International Fabricare Institute v. Environmental Protection Agency

The Safe Drinking Water Act (SDWA) required the Environmental Protection Agency (EPA) (defendant) to establish national drinking-water standards and issue regulations to prevent the harmful contamination of public water systems. The EPA promulgated the required regulations to identify and regulate harmful contaminants in drinking water. The EPA established a maximum contaminant level goal (MCLG) for each contaminant at a level at which no known or anticipated adverse health effects would occur and that allowed for an adequate margin of safety. The regulations also specified an enforceable maximum contaminant level (MCL) for most contaminants that set the maximum permissible level of the contaminant in public water systems. In 1989, the EPA resubmitted its rulemaking with a revised proposal that contained MCLGs and MCLs for 38 organic and inorganic chemicals and responded to public comments. International Fabricare Institute and several other companies (the companies) (plaintiffs) challenged the EPA’s regulations for four contaminants. The EPA considered each of the four contaminants a known or probable human carcinogen. The EPA set MCLGs for all carcinogens at zero because it assumed there was no known threshold that carcinogens could be tolerated. The companies asserted that the EPA did not comply with the Administrative Procedure Act (APA) when it failed to consider two documents written by doctors and scientists that identified shortcomings in the methods and data used. In both documents, the doctors did not conduct new experiments or new statistical analysis but instead opined that low doses of carcinogens were less harmful than generally thought. The EPA stated that it considered the studies but would not change its zero-goal policy because scientific data did not show a safe threshold for carcinogen exposure. The companies petitioned for review in district court.