Subcommittees Examine Scientific Processes Used In Carcinogen Classification

Apr 25, 2012
Subcommittees Examine Scientific Processes Used In Carcinogen Classification

Washington D.C. – Today the House Science, Space, and Technology Committee’s Subcommittee on Investigations and Oversight held a joint hearing with the Small Business Committee’s Subcommittee on Healthcare and Technology to examine how the Department of Health and Human Services’ National Toxicology Program (NTP) develops its Report on Carcinogens (RoC) classification, and how these reports affect small businesses.

The RoC is a congressionally mandated, science-based, public health report that identifies substances that may pose a risk to people in the United States. The NTP published the 12th RoC last year and is embarking on preparations for the 13th RoC.

“As a legislator, I am very concerned with protecting public health and safety,” said Investigations and Oversight Subcommittee Chairman Paul Broun, M.D. (R-GA).  “As a physician, I take this responsibility even more seriously.  When substances are found to be harmful, we should make every effort to minimize the public’s exposure.  We also have a responsibility to ensure that these determinations are appropriate, are not arbitrary or capricious, and are communicated correctly.”

Healthcare and Technology Subcommittee Chairwoman Renee Ellmers (R-NC) added, “While the National Toxicology Program is preparing the 13th Report on Carcinogens, it is important that we have an open conversation about how the process could negatively affect small businesses.  When the government publishes scientific information that could have widespread negative consequence on small business owners, the government has the responsibility to ensure that the information is determined with a scientifically sound process.”  Ellmers continued, “It is extremely important that we protect Americans from harmful substances, but this can be done while also protecting our nation’s primary job creators from premature backlash and unnecessary burdens.”

The recent release of the 12th RoC demonstrates how confusing this process can be.  In a report published last April on the Environmental Protection Agency’s Integrated Risk Information System assessment of formaldehyde, the National Academy of Sciences questioned EPA claims that exposure to formaldehyde can result in increased risk of leukemia and other cancers.  Yet two  months after the Academies’ report, NTP issued the 12th RoC with an upgrade in the listing of formaldehyde to a “known” carcinogen, based in part on claims similar to those made by EPA, and dismissed the Academies’ report in an addendum.  Since then, concerns have been raised about how the RoC is developed and how its findings are communicated. 

Dr. Richard B. Belzer, President of Regulatory Checkbook, testified that science should play a larger role in RoC development. Dr. Belzer said, “For the RoC to ever produce useful information about human carcinogens, the authorizing statute will have to be changed.  Legalese will have to be replaced with the language of science…Only then will it be possible for the RoC to have any practical value for informing decisions.”

Further criticizing processes behind the RoC, Dr. James Bus of The Dow Chemical Company, said that the RoC process “is almost entirely ad hoc and lacks explicit criteria needed to assure consistency and transparency.” Dr. Bus said that the process “lacks adequate checks and balances, including peer review and addressing outside/conflicting data” and also “fails to employ scientific best practices.”

Beyond concerns with the underpinning science behind the RoC, witnesses today also discussed potentially negative implications of ambiguous findings in these reports.  Testifying on behalf of Strongwell Corporation, which makes products such as ballistic panels that protect American soldiers in Iraq and Afghanistan, Mr. John Barker, said his company is “very concerned about the potential regulatory burden that could be placed on our operations should the RoC listing form the basis of regulatory changes.”

Chairman Broun concluded saying, “Because the RoC has such great impact, it is critical that these reports reflect the best available science…Ultimately, we have to ensure that the public has the best information possible in order to protect their health.”
 

The following witnesses testified today before the Committee:

Panel I

Dr. Linda S. Birnbaum, Director, National Institute of Environmental Health Sciences & National Toxicology Program, U.S. Department of Health and Human Services

Mr. Charles A. Maresca, Director of Interagency Affairs, Office of Advocacy, U.S. Small Business Administration

Panel II

Dr. James S. Bus, Director of External Technology, Toxicology and Environmental Research and Consulting, The Dow Chemical Company

Dr. L. Faye Grimsley, Associate Professor, Tulane School of Public Health and Tropical Medicine, Department of Global Environmental Health Sciences

Ms. Bonnie Webster, Vice President, Monroe Industries, Inc.

Ms. Ally LaTourelle, Esq., Vice President, Government Affairs, Bioamber, Inc

Mr. John E. Barker, Corporate Manager, Environmental Affairs, Safety and Loss Prevention, Strongwell Corporation

Dr. Richard B. Belzer, President, Regulatory Checkbook