EDF Health

Selected tag(s): dioxane

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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Hey Trump EPA, your extreme bias in favor of the chemical industry is showing again

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

[See UPDATE in brackets below.]

The Trump Environmental Protection Agency (EPA) has just released drafts of two more chemical risk evaluations it has conducted under the Toxic Substances Control Act (TSCA).  One is for the likely human carcinogen and neurotoxicant 1,4-dioxane, which contaminates public water systems serving more than 7 million Americans in 27 states at levels exceeding the level EPA has traditionally (until now) aimed to meet for general population exposures.  The other is for the flame retardant hexabromocyclododecane, or HBCD, a persistent, bioaccumulative and toxic (PBT) chemical – toxic to human development and highly acutely and chronically toxic to aquatic organisms – that has been banned or heavily restricted in most of the rest of the developed world.

As might have been expected of the Trump EPA, the draft risk evaluations wholly exonerate HBCD and largely do so for 1,4-dioxane.  Especially in the latter case, EPA achieves its improbable finding through quite a sleight of hand:  EPA simply excludes most exposures to the chemical from the scope of its risk evaluation.

Trump EPA political appointees have repeatedly argued that the agency needs to be doing a better job at “risk communication.”  I guess we now know what that means.

Once finalized, EPA’s determinations that these chemicals “do not present an unreasonable risk” will mean it has no obligation or authority to impose any restrictions on their manufacture, processing, distribution, use, recycling or disposal.

We will be looking at these documents more closely in the very limited time EPA has provided for the public to review and comment on them.  But I want to draw attention right off the bat to a telling aspect of how the Trump EPA has presented its risk determination for 1,4-dioxane.

Read More »

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How Pruitt’s EPA finds a dangerous chemical is safe: Ignore most exposures to it

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

The 2016 Lautenberg Act amendments to the Toxic Substances Control Act (TSCA) expanded and enhanced Congress’ vision for how the Environmental Protection Agency (EPA) should evaluate and mitigate the potential risks of chemicals.  

The industry’s interest is simple:  The fewer exposures to a chemical EPA looks at, the more likely it is to find those it does look at safe.

The original TSCA was intended to encompass the full lifecycles of chemicals, from manufacturing to use to disposal, authorizing EPA to regulate any of those activities.  It gave EPA co-authority with the Occupational Safety and Health Administration (OSHA) over chemical exposures in workplaces and with the Consumer Product Safety Commission (CPSC) over chemical exposures from consumer products.  And it provided a wide array of means by which EPA could regulate chemicals to address unreasonable risks it identified, ranging from requiring warnings to limiting the amount of a chemical that could be used in a certain way to an outright ban on all uses of a chemical.  Unfortunately, the original law also contained fatal flaws that rendered this vision unachievable in practice.

Congress finally stepped in to address those flaws through the 2016 amendments.  But the amendments also did something else:  they added several elements that further expanded what EPA was to include in addressing chemical risks.  Congress explicitly required that EPA identify and protect against risks not only to the general population, but to vulnerable subpopulations at potentially greater risk due to heightened exposure or greater susceptibility to a given exposure.  It mandated that EPA prioritize chemicals, and evaluate and regulate their risks, under the chemicals’ “conditions of use,” a term Congress defined broadly to encompass not only the full chemical lifecycle, but also all of the “intended, known, or reasonably foreseen” activities that occur at each lifecycle stage.

And Congress directed EPA to determine whether a chemical’s risks were unreasonable and warranted regulation based solely on its effects on human health or the environment, without regard to costs or other non-risk factors.  Only after EPA completed its science-based evaluation of risks and determined regulation was warranted, was EPA to consider costs and other non-risk factors, and then only in deciding how best to eliminate the unreasonable risk.  Congress also retained the provision of TSCA that relegates to the very last step any consideration of whether other authorities – be they EPA’s or other agencies’ – could be used instead of TSCA.

Each of the new elements has a strong basis in the large body of science that has emerged over the decades since TSCA first passed in 1976 that elucidates how we are exposed to chemicals, how they can affect our basic biology, and how variability in the human population mediates the potential impacts.

Any objective reading of the new law would lead one to expect, therefore, that the breadth and depth of EPA’s chemical risk evaluations would grow considerably.  And for most of the first year after passage of the new law, that was where things appeared to be heading.

Enter the Pruitt EPA.   Read More »

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