EDF Health

Selected tag(s): risk evaluation

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

More words minced this time, but EPA’s science advisors raise serious concerns with its draft risk evaluation of 1-bromopropane

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

The peer review report by the Scientific Advisory Committee on Chemicals (SACC) on EPA’s draft risk evaluation of 1-bromopropane (1-BP) has been released.  This carcinogenic solvent is one of the first 10 chemicals undergoing risk evaluation under the amended Toxic Substances Control Act (TSCA), and the new SACC report covers the fourth of EPA’s draft risk evaluations (DREs) to be peer-reviewed.  We’ve blogged earlier about the SACC’s reports on EPA’s draft risk evaluations for 1,4-dioxane and HBCD and Pigment Violet 29.

At first blush, the new report reads less harshly than the last one, and the SACC notes clear improvements in the content and organization of the 1-BP draft over earlier ones.  But even the Executive Summary raises quite scathing criticisms that go to the heart of whether EPA has developed sufficient data to support its risk determinations for this chemical.  Here is a telling excerpt (p. 17, emphases added):

Overall, the Committee concurred that even though data provided in the DRE underestimated risk, these data did support the finding of unreasonable risk to consumers and occupational conditions, including occupational non-users. Conversely, inadequate data were presented for a robust risk characterization for the environmental assessment, and the information provided did not support the conclusion of “no unreasonable risk to the environment.”

These conclusions mirror those drawn by EDF in the comments we submitted to EPA on the 1-BP DRE.

Themes sounded by the SACC in its earlier peer reviews came up again here.  Read More »

Posted in EPA, Health Policy, Health Science, TSCA Reform / 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 »

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

The Court’s TSCA decision is a much bigger win for public health than first meets the eye

Robert Stockman is a Senior Attorney.  Richard Denison, Ph.D.is a Lead Senior Scientist.

Yesterday the Ninth Circuit Court of Appeals ruled in a landmark case involving a challenge to EPA’s so-called “framework rules” that lay out how it will implement core provisions of the Toxic Substances Control Act (TSCA) as amended in 2016 by the Lautenberg Act.

An array of health, labor and environmental groups, EDF among them, (see full list of petitioners below) had challenged EPA’s Risk Evaluation Rule and Prioritization Rule on the grounds that they deviated in significant ways from amended TSCA’s requirements.

We clearly won on a major issue in the litigation, but a careful reading of the Court’s opinion shows that we effectively won on another key issue even though the court ruled against us.  And several of the court’s other rulings either suggest it agrees with, or outright affirms, our view of TSCA’s core requirements.  On those remaining issues, the Court specifically did not foreclose any of our arguments, making it clear that they could be presented in legal challenges we bring to EPA decisions in risk evaluations and determinations for individual chemicals.

Read on for our analysis.  Read More »

Posted in EPA, Health Policy, TSCA Reform / Also tagged | Comments are closed

EPA’s scientific peer reviewers don’t mince words in blasting its 1,4-dioxane and HBCD risk evaluations

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

Late Friday is getting to be a popular time for the toxics office at the Environmental Protection Agency (EPA) to publicly release the peer review reports of its Scientific Advisory Committee on Chemicals (SACC).

As EPA did for the Committee’s peer review report on the agency’s first draft risk evaluation under the Toxic Substances Control Act (TSCA), EPA quietly posted sometime quite late last Friday the SACC’s reports on the next two chemicals:  the likely carcinogenic solvent 1,4-dioxane and the developmentally toxic flame retardant hexabromocyclododecane (HBCD).

Even a quick read of the Executive Summaries of those reports amply illustrates why EPA sought to bury them.  I’ll focus here on 1,4-dioxane.

The SACC did note that the content and organization of this draft risk evaluation was “much improved” over the first one for Pigment Violet 29.  So much for the good news; things went downhill from there for EPA.  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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