EDF Health

Selected tag(s): Lautenberg Act

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

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 »

Posted in EPA, Health Policy, Industry Influence, TSCA Reform / Also tagged | Leave a comment

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

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 »

Posted in EPA, Health Policy, Industry Influence, TSCA Reform / Also tagged , | Leave a comment

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

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 »

Posted in EPA, Health Policy, TSCA Reform / Also tagged , | Read 2 Responses

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

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.  

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.

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 »

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

EDF requests extension of comment period on TSCA Alternative Testing Strategic Plan due to key document missing from docket

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

Last night EDF submitted a request to the Environmental Protection Agency (EPA) to extend the public comment period on its draft Alternative Testing Methods Strategic Plan under the Toxic Substances Control Act (TSCA).

EPA held a public meeting about the draft Strategic Plan on April 10, 2018.  At that meeting, Dr. Nancy Beck prominently highlighted an analysis that EPA had received from a stakeholder that she described as robust and extensive, and her description of the analysis suggested that it has or could significantly influence EPA’s consideration of the issues raised by the draft Strategic Plan.  When asked if EPA would make this analysis available to the public, an EPA official stated that it would be made available.  But the analysis has not yet been published to the docket.  The due date for comments on the draft Plan is a week from today, April 26, 2018.

Given the emphasis Dr. Beck placed on the analysis and the apparently extensive nature of it, EDF believes the public should be provided access to the document and ample time to review, and if desired, comment on it.  Hence we have requested that:

1)  EPA publish a copy of the relevant analysis to the docket for the draft Strategic Plan.

2)  EPA extend the public comment period by 30 days after it publishes the relevant analysis in the docket.

Because the deadline is impending, EDF requested that EPA respond to this request within three business days, i.e., by Monday, April 23.

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

EDF joins Opening Brief in legal challenge to EPA’s Prioritization and Risk Evaluation Rules

Late yesterday, EDF joined fourteen other Petitioners in filing an Opening Brief in our case challenging EPA’s Prioritization Rule and Risk Evaluation Rule.  The Brief was filed with the U.S. Court of Appeals for the Ninth Circuit.

Our Brief argues that the Toxic Substances Control Act (TSCA), as amended by the Lautenberg Act, requires EPA to comprehensively evaluate a chemical’s hazards and exposures arising from all of its “conditions of use,” a term defined under TSCA as encompassing the chemical’s entire lifecycle from manufacturing and processing to use and disposal.  EPA is then to make a holistic determination of whether the chemical presents an unreasonable risk of injury to human health or the environment, including to potentially exposed or susceptible subpopulations.  EPA’s Rules violate this requirement because EPA asserts unfettered discretion to exclude known or reasonably foreseen exposures and conditions of use from consideration, thereby ignoring potentially important contributors to a chemical’s overall risk.  As a result, the Rules threaten to leave the public—especially vulnerable groups like children, pregnant women, and workers—as well as the environment inadequately protected from the potential risks posed by the thousands of chemicals to which we are exposed every day.

EPA’s response brief in the case is due to the Court on July 5, 2018.  As this litigation proceeds, you can find more information – including all significant legal documents – on EDF’s website.

 

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