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Environmentalists Say Draft EPA Cancer Guidelines Must Be Broader To Protect Children
(from March 5, 2003)

EPA announced in the Federal Register on March 3, 2003 (68 FR 10012-10015) the Draft Final Guidelines for Carcinogen Risk Assessment and is asking for public comment until May 1, 2003. According to the agency, "In particular, the revisions to the Guidelines are intended to make greater use of the increasing scientific understanding of the mechanisms that underlie the carcinogenic process. EPA is especially interested in public comments on the following areas: 1) use of default options; 2) hazard descriptors; 3) mode of action; 4) extrapolation to lower doses; and 5) susceptible populations and lifestages. At the same time, EPA is making available for public comment draft Supplemental Guidance describing possible approaches that could be used to assess risks resulting from early life exposure to potential carcinogens." At the same time, EPA is making available for public comment draft Supplemental Guidance describing possible approaches that could be used to assess risks resulting from early life exposure to potential carcinogens.

The following is taken from the EPA notice: In 1986, EPA published a set of risk assessment guidelines, including Guidelines for Carcinogen Risk Assessment. These Guidelines set forth principles and procedures to guide EPA scientists in assessing the cancer risks from chemicals or other agents in the environment and to inform the public about these procedures. EPA continues to revise its risk assessment guidelines and to develop new guidelines as experience and scientific understanding evolve. EPA has designed its risk assessment guidelines to be flexible enough to accommodate future scientific advances in science and risk assessment practices. Because this current draft has already benefited from extensive public comment and multiple rounds of expert scientific review by EPA's Science Advisory Board (SAB), the Agency is requesting that public comments focus on discussions of specific science issues that are substantively revised or newly addressed since the publication of the 1999 revised draft cancer guidelines.

As part of the revisions process, the Agency published Proposed Guidelines for Carcinogen Risk Assessment in 1996 (61 FR 17960, Apr. 23, 1996). The draft revisions have been subject to extensive public comment and scientific peer review, including three reviews by EPA's Science Advisory Board. In 2001, EPA published a notice (66 FR 59593, Nov. 29, 2001) providing an additional opportunity for public comment on a 1999 draft of the Guidelines. Comments were invited on experience gained in applying previous draft revised Guidelines and on specific issues raised in previous comments by the SAB and the public.

Environmental Commentary

Environmentalists' reaction to the draft is mixed. Advocates support the notion that children, being more sensitive to toxic exposure than adults, require a special analytical framework and extra precautionary standards. To the extent that the guidelines recognize this, environmental advocates see this as a step forward. However, EPA is proposing a standard that applies a ten-fold extra margin of safety for children two years and under, while it has been shown that in some cases chemicals may be as much as 65 time more potent to children under the age of two. EPA data shows that half of a person's lifetime cancer risk is experienced in the first two years of life. Jane Houlihan, vice president of research for Environmental Working Group, also cites that the guidelines focus on mutagenic (damage to DNA) cancer risk, while there other mechanisms of cancer that must be considered. Mutagenic carcinogens include arsenic, benzene, formaldehyde, mutagen X, brominated organics and polycyclic aromatic hydrocarbons. Because there are chemicals with other mechanisms than mutagenicity, such as phthalates and atrazine, Houlihan says that the coverage of the guidelines must be expanded.

EPA contact information: William P. Wood, by phone at: 202-564-3361, by fax at: 202-565-0062, or by email at: http://www.risk.forum@epa.gov.