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The Insider

As Deadline Looms, EPA Draws New Criticisms On Key TSCA Evaluations

As it races to meet a June deadline, EPA is facing mounting criticism from its science advisors and others over its draft chemical evaluations under the Toxic Substances Control Act (TSCA).

But the agency also appears to have scored a big win as many of its advisers seem to be backing its controversial approach for assessing risks of trichloroethylene (TCE).

Under the revised TSCA, EPA must complete the first 10 evaluations of existing chemicals -- those in commerce before the law was first enacted in 1976 -- this June. The agency has been scrambling to meet the deadline even as it gears up to begin assessing the next 20.

The draft evaluations are significant because they form the basis for EPA’s threshold regulatory determination on whether certain chemical uses pose “unreasonable risk” that require risk management.

So far, the agency has released nine of the first ten draft evaluations -- with only the draft assessment of perchloroethylene (perc) still pending.

Most recently, the agency earlier this week released its draft evaluation of six forms of asbestos, which found that some of the substances’ uses pose risks to workers in the chlor-alkali and other industries, as well as occupational non-users and consumers.

As with other EPA draft evaluations, the agency is facing stiff criticism over the draft asbestos assessment -- with lawmakers and environmentalists pushing Congress to address the issue:

Faulting EPA Analysis, Critics Step Up Push For Stalled Asbestos Ban Bill
A key House Democrat and an asbestos awareness group are stepping up efforts to advance stalled bipartisan legislation seeking to ban asbestos, arguing EPA’s recently released draft evaluation of the minerals under the revised toxics law is too narrowly focused and ignores multiple aspects of asbestos risk as well an appellate court ruling.

It “is now clear that this EPA has no intention of addressing this dangerous, proven carcinogen. Therefore, Congress must pass [H.R. 1603] and put an end to this public health threat once and for all,” House Energy and Commerce Committee Chairman Frank Pallone (D-NJ) said in a March 31 statement.

The Asbestos Disease Awareness Organization (ADAO), a major supporter of the bill, is also arguing that EPA’s draft evaluation is flawed -- and bolsters their calls for H.R. 1603’s passage. “We have repeatedly noted [EPA’s] flawed approach fails to fully recognize and evaluate the public health threat of asbestos,” ADAO President Linda Reinstein said in a March 31 statement.

A major chemical industry trade group is also criticizing aspects of the document, which concluded that the few remaining asbestos uses pose unreasonable risk to workers, including in the chlor-alkali industry.

While the draft risk evaluation “recognizes that the use of personal protective equipment is effective worker protection, it appears to rely on inaccurate assumptions that overestimate exposure risks for certain chlor-alkali workers,” the American Chemistry Council (ACC) said in a March 31 statement

EPA’s release of the document -- and its planned review later this month, during the coronavirus pandemic -- also drew criticism from its science advisors, some of whom are public health officials who will not be able to thoroughly review the document as they also try to deal with the emergency:

EPA Readies Review Of Asbestos Risk Finding Despite Calls For Delay
EPA is moving ahead with a planned scientific review of its just-released draft evaluation of asbestos, which found the substance poses unreasonable risk to workers, consumers and others, despite calls from science advisors and other critics who had urged the agency to delay the review until after the coronavirus pandemic.

For example, Henry Anderson, the former chief medical officer for Wisconsin and a member of EPA’s Science Advisory Committee on Chemicals (SACC), reminded EPA last week that it will be difficult for public health officials to both fulfill their emergency duties dealing with the pandemic and thoroughly review EPA’s asbestos and other remaining draft assessments.

Anderson said that he spent the TCE peer review meeting going between a secure facility where Wisconsin public health officials are working on coronavirus response and exiting these meetings to listen to the TCE peer review.

“For those of us in the public health field we’re in for, in the next month or so, really ramping things up. I’d ask EPA to look at whether it is really critically important to have the next meeting in April? I’d rather have their staff work on finalizing some of the documents we’ve already reviewed and haven’t got a final product yet to look at.”

EPA’s draft evaluation of asbestos is not the only TSCA assessment that is drawing criticism.

The agency’s draft evaluation of TCE has also come in for its share of criticisms. For example, several SACC members raised concerns that the TCE assessment included flaws that the advisors had urged the agency to address in other draft evaluations too, though a top official said the agency is seeking to address such concerns:

EPA Says It Is ‘Listening’ To SACC On TSCA But Draws Renewed Criticisms
EPA toxics chief Alex Dunn sought to assure advisors reviewing draft risk evaluations that the agency is “listening to you,” but during a March 24 meeting to review the agency’s draft evaluation of trichloroethylene (TCE) some advisors renewed long-running concerns that have spanned multiple evaluations.

EPA’s advisors and other critics also renewed their criticisms of the agency’s approach for assessing risks to workers, saying the agency was misrepresenting protections provided by personal protective equipment (PPE):

EPA’s Draft TCE Analysis Drives New Calls To Bolster Worker Protections
EPA’s draft evaluation of trichloroethylene (TCE) is driving new calls from its science advisors and a top former OSHA official to strengthen its analyses of occupational exposures to chemicals in the first 10 evaluations, suggesting the agency more fully address protections beyond personal protective equipment (PPE).

But during a March 24-27 SACC meeting, members of the panel struggled to come up with an acceptable way to improve the agency’s method, leaving it unclear how or whether the agency will change its current approach.

Even as EPA drew such criticisms, many of the advisors still supported the agency’s controversial decision to select immunosuppression risks as the harmful endpoint for its TCE assessment, rather than a more conservative approach focused on congenital heart defects.

This means that if EPA finalizes its evaluation based on immunosuppression risks, it likely will not have to regulate the substance as strictly as it would if it choose fetal heart defects as its endpoint:

Many TSCA Advisors Back EPA’s Controversial TCE Risk Approach
Despite some divisions, many of EPA’s toxics advisors appear to be backing the agency’s controversial approach for assessing the risks of trichloroethylene (TCE), the widely used solvent, likely clearing a path for EPA to finalize a less-conservative evaluation under the toxics law than what many environmentalists and other public health advocates favor.

While the advisors are unlikely to reach consensus on the issue, their comments during SACC’s March 26 session suggested that many of them support the agency’s decision to use less-sensitive immunosuppression risks -- rather than more-sensitive cardiac birth defects -- as the adverse health endpoint in its draft TCE evaluation.

The advisors’ comments were based on concerns about the quality of studies showing TCE exposure causes cardiac birth defects, including a controversial 2003 study conducted by Dr. Paula Johnson and others at the University of Arizona that SACC members said may not be of sufficient quality to justify using it as the premiere study in the evaluation.

“When these studies are put under the microscope, you see all these warts,” said SACC Chairman Ken Portier, a biostatistician retired from the American Cancer Society. He agreed with other panelists that the SACC was not going to reach consensus on the issue.

With only weeks remaining before EPA must finalize its first 10 evaluations, it is sure to be a bumpy ride.