EDF Health

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

By / Published: August 17, 2018

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

By / Published: August 17, 2018

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

By / Published: August 15, 2018

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

By / Published: August 9, 2018

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:[pullquote]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.[/pullquote]

  • 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

By / Published: August 6, 2018

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

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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PART 1: EPA rams through its reckless review scheme for new chemicals under TSCA, your health be damned

By / Published: August 1, 2018

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

Part 1               Part 2               Part 3

Overruling the recommendations of its own longtime professional staff, political appointees at EPA have begun green-lighting new chemicals to enter commerce using an approach that shows contempt for the letter and intent of the 2016 reforms to the Toxic Substances Control Act (TSCA).

EDF blogged recently about the new approach and how it drastically deviates from what the law requires.[pullquote]Now any company will be free to produce, import and use the chemical in any manner it chooses and without any obligation to inform EPA of its activities.[/pullquote]

Today EPA posted the first decision made under the new scheme:  It issued a “not likely to present an unreasonable risk” determination for a chemical that, according to its manufacturer International Flavors and Fragrances Inc., is to be imported for use “to reduce malodors.  It will be sold to industrial and commercial customers for their incorporation into industrial, commercial, and household consumer products such as floor cleaners, cat litters, fabric refresher sprays, Etc.”

The “not likely” finding means that International Flavors and Fragrances Inc. can commence manufacture and sale of the chemical, and will not be subject to any conditions or limits.  Once manufacture starts, the chemical will be placed on the TSCA Inventory, and that company or any other will be free to produce, import and use the chemical in any manner it chooses and without any obligation to inform EPA of its activities.   Read More »

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