EDF Health

Getting engaged … in shaping implementation of the new TSCA

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

When President Obama signed the Lautenberg Act into law in June, it marked the beginning of a new phase in the long battle to improve chemical safety. Much of the success or failure of the new law now hinges on how well it is implemented. There are both a critical need and numerous opportunities for those who have a stake in improving our chemical safety system to engage in shaping how the law will be implemented.

To that end, EDF has developed an Engagement Guide that provides an overview of some of the key provisions in the Lautenberg Act and associated opportunities for stakeholder engagement, including:

  • Safety Standard and Vulnerable Subpopulations
  • Science Advisory Committee on Chemicals
  • Prioritizing Chemicals in Use
  • Risk Evaluations of Existing Chemicals Deemed High-Priority
  • First Chemicals to be Reviewed
  • Restrictions on Chemicals that Present an Unreasonable Risk
  • New Chemicals Entering the Market
  • Transparency and Information Access
  • Legal Recourses
  • Preemption of State Authority

I hope you find it useful!

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EDF files comments on three TSCA rules EPA is developing

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

Yesterday was the deadline for stakeholders to file written comments on three rules EPA is now developing, as required under the new Toxic Substances Control Act (TSCA as amended by the Lautenberg Act).  EPA is moving quickly to get input on these rules, which it intends to propose in December in order to stay on track to finalize the rules by June of next year, as mandated under the new law.

The solicitation of written comments follows public meetings EPA held on August 9, 10 and 11 to get input from stakeholders on these rules, at which dozens of stakeholders provided oral comments.  Those meetings were the first EPA public meetings since the Lautenberg Act was signed into law on June 22.

The three rules (and associated docket numbers) on which EPA solicited comments are:

  • Risk-Based Prioritization Procedural Rule, which will set forth the process and criteria EPA will use to prioritize chemicals in commerce. Docket EPA-HQ-OPPT-2016-0399
  • Risk Evaluation Procedural Rule, which will set forth the process EPA will use to conduct risk evaluations of high-priority and industry-requested chemicals. Docket EPA-HQ-OPPT-2016-0400
  • Rule Establishing Fees for the Administration of TSCA, which will detail how EPA will collect fees from companies to defray the costs of administering core activities under the new law. Docket EPA-HQ-OPPT-2016-0401

EDF filed comments yesterday on all three rules, available here, here and here.

Several of the key recommendations from each of our comments follow.   Read More »

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EPA issues first decisions mandated under the new TSCA

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

Today, EPA posted on its website risk determinations for four new chemicals it has reviewed under the new standards prescribed by the Lautenberg Act.  While the premanufacture notices (PMNs) for these chemicals were received by EPA prior to the June 22 signing of the new TSCA, EPA has reviewed them in the context of the new requirements.  (Unlike reviews of chemicals already in use, which may take some years to conduct, EPA reviews of new chemicals are generally to be completed within 90 days, which is why we’re already seeing these appear so soon after enactment.)

These decisions are notable in that they are the very first formal decisions EPA has made under the new law.  Based on an admittedly quick review of the decisions, I’ll offer a few observations.   Read More »

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We appear to have gotten lucky in the January 2014 West Virginia chemical spill

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

[UPDATE:  Please see additions below.  On reflection, my “got lucky” theme here may well have been a poor choice, as I certainly did not mean to imply that the spill was anything other than a nightmare for affected residents; rather, it was my attempt to again highlight the extent to which officials were flying blind at the time due to numerous systemic failures.  While the NTP study I discuss here answers some questions and I believe is cause for some relief, it did not address all concerns, leaves considerable uncertainty, and doesn’t begin to undo the damage of this incident and its continuing aftermath.  Apologies to anyone who took my phrase to imply otherwise.]

Readers may recall that I blogged extensively about the January 2014 spill of chemicals into the Elk River near Charleston from tanks used to store the chemical near the river’s edge, which disrupted the drinking water supply and the lives of 300,000 residents for many weeks thereafter.

A key concern was the dearth of health data – both publicly available and otherwise – on the key chemical components of the spilled mixture, which was used to wash coal.  As I reported in a series of blog posts, despite scant data, federal and state officials rushed to establish – and then defend their establishment of – a concentration of one part per million (1 ppm) as the “safe” level of the main component, 4-methylcyclohexanemethanol (MCHM), of the spilled mixture.  I pointed to the lack of a scientific basis for that level, largely because of the lack of adequate health information.

That remained the case even after the chemical’s producer, Eastman Chemical, decided to make public its studies of the chemical that it had hidden, claiming them to constitute trade secrets.  I tried to be careful not to claim MCHM or other spilled chemicals posed health risks, but rather that the lack of safety data was highly concerning, given the widespread extent of exposure.

Among the many outcomes of the spill was an agreement by the National Toxicology Program (NTP) to undertake a thorough study of the potential health and environmental effects of MCHM and other component chemicals.  That study is now complete, and the results were released last week.   Read More »

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Understanding basic process flows under the new TSCA

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

As an additional resource for people delving into the new Lautenberg Act that was signed by President Obama last week, I have developed some flow charts depicting the basic processes applicable to existing chemicals already in commerce and new chemicals prior to market entry.

Comparisons are shown between the processes under the old and new laws.

A PDF version is available here; or click on the thumbnails below.

 

FRL21-TSCA flowcharts 6-28-16 Slide1FRL21-TSCA flowcharts 6-28-16 Slide2FRL21-TSCA flowcharts 6-28-16 Slide3FRL21-TSCA flowcharts 6-28-16 Slide4

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What an honor

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

After 30 years in Washington, maybe I should be more jaded, but today was a big day. Not only did I have the incredible honor this morning of meeting with President Obama, but it was just prior to getting to witness his signing of a bill that I think is going to make a big difference in our lives.

When I started working on and with the Toxic Substances Control Act (TSCA) some 15 years ago and began trying to help build the case for its reform, never in a million years did I contemplate such an honor, let alone being able to work so closely on and then witness the historic signing of this strong new law.

The small group that met with the President included not only people in Washington who worked for this reform but also those who have been impacted by our broken law or stand to benefit the most from the new law:  Young adults and parents of children who have had chronic diseases and conditions like cancer and autism for which there is growing concern about the contribution of chemical exposures.   Read More »

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