EDF Health

The Trump EPA says “precede” means “follow”

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

[Corrections added below in bracketed italics on 1-17-20]

Last month EPA finally released its long-awaited update to its controversial 2017 New Chemicals Decision-Making Framework, which describes how EPA is conducting risk reviews of new chemicals under the Toxic Substances Control Act (TSCA).  While we are still reviewing it and will be filing comments, it is clear the new document suffers from many of the same problems as the prior version, as well as raising additional concerns.

A core problem of both documents is EPA’s illegal bifurcation of its treatment of a new chemical’s “intended” conditions of use – those proposed by the company submitting a premanufacture notification (PMN) to EPA – from the chemical’s “reasonably foreseen” conditions of use.  EPA does so despite TSCA’s clear instruction that EPA address potential risks from both categories in an integrated manner and at the same time.  EPA’s frameworks instead relegate any consideration of “reasonably foreseen” conditions of use to a separate, later process undertaken upon receipt of a separate notification submitted to EPA in response to a Significant New Use Rule (SNUR) – assuming EPA has actually promulgated a final SNUR for the chemical in question.

EPA has now used this bifurcated approach to greenlight hundreds of new chemicals for market entry – finding that they are “not likely to present an unreasonable risk” based on a review only of the chemicals’ intended conditions of use.  EDF has blogged in detail about the inadequacies of EPA’s “SNUR-only approach” and the disturbing extent of its application.

EPA has yet to provide any legal justification for its approach – how it believes the approach comports with TSCA – let alone demonstrate how it provides for protection of health and the environment despite deviating from what Congress intended EPA do under the law.

How on earth can EPA assert with a straight face that it is promulgating SNURs that precede its “not likely” determinations?

While we will have much more to say on the new framework, in the remainder of this post I want to focus on EPA’s characterization of its reliance on the SNUR-only approach.  EPA now says it has expanded that approach to two different scenarios:  One is “SNURs that Precede “Not Likely” Determinations” and the other is “SNURs that Follow “Not Likely” Determinations.”

We have examined the accuracy of EPA’s claim that the first type of SNUR precedes EPA’s “Not Likely” determination for a given new chemical.  The timing is critical here:  If there is a significant lag between EPA’s “Not Likely” determination and the issuance of a SNUR, all kinds of problems arise, which we have discussed previously.  To name two:

  • If a company engages in what EPA plans to deem a “significant new use” during the gap between the determination and at least proposal of a SNUR, then EPA cannot subject that use to the notification requirements of the SNUR because the use is “ongoing” and no longer “new.” That includes a new use engaged in by the company that got a green light for its chemical based on EPA’s review of only its intended conditions of use.
  • Such a company that wants to have the ability to engage in uses beyond those it said it initially intended would have serious incentives to seek to avoid having EPA issue the SNUR. Because SNURs are done through rulemaking, the company can urge EPA to block or modify the SNUR through the rulemaking process.  It can also apply pressure on EPA not to pursue a SNUR at all.

So is EPA being accurate when it claims that a large number of its SNURs precede EPA’s “Not Likely” determination for those same new chemicals?

The answer is a resounding no:  Read More »

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Next TSCA chemical peer reviews and draft risk evaluations to be delayed. You’ll never guess why.

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

We’re hearing that EPA has cancelled the next meeting of its Scientific Advisory Committee on Chemicals (SACC), which was scheduled for October 21-25.  The SACC is conducting peer reviews of EPA’s draft risk evaluations of the first 10 chemicals to undergo safety reviews under the Toxic Substances Control Act (TSCA).

Word is that the panel was to use its October meeting to peer-review the draft risk evaluations for methylene chloride and N-methylpyrrolidone (NMP).  But release of those drafts has been delayed, leaving insufficient time for the SACC to review them before the meeting.

We’re also hearing why release of the drafts has fallen behind.  The drafts were on track for release late last month, but apparently were blocked based on objections about at least the draft risk evaluation for methylene chloride.  The objections were lodged by Dr. Nancy Beck.  Read More »

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No, Bergeson & Campbell, the public’s right to know about new chemicals is not a distraction or waste of resources

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

Earlier this month, EDF and other NGOs filed a notice of intent (NOI) to sue the Environmental Protection Agency for violations of the Toxic Substances Control Act and its own regulations that deny the public timely access to information on chemicals companies seek to bring onto the market.

Members of the public have a right to know about chemicals entering the market because they may well be exposed to them.  And they have a right to know about and meaningfully participate in EPA’s review of the safety of those chemicals because such transparency, accountability, and public participation are fundamental to good government, as well as being required by the law.

This week the industry law firm Bergeson & Campbell (B&C) offered a commentary on the NOI, lamenting it as “hugely distracting and draw[ing] resources and [EPA] management’s attention away from other priorities.”  Note that B&C represents many companies that submit new chemicals to EPA for review under TSCA and has been a central actor in the chemical industry’s efforts to weaken those reviews.

In its commentary, B&C acknowledges that the NOI has identified real legal violations committed by EPA, and that these violations result in the public having less information about the agency’s new chemicals program.  But B&C asserts that the violations don’t really matter because they have been going on for a long time, not just under this administration.  While that is true in some cases, the argument ignores the two elephants in the room.  Read More »

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EPA’s latest move to deflect criticism of its TSCA risk evaluations: Muzzle its science advisors

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

Readers of this blog know that Environmental Defense Fund (EDF) has voiced strong opposition to a number of decisions made by the Environmental Protection Agency (EPA) that aim to limit the risks it finds when evaluating the safety of chemicals under the Toxic Substances Control Act (TSCA).

These decisions include:

  • excluding from its analysis known human and environmental exposures to a chemical, based on unwarranted assumptions that those exposures are adequately managed by other statutes;
  • claiming without support that workers are protected by assuming universal and universally effective use of personal protective equipment throughout chemical supply chains and the adequacy of OSHA regulations that either don’t apply or are decades out of date;
  • arbitrarily loosening EPA’s longstanding risk standards governing when cancer incidences are deemed unacceptably high; and
  • choosing not to exercise its enhanced authorities under TSCA to require submission of robust information on chemicals’ hazard and exposures, resorting instead to questionable assumptions and relying on voluntarily submitted industry data that are unrepresentative or of poor or indeterminate quality.

Through these decisions, EPA increases the likelihood that it will either not find unreasonable risk and thereby avoid regulating the chemical, or if that can’t be accomplished, find risks that are low enough that it can impose few restrictions, thereby burdening industry as little as possible.

In response to each of these decisions, EPA has received dozens of highly critical comments on its draft risk evaluations from state and local governments, labor and health groups, environmental NGOs and members of the scientific community.  And in the first several peer reviews conducted by its Scientific Advisory Committee on Chemicals (SACC), many of the scientists voiced quite similar concerns during the committee’s public meetings (as of yet, final peer review reports have not been issued).

Rather than address the problems, EPA has adopted a new tactic to stifle the criticism, one that is quite chilling (literally and figuratively):  It is telling the SACC that these issues are off-limits to the peer reviewers because they represent policy decisions that are beyond the charge given to the SACC.  This is beyond the pale, for several reasons.  Read More »

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EPA needs to stop misleading the public and its peer reviewers about the data it has obtained from the European Chemicals Agency

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

In numerous assessment documents issued by the Environmental Protection Agency (EPA) developed in its implementation of the Toxic Substances Control Act (TSCA), EPA cites as a source the European Chemicals Agency (ECHA).  ECHA is the agency that administers the European Union’s (EU) REACH Regulation, which (unlike TSCA) requires the registration of chemicals in commerce by companies that wish to continue to produce and use the chemicals in the EU.

When companies register chemicals under REACH, they are required to develop and submit a “dossier” of certain information on production and use as well as on physical-chemical properties, fate, hazard, exposures and risks.  ECHA then makes information available on its website.

In its draft risk evaluations for the first 10 chemicals undergoing evaluations under TSCA, as well as in some of its support documents for high-priority substance designations under TSCA, EPA has heavily relied on these dossiers.  But in doing so, EPA has grossly mischaracterized the source and nature of the data it references as coming from ECHA.

EDF has been raising concerns about EPA’s mischaracterizations for some time now (see section 1.E of our comments on EPA’s draft risk evaluation for 1,4-dioxane), but they persist.  And as recently as yesterday, members of the peer review panel reviewing EPA’s draft documents have been led by EPA statements and citations to assume a degree of completeness and government review of these data that is simply false.

EPA needs to immediately cease and desist in its mischaracterizations.  Read More »

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1,4-dioxane: The case of the disappearing tumors

Rachel Shaffer is a consultant.  Richard Denison, Ph.D.is a Lead Senior Scientist.

As we highlighted in a previous post, EDF filed extensive comments on EPA’s draft risk evaluation for 1,4-dioxane. Among the many concerns we raised was a decision by the Trump EPA to completely dismiss female mouse liver cancer data used by EPA’s Integrated Risk Information System (IRIS) program as key inputs to its cancer risk modeling conducted in 2013. The Agency appears to be trying every trick in the trade – such as excluding most exposure sources and routes – in its effort to conclude that the chemical presents few or no risks to human health or the environment. Read on for more on this latest one. Read More »

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