A Sacramento County Superior Court judge has issued a tentative ruling determining that the December 2013 listing of, Diisononyl Phthalate (DINP), by the state’s Carcinogen Identification Committee (CIC) followed the committee’s guidelines.
Sacramento Superior Court Judge Christopher Krueger concluded that the petitioner, American Chemistry Council (ACC) failed to show that the CIC did not follow its guidelines when it determined DINP is a Proposition 65 carcinogen.
Last June, ACC, a leading trade association representing the chemical industry, filed a Writ of Mandate to reverse CIC’s listing. The petition was brought under Code of Civil Procedure section 1085, which may be used to correct an abuse of discretion when an agency acts in a quasi-legislative capacity. The court’s inquiry in such a case is limited to whether the agency’s action was arbitrary, capricious, or entirely lacking in evidentiary support.
A similar petition brought by ExxonMobil Corp. in 2009 to overturn the listing of di-isodecyl phthalate (DIDP) failed to show that OEHHA was arbitrary or capricious in its listing decision.
Before evaluating the petition Judge Krueger observed, “the CIC determined by a simple majority vote that DINP had been clearly shown to cause cancer. The CIC never explained the basis for its
determination, and thus never explained how (or even whether) it evaluated the evidence on whether the animal studies were relevant to humans. This is not a criticism of the CIC. An administrative body making a quasi-legislative decision like the one at issue here is not generally required to either make findings or explain how the evidence supports its decision. But the lack of findings or an explanation may make it difficult for Petitioner to show the CIC’s decision was arbitrary or capricious. This difficulty is then compounded by the fact that, absent evidence to the contrary, the court must presume the CIC properly performed its duties. Here, the primary evidence to the contrary consists of the transcript of the public hearing. But at no point during that hearing did the CIC clearly explain its views on the evidence on human relevance. Thus, the court must return to the presumption that the CIC properly performed its duties, and to the fact that it is Petitioner’s burden of proof to show the CIC’s decision is arbitrary, capricious, or without evidentiary support.”
ACC’s argument that the committee’s listing decision was arbitrary and capricious boiled down to one reason: it failed to properly consider evidence regarding whether the animal studies showing DINP causes cancer in rodents are relevant to humans.
Judge Krueger in his tentative decision provided a brief overview of the landmark 1989 decision in AFL-CIO v. Deukmajian which ruled that “the argument necessarily assumes that ‘chemicals known to the state to cause cancer or reproductive toxicity’ (§ 25249.5) refers only to those “known to the state to cause cancer or reproductive toxicity in humans.’ No such limitation is expressed in the act.”
The Deukmajian court ruled “the omission of any such limitation implies that chemicals are to be listed and hence subject to the Act even if they are known to be carcinogenic as to animals only.”
Judge Krueger emphasized that Deukmajian Court’s finding that “Moreover, and perhaps more importantly for purposes of this case, the Deukmejian court made the following critical point about cancer research: The qualitative assessment of carcinogenic risks to humans ordinarily is based on data from experiments in animals. It is unethical to test humans, and because of the 20-to 30-year latency period of many human cancers, epidemiological studies do not adequately warn humans and protect them from the risk of exposure to new carcinogens. For recognized human carcinogens, the first evidence of carcinogenicity frequently is found in test animals; only afterwards are cancer effects looked for, and found, in humans. Thus, the principle which supports qualitative animal to human extrapolation from carcinogenesis has been accepted by
all health and regulatory agencies and is regarded widely by scientists in industry and academia as a justifiable and necessary inference.”
“In other words, a chemical that causes cancer in animals is assumed to cause cancer in humans unless shown otherwise,” Judge Krueger observed. “The CIC’s guidance criteria recognize this point by providing a chemical will normally be identified for listing if the evidence shows it causes cancer in animals ‘unless the mechanism of action has been shown not to be relevant to humans.’ Here, it is undisputed that DINP has been shown to cause cancer in animals. The CIC thus acted well within its discretion in assuming it also causes cancer in humans.”
The court rejected ACC’s arguments that the CIC disregarded evidence other than animal studies showing DINP is carcinogenic, and did not consider evidence that it is not a human carcinogen.
“The court is not convinced, because it is clear the CIC considered the evidence Petitioner accuses it of disregarding.” Judge Krueger observed that “one of Petitioner’s members submitted a lengthy critique of OEHHA’s Hazard Identification Document. This critique discusses in great detail the studies that Petitioner claims show DINP-caused animal cancers are not relevant to humans. The CIC was provided with this critique prior to its meeting. Indeed, OEHHA states in its opposition that the CIC was provided with almost all of the studies that Petitioner relies on to show DINP is not a human carcinogen – a fact which Petitioner does not dispute. Moreover, Petitioner and several of its members gave a lengthy presentation at the public meeting, reviewing and explaining in detail the evidence on human relevance. Finally, most of the CIC’s members frankly acknowledged they were struggling with the question of whether the evidence that DINP caused cancer in animals was relevant to humans. Member Landolf stating ‘I struggle with the issue of the relevance to human tumors’; Member Reynolds noting key issue ‘is really whether the mechanism of action has been shown to be relevant in humans’; Member Eastmond stating ‘The key question now becomes, are those [cancers] relevant to humans?’; Member Bush stating “I guess what I’m wrestling with is whether this is meaningful for humans?; Chairperson Mack stating: ‘I understand completely the points . . . the regulated community has made about the mechanism issue’.” Thus, far from disregarding Petitioner’s evidence, the hearing transcript demonstrates the CIC considered, and wrestled with this evidence.
The Court also rejected ACC’s argument that the listing decision was made based upon an incorrect interpretation of the law provided by OEHHA General Counsel Carol Monahan-Cummings, observing that “OEHHA’s staff counsel clearly informed the CIC that its listing decision should be based on its own published criteria for listing, a copy of which was provided. Petitioner argues only that the evidence is voluminous and the CIC would not have had time to review it all prior to its meeting. Absent evidence to the contrary, the court will assume the CIC reviewed sufficient evidence to come to an informed decision to each member prior to the hearing: “you have those criteria in front of you. You[r] listing decisions should be based on those criteria.” Those criteria state the CIC will normally identify a chemical for listing if the weight of scientific evidence shows it causes invasive cancer in animals “unless the mechanism of action has been shown not to be relevant to humans. OEHHA’s counsel later reiterated.