Cancer testing revamp races on, worrying greens and industry

By Corbin Hiar | 07/26/2019 01:25 PM EDT

EPA leaders are pushing forward with an overhaul of the way the agency evaluates the dangers of environmental contaminants after a brief consultation with outside scientists — a process that environmentalists claim was rushed and could be misused.

EPA headquarters in Washington.

EPA headquarters in Washington. Francis Chung/E&E News

EPA leaders are pushing forward with an overhaul of the way the agency evaluates the dangers of environmental contaminants after a brief consultation with outside scientists — a process that environmentalists claim was rushed and could be misused.

Even the chemical industry, which is broadly supportive of the deregulatory fervor of the Trump administration’s EPA, fears the agency may be attempting to do too much too soon in its bid to reconsider a set of crucial but complicated protocols.

At issue is EPA’s effort to update its cancer and noncancer risk assessment guidelines. They help EPA staff gauge and minimize the dangers posed by chemicals, pollutants, climate change and other threats to human health and the environment.


EPA’s cancer testing protocols were most recently updated in 2005 after more than a dozen years of review. But the agency has struggled for decades to create unified guidance for evaluating noncancer risks.

For the latest revamp, EPA Science Advisory Board Chairman Michael Honeycutt in June gave his fellow board members less than a month to highlight issues they thought the agency should consider when evaluating risks (E&E News PM, June 6).

Now, 16 of the SAB’s 45 members and 11 members of the board’s Chemical Assessment Advisory Committee have individually weighed in. Their more controversial suggestions include embracing hormesis — the theory that low doses of toxic chemicals and radiation can have beneficial effects — and advocating for the inclusion of economic considerations in risk assessments, a move that’s specifically barred by some environmental laws.

Yet the biggest concern for critics of current EPA leaders is not that some SAB members are pushing disputed concepts while others choose to stay silent. It’s that board members aren’t being given the time to debate those ideas together and reach a scientific consensus.

"The premise that the SAB should quickly (in just a few weeks) cobble together ad hoc comments from its members, rather than engage an appropriately constituted panel to carefully deliberate on complex issues, is silly," Chris Frey, an engineering professor at North Carolina State University, wrote in an email.

"In my experience serving on and chairing various scientific review and advisory panels, interactive deliberation by a well-chosen highly qualified group of recognized experts, without obvious motivational biases such as getting a paycheck from regulated industries, substantially improves the overall quality of scientific advice to an agency," said Frey, an SAB member from 2012 until last year. "A consultation process based on individually prepared comments is highly susceptible to cherry picking by the agency."

That selectively applied feedback "could mean less health-protective risk assessments of hazardous chemicals," said Genna Reed, a top analyst at the Union of Concerned Scientists watchdog group. "The degradation of a consultative, peer-review process in its science advisory committees stands to bear fruit for an administration interested in stripping away protections that are inconvenient for the oil and gas and chemical industries."

Congressional auditors this month faulted EPA for repeatedly bypassing normal procedures in making appointments to the SAB and Clean Air Scientific Advisory Committee. Instead of selecting from the nominees who staffers determined had the strongest qualifications, agency leaders often chose ones with strong industry ties (Greenwire, July 15).

Asked about its plans for the SAB’s feedback, EPA said it would take the members’ responses into consideration along with comments on the guidelines made at the board’s June meeting. But it’s unclear whether the SAB will collectively have an opportunity to provide input on EPA’s risk assessment process.

"The typical SAB consensus process, which can take many months, was not deemed as necessary at this point in our effort," an agency spokesperson said in a statement. "Future engagement with SAB on this issue is envisioned."

Reaching scientific consensus, however, would be extremely difficult on the timeline EPA is pursuing. Agency sources previously told E&E News that EPA leadership is looking to make changes to the guidelines by the end of the year (Greenwire, May 31).

But a great deal of scientific research has been published about carcinogens in the 14 years since EPA’s cancer risk assessment guidelines were last updated, much of which would need to be reviewed. And issuing formal noncancer guidelines has previously been derailed over internal disputes about how to define "adverse," according to a former EPA staffer.

Chemical industry concerns

Even some supporters of EPA leaders are troubled by the intended speed of the overhaul.

EPA should "allow sufficient time for expert input and peer review of any new or modified guidelines," SAB member Kimberly White, a senior director at the American Chemistry Council trade group, wrote in her comments. "It generally takes multiple years to draft, review and update guidance of this nature to ensure it adequately reflects the current state of scientific discourse and relevant approaches. Effective and timely peer review is essential to ensure the development of scientifically defensible guidelines and applicability of the guidance to inform decision-making."

White, who was appointed to the board by former Administrator Scott Pruitt, urged EPA to "not unduly truncate this review process."

Nevertheless, critics suspect EPA’s aggressive timeline for the overhaul is driven more by political than scientific considerations. If the guidelines are released this year, they could be in place by the end of President Trump’s first — and potentially only — term in office.

EPA political leaders aren’t serious about "listening to and engaging with the scientific advisers," said Penny Fenner-Crisp, who was a staff scientist at EPA for 22 years. "They’re just doing this for perfunctory reasons — just to say they did — and to be less criticized than if they were to absolutely ignore them and never convened another advisory committee meeting."

Selectively applying the SAB’s feedback to support weaker EPA risk assessment guidelines would not only be bad for public health, according to Bernard Goldstein, dean emeritus of the University of Pittsburgh Graduate School of Public Health. It would also damage the agency and board.

"EPA, the way it’s built by having its own science within the agency, has over the years developed very strong scientific advisory processes so as to limit the possibility that the EPA political leadership can lean on the scientists to get the answers they want," he said. "This is a way of crippling it."

Goldstein served as EPA’s assistant administrator for research and development during the Reagan administration and is now, like Fenner-Crisp, a member of the EPA advocacy group the Environmental Protection Network.

"A very quick process is not appropriate for something as complex as these guidelines," he added.