An Evaluation of the Human Carcinogenic Potential of Ethylene Glycol Butyl Ether: Interim Final Position Paper
In order to determine the merit of a petition to remove ethylene glycol ether (EGBE) from the Agency's Hazardous Air Pollutant (HAP) list, EPA has developed an interim final position paper, An Evaluation of the Human Carcinogenic Potential of Ethylene Glycol Butyl Ether, that evaluates the relevance to humans of tumors observed in mice following two-years of inhalation exposure to this widely used solvent. Key to this assessment has been the determination of the relationship between the primary noncancer effects observed in the experimental animals, forestomach irritation and red blood cell damage, and the observed forestomach and liver tumors. In May, 2003, a draft of the position paper received a letter review by five scientists external to EPA. The paper was revised, and the resultant interim final position paper was used as part of the support for the Agency's proposed rule to delist EGBE from the HAP list (68 FR 65648, November 21, 2003). The public comments on this proposed ruling were due January 20, 2004 and can be viewed at www.regulations.gov (ID OAR-2003-0188). The current, interim final position paper states that the existing evidence indicates that prevention of the noncancer effects of EGBE exposure can be expected to prevent carcinogenic outcomes as well. However, it also identified some important genotoxicity and toxicokinetic data gaps that would need to be filled before a definitive determination can be made. On May 19, 2004, a workshop will be held to provide for an external panel review by seven experts capable of evaluating these data gaps and the conclusions of EPA's position paper in light of the recent research and literature that has been submitted to the Agency in response to the Agency's proposed EGBE ruling.