Perhaps the most telling example can be found in the recent IRIS review of formaldehyde. Numerous health organizations have concluded that the evidence shows that the levels of formaldehyde most people encounter do not cause adverse health effects. Despite this, EPA completed its IRIS review, asserting that a link exists between exposure to formaldehyde and certain types of leukemia. EPA’s review quickly came under scrutiny.
The NAS report also offered a harsh critique of the IRIS program in general and devoted an entire chapter to program improvements that they saw as “critical for the development of a scientifically sound IRIS assessment.”
Part of the problem stems from the fact that IRIS relies on outdated methods. Over the years, researchers and health professionals have gained a greater scientific understanding of the human body; the ways chemicals can interact with the body at different levels of exposures; and how that knowledge applies to determine the safe use of chemicals. However, IRIS risk assessments lag behind these advances and rely too heavily on outdated assumptions formulated in the 1970s.
And, there is little independence in the program’s review process. The IRIS office controls the development of the assessment, the design of the peer review, and the evaluation of the peer review findings. Ultimately, the IRIS program itself decides which recommendations from peer review groups to act upon and which to ignore. As we have seen in recent assessments like that of dioxin, EPA has exhibited steadfast reluctance to improve assessments by addressing the recommendations of independent experts.
The current deficiencies and lack of confidence in the program cause delays and unnecessary costs. Flawed assessments create public confusion, unwarranted alarm, unnecessary product de-selection and litigation, all of which can put jobs at risk without sound scientific basis.
To restore credibility to the program, there must be an honest broker to ensure that EPA adequately considers and incorporates changes from peer reviews and public comments. While EPA announced some process changes earlier this week, we remain concerned about the lack of a truly independent peer review process. ACC continues to believe that NAS should review all pending IRIS assessments to ensure their quality until the systemic problems with the program are fixed.
While NAS review of pending assessments will help improve the program in the interim, EPA must also initiate a comprehensive overhaul of IRIS. For example, assessments under IRIS need to be based on proven scientific data and 21st century knowledge of how chemicals interact with the human body. These changes will ensure that the program completes assessments more efficiently and provides answers to the public, public health professionals and industry in a far more timely way.
Beginning with this week’s hearing, we hope Congress will help the administration renew its commitment to science, and fix IRIS so it can effectively protect health, safety and the environment and preserve the ability of American industry to innovate, compete and create jobs.
Cal Dooley is the president and CEO of the American Chemistry Council and a former Democratic member of Congress from California.