Evaluating Studies to Understand if a Chemical Causes Cancer

IRIS graphic identifier

By Kacee Deener

When friends ask me what I do, I always mention the Integrated Risk Information System (IRIS) Program and explain that through IRIS, EPA scientists help protect public health by evaluating scientific information on the health effects that may result from exposure to environmental contaminants.  The questions inevitably come up—how do you do that, and what kind of information do you look at?

Scientists around the world contribute to the knowledgebase about the health effects of chemicals.  A particular area of interest has been chemicals’ potential to cause cancer.

Because EPA’s work must be grounded in the best possible science, we recently updated how we consider some of the cancer research of the Ramazzini Institute (RI), a laboratory in Italy known throughout the world for their extensive work in this area, completing cancer studies for more than 200 compounds.

A few years ago, the National Toxicology Program (NTP) identified differences of opinion between their own scientists and those from the Ramazzini Institute in diagnosing certain types of cancers in a study on methanol.  The scientific community—including EPA—was concerned, since Ramazzini data was included in IRIS evaluations.  We reviewed all of our IRIS assessments to determine which, if any, relied substantially on RI data; we found four that did, and we put those assessments on hold.

To follow up, EPA and the National Institute of Environmental Health Sciences cosponsored a group of scientists with expertise in evaluating tissue samples and making disease diagnoses, a Pathology Working Group (PWG), to review several Ramazzini Institute studies. They found some instances where respiratory infections in Ramazzini study animals made definitive diagnoses difficult, and disagreed with some Ramazzini diagnoses, primarily certain leukemias and lymphomas that had been identified. Therefore, EPA decided not to rely on RI data on lymphomas and leukemias in IRIS assessments. There was agreement, though, in diagnosing solid tumors, and EPA decided to continue to consider Ramazzini Institute solid tumor data in IRIS assessments.

This has been an important issue in the world of chemical risk assessment. Last week, this was highlighted once again when a paper authored by EPA scientists, Scientific Considerations for Evaluating Cancer Bioassays Conducted by the Ramazzini Institute, was published in Environmental Health Perspectives.  The article interprets Ramazzini Institute study results and compares their testing protocols with those used by other federal agencies.  The results were consistent with the PWG findings—Ramazzini Institute results for cancer endpoints other than lymphoma and leukemias, and some cases of tumors of the inner ear and cranium, are generally consistent with those of the National Toxicology Program and other laboratories.  The paper also notes that, while differences in Ramazzini Institute testing protocols can complicate the interpretation of study results, they may also provide chemical risk assessors with insights that might not be observed in other laboratories.

The short answer to my friends’ questions is that EPA works to use the best available science—from across the U.S. and around the world—to support IRIS and our other assessments designed to protect public health.

About the Author:  Kacee Deener is the Communications Director in EPA’s National Center for Environmental Assessment, home of the IRIS Program.  She joined EPA 12 years ago and has a Masters degree in Public Health.

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