EPA Acts to Involve Scientific Review Sooner

On February 28, 2022, the EPA issued an internal memorandum detailing rules for an improved process to engage its Scientific Advisory Board (SAB) sooner in the review of scientific and technical components of proposed EPA decisions.

Timely expert advice, based on the review of scientific and technical information, from the SAB to support Agency decisions has historically been a challenge for the EPA. This “forward-looking” process will make it easier to identify when SAB input will be needed so it can be provided in a more appropriate time frame, making the advice more useful to the EPA.

“The improved process builds on the principle that early engagement with the SAB is a priority and will best enable the EPA to benefit from the expert advice received from the SAB,” the memo states.

The SAB is an independent group whose members are scientists, engineers, economists, and social scientists who are recognized experts in their respective fields. The SAB’s responsibilities are to:

1. Review the quality and relevance of the scientific and technical information being used by the EPA or proposed as the basis for Agency regulations.
2. Review EPA research programs and plans.
3. Provide science advice as requested by the EPA administrator.
4. Advise the Agency on broad scientific matters.

The new process for engaging the SAB in reviews is:

• Early engagement of the SAB in peer review activities.
• The formation of a new SAB Work Group to examine, screen, and identify potential actions proposed by the EPA that may warrant SAB review. The Work Group would then take its recommendations to the full board for its consideration.
• EPA submission to the SAB of information regarding planned actions in the Agency’s Semiannual Regulatory Agenda expected to undergo interagency review.
• EPA transmittal to the SAB of all proposed actions sent to the Office of Management and Budget for interagency review, as well as the relevant supporting scientific and technical information.
• Periodic internal preparatory meetings of the new SAB Work Group to examine planned actions sent to the SAB; receive information about planned actions from the Agency; identify aspects, if any, of the scientific and technical basis supporting the planned actions that may or may not warrant review by the full SAB; and prepare a report to the full SAB with recommendations for or against peer review for each planned action.
• Public meetings of the full SAB to decide whether to undertake SAB peer reviews recommended by the SAB Work Group and to conduct other types of peer reviews (described below) as necessary.

“Consistent with its statutory role, the SAB focuses on the ‘adequacy of the scientific and technical basis’ of EPA actions that the SAB reviews. Thus, it is not the SAB’s role to review the policy aspects of EPA actions,” the memo states.

Materials made available to the Work Group are designated as internal information that is not to be released to the public.

The memo precisely outlines the information to be made available to the SAB office regarding planned actions:

1. Name of the proposed regulatory action;
2. RIN number;
3. EPA office originating the proposed regulatory action;
4. Nature of the proposed regulatory action (e.g., administrative, renewal without significant revision, economically significant, etc.);
5. Brief description of the action and statement of the need for the proposed regulatory action;
6. Expected timeline related to proposed and final regulatory action and whether the timelines are driven by legal requirements;
7. The key science or scientific and technical work products pivotal to the planned regulatory action, including:
   1. A brief description of the scientific and technical work products that have been developed to inform decisions regarding the planned action and the impact of the science on the proposed action;
   1. A brief description of the approach the Agency is taking to develop the needed scientific or technical basis (e.g., interagency collaboration, workshops to inform the analysis) and an indication of whether the scientific and technical approaches are new to the EPA; and
   1. An indication of whether the scientific and technical basis meets the EPA Peer Review Handbook definition of “an influential scientific or technical work product” that “has a major impact, involves precedential, novel, and/or controversial issues, or the agency has a legal and/or statutory obligation to conduct a peer review.”
8. A brief description of previous peer reviews of the work products, including dates and references to SAB reviews of previous versions of the scientific and technical analyses and/or regulatory action; and
9. Other federal advisory committee consultation and rationale, where applicable.

The new process is effective immediately.