Richard Denison

Thanks for the warm “welcome back into the fray.” I am pleased you found my comments thoughtful and intend to stay engaged in what I hope is a positive and informative manner. As noted in my earlier post, having retired from EPA these are my personal thoughts.

Regarding your SPP response points, while I agree that EPA has a certain flexibility in how it goes about meeting the commitments, I believe it is the clear intent of the SPP commitments to undertake risk assessment and risk management. And thus casting it (as your last response does) as “nothing in the SPP precluded EPA from shifting…(n)or did the SPP require EPA to make that shift” from hazard to risk assessment is an under-reading of the commitments made. US and Canadian actions are risk-based as you know and their bulleted commitments in the SPP text need to read in that context: “the United States to assess and initiate needed action…” and “Canada to complete assessments and take regulatory action…” Further to this understanding is the last of this set of bullet points in the text: “the three countries to enhance appropriate coordination in areas including testing, research, information gathering, assessment, and RISK management actions” (emphasis added). And my “most to the point” comment is that the SPP commitments, as commitments made by the US government together with Canada and Mexico, are superior to and overtake informal EPA commitments made to pursue the NPPTAC recommendation. I appreciate that you don’t agree with this course and that you prefer the approach in the NPPTAC recommendation, but the reality of the operative commitment is otherwise.

Regarding IATA, while much of the discussion is focused on categories, QSAR, etc., the OECD meaning is broader as outlined in its “Report of a Workshop on Integrated Approaches to Testing and Assessment (IATA)” (http://www.oecd.org/dataoecd/45/52/40705314.pdf) (emphasis added below):

From the Introduction: The Joint Meeting encouraged member countries to continue exchanging information and understanding views on applying the various building blocks in vivo and in vitro testing, (Q)SAR models, toxicogenomics, category and read-across assessment methodologies, weight of evidence, EXPOSURE CONSIDERATIONS, etc. to different kinds of chemicals and in different regulatory frameworks. (p 15)

From the Recommendations: Develop practical guidance on how to use screening information (including non-test data) to determine the most relevant endpoints for risk assessment, also taking into account EXPOSURE PATHWAYS (including environmental fate and transport). (p 20)

Regarding my point that assessments “can be revisited” and your question as to what will spur development of the information, there are a few future opportunities that will broadly inform new assessments:

the next cycle of IUR reporting will hopefully be more fully informative regarding exposures and uses, and

the testing that will be done under REACH should provide additional endpoint information which I expect EPA will be able to access either directly from the European Chemicals Agency (ECHA) or via the OECD’s eChemPortal (http://webnet3.oecd.org/echemportal/). The deadline for EU HPV dossiers is December 2010.

Regarding the first of these, I appreciate your efforts to improve the IUR reporting. However, while a more comprehensive treatment of what was/was not received has some value, given the realities of limited resources, I submit it is more important to get the reporting right in the next IUR cycle. In this regard, and recognizing the difficulties presented by increased reporting burden in light of Paperwork Reduction Act requirements, some of the key changes that I hope you are thinking about include the following: change the IUR’s reporting standard (e.g., to “reasonably ascertainable” rather than the current “readily obtainable”); apply the exposure/use reporting requirements to all IUR subject chemicals (i.e., down to 25,000 lbs/yr from the current 300,000 lbs/yr trigger); and, although most significant in terms of increased burden, extend reporting to processors (various options should be considered, including limiting this to the 300,000 lb/yr tier initially). In the category of good government, a flat requirement for electronic-only reporting would also be a great improvement and a cost-saver for EPA.

Regarding the second point, most domestic stakeholders agree that the US needs to figure out how to benefit from and apply the work that will be done under REACH in Europe. My view is that EPA’s toxics program, in order to meet its many competing demands despite its limited resources, needs to be prudent in its ChAMP test rule commitments given (1) the difficulty the Agency has had in completing such actions and (2) the expectation that it will have access to significant new information once it has been processed by ECHA and made available (which is likely to occur before a test rule can be proposed and promulgated, the testing completed, and then reported to EPA). The case you cite of the eight high-priority rankings (where, unacceptably, no hazard data were available) is an example of that prudence. By taking measured test rule actions at this time, thereby preserving resources for other assessment or control purposes, and recognizing that the REACH data (which will be relevant to many but, admittedly, not all of the US HPV chemicals) will come available in the relative near term will allow EPA to resolve many of the possible “false negatives” that concern you while allowing the Agency to focus more immediate attention on the “putative positives” that the available HPV Challenge and IUR data suggest. Once the extent of the overlap with REACH HPVs is clear, EPA can then determine which US HPV chemicals will require more attention to upgrade the available data sets.

All of which make me more sanguine about EPA’s course under ChAMP and the prospects for improved chemical assessment and management performance in the US over the short to intermediate term, even as we both look forward to a new statutory authority.

As always, with my best regards,
Charlie Auer

Welcome back into the fray! Thanks very much for posting your thoughtful comment and for your engagement on this issue, which I hope (and expect) will continue in this and other forums.

I certainly agree that nothing in SPP precluded EPA from shifting from doing hazard characterizations of HPV chemicals to making risk-based decisions. Nor did the SPP require EPA to make that shift, any more than it now precludes EPA from readjusting its priorities. Most to the point: EPA's decision to use the SPP commitment as the pivot to shift to risk decisions has had the effect of dramatically slowing down, if not derailing, meeting the Agency's public "chemical-right-to-know" commitment to develop and publish hazard characterizations for all HPV Challenge chemicals by the end of 2009.

We will, it appears, have to continue to agree to disagree on the importance of providing full SIDS hazard data sets for all HPV chemicals – a core promised outcome of the HPV Challenge. Having access to such data – and the associated hazard characterizations – is critical to inform all stakeholders and actors in chemical supply chains. That information is relevant to improving decision-making, no matter what the particular use or uses of such chemical may be; indeed, it's especially important given how limited and unreliable the available information on use and exposure is!

With respect to data gaps, we have never argued that all chemicals need necessarily be individually tested for all endpoints. As you know, EDF has been willing to support the appropriate use of read-across within chemical categories and related approaches to filling SIDS endpoints – and that's what I believe is the intent behind employing the "integrated assessment and testing approaches" to which you refer.

But, as the case examples we've posted here make abundantly clear, those approaches do not and cannot compensate for a wholesale lack of data – or a clearly inadequate study – on a given endpoint. Nor can they support read-across between chemicals that are only loosely structurally related or whose physical-chemical properties differ significantly.

The resulting deficiencies are both gaps and needs, without which there's simply no way to support a reasonable hazard, let alone risk, characterization of a chemical. Rather than proceed to rank chemicals as if such gaps did not exist, EPA has a responsibility to clearly identify such gaps and aggressively act to fill them. Yet we have identified numerous examples – with more to come – where EPA fails to do either.

Such gaps – whether in hazard or use/exposure data – matter less when the available data already flag a chemical as being of high concern. In such cases, more and better data may refine the assessment, but that is more likely to happen because the chemical has been so flagged. But it's a huge problem if, despite such gaps, EPA ranks a chemical as being of low concern. By our count, EPA has to date ranked as low priority and low hazard dozens of chemicals for which there are significant gaps in their SIDS data sets.

You argue that any of these assessments "can be revisited as new information (hazard or exposure) is received." But what will spur development of such information, if EPA is saying for low-priority chemicals that no further action is needed? (In fact, EPA’s high-priority ranking of eight HPV chemicals that lack any hazard data whatsoever is an example of using the ranking process to spur the generation of data.)

I certainly accept your call for us to engage (as, indeed, we have been doing already) in identifying ways to improve industry reporting under the IUR. We've met twice with EPA IUR staff to discuss our concerns. I would urge EPA to develop a comprehensive and transparent public assessment of the full extent of data received – and not received – under the IUR, and to itself recommend needed changes. Unlike the public, EPA has access to the roughly one-third of the data that were not released because they are claimed confidential by their submitters.

I also fully agree that EPA can and should be moving forward, doing what it can credibly do with the tools it has, even as we await TSCA reform. My hope is that EPA will fully engage in pressing for such reform. One of the best things it can do is to be accurate and forthright about the limits of the data and authorities it has. These things can best be achieved, in my view, by resetting ChAMP to do what it can credibly do, as I laid out in this blog post.

Again, Charlie, thanks for engaging on this. I would welcome others to do so as well, both on what you think ChAMP is doing well or not, and on the specific cases we've critiqued.

After my retirement in January I spent 3 weeks that month doing volunteer reconstruction in New Orleans (a great experience with the St. Bernard Project but sadly thousands of homes throughout NO remain to be dealt with), and since then I have started getting back into chemical assessment and management issues, including reading your blog and would like to offer some perspective. To be clear, having retired from EPA as the Director of the Office of Pollution Prevention and Toxics, these are my personal thoughts.

While I have a very high regard for your ideas and look forward to future opportunities to work together, I do believe that some of your criticisms of EPA’s ChAMP work, despite being cloaked in references to NPPTAC recommendations and the SPP agreement, are not well founded while others overstate the situation. As you outline in your most recent blog, you have closely followed EPA’s efforts and I thank you for that. While at EPA, I appreciated both your support and your criticisms – nonetheless, there are matters where we have agreed to disagree and it looks like that will continue.

I know from my time at EPA that you are in error in claiming that EPA in preparing ChAMP risk characterizations has gone beyond its SPP commitment – while the words “risk assessment” do not appear in the SPP text, neither do the words “hazard assessment.” Furthermore, EPA press materials on the SPP agreement make clear the role of risk:

August 21, 2007
The United States, Canada, and Mexico will work together to ensure the safe manufacture and use of industrial chemicals. The partnership will be built on EPA's ongoing efforts to study and characterize the risks of chemicals that are produced in high volumes. The United States is committing to complete, by 2012, risk characterizations and initiate needed actions on more than 9,000 chemicals produced above 25,000 pounds per year in the country. [R http://yosemite.epa.gov/opa/admpress.nsf/0cd7fdf95b701616852572a000658ef2/77660c0da9fe643e8525733e0065d48b!OpenDocument ]

I appreciate another of your points that OPPT’s advisory committee, the NPPTAC, did not recommend that EPA undertake risk characterizations. While conceding this point, I hasten to note that as you know the NPPTAC was never asked to consider extending EPA’s assessment efforts to include risk screening. This request was not possible because the Inventory Update Rule (IUR) reporting of exposure and use information was not available to EPA before the Advisory Committee was terminated due to a loss of balance in its membership. While it is difficult to surmise what the NPPTAC and its members might have advised, the fact is that the NPPTAC’s hazard characterization recommendation has been overtaken by the US government’s SPP commitment to assess on the basis of risks and the ChAMP risk-based characterizations (and the hazard-based characterizations on MPV chemicals) being posted represent EPA moving out to meet its SPP commitments. Thus, I hope you now appreciate that proceeding with the ChAMP risk characterizations does NOT represent a decision taken by EPA “entirely on its own” as you claim in your May 7 blog.

You also raise issues with EPA’s use of the HPV Challenge data sets. While I certainly won’t argue against the assessment value of complete screening data sets, I disagree that incomplete data sets are necessarily inadequate for a screening level assessment. I am not alone in this view, as the OECD, since the time when it agreed the SIDS data set, has come to recognize and value concepts such as “integrated assessment and testing approaches” as a valuable component in an overall strategy of testing and assessment. While much of the debate in the OECD and in the HPV Challenge once focused exclusively on “data gaps,” it now focuses more on “data needs.”

Relatedly, I believe that EPA’s use of the IUR exposure and use data is an important component in the ChAMP efforts and in judging data needs. While you criticize the IUR data and while I acknowledge its limitations, the fact remains that the IUR data, despite being limited to manufacturers, represents what is at this time the most current and comprehensive reporting of existing chemical exposure information available to any government and the information will continue to be updated over time under the current regulation. I believe that the government, having required industry to submit the IUR exposure/use data, has a responsibility to use that information for the intended purpose and in so doing to identify issues and problems with the data and apply that understanding to produce improved reporting. I encourage you and others having an interest in this issue to closely follow – and offer comment on – any amendments to the IUR reporting regulation which EPA proposes. While I believe it is a question of “when” not “if” TSCA will be revised, I believe it is prudent for EPA to continue to develop such tools and approaches – and for the Agency to continue its risk-based ChAMP efforts until a new law is enacted.

A final point is the statement in your April 20 blog that asks why EPA thinks “such incomplete [IUR] data …is sufficient to draw DEFINITIVE EXPOSURE AND RISK CONCLUSIONS about HPV chemicals” (emphasis added). I don’t believe this is what is being done/claimed by EPA. It is clear to me that EPA is conducting relative screening level assessments that serve to inform priority decisions at this time and which can be revisited as new information (hazard or exposure) is received. Could the IUR data sets be improved, certainly, but I don’t believe the limitations preclude their use for the purposes of initial risk screening assessments.

Richard, thanks for the opportunity to offer my thoughts on some of the debatable points in your recent blog postings. I am concerned that your approach would have EPA turn back the clock and ignore its SPP risk screening commitment. EPA has been struggling to meet its chemicals responsibilities despite a 30-year old law and grossly inadequate resources – perhaps new legislation will deal effectively with the issues and needs presented but until then I believe EPA needs to continue to strive to meet the needs using ALL the information it has available to it.

With my best regards,
Charlie Auer