On April 24, 2019, the U.S. Office of Management and Budget (OMB) issued a memorandum to executive departments and agencies that revises the standards for information used in regulatory functions (Memorandum) with potentially dramatic consequences for the scientific studies and analyses used in certain rulemaking, risk assessments and policy or guidance documents. The Memorandum updates OMB’s Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility and Integrity of Information Disseminated by Federal Agencies, 67 Fed. Reg. 8452 (Feb. 22, 2002) (2002 Guidelines), which interpreted agency responsibilities under the Information Quality Act, 44 U.S.C. § 3516. Agencies, including the Environmental Protection Agency (EPA), the Department of the Interior, the Food and Drug Administration (FDA), and the Department of Health and Human Services have their own information quality guidelines that implement OMB’s 2002 Guidelines.
The 2019 Memorandum directs agencies to expand peer review processes, to increase public access to data, to ensure reproducibility of analyses and to make the request for correction process more responsive. The majority of the changes apply to “influential information,” which the 2002 Guidelines define as information that could have a substantial impact on important public policy or private-sector decisions. Agencies retain discretion to designate which information is influential without review by OMB.
- In the environmental context, “influential information” could include analyses supporting Clean Air Act standards for certain pollutants, chemical risk assessments or other rules or policy documents related to substances or pollutants of high public concern.
- In the FDA setting, agency guidance has defined “influential information” as “disseminated information that results from or is used in support of agency actions that are expected to have an annual effect on the economy of $100 million or more or will adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or tribal governments or communities.” FDA has explained that because this definition pertains to the information rather than to the action the information may support, even where an FDA action is itself very important, individual pieces of information supporting it may or may not be considered “influential.” FDA has cited the information disseminated with respect to quality mammography standards and to hazard analysis and critical control point procedures for the safe and sanitary processing and importing of juice as two examples of influential information.
Key aspects of the recent Memorandum:
- Increased access to data. The 2002 Guidelines require that influential analyses must be disseminated with sufficient details to allow third-party reproduction with specific details on the uses and limitations of data sets. The Memorandum now directs agencies to provide wider access to data, models and analyses used for influential information, as well as any specialized computer code used, if consistent with applicable law and policy. Additionally, agencies should provide the underlying assumptions, uncertainties and probabilities associated with influential information. This may mean that parties interested in rulemaking may have even greater access to data sets used by agencies and their contractors in those proceedings.
- Expanded peer review processes. The Memorandum instructs agencies to ensure compliance with the OMB’s Final Information Quality Bulletin for Peer Review, issued in 2004. Compliance with the bulletin was already required under the Information Quality Act, but OMB suggests in the Memorandum that “only some agencies have robust peer review mechanisms.” Agencies have existing obligations to conduct peer review of influential scientific information and send annual reports of completed peer reviews to OMB. The Memorandum instructs agencies to increase reviewers’ focus on objectivity of data and requires a second round of peer review if there are substantial changes based on the first. These requirements could make rulemakings more time-intensive where influential information is involved.
- Requests for correction. The Memorandum seeks to limit agencies to 120 days to respond to requests for correction from the public that challenge whether the agency has complied with applicable guidelines for disseminating information. It also includes a provision for peer review and OMB review of responses to requests for correction as well as a general prohibition of the same agency staff responding to the request for corrections as worked on the subject of the request. Parties interested in rulemaking may find that this increases agency responsiveness when challenging whether data or analyses conform to applicable guidelines.
In sum, OMB’s new Memorandum may facilitate third-party review of data and analyses when preparing comments on proposed regulations or risk assessments. Private parties interested in pending agency decisions should take note of the rules that apply to data and analyses used by agencies in those proceedings and be prepared to file requests for correction when necessary. These new peer review and request for correction requirements may lengthen certain rulemaking or other proceedings but also provide more opportunities to ensure that agency actions are based on appropriate information.
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