Section 25249.6 shall not apply to any of the following:
(a) An exposure for which federal law governs warning in a manner that preempts state authority.
(b) An exposure that takes place less than twelve months subsequent to the listing of the chemical in question on the list required to be published under subdivision (a) of Section 25249.8.
(c) An 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 (1000) 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. In any action brought to enforce Section 25249.6, the burden of showing that an exposure meets the criteria of this subdivision shall be on the defendant.

Added by initiative measure, Proposition 65, approved November 4, 1986, January 1, 1987.

Editor's Notes- For legislative findings, declarations, severability, and effective date of initiative, see the Note to Ch 6.6 (H & S C §§ 25249.5 et seq.).

Cross References: Required warning: H & S C § 25249.6.

List of toxic chemicals: H & S C § 25249.8.

Definitions: H & S C § 25249.11.

Collateral References: 12 Witkin Summary (10th ed) Real Property § 911.

NOTES OF DECISIONS

California's Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65), H & S C § 25249.6, provides that no person in the course of doing business shall knowingly and intentionally expose any individual to a chemical known to the State to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual except as provided in H & S C § 254249.10, which provides that warnings are not mandated where the federal law governs the warnings to a specific exposure. Therefore, the Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act (MDA), 21 USCS §§ 321 to 394 preempted Proposition 65. Committee of Dental Amalgam Alloy Mfrs. v. Henry (1994, SD Cal) 871 F Supp 1278, 1994 US Dist LEXIS 15566.

In an action alleging a violation of the Safe Drinking Water and Toxic Enforcement Act of 1986, commonly known as Proposition 65, based on defendant dentists' failure to warn employees and patients that “silver fillings” contained mercury and mercury compounds, which were reproductive toxins, the trial court misapplied the burden of producing evidence in granting a defense motion for summary judgment. Defendants, who invoked the exposure exemption to the warning requirement (H & S C §§ 25249.10(c), 25249.6), had an initial burden of production to make a prima facie showing that the affirmative defense applied. Because defendants made no such showing, the burden did not shift to plaintiff to raise a triable issue. Consumer Cause, Inc. v. SmileCare (2001, 2nd Dist) 91 Cal App 4th 454, 110 Cal Rptr 2d 627, 2001 Cal App LEXIS 628.

Superior court did not err in only requiring a manufacturer to establish by a preponderance of the evidence, under Ev C § 115, that exposure to a chemical presented no significant risk of cancer in humans. Although a chemical has to be “clearly shown” to cause cancer before it may be listed under H & S C § 25249.8(b), the warning exemption of H & S C § 25249.10(c) does not similarly require it to be clearly shown that exposure to the chemical poses no significant risk of causing cancer; this indicates the burden of proving the exemption is less than by clear and convincing evidence. Baxter Healthcare Corp. v. Denton (2004, Cal App 3rd Dist) 120 Cal App 4th 333, 15 Cal Rptr 3d 430, 2004 Cal App LEXIS 1054, review denied, (2004) 2004 Cal. LEXIS 9470.

Superior court did not engage in a de novo review of an administrative decision of the Office of Environmental Health Hazard Assessment but simply determined that, because a manufacturer presented persuasive evidence that exposure to a chemical in its products posed no significant risk of causing cancer in humans, the warning requirement exemption of H & S C § 25249.10(c) applied to the prescription medical devices containing the chemical that were made by the manufacturer; the determination of whether the statutory exemption applies to a particular product is for the trial court. Baxter Healthcare Corp. v. Denton (2004, Cal App 3rd Dist) 120 Cal App 4th 333, 15 Cal Rptr 3d 430, 2004 Cal App LEXIS 1054, review denied, (2004) 2004 Cal. LEXIS 9470.

Office of Environmental Health Hazard Assessment failed to establish that H & S C § 25249.10 does not allow a business to bring a declaratory relief action under CCP § 1060 for the purpose of determining whether the business is exempted from the warning requirement of the Safe Drinking Water and Toxic Enforcement Act of 1986. Baxter Healthcare Corp. v. Denton (2004, Cal App 3rd Dist) 120 Cal App 4th 333, 15 Cal Rptr 3d 430, 2004 Cal App LEXIS 1054, review denied, (2004) 2004 Cal. LEXIS 9470.

Manufacturer was entitled to a declaration of its rights and obligations under CCP § 1060 and H & S C § 25249.10 of the Safe Drinking Water and Toxic Enforcement Act of 1986; the manufacturer was compelled either to provide a stigmatizing warning regarding its products, even though it could show that the chemical did not cause cancer in humans, or risk being subjected to an enforcement action and costly civil penalty if its theory was rejected in an enforcement action. Baxter Healthcare Corp. v. Denton (2004, Cal App 3rd Dist) 120 Cal App 4th 333, 15 Cal Rptr 3d 430, 2004 Cal App LEXIS 1054, review denied, (2004) 2004 Cal. LEXIS 9470.

Action under Proposition 65, H & S C § 25249.5 et seq., was not ripe when the trial court entered a consent judgment that specified the warnings to be given if necessary in the future because plaintiff had admitted that the stainless steel surgical devices involved, which contained nickel, did not violate Proposition 65 and that all covered products fell within the no-significant-risk level provided in H & S C § 25249.10(c). Consumer Cause, Inc. v. Johnson & Johnson (2005, Cal App 2nd Dist) 132 Cal App 4th 1175, 34 Cal Rptr 3d 258, 2005 Cal App LEXIS 1495.

Consumers' lawsuit alleging that manufacturers of vaccines failed to warn of exposure to a toxic substance as required by Health & Saf. Code, § 25249.6, lacked merit because the standard warnings approved under federal law are deemed clear and reasonable warnings for prescription drugs by Cal. Code Regs., tit. 22, § 12601(b)(2)(A), which was validly enacted in accordance with Health & Saf. Code, § 25249.12, subd. (a); obtaining informed consent provided a specific warning beyond the requirements of Health & Saf. Code, § 25249.11, subd. (f), and there was no conflict with the provisions of Health & Saf. Code, § 25249.10. Vaccine Cases. William F. Bothwell v. Abbott Labs. (2005, Cal App 2nd Dist) 134 Cal App 4th 438, 36 Cal Rptr 3d 80, 2005 Cal App LEXIS 1840.

Consumers' lawsuit alleging that manufacturers of vaccines failed to warn of exposure to a toxic substance as required by Health & Saf. Code, § 25249.6, lacked merit because the standard warnings approved under federal law are deemed clear and reasonable warnings for prescription drugs by Cal. Code Regs., tit. 22, § 12601(b)(2)(A), which was validly enacted in accordance with Health & Saf. Code, § 25249.12, subd. (a); obtaining informed consent provided a specific warning beyond the requirements of Health & Saf. Code, § 25249.11, subd. (f), and there was no conflict with the provisions of Health & Saf. Code, § 25249.10. Vaccine Cases. William F. Bothwell v. Abbott Labs. (2005, Cal App 2nd Dist) 134 Cal App 4th 438, 36 Cal Rptr 3d 80, 2005 Cal App LEXIS 1840.

Award of attorney fees of more than $ 540,000 was unconscionable in an action by parties a shell entity that alleged exposure under H & S C § 25249.6, to carcinogens that were commonly present pretty much everywhere, such as in furniture and paint and electric lights. In reversing a consent judgment that contained the award of attorney fees, the court noted that litigation under the Safe Drinking Water and Toxic Enforcement Act of 1986, H & S C § 25249.5 et seq. was absurdly easy given the burden shifting provisions of H & S C § 25249.10. Consumer Defense Group v. Rental Hous. Indus. Mbrs. (2006) 137 Cal App 4th 1185, 40 Cal Rptr 3d 832, 2006 Cal App LEXIS 407.