The ILSI/HESI Workshopon Alternatives to Carcinogenicity Testing aims to develop and apply new methods for assessment of potential carcinogenic risk to humans from various chemicals. The Workshoprepresents a major cooperative scientific effort. The long-term goals should be to greatly enhance the effi ciency and reliability of such testing and to supplant, not just supplement, lifetime rodent bioassays. There are now well-established frameworks for risk assessment and risk management, putting risks into public health context and engaging stakeholders. The Lave-Omenn value-of-information model provides a useful way to assess the social costs and benefits of different strategies for testing large numbers of chemicals.
Ashby J., Tennant RW (1994). Prediction of rodent carcinogenicity of 44 chemicals: Results. Mutagenesis9: 7—15.
2.
Calkins DR, Dixon RL, Gerber CR, Zarin D., Omenn GS (1980). Identifi cation, characterization, and control of potential human carcinogens: A framework for federal decision-making. J Natl Cancer Inst61: 169—175.
3.
deSerres Fj, Ashby J (eds) (1981). Evaluation of Short-Term Tests for Carcinogens: Report of the International Collaborative Program, Elsevier, New York.
4.
EPA (1996a). Food Quality Protection Act (FQPA): Offi ce of Pesticide Programs, Washington DC .
5.
EPA (1996b). Proposed Guidelines for Carcinogen Risk Assessment. EPA/ 600/P-92/003C). Offi ce of Research and Development, Washington DC.
6.
EPA (1998). Chemical Hazard Availability Study. EPA Offi ce of Pollution Prevention and Toxics, Washington DC.
7.
FaustmanEM, Omenn GS (2001). Risk assessment. In: CasarettandDoull's Toxicology, 6th ed, Klaassen CD (ed). McGraw-Hill, New York , pp. 83—104.
8.
GoldLS, Manley NB, SloneTH, RohrbachL. (1999). Supplementto the CarcinogenicPotency Database (CPDB): Results of animal bioassays published in the general literature in 1993 to 1994 and by the National Toxicology Program in 1995 to 1996. Environ Health Perspect107, Suppl 4: 527—600.
9.
Gold LS, Slone TH, Ames BN ( 1998). What do animal cancer tests tell us about human cancer risk? Overview of analyses of the carcinogenic potency database. Drug Metabolism Reviews30: 359—404.
10.
Goldberg L (ed) (1973). Carcinogenesis Testing on Chemicals, CRC Press , Boca Raton, Florida.
11.
Hill AB (1965). The environment and disease: Association or causation?Proc Roy Soc Med58: 295—300.
12.
International Conference on Harmonization, Expert Working Group on Safety (1996). Draft guideline on testing for carcinogenicity of pharmaceuticals. Fed Reg61: 43298—43300.
13.
Lave LB, Ennever FK, Rosenkranz HS, Omenn GS (1988). Information value of the rodent bioassay. Nature336: 631—633.
14.
Lave LB, Omenn GS (1986). Cost-effectiveness of short-term tests for carcinogenicity . Nature324: 29—34.
15.
McClain RM (1994). Mechanistic considerations in the regulation and classifi cation of chemical carcinogens. In: Nutritional Toxicolocy, Kotsonis F, Mackey M, Hijele J (eds). Raven, New York, pp 278—304.
16.
National Research Council ( 1994). Science and Judgment in Risk Assessment. National Academy Press, Washington, DC.
17.
Omenn GS (2000). The post-genomic era: A crucial role for the public health sciences. Environ Health Perspect108: 160—161.
18.
Omenn GS, Faustman EM (2001). Risk assessment and risk management. In: Oxford Textbook of Public Health, 4th ed, Detels R, McEwen J, Baeglehole R, Tanaka H (eds). In press.
19.
Omenn GS, Lave LB ( 1988). Scientifi c and cost-effectiveness criteria in selecting batteries of short-term tests. Mutation Res205: 41—49.
20.
Omenn GS, Stuebbe S., Lave LB ( 1995). Predictions of rodent carcinogenicity testing results: Interpretation in light of the Lave-Omenn Value-of-Information Model. MolecularCarcinogenesis14: 37—45.
21.
Pereira MA, Stoner GD (1985). Comparison of rat liver foci assay and strain A mouse lung tumor assay to detect carcinogens: A review. Fund Appl Toxicol5: 688—699.
22.
Presidential/Congressional Commission on Risk Assessment and Risk Management (1997a,b). A Framework for Environmental Health Risk Management (Vol 1); Risk Assessment and Risk Management in Regulatory Decision-Making (Vol 2). Government Printing Offi ce, Washington, DC.
23.
Roe D., Pease W., Florini K., Silbergeld E. (1997). Toxic Ignorance. Environmental Defense Fund, Washington, DC.
24.
Robinson D. (1998). International Life Sciences Institute's role in the evaluation of alternative methodology for the assessment of carcinogenic risk. Toxicol Pathol26: 474—475.
25.
Tennant RW, Spalding JW, Stasiewicz S., Ashby J. (1990). Prediction of the outcome of rodent carcinogenicity bioassays currently being conducted on 44 chemicals by the U.S. National Toxicology Program. Mutagenesis5: 3—14.
