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EPA Workshops Aim To Address Criticisms Over IRIS Assessment Process

Some of the events will target specific major pending risk analyses, including EPA's risk assessments for hexavalent chromium and other key chemicals.

According to a newly released InsideEPA.com bulletin, the Environmental Protection Agency is readying a series of workshops aimed at addressing lingering criticisms over delays, a lack of public input and other flaws in its Integrated Risk Information System program, or "IRIS," with some of the events targeting specific major pending risk analyses including the agency's risk assessments for hexavalent chromium (Cr6) and other key chemicals.

Even as EPA pushes ahead with efforts to make the IRIS process more transparent and scientifically rigorous, chemical industry officials continue to question the amount of progress the agency is making.

Kimberly Wise, a toxicologist with the American Chemistry Council (ACC), said in Feb. 26 remarks at the annual industry conference GlobalChem at National Harbor, MD, that EPA has not updated the risk assessment process since former EPA Administrator Lisa Jackson unveiled the 23-month, 7-step process in May 2009.

"In 2013, the missing parts are problem formulation, planning and scoping, stakeholder engagement and document management," Wise said. "It would be really helpful to know how this is included in the 2009 process."

EPA officials at the conference said that the agency continues to try and improve how it conducts the IRIS studies, which are often used as the basis for decisionmaking. Lynn Flowers, the deputy director for health at EPA's National Center for Environmental Assessment (NCEA) -- which manages the IRIS program -- announced that staff is preparing for four upcoming workshops that will target major aspects of the process long criticized by industry.

The first is a virtual meeting slated for late spring focusing on the Cr6 assessment, according to Flowers' slide presentation at GlobalChem. Industry groups have raised data quality concerns over the agency's controversial 2010 draft assessment for Cr6 that labeled the metal a human carcinogen and was expected to drive stricter regulatory standards.

EPA will then hold a workshop at its Research Triangle Park, NC, campus to discuss scientific information on mouse lung tumors, also in the late spring. Flowers said the focus of the mouse lung tumor workshop is to "get information around the state of the science regarding napthalene, ethyl benzene and styrene" -- three chemicals for which EPA is developing IRIS assessments that also could drive new regulatory requirements.

Flowers also said that in the early summer, the agency will hold a "public dialogue session" on systematic review, a new methodology for performing literature searches, evaluating studies and data, and answering scientific questions that the National Toxicology Program and various academic researchers are developing.

Staff is also planning a "public dialogue session" on weight of evidence in early summer, according to Flowers' slides. Some EPA critics claim flaws in how the agency assesses weight of evidence in IRIS studies.

The workshops reflect EPA's ongoing efforts to overhaul the IRIS process, which includes recent text the agency added to its IRIS website Feb. 6 saying the agency had augmented some of the existing IRIS development steps to include elements that new NCEA Director Ken Olden is introducing, including internal and external stakeholder meetings in the early stages of drafting IRIS assessments.

Shortly after EPA posed the text to its website, it was removed. An agency spokeswoman says, "Language about specific enhancements to the EPA's [IRIS] process was prematurely posted to EPA's webpage."

Another key event in reviewing the IRIS program will be the first meeting of EPA Science Advisory Board's (SAB) new Chemical Assessment Advisory Committee, which the board says will be held April 2-3 in Washington, DC. Former research chief Paul Anastas prompted the new committee's creation in response to a critical review of EPA's draft IRIS assessment of formaldehyde in 2011 by the National Academy of Sciences.

An agenda for the meeting is yet to be made publicly available. According to SAB's website, the meeting will include a "briefing on the IRIS program and the development of IRIS toxicological reviews."

The full release is available from InsideEPA.

 

 

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