EDF Health

EPA’s final risk evaluation of trichloroethylene is scientifically flawed and understates risks to workers, the general public and those most susceptible

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

Today the Trump Environmental Protection Agency (EPA) issued its final risk evaluation for trichloroethylene (TCE).  It largely tracks the agency’s draft document, retaining numerous flaws that severely understate the highly toxic chemical’s risks to workers, the general public and those most susceptible to its health impacts.

Among the evaluation’s most serious deficiencies is the abandonment of a bedrock principle of chemical risk assessment: that risk estimates be based on the most sensitive health effect.  Sadly, the final document retains the unprotective approach the Trump White House forced EPA to adopt, as reported in detail by Elizabeth Shogren of Reveal News.

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 evaluation ignores or downplays each of these exposure sources and pathways.

Below we summarize some of the major concerns in EPA’s evaluation that we addressed in detail in our comments.

One silver lining:  Despite its glaring deficiencies, the risk evaluation did find that the great majority of TCE’s conditions of use present unreasonable risks—even as it grossly understated the extent of those risks.  As a result, EPA must now proceed to regulate those activities, providing the new Administration an opportunity to rectify the serious problems created by the Trump EPA.  Read More »

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Industry’s influence over EPA could get even worse: Chemical advisory board nominees rife with conflicts of interest

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

Today Environmental Defense Fund, Earthjustice, Natural Resources Defense Council, Physicians for Social Responsibility, and Union of Concerned Scientists filed comments on EPA’s list of nominees for appointment to its Science Advisory Committee on Chemicals (SACC).  The SACC conducts peer reviews of chemical risk evaluations EPA conducts under the Toxic Substances Control Act (TSCA).

EPA can rectify this sad state of affairs by excluding these and any other conflicted individuals under consideration from membership on the SACC when EPA adds new members.

Our comments identified 19 nominees that have serious actual or potential conflicts of interest that should disqualify them from being appointed to the SACC.  Unfortunately, their inclusion in EPA’s list of nominees suggests either that EPA has not conducted even the most cursory of conflict-of-interest screenings of these nominees, or that the agency intends to flout conflict-of-interest concerns and skew the balance of its science advisors even further in its drive to prioritize the interests of industry over public health and environmental protection.  The most recent example of this is EPA’s appointments or elevation of members on the agency’s Science Advisory Board earlier this month.

Over the past several months, EPA received a slew of nominations for SACC membership of individuals that are employed either by companies with direct financial interest in specific chemicals or related science policy issues that fall within the remit of the SACC, or by consulting firms hired by those companies or their trade associations to represent their interests before EPA.

As extensively documented in the comments we submitted today, these individuals should not be appointed to the SACC because they trigger one or both of the federal requirements for excluding individuals from membership on federal advisory groups:  having potential or actual conflicts of interest, or creating an appearance of a lack of impartiality.  Read More »

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

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).

EPA’s steps to endanger its ability to collect the fees under TSCA that Congress mandated border on self-sabotage.

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 »

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Under the Trump EPA, no risk to workers is too high to impede a new chemical’s unfettered entry into the market

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

The Trump EPA’s understating of the risks to workers posed by both existing and new chemicals under the Toxic Substances Control Act (TSCA) has been a frequent topic for this blog.  This disturbing, illegal policy continues unabated and, if anything, has accelerated and expanded to outright dismissal of worker health concerns.

The Trump EPA’s blatant shirking of its clear responsibilities under TSCA to identify and mitigate the serious risks that chemicals present to workers – who are on the front lines of chemical exposures – surely constitutes one of its most egregious failings.

In its reviews of new chemicals, EPA now frequently identifies serious risks to workers that exceed its own risk benchmarks, often many times over.  How great are the exceedances EPA finds and ignores?  Our examination of recent cases, described below, reveals exceedances as high as 25,000-fold.  In other words, EPA has found and then dismissed worker exposures to new chemicals at levels as much as 25,000 times higher than it deems acceptable. That is not a typo:  In a very recent case EPA found a dermal risk of reproductive effects to workers that exceeded its own benchmark by a factor of 25,000.

Any reasonable new chemical review that identified excess risk would then impose conditions blocking or conditioning the market entry of these chemicals in a manner sufficient to mitigate the identified risks.  Indeed, that is exactly what TSCA requires EPA to do.

Instead, the Trump EPA over and over again clears these chemicals entirely, ignoring its own risk findings to assert that the chemicals are “not likely to present unreasonable risk.”  This has now been done for hundreds of new chemicals EPA has reviewed in the past two years.

To illustrate what EPA is doing, we examined the 29 new chemicals EPA found “not likely to present unreasonable risk” (“not likely” determinations) since the beginning of June of this year.  Read More »

Also posted in EPA, Health Policy, Regulation, TSCA Reform, Worker Safety / Tagged | Read 2 Responses

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

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).

EPA has once again ignored expert scientific input it received from its own advisors.

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 »

Also posted in EPA, Health Policy, Health Science, Public Health, Regulation, TSCA Reform, Worker Safety / Tagged , | Read 1 Response

Greasing the skids: The Trump EPA is green-lighting dozens of new PFAS under TSCA

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

Under an obscure and opaque – and increasingly used – exemption that EPA provides under the Toxic Substances Control Act (TSCA), EPA has been quietly approving companies’ requests to introduce new poly- and per-fluorinated substances (PFAS) onto the market.  And it seems to be ramping up.

Under this EPA the “low-volume exemption” (LVE) application process is proving to be very smooth sailing for getting new PFAS onto the market.

PFAS is a class of chemicals that are showing up as environmental contaminants all over the country.  They are linked to large and growing list of adverse effects on human health.  These concerns have led to increased scrutiny about EPA’s actions to allow new PFAS to enter commerce.  EDF and others have raised concerns about a number of premanufacture notices (PMNs) companies have filed seeking approval to introduce new PFAS into commerce (see here and here); the PMN process is the standard way in which companies are to notify EPA of their intent to start manufacturing a new chemical.

But EPA has created other pathways to quickly get a chemical on the market, whereby companies can apply for an exemption from the PMN process.  As documented in this post, we have identified a whole lot of PFAS coming into EPA’s new chemicals program through exemptions, and most of them are getting quickly approved.  Worse yet, this side process is highly insulated from public scrutiny.  Read More »

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