EDF Health

EPA moves chemical reporting into the 21st century – though we’ll have to wait until mid-decade to actually get there

By / Published: August 3, 2011

Richard Denison, Ph.D., is a Senior Scientist.  Allison Tracy is a Chemicals Policy Fellow.

A major initiative of EPA’s toxics office finally made it across the finish line yesterday when EPA posted a pre-publication copy of the final rule upgrading its chemical reporting system under the Toxic Substances Control Act (TSCA).  The process took over 16 months just to get from the draft of the proposed rule to yesterday’s final rule, with EPA having to endure not one but two nearly six-month regulatory reviews by the Office of Management and Budget.

The wait was largely worth it:  EPA’s new program – renamed the Chemical Data Reporting (CDR) rule – significantly advances chemical production and use reporting relative to its predecessor, the more arcane-sounding Inventory Update Reporting (IUR) rule.  Most, though not all, of the critical elements EPA proposed last year made it through to the final rule.  The catch is we’ll have to wait until 2016 for the program to reach its full potential.  Read More »

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Gasping for breath: Asthma-inducing diisocyanates enter our homes and schools

By Jennifer McPartland / Published: July 21, 2011

Johanna Katz is a Cornell Iscoll intern at EDF.  Jennifer McPartland, Ph.D., is a Health Scientist.

Toxic chemicals called diisocyanates are long-established as occupational hazards known to cause severe respiratory problems to workers who use or are otherwise exposed to them (see here).  In fact, diisocyanates are the number one cause of workplace-induced asthma (see here and here).  Recently, potential exposure of the general public to diisocyanates has grown, as these chemicals are increasingly used in consumer products.  This is certainly a troubling trend considering that the primary health effect of these chemicals, asthma, is a massive and growing public health problem, especially among children.  And some of the newest uses of diisocyanates are in products to which children are quite likely to be exposed.

Asthma is at an all-time high, affecting more than 24 million Americans, and creating astronomical health and productivity costs upwards of $20 BILLION each year.  And while diisocyanates are but one of many contributors to the increasing rate of asthma in the general population, we surely don’t need to be bringing more products containing such chemicals into our homes, schools, and workplaces. That will only make matters worse.

So what exactly are diisocyanate chemicals, where are they found, and what’s the federal government trying to do about them?  Read on to find out.  Read More »

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Funny name, serious concern: EPA proposes Significant New Use Rule for 14 glymes

By / Published: July 11, 2011

Allison Tracy is a Chemicals Policy Fellow. Richard Denison, Ph.D., is a Senior Scientist.

EPA today proposed a Significant New Use Rule (SNUR) that, once finalized, would mandate that companies notify EPA prior to engaging in any “significant new use” of any of the 14 chemicals EPA has identified collectively as glymes.  Among other concerns, EPA has identified their use in various consumer products and their potential to cause reproductive and developmental toxicity.  For most of the glymes, the significant new use would be any use in a consumer product beyond those that are already ongoing.  For two of these chemicals, the significant new use would be any use.

This proposed SNUR, which was mired at the Office of Management and Budget (OMB) for more than six months, is now out for a 60-day public comment period.  A SNUR is essentially the only means available to EPA under the Toxic Substances Control Act (TSCA) by which it can try to limit the use of an existing chemical of concern.  It is far from a perfect means of doing so.

Nonetheless, within its limited authority under TSCA, today’s step by EPA brings at least some degree of scrutiny over a quite nasty group of chemicals.  Read More »

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What are you, really? How our microbiome mediates chemical exposures

By Allison Tracy / Published: July 5, 2011

Allison Tracy is a Chemicals Policy Fellow. Richard Denison, Ph.D., is a Senior Scientist.

For millennia people have contemplated the question “who am I?”  But how about the even more fundamental question, “what am I”?  The human body is made up of about 10 trillion cells that form our tissues and organs.  But did you know that the human gut is the home to microbes that comprise 10 times more – that is, 100 trillion – cells?  And that, while the human genome contains about 23,000 genes, there are some 3 million genes in the microbes living in the human gut?  Obviously, this complicates things.  It arguably means we could be considered to be more microbe than human!

These numbers should tip us off to the importance of what is known as our “microbiome.”  New science is shedding light on the central function of the microbiome as a mediator between external agents to which we’re exposed and the impacts of those exposures.  Recent studies show, for example, that as chemicals pass through the gastrointestinal tract, they undergo major changes in bioavailability (i.e., how easily they are taken up into our bodies) and in their toxicity.  Recognition of the role of the microbiome is shifting the playing field for toxicology in fundamental ways.   Read More »

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Waiting for Godot: 405 days and counting at OMB on EPA’s modest proposal to identify chemicals of concern under TSCA

By / Published: June 21, 2011

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

Yesterday, three legal scholars from the Center for Progressive Reform (CPR) sent a letter to Cass Sunstein, Administrator of the Office of Information and Regulatory Affairs (OIRA) in the White House Office of Management and Budget (OMB).  That letter rebutted on legal grounds the call made by the U.S. Chamber of Commerce in its own letter to Mr. Sunstein for OMB to force EPA to withdraw its proposal to use its authority under the Toxic Substances Control Act (TSCA) to list chemicals of concern.

EPA’s proposal, which entails use of its clear authority under Section 5(b)(4) of TSCA, has been stalled at OIRA for 405 days as of today, with OIRA refusing even to allow the proposal out for public comment.  I wrote an extensive blog post earlier about all of the reasons why EPA’s proposal is legally sound and makes good market sense.  That post – titled “Why is OMB blocking EPA from using even its limited authority under TSCA?” – went up way back in December, and there’s been no movement on the proposal since then.

CPR’s letter rebuts the Chamber’s claims, noting that it plain and simply “Gets the Law Wrong.”  EDF, too, has developed a legal analysis of EPA’s authority under TSCA to identify and list chemicals of concern, which is fully consistent with CPR’s analysis but goes further to address a few other legal aspects of the issue.  That’s why I’ve decided to post it here.

I’ll leave you to read our memo for the details, but provide its conclusion here as a teaser:

“EPA has clear authority under Section 5(b)(4) to list chemicals of concern and is not required to establish criteria in advance of the issuance of a proposed rule listing specific chemicals.  EPA’s authority also extends to the listing of categories of chemicals.  The legal threshold for action under Section 5(b)(4) should be interpreted as identical to that in Section 4(a), which requires only a “more than theoretical” basis for concluding that a chemical “may present” an unreasonable risk.  Even if Section 5(b)(4) is interpreted to mean something different from that in Section 4(a), it should be interpreted to be far less restrictive than the standard in Section 6.  In addition, Section 5(b)(4) does not require consideration of economic impact in the decision to list a chemical.  Finally, the statute is clear that listing of a chemical in a proposed rule under Section 5(b)(4) triggers export notification under Section 12, and may require the issuance of a SNUR [Significant New Use Rule] with respect to significant new uses of the chemical.”

It’s a sad state of affairs when even this modest step proposed by EPA to use its clear authority under TSCA is not even being allowed by OMB to see the light of day and benefit from public review and comment.

Samuel Beckett’s play, which I borrowed for the title of this post, is described as an absurdist play.  That pretty much sums up the endless review by OMB of EPA’s modest proposal.

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More progress under REACH: 13 more chemicals en route to the Authorization list

By Allison Tracy / Published: June 20, 2011

Allison Tracy is a Chemicals Policy Fellow.

The European Chemicals Agency (ECHA), the agency responsible for implementation of the EU’s REACH Regulation, posted a press release last week listing 13 chemicals it proposes to advance from its list of “Substances of Very High Concern” (SVHCs), also known as the Candidate List for Authorization, to its list of chemicals subject to Authorization, also known as Annex XIV.

Authorization is one of the main pillars of REACH, via which use of designated SVHCs is limited to those uses specifically authorized by EU authorities. Following the public consultation period that is now underway, some or all of the 13 chemicals will move to the Authorization list.   Read More »

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