Tag Archives: Significant New Use Rule (SNUR)

Doing its best under a flawed law: 35 groups file comments supporting EPA efforts to reduce exposure to toxic flame retardants

Jennifer McPartland, Ph.D., is a Health Scientist. Richard Denison, Ph.D., is a Senior Scientist.

Today Environmental Defense Fund and Earthjustice, joined by 33 other health and environmental groups, filed comments that urge the U.S. Environmental Protection Agency (EPA) to swiftly move forward with two proposed actions to regulate a group of toxic flame retardants called PBDEs (polybrominated diphenyl ethers). 

The first proposed rule would require anyone intending to begin production, processing or import of any PBDE, or a product containing one, to notify EPA before doing so.  This would give the agency an opportunity to evaluate the risks of the proposed activity and if necessary take action to restrict or prohibit it.  The second proposed rule would require anyone who continues after 2013 to produce, process or import any PBDE, or a product containing one, to conduct extensive tests needed to allow EPA to determine the risks posed by those ongoing activities.   Read More »

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No orphan left behind: Health and environmental NGOs support EPA’s proposed paired rules to address high production volume "orphan" chemicals

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

Environmental Defense Fund today submitted comments along with 15 other health, environmental justice and state and national environmental organizations, in support of EPA’s proposed rule to address the final batch of 45 “orphan” chemicals that were never sponsored under the agency’s earlier High Production Volume (HPV) Challenge Program.

An earlier post to this blog highlighted and applauded the novel, innovative and efficient approach EPA has proposed, which actually entails the coupling of two rules:

(1) a test rule for 23 of these HPV chemicals for which EPA can make the requisite exposure findings to require testing, combined with:

(2) a Significant New Use Rule (SNUR) for the other 22 HPV chemicals for which EPA cannot presently make such findings, which requires companies to notify EPA if their production or use of those chemicals changes so as to increase the potential for exposure and then warrant testing.

The comments we filed today reiterate our strong support for this approach – and propose that the same approach be extended to several additional batches of HPV chemicals that still lack a basic set of hazard data.

Read More »

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EPA proposes yet another TSCA workaround: Creative, yes, but why not just give it the authority it needs?

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

One thing I’ve learned in observing EPA try to operate under the Toxic Substances Control Act (TSCA) over the years is that – faced with limited authority and significant evidentiary and resource burdens – the Agency often has to resort to a workaround to get something it needs to do done.

Can’t ban a nasty chemical?  Wait until it’s voluntarily withdrawn and then pounce on it with a Significant New Use Rule (SNUR) to try to wedge the door closed.  Witness PFOS and penta and octaBDE.  (Under TSCA, without a SNUR in place on a chemical, a new producer or importer could start up without even letting EPA know; where EPA has issued a SNUR for a chemical, advance notification is required and EPA least has a chance to weigh in before production or import proceeds.)

Can’t require an up-front minimum data set for new chemicals?  Recommend to companies that for certain chemicals they submit such a data set along with the pre-manufacturing notice (PMN) they’re required to file, or risk having EPA extend the review of their new chemical or negotiate with them to do the testing.  EPA has made such “recommendations” for those relatively few new chemicals where the company “anticipates” at the outset producing it in large amounts in the first three years or where significant release or exposure is projected. 

The latest such workaround?  EPA’s simultaneous issuance of a proposed test rule and a proposed SNUR for a batch of high production volume (HPV) “orphan” chemicals that no company agreed to sponsor under the Agency’s voluntary HPV Challenge Program.

Necessity is the mother of invention, they say, and these creative new proposals are a case in point.  But, my oh my, there’s gotta be a better way…. Read More »

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

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

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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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 »

Posted in Health Policy, TSCA and REACH | Also tagged , | Comments closed

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 »

Posted in Health Policy, Nanotechnology, TSCA | Also tagged , , , , | Comments closed

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 »

Posted in Health Policy, Nanotechnology, TSCA | Also tagged , , , , | Comments closed

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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