[Pharmwaste] EPA Seeks NAS Advice On How To Assess Chemicals' Safer Alternatives

[DeBiasi, Deborah (DEQ)]

EPA Seeks NAS Advice On How To Assess Chemicals' Safer Alternatives
Posted: September 25, 2013

At EPA's request, the National Academy of Sciences (NAS) is launching a panel to provide the agency with advice on how it can better assess human health and/or ecological risks of alternatives to existing chemicals of concern, which could help the agency bolster its Design for the Environment program (DfE), which seeks to conduct such assessments.
"We're going to be getting some advice from an NAS panel in the coming months about how we do these kinds of assessments," EPA toxics chief Jim Jones told the Safer Consumer Products Summit in Washington, D.C. Sept. 18. "We are very excited about alternatives assessments that we do under DfE."
But Paul Anastas, the agency's former research chief, is urging officials to devote more resources toward such green chemistry approaches.
The new NAS committee, "Design and Evaluation of Safer Chemical Substitutions -- A Framework to Inform Government and Industry Decisions," whose members are provisionally appointed, is charged with "develop[ing] a decision framework for evaluating potential safer substitute chemicals as determined by human health and ecological risks," according to NAS' website.
The NAS committee, which EPA is sponsoring, could help bolster the DfE program, which EPA officials and others have acknowledged lacks utility under current law. Environmental and health groups strongly criticized the program in 2012 because EPA's draft analysis of alternatives to the widely used chemical bisphenol-A (BPA) failed to interpret the toxicity data and downplayed the substances' potential endocrine disruption risks.
The agency Sept. 24 unveiled an alternatives assessment of hexabromocyclododecane (HBCD), a flame retardant chemical, that went further than the BPA assessment, finding that the substance has "persistent, bioaccumulative and toxic characteristics." The agency also identifies a butadiene styrene brominated copolymer as being "anticipated to be safer" than HBCD.
But in a statement announcing the HBCD alternatives assessment, Jones reiterated past concerns that the program has limited utility by itself and that Congress should strengthen the agency's regulatory authority under the Toxic Substances Control Act (TSCA).
"While EPA continues to support much needed reform of the [TSCA], EPA is taking steps now to address the public's concern with certain flame retardant chemicals, including making information available to companies to help them make decisions on safer chemicals," said Jones said in a statement. "The conclusions in this report are enabling companies who choose to move away from HBCD to do so with confidence that the potential for unintended consequences is minimized."
DfE Process
At the Safer Consumer Products Summit, Jones described DfE's approach to performing alternatives assessments, selecting chemicals that are of interest to stakeholders, and might be considered chemicals of concern. Program staff then invite stakeholders' participation in providing and discussing information about the chemical and potential alternative chemicals.
Jones, EPA's assistant administrator for the Office of Chemical Safety and Pollution Prevention, described alternatives assessments as a key component of his three-part strategy for managing chemicals that were on the market before TSCA was passed in 1976, and are more challenging for EPA to regulate because they are grandfathered from some requirements that apply to "new" chemicals.
He called this "promoting basically safer chemistries" in his Sept. 18 remarks. "I really want to talk in particular around Design for the Environment [DfE], a very exciting program and one that we're hoping we can take to a whole new level."
Anastas, EPA's last confirmed assistant administrator for the Office of Research and Development, charged in his remarks at the summit that DfE and other related programs receive too little funding compared with EPA's traditional regulatory role. Anastas, who resumed his position as the director of Yale's Center for Green Chemistry and Green Engineering last February after leaving EPA, was a key proponent of green chemistry and sustainability policy while at the agency.
"The traditional role of EPA is crucial, absolutely essential, must be strong and supported. And there's been a recognition at EPA that it's profoundly not enough," Anastas said Sept. 18. "The question of whether to regulate or to facilitate is best answered by saying, 'Of course, the answer is both.' And how to move from that traditional, and still, make no mistake about it, still the absolute core and the lion's share of all the attention of EPA is around that traditional role. When we talk about these brilliant programs like DfE and these other pollution prevention programs, make no mistake about it those are tremendously effective, very valuable and dramatically under-resourced. And those need to be supported."
The NAS committee's website says that it will "identify the scientific information and tools required by regulatory agencies and industry to improve and increase consideration of potential health and environmental impacts early in the chemical design process. The decision framework will be capable of integrating multiple and diverse data streams to support early consideration of potential health and environmental impacts as a part of fit-for-purpose decision making."
The committee's framework will explain how alternatives' benefits, human health risks and ecological risks can be described, and how the tradeoffs between these factors, "efficacy, process safety and resource use can be quantified."
In addition to creating the report, the committee will also provide two examples of alternatives assessments to demonstrate how the framework can be applied, according to the NAS website. The report indicates the committee's report "is expected to be issued in spring 2014."
The committee membership is provisional, with NAS accepting comments on its proposed members. The provisional chairman is David Dorman, a toxicology professor at North Carolina State University. Dorman was a member of the NAS committee that critically reviewed EPA's draft Integrated Risk Information System (IRIS) assessment of formaldehyde, including the now-famous chapter outlining improvements it recommended EPA make to all IRIS assessments.
Other provisional members include Ivan Rusyn, a genomics research professor at the University of North Carolina Chapel Hill who served on the NAS formaldehyde review committee with Dorman, Joel Tickner, an associate professor in the Department of Community Health and Sustainability of the University of Massachusetts Lowell and Greg Paoli, a Canadian risk assessment consultant. Paoli was a member of the NAS committee that in 2009 published the influential risk assessment report "Science and Decisions: Advancing Risk Assessment."
The committee held two conference calls last week, and its first meeting is scheduled for Oct. 10-11 in Washington, D.C. -- Maria Hegstad

Deborah L. DeBiasi
Email:   Deborah.DeBiasi at deq.virginia.gov
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Virginia Department of Environmental Quality
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PPCPs, EDCs, and Microconstituents
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