Recently disclosed documents show that the Office of Information and Regulatory Affairs (OIRA) weakened a proposed Food and Drug Administration (FDA) food safety rule. During the regulatory review process, OIRA removed important safety testing requirements from the "preventative controls" rule, which were intended to prevent foodborne pathogens from entering the food supply. Unfortunately, this is nothing new. OIRA has a long track record of changing the draft rules it reviews, often weakening them to appease regulated entities. In this case, the public was made aware of the rule revisions only because FDA followed the requirement to disclose changes made during OIRA review.

Congress tasked the FDA with issuing a set of new food safety standards when it passed the Food Safety Modernization Act (FSMA) in 2011. The FDA finally released some of these proposals in January 2013, including one rule that would require food facilities to develop and implement controls to significantly minimize or prevent hazards. FDA had included in the draft rule requirements to conduct environmental monitoring for pathogens and finished product testing. In the published proposal, these requirements were removed from the text of the rule and only mentioned in an appendix.

Later, when FDA published both the draft it submitted to OIRA for review and the proposal that was ultimately published for public comment, it became clear that testing requirements had been stripped from FDA's original draft. This is not the first time an agency's original idea was supplanted by a weaker version during OIRA review.

Track Record of Rule Changes and Lackluster Transparency

Executive Order 12866 requires agencies to submit all significant proposed and final rules to OIRA, housed within the Office of Management and Budget (OMB) at the White House, for review before they are published for public comment or finalized. It also requires agencies to "[i]dentify for the public, in a complete, clear, and simple manner, the substantive changes between the draft submitted to OIRA for review and the action subsequently announced." The agency must also identify those changes that were made at the suggestion or recommendation of OIRA. Despite this requirement, agencies rarely disclose what changes OIRA makes to rules.

Even when agencies disclose the changes made to the original draft during review, it is not always clear which changes were made at the behest of OIRA, and it can be nearly impossible to determine exactly when the changes were made and the reasons or motivations for the changes. This lack of adequate disclosure and thorough explanation is especially disconcerting given OIRA's tendency to weaken rules.

The documents that FDA disclosed illustrate this pattern. It was apparent from the drafts that "FDA thought testing was critical to effective preventive control programs and OMB made them take it out," David Plunkett of the Center for Science in the Public Interest told The Huffington Post. "It's OMB once again protecting corporate bottom lines at the expense of protection for public health," Plunkett also explained to Food Safety News.

Other important health and safety rules have suffered a similar fate during OIRA review. A rule regulating hazardous coal ash, proposed by the U.S. Environmental Protection Agency (EPA) in 2010, was significantly changed while under OIRA review. EPA's original draft offered one strong regulatory option but asked for public comment on alternatives. By the time the rule was published in the Federal Register, it included two co-proposals – EPA's original proposal and a weaker, presumably OIRA-supplied alternative proposal. Not surprisingly, industry continues to push for the weaker option, and there has still been no final action on the coal ash rule.

The Center for Progressive Reform issued a report in 2011 citing a number of recent examples of rules being weakened after industry groups lobbied OIRA. In one instance, the EPA dropped a key testing provision from its 2010 proposed lead paint rule after the home-renovation industry complained to OIRA. In another, air pollution standards were significantly weakened compared to EPA's original proposal to reduce costs.

Despite OIRA's dominating influence over agency rulemaking, its review process has been historically opaque. In a 2003 report, the U.S. Government Accountability Office (GAO) found that OIRA often made substantial changes to rules under review, but the review process was not well documented or clear. Although 400 rules were changed, returned, or withdrawn during the one-year period examined, GAO focused on 85 rules from health, safety, and environmental agencies. Of those 85 rules, 25 were significantly affected while undergoing OIRA review. For many rules, OIRA recommended that agencies remove or delay regulatory provisions and add compliance flexibility.

For example, at the behest of OIRA, the EPA:

• Removed a substance from a list of hazardous constituents in a rule intended to identify hazardous wastes;
• Delayed the compliance date for states to report pollution emissions; and
• Added compliance alternatives and exemptions to rules seeking to minimize the adverse environmental impacts at power facilities that withdraw water from U.S. water bodies.

OIRA also returned a number of rules to agencies within the Department of Transportation, and others were withdrawn at OIRA's suggestion.

GAO also found that agencies often could not explain why changes were made to rules and observed that "agencies' docket files did not always provide clear and complete documentation of the changes made during OIRA's review or at OIRA's suggestion, as required by the executive order."

Conclusion

The public has a right to know how and why government agencies craft the standards they issue, especially when the process is being influenced by political and industry interests. FDA's release of documents for the preventative controls rule allowed the public to see how the rule the agency ultimately proposed differed from the draft rule it submitted to OIRA, but this is not enough. To truly improve accountability, agencies and OIRA should provide clear, complete explanations of what was changed, who recommended or influenced the change, and why.