Dose-response implications of the University of Alabama study of lymphohematopoietic cancer among workers exposed to 1,3-butadiene and styrene in thesynthetic rubber industry
Rl. Sielken et C. Valdez-flores, Dose-response implications of the University of Alabama study of lymphohematopoietic cancer among workers exposed to 1,3-butadiene and styrene in thesynthetic rubber industry, CHEM-BIO IN, 135, 2001, pp. 637-651
New quantitative cancer risk estimates for exposure to 1,3-butadiene are pr
esented. These estimates are based on the most recent human epidemiologic d
ata developed by Drs Delzell and Macaluso and their colleagues at the Unive
rsity of Alabama at Birmingham. The implications of Poisson regression anal
yses of the relative rate for leukemia are explored using their updated dos
e estimates and lymphohematopoietic cancer data. The Poisson regression mod
el in these analyses has the same form as in the U.S. Environmental Protect
ion Agency (EPA)'s draft risk assessment of 1,3-butadiene [U.S. Environment
al Protection Agency, Health Risk Assessment of 1,3-Butadiene - External Re
view Draft, National Center for Environmental Assessment, Office of Researc
h and Development, 63 Fed. Reg. 7167 (February 12, 1998) Publication NCEA-W
-0267, Washington, 1998]. Consistent with the proposed cancer risk assessme
nt guidelines of the EPA and the EPA's draft risk assessment, the explorati
on includes the maximum likelihood estimate of the 'effective concentration
' (EC01) corresponding to an extra risk of leukemia of 0.01 (1%) from a lif
etime continuous exposure to 1,3-butadiene based on a linear dose-response
model and the cumulative 1,3-butadiene dose metric (ppm-years). The incorpo
ration of the most recent exposure estimates results in a 2.5-fold decrease
in the estimates of leukemia risks computed by EPA. In addition, three cha
nges proposed by the American Chemistry Council (formerly the Chemical Manu
facturers Association) to the EPA's Science Advisory Board (SAB) for EPA's
draft risk assessment of 1,3-butadiene are incorporated into the calculatio
n. This results in approximately an additional fivefold decrease in the ris
k estimates of leukemia. The leukemia cancer risk estimates in the EPA's dr
aft risk assessment of 1,3-butadiene decrease by approximately a factor of
13-fold when the updated epidemiologic data and the alternative numbers pro
posed by industry to the SAB are both incorporated. Specifically, the maxim
um likelihood estimate of the EC01 increases from EPA's 1.2 ppm to 2.8 ppm
on the basis of the updated epidemiologic data and increases further to 15.
1 ppm when the CMA's proposed changes are also incorporated. (C) 2001 Elsev
ier Science Ireland Ltd. All rights reserved.