EDF Health

EPA seriously underestimates its costs under TSCA and lowballs industry fees as a result

By / Published: May 25, 2018

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

Yesterday EDF filed extensive comments on the Environmental Protection Agency’s (EPA) proposal for the last of the so-called “framework rules” called for under the 2016 amendments to the Toxic Substances Control Act (TSCA).  This rule, once finalized, will establish the “user fees” Congress authorized EPA to collect from chemical manufacturers and processors to help defray EPA’s costs for implementing TSCA.

The 2016 Lautenberg Act amendments to TSCA greatly expanded both EPA authorities and responsibilities under TSCA.  These extended to chemical testing; conducting risk reviews of new chemicals and prioritizing and conducting risk evaluations of existing chemicals; managing potential or identified risks of both new and existing chemicals; collecting, reviewing and providing access to chemical information; and reviewing confidential business information (CBI) claims asserted by companies when submitting information to EPA.

To determine the level of user fees, EPA is first required to determine its full costs to exercise these authorities and carry out these responsibilities.  Fees are then to be set so as to recoup 25% of those costs or $25 million annually, whichever is lower.  Separate fees are to be collected to cover EPA’s costs to conduct risk evaluations of chemicals companies request, apart from risk evaluations EPA initiates.

So it is vital that EPA fully and as accurately as possible account for its costs, and that it set fees that meet the intent and letter of the law.

Unfortunately, EPA’s proposed rule falls far short of the mark.  EPA has severely underestimated its baseline program costs, both by omitting costs for some relevant activities altogether and by understating the extent or actual cost of other activities.  In some cases EPA set fees at a low level based only on industry’s request that it do so or by invoking factors that are not consistent with the law.  In the proposal and supporting documents, EPA has provided scant detail or conflicting information on how it calculated many of its costs, making it difficult or impossible for stakeholders to know whether EPA’s estimates are at all accurate.

As a result of these flaws, EPA has set some fees at levels below those required by TSCA and the resulting funds will not be sufficient to recoup the costs TSCA authorized EPA to defray through user fees.

This post will highlight some of the many concerns and questions we discuss in detail in the comments we have submitted.   Read More »

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Methylene chloride in paint strippers: A ban is the only health-protective path forward

By / Published: May 15, 2018

Lindsay McCormick is a Project Manager and Richard Denison, Ph.D., is a Lead Senior Scientist.

Last week, EPA signaled it will advance a delayed rule regulating consumer and worker use of methylene chloride-based paint strippers.  Numerous details of EPA’s announcement remain to be filled in, and we caution EPA to avoid approaches short of the ban that was proposed.

The record for EPA’s proposed ban is clear:  Allowing such products to stay on the market based on reliance on such factors as increased labeling, protective equipment, or training requirements simply will not protect the public’s or workers’ health.

Sadly, the companies that make the chemical and paint strippers containing it are already seeking to resurrect those old arguments.   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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Critical “blanks” in EPA’s methylene chloride announcement need to be filled in if it is to be health-protective

By / Published: May 10, 2018

EPA’s announcement that it will move forward on its proposed rule to ban the use of methylene chloride in paint and coating removal products, while encouraging, left critical details unanswered.  We look forward to EPA filling in the blanks.

EDF posted a statement earlier on the announcement here.  In addition, here are five things the final rule must do to be health-protective:

  • Ban distribution in commerce and use of methylene chloride for paint and coating removal
  • Extend to both consumer and commercial uses to ensure that workers are also protected
  • Not provide exemptions based on training, labeling or use of protective equipment
  • Be finalized and implemented quickly
  • Require full compliance within as short as possible a period

 

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Encouraging EPA Response to Families on Deadly Paint Stripping Chemical

By EDF Blogs / Published: May 10, 2018

This statement is attributable to Dr. Sarah Vogel, Vice President for Health, Environmental Defense Fund:

“On Tuesday, Wendy Hartley and Cindy Wynne – both of whom lost their sons to methylene chloride exposure – met with members of Congress and EPA Administrator Scott Pruitt, asking that use of this deadly chemical in paint and coating removal products be banned.

We are encouraged that today EPA has decided to reverse course and move forward to finalize its proposed rule banning methylene chloride in these products.  We are also encouraged that EPA is not re-evaluating the paint stripping uses of methylene chloride and is relying on its previous risk assessments, which found very high risks to consumers and workers from these products.

It needs to be noted that EPA’s statement falls short of committing to finalize a ban.  It is vitally important that EPA move quickly to implement a ban, and that includes ensuring necessary administrative procedures are followed to guarantee a permanent ban and that these products are promptly removed from store shelves. We and families across this country will be watching closely to make sure this Administration actually delivers on today’s promise from Administrator Pruitt.

The credit for any step forward here belongs entirely to the brave members of the Hartley, Wynne and Atkins families who, to honor their sons and protect all of us, fought to ban this deadly chemical. They received important support from Senators Graham, Carper, Scott, and Udall and Representatives Sanford, Pallone, DeGette, Tonko, and Lowey, and others.

We will delay any celebration until paint strippers containing this deadly chemical are actually off the market.  There are a number of steps that now must be taken in order to effectively finalize and implement this ban.

But if methylene chloride in paint strippers is effectively removed from the marketplace, it will be a good day for American families.”

 

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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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