EDF Health

EDF submits extensive comments critical of EPA OPPT’s TSCA systematic review document

Ryan O’Connell is a High Meadows Fellow; Jennifer McPartland, Ph.D., is a Senior Scientist.

Last night, Environmental Defense Fund (EDF) submitted critical comments on EPA’s Office of Pollution Prevention and Toxics’ (OPPT) “systematic review” document that OPPT is using to evaluate chemicals’ risks under the Toxic Substances Control Act (TSCA).

Systematic review, a hallmark of the clinical sciences, employs structured approaches to identifying, evaluating, and integrating evidence in a manner that promotes scientific rigor, consistency, transparency, objectivity, and reduction of bias.

Unfortunately, OPPT’s systematic review document deviates dramatically from the best practices in systematic review—practices developed over decades based on empirical evidence and experience in application. OPPT’s approach also significantly diverges from recent recommendations of the National Academy of Sciences (see here and here).

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EDF files extensive comments critical of EPA’s problem formulations for the first 10 chemicals being reviewed under TSCA

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

Last night, Environmental Defense Fund (EDF) submitted more than 200 pages of comments providing a detailed critique of each of the “problem formulations” EPA issued in June for the first 10 chemicals in commerce undergoing risk evaluations under the Toxic Substances Control Act (TSCA).  EDF also delivered 45,000 comments to EPA from members of the public across the country echoing our concerns.

The EPA documents lay out the scope of each of the risk evaluations EPA will conduct.  They are highly flawed and deviate in numerous ways both from what TSCA requires and from use of the best available science.   Read More »

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This EPA has a blatant double standard when it comes to transparency on new chemicals under TSCA

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

I’ve blogged extensively over the past year about the Trump EPA’s moves to dismantle health-protective reviews of new chemicals under the Toxic Substances Control Act (TSCA).  A remarkable feature of those moves is that they have been cast as an effort to improve transparency in the new chemicals review process.

A year ago when Scott Pruitt unveiled his intent to institute “Improvements to New Chemical Safety Reviews,” he cast it as necessary to increase the program’s transparency, using the word no fewer than five times in the press release.  When EPA released its “Points to Consider” guidance to aid companies in expediting getting their new chemicals through the review process, EPA touted it as a move to “improve transparency with the public.”

In fact, it seems that whenever the agency has acted to assist companies under the new chemicals program, it’s all about transparency.  But as for the public?  EPA has actually denied the public access to information it has a right to, and has taken steps to hide information from the public that it used to make available.   Read More »

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PART 3: EPA rams through its reckless review scheme for new chemicals under TSCA, your health be damned

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

Part 1               Part 2               Part 3

I’ve been blogging over the last week about how political appointees at EPA are starting to clear new chemicals to enter commerce based on a new – apparently unwritten and certainly not public – review process that ignores the law and will put the health of the public, workers and the environment at greater risk than even under the weak reviews conducted before Congress’ 2016 overhaul of the Toxic Substances Control Act (TSCA).

The first green light was given to a fragrance chemical intended for use in a wide array of everyday consumer products.  Here is its formal name, a simpler synonym used by its manufacturer, and an identifier called a CAS number:

Late in the review process EPA switched to analogue chemicals to estimate toxicity that are 500-fold less toxic than the analogue identified by the company and EPA's own models.

  • Name: Oxirane, 2-methyl-, polymer with oxirane, bis[2-[(1-oxo-2-propen-1-yl)amino]propyl] ether
  • Synonym: Jeffamine diacrylamide
  • CAS: 1792208-65-1

In this post I want to look more at what is known – and not known – about the chemical’s hazards.  While the chemical is a polymer, it includes “low molecular weight (LMW) components” that are the primary hazard concern.   Read More »

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PART 2: EPA rams through its reckless review scheme for new chemicals under TSCA, your health be damned

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

Part 1               Part 2               Part 3

I blogged last week about how political appointees at EPA are starting to clear new chemicals to enter commerce based on a new – apparently unwritten and certainly not public – review process that ignores the law and will put the health of the public, workers and the environment at greater risk than even under the weak reviews conducted before Congress’ 2016 overhaul of the Toxic Substances Control Act (TSCA).

In this post I’ll start to take a deeper look at the specific fragrance chemical that is the subject of EPA’s first decision under the new scheme:

Oxirane, 2-methyl-, polymer with oxirane, bis[2-[(1-oxo-2-propen-1-yl)amino]propyl] ether
CAS 1792208-65-1

Recall that, even as it declared the chemical safe, EPA noted its “potential for the following human health hazards: irritation, mutagenicity, developmental/ reproductive toxicity, neurotoxicity, and carcinogenicity.”  I’ll explore those hazard concerns more in a subsequent blog post.  Here, let’s consider use of and exposure to the chemical.

Here’s the thing:  None of the parameters of the intended use is binding.  They can be deviated from at any time without consequence.

With its decision, EPA has allowed this chemical to enter the market without any conditions whatsoever placed on how or how much of it can be produced or used or by whom.  This is in fact the aim of the new scheme and, barring another change in course, we can now expect this outcome for the great majority of new chemicals EPA reviews.  It will be achieved by EPA routinely making determinations that the chemicals are “not likely to present an unreasonable risk.”   Read More »

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Paint-lead hazard standard – A reconsideration

Tom Neltner, J.D.is Chemicals Policy Director

After 20 years working on lead poisoning prevention, it has become almost second nature for me to object when someone suggests that children eating paint chips is a significant route of exposure. All too often, the claim implies that the blame rests with parents who are not conscientious enough to clean or maintain their home or to properly care for their children. The implication is demeaning to the parents and distracts from the often – invisible lead dust hazards on floors that pose the greatest risk to children. So when I hear that idea, I quickly respond that dust is the key route of exposure.

However, a discussion with Hannah Chang at Earthjustice over my blog on the Environmental Protection Agency’s (EPA) July 2, 2018 proposed rule helped me realize that I was misguided with regards to defining the hazards of lead-based paints. She is the main attorney for the organizations that convinced a panel of judges in the Ninth Circuit Court of Appeals to order the EPA to update its lead-based paint hazard standard.

Hannah Chang told me I missed the most compelling point when I pointed out in my previous blog that “EPA did not appear to have considered HUD’s 2007 American Healthy Housing Survey, which should provide a solid basis for identifying the relationship between lead in paint and lead in dust.”  She was right; my logic was too focused on dust as the primary source of exposure. Here is my reasoning; it may be helpful to those planning to submit comments to EPA by the August 16 deadline on the proposed rule.

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