Americans deserve safe food. However, a bill making its way through Congress would prevent agencies from putting in place food safety regulations to protect public health. The bill’s proponents have maintained that food safety regulations highlight why S.951—formally titled the Regulatory Accountability Act of 2017, but more accurately dubbed the Filthy Food Act— would not be burdensome or slow down the regulatory process. Those claims, however, do not stand up to scrutiny.
The Filthy Food Act would saddle agencies with burdensome new analytical and procedural requirements, restrict the use of scientific research, transfer authority from technical agency experts to the White House “regulatory czar,” give opponents of strong standards more opportunities to delay, shroud the regulatory process in uncertainty with a raft of undefined and ambiguous terms, and elevate the role of courts and adversarial tribunals in the rulemaking process.
The truth is that this legislation would paralyze the rulemaking process, and in doing so, prolong American consumers’ exposure to evolving food safety threats. The Filthy Food Act would not compel agencies to ‘do the right thing’ so much as it would lead them to do nothing. As a result, consumers would not have the benefit of food safety protections like those recently implemented under the 2011 Food Safety Modernization Act (FSMA).
FSMA and the Filthy Food Act
A look back at the major rules issued under FSMA illustrates the crippling effect that the Filthy Food Act would have.
Consider, for example, the Food and Drug Administration’s (FDA’s) “Sanitary Transportation” rule. The rule is designed to protect food from becoming contaminated during transport, and it only recently went into effect for large companies this past April—over six years after FSMA was signed into law. As with other major FSMA rules, FDA had little difficulty estimating the costs of the rule to industry, but it concluded that it lacked sufficient data to quantify the rule’s benefits. In the agency’s words, “The causal chain from inadequate food transportation to human and animal health and welfare can be specified but not quantified.”
Under the Filthy Food Act, however, FDA would have a mandate to “adopt the most cost-effective rule,” a term that the Act fails to define. This means that the agency would either have to forge ahead with some sort of enumeration of speculative food safety benefits, or make a “finding of good cause” to issue a rule without a complete cost-benefit analysis. Both decisions would be subject to judicial review under the Act, and so would likely consume significant agency resources, causing more delay.
The Filthy Food Act’s trial-like “public hearing” provisions would also delay or entirely thwart food safety protections and divert resources from protecting the public. By definition, all of the major FSMA rules would trigger a provision that gives “any interested person” the right to petition FDA for a trial-like adversarial hearing. For most rules, the agency may deny the petition, but only if it “reasonably determines” that the hearing will cause unreasonable delay or fail to “advance the consideration of the proposed rule.” A decision to deny a petition is also subject to judicial review.
Proponents of the Filthy Food Act have claimed that it would not have affected the FSMA rulemaking process, in part because “it is unlikely that a petition asking the FDA to undergo the additional RAA regulatory processes would have been filed.” This claim is completely unfounded. While FDA’s FSMA rules have broad consumer and industry support, they represent many compromises. It is hardly farfetched to think that some deep-pocketed stakeholders might have used the petition provision—and the threat of subsequent litigation challenging a denial—to advance their narrow agendas before the agency.
Beyond Major Rulemaking
The Filthy Food Act not only creates new analytical requirements for new “major” or “high impact” rules and regulations. It also erects barriers for “major” agency guidance on existing rules to overcome. As with the affected rulemaking procedures, the Office of Information and Regulatory Affairs (OIRA) Administrator would determine what meets the definition of “major guidance,” potentially on the basis of vague factors like the guidance’s potential “adverse effect on competition,” or whether it would increase costs for “individual industries.” Once handed down, this “major” designation would require agencies to calculate direct, indirect and cumulative costs and benefits associated with the guidance, submit it to OIRA for review, and comply with yet to be promulgated OIRA guidelines for issuance of “major guidance.”
These requirements are particularly troublesome because agencies use guidance to respond to changed circumstances, to clarify the grounds for enforcement actions, and to take faster action on emerging food safety threats than they can otherwise accomplish with rulemaking. The response of USDA’s Food Safety and Inspection Service (FSIS) to the 1993 outbreak of E. Coli O157:H7 in Jack in the Box restaurant hamburgers provides an illustration.
The Jack in the Box outbreak sickened over 600 people. Some 150 people—mostly children—required hospitalization, including dozens that suffered long-term health impacts associated with Hemolytic Uremic Syndrome and four young children who died. In response, FSIS announced that it would begin testing ground beef for E. Coli 0157:H7 and treating it as “adulterated” under the Federal Meat Inspection Act if it tested positive. The meat industry filed a lawsuit challenging the new policy, but a federal court held that the USDA’s decision to consider E. Coli 0157:H7 an “adulterant” was an “interpretive rule” or “guidance,” not subject to notice-and-comment rulemaking requirements. In the years since, the rate of E. coli illnesses has fallen by nearly 50 percent, and FSIS has expanded on its guidance to include other strains of E.Coli that have been associated with foodborne illness. Had the Filthy Food Act been in effect during the Jack in the Box outbreak, however, there is little doubt that the FSIS “interpretive rule” would have qualified as “major guidance,” delaying agency action and giving industry opponents of the policy more opportunities to stymie the change and defend the status quo.
No business wants to defend practices that deliver unsafe food to American consumers. That is why Consumer Federation of America has joined other advocates in asking food companies not to support the Filthy Food Act. S. 951 would lock in the status quo by grinding the regulatory process to a halt. As a result, it would leave public health authorities flatfooted to meet the challenges of constantly evolving foodborne pathogens. The result would be unacceptable harm to American consumers.