FSMA Preventive Controls and OMB: No Cloak or Dagger

 By Ricardo Carvajal –

When FDA published its proposed rule on preventive controls as authorized by FSMA, we noted that FDA requested comment on a number of important issues that were not addressed in the text of the regulation itself, namely product testing, environmental monitoring, and supplier approval and verification.  These elements were extensively discussed in an appendix to the proposed rule.  FDA has since made clear that they could yet be integrated into the final rule pending further evaluation. 

Prior to its publication, the proposed rule was under review for a year by the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA).  The recent publication of documents showing changes made as a consequence of OMB’s review has prompted some surprise, as well as observations that OMB effectively watered down the regulation – in part by striking provisions that would have required product testing, environmental monitoring, and supplier approval and verification.

OMB review of significant regulatory actions has been a standard feature of agency rulemakings for over 30 years through both Republican and Democratic administrations, pursuant to Executive Order (EO) 12866 issued by President Clinton and its predecessor EO 12291 issued by President Reagan.  The purpose of that review has been explained by OMB as follows:

The OIRA review process under Executive Order 12866 seeks to ensure that agencies, to the extent permitted by law, comply with the regulatory principles stated in the Executive Order and that the President’s policies and priorities are reflected in agency rules. Such review also helps to promote adequate interagency review of draft proposed and final regulatory actions, so that such actions are coordinated with other agencies to avoid inconsistent, incompatible, or duplicative policies. OIRA review helps to ensure that agencies carefully consider the consequences of rules (including both benefits and costs) before they proceed.

Although the emphasis added to the above paragraph is ours, OIRA’s former administrator has noted that the current Administration places “a great deal of emphasis on careful analysis of costs and benefits.”  It should therefore come as no surprise that FDA’s proposed rule emerged from OMB review with some significant changes, and testing requirements were logical targets for scrutiny given their estimated costs (see the economic analysis of the preventive controls rule here).  The preventive controls proposed rule is certainly not the first FDA regulation to be subject to rigorous scrutiny and a bit of pruning during the course of OMB review, and the final rule will have to run the same gauntlet. 

We note also that the posting of the OMB review documents is entirely consistent with EO 12866, which states:

After the regulatory action has been published in the Federal Register or otherwise issued to the public, the agency shall… [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; and… [i]dentify for the public those changes in the regulatory action that were made at the suggestion or recommendation of OIRA.