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Letter dated 12/01/10 - Department of Health and Human Services

Via Electronic Mail

The Honorable Kathleen Sebelius
Department of Health and Human Services (HHS)
200 Independence Ave., S.W.,
Room 615-F
Washington, DC 20201

Dear Secretary Sebelius:

The U.S. Small Business Administration Office of Advocacy has received the attached letter from representatives of small businesses expressing concerns about the forthcoming listing of styrene as a “reasonably anticipated” carcinogen in the National Toxicology Program (NTP) Report on Carcinogens. The letter cites concerns about the process by which the NTP report has been developed and asserts that the report may not be based on the best available science because of these procedural issues.

Congress established the Office of Advocacy under Pub. L. No. 94-305 to advocate the views of small entities before Federal agencies and Congress. Because Advocacy is an independent body within the U.S. Small Business Administration (SBA), the views expressed by Advocacy do not necessarily reflect the position of the Administration or the SBA.

As Chief Counsel for Advocacy, I share the concerns expressed by these small businesses about the NTP process. It is crucial that the science used by HHS to make these determinations be above reproach, particularly as the NTP label becomes increasing important to regulatory determinations made by other federal agencies and state regulatory authorities. I also am concerned that technical labels used by government bodies, such as NTP, can mislead the public about the true nature of risks to health and safety and lead to adverse effects on the purchasing preferences of consumers and businesses without corresponding benefits.

For these reasons, I believe that the NTP should be committed to an open and transparent process that relies on the best peer reviewed science available and follow the best practices to avoid conflicts of interest. I also encourage NTP to consider all relevant scientific data in making its recommendations, including studies that show negative or null results. The exclusion of these studies from consideration would result in an incomplete data set, which is contrary to best scientific practice.

I ask that you carefully consider these concerns as the 12th Report on Carcinogens is finalized and the preparations for the 13th report are begun.



Winslow Sargeant, Ph.D.
Chief Counsel for Advocacy


The Honorable John Holdren, Director
Office of Science and Technology Policy

The Honorable Cass R. Sunstein, Administrator
Office of Information and Regulatory Affairs
Office of Management and Budget

Linda S. Birnbaum, Ph.D., Director,
National Institute of Environmental Health Sciences
National Institutes of Health
Department of Health and Human Services