Opinion ID: 744479
Heading Depth: 3
Heading Rank: 6

Heading: dmp

Text: 81 DMP is an organic compound used in the manufacture of a number of products. The EPA proposed to list DMP under subheading (B) based on chronic effects indicated in two studies, both conducted by the same researcher in the Soviet Union in the 1960s. In both studies, rats which were orally administered DMP produced histologic lesions in the liver and kidneys. As indicated in the contractor's report, but not in the EPA's proposed rule, the Interagency Testing Committee (ITC) assigned low confidence to the studies because details of the experiments were not reported. In particular, the studies do not indicate (1) the strain of animals used; (2) the number of animals tested at each dose level; (3) the number of animals in the control group (one experiment only); or (4) the purity of the test article. EPCRA requires the agency to rely only on generally accepted scientific principles or laboratory tests, or appropriately designed and conducted epidemiological or other population studies. 42 U.S.C. § 11023(d)(2). EPA Guidelines require it to base listing decisions on laboratory tests that follow an acceptable standard protocol. Guidelines at 29. Any one of the flaws indicated in the Soviet studies would render the study invalid under EPA regulations, see 40 CFR § 792.185 (1994), which require reports of studies to disclose, inter alia, the number of animals or other test organisms used, sex, body weight range, source of supply, species, strain and substrain, age, and procedure used for identification, a description of the dosage, dosage regimen, route of administration, and duration, a description of all circumstances that may have affected the quality or integrity of the data, and the locations where all specimens, raw data, and the final report are to be stored. 82 The EPA concedes that the ITC had low confidence in the studies, but argues that additional data considered along with the Soviet studies presents sufficient weight of the evidence for listing DMP. 59 Fed.Reg. 61,432, 61,455. The EPA asserts that it also relied on a third study in which mice were exposed to DMP. The proposed rule does not refer to the mouse study. The contractor's report did not cite the mouse study, nor did the Integrated Risk Information System, an EPA data base containing consensus positions on the toxicity of chemicals. Rather, the HERD profile on DMP cites the Hazardous Substances Data Bank entry for DMP which, in turn, cites the mouse study. If the agency in fact relied on the mouse study its reliance is well hidden in the record. We hold that the EPA's reliance on tests that were largely undocumented violates the agency's Guidelines and evidences arbitrary and capricious agency action. We, therefore, remand for further proceedings.