(How) Can ChAMP get back on track?

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

As I noted in our first post on ChAMP, after getting off to a strong start in 2007, EPA's abrupt decision in 2008 to steer ChAMP in the direction of cranking out hasty risk decisions was entirely its own.  Can ChAMP be put back on track? 

Neither EPA's own advisory committee – which had many members from the chemical industry as well as a few environmental NGOs – nor the commitment made by the U.S. under the North American Security and Prosperity Partnership (SPP) agreement signed with Canada and Mexico in August 2007, called for such risk assessments or risk-based prioritizations.

The commitment EPA made under the SPP agreement was "to assess and initiate needed action on the over 9,000 existing chemicals produced above 25,000 lbs/yr in the United States."  There was no mention of risk assessment anywhere in the agreement.  Indeed, at that time, EPA had already begun to publish hazard characterizations, which, as assessments of the hazards of high production volume (HPV) chemicals – fully meet the terms of its SPP commitment.

EPA's focus on developing HPV chemical hazard characterizations was also precisely what it had committed to do when it adopted, in November 2005, the recommendations of its own National Pollution Prevention & Toxics Advisory Committee (NPPTAC).  Specifically, it agreed to complete and make public such hazard characterizations on all HPV chemicals for which it had received final data sets from the HPV Challenge – some 1,200 chemicals – within four years.

How close is EPA to meeting that commitment, with only six months to go?  As of today, EPA has issued only about 130 hazard characterizations covering about 315 HPV chemicals (many of the chemicals are in categories).

So EPA's rush to risk is not only resulting in flawed risk decisions that are prematurely exonerating hundreds of chemicals, as described in our earlier posts.  It is also causing EPA to renege on its promise to characterize the hazards of all sponsored HPV chemicals in a timely manner – and to clearly identify gaps in the quality and completeness of the data received under its voluntary program.

In short, EPA is compromising the public's right to know about the hazards of the most widely used chemicals in U.S. commerce.  That's quite ironic when you consider EPA bills the HPV Challenge and ChAMP as cornerstones of its Chemical Right to Know Initiative.

What should EPA be doing under ChAMP?

EDF is the only environmental NGO that has been willing to engage with EPA, first on the HPV Challenge and more recently on ChAMP.  We served on advisory panels, participated in public meetings, carefully peer-reviewed draft assessments, filed comments and met with EPA staff repeatedly.

Even now, we are the only voice in our community arguing that the HPV data and ChAMP could provide value if it got back on track.

We have pointed out that many of the shortcomings of the HPV and ChAMP initiatives are due to EPA's limited authority under the Toxic Substances Control Act (TSCA), and we are actively working toward fundamental reform of TSCA to give EPA the tools it needs to do a better job.

But we also believe that in the interim, and despite EPA's constraints under TSCA, EPA can and should be doing a more credible and valuable job under ChAMP.

EPA should:

  • Return the focus of ChAMP to completing high-quality hazard characterizations for HPV chemicals, rather than rushing to issue highly suspect risk characterizations based on flawed assumptions and poor-quality use and exposure information.
  • For each chemical assessed, clearly identify and communicate to the public all gaps or quality concerns in available data.
  • Stop assigning low-priority rankings to chemicals, especially those with data gaps in the most basic, minimum set of screening-level hazard data. As we said before, it's one thing for EPA to identify as high-hazard those chemicals where, despite the data gaps, available data demonstrate high toxicity. It's quite another for EPA to effectively exonerate chemicals as low-hazard or low-priority when not even a bare-minimum data set is available for them.
  • Adopt a health-protective approach to hazard screening: Where data are uncertain, of questionable quality or equivocal, assume a hazard exists until and unless a chemical's manufacturer provides the data to show otherwise.
  • Issue test rules to require that gaps in submitted data sets be filled.
  • Significantly accelerate issuance of test rules for all of the unsponsored HPV Challenge chemicals, and for the hundreds of newly emerged HPV chemicals that have never been sponsored.
  • For the ~4,000 medium-production volume (MPV) chemicals – which are also covered by the SPP commitment, and for which even less data are available than for HPV chemicals – focus on identifying and acting to address data needs to support more robust hazard assessments, rather than pursuing its current approach of using scientifically unsupportable extrapolations of data among loosely defined "clusters" of such chemicals.

For chemicals for which significant hazards are identified, here are some of the good recommendations that NPPTAC offered as steps EPA could take even under its current TSCA authorities, which EPA has yet to act upon (under each, I've added a few elaborations and additional thoughts of my own in brackets):

  • Gather additional information on uses (e.g., by use function, category, release potential, or benefit) and exposure (to humans and/or the environment).
    • [Listing such substances on the Toxics Release Inventory would be a great way to get direct exposure data. Efforts to get better use and exposure information - well beyond the data EPA got from manufacturers under its Inventory Update Rule (IUR) - could extend to downstream users of chemicals. Information on functional use would help in identifying safer substitutes within the same functional class.]
  • Gather additional information on hazards to support a more in-depth characterization.
    • [Our reviews of EPA's risk decisions have identified many cases where available studies raise more questions than they answer, or identify additional concerns. EPA should require further testing in such cases.]
  • Identify existing risk management programs and practices. Evaluate existing Federal and State regulatory controls (e.g., occupational exposure limits).
    • [Instead, in many cases EPA merely asserts the existence or effectiveness of such practices, and seems particularly averse to even suggesting that some risk management might be needed.]
  • Provide information referrals or recommendations for actions to other EPA program offices or other Federal or State agencies.
    • [These could include referrals to OSHA requesting action on chemicals posing high worker hazards, proposing that the Centers for Disease Control or the U.S. Geological Survey add such chemicals to their biomonitoring and surface water monitoring programs, referring chemicals to its own Design for Environment (DfE) program to assess the availability and safety of available alternatives to hazardous chemicals, and referring such chemicals to the Food and Drug Administration where they have uses or are in consumer goods that fall under its jurisdiction.]

That's more than enough to keep the EPA toxics office busy for the foreseeable future.

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4 Comments

  1. cauer
    Posted May 18, 2009 at 12:20 pm | Permalink

    Dear Richard,

    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

  2. Posted May 20, 2009 at 2:34 pm | Permalink

    Charlie:

    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.

  3. cauer
    Posted May 22, 2009 at 6:41 am | Permalink

    Richard,

    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

  4. Posted June 8, 2009 at 1:33 pm | Permalink

    To continue this thread and see my response to Charlie's second comment just above, please go to this new post.

    Richard Denison

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