EPA seeks to improve TSCA data reporting; a real litmus test looms for the chemical industry

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

While I was on vacation last week, EPA's proposed rule to improve chemical information reporting under its so-called Inventory Update Rule (IUR) was finally published in the Federal Register.  (I say "finally" because the proposal languished for almost 6 months over at OMB, nearly double the 90 days such mandatory reviews are supposed to take.  That unfortunate delay is curious given the relatively modest changes that appear to have been made by OMB – mostly limited to compelling EPA to shift a few elements from proposals to options open to comment, and requiring EPA to expand the range of issues on which it now seeks comment.)

I won't summarize the EPA proposals here; EPA's factsheet does a good job of that, and Daniel Rosenberg at NRDC has also nicely recapped the proposal on his blog.  Suffice it to say that the proposed changes would go far to address the many failings of the current IUR, which amply manifested themselves in the last reporting cycle and severely hampered EPA's ability to assess high production volume (HPV) chemicals under its ill-fated ChAMP Initiative.

So how will the chemical industry react?  Here's why I'll be watching intently. 

Perhaps the most prominent of all of the chemical industry's talking points about chemicals management is that all decisions on chemicals must be risk-based.  (Let's set aside for the time-being the contradiction between that position and the industry's demand in the context of TSCA reform that new chemicals be allowed onto the market without a risk-based safety determination.)

A risk-based system demands robust chemical production and use information

The only means by which sound risk-based decisions can be made is for EPA to have access to robust information not only on a chemical's hazards, but also on chemical production, processing and use to inform its assessment of the potential for exposure to the chemical.  (Recall that risk = hazard x exposure.)  Under TSCA, the only routine means for EPA – and for that matter the entire Federal government – to collect chemical production, processing and use data is the IUR.

So, if the chemical industry is serious about wanting a risk-based system – one that will actually restore the confidence of its customers as well as the public about the safety of chemicals – surely it'll welcome and support EPA's proposals to ensure it has the chemical production, processing and use data it needs, right?

We'll see.  The last time EPA proposed changes to the IUR, back in 2003, the industry flooded the Agency with comments seeking to limit the reporting requirements; if you don't believe me, just peruse this docket containing the hundreds of industry comments EPA had to address.

Will ACC abide by its principles calling for greater EPA authority to get good chemical information?

The American Chemistry Council's much-touted principles for modernizing TSCA also call for EPA to have ample authority to get the data it needs to determine safety, and for the industry to bear the responsibility of providing the data it possesses or can generate.

Having good information is also critical to EPA's ability to effectively prioritize chemicals, another of ACC's ten principles (though, as I reported in a recent post, ACC appears to be having second thoughts about prioritization, based on its President's recent Congressional testimony).

So the extent to which the chemical industry lends its support to EPA's proposal – or simply resorts to its old nickel-and-diming ways of the past – will be a good test of whether those principles actually mean anything or not.

The industry continues to attack every attempt by EPA to act on chemicals of concern

I'm frankly more than a bit skeptical about how industry will respond.  That skepticism was boosted after seeing ACC's latest tirade about the new batch of chemical action plans EPA issued this week.  That attack came despite ACC's principle (#6) calling for EPA to "be empowered to impose a range of controls to ensure that chemicals are safe for their intended use, … [including] labeling, handling instructions, exposure limits and engineering controls to use restrictions and product bans."

EPA's latest plans address benzidine dyes, the flame retardant hexabromocyclododecane (HBCD) and nonylphenol ethoxylates (NPEs).  Mike Walls of ACC went after EPA for targeting HBCD in particular.

To give you a sense of how extreme ACC's position is, HBCD is a persistent, bioaccumulative and toxic (PBT) chemical that is in the crosshairs of authorities worldwide:

  • The European Union has not only identified HBCD as a "Substance of Very High Concern" (SVHC) under REACH, it has also placed it on its Candidate List of SVHCs – the first step toward subjecting it to REACH's authorization process, and HBCD is one of only seven Candidate List SVHCs the EU has prioritized for action – the second step in the authorization process.
  • HBCD is also moving along the rather convoluted process leading to restrictions under the global Stockholm Convention governing persistent organic pollutants (POPs), and will be on the agenda for the 6th meeting of the POPs Review Committee to be held in Geneva in October.

More frequent is better – even the industry would seem to agree

One improvement EPA is proposing to the IUR is to require more frequent collection and reporting of chemical production information – a direct response to what EPA terms "mounting evidence that many chemical substances, even larger volume chemical substances, often experience widespread fluctuations in manufacturing volume from year to year."  EDF has been raising this concern about the IUR for years.

I was pleased to see that EPA has cited in its Federal Register notice (see p. 49644) comments that several industry sources – the American Petroleum Institute, Society of Chemical Manufacturers and Affiliates (SOCMA) and Procter & Gamble – submitted to EPA in regard to a different matter.  Those comments corroborate the year-to-year fluctuation, and lend support to EPA's proposal to require more frequent reporting.  Hopefully this will make it harder for the industry now to reverse course and oppose EPA's proposal.

Let's wait and see

So, EDF, for one, will be watching closely to see how hard the chemical industry pushes back against EPA's modest proposals – which, after all, are merely intended to provide EPA, the market and the public with the information they need to make better informed decisions.  Surely the industry can support that?

Fighting information requirements has been second nature to the industry for so long that it may be hard to change its ways.  Let me close, therefore, by pointing to one encouraging sign.  Some companies subject to the EU's REACH Regulation (under which the first registration deadline is rapidly approaching) seem to be coming around, seeing actual benefits from the information REACH has compelled them to develop and report.

Case in point:  As reported by Chemical Watch [subscription required] last month, a new report by the German chemical industry trade association VCI – ACC's direct counterpart – discusses implementation of the Global Product Strategy (GPS) of the International Council of Chemical Associations (ICCA), of which ACC is the U.S. representative.

The report touts the efforts of companies like BASF, Dow Chemical, Bayer and Evonik (formerly Degussa) to meet market, government and public demands for more chemical information and evidence of safety.  It quotes Dr. Klaus Engel, Chairman of Evonik (which I should note also operates here in the U.S.):

"The data requirements under REACH are enormous.  While some used to consider this a bother, for GPS it's now a blessing."

Seeing as we're going second, after the EU has already acted, don't we have a chance in the U.S. to turn such welcome hindsight by the industry into foresight when it comes to reforming our own chemicals policies?

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One Comment

  1. Bill Katakis
    Posted August 21, 2010 at 2:32 am | Permalink

    EPA, Please, consider the last several years work on cancer stem cells and keep it in mind when you set up standards and tests for nano particles, as well as the 70,000 chemicals that remain untested for carcinogenic potential. Cancer stem cells pump out chemo, and grow faster when exposed to radiation, unless actually fried. They can be latent then wake up, they can be created from normal cells, from repair stem cells,(Gostjeva et al, M.I.T.) and even consist of "reawakened" embryonic stem cells from our fetal and childhood growth phases, (Laird, USC, Journal Nature Genetics) The creation and direction of these cells by chemicals and nano products must be part of the testing that insures human safety. Cancer stem cells are indeed cancer's evil heart.

    Sincerely,

    Bill Katakis and my collaborator, the late Robert Bruandage PhD Biophysics

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