EPA Transparency Rule Revision Fails to Allay Critics

The Environmental Protection Agency is set to close the public comment period on its revisions to its proposed “Strengthening Transparency in Regulatory Science” rule on May 18. EPA asserts the rule, which it first proposed in 2018, will improve the integrity of the agency’s work by limiting its use of scientific studies that lack readily accessible data and models.

However, the rule has drawn fire from an array of critics, who, among other charges, argue that it will distort the agency’s decision-making processes and risk exposing private medical data and other confidential information. A number have also cast the rule as a bad-faith ploy to hamstring EPA’s ability to regulate, asserting it is inspired by strategies tobacco companies used in past fights over smoking regulations. In response to an avalanche of comments, EPA crafted a supplement to the rule, which it released in March.

Democrats on the House Science Committee, who have consistently opposed the rule, issued a memorandum last week summarizing answers that EPA staff gave to questions about the supplement. The memo states that EPA offered important new details about its plans that are absent from the text of the supplement and that agency staff were unable to answer key questions about how the rule would be implemented.

EPA’s Science Advisory Board (SAB) issued its own report last month noting that the supplement had failed to quell many of the board’s concerns about the rule. EPA Administrator Andrew Wheeler has said the agency will consider the board’s latest comments, while maintaining the supplement addressed many of its initial concerns.

EPA proposes two access alternatives for sensitive information

A main focus of the supplement is its addition of provisions that aim to address concerns about the handling of confidential information. The supplement seeks comment on two possible options for how EPA could handle such information: a tiered access approach and a weighted consideration approach.

Under the tiered access option, potentially sensitive information would be available only to authorized users, not the general public. The supplement explains, “Restricted access for researchers through secure data enclaves for personally identifiable information or through nondisclosure agreements for confidential business information may result in access to sufficient information about the data and models to allow for independent validation.” It observes that agencies such as the Centers for Disease Control and Prevention and the National Center for Health Statistics already use such means to provide restricted data access.

However, the Science Committee memo notes that EPA expects it would rely heavily on researchers to facilitate access to the data under such a tiered system. When agency staff want to consider using a particular study, they would reach out to the researchers involved, who then would have to judge the sensitivity of the study’s data for themselves and manage the logistics of making it available in compliance with the rule and relevant privacy requirements. The memo asserts that EPA should have informed the research community about this burden so that stakeholders could offer appropriate comments.

Under the weighted approach, EPA would give “greater consideration” to studies with available data, but it would not entirely exclude those that fail to satisfy the transparency requirement. The Science Committee memo states EPA was unable to expand on how the agency would assign weight to studies and asserts that its efforts could “upend” more traditional balances between study types, for example by giving a small-scale animal study stronger consideration than a large-scale human epidemiological study.

While the SAB report does not offer detailed comments on either approach, it does offer more general observations about the technical challenges and costs involved in making data broadly available, especially for historical data sets that may be difficult or impossible to reconstruct. As an alternative, the report suggests the transparency requirements could be modified to apply only to studies that are completed after the rule is implemented.

The report also acknowledges that the rule would give the EPA administrator the flexibility to waive transparency requirements, but notes that it provides no firm guidelines for how such waivers should be granted. Cautioning against such an approach, it argues that “case-by-case exceptions without such criteria may create public concerns about inappropriate exclusion of scientifically important studies.”

In the supplement, EPA requests further comment on what considerations should go into the waiver process, and specifically proposes to “use the age of data and models as a factor in the determination that compliance with the rule is impracticable”

Supplement clarifies and expands rule’s scope

The core principle of EPA’s rule is that the agency must ensure the science underlying its actions are “publicly available in a manner sufficient for independent validation.”

The supplement notes that many of the comments on the initial rule concerned the definitions, or absence thereof, of key terms such as “independent validation.” EPA now proposes to define that term as “the reanalysis of study data by subject matter experts who have not contributed to the development of the original study to demonstrate that the same analytic results are capable of being substantially reproduced.” Accordingly, it specifically notes EPA does not intend to require researchers to actually be able to repeat the entire study.

Meanwhile, the supplement proposes a significant expansion of types of studies and agency actions the rule would apply to. EPA initially proposed that the rule would only apply to studies presenting the dose response data and models that would underlie major regulations, but the supplement broadens the scope to encompass all types of data and models underlying “significant regulatory decisions and influential scientific information.”

The supplement defines influential scientific information as information with a “clear and substantial impact on important public policies and private sector decisions.” The Science Committee memo notes that, according to EPA, agency personnel will determine whether information they are producing, such as risk assessments, falls under this category at the time they initiate their work. EPA clarified, though, that the transparency requirement would only apply to “pivotal” studies used in such information products, not to any used only as “context.” However, both the Science Committee memo and the SAB report argue that the rule remains unclear on how EPA plans to handle the distinction between pivotal and non-pivotal science.

Although the original proposal states the transparency requirements would only apply to significant new regulations, Science Committee members tried to determine at a hearing last year whether they would be applied when rules come up for review. The supplement is silent on the matter, but the Science Committee memo notes that EPA confirmed during a briefing that “the rule’s application to ‘prospective rulemaking’ includes statutorily mandated reviews of existing standards.”

Science Committee calls for comment extension

EPA’s supplement has spurred renewed criticism from House Science Committee Democrats, who remain skeptical of its aims and the process the agency has followed. In a March 5 statement , House Science Committee Chair Eddie Bernice Johnson (D-TX) called the revised rule an “even more extreme assault on the agency’s ability to use the best available science.”

Given the scope of the supplement’s revisions, the Democrats requested that EPA extend the comment period from its initial length of 30 days, noting that EPA agreed in 2018 to extend the comment period for the less-detailed original proposal to 109 days. However, this time EPA only added an additional month.

Johnson sought another extension on May 6, citing the disruptions the pandemic has caused, particularly for key stakeholders from the public health community. Lawmakers in the House and Senate have similarly urged EPA to slow its rulemaking for the duration of the pandemic. So far, though, EPA has not signaled any further plans to extend the comment period.

The rule has also stoked tension between EPA and SAB. Notably, the board voted to conduct a full review of the rule after members objected that they had not initially been consulted about it. Last year, the agency floated a proposal internally to restrict the ability of board members to vote to review regulatory proposals, which Johnson suggested could be a “retaliatory action” against the board’s review of the transparency rule. EPA has not yet taken any action toward implementing the idea.