EDF Health

Selected tag(s): Risk evaluation

What the heck is going on with EPA’s risk evaluation fees under TSCA?

By Richard Denison / Published: August 31, 2020

Richard Denison, Ph.D., is a Lead Senior Scientist.

What a mess.  That’s the best that can be said from the outside about the process EPA has followed to decide which companies are to pay fees to help defray the agency’s costs of conducting risk evaluations for the next 20 chemicals under the Toxic Substances Control Act (TSCA).[pullquote]EPA’s steps to endanger its ability to collect the fees under TSCA that Congress mandated border on self-sabotage.[/pullquote]

These fees were set forth in EPA’s final TSCA fees rule issued in October 2018.  The total fee assigned to each of the next 20 chemicals for which risk evaluations are now underway was set at $1.35 million.  That fee is to be paid by manufacturers (including importers) of a chemical.  TSCA provided EPA with authority to charge processors of these chemicals a fee as well, but the agency opted to exclude processors from such fees in its final rule (see p. 52,696).  EPA also opted not to charge fees to cover any of the costs it incurred for the first 10 risk evaluations (see p. 52,708 of the fees rule), although it had authority to do so.

Last week EPA issued what it calls its “interim final list” of companies obligated to pay fees to cover the costs of the next 20 risk evaluations.  The list is dramatically scaled-back from the agency’s earlier list, and it is impossible for the public to understand the basis for the changes.  That is in no small part due to the convoluted, opaque, and legally suspect process EPA has followed.  Read More »

Posted in Health policy, Industry influence, TSCA reform / Also tagged , | Comments are closed

EPA flouts the law, science, and its obligation to protect public health yet again: The 1-bromopropane final risk evaluation

By Richard Denison / Published: August 11, 2020

Richard Denison, Ph.D., is a Lead Senior Scientist.

Today, the Trump EPA released its second final risk evaluation and determination under the reformed TSCA, for the carcinogenic solvent, 1-bromopropane (1-BP). [pullquote]EPA has once again ignored expert scientific input it received from its own advisors.[/pullquote]

As was the case with the final document for methylene chloride – which has already been challenged in court (see here and here) – EPA has doubled down on the illegal, unscientific, and un-health protective approach it has taken in all of its draft risk evaluations for the first 10 chemicals reviewed under TSCA.

EDF will be closely examining this final document, but it is already apparent that EPA continues to grossly and systematically underestimate the exposures to and risks of 1-BP to the general public, workers and the environment.

Below are four examples of the flaws; each was raised by EPA’s own Science Advisory Committee on Chemicals (SACC) in its peer review as serious deficiencies – expert scientific input that EPA has simply chosen to ignore in finalizing the document:  Read More »

Posted in Health policy, Health science, Industry influence, Public health, Regulation, TSCA reform, Worker safety / Also tagged , | Read 1 Response

“Illegal, unscientific, and un-health protective”: Summing up EPA’s final methylene chloride risk evaluation

By Richard Denison / Published: June 19, 2020

Richard Denison, Ph.D., is a Lead Senior Scientist.

Today, the Trump EPA released its first final risk evaluation and determination under the reformed Toxic Substances Control Act (TSCA), for the carcinogenic and acutely lethal chemical methylene chloride.

Sadly, despite EPA’s rush to issue this document as the 4th anniversary of TSCA reform on June 22 approaches, EPA doubled down on the illegal, unscientific, and un-health protective approach it has taken in all of its draft risk evaluations for the first 10 chemicals reviewed under TSCA.

EDF will be closely examining this final document, but it is already apparent that EPA has grossly and systematically underestimated the exposures to and risks of methylene chloride.  Read More »

Posted in Health policy, Health science, Industry influence, Public health, Regulation, TSCA reform, Worker safety / Also tagged , , | Comments are closed

NGOs call on EPA to revise the draft scopes for its upcoming risk evaluations to comply with TSCA and its own regulations

By Richard Denison / Published: May 14, 2020

Richard Denison, Ph.D., is a Lead Senior Scientist.

Environmental Defense Fund, Earthjustice, Natural Resources Defense Council, and Safer Chemicals Healthy Families yesterday told the Environmental Protection Agency (EPA) that the 20 draft scope documents the agency released for public comment on April 9 and April 23, 2020, fail to meet TSCA and EPA regulatory requirements.  The groups called on EPA to revise the drafts to include the information that both TSCA and EPA’s Risk Evaluation Rule require be included, and then make the revised draft scopes available for public comment.  Read More »

Posted in Health policy, Regulation, TSCA reform / Also tagged , , | Comments are closed

Peer reviewers of EPA’s TCE report must affirm that the key risk is fetal heart damage

By Richard Denison / Published: April 1, 2020

Richard Denison, Ph.D., is a Lead Senior Scientist.

Last week, the EPA Science Advisory Committee on Chemicals (SACC) conducted a virtual peer review meeting for the Agency’s draft risk evaluation of trichloroethylene (TCE). As expected, there was substantial discussion on the appropriateness of EPA’s decision to make risk determinations based on immune endpoints rather than fetal cardiac malformations (FCMs). Unfortunately, the review panel lacked anyone with specific expertise in cardiac development.

During the meeting, many of the peer review panelists signaled an initial inclination toward supporting EPA’s decision to use immune endpoints for risk determinations. However, panel members also noted with serious concern the recent investigations that have uncovered political influence exerted on EPA that led it to base the risk determinations in the draft risk evaluation on immune endpoints instead of FCMs.

Stepping back from the specifics of the discussions last week, it is important to understand the longstanding basis and support for EPA’s reliance on FCMs, the unprecedented nature of EPA’s decision to now move away from it, and the adverse implications of the decision for EPA’s ability to adequately manage the risks of TCE to all relevant subpopulations.

This decision is a major departure from thoroughly peer-reviewed science, fails to protect the most sensitive populations as mandated by TSCA, and deviates dramatically from existing Agency guidance. These concerns, discussed at length in EDF’s comments in the TCE Docket, are briefly summarized below:  Read More »

Posted in Health policy, Health science, Industry influence, Regulation, TSCA reform / Also tagged , | Comments are closed

EPA’s draft risk evaluation of trichloroethylene contains major scientific flaws that understate the chemical’s risk and demand robust review

By Richard Denison / Published: March 19, 2020

Richard Denison, Ph.D., is a Lead Senior Scientist.

Yesterday Environmental Defense Fund (EDF) filed comments on the Environmental Protection Agency’s draft risk evaluation for the highly toxic chemical trichloroethylene, or TCE.

This draft, readers will recall, is the document that the Trump White House forced EPA to dramatically weaken just prior to public release, as reported in detail by Elizabeth Shogren of Reveal News.

It is also the document that EPA seems intent on subjecting to a rushed peer review next week in a 4-day virtual meeting of the Scientific Advisory Committee on Chemicals (SACC) – despite numerous reasons why, in the midst of the current COVID-19 public health crisis, such a meeting simply will not provide the robust scientific review that this draft warrants.  EDF has urged EPA to postpone the SACC review so that it can be done under circumstances that are conducive to a proper review and fair to SACC members and stakeholders who would like to participate.

EDF submitted comments yesterday in order to meet the very tight deadline EPA set for comments if they are to be considered by the SACC.  Our comments raise numerous scientific deficiencies in EPA’s draft.  These flaws arise from a host of unwarranted and unsupported assumptions and methodological approaches that systematically lead EPA to understate the risks posed by this chemical to pregnant women, infants and children; to workers; to consumers; to the public; and to the environment.

Exposure to TCE is ubiquitous, coming from ambient and indoor air, vapor intrusion from contaminated sites, groundwater and drinking water wells, and food – yet EPA’s draft ignores or downplays each of these exposure sources and pathways.

It is vital that the current public health crisis caused by COVID-19 not be allowed to compromise the quality and integrity of scientific assessments of other critical public health risks we face.

Below I summarize some of the major concerns in EPA’s draft that we address in detail in our comments.  Read More »

Posted in Health policy, Health science, Industry influence, Regulation, TSCA reform / Also tagged , , , | Comments are closed