The following blog is a segment of a three part series regarding EPA’s Integrated Risk Information System (IRIS) program.
Part III: The Industry’s Commitment to Objective Chemical Assessments
Over the past several months, there have been claims that industry is trying to block chemical assessments. Industry does not seek to discredit or limit regulation; rather Americans deserve to know that high quality science is the foundation of government decision-making.
Since 2010, numerous peer-reviewed studies have been published and submitted to EPA regarding formaldehyde. Industry has regularly met with EPA career-level staff, including the Director of the Integrated Risk Information System (IRIS) program and the Director of the National Center for Environmental Assessment (NCEA) to share critical science on formaldehyde. These efforts were intended to ensure the assessment of formaldehyde is objective, employs rigorous scientific standards, and is reflective of real-world human exposure. Members of the scientific community have frequently called attention to the IRIS program’s failure to utilize the best available science or modern scientific approaches to draw conclusions regarding human health risk.
When reaching conclusions about human health risk, the IRIS program consistently fails to integrate scientific evidence in a systematic and balanced way. Moreover, the IRIS program has yet to demonstrate or document its full implementation of a series of recommendations made by the National Academy of Sciences in 2011 and 2014, including developing a clear set of criteria for judging the relative merits of individual mechanistic, animal, and epidemiologic studies for estimating human dose-response relationships as well as issuing a handbook to outline the IRIS assessment process.
IRIS assessments are also known to generate overly conservative estimates that are not reflective of actual human health risk. Some recent IRIS assessments have even proposed that exposure to certain chemicals at levels that are below those levels naturally produced by the human body or below natural environmental background levels poses an unacceptable risk. These kinds of conclusions defy common sense.
Since IRIS assessments don’t undergo a “reality check” to ensure the risk values make sense, they can lead to unnecessary public alarm and cause the Agency to make poor risk management decisions. Simply utilizing IRIS information, regardless of the quality or relevance of the science, is not acceptable and is counter to the congressionally-mandated scientific standards required for EPA assessments.
Ensuring the safety of our industry’s products and addressing potential risks from exposure is important. We take this responsibility seriously. To accomplish this task, a transparent science-based approach that incorporates current knowledge about chemical hazards and relevant human exposures is imperative.