Mateel Envtl. Justice Found. v. Office of Envtl. Health Hazard Assessment

• Decision Date: 05 June 2018
• Docket Number: A148711
• Citation: 234 Cal.Rptr.3d 198,24 Cal.App.5th 220
• Court: California Court of Appeals Court of Appeals
• Parties: MATEEL ENVIRONMENTAL JUSTICE FOUNDATION, Plaintiff and Appellant, v. OFFICE OF ENVIRONMENTAL HEALTH HAZARD ASSESSMENT et al., Defendants and Respondents; California Chamber of Commerce et al., Intervenors and Respondents.

24 Cal.App.5th 220

234 Cal.Rptr.3d 198

MATEEL ENVIRONMENTAL JUSTICE FOUNDATION, Plaintiff and Appellant,

v. OFFICE OF ENVIRONMENTAL HEALTH HAZARD ASSESSMENT et al., Defendants and Respondents;California Chamber of Commerce et al., Intervenors and Respondents.

A148711

Court of Appeal, First District, Division 2, California.

Filed June 5, 2018

As Modified June 21, 2018

Lexington Law Group, Eric S. Somers, Howard J. Hirsch, San Francisco, Joseph Mann, Casey Fisher, Klamath Environmental Law Center, William Verick, Eureka, David H. Williams, for Plaintiff and Appellant

Attorneys General of California, Xavier Becerra, Kamala D. Harris, Susan S. Fiering, Supervising Deputy Attorney General, Harrison M. Pollak, Deputy Attorney General, for Defendants and Respondents

Arnold & Porter Kaye Scholer, LLP, Trenton H. Norris, Sarah Esmaili, San Francisco, for Interveners and Respondents

David Roe, in pro. per.

Kline, P.J.

INTRODUCTION

In 1989, the predecessor to respondent Office of Environmental Health Hazard Assessment (OEHHA), the lead agency charged with implementing California's Safe Drinking Water and Toxic Enforcement Act (Proposition 65) ( Health & Saf. Code, § 25249.5 et seq. ), adopted a regulation setting a "maximum allowable dose level" or MADL for lead as a reproductive toxicant. ( Cal. Code Regs., tit. 27, § 25805, subd. (b).)¹

In 2015, appellant Mateel Environmental Justice Foundation (Mateel) sued OEHHA, seeking a writ of mandate ( Code Civ. Proc., § 1085 ) and other relief to compel OEHHA to repeal that part of Regulations section 25805 setting a MADL for lead as a reproductive toxicant, seeking to invalidate the regulatory "safe harbor" level for lead of 0.5 microgram per day ("μg/day"). The trial court denied Mateel's motion for judgment on the pleadings for declaratory relief and/or writ of mandate and entered judgment in favor of OEHHA.² This timely appeal followed.

Mateel argues that OEHHA failed to comply with the Proposition 65 mandate that the MADL be based on an exposure having "no observable effect" when it utilized a "surrogate" "no observable effect level" (NOEL) derived from the "permissible exposure limit" (PEL) for lead set by the United States Occupational Safety and Health Administration (OSHA). Mateel further argues that even if the blood lead level OSHA determined should be maintained for men and women who wished to plan pregnancies were appropriate to consider as a NOEL, the OSHA PEL was not set at a level to achieve this target, that OEHHA failed to make a downward adjustment to account for this disconnect between the PEL and the target NOEL, and nothing in the record indicates OEHHA considered this issue in setting the MADL.

We shall affirm.

STATUTORY BACKGROUND

In 1986, Californians adopted Proposition 65 through the voter initiative process. "Proposition 65 requires that, at least once per year, 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.' (§ 25249.8, subd. (a).) The listing of a chemical triggers two requirements. The first requirement, contained in section 25249.5, prohibits businesses from discharging the chemical 'into water or onto or into land where such chemical passes or probably will pass into any source of drinking water.' " ( Exxon, supra, 169 Cal.App.4th at p. 1268, 87 Cal.Rptr.3d 580.) We are concerned here with the second requirement, contained in section 25249.6, which requires companies that expose consumers to carcinogens or reproductive toxins to give "clear and reasonable warning" before exposing individuals to the listed chemical. (§ 25249.6; see e.g. Environmental Law Foundation v. Beech-Nut Nutrition Corp. (2015) 235 Cal.App.4th 307, 312, 185 Cal.Rptr.3d 189 ( Beech-Nut ).)

Under section 25249.10,³ the warning requirement does not apply to "[a]n exposure for which the person responsible can show that the exposure poses no significant risk assuming lifetime exposure at the level in question for substances known to the state to cause cancer, and that the exposure will have no observable effect assuming exposure at one thousand (1,000) times the level in question for substances known to the state to cause reproductive toxicity, based on evidence and standards of comparable scientific validity to the evidence and standards which form the scientific basis for the listing of such chemical pursuant to subdivision (a) of Section 25249.8." (§ 25249.10, subd. (c), italics added; see e.g., Exxon, supra , 169 Cal.App.4th at p. 1268, 87 Cal.Rptr.3d 580.)

Section 25249.8, subdivision (b) describes the standards of scientific validity required for listing the chemical that section 25249.10, subdivision (c) references: "A chemical is known to the state to cause cancer or reproductive toxicity within the meaning of this chapter if 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 if a body considered to be authoritative by such experts has formally identified it as causing cancer or reproductive toxicity, or if an agency of the state or federal government has formally required it to be labeled or identified as causing cancer or reproductive toxicity."

"Lead is a toxic metal that, even at low levels, may cause a range of health effects, including behavioral problems and learning disabilities." ( Beech-Nut, supra, 235 Cal.App.4th at p. 312, 185 Cal.Rptr.3d 189.) It was identified as a known carcinogen and reproductive toxin under Proposition 65.

" 'The "no observable effect level," or NOEL, is a scientific term denoting the maximum dose level at which a chemical is found to have no observable reproductive effect. [Citation.] The NOEL is determined through scientific inquiry and assessment as detailed in the framework set forth in the regulations. [Citations.] In turn, the NOEL is divided by 1,000 to arrive at the [MADL], which is the threshold warning level for a listed chemical.' [Citations.] Thus, the [MADL] is set as one one-thousandth of the NOEL." ( Beech-Nut, supra, 235 Cal.App.4th at p. 313, 185 Cal.Rptr.3d 189.) The NOEL is defined as "an exposure level with no biologically or statistically significant increase in the frequency or severity of adverse effects among the exposed group relative to a control group." (OEHHA, Technical Support Document for the Derivation of Noncancer Reference Exposure Levels (June 2008) p. 39.)⁴

Section 25801 of the Regulations addresses the determination of the NOEL, explaining that for purposes of the warning exemption and "safe harbor," that NOEL is "the maximum level of exposure at which a chemical has no observable reproductive effect" and repeating the statutory requirement that the determination that the "no observable effect" level for purposes of section 25249.10, subdivision (c) "shall be based on evidence and standards of comparable scientific validity to the evidence and standards which form the scientific basis for the listing of a chemical as known to the state to cause reproductive toxicity." (Regs., § 252801, subd. (b).)⁵

ADMINISTRATIVE PROCEEDINGS

In 1989, after an extensive administrative process, the Agency adopted regulations governing its implementation of Proposition 65, including article 8, "No Observable Effect Levels." (Regs., §§ 25801-25821.) The Agency determined the MADL for lead, setting the regulatory safe harbor level for reproductive toxicity at 0.5 micrograms per day. (Regs., § 25805, subd. (b).)⁶ In its "Final Statement of Reasons" (FSOR),⁷ the Agency explained the need for adoption of these regulations. "The Act [Proposition 65] exempts discharges, releases and exposures which, making certain assumptions, pose no significant risk of cancer or would produce no observable reproductive effect. The Act specifies that any claim of exemption under Health and Safety Code section 25249.10, subsection (c) must be based upon evidence and standards of comparable scientific validity to the evidence and standards which form the scientific basis for the listing of the substance as a chemical known to the state to cause cancer or reproductive toxicity. However, ... the Act does not specify levels of exposure to reproductive toxins which have no observable effect, and provides no methods for determining those levels." (FSOR, pp. 4–5.)

The Agency recognized that "[t]here is no fixed way to perform the steps necessary to specifically determine ... no observable effect. The methods used may vary depending upon the data available, and the objectives of the risk assessor or risk manager. The purpose of these regulations is to provide some 'safe harbor' levels and methodologies, and criteria for exposure assessment, which will assist persons in making certain that their discharges, releases or exposures pose no significant risk or would have no observable effect within the meaning of the Act." (FSOR, p. 4.)

The Agency also recognized that lead had been included on the Governor's initial listing of chemicals known to cause reproductive toxicity because it had been identified by OSHA as a known human reproductive toxicant based upon evidence of its effects on humans (FSOR, p. 77) and the Agency relied on OSHA's PEL of 50 micrograms per cubic meter to establish the reproductive safe harbor level. "OSHA multiplied the OSHA PEL of 50 micrograms per cubic meter by 10 cubic meters (the amount OSHA determined workers breathed over an eight-hour period) to yield a value of 500 micrograms, which [the Agency] then divided by 1,000 to arrive at the 0.5 microgram-per-day standard." ( Beech-Nut, supra, 235 Cal.App.4th at pp. 313-314, 185 Cal.Rptr.3d 189.) "The reproductive safe harbor level presumes that one can be exposed to 1,000 times the safe harbor level without suffering any adverse reproductive effects." ( Id. at p. 317, 185 Cal.Rptr.3d 189.)

In setting the MADL, the Agency acknowledged the...