EDF Health

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

By / Published: September 3, 2019

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.

 

Also posted in Health policy, Health science, Regulation / Tagged , , | Comments are closed

Trump EPA caves again to industry demands on new chemicals, and workers pay the price

By / Published: August 8, 2019

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

Isocyanates are nasty chemicals, including when they are left over as residuals after manufacturing other chemicals.  Here are the kinds of risks they pose, according to the National Institute for Occupational Safety and Health (NIOSH):

Isocyanates are powerful irritants to the mucous membranes of the eyes and gastrointestinal and respiratory tracts.  Direct skin contact can also cause marked inflammation.  Isocyanates can also sensitize workers, making them subject to severe asthma attacks if they are exposed again. There is evidence that both respiratory and dermal exposures can lead to sensitization.  Death from severe asthma in some sensitized subjects has been reported.

In prior reviews of new chemicals under the Toxic Substances Control Act, EPA has repeatedly indicated that “[i]socyanate exposure has been identified as the leading attributable cause of work-related asthma, and prevalence in the exposed workforce has been estimated at 1-20 percent.”

Both NIOSH and EPA have raised even greater concern over activities involving spray application of chemicals containing isocyanates.  In 2006, NIOSH issued a rare alert calling for workers to undergo medical surveillance and wear high-efficiency respirators and gloves when engaged in such activities.

Even in the recent past, when reviewing new chemicals containing isocyanate residuals, EPA has typically (1) issued a consent order subjecting the company submitting the chemical for review to multiple conditions in order to limit workplace inhalation exposures to the residuals, and (2) followed up with a Significant New Use Rule (SNUR) that extends those conditions to other companies, requiring them to notify EPA prior to engaging in any activity that exceeds those workplace limits.  And the only case since TSCA was amended in 2016 where EPA found a new chemical “presents an unreasonable risk” – as opposed to the more common, lower-bar finding that it “may present an unreasonable risk” – involved residual isocyanates present after manufacture of two new chemicals.

In such cases EPA has imposed some combination of three types of conditions on manufacture of such chemicals:  prohibitions on activities that could generate inhalable forms of the chemical and result in inhalation exposures; strict requirements for the use of high-efficiency respirators and gloves; and a strict limit on the amount of isocyanate residuals allowed to be present in the new chemical, typically in the range of 0.1% to 0.2%.

So it is quite disturbing to see how EPA has dealt with the most recent such new chemical for which EPA has issued its final decision – which requires that companies employ NONE of these protections.  Read More »

Also posted in Health policy, Regulation, TSCA reform, Worker safety / Tagged , , , | Comments are closed

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

By / 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 »

Also posted in Health policy, Health science, Worker safety / Tagged , , , | Read 2 Responses

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

By / Published: July 2, 2019

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.[pullquote]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.[/pullquote]

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 »

Also posted in Health policy, Regulation, TSCA reform / Tagged , , , | Comments are closed

New Report: Toxic Consequences – Trump’s Attacks on Chemical Safety Put Our Health at Risk

By Sam Lovell / Published: June 17, 2019

Sam Lovell, Project Manager.

Today, EDF released a report detailing the major threats to public health and future generations from the Trump Environmental Protection Agency’s (EPA) attacks on the 2016 chemical safety law. Just three years after Congress passed bipartisan legislation, the Lautenberg Act, to overhaul the Toxic Substances Control Act (TSCA), implementation of the law has gone dangerously off the rails – putting public health at risk.

“At almost every turn, the Trump administration has failed to live up to the letter and spirit of the historic bipartisan reform of TSCA that Congress passed in 2016. Toxic chemicals can cause cancers and other life-threatening illness. The American people expect the Environmental Protection Agency to live up to its mission and to protect them from these threats.  At the three-year anniversary of our overwhelmingly bipartisan reform of TSCA, EPA continues to ignore expert scientific staff and walk back protections for workers and consumers. ” said Senator Tom Udall.  “EPA leaders – starting with Andrew Wheeler – must change course, commit themselves to protecting the public, and carry out the Lautenberg Act as Congress wrote it.”

The report notes that recent history holds countless stark examples of what can happen when chemical risks are not adequately addressed. We risk making similar mistakes unless the current EPA fundamentally changes course in its implementation of the law. The Trump Administration is allowing new chemicals onto the market with little or no health information and only cursory safety reviews; ignoring real-world exposures when evaluating chemicals already in use today; blocking needed restrictions on dangerous uses of toxic chemicals; and denying the public access to health information on chemicals. These are not merely process problems: the consequences of the Trump EPA’s actions will be felt by our children and subsequent generations.

Read More »

Also posted in Health policy, Public health / Tagged , | Comments are closed

The Trump EPA is setting back chemicals policies by decades

By / Published: June 13, 2019

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


Tacoma, WA 1972

As we approach the third anniversary of the historic passage of bipartisan legislation to overhaul our nation’s broken chemical safety system, we’re hearing that political appointees at the agency are gearing up to celebrate their “successes” in implementing the law.[pullquote]Even more disturbing than its individual actions are the methodical steps the Trump EPA is taking to dismantle decades of progress in our country’s chemicals policies.[/pullquote]

While the chemical industry may well have things to celebrate, it’s simply not the case for the rest of us:  Comments from former top EPA officials, members of Congress, state and local governments, labor groups, firefighters, water utilities, public health groups, and a broad range of environmental groups make crystal clear that there’s nothing warranting celebration.  EPA’s actions are threatening the health of American families.

But as I reflect on how implementation of the Toxic Substances Control Act (TSCA) has gone off the rails under the Trump EPA, even more disturbing than its individual actions are the methodical steps it is taking to dismantle decades of progress in our country’s chemicals policies.  In this post, I’ll briefly highlight five such policies and how this EPA is undermining them:

  • Pollution prevention
  • Inherent safety and hazard reduction
  • Protection of vulnerable subpopulations and environmental justice
  • Holistic, real-world risk assessment
  • Public right to know

Read More »

Also posted in Health policy, Regulation, TSCA reform, Worker safety / Tagged , , , , | Read 2 Responses