September 2005
Council Petitions EPA Regarding Carcinogen Classification
On August 23, the American Council on Science and Health (ACSH) petitioned the EPA to eliminate "junk science" from the process by which it determines whether a substance is likely to cause cancer in humans. The petition, filed on behalf of ACSH by the Washington Legal Foundation (WLF), a public interest law firm, argues that current EPA guidelines violate the Information Quality Act (IQA), the law that requires the federal government to ensure the "equality, objectivity, utility, and integrity" of information it dispenses to the public. Specifically, EPA routinely declares chemicals "carcinogens" - implying a likelihood of a health threat to humans - based solely on the creation of tumors in laboratory rodents by the administration of maximally-tolerated doses irrelevant to ordinary human exposure levels. Furthermore, effects in a single species may not be applicable to another species (rat tests do not even reliably predict effects in mice, which are closely related to rats, let alone effects in humans), though similar effects in multiple species might be an indicator of a genuine problem.
As documented in a current ACSH report, declaring substances "carcinogens" (when they would more properly be called high-dose rodent carcinogens) is a chief source of health panics, public outcry, activist crusades against chemicals, and waste of resources from unnecessary abatement, cleanup, and product recall/reformulation/replacement. The EPA recently adopted Guidelines for Carcinogen Risk Assessment that provide guidance to agency personnel in making determinations that a substance is either a human carcinogen or is "likely" to be carcinogenic to humans. The ACSH/WLF petition requests that EPA comply with the IQA by eliminating "junk science" from those Guidelines. In particular, ACSH and WLF request that EPA eliminate statements that indicate that a substance may properly be labeled a "likely" human carcinogen based solely or primarily on the results of animal studies. Such statements are scientifically unsound, argues the petition, which notes that the great majority of toxicologists share that assessment. The law permits EPA, if it so chooses, to adopt policies that err on the side of caution when faced with genuinely equivocal evidence regarding a substance's carcinogenicity, but the IQA does not permit EPA to distort the scientific evidence in furtherance of such policies. The petition argues that EPA distorts scientific evidence through its Guidelines' use of "default options," its purported right - based not on scientific evidence but its regulatory mission to protect human health - to assume that tumors in lab rodents indicate that much smaller doses can cause cancer in humans. Erring on the "safe side" in regulatory decisions does not, argues the petition, permit EPA to falsely claim that such regulated substances truly are "likely to be carcinogenic to humans." To do so, argues ACSH, is a distortion of both science and law. (ACSH release, 8/23/05).
