Richard Denison, Ph.D., is a Senior Scientist.
This new post serves as a response to Charlie Auer's most recent comment responding to our critique of ChAMP. (To see the whole exchange, start here, then go here, here and here.) So far, this exchange has focused mainly on our disagreement over whether or not EPA is somehow required to do risk assessments under ChAMP. At some point, I hope Charlie and others will engage on the substance of our critique – the serious concerns we've raised about the quality and validity of the ChAMP assessments.
Risk-based at all costs?
In Charlie's latest comment, his main interest seems to be to lock in EPA's current approach under ChAMP. He steadfastly maintains that EPA now has no choice but to turn out risk decisions for HPV chemicals under ChAMP, given its 2007 commitment under the Security and Prosperity Partnership (SPP) signed by President Bush.
For all the reasons I've stated earlier, I strongly dispute that conclusion. Indeed, it is striking how the chemical section of the SPP agreement – including the very language Charlie cites ("the three countries [are] to enhance appropriate coordination in areas including testing, research, information gathering, assessment, and risk management actions") – seems to go out of its way to avoid linking the words "risk" and "assessment." That term never appears.
I don't dispute, as Charlie says, that "US and Canadian [regulatory] actions are risk-based." Indeed, EDF supports the view that, in most cases, chemical regulatory actions ought to be risk-based, or certainly ought to take into account both hazard and exposure.
Now, if ChAMP were actually proposing any actions to mitigate risk, e.g., to restrict production or use of any HPV chemicals through regulation, Charlie's argument might be germane. But as we've noted, ChAMP's not doing that, even for the few chemicals it has designated to be of high risk and high priority.
So the fact that EPA will only consider regulating a chemical based on risk in no way requires that EPA must do risk assessments under ChAMP – regardless of whether the data available to the agency are sufficient to support such assessments.
Indeed, the SPP agreement was signed well before the use and exposure information EPA has collected under the Inventory Update Rule (IUR) were made public and its major deficiencies were realized. I disagree with Charlie that the mere fact that EPA collected such data compels it to use them regardless of their adequacy.
As we noted in our last two posts on ChAMP, in cases where hazard concerns warrant action, there are lots of steps the agency could be taking to manage or reduce potential risks – without having to wait for the emergence of use and exposure data of sufficient quality to carry out a risk assessment. EPA itself has taken such actions occasionally, for example in launching the 2010/2015 PFOA Stewardship Program.
Sacrificing the public's chemical right-to-know on the altar of risk
Add to this the fact that EPA's insistence on pursuing the "rush to risk" under ChAMP is delaying the public's right-to-know about the hazards of HPV chemicals, and I have to strongly question the wisdom of EPA's devoting most of its limited chemical program resources to doggedly pursuing this course.
I also am disturbed by Charlie's conclusion that his and EPA's interpretation of the SPP commitments "are superior to and overtake informal EPA commitments made to pursue the NPPTAC recommendation." Recall that NPPTAC recommended, and EPA agreed, that the agency issue hazard characterizations and identify remaining data gaps for some 1,200 HPV chemicals by the end of 2009, which it's nowhere closing to meeting.
What NPPTAC called for did not come out of thin air: It reflected the core purpose of the HPV Challenge, which was in turn the cornerstone of EPA's much-touted chemical right-to-know initiative: It would be tragic indeed if EPA chooses to negate its public right-to-know commitments by saying they've been trumped by a political decision made by the last administration.
Under ChAMP, the minimum data set has become wholly optional
Charlie cites OECD guidance calling for integrating exposure considerations into assessment activities. We have no quarrel with that, as long as the exposure information is sufficient; but as our examples amply demonstrate, that is not the case with the IUR data.
Nor does consideration of exposure in any way obviate the need for a complete Screening Information Data Set (SIDS). International experts convened by the OECD, including from the U.S., devised the SIDS to be the minimum amount of hazard data needed on which to base a screening-level assessment. EPA itself has repeatedly acknowledged this fact; see, for example, p. 15 of this EPA report on the HPV Challenge. Outside of some very limited derogations (e.g., for closed-system intermediates) from certain endpoints, full SIDS data sets are to be provided – wholly independent of exposure considerations.
The need for such complete screening data sets is all the more critical given that EPA is intent on making low-priority designations that preclude, for the foreseeable future, any further data development. Yet under ChAMP, EPA is routinely making such designations for chemicals that lack the basic SIDS data set.
Acknowledging the limitations
It's very helpful and refreshing that Charlie, as former head of EPA's toxics office, acknowledges that EPA faces high hurdles in trying to mandate testing through issuing TSCA test rules. That's what many of us have been saying for years, and it's among the strongest arguments for why we so badly need fundamental reform of TSCA.
But even without issuing test rules, EPA could help this situation enormously by forthrightly and transparently identifying and acknowledging the significant gaps and deficiencies in the quality of data remaining for HPV chemicals sponsored under the Challenge. Instead, Charlie and EPA are papering over the problems through their rhetorical sleight-of-hand of substituting "data gap" with "data need."
Interestingly, Charlie argues that instead of our pressing EPA to pursue test rules, we should just wait for the European Union's REACH Regulation to provide most of the data we need. As tempting as that sounds, some notes of caution are warranted. First, for all tests involving laboratory animals, REACH requires only that test proposals, not test results, be submitted at the time of registration. So even in the best of circumstances, much of the data we need for HPV chemicals likely won't be available for some time after the registration deadline of December 2010. Second, as I've discussed at length elsewhere, it remains to be seen just how much testing will be required under REACH.
I also appreciate that Charlie has acknowledged the need for major changes in EPA's Inventory Update Rule, given the hugely disappointing results of the latest data collection effort. I agree with many of his thoughtful proposals for needed fixes. I'd add another: Require annual reporting of production and use data. The current reporting requirement is limited to only a single year once every five years – yielding a highly distorted view of actual chemical production (for more on this, see p. 38 of this paper).
But given the rate at which ChAMP is churning out risk decisions using the current IUR data, I must heartily disagree with his notion that we should set aside concerns about those data and only focus on making improvements for the next IUR collection cycle. That collection won't even begin until 2011, and if this last round is any guide, data won't be released until 2013 or 2014. On EPA's current trajectory, ChAMP will have already cranked through all of the HPV chemicals by then.
Bottom line: ChAMP embodies a blatant double standard
Charlie's responses to date (and the lack of any response from current EPA staff) suggest an unwillingness to engage on the substance of our critique of EPA's ChAMP assessments – its systematic reliance on incomplete and/or poor-quality data, a problem further compounded not only by EPA's refusal to reject such data and identify them as gaps, but its use of such flawed data as a basis to claim no or low toxicity, and thence to draw unwarranted low-risk conclusions about hundreds of HPV chemicals.
All of this brings me to the crux of the problem: Under ChAMP, EPA appears more than willing to rely on limited hazard, use and exposure data to effectively exonerate scores of chemicals, by relegating them to the low-priority dustbin. Yet in the few cases where EPA has had to conclude, using the same quality of data, that a chemical poses a high level of concern, no action to control such chemicals is even proposed.
Charlie's characterization of such high-priority chemicals as being only "putative positives" is quite telling. It's a clear illustration of just how high a bar EPA has set to initiate action to reduce use of or exposure to (or even mandate testing of) a problematic chemical – in contrast to the remarkably low bar it must clear to dismiss a chemical altogether.
That's a double standard I just can't abide.