EDF Health

Finally something we can (mostly) commend EPA for doing under TSCA

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

Readers of this blog will know how concerned EDF is with ensuring the public’s right to know about chemicals to which they may be exposed.  We have repeatedly sounded the alarm when EPA has taken steps to deny public access to chemical information, whether for chemicals entering the market or those already in commerce.  Even in recent months, EPA has sided with chemical companies in denying access to health and safety information on chemicals EPA is assessing under the Toxic Substances Control Act (TSCA).

So we were pleasantly surprised by a letter to an industry group that EPA posted on Friday.  Read More »

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Top takeaways from The Intercept’s investigation into Trump’s toxic rollbacks

Regulatory decisions by federal agencies in Washington often feel distant – bureaucrats moving paper in ways that don’t matter to regular people. But a devastating new story by reporter Sharon Lerner of The Intercept makes clear just how awful the Trump administration’s actions on chemical safety have been for average Americans.

Lerner shows that the Trump EPA has repeatedly bowed to industry lobbyists to allow dangerous chemicals to stay on or enter the market with little or no restrictions.

EPA’s actions are not abstract bureaucratic events to Angela Ramirez, who was diagnosed with breast cancer after years of living and working “near two facilities that were emitting a cancer-causing chemical called ethylene oxide.” EPA scientists knew “that exposure to ethylene oxide caused elevated rates of tumors in the brain, lungs, uterus, and lymph systems” – but under the Trump administration, following pressure from an industry trade group, EPA decided not to follow its own science deciding whether to limit the chemical.

Lerner reports that the Trump administration, stacked with political appointees who have worked, lobbied or advocated for the chemical, tobacco, and coal industries, has been systematically undermining EPA’s ability to use the best science and get the best expert advice to protect families. They’ve been attacking programs like the Integrated Risk Information System, or IRIS, which provides evidenced-based analysis to the government to make public health decisions.

From Texas to Delaware and across the country, Lerner shows the impact of an administration that seems entirely focused on doing the bidding of industry, rather than pursing its legal mission to protect public health. They are doing so both broadly – weakening a new chemical safety law –and in a series of individual chemical assessment decisions. “Each time we see one of these assessments, there are ways in which the science has been played with,” EDF’s Lead Senior Scientist Richard Denison told Lerner.

To read more about what Lerner calls “Trump’s cancer gang” and their attacks on science and public health, check out her full article.

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

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 »

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

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 »

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

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

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 January 13, 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 »

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