Readers of MassTortDefense who have an interest in toxic torts may wish to take note that the Environmental Protection Agency’s (EPA) Office of Research and Development recently announced revisions to the Integrated Risk Information System (IRIS).

What Is IRIS?

IRIS is a compilation of electronic reports on specific substances found in the environment and their potential to cause human health effects. IRIS was initially developed for EPA staff in response to a growing demand for consistent information on substances for use in risk assessments, decision-making and regulatory activities. For each chemical contained in IRIS,  the database contains summary information on the studies evaluated, any uncertainties or assumptions made in the studies, a statement of the level of confidence that EPA has in the study, the names of EPA scientists to contact for more information, and complete bibliographic citations. See Report of the IRIS Quality Action Team on External Peer Review and Public Involvement at 5 (July 1994).

IRIS provides human health risk information describing the potential adverse health effects that may result from exposure to over 540 environmental contaminants. IRIS includes descriptions of hazard identification and dose-response information, quantitative risk estimates for chronic non-cancer and cancer effects, and access to searchable scientific documentation.

Not Just Regulatory

While EPA often will base regulatory rules on IRIS evaluations, this is not just a regulatory issue. IRIS is generally accepted as a reliable source of information on the potential hazardous effects of those chemicals that are included in IRIS. See National Oilseed Processors Ass’n v. Browner, 924 F.Supp. 1193 (D.D.C.,1996). Thus, proffered experts in the toxic tort branch of products litigation may refer to and seek to rely on IRIS. E.g., Avance v. Kerr-McGee Chemical, 2006 WL 39124272 (E.D. Texas 1/1//07); Allgood v. General Motors, 2006 WL 2669337 (S.D. Ind. 9/18/06). And this is true of class actions, e.g., Pohl v. NGK Metals Corp., 2003 WL 24207633 (Pa. Com. Pl. 7/9/03)(rejecting medical monitoring class action), and mass toxic torts. E.g., In re Welding Fume Products Liab. Litig., 2006 WL 4507859 (N.D. Ohio 8/8/06).

The upcoming changes are to the process for developing chemical assessments, and will include an expanded process for recommending a substance be assessed; the earlier involvement of other agencies and the public; hosting “listening sessions” to allow for the broader participation and engagement of interested parties; and an even more rigorous scientific peer review of IRIS assessments.

How It Works And How It Will Change

On an annual basis, the IRIS Program requests nominations for new or updated IRIS assessments from EPA Program Offices and Regions and from the public. The IRIS process has started with the development of a draft Toxicological Review for the chemical.  A health scientist, referred to as a Chemical Manager, is assigned to each substance. The Chemical Manager is responsible for developing the draft assessment and shepherding draft documents though the review process. Development of a draft assessment consists of a literature search and preparation of a draft Toxicological Review and an IRIS Summary. The Chemical Manager may work with a team of toxicologists, epidemiologists, and statisticians in reviewing and analyzing the available literature. EPA’s risk assessment guidelines form the basis for the analysis. This work is often supported by an EPA outside contractor.

The next stage includes internal and external scientific reviews of the draft document, conducted in accordance with Agency guidance on peer review. These may include internal (EPA) peer review, a review by a standing group of senior health scientists representing EPA’s Offices and Regions and by selected senior health scientists with scientific expertise relevant to the substance, review by other federal agencies, and external peer review, typically via a panel meeting. Final steps are the EPA response to review comments, and development and posting on the IRIS web site of an IRIS Summary and final Toxicological Review.

The new steps in the process include increased participation by other federal agencies and the public in the development of the Toxicological Review and greater opportunities for other federal agencies to conduct research to fill data gaps. Together, these changes to the IRIS process are supposed to help create a more predictable, streamlined, and transparent process for conducting IRIS assessments. A major stated goal of the Agency is to define the important role that public and inter-agency comments and interactions play in the process, and to foster greater communication and sharing of relevant scientific information between experts, interested parties, and EPA.

Effects on Readers?

The revised procedure is not without controversy, as environmental groups and Democratic legislators – ironically those often calling for more public input and participation – have argued that chemical risk assessments will become a “special-interest scrum.”  But for clients of readers of MassTortDefense, it may offer increased opportunities to ensure their voice is at least heard.