There is widespread potential for human exposure to disinfection byproducts
(DBPs) in drinking water because everyone drinks, bathes, cooks, and clean
s with water. The need for clean and safe water led the U.S. Congress to pa
ss the Safe Drinking Water Act more than 20 years ago in 1974. In 1976, chl
oroform, a trihalomethane (THM) and a principal DBP, was shown to be carcin
ogenic in rodents. This prompted the U.S. Environmental Protection Agency (
U.S. EPA) in 1979 to develop a drinking water rule that would provide guida
nce on the levels of THMs allowed in drinking water. Further concern was ra
ised by epidemiology studies suggesting a weak association between the cons
umption of chlorinated drinking water and the occurrence of bladder, colon,
and rectal cancer. In 1992 the U.S. EPA initiated a negotiated rulemaking
to evaluate the need for additional controls for microbial pathogens and DB
Ps. The goal was to develop an approach that would reduce the level of expo
sure from disinfectants and DBPs without undermining the control of microbi
al pathogens. The product of these deliberations was a proposed stage 1 DBP
rule. It was agreed that additional information was necessary on how to op
timize the use of disinfectants while maintaining control of pathogens befo
re further controls to reduce exposure beyond stage 1 were warranted. In re
sponse to this need, the U.S. EPA developed a 5-year research plan to suppo
rt the development of the longer term rules to control microbial pathogens
and DBPs. A considerable body of toxicologic data has been developed on DBP
s that occur in the drinking water, but the main emphasis has been on THMs.
Given the complexity of the problem and the need for additional data to su
pport the drinking water DBP rules, the U.S. EPA, the National institute of
Environmental Health Sciences, and the U.S. Army are working together to d
evelop a comprehensive biologic and mechanistic DBP database. Selected DBPs
will be tested using 2-year toxicity and carcinogenicity studies in standa
rd rodent models, transgenic mouse models and small fish models; in vitro m
echanistic and toxicokinetic studies; and reproductive, immunotoxicity, and
developmental studies, The goal is to create a toxicity database that refl
ects a wide range of DBPs resulting from different disinfection practices.
This paper describes the approach developed by these agencies to provide th
e information needed to make scientifically based regulatory decisions.