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Selected tag(s): Significant New Use Rule (SNUR)

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

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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Enduring TSCA myths: Absence of evidence of harm = evidence of absence of harm

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

A subcommittee of the Senate Environment and Public Works Committee held a hearing on reform of the Toxic Substances Control Act (TSCA) last week.  It’s good to have attention drawn to the issue so early in the new Congress.

But – especially if you missed Senator Lautenberg’s opening statement and the testimony of EPA Assistant Administrator Steve Owens – you may well have come away from the hearing with the impression that TSCA is basically working quite well and really only needs a few tweaks, or what the chemical industry loves to call “modernization.”

Nothing could be further from the truth, of course.  This 35-year-old law is not only outdated, it’s proven ineffectual in myriad ways.  The false impression that all TSCA needs is a little polishing-up was, unfortunately, bolstered by the invoking of two particularly pernicious myths about TSCA by some of the other hearing witnesses.

The first myth, which I’ll deal with in this post, is that EPA’s new chemicals program has worked very well – so often repeated by some former EPA officials that it has become virtual dogma.

The second myth, which I’ll address in a subsequent post, is that we can confidently rely on existing information to identify all of the chemicals of concern on the market today, and safely set aside the rest.  Read More »

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Regulating nanomaterials to life, not death

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

As we enter a new year and legislative season, we face a changed political climate where the thought of new regulation is anything but de rigueur.  I will argue in this post that a little regulation would have done – and still could do – the world of nanotechnology a world of good.

Come again?

Back when the debate over nanomaterial safety really got started, which I would place ‘round about 2004 (or was that just my first involvement in it?), there seemed to be broad agreement on first-order needs to ensure that nanotechnology would survive and thrive.  The aim was to “get it right the first time,” by identifying and addressing potential risks up front and in the open.  That meant we needed to adequately fund and direct risk research.  We also needed to make sure adequate regulatory authority existed to address potential risks, ideally before they arose.

Most fundamentally, there was virtual consensus on the need for prompt action to ensure regulatory agencies had at hand the basic information they needed to understand the lay of the nano-land:  what nanomaterials are already being produced and are in the pipeline; in what applications and products are they being used; and where along the nanomaterial lifecycle are the most likely points for potential releases and exposures.

With respect to this most fundamental of needs, I’m sorry to say that, in 2011, we are essentially no closer to achieving it than we were in 2004.  Read More »

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State-level nano regulation: Yes, indeed, the industry “should have seen it coming” – it caused it!

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

I just read an interesting column by John DiLoreto, CEO of NanoReg, that appears online at Nanotechnology Now.  It’s titled “We Should Have Seen It Coming: States Regulating Nanotechnology.”  It nicely describes the important role states play in advancing environmental policy and regulation – especially when the feds are asleep at the wheel.  And it also gives a neat rundown of the various state actions aimed at nanomaterials that are underway.

But, search as I might, I couldn’t find a single acknowledgment in Mr. DiLoreto’s latest column – or in his earlier related column titled “What Drives the Regulation of Nanomaterials?” – of the role the nanotechnology industry itself played in bringing all of this on itself.

That’s quite an omission, in my view, given that the industry’s actions (or, more accurately, the lack thereof) played a central role in getting us to where we are (or, more accurately, aren’t) today on nanotechnology oversight.  That includes driving states to feel they had to step in to fill the federal void.   Read More »

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EPA deserves an “A for Effort” for its new Chemical Action Plans

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

Just squeaking in under its self-imposed deadline, late on December 30 EPA issued the first batch of chemical action plans it has promised under its enhanced chemical management program.  In doing so, EPA has signaled its intention to do all it can using its existing authority under the Toxic Substances Control Act (TSCA) – even as it also makes clear that authority is “both outdated and in need of reform.”  To my ear, that strikes just the right balance. Read More »

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The nanotube SNURs: Nano step forward, nano step back

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

In June, EPA published a Federal Register notice that included Significant New Use Rules (SNURs) for two carbon nanotubes (as well as 21 other chemicals).  That notice certainly got the attention of lawyers in town (see here, here and here).  The nanotube SNURs would require anyone planning to produce or process either of the two substances to notify EPA if the person intended not to comply with the (rather limited) risk management conditions specified by EPA.  Well, as reported yesterday by Sara Goodman of E&E News, EPA is now withdrawing the SNURs, at least temporarily.

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