The National Academies’ National Research Council released its long-awaited report on IRIS this week, and the results are good for EPA. The report praises the IRIS program and its leadership, including Drs. Olden and Cogliano, for making great strides to improve how IRIS assessments are developed.
To get a real appreciation for how positive this report is, it’s important to put it in context. In 2011, a different NAS/NRC committee led by the same chairperson went out of its way to criticize the IRIS program for creating what the committee viewed as overly ponderous, sometimes confusing documents. That committee, which was organized to peer review a draft assessment of formaldehyde, went beyond its charge to complain about an IRIS assessment development process that it cast as not being fit for its weighty purpose (developing the scientific evidence upon which agencies regulate drinking water, Superfund cleanup, and other public health concerns). The 2011 report led to much Sturm und Drang about the future of the IRIS program, controversy that was further stirred by Members of Congress beholden to the chemical industry. In negotiations over the agency’s multi-billion dollar budget, the relatively puny IRIS program was singled out for special attention and EPA relented to sponsor the NAS committee that produced this week’s report.
With all of this attention, the IRIS program’s leadership team has been hard at work developing new policies, procedures, and organizational structures that will hopefully lead to more robust assessments completed more quickly. The NAS committee expressed a belief that the potential for improvement is there, but held out final judgment until the recent changes have been tested. And that’s the key point of context. IRIS assessments are critical to protective regulation, but in the three years since NAS dropped its bombshell formaldehyde report, the IRIS program has produced just five final assessments. Around that time, we estimated that more than 250 chemicals needed IRIS assessments to support better regulation of toxics in the air, water, and land.
While the NAS committee continued in this report to promote new stakeholder engagement opportunities that will inevitably lead to delay in the IRIS assessment development process, it thankfully endorsed one concept that could speed things up. “Stopping rules” are a way for the agency to say “we’ve searched the literature and developed a workable – if not absolute – understanding of the state of the science; now we’re stopping the literature review and moving on to the next stage of the assessment process.”
New studies are always popping up, so IRIS program staff need a way to determine when enough is enough. The more obstinate defenders of the status quo, who want to delay any new assessments or consequent regulations, suggest that stopping rules create the risk of over-regulating chemicals because they allow agencies to ignore new evidence of lower toxicity. But well-crafted rules are not biased one way or the other, in terms of what types of studies will be left for review in later editions of an assessment. Moreover, in a world of drastically shrinking agency resources, stopping rules are a practical necessity—the only way for the agency to keep pace with the need for new assessments.
The NAS committee also included a revolutionary – for the IRIS program, at least – recommendation regarding the role of environmental advocates and community groups. Borrowing from the Superfund program, the committee suggested that EPA provide technical assistance to under-resourced stakeholders who want to participate in the IRIS assessment development process. EPA could provide grants and consultative services to environmental and public health groups that have legitimate interests in the outcome of IRIS assessments but lack the multi-million dollar budgets that the chemical industry and its trade associations can bring to bear on IRIS.
This report should quell the uneasiness over the future of the IRIS program. Olden, Cogliano, and their team have put the program on firm footing and can now get to the business of cranking out new assessments.