EDF Health

EPA’s approach to 1,4-dioxane falls short of protecting fenceline communities

Clear water pouring from a pitcher into a glass.What’s New?

Recently, the Environmental Protection Agency (EPA) embarked on a critical Toxic Substances Control Act (TSCA) supplemental risk evaluation of 1,4-dioxane [PDF, 8.7MB]– a highly carcinogenic chemical that contaminates drinking water supplies across the country and is present in products, such as cleaning supplies and personal care products.

This draft supplemental risk evaluation represents a significant step forward because it addresses many of the omissions from the original 1,4-dioxane risk evaluation. Unfortunately, as we noted in our comments to EPA, a closer examination reveals several shortcomings in how EPA addresses risks to fenceline communities—people living, playing, and working near industrial facilities that release toxic chemicals into the air and water. Read More »

Posted in Chemical exposure, Chemical regulation, Cumulative impact, Cumulative risk assessment, TSCA / Tagged , , | Authors: , / Read 1 Response

Haste makes waste: The Trump EPA’s 1,4-dioxane supplement may be its shoddiest TSCA work yet

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

Yesterday EDF submitted comments on a supplement to EPA’s 1,4-dioxane risk evaluation under the Toxic Substances Control Act (TSCA), which the agency issued a scant three weeks ago.

This solvent is a likely human carcinogen that contaminates drinking water nationwide and is present in millions of consumer products.[pullquote]What EPA left out of its analysis swallows what it included.[/pullquote]

The supplement expands the scope of EPA’s ongoing risk evaluation of 1,4-dioxane.  It now includes certain water exposures and certain exposures of consumers to products in which the chemical is present as a contaminant (more technically, a “byproduct”).

EPA rushed the public comment period, providing only 20 days and refusing requests from at least 14 organizations for an extension.  The agency also cut out another vital step in the process – peer review –in violation of its own rules for how risk evaluations are to be conducted.

But that wasn’t the only thing EPA rushed.  The Supplement itself was an 11th-hour affair, done mainly to appease a hypocritical demand from the formulated chemical products industry.

The haste with which it was assembled badly shows.  The additional exposures EPA examined are so narrowly constructed as to omit major, and potentially the largest, sources of exposure and risk people face from the presence of 1,4-dioxane in water and products.

And what EPA left out of its analysis swallows what it included.  Read More »

Posted in Health policy, Health science, Regulation, TSCA reform, Worker safety / Tagged , , | Comments are closed

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.[pullquote]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.[/pullquote]

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 Health policy, Regulation, TSCA reform / 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 »

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