American Chemistry Council v. Office of Environmental Health etc.

CourtCalifornia Court of Appeal
DecidedJuly 8, 2020
DocketC079260
StatusPublished

This text of American Chemistry Council v. Office of Environmental Health etc. (American Chemistry Council v. Office of Environmental Health etc.) is published on Counsel Stack Legal Research, covering California Court of Appeal primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
American Chemistry Council v. Office of Environmental Health etc., (Cal. Ct. App. 2020).

Opinion

Filed 6/10/20; Certified for Publication 7/8/20 (order attached)

IN THE COURT OF APPEAL OF THE STATE OF CALIFORNIA THIRD APPELLATE DISTRICT (Sacramento) ----

AMERICAN CHEMISTRY COUNCIL, C079260

Plaintiff and Appellant, (Super. Ct. No. 34-2014- 80001868-CU-WM-GDS) v.

OFFICE OF ENVIRONMENTAL HEALTH HAZARD ASSESSMENT et al.,

Defendants and Respondents.

Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health & Saf. Code, §§ 25249.5-25249.13), requires the Governor to publish a “list of those chemicals known to the state to cause cancer or reproductive toxicity.” (Health & Saf. Code, § 25249.8.) In 2013 the Carcinogen Identification Committee (Committee) voted to list the chemical diisononyl phthalate (DINP) as a cancer causing chemical. DINP is used to soften vinyl for use in flooring, wire insulation, gloves, garden hoses, artificial leather, and roofing materials. The Committee concluded DINP causes various types of cancer in animals and that the mechanisms by

1 which DINP causes cancer in animals are relevant to humans. Subsequently, the Office of Environmental Health Hazard Assessment (OEHHA) added DINP to the Proposition 65 list. Plaintiff American Chemistry Council (Chemistry) challenged the action, arguing it was arbitrary and capricious. The Chamber of Commerce of the United States filed an amicus curiae brief in support of Chemistry. Chemistry appeals the trial court’s denial of its petition for writ of mandate, arguing there is insufficient evidence that DINP causes cancer in humans. We shall affirm the judgment.

FACTUAL AND PROCEDURAL BACKGROUND

Proposition 65 Process Proposition 65 involves a two-step process. First, chemicals are placed on a list of substances known to cause cancer or reproductive toxicity. (Health & Saf. Code, § 25249.8, subd. (a).)1 Second, the statute prohibits businesses from exposing individuals to listed chemicals without providing a warning and from discharging listed chemicals into sources of drinking water unless the business can establish that the exposure or the discharge to drinking water is below the level that will pose no significant risk. (§§ 25249.5, 25249.6, 25249.9, 25249.10, subd. (c).) Chemicals must be listed under Proposition 65 if they are identified as causing cancer or reproductive toxicity on the basis of animal studies. Proposition 65 “applies to those chemicals which respected scientific agencies have already determined cause cancer or reproductive toxicity in humans or animals.” (AFL-CIO v. Deukmejian (1989) 212 Cal.App.3d 425, 441.) Human testing is unethical, and because of the long latency period of human cancers, waiting for human studies cannot adequately protect humans from the risk of cancer. As a consequence, the principle of extrapolating from evidence

1 All further statutory references are to the Health and Safety Code unless otherwise noted.

2 of cancer in animals to humans “ ‘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.’ ” (Id. at p. 438, fn. 7.) OEHHA must list a chemical: (1) if the chemical is identified by reference in certain Labor Code sections; (2) if a body considered authoritative by the group of independent scientists known as the state’s qualified experts has formally identified the chemical as causing cancer; (3) if a state or federal agency has formally required the chemical to be labeled or identified as causing cancer (§ 25249.8, subds. (a), (b)); or (4) upon review by the state’s qualified experts who, in their opinion, determine “the chemical has been clearly shown through scientifically valid testing according to generally accepted principles to cause cancer” (§ 25249.8, subd. (b)). This case involves the fourth mechanism for identifying cancer causing chemicals.

Committee Composition and Guidance Criteria Independent experts with degrees and research experience in various scientific fields comprise the Committee. (Cal. Code Regs., tit. 27, § 25302, subd. (b)(1)(i), (ii).) The Governor appoints the committee chairperson, who calls and presides over meetings, designates an executive secretary, and designates subcommittees. (Cal. Code Regs., tit. 27, § 25302, subd. (c).) The chairperson possesses no special authority apart from these administrative duties. The state’s qualified experts for the purpose of identifying carcinogens are members of the Committee. (Cal. Code Regs., tit. 27, § 25302, subd. (a).) The Committee’s guidance criteria govern the review of a given chemical. Under the criteria, the Committee uses a weight of evidence approach to evaluate the information on any given chemical, including “all evidence bearing on the issue of carcinogenicity shown through scientifically valid testing according to generally accepted principles” of scientific inquiry.

3 At issue in the case before us is criterion No. 1D, which states the Committee will “normally identify a chemical for listing” if “the weight of scientific evidence clearly shows that [the] chemical causes invasive cancer in humans, or that it causes invasive cancer in animals (unless the mechanism of action has been shown not to be relevant to humans).” As the trial court aptly noted “This case is about that ‘unless.’ ” Guidance criteria are not intended to be binding regulations or to be slavishly followed. Instead, “these criteria are intended to give the Committee maximal flexibility in evaluating all pertinent scientific information” and “are intended neither to limit the scope of the Committee’s consideration of all appropriate cumulated scientific information, nor to limit the use of best scientific judgment available at the time.” The criteria require “scientific judgments which can only be based on experience . . . Thus, few of the criteria are amenable to the use of absolute restrictions of either a quantitative or qualitative nature.” The Committee does not conduct independent scientific studies or experiments on the carcinogenicity or toxicity of chemicals. Instead, OEHHA prepares a summary of the current state the scientific evidence on the chemicals’ carcinogenicity, a hazard identification document (HID). To prepare the HID, OEHHA reviews scientific literature on the chemical and solicits information from the public. Once prepared, the HID is released to the Committee and the public for a 45-day comment period. At the close of the comment period, OEHHA provides the Committee with a copy of all comments and supporting documents for review.

Consideration of DINP by the Committee In 2009 the Committee began reviewing DINP when OEHHA asked it to rank a set of chemicals for review. Chemistry and other entities submitted over 200 pages of comments to support the argument that DINP should be ranked as no or low priority for review. They argued the mechanism of carcinogenesis does not operate in humans.

4 However, the Committee voted on May 29, 2009, to rank DINP as a high priority chemical for its review. OEHHA issued a notice to interested parties on October 16, 2009, soliciting information on the carcinogenicity of DINP. The public comment period lasted 60 days. OEHHA, after reviewing the submitted material, prepared a 77-page HID. The HID included the most current and pertinent information on the carcinogenicity of DINP, including research and evidence on the mechanisms of action by which DINP operates. The HID was not intended to be a comprehensive document citing every study, but a “look at new more recent literature and thinking on those hypotheses.” Although there were no human studies of the carcinogenicity of DINP, the HID discussed 12 dietary carcinogenicity studies on laboratory animals. OEHHA provided the studies to the Committee. No known carcinogenicity studies were omitted.

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Related

AFL-CIO v. Deukmejian
212 Cal. App. 3d 425 (California Court of Appeal, 1989)
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169 Cal. App. 4th 1264 (California Court of Appeal, 2009)
City of Sacramento v. State Water Resources Control Board
2 Cal. App. 4th 960 (California Court of Appeal, 1992)
Western Crop Protection Ass'n v. Davis
95 Cal. Rptr. 2d 631 (California Court of Appeal, 2000)

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American Chemistry Council v. Office of Environmental Health etc., Counsel Stack Legal Research, https://law.counselstack.com/opinion/american-chemistry-council-v-office-of-environmental-health-etc-calctapp-2020.