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Selected tag(s): dioxane

Passing the buck: The Trump EPA’s mind-boggling efforts to ignore the risks of 1,4-dioxane in drinking water

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

Readers of this blog will recall the major concerns EDF, EPA’s science advisors, and many others have raised about the Trump EPA’s systematic exclusion from its risk evaluations of all human exposures to chemicals released to air, water and land.  EPA has taken this illegal, unscientific and un-health protective approach across the board in the risk evaluations it has issued to date in draft or final form under the Toxic Substances Control Act (TSCA).

EDF first flagged the emergence of this fatally flawed approach over two years ago, and again when it was applied to the likely human carcinogen 1,4-dioxane, one of the first 10 chemicals undergoing TSCA risk evaluations.  Since then the Trump EPA has doubled down, repeatedly defying its own science advisors who have called out this deficiency in virtually all of their peer reviews of EPA’s draft risk evaluations.  EPA is clearly refusing to budge, issuing two final risk evaluations for methylene chloride and 1-bromopropane that seek to codify the approach.

EPA’s Office of Water is deferring any decision on whether to regulate 1,4-dioxane in drinking water, pending completion of a risk evaluation that expressly excludes that exposure.  That exclusion is in turn based on the TSCA office’s claim that the Office of Water already has it covered.

The asserted basis for ignoring tens of millions of pounds of these chemicals released annually is EPA’s claim that the releases are adequately managed under other laws the agency administers.  To bolster that claim, EPA also asserts that it has closely consulted with the EPA offices that administer those other laws to ensure this is the case.  Let’s take a closer look at the nature – and apparent effects – of that consultation in one setting:  1,4-dioxane in drinking water, which falls under the authority of the Safe Drinking Water Act (SDWA) administered by EPA’s Office of Water.  Read More »

Posted in EPA, Health Policy, Regulation, TSCA Reform / Also tagged | Read 1 Response

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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EPA’s latest move to deflect criticism of its TSCA risk evaluations: Muzzle its science advisors

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

Readers of this blog know that Environmental Defense Fund (EDF) has voiced strong opposition to a number of decisions made by the Environmental Protection Agency (EPA) that aim to limit the risks it finds when evaluating the safety of chemicals under the Toxic Substances Control Act (TSCA).

These decisions include:

  • excluding from its analysis known human and environmental exposures to a chemical, based on unwarranted assumptions that those exposures are adequately managed by other statutes;
  • claiming without support that workers are protected by assuming universal and universally effective use of personal protective equipment throughout chemical supply chains and the adequacy of OSHA regulations that either don’t apply or are decades out of date;
  • arbitrarily loosening EPA’s longstanding risk standards governing when cancer incidences are deemed unacceptably high; and
  • choosing not to exercise its enhanced authorities under TSCA to require submission of robust information on chemicals’ hazard and exposures, resorting instead to questionable assumptions and relying on voluntarily submitted industry data that are unrepresentative or of poor or indeterminate quality.

Through these decisions, EPA increases the likelihood that it will either not find unreasonable risk and thereby avoid regulating the chemical, or if that can’t be accomplished, find risks that are low enough that it can impose few restrictions, thereby burdening industry as little as possible.

In response to each of these decisions, EPA has received dozens of highly critical comments on its draft risk evaluations from state and local governments, labor and health groups, environmental NGOs and members of the scientific community.  And in the first several peer reviews conducted by its Scientific Advisory Committee on Chemicals (SACC), many of the scientists voiced quite similar concerns during the committee’s public meetings (as of yet, final peer review reports have not been issued).

Rather than address the problems, EPA has adopted a new tactic to stifle the criticism, one that is quite chilling (literally and figuratively):  It is telling the SACC that these issues are off-limits to the peer reviewers because they represent policy decisions that are beyond the charge given to the SACC.  This is beyond the pale, for several reasons.  Read More »

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

1,4-dioxane: The case of the disappearing tumors

Rachel Shaffer is a consultant.  Richard Denison, Ph.D.is a Lead Senior Scientist.

As we highlighted in a previous post, EDF filed extensive comments on EPA’s draft risk evaluation for 1,4-dioxane. Among the many concerns we raised was a decision by the Trump EPA to completely dismiss female mouse liver cancer data used by EPA’s Integrated Risk Information System (IRIS) program as key inputs to its cancer risk modeling conducted in 2013. The Agency appears to be trying every trick in the trade – such as excluding most exposure sources and routes – in its effort to conclude that the chemical presents few or no risks to human health or the environment. Read on for more on this latest one. Read More »

Posted in EPA, Health Policy, Health Science, Industry Influence, Regulation / Tagged | Comments are closed

Should EPA grant industry’s hypocritical request to now address 1,4-dioxane’s risks as a byproduct, it must meet a number of conditions

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

Environmental Defense Fund (EDF) submitted extensive comments last week to the Environmental Protection Agency (EPA) that raise numerous serious concerns with EPA’s draft risk evaluation for the likely human carcinogen 1,4-dioxane.  EDF’s comments are available here.

I want to use this post to highlight one of the many issues:  For years, the industry has urged EPA not to include 1,4-dioxane’s presence as a byproduct in various formulated products within the scope of its risk evaluation for the chemical; see comments specific to 1,4-dioxane from the American Cleaning Institute, Procter & Gamble, and the Household & Commercial Products Association; and more general comments urging exclusions for byproducts and “trace levels” from the American Chemistry Council and the Consumer Specialty Products Association Comment.

Not surprisingly, the Trump EPA’s draft risk evaluation for 1,4-dioxane did just that, a major problem EDF objected to on legal and scientific grounds.

Then in late July, the industry abruptly reversed itself.  A comment letter submitted to EPA by the American Cleaning Institute and the Grocery Manufacturers Association says the industry has changed its mind and is now calling on EPA to include 1,4-dioxane’s presence as a byproduct as a condition of use in its risk evaluation.

Why the shift?  At this late hour it has dawned on the industry groups that any final action by the agency on the chemical that excludes 1,4-dioxane’s presence as a byproduct as a condition of use in its risk evaluation will not preempt states from acting to regulate this condition of use.

The industry’s hypocrisy aside, if EPA decides to grant this industry request, which has arrived long after EPA initiated the risk evaluation process, EPA should do so only subject to conditions that are critical to meet if its decision and risk evaluation are to maintain any semblance of credibility:

  • EPA needs to use its mandatory information authorities to require the submission and development of relevant information on the presence of 1,4-dioxane as a byproduct in industrial, commercial and consumer materials and products, as input into a revised draft risk evaluation.
  • EPA must promptly make all such information it receives public, subject only to redactions of information claimed confidential by the submitters that EPA determines meet all applicable requirements of TSCA section 14. It should be noted that much of the relevant information will constitute health and safety information that is not eligible for protection under section 14 and must be made public.
  • EPA needs to carefully and thoroughly develop and fully integrate an analysis of the potential exposures and risks arising from the presence of 1,4-dioxane as a byproduct into all aspects of its risk evaluation, given that inclusion of the presence of 1,4-dioxane as a byproduct will affect all of the exposure and risk estimates EPA has examined in the current draft risk evaluation.
  • EPA must publish a revised draft risk evaluation for public comment, providing the public with ample time to review the new draft and develop meaningful comments.
  • EPA must subject its revised draft risk evaluation to full peer review by the Scientific Advisory Committee on Chemicals (SACC), providing the committee with ample time to review the new draft and develop meaningful comments.

Any credible evaluation of the contribution to 1,4-dioxane’s overall health and environmental risks due to its presence as a byproduct must be based on complete, reliable information that is publicly accessible, and must reflect input from both the public and expert peer reviewers.  For EPA to do anything less will simply cast yet more doubt on its trustworthiness and independence from industry interests.

 

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

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

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 »

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