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May 13, 2010

TSCA Reform Webinar Follow-up

The ACTA Group

Thank you for participating in Bergeson & Campbell, P.C.’s webinar on TSCA Reform on Monday, May 10, 2010. We are delighted that you were able to participate, and hope that you found the information and format useful and convenient.

Apropos of our recent webinar, we thought we would use this occasion to share Charlie Auer’s response to a recent blog posting by Dr. Richard Denison regarding the reasons why Charlie believes some aspects of the current legislative initiatives to amend TSCA may reflect a bias against new chemicals. Charlie’s response is below.

Thank you for your thoughts, and thanks again for participating in our webinar.

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Dear Richard,

Regarding your recent posting, I guess every advocate needs a bogeyman and it seems I am it for this issue. I was surprised to see myself characterized as “the most vocal proponent” of a perspective. Wow. To begin, while I have industry clients in my little consulting company, I am speaking for myself and no one else on this issue. To further clarify, I am basing my comments on my lengthy experience at EPA in assessing and managing TSCA chemicals, including being personally involved in evaluating over 10,000 chemicals, many of them new chemicals, including during my time as chair of EPA’s Structure Activity Team (for about 8-10 years as I recall) and continuing thereafter as I moved up to the position of Office Director. Based on this experience I am quite familiar with the kinds of chemicals being introduced into commerce, as well as those already in commerce.

While at EPA during the early days of TSCA, we used to talk about “old new chemicals” and “new new chemicals.” Most new chemicals are “old new chemicals” which means that they are at best continuous improvement variations on their existing chemical competitors – they might be more selective or efficient in their chemical or product performance, or designed to avoid a particular issue or toxicity, or more energy efficient, or avoid the need for solvents in their applications, or any of a wide variety of often – but not always – minor continuous improvements, including in many cases multiple such improvements in a single new chemical. “New new chemicals” on the other hand are novel structures which approach a chemistry need in a new way. Relatively few new chemicals are of this type but they can represent important new developments. Carbon nanotubes are an example of such “new new chemicals.”

I believe it is important to encourage the introduction of both “old” and “new” new chemicals since both can contribute to the realization of a safer and greener chemical economy. Your blog posting broad-brushed my views. Yes, I do believe, based on my experience, that in general “old” new chemicals represent at least a relative improvement (i.e., safer and greener) compared to existing chemicals and to new chemicals from prior years. Which is not to say that new chemicals are without possible issues and concerns or that retrograde new chemicals are never notified: based on figures in the IG’s recent report EPA has imposed regulatory controls on 8% of new chemicals and an additional 5% were withdrawn by the notifier often in the face of proposed regulation (I note that this 13% figure is not unlike the 17% that the Canadians identified as needing more scrutiny in their Canadian Environmental Protection Act (CEPA) categorization effort). These actions included, e.g., during the 1980s stopping the introduction of benzidine, beta-naphthylamine, and other (likely) carcinogenic aromatic amine dyes; encouraging the introduction of “P-series” glycol ethers as replacements for “E-series” glycol ethers; working to understand the potential hazards and risks of new acrylate monomers and the “100% solids” acrylate polymer coatings made from them, and once this understanding was obtained, encouraging this important innovation which reduced solvent exposures and energy requirements; and numerous other improvements which may not have occurred without the oversight and encouragement of the new chemicals program.

Regarding “new” new chemicals, EPA’s approach in every instance was to treat these materials cautiously, imposing regulatory controls while taking steps to ensure an adequate understanding of their potential risks was developed. And this is what EPA has done with CNTs – exposures are tightly controlled and testing is being required strategically to ensure that needed understanding will be developed in a way that spreads the testing burden among the notifiers while allowing for the innovation benefits to be realized within limits (e.g., not all proposed uses are allowed, exposure controls are imposed, etc. – in fact while I was the Office Director all nanoscale new chemicals cases were run by me for the final decision regarding the regulatory and testing requirements and to ensure a high level of policy input into the development of the regulatory approach).

But I digress, since the major concern in your blog was on my view that imposing an upfront and immediately effective requirement for a minimum data set (MDS) on all new chemicals represented a “strong bias against new chemicals.” As your statistics show, over roughly the same period, there were 4,000 new chemicals introduced in the EU versus over 20,000 in the US. Considering that we notify polymers (~55% of PMNs), and they generally don’t (polymers made with >2% of a new monomer were considered new chemicals in the EU), and that your figures do not include the over 8,800 “low volume” section 5(h)(4) regulatory exemption chemicals that have been approved by EPA through 2006 (see pages 7-12) – 4,000 versus almost 18,000 nonpolymeric new chemicals introduced into commerce is a stark and telling difference. The major difference between the US and the EU’s scheme (other than premanufacture versus premarket notification, respectively) is the requirement for a minimum data set in the EU – so yes, it is clear that an upfront testing requirement while it does provide data at the outset, does have the cost of a significant reduction in the number and likely the variety of new chemicals. This I believe, based on my experience with new chemicals (which says they are generally safer and greener), would negatively affect both access to, and the timing of access to, new chemicals in the US.

I believe this is an important issue to wrestle with. I further believe it is on the proponents of the “upfront MDS” approach to make some kind of a showing that the US approach has failed in some way. Given the potentially large costs that would be imposed upfront on new chemicals with resultant likely significant drops in innovation through declines in the introduction of new chemicals, what is the evidence that such costs are reasonably justified and necessary? Recognizing that almost 30,000 new chemicals have been introduced into US commerce, if the problem is as serious as you believe surely something more than vague “concerns” must be behind your issue. While I was at EPA, we regularly “checked our work” looking for errors or problems in new chemical decisions (and not just the GPRA reviews the IG’s report talked about) and few problems were found especially when considering potential risks. For example, while EPA may have underestimated or missed a toxicity endpoint, the new information did not change the assessment of risks or the controls imposed (how can this be? Well, for instance, EPA identified a concern for neurotoxicity and liver toxicity was seen in the section 5(e) study, but the overall risks were not different). Nonetheless, EPA continuously ran the new information or test data back into its assessment approaches to strengthen them for the future. This is not to say EPA was perfect but rather that, in my view, it did a responsible and credible job of protecting the American public and environment despite the limitations in the law.

So what does this mean in the context of the MDS? I believe it provides a reasonable basis for a more flexible and measured approach that helps to continue the kind of new chemical innovation that was realized under TSCA while taking steps to improve the approach and ensure against errors. Despite your characterization of my views, I do not oppose MDS testing on new chemicals, rather I believe that both new and existing chemicals should be treated equivalently and that the timing of the testing requirement on new chemicals is a critical component in the approach. I outlined my thinking in an October 2009 co-authored paper in BNA, a copy of which can be obtained here, as follows:

Congress should find mechanisms to revise TSCA to enhance data submission requirements for new chemicals, and to do this in a way that enhances the capacity for the U.S. to keep innovation and market incentives within the U.S. economy. One way to meet these goals is to make the new chemical requirements generally consistent with the reporting and testing requirements to be imposed on existing chemicals. This can be achieved by:

  • requiring premarket notifications for new chemicals to include basic production, exposure, and use information plus any available hazard and environmental fate information that the company has generated for the substance world-wide, with EPA having the ability to require early development of test data when the Agency identifies any concerns; and
  • requiring the notifier to undertake and complete the same data set that would be required for existing chemicals when the chemical reaches certain production volumes, in accordance with the same time period allowed for an initial report on existing chemicals that EPA establishes (three years might be a workable initial reporting period for submittal of such test data on chemicals newly entering the market).

Following premarket notification and meeting such an initial data submission requirement, a “formerly-new” chemical would need to meet any regular periodic testing and reporting requirements that are established for existing chemicals.

Thus I would approach the MDS differently and not apply a blunt upfront requirement for the MDS as the current legislative drafts do. As is evident, it is not accurate to claim that I am opposed to minimum testing on new chemicals, rather my approach is more nuanced and focused on using the statute to encourage the introduction of such chemicals while making it clear that they would need to meet the same test data standards as those on existing chemicals and with a time-frame generally similar to that applied to existing chemicals. While my approach would doubtless also have an impact on the introduction of new chemicals, I believe it is more measured and balanced and would avoid the blunt impact of an upfront MDS while ensuring that this gap in understanding was filled within a few years time.

Your blog posting raised a number of other issues which I may come back to in the future. ‘Til then


Charlie Auer
Charles Auer & Associates, LLC