EDF Health

The Trump EPA says “precede” means “follow”

By / Published: January 10, 2020

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.

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

Also posted in Industry influence, Regulation, TSCA reform / Tagged , , | Comments are closed

More words minced this time, but EPA’s science advisors raise serious concerns with its draft risk evaluation of 1-bromopropane

By / Published: December 16, 2019

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

The peer review report by the Scientific Advisory Committee on Chemicals (SACC) on EPA’s draft risk evaluation of 1-bromopropane (1-BP) has been released.  This carcinogenic solvent is one of the first 10 chemicals undergoing risk evaluation under the amended Toxic Substances Control Act (TSCA), and the new SACC report covers the fourth of EPA’s draft risk evaluations (DREs) to be peer-reviewed.  We’ve blogged earlier about the SACC’s reports on EPA’s draft risk evaluations for 1,4-dioxane and HBCD and Pigment Violet 29.

At first blush, the new report reads less harshly than the last one, and the SACC notes clear improvements in the content and organization of the 1-BP draft over earlier ones.  But even the Executive Summary raises quite scathing criticisms that go to the heart of whether EPA has developed sufficient data to support its risk determinations for this chemical.  Here is a telling excerpt (p. 17, emphases added):

Overall, the Committee concurred that even though data provided in the DRE underestimated risk, these data did support the finding of unreasonable risk to consumers and occupational conditions, including occupational non-users. Conversely, inadequate data were presented for a robust risk characterization for the environmental assessment, and the information provided did not support the conclusion of “no unreasonable risk to the environment.”

These conclusions mirror those drawn by EDF in the comments we submitted to EPA on the 1-BP DRE.

Themes sounded by the SACC in its earlier peer reviews came up again here.  Read More »

Also posted in Health science, TSCA reform / Tagged , , , | Comments are closed

EDF asks EPA to strengthen key lead service line definition, inventory, and notification provisions in its proposed revision to the LCR

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: December 13, 2019

Tom Neltner, J.D., Chemicals Policy Director, Lindsay McCormick, Program Manager, and Sam Lovell, Project Manager.

See all blogs in our LCR series.

Yesterday, EDF submitted comments to the Environmental Protection Agency (EPA) on their proposed revisions to the Lead and Copper Rule (LCR), focusing on changes that EPA should to make to the:

  • Definition of a lead service line (LSL);
  • Requirements for water systems to develop LSL inventories; and
  • Notification of individual consumers who drink water that passes through an LSL.

We highlighted strengths and weaknesses of the LCR in a blog earlier this week, and we encourage states and communities to consider adopting the positive provisions now in addition to the changes we ask EPA to adopt in these comments. Below is a summary of our comments on these three issues. We plan to address other issues on the proposed revisions to the LCR in later comments.

Lead Service Line Definition

EPA’s proposed change to the current definition of an LSL at 40 CFR § 141.2 is flawed because it continues to exempt goosenecks, pigtails, or other connectors made of lead. These connectors are a major source of lead in drinking water not just because they are made of lead, but because they can release significant amounts of lead particulate into water as they flex with temperature, are scoured by turbulent water flow, and as other conditions change.

The exemption of these connectors from the definition of an LSL would render a water system’s LSL inventory and periodic notices to customers misleading because service lines described as “non-lead” may actually have some lead pipe in them. This will give residents a false sense of security. We recommend that the agency modify the proposed definition by deleting the exemption and explicitly stating that goosenecks, pigtails and connectors made of lead are LSLs.

Read More »

Also posted in Drinking water, Lead, Regulation / Tagged , , , , , | Authors: / Comments are closed

Despite its flaws, states and communities should get ahead of the curve on EPA’s proposed lead in drinking water rule

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: December 10, 2019

Tom Neltner, J.D., Chemicals Policy Director, Lindsay McCormick, Program Manager, and Sam Lovell, Project Manager.

See all blogs in our LCR series.

In October, the Environmental Protection Agency (EPA) proposed changes to its outdated Lead and Copper Rule (LCR), the federal regulation designed to control those contaminants in drinking water. As the result of more than a decade of work by dedicated agency experts, the proposal makes several improvements to key parts of the rule, including requirements for lead service line (LSL) inventories and customer notification. LSLs are the lead pipes that connect the main under the street to homes and buildings and are the most significant source of lead in drinking water.

Unfortunately, EPA’s proposed rule has several serious flaws, including that it:

  • Continues to treat full LSL replacement as a last resort. The proposed rule should make LSL replacement an integral part of a long-term solution, including periodic benchmarks for all water systems to achieve regardless of water testing results.
  • Continues to allow water systems to conduct partial replacements where the property owner is unwilling or unable to pay the cost for the portion not owned by the water system. Partial LSL replacement may significantly increase lead levels in drinking water for months and does not reliably reduce lead levels in the long term. While water systems would be required to gives residents tools (e.g. advanced notice and filters) to reduce the exposure, more is needed. EPA’s own analysis finds that relying on a resident’s ability-to-pay to replace the LSL on their property to avoid partial replacements will leave low-income households with disproportionately higher health risks.
  • Backslides on the rate of mandatory LSL replacement. When a water system’s lead levels are so high that full LSL replacement is mandated, EPA proposes an annual replacement rate that gives the system at least 33 years rather than the current minimum of 15 years to replace all of its LSLs. While more systems are likely to have to conduct mandatory full LSL replacement because of the stricter sampling requirements, most will not.

EPA is accepting comments on the proposed revisions until February 12, 2020. We are preparing detailed comments calling for the agency to fix the flaws before finalizing the rule, and we encourage others to comment as well.

Despite these shortcomings, we want to highlight four positive elements of the proposed rule and encourage states and communities to consider implementing them now – not just because they are likely to be required in the future – but also because they set the stage for full LSL replacement. These elements are that water systems must:

  • Develop an LSL inventory, update it annually, and make it publicly accessible;
  • Notify customers that they have or may have an LSL;
  • Take precautions when disturbing LSLs; and
  • Sample more homes with LSLs and take earlier action based on the results.

In this blog, we provide an overview of these key improvements. In future blogs, we will describe our recommendations to strengthen the rule based on our comments to the agency.

Read More »

Also posted in Drinking water, Lead, Regulation / Tagged , , , , , , | Comments are closed

When will EPA fully explain and legally justify its reviews of new chemicals under TSCA?

By / Published: December 9, 2019

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

Over two years have passed since EPA published its first, highly controversial New Chemicals Decision-Making Framework.  This document attempted to lay out major changes EPA was making, in response to relentless industry pressure, to its reviews of new chemicals entering the market.  Prior to this, EPA had been conducting reviews that largely conformed to the new requirements for these reviews that Congress included in the reforms to the Toxic Substances Control Act (TSCA) enacted in June 2016.

Among the many concerning aspects of EPA’s new approach were its herculean efforts to avoid finding a new chemical “may present an unreasonable risk” or that the information available to EPA is insufficient to permit a reasoned evaluation of the chemical.  Under reformed TSCA, either of those findings requires EPA to issue an order – as specified under section 5(e) of TSCA – that restricts the chemical, requires testing, or both in a manner sufficient to ameliorate the potential risk.

One of EPA’s new tactics was to illegally bifurcate its review of a company’s “intended” uses of the new chemical from other “reasonably foreseen” uses.  The company would get the coveted unfettered approval to enter commerce, based on an EPA review limited to its intended uses; these approvals take the form of EPA issuing a finding that the chemical is “not likely to present an unreasonable risk.”  Any review of other reasonably foreseen uses would be relegated (if it took place at all) to a later, wholly separate process that would only be triggered if EPA also promulgated a so-called “significant new use rule” (SNUR).  Under such a SNUR, a company seeking to engage in a reasonably foreseen use of the chemical EPA identified would be required to first notify EPA, who would then conduct a review of that new, now “intended,” use.

These SNURs are often referred to as “non-5(e) order SNURs” because they do not follow from EPA’s issuance of an order under section 5(e) – indeed, avoiding such orders was the whole point.  We have previously addressed the many problems – legal, policy, and scientific – with this approach; see for example, here and here.  These include:

  • the failure to assess all intended and reasonably foreseen uses of a new chemical at the same time, as required by TSCA and necessary to consider the potential for people to be subject to multiple exposures; and
  • the inability to require testing of the new chemical substance using a SNUR, which can be required through an order.

EPA held a public meeting and took public comment on its 2017 Framework at the time it was published.  But it never responded to the many comments it received criticizing its framework.  And when EPA was sued over its use of the Framework, it dodged the suit by claiming it was not using the Framework (see p. 14 here), leading to the lawsuit being withdrawn.  (Later in this post below we discuss that EPA has in fact been repeatedly using the core feature of the Framework.)

Meanwhile, hundreds of decisions made with no public framework

EPA has never made public any subsequent description of its decision-making approach or justification for it, despite the hundreds of new chemical approvals it has been cranking out ever since.  EPA has also never responded to the numerous public comments it received criticizing its framework.

Frustration over this situation led to a Congressional call for EPA to publish and then take comment on an updated description of its new chemicals review process.  Last January, EPA Administrator Andrew Wheeler made a commitment to Senator Carper to publish a revised new chemicals framework that would specify: “(i) the statutory and scientific justifications for the approaches described, (ii) the policies and procedures EPA is using/plans to use in its PMN reviews, and (iii) its responses to public comments received,” and to provide opportunity for public comment on the revised framework.

Last month EPA announced that it will hold a “Public Meeting on [the] TSCA New Chemicals Program,” which is to take place tomorrow, December 10.  However, while the agenda includes a speaker who will provide an “overview” of what EPA is now calling its “working approach,” EPA’s announcement indicated it would not release any actual document before the public meeting; instead, it will do so “by the end of the year.”  And while the meeting agenda provides for “public feedback” at the end of the meeting, the lack of any document to respond to will surely limit the ability of the public to provide meaningful input.

Absent such a public document, the rest of this post will provide our best understanding of how EPA has been reviewing new chemicals over the last two years, based on our scrutiny of each such decision.  Read More »

Also posted in Regulation / Tagged , , , | Comments are closed

While harder to discern, another EPA risk evaluation severely understates risk, this time for methylene chloride

By / Published: November 27, 2019

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

When EPA released the draft of its risk evaluation for methylene chloride at the end of last month, some were surprised that EPA had identified numerous unreasonable risks presented under a variety of the chemical’s conditions of use.

In an earlier post, EDF provided some context, noting how dangerous the chemical is and raising initial concerns that EPA was once again excluding known uses and exposures, making unsupported assumptions, and applying inappropriate risk benchmarks that were once again leading it to significantly understate the actual risks posed by methylene chloride.

Four weeks later, EDF has confirmed these concerns in spades.  Last night we filed 84 pages of comments on the draft risk evaluation, for consideration by EPA’s Scientific Advisory Committee on Chemicals (SACC), which will meet next week to peer review the draft.

EDF’s deep dive into the draft demonstrates that EPA has employed a host of unwarranted and unsupported assumptions and methodological approaches that lead it to either avoid identifying unreasonable risk when it should have, or to understate the extent and magnitude of the unreasonable risks it did identify.  Below we summarize some of the major concerns, which are addressed in detail in our comments.  Read More »

Also posted in Health science, Regulation, TSCA reform, Worker safety / Tagged , , , | Comments are closed