EDF Health

Selected tag(s): New chemicals

Have we learned anything in the last 4 decades when it comes to allowing chemicals like PCBs onto the market?

Richard Denison, Ph.D.is a Lead Senior Scientist.  Stephanie Schwarz, J.D., is a Legal Fellow.

The Science section of today’s New York Times reports “Killer Whales Face Dire PCBs Threat” – more than four decades after Congress largely banned PCBs (polychlorinated biphenyls).

Concentrations of the chemicals in the blubber of orcas living in waters off the coasts of industrialized countries remain high, and new research indicates the contamination presents an existential threat to the survival of these populations.

Reading the article brought to mind concerns we have raised in recent comments to EPA on proposed rules it has issued for new chemicals under the Toxic Substances Control Act (TSCA).  Read More »

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The TSCA new chemicals mess: A problem of the chemical industry’s own making

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

Nary a day goes by without a complaint being lodged by someone in the chemical industry, or in one of the myriad law firms that represent its interests in Washington, D.C., about the delays in EPA’s approval of new chemicals under the Toxic Substances Control Act (TSCA).

Here’s the irony:  Those delays and the general chaos in the TSCA new chemicals program are entirely of the industry’s own making.   Read More »

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EPA needs to get its SNURs in order under TSCA

Stephanie Schwarz, J.D., is a Legal Fellow.  Richard Denison, Ph.D.is a Lead Senior Scientist.

On Friday EDF submitted comments to EPA on a batch of Significant New Use Rules (SNURs) the Environmental Protection Agency (EPA) published on August 1 pursuant to the Toxic Substances Control Act (TSCA).

The SNURs relate to 145 new chemicals for which EPA had earlier issued consent orders that imposed certain conditions on the substances.  Those consent orders date back to when EPA was still pursuing the development of such orders for many new chemicals it reviewed, and prior to the recent “pivots” it has been making in an effort to avoid issuing orders by circumventing the requirements of the TSCA provisions governing new chemicals.

TSCA anticipates that EPA will promulgate SNURs to follow up on consent orders.  In fact, TSCA section 5(f)(4) requires that when EPA issues an order, EPA must either promulgate a SNUR or provide a statement explaining why EPA is not doing so.  And when EPA does promulgate such a SNUR, the SNUR must “identif[y] as a significant new use any manufacturing, processing, use, distribution in commerce, or disposal of the chemical substance that does not conform to the restrictions imposed by the … order.”

EDF strongly supports EPA’s use of SNURs to follow up on consent orders it issues.  That is because the order only applies to the original company that submitted a premanufacture notice (PMN) to EPA for a new chemical.  A proper SNUR then requires that company or any other company that seeks to deviate from the conditions in the order to first notify EPA, triggering a review of that “significant new use.”

While EDF supports EPA’s issuance of SNURs for these 145 new chemicals, our review of the proposed SNURs raised concerns, prompting us to file “adverse” comments.  Our comments raise two major concerns:

First, EPA has adopted an ad hoc testing policy in the direct final rule that does not comply with the requirements of TSCA, without sufficient explanation, and without providing any notice and opportunity for public comment on the policy. EPA needs to avoid adopting such an ad hoc policy.

Second, as noted above, TSCA (as well as EPA’s longstanding policy) requires SNURs to “conform” to the restrictions in the corresponding orders.  Yet we identified numerous inconsistencies between the orders and SNURs.  EPA must ensure that the final SNURs identify as a significant new use any activity that is not consistent with the restrictions in the corresponding consent orders.

See our comments for details.

NOTE:  EPA had published the SNURs both as a direct final rule and as a proposed rule, noting that if it received any adverse comments, it would withdraw the direct final rule and consider the comments received in the process of finalizing the proposed rule.  We expect EPA will now pursue this course.

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

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 »

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

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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