W23 - Symposium
Examples and Challenges to Understanding the Mutagenic Mode of Action in EPA's New Supplemental Guidance for Assessing Cancer Risks from Early Life ExposuresScotland B 3:30-5:00 pm
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| Chair(s): L. Salamone
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In March of 2005, EPA released it Supplemental Guidance for Assessing Risk from Early Life Exposure to Carcinogens (SGAC). The SGAC details guidance for EPA risk assessors to adjust estimates of lifetime cancer risk for mutagenic carcinogens to account for potential increased early life susceptibility. EPA has not yet applied its mode of action criteria to determine which chemicals are carcinogenic by a mutagenic mode of action, but activities to regulate chemicals using this SGAC will begin soon. This Symposium will discuss challenges to implementation and interpretation of the guidance, from an industry and a state perspective, present a case study of one such example, summarize the state of the science for chemical carcinogens, with an emphasis on evaluation frameworks for establishing a mutagenic mode of action, to include a discussion of practical criteria for arriving at a weight of evidence conclusion regarding a “mutagenic mode of action.”
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W23.1 Challenges of Implementation of EPA's New Supplemental Guidance for Assessing Cancer Risks from Early Life Exposures. Becker R. A.; American Chemistry Council Rick_Becker@americanchemistry. com
Abstract: The science behind the development of the guidelines was extensive, but examples of how the guidance would be applied are only beginning to emerge. How might federal and state agencies use the guidance to implement public health or environmental standards? How will the guidance affect decision making for industry?
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W23.2 Practical Criteria for Concluding that a Carcinogen is Acting via a Mutagenic Mode of Action. Butterworth B.E.; Butterworth Consulting bebutterworth@earthlink.net
Abstract: How difficult is the challenge to establish a nongenotoxic mode of action given the highly protective nature of regulatory carcinogen risk assessments? The type of data required and practical aspects of determining carcinogenic mode of action will be reviewed. Emphasis will be on evaluation frameworks for establishing a mutagenic mode of action. The strengths, weaknesses and relevance of select bacterial, cell culture, whole animal, and human cell assays will be contrasted. What criteria can be used to establish a weight of evidence conclusion, particularly with large data sets where there is invariably a scattering of reported positive responses, even for clearly nongenotoxic compounds?
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W23.3 A State's View of the EPA's New Supplemental Guidance for Assessing Cancer Risks from Early Life Exposure. DiZio S.; California Environmental Protection Agency sdizio@dtsc.ca.gov
Abstract: How does a state envision the challenges posed by the new Supplemental Guidance? An example from state experience showing how the new guidance will influence efforts to acquire property, build, or expand school sites.
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