EDF Health

Selected tag(s): New chemicals

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 »

Posted in Health policy, Industry influence, TSCA reform / Also tagged , , , | Read 2 Responses

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 »

Posted in Health policy, Regulation, TSCA reform / Also tagged , , | Comments are closed

Six Senators key to TSCA reform question EPA’s new chemical reviews in letter to Wheeler

By / Published: July 24, 2018

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

In a letter sent today to the Environmental Protection Agency’s Acting Administrator Andrew Wheeler, six Senators who were instrumental to achieving the 2016 Lautenberg Act’s reforms to the Toxic Substances Control Act (TSCA) raised “serious concern” about further weakening changes EPA is poised to make in its review of new chemicals.

EDF had blogged about the changes last week.

The Senators’ letter includes a “request that your staff brief our offices about the planned changes prior to moving to implement them.”

The letter was signed by Senators Tom Udall, Tom Carper, Sheldon Whitehouse, Ed Markey, Cory Booker, and Jeff Merkley.

The Senators noted that “While in the months after passage EPA began to implement these provisions in a manner we believe was faithful to both the letter and spirit of the law, beginning in the middle of last year EPA signaled it would change course by narrowing the scope of its new chemical reviews and the requisite risk determinations in a manner that deviated from the statute.”

EDF has for many months raised concerns over the steady effort by Trump Administration political appointees at EPA to undermine the provisions of the Lautenberg Act intended to significantly enhance EPA reviews of new chemicals prior to allowing them onto the market.  The latest moves deviate even further from the requirements of the new law and threaten public and worker health.

EDF hopes that today’s letter will help convince EPA to return to a lawful, health-protective approach to conducting reviews of new chemicals under TSCA.

Posted in Health policy, TSCA reform / Also tagged , | Comments are closed

Trump’s EPA pivots yet again on reviews of new chemicals under TSCA, leaving public and worker health in the dust

By / Published: July 17, 2018

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

EDF has learned from multiple sources that political appointees at the Environmental Protection Agency (EPA) are on the verge of taking yet another huge lurch away from what the 2016 reforms to the Toxic Substances Control Act (TSCA) require when EPA reviews the safety of new chemicals prior to their market entry.  A reporter at Bloomberg Environment has heard the same thing, and published an article this morning on some of the changes.

The Trump EPA apparently intends to abandon its November 2017 “New Chemicals Decision-Making Framework,” which already strayed far from the law’s requirements.  That approach would have allowed EPA staff to limit their review of a new chemical only to the intended uses identified by its manufacturer, despite the law’s clear mandate that EPA consider known or reasonably foreseen, as well as intended, uses when conducting its review.  Under the framework, where EPA had concerns about reasonably foreseen but not intended uses – rather than issue an order as required by the law – EPA would take two other steps:  make a “not likely to present an unreasonable risk” determination for the chemical, clearing it to enter commerce; and issue a Significant New Use Rule (SNUR), which could trigger a separate, future review on any subsequently intended use, wholly divorced from the initial review.

Initially, EPA staff indicated the “not likely” finding would be made only once a final SNUR had been promulgated.  That then slipped to have issuance of the finding coincide with the proposal of the SNUR.  That then slipped further to allow the finding to be issued based on EPA’s mere intent to develop a SNUR.

Now, however, the Trump EPA plans to decouple completely its ability to issue a “not likely” finding from any dependency at all on promulgation of a SNUR.  How then, you might well ask, would EPA consider reasonably foreseen uses of a new chemical?  The short answer is, it won’t.   Read More »

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Testing analysis for TSCA new chemicals embraced by EPA’s Beck has serious omissions

By / Published: May 11, 2018

Richard Denison, Ph.D., is a Lead Senior Scientist.  Ryan O’Connell, EDF High Meadows Fellow, and Stephanie Schwarz, EDF Legal Fellow, assisted in the research informing this post.

[UPDATED 5-15-18:  See clarifications and a correction added in brackets below.]

As noted in a previous blog post, EDF recently filed a request for an extension of the public comment period on EPA’s draft Alternative Testing Methods Strategic Plan under the Toxic Substances Control Act (TSCA).  This was due to the lack of public access to documents that Dr. Nancy Beck had prominently alluded to, without identifying, at EPA’s April 10, 2018, public meeting on the draft plan.  EDF requested a 30-day extension starting once the documents were placed in the docket for the draft plan.

On April 27, EPA provided a 15-day extension after placing the documents in question into the docket.  It turns out the documents (a letter and an attached spreadsheet) are from two animal welfare organizations, People for the Ethical Treatment of Animals (PETA) and Physicians Committee for Responsible Medicine (PCRM).  They are not, were not submitted as, and apparently were not intended to be, comments on the draft plan, however; rather, they raise the groups’ concerns over the increase in testing of new chemicals under the new TSCA, based on an analysis they said indicates EPA more frequently included testing provisions when issuing consent orders for new chemicals after passage of the new law than it did before.

Given that the documents PETA and PCRM submitted were not comments on the draft plan and were not submitted in that context, it is all the more curious why Dr. Beck so prominently noted and expressed such enthusiasm for them at the EPA public meeting held about the draft plan – especially because it appears she did so before EPA had conducted any serious review of the documents, which as you’ll see below, is a big problem.

I suspect Dr. Beck’s interest in the PETA/PCRM letter and analysis has little to do with sparing laboratory animals and much more to do with her seeing the documents as providing a useful pretext for her concerted efforts to avoid imposing testing requirements on new chemicals – a clear priority for her previous employer, the American Chemistry Council (ACC).  Industry has incentives to avoid testing due to its costs and the risks that testing may reveal a chemical presents significant risks to health or the environment.

Now that we’ve had a chance to review the PETA/PCRM documents, I want to use this post to highlight two things:

  • First, the PETA/PCRM analysis erroneously understated the extent of testing EPA required prior to the passage of the Lautenberg Act, because it failed to count any of the testing requirements for two-thirds of the new chemicals it examined for which EPA issued consent orders in 2015 and 2016.
  • Additional context is required when assessing the extent of testing of new chemicals EPA was mandating under the new TSCA, which was not provided in the PETA/PCRM analysis.

Read More »

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EPA practices are hindering transparency and public confidence in TSCA’s new chemicals program

By / Published: April 23, 2018

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

Part 1               Part 2               Part 3               Part 4

This is our final post in a series spurred by our review of 69 public files for new chemicals we received from EPA’s Docket Center.  For most of these chemicals, EPA made a determination that they are “not likely to present unreasonable risk” under the Toxic Substances Control Act (TSCA), which greenlights their entry into commercial production.

In our previous post we demonstrated EPA is not complying with a number of provisions under TSCA that require the agency to make public the premanufacture notices (PMNs), notices of commencement (NOCs), and information that is submitted with them.  In this post we look further into how, through these failures and others, EPA has impeded meaningful transparency in the new chemicals program.

As originally enacted in 1976, TSCA recognized the value of public access to information, like health and safety information (see, e.g., TSCA § 14(b)).  Even in EPA’s original (1983) regulations establishing the new chemicals review program, EPA recognized that “[p]ublic participation cannot be effective unless meaningful information is made available to the interested persons” (see here p. 21737).  Among the many flaws of the original TSCA, however, was the law’s inability to ensure EPA delivered the promised transparency when it came to both information EPA receives and the agency’s decisions on new chemicals.

The amendments to TSCA in 2016 were meant, in part, to expand public access to information about both chemicals and agency decisions, and in doing so increase public confidence.  For instance, under § 26, EPA must now make available to the public “all notices, determinations, findings, rules, consent agreements, and orders.”  And under § 5, EPA must now make an affirmative determination on new chemicals, which under § 26 must be made public.  These changes, in addition to the original TSCA provisions, clearly envision a robust program under which the public is able to readily access non-confidential information on new chemicals and information on EPA’s decisions about them.  [pullquote]Coupled with the policy changes EPA has made, the concerns we raise here make clear that EPA under this Administration intends to weaken a new chemicals program that Congress sought to strengthen through TSCA reform – and hide as much of it from public view as possible.[/pullquote]

As implemented, however, a number of features of the new chemicals program severely hamper the ability of the public to understand EPA’s decision-making or engage in the new chemicals program.  In addition to the failings we have discussed in previous posts in this series, this post will address several others:

  • the convoluted and fragmented public information “system” EPA has created for PMNs;
  • the failure of EPA to provide access to agency-generated health and safety information on PMN substances; and
  • EPA’s failure to publish Notices of Commencement (NOCs) and EPA’s determinations on confidentiality claims for specific chemical identity in those NOCs.

Read More »

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