EDF Health

ACC and 1,4-dioxane: Its “late hit” tactics are just more of the same

By Richard Denison / Published: July 30, 2019

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

The American Chemistry Council (ACC) was up to all of its old tricks yesterday at the first day of the Environmental Protection Agency’s (EPA) panel that is conducting a peer review of EPA’s draft risk evaluation of the likely human carcinogen, 1,4-dioxane.  We blogged last week about the extensive comments EDF submitted to the peer review panel on this flawed assessment.

Yesterday ACC rolled out the same game plan the industry has used for years to slow down, derail, or obfuscate chemical assessments conducted by EPA’s Information Risk Information System (IRIS), and more recently, the last Administration’s effort, now aborted by the Trump EPA, to restrict high-risk uses of the highly toxic chemical trichloroethylene (TCE).

In the public comment period yesterday afternoon, ACC Senior Director Steve Risotto revealed to the peer review panel that ACC has sponsored a new “study” that he says – lo and behold – supports all of the positions downplaying 1,4-dioxane’s carcinogenicity that ACC has espoused for years.

The aim of this is to get EPA to set the level of exposure to 1,4-dioxane that would be deemed acceptable well above the level EPA would set if 1,4-dioxane is assumed to pose a risk at any level of exposure.  (Briefly, if EPA determines that 1,4-dioxane does not have a safe threshold, it must extrapolate exposures to zero to set acceptable risk levels in its risk evaluation. If, as ACC wants, EPA finds that there is a threshold below which exposure poses no risk, then the Agency’s risk calculations will be much less conservative.)

So, where is ACC’s new study?  Well, it’s not public.  It hasn’t been provided to the peer review panel.  It hasn’t been published by ACC.  There’s no indication it’s been peer-reviewed.  Read More »

Posted in Health policy, Health science, Industry influence, Worker safety / Tagged , , , | Read 2 Responses

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

By Richard Denison / Published: July 22, 2019

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).

 

Posted in EPA, Health policy, TSCA reform / Tagged , , | Comments are closed

A tale of two public comment extension requests: How they fared under the Trump EPA

By Richard Denison / Published: December 10, 2020

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

In recent weeks EPA has issued for public comment significant modifications to its draft risk evaluations under the Toxic Substances Control Act for two chemicals:  Pigment Violet 29 (PV29) and 1,4-dioxane.  Because EPA initially provided relatively brief comment periods on the modifications, both were subject to requests for extensions of the comment period.

The table below tells the story of how these two requests fared under the Trump EPA.  Read More »

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

Two chemicals that remind us why we should exercise caution with the oil industry’s wastewater

By EDF Blogs / Published: October 14, 2020

Cloelle Danforth, Scientist. 

This post originally appeared on the EDF Energy Exchange blog.

Over the past few years, we’ve written a lot about the wastewater generated from oil and gas production — specifically, how little is known about what’s in it and the potential risks of exposure.

But as states try to set standards for how to safely treat and dispose of this waste, there are two chemicals in particular that deserve to be among the regulatory priorities.

The first is a class of synthetic chemicals known as per- and polyfluoroalkyl substances — PFAS for short. Members of this class, often referred to as “forever chemicals” because they are highly persistent in the environment, are known to cause adverse health impacts in humans. This can include a range of symptoms, including damage to the immune system, low infant birth weights and cancer.

The second chemical is 1,4-dioxane. Short-term exposure to this carcinogen can cause immediate health impacts, like eye, nose and throat irritation and impaired lung function. Prolonged exposure can lead to liver and kidney damage, as well as cancer.

Read More »

Posted in PFAS, Public health / Tagged | Comments are closed

The Trump EPA reaches a shocking new low in failing to protect workers under TSCA

By Richard Denison / Published: January 30, 2020

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

Just when I thought EPA putting workers’ health at risk by shirking its responsibilities under the Toxic Substances Control Act (TSCA) couldn’t get any worse, it has.[pullquote]The notion that worker protection can or should be relegated to the equivalent of a shock avoidance experiment is deeply offensive if not outright immoral.[/pullquote]

In its risk evaluations of existing chemicals (see our comments here and here) and its reviews of  new chemicals (see our comments here) entering the market, EPA has found ways bordering on the diabolical to avoid identifying or to understate the extent and nature of risks to workers making or using those chemicals.  The agency:

  • Simply assumes without evidence that workers will wear fully effective personal protective equipment (respirators and gloves).
  • Distorts OSHA regulations and claims they apply where they don’t.
  • Treats voluntary instruments that impose no binding requirements as if they were mandatory.
  • Assumes that if the average worker’s exposure does not exceed its acceptable risk level, then it doesn’t matter if there are exceedances for those workers most highly exposed.
  • Has unquestioningly accepted and used manufacturers’ undocumented data on workplace exposure levels even when data from more authoritative sources show far higher exposures.
  • And has adopted a cancer risk benchmark that is as much as two orders of magnitude more permissive of risk than warranted under TSCA.

All this despite TSCA’s express identification of workers as a “potentially exposed or susceptible subpopulation” that warrants special protection.

As appalling as all of this is, it just got worse. Read More »

Posted in Health policy, Industry influence, TSCA reform / 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

By Richard Denison / Published: December 16, 2019

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 »

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