Congress of the United States

Washington, D.C. 20515

July 17, 1996
Ms. Carol Browner
Administrator
U.S. Environmental Protection Agency
401 M Street, S.W.
Washington, D.C. 20460

Dear Administrator Browner:

We are writing concerning EPA's recent proposal to update its cancer risk assessment guidelines. it has come to our attention that the proposed guidelines may be misleading thereby depriving the public of a full and fair opportunity to provide comments. It is unclear whether the requirement that epidemiologic studies be statistically significant is included in the proposed guidelines.

EPA's current cancer risk assessment guidelines include the requirement that epidemiologic studies be statistically significant prior to inferring causal relationships between a human exposure of concern and cancer. However, it is my understanding that this requirement may not be contained in the proposed guidelines. Moreover, I have heard that the proposed guidelines discuss statistical significance in a way that may mislead the public into thinking that statistical significance remains a requirement when, in fact, it does not.

While we are deeply concerned that EPA has effectively proposed to delete the statistical significance requirement, an action that conflicts with the position of the National Research Council, at this point, we are more concerned that EPA has not made full and fair disclosure of its intentions. We would appreciate it if you can clarify whether this requirement is or is not included in the proposed cancer risk assessment guidelines. If it is included, please comment on how the agency intends to make it clear to the public as to whether or not it is included.

We appreciate your assistance in securing a swift response to this matter.

Sincerely,

/s/
William F. Clinger, Jr.
Chairman
Committee on Government Reform and Oversight

/s/
Robert S. Walker
Chairman
Committee on Science

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