s salmonella rule stretches all the way back to the Clinton Administration when in July of 1999 the FDA and the Department of Agriculture (USDA) agreed that a new approach was needed to ensure the safety of eggs. At the time, and up until recently, the two agencies had shared responsibility for overseeing egg safety—and the shared responsibility led to gaps in regulatory protections that allowed problems like salmonella contamination to persist. The FDA’s rule was meant to put an end to this by putting into place new regulations to prevent contamination while giving the agency clear oversight and enforcement authority to ensure industry compliance. Before the FDA could complete the rule, however, the Bush Administration rolled into Washington, hell-bent on advancing an anti-regulatory agenda. Important health and safety rulemakings were slowed or in some cases effectively stopped; it took until September of 2004 for the FDA to publish its proposed salmonella rule, with the public comment period ending three months later. The delays only continued after that point, as the FDA reopened (May of 2005) and then extended (June of 2005) the comment period. Consequently, the FDA did not get around to sending a draft final rule to OIRA for review until July of 2008—nearly four years after the draft rule was first published.
It’s at this point that the salmonella rule story takes an odd twist. According to OIRA records, on November 19, 2008—111 days into the review of the draft final rule and during the lame duck period of the Bush Administration—FDA withdrew the rule, thereby ending OIRA’s review before it could be completed. The FDA provided no explanation for its decision. Given the limited information that’s available, it's impossible to know what role OIRA played, but here's what we do know: OIRA’s meeting records show that egg industry officials came in soon after the final rule was submitted for review to make the case that the rule was unnecessary, because (1) salmonella contamination was no longer a big problem, (2) state and industry were doing enough on their own to prevent salmonella contamination, and (3) enforcing the salmonella rule would be too big a drain on the FDA’s limited resources. As such, industry argued, the FDA should abandon the rule and instead endorse the various state programs for preventing salmonella contamination in eggs.
Another fact: In May of 2009, soon after President Obama took office, the FDA sent another draft final salmonella rule to OIRA for review—this second one virtually identical to the first—and it was approved by OIRA a couple of months later, despite renewed protests from industry.
The reason we know so little about what happened to the FDA’s draft final salmonella rule during the first review in 2008 is because OIRA operates with a complete lack of transparency. To begin with, if OIRA dislikes a rule that has been submitted to it for review, it is supposed to send it back to the submitting agency along with a Return Letter explaining its objections. If, as the evidence invites one to infer, OIRA squashed the FDA’s salmonella rule because it deemed it too costly for industry, then it did not comply with that requirement. Instead, OIRA’s records chalk this up as an FDA-initiated withdrawal, rather than as an OIRA-initiated Return, rendering this requirement inapplicable. Furthermore, section 6(b)(4)(D) of Executive Order 12866—the Order that governs OIRA’s regulatory review function—requires OIRA to “make available to the public all documents exchanged between OIRA and the agency during the review by OIRA” “after the agency has announced its decision not to publish or issue the regulatory action.” These documents would undoubtedly shed some light on whether the decision to withdraw the salmonella rule came initially from the FDA or if it was foisted upon the agency by OIRA. Unfortunately, as is so often the case, OIRA did not comply with this requirement either. (Note that this requirement applies even when an agency withdraws the rule during review, which is, according to OIRA’s records, what happened in the case of FDA’s salmonella rule.) A review of the electronic docket for the FDA’s salmonella rule on regulations.gov (Docket ID # FDA-2000-N-0190) contains zero, zip, zilch, nada, not even one document related to OIRA’s 2008 review.
Meanwhile, members of the public can demand these documents until they turn blue in the face, but their demands will undoubtedly go unheeded. In the past, OIRA has claimed that review documents are exempt from the Freedom of Information Act (FOIA), because they constitute interagency deliberation—a weak argument considering that Executive Order 12866 was clearly meant to supersede FOIA’s exemptions.
Let’s hope that someone with a little more authority—I’m looking at you, Congress—investigates this instance of potential interference by OIRA and demands that the documents related to its review of the first draft final salmonella rule be released. These documents will almost certainly reveal who was responsible for delaying the FDA’s rule by more than a year, needlessly placing American health and safety at risk. I can think of 1,470 people who deserve a full explanation for why they were allowed to be harmed by unsafe eggs. The release of OIRA’s review documents may be their best hope for getting at least a partial explanation.
Whatever the cause of the delay, here we have a classic example of how the failure of the regulatory process to produce a timely regulation contributed to a real-world crisis—one that made nearly 1,500 people sick and cost the industry untold millions to recall all those eggs. Washington treats these incidents as if they were just bureaucratic dust-ups, insights into who’s up and who’s down. But they have very real consequences.