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Styrene Information and Research Center v. Office of Environmental Health Hazard Assessment

October 31, 2012

STYRENE INFORMATION AND RESEARCH CENTER, PLAINTIFF AND RESPONDENT,
v.
OFFICE OF ENVIRONMENTAL HEALTH HAZARD ASSESSMENT, DEFENDANT AND APPELLANT; CELANESE CORPORATION, INTERVENOR AND RESPONDENT.



(Super. Ct. No. 34200900053089CUJRGDS) APPEAL from a judgment of the Superior Court of Sacramento County, Shelleyanne W.L. Chang, Judge.

The opinion of the court was delivered by: Hull , J.

CERTIFIED FOR PUBLICATION

Affirmed.

Proposition 65, an initiative measure adopted by the voters in 1986, enacted the Safe Drinking Water and Toxic Enforcement Act of 1986 (hereafter Proposition 65) (Health & Saf. Code, § 25249.5 et seq.; further undesignated section references are to the Health and Safety Code). Proposition 65 requires the Governor to maintain a list of chemicals known to the state to cause cancer or reproductive toxicity. (§ 25249.8, subd. (a).) Once a chemical is placed on the list, businesses that manufacture, import or use such chemicals are subject to various restrictions. (See, e.g., § 25249.5, 25249.6.)

At a minimum, the Proposition 65 list must include substances identified by reference in Labor Code section 6382, subdivisions (b)(1) and (d). (§ 25249.8, subd. (a).) Labor Code section 6382, subdivision (d), identifies by reference "any substance within the scope of the federal Hazard Communication Standard [(HCS)] (29 C.F.R. Sec. 1910.1200) . . . ." The HCS in turn identifies several sources "as establishing that a chemical is a carcinogen or potential carcinogen," including "International Agency for Research on Cancer (IARC) Monographs (latest editions)." (29 C.F.R. § 1910.1200(d)(4)(ii).)

The IARC categorizes chemicals into groups based on level of carcinogenicity. Group 1 chemicals are those known to cause cancer in humans; Group 2A chemicals are those that are "probably" carcinogenic to humans, based on sufficient evidence of carcinogenicity in experimental animals; Group 2B chemicals are those that are "possibly" carcinogenic to humans, based on less than sufficient evidence of carcinogenicity in experimental animals; Group 3 encompasses chemicals for which there is inadequate evidence of carcinogenicity in either humans or animals; and Group 4 chemicals are those for which there is evidence that they do not cause cancer in either humans or animals.

In AFL-CIO v. Deukmejian (1989) 212 Cal.App.3d 425 (Deukmejian), this court concluded a chemical must be included on the Proposition 65 list if it is identified by reference in Labor Code section 6382, subdivision (d), as one known to cause cancer in either humans or animals.

The issue presented in this matter is whether chemicals categorized in Group 2B by an IARC monograph may be included on the Proposition 65 list. The trial court answered the question in the negative, and we agree. Notwithstanding the requirement in Health and Safety Code section 25249.8, subdivision (a), that the list contain, at a minimum, the substances identified by reference in Labor Code section 6382, subdivision (d), that Labor Code provision addresses "hazardous substances," which extends beyond those that cause cancer or reproductive toxicity. Thus, the reference to Labor Code section 6382 in Health and Safety Code section 25249.8, subdivision (a), must be read in conjunction with the prior language requiring the Governor to publish a list of chemicals "known to the state to cause cancer or reproductive toxicity." Because chemicals may be included in IARC Group 2B based on less than sufficient evidence of carcinogenicity in either humans or experimental animals, they may not qualify for Proposition 65 listing on that basis alone.

In this matter, defendant Office of Environmental Health Hazard Assessment (OEHHA), the state agency charged with implementing Proposition 65, published a notice entitled, "Request for Comments on Chemicals Proposed for Listing by the Labor Code Mechanism." The notice identified two chemicals, styrene and vinyl acetate, that had previously been identified in IARC monographs as possible carcinogens within Group 2B.

Plaintiff Styrene Information and Research Center (SIRC) filed this action to prohibit the listing of styrene. Celanese Corporation (Celanese) intervened in the action to prohibit the listing of vinyl acetate. SIRC and Celanese (hereafter plaintiffs) argued there was insufficient evidence either chemical was a known carcinogen. OEHHA argued in opposition that both chemicals met the statutory definition of known carcinogens within the meaning of section 25249.8, subdivision (a). The trial court entered judgments on the pleadings for plaintiffs, and OEHHA appeals. We affirm the judgments.

Statutory background

"Proposition 65 imposes two significant requirements on businesses. First, it prohibits businesses from discharging into drinking water sources any chemical 'known to the state to cause cancer or reproductive toxicity' (the discharge prohibition). (§ 25249.5.) Second, it requires businesses to provide a public warning if they 'knowingly and intentionally expose any individual to a chemical known to the state to cause cancer or reproductive toxicity' (the warning requirement). (§ 25249.6.)" (California Chamber of Commerce v. Brown (2011) 196 Cal.App.4th 233, 238-239 (Brown).)*fn1 The discharge prohibition becomes effective 20 months after a chemical is added to the Proposition 65 list. (§ 25249.9, subd. (a).) The warning requirement goes into effect 12 months after a chemical is first listed. (§ 25249.10, subd. (b).) "A business that violates the discharge prohibition or warning requirement can be sued in a public or private enforcement action and is subject to injunctive relief and civil penalties. (§ 25249.7, subds. (a), (b).)" (Brown, at p. 239.)

Section 25249.8, subdivision (a), reads: "On or before March 1, 1987, the Governor shall cause to be published a list of those chemicals known to the state to cause cancer or reproductive toxicity within the meaning of this chapter, and he shall cause such list to be revised and republished in light of additional knowledge at least once per year thereafter. Such list shall include at a minimum those substances identified by reference in Labor Code Section 6382(b)(1) and those substances identified additionally by reference in Labor Code Section 6382(d)." (Italics added.) Section 25249.8, subdivision (b), defines the phrase "known to the state to cause cancer or reproductive toxicity within the meaning of this chapter" to include instances where: "[(1)] in the opinion of the state's qualified experts it has been clearly shown through scientifically valid testing according to generally accepted principles to cause cancer or reproductive toxicity, or [(2)] if a body considered to be authoritative by such experts has formally identified it as causing cancer or reproductive toxicity, or [(3)] if an agency of the state or federal government has formally required it to be labeled or identified as causing cancer or reproductive toxicity." (§ 25249.8, subd. (b).) Section 25249.8, subdivision (b), essentially provides a means by which the Proposition 65 list may be supplemented beyond the minimum requirements of section 25249.8, subdivision (a). (Deukmejian, supra, 212 Cal.App.3d at pp. 439-440.)

Section 25249.8, subdivision (a), requires the listing of chemicals identified by reference in Labor Code section 6382, subdivisions (b)(1) or (d). "Labor Code section 6382 is part of the Hazardous Substances Information and Training Act (HSITA) (Lab. Code, § 6360 et seq.) and sets forth criteria for the preparation and amendment of a list of 'hazardous substances' in the workplace (id., § 6380), known as the 'HSITA list.' (Id., § 6380.)" (Brown, supra, 196 Cal.App.4th at p. 240.)

Labor Code section 6382, subdivision (b), identifies the hazardous substances to be included on the HSITA list. Subdivision (b)(1) refers to "[s]ubstances listed as human or animal carcinogens by the [IARC]." Subdivision (d) further provides that, "in addition to those substances on the director's list of hazardous substances, any substance within the scope of the federal Hazard Communication Standard (29 C.F.R. Sec. 1910.1200) is a hazardous substance subject to this chapter."

The HCS "was created in 1983, pursuant to title 29 United States Code section 655," which "authorized the Department of Labor, through the Occupational Safety and Health Administration (OSHA), to promulgate 'a final occupational safety and health standard entitled "Hazard Communication" (29 CFR § 1910.1200).' (48 Fed.Reg. 53280 (Nov. 25, 1983).)" (Brown, supra, 196 Cal.App.4th at p. 241.)

Two provisions of the HCS require a manufacturer, importer or employer to treat a chemical as a hazardous substance if it is identified as such by certain sources. (Brown, supra, 196 Cal.App.4th at p. 241.) One such provision is relevant to the present matter. Subpart (d)(4) identifies the following sources as establishing that a chemical is "a carcinogen or potential carcinogen for hazard communication purposes: [¶] (i) National Toxicology Program (NTP), Annual Report on Carcinogens (latest edition); [¶] (ii) International Agency for Research on Cancer (IARC) Monographs (latest editions); or [¶] (iii) 29 C.F.R. part 1910, subpart Z, Toxic and Hazardous Substances, Occupational Safety and Health Administration." (29 C.F.R. § 1910.1200(d)(4), italics added.)

A 2006 Preamble to the "IARC Monographs on the Evaluation of Carcinogenic Risks to Humans," which describes the scientific principles and procedures used in developing IARC monographs, contains a description of the various categories in which tested substances are placed.

Group 1 consists of substances determined to be carcinogenic to humans and is described as follows: "This category is used when there is sufficient evidence of carcinogenicity in humans. Exceptionally, an agent may be placed in this category when evidence of carcinogenicity in humans is less than sufficient but there is sufficient evidence of carcinogenicity in experimental animals and strong evidence in exposed humans that the agent acts through a relevant mechanism of carcinogenicity."

Group 2A, those substances determined to be "probably" carcinogenic to humans, is described as follows: "This category is used when there is limited evidence of carcinogenicity in humans and sufficient evidence of carcinogenicity in experimental animals. In some cases, an agent may be classified in this category when there is inadequate evidence of carcinogenicity in humans and sufficient evidence of carcinogenicity in experimental animals and strong evidence that the carcinogenesis is mediated by a mechanism that also operates in humans. Exceptionally, an agent may be classified in this category solely on the basis of limited evidence of carcinogenicity in humans. An agent may be assigned to this category if it clearly belongs, based on mechanistic considerations, to a class of agents for which one or more members have been classified in Group 1 or Group 2A."

Group 2B, those substances "possibly" carcinogenic to humans, is described as follows: "This category is used for agents for which there is limited evidence of carcinogenicity in humans and less than sufficient evidence of carcinogenicity in experimental animals. It may also be used when there is inadequate evidence of carcinogenicity in humans but there is sufficient evidence of carcinogenicity in experimental animals. In some instances, an agent for which there is inadequate evidence of carcinogenicity in humans and less than sufficient evidence of carcinogenicity in experimental animals together with supporting evidence from mechanistic and other relevant data may be placed in this group. An agent may be classified in this category solely on the basis of strong evidence from mechanistic and other relevant data."

The term "limited evidence of carcinogenicity" is defined in the preamble as follows: "The data suggest a carcinogenic effect but are limited for making a definitive evaluation because, e.g. (a) the evidence of carcinogenicity is restricted to a single experiment; (b) there are unresolved questions regarding the adequacy of the design, conduct or interpretation of the studies; (c) the agent increases the incidence only of benign neoplasms or lesions of uncertain neoplastic potential; or (d) the evidence of carcinogenicity is restricted to studies that demonstrate only promoting activity in a narrow range of tissues or organs." The term "inadequate evidence of carcinogenicity" is defined thusly: "The studies cannot be interpreted ...


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