Richard Denison, Ph.D., is a Lead Senior Scientist. Rachel Shaffer is a research assistant.
[UPDATE 6/24/14: Perhaps in response to this post of last week, an updated agenda for this week’s IRIS meeting was posted by EPA today that reflects a somewhat more balanced set of speakers. Industry interests appear to have consolidated their number of slots, down from a high of 8 to a high of 6 per issue, and down from a high of 6 to a high of 4 individuals per issue from the same consulting firm. In addition, several additional slots are assigned to non-industry speakers. If you wish to see the changes, here is the agenda we linked to that was current as of last week, and here’s the updated agenda posted today.]
In comments EDF made at a November 2012 stakeholder meeting held by EPA’s Integrated Risk Information System (IRIS) program, we warned that the tendency of the IRIS program to respond to criticism by expanding opportunities for “public” input would serve to increase rather than decrease the imbalance in stakeholder input.
We noted that providing more opportunities for participation not only lengthens the timeline for completing assessments; it also virtually ensures the input received by EPA is imbalanced and badly skewed toward the regulated community. That’s because companies that produce and use each chemical to be assessed – and the trade associations and myriad hired consultants that represent them – have a clear vested financial interest in the outcome of the assessment. They can and will take advantage of each and every opportunity for input, and they will be better represented than other stakeholders each and every time.
IRIS recently began holding bimonthly meetings focused on “key science issues” relating to upcoming assessments. And guess what? An army of industry representatives, including staff for trade associations and paid consultants, are overwhelming the agendas.
Exhibit A: Have a quick look at the list of speakers in the agenda for this month’s bimonthly meeting. A striking imbalance, no? As many as 8 industry representatives are set to speak on a given issue, including 6 from the same consulting firm! [UPDATE 6/24/14: See the top of this post for a description of the updated, slightly more balanced agenda; here is the agenda we had linked to that was current as of last week, and here’s the updated agenda posted today.]
It isn’t only EDF that has raised this concern. In its just-issued review of the IRIS program, Review of EPA’s Integrated Risk Information System (IRIS) Process (p. 5), the National Academy of Sciences’ National Research Council (NRC) recognized the same problem, warning that “not all stakeholders who have an interest in the IRIS process have the same scientific or financial resources to provide timely comments, and expanded opportunities for stakeholder involvement might lead to a further imbalance of public input.”
Achieving balance involves more than just improving accessibility; it also requires ensuring that actual participation is balanced, through placing speaking limits on overrepresented stakeholders and undertaking explicit outreach and providing support to underrepresented stakeholders. In its seminal 2009 report, Science and Decisions: Advancing Risk Assessment (p. 13), the NRC advised EPA to develop “incentives to allow for balanced participation of stakeholders, including impacted communities and less advantaged stakeholders.”
Similarly, in its 2014 review of the IRIS program, the NRC specifically suggested that the Agency look to efforts like the Superfund Program’s Technical Assistance Grants (TAGs) as models to support participation from a more diverse range of individuals.
EDF appreciates the IRIS program’s intent to streamline the assessment development process by providing an early, upfront opportunity for stakeholder input. However, without accompanying efforts to ensure more balanced participation, these opportunities can make matters worse rather than better.
We urge the EPA to immediately initiate steps to mitigate this growing and disconcerting imbalance. In conjunction with implementing these NRC recommendations regarding balancing input and resource assistance, Agency officials should also develop more effective approaches for soliciting input from relevant scientific experts and academic researchers to ensure better balance of participation.
Otherwise, a well-intended step becomes a further factor undermining confidence in EPA’s IRIS program.
2 Comments
Too right. As to implementing the NRC’s Silver Book progressive recommendations for risk assessment (RA), see how skewed to industry the parties are: http://www.allianceforrisk.org/ARA_Dose-Response_Sponsors.htm
ARA’s project mission is to make RA “fit for purpose” (the Silver Book’s mantra) …I guess that means keeping it as insensitive as always to detect actual toxicities; necessitating deep-sixing NRC recommendations such as assume no safe threshold dose (a big issue n making EU’s REACh law effective at banning chems, also).
Wake up everyone to the central fact: not only does industry perform the toxicity tests in all ‘pre-market’ (i.e. most) RAs; but the insensitive test methods that guarantee approval were developed by industry 120 – 90 yrs. ago (they may’ve been sensitive then, but they haven’t kept up), and it appears industry worked hard & fast to make them the standard for RA globally, after being forced to perform under GLP (the result of a whistleblower’s scandal at a huge industry testing lab, IBT).
Excellent points, Anthony! A few elaborations:
1. ARA is indeed skewed, but they are quite eager to portray it differently. Because I have long enjoyed working productively with folks from across the spectrum, I was a member of their group for a while, and by virtue of that they continually referred to “balanced participation from industry and NGOs” (I think I was the only participant remotely label-able as “NGO”). But when they wrote a error-laden and smug manuscript about “evolving beyond risk defaults,” and after I tried in vain to improve it over several iterations, I asked for my name to be removed– they did so, but refused to consider a footnote indicating that despite my presence on their webpage, I affirmatively dissented (rather than “failed to show up”) from the article (since published in Regulatory Toxicology & Pharmacology).
2. As a member of the NAS Silver Book committee, of course I can’t speak for the group, but I don’t think we were using “fit for purpose” as a mantra, nor is ARA using it the way we did. There’s nothing noteworthy or new about tailoring the assessment to fit the stakes and details of the decision. What we instead tried to do, (and what I tried to do with more freedom in a subsequent article (see https://www.law.upenn.edu/cf/faculty/afinkel/workingpapers/HERA_%28finkel%29%20solution-focused%20collection%20merged.pdf), was to suggest that the best “purposes” are those where bold questions are posed about alternative ways to fulfill a social or market need, and risk assessment (and economic cost assessment) used to compare alternatives, not just navel-gaze about risks in a vacuum. I know you’ve written about BPA in the past, and I would suggest that (1) traditional risk assessment would attempt to derive an acceptable limit for BPA in water stored in bottles; (2) a step towards “solution-focused risk assessment” would be to compare various plastic and metal designs for bottles (risks and costs of each); and (3) a truly useful solution-focused assessment would seek to “nudge” the market back to the time I remember when we (US figures) weren’t buying and discarding 29 billion bottles (of ANY composition) every year in order to consume a substance that falls freely from the sky. No leachate from drinking fountains…