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

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 commentsRead More »

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EPA’s draft risk evaluation of carbon tetrachloride is riddled with unsupported exclusions and assumptions

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

Next week, the Scientific Advisory Committee on Chemicals (SACC), established under the Toxic Substances Control Act (TSCA) to peer-review EPA’s draft chemical risk evaluations, will meet to review the latest of those drafts, for the likely human carcinogen carbon tetrachloride.

As with other recent draft risk evaluations, EPA has been scheduling the SACC meetings in the middle of rather than following the public comment period.  This means the public has at best a few weeks to digest these huge documents and draft and submit comments in order to have them be part of the record that the SACC is allowed to take into consideration in its peer review.

However, we have learned that EPA is now further constraining the SACC’s schedule, requesting that the panel members come to the peer review meeting with their comments already drafted, and then delivering their final report within 60 days rather than the 90 days previously provided.  These developments further jam both the public and the SACC in their efforts to ensure EPAs work is subject to a robust peer review.

Whatever the reasons for EPA making these changes, EDF decided to expedite our initial comments to seek to ensure they could be considered.  We submitted comments last week, a full week before the February 19 deadline, to ensure the SACC received and had sufficient time to review them in advance of the peer review meeting.

We deemed this critical because of the glaring gaps and flaws in EPA’s draft that lead it yet again to drastically understate the risks of this chemical.  These include the same problems that have plagued the draft risk evaluations for other chemicals, as well as new ones.  Read More »

Posted in EPA, Health Policy, Health Science, Industry Influence, Regulation, TSCA Reform, Worker Safety / Also tagged , | Comments are closed

While harder to discern, another EPA risk evaluation severely understates risk, this time for methylene chloride

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

When EPA released the draft of its risk evaluation for methylene chloride at the end of last month, some were surprised that EPA had identified numerous unreasonable risks presented under a variety of the chemical’s conditions of use.

In an earlier post, EDF provided some context, noting how dangerous the chemical is and raising initial concerns that EPA was once again excluding known uses and exposures, making unsupported assumptions, and applying inappropriate risk benchmarks that were once again leading it to significantly understate the actual risks posed by methylene chloride.

Four weeks later, EDF has confirmed these concerns in spades.  Last night we filed 84 pages of comments on the draft risk evaluation, for consideration by EPA’s Scientific Advisory Committee on Chemicals (SACC), which will meet next week to peer review the draft.

EDF’s deep dive into the draft demonstrates that EPA has employed a host of unwarranted and unsupported assumptions and methodological approaches that lead it to either avoid identifying unreasonable risk when it should have, or to understate the extent and magnitude of the unreasonable risks it did identify.  Below we summarize some of the major concerns, which are addressed in detail in our comments.  Read More »

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Another EPA risk evaluation grossly understates risks, this time of 1-bromopropane

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

On Friday EDF filed detailed comments with the Environmental Protection Agency (EPA) critical of its draft risk evaluation for the carcinogenic solvent, 1-bromopropane (or 1-BP).  As was the case with 1,4-dioxane, EPA has grossly understated the risks from exposure to this chemical, for both cancer and non-cancer health effects.  EPA has also inappropriately dismissed human studies that show neurological effects at 1-BP exposures lower than EPA assumed to be safe.

While the draft risk evaluation did find that some uses of 1-BP present unreasonable risks, even in those cases it understated the extent of the risk – which, if not ameliorated, means that any regulation it subsequently promulgates will be under-protective.

EPA has also abdicated its responsibility under the Toxic Substances Control Act (TSCA) to identify and evaluate the risks the chemical presents to consumers and the general population by excluding from its risk evaluation conditions of use and exposures that are known or reasonably foreseen.  EPA has not met its mandatory duty under TSCA to thoroughly identify and evaluate the risks to vulnerable subpopulations.  EPA has utterly failed to utilize the enhanced authorities Congress granted it in 2016 to ensure that it has or obtains robust information on 1-BP’s uses, hazards and exposures, resulting in serious information and analytic gaps and deficiencies that severely undermine the scientific quality of its risk evaluation.

Below we list major concerns that EDF addressed in our comments (with references to the corresponding section of the comments).  Read More »

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Trump EPA grossly understates workers’ risks to 1,4-dioxane while ignoring those to the general public

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

On Friday, the Environmental Defense Fund (EDF) filed extensive comments on a draft risk evaluation for the likely human carcinogen 1,4-dioxane EPA issued on July 1.  While the formal public comment period runs until August 30, Friday was the deadline EPA set for comments if submitters want them to be considered by the Scientific Advisory Committee on Chemicals (SACC), which will be conducting peer review of the draft risk evaluations for this chemical and another, the flame retardant hexabromocyclododecane (HBCD), next week.

In its draft risk evaluation for 1,4-dioxane, the Environmental Protection Agency (EPA) has grossly understated the risks that workers and the environment face from exposure to the chemical.  EPA has also abdicated its responsibility under the Toxic Substances Control Act (TSCA) to identify and evaluate the risks the chemical presents to consumers and the general population by excluding from its risk evaluation conditions of use and exposures that are known or reasonably foreseen.  EPA has not met its mandatory duty under TSCA to identify and evaluate the risks to vulnerable subpopulations, falsely asserting there is no evidence that certain subpopulations are or may be more susceptible to adverse effects from exposure to the chemical.  EPA has utterly failed to utilize the enhanced authorities Congress granted it in 2016 to ensure that it has or obtains robust information on 1,4-dioxane’s uses, hazards and exposures, resulting in serious information and analytic gaps and deficiencies that severely undermine the scientific quality of its risk evaluation.

EDF’s comments raised numerous major concerns with EPA’s draft.  Among them are the following (see the noted section of the full comments for the details):

  • EPA has ignored evidence that some subpopulations are or may be more susceptible to 1,4-dioxane exposures than the general population (see section 1.A).
  • EPA has distorted OSHA requirements and over-relied on personal protective equipment, ignoring its real-world limitations (see section 1.B).
  • EPA has, without scientific basis, sought to sow doubt on the use of a linear, non-threshold model for 1,4-dioxane’s carcinogenicity, an approach that reflects longstanding agency policy and consensus in the scientific community (see section 1.D).
  • EPA has dismissed the liver tumors observed in female mice in the key oral cancer study it uses to extrapolate dermal cancer risks. Its insufficient rationale ignores the IRIS program’s basis for including these tumors and its determination that they are the most sensitive endpoint, which has been affirmed through peer review.  As a result, cancer risk is significantly understated, a concern also noted by the New Jersey Department of Environmental Protection. (See section 1.E.ii.)
  • EPA has excluded all exposures and risks to consumers (and to workers from at least one use), based on 1,4-dioxane’s presence in such products as a byproduct rather than being intentionally used, a distinction without any basis in science (see section 2.A).
  • EPA has excluded from its risk evaluation all general population exposures to 1,4 dioxane, based on EPA’s unsupported assertion that existing regulatory programs under other statutes EPA administers have addressed or are in the process of addressing potential risks of 1,4-dioxane in all media pathways (see section 2.B).
  • In several instances, EPA’s decisions are inconsistent with Agency guidelines (see section 4.B.i).
  • EPA fails to consider combined exposures to workers from different routes and sources (see section 4.B.ii).
  • EPA has significantly understated the extent of risks to workers it has identified (see section 5).
  • EPA’s “expectation” of compliance with existing laws and standards as a basis for not finding unreasonable risk is unwarranted (see section 6.A).
  • EPA finds no unreasonable risk even when the high-end risk exceeds relevant benchmarks, an approach that is not adequately protective (see section 6.B).
  • EPA’s allowance of a 1 in 10,000 cancer risk for workers is a major and unwarranted deviation from longstanding agency policy and practice to regulate upon finding cancer risks on the order of 1 in 1 million (see section 6.C).
  • EPA’s systematic review to support the risk evaluation is flawed and not reflective of best practices (see section 7).

 

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Round 2 on PV29 reveals even deeper flaws in EPA’s TSCA risk evaluation of the chemical

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

On Friday, Environmental Defense Fund (EDF) submitted a new set of extensive comments to the Environmental Protection Agency (EPA) in response to its March release of additional information on Pigment Violet 29 (PV29), the first chemical to undergo a risk evaluation under the Toxic Substances Control Act (TSCA) following the law’s amendment in 2016.

After EDF and others criticized both the dearth of health and environmental data on PV29, and EPA’s illegal withholding of those data, EPA released some additional information and opened a new comment period in mid-April.  In releasing the new information, EPA was quick to judgment, asserting that “[t]he release of these studies does not change the Agency’s proposed ‘no unreasonable risk’ determination as concluded in the draft risk evaluation published in November.”

EDF’s 100 pages of comments in Round 1 enumerated the myriad ways EPA has failed to demonstrate that PV29 does not present unreasonable risk.  Unfortunately, if anything, Round 2 has only deepened our concerns over the inadequacy of EPA’s risk evaluation.   Read More »

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