NGOs have raised the alarm that a new "secret science" policy at the US EPA could result in suppressing crucial data needed to take action on hazardous chemicals under TSCA.
The concern has come in response to the agency’s signalling its intent to roll out a new science transparency policy that would bar the agency from using studies that are not publicly available to underpin regulatory decisions.
The EPA announced the development in the unusual form of a news release linked to an exclusive interview with agency Administrator Scott Pruitt (pictured) run by the conservative news outlet The Daily Caller. Further details on the initiative were not immediately available, and the EPA press office did not respond to a request for comment.
However, reports indicate the new approach will be based on the HONEST Act – a bill that would bar the EPA from taking regulatory actions based on science that is "not transparent and reproducible". Proponents have said it will allow independent scientists to validate studies the agency uses in support of its regulations.
But among its detractors is NGO the Union of Concerned Scientists which says adoption of such an approach could "radically limit the types of science that the EPA can use in developing public health and environmental protections."
Liz Hitchcock, acting director of NGO Safer Chemicals, Healthy Families, told Chemical Watch the new policy could "ultimately take the EPA backward at a time when it could use new authorities under TSCA to really protect the public from toxic chemicals".
"Efforts to suppress science and discount peer-reviewed studies in EPA's evaluation and regulation of toxic chemicals would add new layers of work to the examination of those chemicals and to identification of public health protections," she said.
And Richard Denison, lead senior scientist at the Environmental Defense Fund, told Chemical Watch there is a host of information under TSCA that cannot be made public. It might be proprietary, be subject to legal restrictions in terms of the ability to disclose it, or contain data that is private because it relies on access to medical records or other proprietary information.
"There’s an issue that even if EPA had infinite resources and infinite time, it might not be able to make all information underlying a study public," said Dr Denison. And in those cases, "it would simply have to pretend that study didn’t exist".
He flagged up similar concern with the potential requirement that studies be replicable. Epidemiological studies and monitoring data in workplaces, for example, may be associated with circumstances that can’t be replicated, he said.
This policy may well "engender huge arguments and fights over every piece of information that the agency seeks to use," he said. "That does not bode well for efficient and effective implementation of the [TSCA] law."
The EDF has filed a Freedom of Information Act request in an effort to force the EPA to furnish the documents outlining the details of the new policy and its development.
The American Chemistry Council (ACC) announced its support of the HONEST Act when it was introduced last year.
It told Chemical Watch it looks forward to reviewing the EPA’s forthcoming policy, but with a particular interest in "understanding how the agency will properly protect confidential business information, proprietary interests, and competitive intelligence".
EPA acting where Congress has not
According to the Daily Caller article the pending policy "mirrors" Representative Lamar Smith’s (R–Texas) Honest and Open New EPA Science Treatment Act (HONEST Act) – a bill that has been introduced in some form during several sessions of Congress, but has repeatedly failed to secure passage.
The bill calls for barring the EPA from proposing, finalising or disseminating regulations, assessments, guidance and other actions, unless all scientific and technical information relied upon to develop them is:
- the "best available science";
- specifically identified; and
- publicly available in a manner "sufficient for independent analysis [and] substantial reproduction of research results".
The bill (HR 1430) passed the House last March, but has not been taken up by the Senate.
A spokesperson for Mr Smith's Science Committee told Chemical Watch: "the chairman has long worked toward a more open and transparent rulemaking process at EPA, and he looks forward to any announcement from Administrator Pruitt that would achieve that goal."
NGOs are complaining that Mr Pruitt's action sidesteps the legislative process – particularly for a bill that has repeatedly failed to make it out of Congress.
And the HONEST Act, in particular, has attracted concern from House Democrats and public advocates after news reports surfaced that Mr Pruitt deliberately withheld EPA staff concerns from the Congressional Budget Office (CBO) early last year. These include an estimate that the bill would cost $250m a year to implement, "while threatening agency know-how and jeopardising personal and confidential business information", according to a leaked memo.
Nor would this represent the first time Mr Pruitt has taken a failed legislative action into his own hands. Last year, he issued a Directive barring researchers receiving US EPA grants from advisory panels – a key provision in the stalled EPA Science Advisory Board Reform Act of 2017 (HR 1431). NGOs and researchers have since filed a suit against that Directive.