§ 25703. Quantitative Risk Assessment

​

(a) A quantitative risk assessment which conforms to this section shall be deemed to determine the level of exposure to a listed chemical which, assuming daily exposure at that level, poses no significant risk. The assessment shall be based on evidence and standards of comparable scientific validity to the evidence and standards which form the scientific basis for listing the chemical as known to the state to cause cancer. In the absence of principles or assumptions scientifically more appropriate, based upon the available data, the following default principles and assumptions shall apply in any such assessment:

(1) Animal bioassay studies for quantitative risk assessment shall meet generally accepted scientific principles, including the thoroughness of experimental protocol, the degree to which dosing resembles the expected manner of human exposure, the temporal exposure pattern, the duration of study, the purity of test material, the number and size of exposed groups, the route of exposure, and the extent of tumor occurrence.

(2) The quality and suitability of available epidemiologic data shall be appraised to determine whether the study is appropriate as the basis of a quantitative risk assessment, considering such factors as the selection of the exposed and reference groups, reliable ascertainment of exposure, and completeness of follow-up. Biases and confounding factors shall be identified and quantified.

(3) Risk analysis shall be based on the most sensitive study deemed to be of sufficient quality.

(4) The results obtained for the most sensitive study deemed to be of sufficient quality shall be applicable to all routes of exposure for which the results are relevant.

(5) The absence of a carcinogenic threshold dose shall be assumed and no-threshold models shall be utilized. A linearized multistage model for extrapolation from high to low doses, with the upper 95 percent confidence limit of the linear term expressing the upper bound of potency shall be utilized. Time-to-tumor models may be appropriate where data are available on the time of appearance of individual tumors, and particularly when survival is poor due to competing toxicity.

(6) Human cancer potency shall be derived from data on human or animal cancer potency. Potency shall be expressed in reciprocal milligrams of chemical per kilogram of bodyweight per day. Interspecies conversion of animal cancer potency to human cancer potency shall be determined by multiplying by a scaling factor equivalent to the ratio of human to animal bodyweight, taken to the one-fourth power.

(7) When available data are of such quality that physiologic, pharmacokinetic and metabolic considerations can be taken into account with confidence, they may be used in the risk assessment for inter-species, inter-dose, and inter-route extrapolations.

(8) When the cancer risk applies to the general population, human body weight of 70 kilograms shall be assumed. When the cancer risk applies to a certain subpopulation, the following assumptions shall be made, as appropriate: 

Subpopulation/Age/Kilograms of Body Weight

Man (18+ years of age)70

Woman (18+ years of age) 58

Woman with conceptus 58

Adolescent (11-18 years of age) 40

Child (2-10 years of age) 20

Infant (0-2 years of age)10

(b) For chemicals assessed in accordance with this section, the risk level which represents no significant risk shall be one which is calculated to result in one excess case of cancer in an exposed population of 100,000, assuming lifetime exposure at the level in question, except where sound considerations of public health support an alternative level, as, for example:

(1) where chemicals in food are produced by cooking necessary to render the food palatable or to avoid microbiological contamination; or

(2) where chlorine disinfection in compliance with all applicable state and federal safety standards is necessary to comply with sanitation requirements; or

(3) where a clean-up and resulting discharge is ordered and supervised by an appropriate governmental agency or court of competent jurisdiction.

​

Cal. Code Regs., tit. 27, § 25703

​

§ 25704. Exposures to Listed Chemicals in Coffee Posing No Significant Risk

Exposures to chemicals in coffee, listed on or before March 15, 2019 as known to the state to cause cancer, that are created by and inherent in the processes of roasting coffee beans or brewing coffee do not pose a significant risk of cancer.
 

Cal. Code Regs., tit. 27, § 25704

​

§ 25705. Specific Regulatory Levels Posing No Significant Risk

​

(a) Daily exposure to a chemical at a level which does not exceed the level set forth in subsections (b), (c) and (d) for such chemical shall be deemed to pose no significant risk within the meaning of Section 25249.10(c) of the Act.

(b) Levels of exposure deemed to pose no significant risk may be determined by the lead agency based on a risk assessment conducted by the lead agency pursuant to the guidelines set forth in Section 25703, or a risk assessment reviewed by the lead agency and determined to be consistent with the guidelines set forth in Section 25703.

(1) The following levels based on risk assessments conducted or reviewed by the lead agency shall be deemed to pose no significant risk:

Chemical Name Level (micrograms/day)

*Fibers equal to or greater than 5 micrometers in length and 0.3 micrometers in width, with a length to width ratio of greater than or equal to 3:1 as measured by phase contrast microscopy.

(c) Unless a specific regulatory level for a chemical known to the state to cause cancer has been established in subsection (b), levels of exposure deemed to pose no significant risk may be determined by the lead agency based on state or federal risk assessments.

(1) Any interested party may request the lead agency to reevaluate a level established in this subsection based on scientific considerations that indicate the need for the lead agency to develop its own risk assessment or to conduct a detailed review of the risk assessment used to derive the level in question. Such request shall be made in writing, and shall include a description of the scientific considerations that indicate the need for the lead agency to develop its own risk assessment or to conduct a detailed review of the risk assessment used to derive the level in question. The lead agency may establish a level for the chemical in question in subsection (b) as it deems necessary.

(2) The following levels based on state or federal risk assessments shall be deemed to pose no significant risk:

Chemical Name Level (micrograms/day)

(d) Unless a specific regulatory level has been established for a chemical known to the state to cause cancer in subsection (b) or (c), levels of exposure deemed to pose no significant risk may be determined by the lead agency using an expedited method consistent with the procedures specified in Section 25703.

(1) Any interested party may request the lead agency to reevaluate a level established in this subsection and to consider the adoption, in subsection (c), of a level based on a state or federal risk assessment. Such request shall be made in writing, and shall include a copy of the state or federal risk assessment which the interested party wishes the lead agency to consider as the basis for a level in subsection (c). The lead agency may establish a level in subsection (c) for the chemical in question based on a state or federal risk assessment as it deems necessary.

(2) Any interested party may request the lead agency to reevaluate a level established in this subsection based on scientific considerations that indicate the need for a conventional risk assessment. Such request shall be made in writing, and shall include a description of the scientific considerations that indicate the need for a conventional risk assessment. The lead agency may conduct a conventional risk assessment for the chemical in question, and establish a level in subsection (b) as it deems necessary.

(3) The following levels of exposure based on risk assessments conducted by the lead agency using an expedited method consistent with the procedures specified in Section 25703 shall be deemed to pose no significant risk:

Chemical Name Level (micrograms/day)

Cal. Code Regs., tit. 27, § 25705

​

§ 25707. Routes of Exposure

 

(a) Where scientifically valid absorption studies conducted according to generally accepted standards demonstrate that absorption of a chemical through a specific route of exposure can be reasonably anticipated to present no significant risk of cancer at levels of exposure not in excess of current regulatory levels, the lead agency may identify the chemical as presenting no significant risk by that route of exposure. Any exposure, discharge or release of a chemical so identified shall be deemed to present no significant risk to the extent that it results in exposure to humans by the identified route, and does not exceed the level established in any other applicable federal or state standard, regulation, guideline, action level, license, permit, condition, requirement or order.

(b) The following chemicals present no significant risk of cancer by the route of ingestion:

(1) Asbestos

(2) Beryllium and beryllium compounds

(3) Cadmium and cadmium compounds

(4) Nickel and nickel compounds

​

(Cal. Code Regs., tit. 27, § 25707 

​

§ 25711. Levels Based on State or Federal Standards

​

(a) Except as otherwise provided in section 25705, 25707, or 25709, levels of exposure deemed to pose no significant risk may be determined as follows:

(1) Where a state or federal agency has developed a regulatory level for a chemical known to the state to cause cancer which is calculated to result in not more than one excess case of cancer in an exposed population of 100,000, such level shall constitute the no significant risk level.

(2) For drinking water, the following levels shall be deemed to pose no significant risk:

(A) Drinking water maximum contaminant levels adopted by the Department of Health Services for chemicals known to the state to cause cancer;

(B) Drinking water action levels for chemicals known to the state to cause cancer for which maximum contaminant levels have not been adopted;

(C) Specific numeric levels of concentration for chemicals known to the state to cause cancer which are permitted to be discharged or released into sources of drinking water by a Regional Water Quality Control Board in a water quality control plan or in waste discharge requirements, when such levels are based on considerations of minimizing carcinogenic risks associated with such discharge or release.

​

Cal. Code Regs., tit. 27, § 2571

​

§ 25801 - General

​

(a) The determination of whether a level of exposure to a chemical known to the state to cause reproductive toxicity has no observable effect for purposes of Section 25249.10(c) of the Act 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. Nothing in this article shall preclude a person from using evidence, standards, assessment methodologies, principles, assumptions or levels not described in this article to establish that a level of exposure has no observable effect at one thousand (1,000) times the level in question.

(b) A level of exposure to a listed chemical shall be deemed to have no observable effect, assuming exposure at one thousand times that level, provided that the level is determined:

(1) By means of an assessment that meets the standards described in Section 25803 to determine the maximum dose level having no observable effect, and dividing that level by one thousand (1,000) to arrive at the maximum allowable dose level; or

(2) By application of a specific regulatory level for the chemical in question as provided in Section 25805.

(c) For purposes of this article, "NOEL" shall mean that no observable effect level, which is the maximum level of exposure at which a chemical has no observable reproductive effect.

(d) The chemicals specifically contained in this article do not include all chemicals listed as causing reproductive toxicity for which there is a level of exposure which has no observable effect assuming exposure at one thousand times the level in question. The fact that a chemical does not specifically appear in this article does not mean that it has an observable effect at any level.

(e) This article establishes exposure levels solely for purposes of Section 25249.10(c) of the Act. Nothing in this article shall be construed to establish exposure levels for other regulatory purposes.

(f) Whenever the lead agency proposes to formally adopt a regulation pursuant to Sections 25801 through 25821, such as a maximum allowable dose level, the lead agency shall provide each member of the Developmental and Reproductive Toxicant Identification Committee notice of the proposed action, the proposed change to the regulation, and a copy of the initial statement of reasons supporting the proposal for their review and comment. The Committee shall be given at least 45 days to comment. Any such comment by members of the Developmental and Reproductive Toxicant Identification Committee shall become a part of the formal rulemaking record. Nothing in this section shall be construed to require the members of the Developmental and Reproductive Toxicant Identification Committee to submit any comments. This procedure complies with the peer review requirements of section 57004 of the California Health and Safety Code.

​

Cal. Code Regs., tit. 27, § 25801

​

§ 25821. Level of Exposure to Chemicals Causing Reproductive Toxicity

​​

(a) For purposes of the Act, "level in question" means the chemical concentration of a listed chemical for the exposure in question. The exposure in question includes the exposure for which the person in the course of doing business is responsible, and does not include exposure to a listed chemical from any other source or product.

(b) For purposes of Section 25249.10(c) of the Act, the level of exposure to a chemical listed as causing reproductive toxicity shall be determined by multiplying the level in question (stated in terms of a concentration of a chemical in a given medium) times the reasonably anticipated rate of exposure for an individual to a given medium. The reasonably anticipated rate of exposure shall be based on the pattern and duration of exposure that is relevant to the reproductive effect which provided the basis for the determination that a chemical is known to the state to cause reproductive toxicity. (For example, an exposure of short duration is appropriate for a teratogenic chemical, whereas a chronic or protracted exposure is appropriate for one that retards fetal growth.)

(c) The following assumptions shall be used to calculate the reasonably anticipated rate of exposure to a chemical listed as causing reproductive toxicity, unless more specific and scientifically appropriate data are available:

(1) The assumptions set forth in subsection (d) of Section 25721 shall be used to calculate the reasonably anticipated rate of exposure to a chemical listed as causing reproductive toxicity, unless more specific and scientifically appropriate data are available.

(2) For exposures to consumer products, the level of exposure shall be calculated using the reasonably anticipated rate of intake or exposure for average users of the consumer product, and not on a per capita basis for the general population. The rate of intake or exposure shall be based on data for use of a general category or categories of consumer products, such as the United States Department of Agriculture Home Economic Research Report, Foods Commonly Eaten by Individuals: Amount Per Day and Per Eating Occasion, where such data are available.

(3) Where a maternal exposure to a chemical listed as causing reproductive toxicity has an effect on the conceptus (embryo or fetus), the level of exposure shall be based on the reasonably anticipated rate of exposure for the mother during the nine-month gestation period.

 

Cal. Code Regs., tit. 27, § 25821

 

§ 25903. Notices of Violation.

​

(a) For purposes of Section 25249.7(d) of the Act, "notice of the violation which is the subject of the action" (hereinafter "notice") shall mean a notice meeting all requirements of this section. No person shall commence an action to enforce the provisions of the Act "in the public interest" pursuant to Section 25249.7(d) of the Act except in compliance with all requirements of this section.

(b) Contents of Notice.

(1) General Information. Each notice shall include as an attachment a copy of "The Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65): A Summary" (see Appendix A) prepared by the lead agency. This attachment need not be included in the copies of notices sent to public enforcement agencies. A copy of this attachment may be obtained by writing to the Office of Environmental Health Hazard Assessment at P.O. Box 4010, Sacramento, CA 95812-4010.

(2) Description of Violation. A notice shall provide adequate information from which to allow the recipient to assess the nature of the alleged violation, as set forth in this paragraph. The provisions of this paragraph shall not be interpreted to require more than reasonably clear information, expressed in terms of common usage and understanding, on each of the indicated topics.

(A) For all notices, the notice shall identify:

1. the name, address, and telephone number of the noticing individual or a responsible individual within the noticing entity and the name of the entity;

2. the name of the alleged violator or violators;

3. the approximate time period during which the violation is alleged to have occurred; and

4. the name of each listed chemical involved in the alleged violation;

(B) For notices of violations of Section 25249.5 of the Act, a general identification of the discharge or release and of the source of drinking water into which the discharges are alleged to have occurred, to be occurring or to be likely to occur.

(C) For all notices of violation of Section 25249.6 of the Act, the route of exposure by which exposure is alleged to occur (e.g., by inhalation, ingestion, dermal contact);

(D) For notices of violation of Section 25249.6 of the Act involving consumer product exposures, the name of the consumer product or service, or the specific type of consumer product or services, that cause the violation, with sufficient specificity to inform the recipients of the nature of the items allegedly sold in violation of the law and to distinguish those products or services from others sold or offered by the alleged violator for which no violation is alleged. The identification of a chemical pursuant to subsection (b)(2)(A)4. must be provided for each product or service identified in the notice.

(E) For notices of violation of Section 25249.6 of the Act involving occupational exposures:

1. the general geographic location of the unlawful exposure to employees, or where the exposure occurs at many locations, a description of the occupation or type of task performed by the exposed persons;

2. where the alleged violator is the manufacturer or distributor of the chemical or products causing the exposure, the notice shall identify products in the same manner as set forth for consumer product exposures in subparagraph (b)(2)(D), above;

3. the notice shall include the language set forth in California Code of Regulations, Title 8, Section 338(b);

(F) For notices of violation of Section 25249.6 of the Act involving environmental exposures as defined in subsection 25601(d) of this chapter, the notice shall identify, the location of the source of the exposure. Where numerous sources of the exposure are alleged, the location need not be listed if the notice identifies each facility or source of exposure by stating those common characteristics that result in the allegedly unlawful exposure in a manner sufficient to distinguish those facilities or sources from others for which no violation is alleged. The notice shall state whether the exposure for which a warning allegedly is required occurs beyond the property owned or controlled by the alleged violators.

(3) Where the alleged violations fall within more than one of the categories described in subparagraph (b)(2)(B) to (b)(2)(F) above, then the notice shall comply with all applicable requirements.

(4) A notice is not required to contain the following information:

(A) The specific retail outlet or time or date at which any product allegedly violating the Act was purchased;

(B) The level of exposure to the chemical in question;

(C) The specific admissible evidence by which the person providing the notice will attempt to prove the violation;

(D) For products, the UPC number, SKU number, model or design number or stock number or other more specific identification of products;

(E) For geographic areas, the lot, block, or other legal description of the property in question.

(c) Service of Notice.

(1) Notices shall be served by first class mail or in any manner that would be sufficient for service of a summons and complaint under the California Code of Civil Procedure. In lieu of service as prescribed in the California Code of Civil Procedure, a notice may be served on the Attorney General and a district attorney or city attorney by electronic mail if:

(A) the Attorney General, District Attorney or City Attorney has specifically authorized such service and the authorization appears on the Attorney General's Web site;

(B) the Notice and related documents are sent to the electronic mail address specified, and in the format (e.g. Word, Adobe Acrobat) specified.

(C) Service by this method is not effective until the documents are actually received. Notice is actually received when it is acknowledged by the recipient.

(D) Where a document is served electronically, time shall be computed as it would for service by mail within the State of California.

(2) A certificate of service shall be attached to each notice listing the time, place, and manner of service and each of the parties upon which the notice was served.

(3) Notices shall be served upon each alleged violator, the Attorney General, the district attorney of every county in which a violation is alleged to have occurred, and upon the city attorneys of any cities with populations according to the most recent decennial census of over 750,000 and in which the violation is alleged to have occurred.

(4) Where the alleged violator has a current registration with the California Secretary of State that identifies a Chief Executive Officer, President, or General Counsel of the corporation, the notice shall be addressed to one of those persons.

​

Cal. Code Regs., tit. 27, § 25903.​

 

Office of Environmental Health Hazard Assessment

Title 27, California Code of Regulations

Article 6 Clear and Reasonable Warnings​

​

Providing warnings that are associated with the products on the internet website or in a catalog prior to the consumer completing a purchase is a reasonable way to ensure the consumer receives the warning prior to exposure. It also furthers the purposes of Proposition 65 by providing consumers with the information before they make a final purchasing decision, thus furthering the right-to-know purposes of the statute. Given that the internet website and catalogs are remote from the actual product being displayed for purchase, the consumer would not likely see the warning until after the product is delivered. This limits the ability of consumers to choose not to purchase the product and would require them to go through additional time and expense to return the product once they receive the warning. Some purchases may be deemed final by the retail seller, thus leaving the consumer with no recourse. OEHHA believes that it is reasonable, for purposes of the safe harbor provisions of these regulations, for retail sellers to provide the warning to potential purchasers prior to or during the purchase. The regulations were modified to require product manufacturers to provide warning language to retail sellers. Retail sellers of products are responsible for passing this information on to the consumers via their websites.

 

Office of Environmental Health Hazard Assessment Title 27, California Code of Regulations, Article 6 Clear and Reasonable Warnings, page 89.

​

OEHHA believes, for the reasons already stated in response to similar comments and in the ISOR, that the warning symbol is a reasonable and necessary part of the safe harbor warning. Id., page 103.

​

PROPOSITION 65 

CLEAR AND REASONABLE WARNINGS

QUESTIONS AND ANSWERS FOR BUSINESSES

​

Responsibility to Provide Warnings

 

Q11: Who should provide a warning?

 

A11: Consistent with the Act, OEHHA’s new regulations place primary responsibility for providing warnings on product manufacturers, producers, packagers, importers, suppliers or distributors. For consumer product exposures, businesses in the above categories must either provide a warning on the product label or labeling, or provide notice and warning materials to “the authorized agent” for a retail seller and receive an acknowledgment that the notice and materials were received [Section 25600.2(b)]. The retail seller is responsible for placement and maintenance of the warning materials he/she receives from the product manufacturer, producer, packager, importer, supplier or distributor [Section 25600.2(d)]. Businesses should carefully review the new requirements.

 

Q13: If a company is a manufacturer or producer of a consumer product, but does not sell it directly to retailers, how can it comply with the requirement to provide warnings to retail sellers?

 

A13: A consumer product manufacturer that does not sell directly to retailers has two options for compliance: (1) Provide a warning on the product label or labeling3 ; or (2) Provide both a written notice that a warning is required and warning materials (such as shelf signs) to the packager, importer, supplier or distributor via their authorized agent [Section 25600.2(b)]. Manufacturers and others in the chain of commerce should take appropriate actions to ensure that the warning is passed along to the retailer and ultimately to the consumer [Final Statement of Reasons (FSOR), p. 39]. How that is done will vary from situation to situation. A manufacturer or producer may choose to enter into a contract with other businesses along the chain of commerce for their product and/or the retailer to ensure that the warning is appropriately transmitted to the retailer and end consumer [Section 25600.2(i)].

 

Q14: If a company manufactures component parts or ingredients that are sold in bulk to other manufacturers or formulators, how can it comply with the requirement to provide a warning, especially if the need for a warning depends on the concentration or the manner of use of the listed chemical in the final product?

 

A14: A company that manufactures component parts or ingredients that include listed chemicals can comply with the obligation to warn persons who can be occupationally exposed to the bulk product by providing warnings consistent with Section 25606. The company would only have responsibility for a consumer warning if it has knowledge that the end use of the component part or ingredient can expose a consumer to a listed chemical (See FSOR, p. 138). For example, if a manufacturer of a food ingredient knows that the ingredient is typically used in certain types of prepared foods and could thereby result in an exposure under the Act, then the ingredient manufacturer should provide the warning to the product manufacturer [Section 25600.2]. The product manufacturer is then responsible for determining whether the product they are manufacturing causes an exposure to the chemical at a level that requires a warning. If so, the product manufacturer is responsible for passing the information along to its customers or the product retailer [Section 25600.2]. In such a situation, the ingredient manufacturer may also choose to work with the product manufacturer to evaluate whether the product should have a warning and may enter into a contract with product manufacturers to ensure that the warning is transmitted to the retailer and ultimately the consumer [Section 25600.2(i)]. 3 Section 25600.2 sets the responsibilities to provide a warning under the Act, but does not in and of itself provide a safe harbor. A business wishing to claim safe harbor protection must follow the method and content requirements set forth in Article 6, Subarticle 2. 

 

Safe Harbor Methods and Content

 

Q15: What are the type size requirements for safe harbor warnings?

 

A15: Type size requirements depend on the category of exposure covered by the safe harbor warning. Consumer product exposure warnings must generally be prominently displayed on a label, labeling, or sign, and must be displayed with such conspicuousness as compared with other words, statements, designs or devices on the label, labeling, or sign, as to render the warning likely to be seen, read and understood by an ordinary individual under customary conditions of purchase or use [Section 25601(c)]. Some safe harbor warnings, such as short-form warnings for consumer products [Section 25602], environmental exposure warnings [Sections 25604, 25605], and several “tailored warnings” [Section 25607.1, et seq.], have specific minimum typesize requirements. You should refer to the safe harbor methods corresponding to the exposure category for which you are providing a warning to determine if there are any applicable type size requirements.

​

Consumer Product Exposure Warning Methods

 

For additional information regarding safe harbor consumer product exposure warnings provided on the internet and in catalogs, see “Questions and Answers for Businesses: Internet and Catalog Warnings”, which is available on the Proposition 65 Warnings Website.

 

Q16: What are the ways to provide safe harbor warnings for consumer product exposures?

 

A16: The safe harbor methods and content for providing a consumer product exposure warning can be found in Sections 25602 and 25603. Section 25602(a) describes four safe harbor warning methods:

 A product-specific warning provided on a posted sign, shelf tag, or shelf sign, at each point of display of the consumer product.

 A product-specific warning provided via any electronic device that automatically provides the warning to the purchaser before purchase without requiring the purchaser to seek out the warning.

 A warning on the label that complies with the content requirements in Section 25603(a); namely, the warning symbol, the signal word, “WARNING:”, and the applicable warning message.

 A short-form warning on the label that complies with the content requirements in Section 25603(b); namely, the warning symbol, the signal word, “WARNING:”, and the applicable truncated warning message. The warning must be in a type size no smaller than the largest type size used for other consumer information on the product and in no case in a type size smaller than 6-point type.

 

Q17: If a consumer product has exterior packaging, is a warning label required on both the packaging and on the product itself?

 

A17: No, a “label” is defined as a display of written, printed or graphic material that is printed on or affixed to a product or its immediate container or wrapper [Section 25600.1(i)]. The warning label should be placed in a manner to ensure that consumers receive the warning prior to exposure. A warning must be visible on exterior packaging that is opaque if an exposure requiring a warning can occur upon opening the package [FSOR, p. 258]. A business may also choose to provide a warning on both the exterior packaging and the product itself.

 

Q18: Can an owner’s manual be used for providing a safe harbor warning?

 

A18: No, a standalone warning in an owner’s manual is not a safe harbor warning method for consumer product exposures [FSOR, p. 74]. For some products (specifically diesel engines, passenger vehicles and recreational vessels), owner’s manuals are included as part of a safe harbor warning method used in conjunction with another warning method [Sections 25607.14, 25607.16, and 25607.18].

 

Q19: Can a sign combine two different safe harbor warnings?

 

A19: It is possible to provide two or more warnings on a single sign. However, the entire applicable warning content for the type of exposure is required for safe harbor warnings in Subarticle 2. Combining the content of multiple warnings into one warning message would generally not comply with the safe harbor requirements. For example, if a vehicle repair facility allowed smoking at its facility such that warnings were required both for the environmental exposure to petroleum products and tobacco smoke, the required warning elements for each situation must be included for the safe harbor. A combined sign would need to be 8 ½ by 11 inches in dimension (designated smoking area requirement), posted at each public entry of the repair facility as well as within the area in which smoking occurred, printed in no smaller than 32-point type (repair facility requirement) with the messages enclosed in boxes to satisfy the safe harbor requirements. [Sections 25607.26, 25607.27, 25607.28, and 25607.29] A simpler method would be to provide separate warnings using the applicable methods and content.

 

Q20: Can a business provide a general Proposition 65 warning at each public entrance to a store instead of providing warnings for specific consumer products?

 

A20: No, the safe harbor consumer product exposure warning methods are described in Section 25602, subsections (a)(1)-(4). The safe harbor warning methods in Subarticle 2 do not include a standalone warning at public entrances purporting to cover all possible consumer product exposures. Such a warning would not meet the requirements for safe harbor warnings under the new regulations. Safe harbor warnings must be clearly associated with the product that is the subject of the warning and comply with the other requirements in Subarticle 2.

 

Consumer Product Exposure Warning Content Warning Symbol

 

Q21: Which American National Standards Institute (ANSI) International Organization for Standardization (ISO) number is required for the yellow warning symbol?

 

A21: The Article 6 regulations did not adopt the ANSI standards for warning symbols, and there is no requirement that the warning symbol color correspond to a specific ISO number. The regulations only require that the warning symbol be “yellow.” OEHHA provides sample compliant warning symbols that a business may download and use. Q22: If a business does not have the ability to print in color, can the business print the warning symbol in black and white? A22: Yes, if a business does not use the color yellow for other information printed on the label or sign, the business may print the warning symbol in black and white [Section 25603(a)].

​

... Q30: Is information required by other agencies such as warning messages, and nutritional information (calories, serving size, etc.) considered “consumer information”? Does that include the headings for those items?

 

A30: Yes, information such as warnings and nutritional information are “consumer information” for purposes of the minimum type size required for a short-form warning [Section 25600.1(c)]. There is no exception in the definition for headings.

 

Q31: If the space on a product label is too small and the short-form warning cannot be placed in one line, can the short-form warning be placed in two/three lines?

 

A31: Yes, there is no requirement that the short-form warning content fit on one line, however, the requirements such as the location of the warning symbol to the left of the warning message, height of the signal word, and the minimum type size must be followed if the business wishes to claim safe harbor protection.

 

Q32: If a business provides a short-form warning on the consumer product, can the same warning be provided on a website?

​

A32: Yes, a consumer product warning provided on a website pursuant to Section 25602(b) can use the same short-form warning content that the business is providing on the product. The business may also use a picture of the label on the product for the website warning.

​

​

Cal EPA Office of Environmental Health Hazard Assessment 5 Proposition 65 Clear and Reasonable Warnings Questions and Answers for Businesses Revised - July 2018

​

CALIFORNIA CODE OF CIVIL PROCEDURE (§§ 1 — 2107)

​

Part 2 Of Civil Actions (Titles 1 — 14)

   Title 14 Miscellaneous Provisions (Chs. 1 — 10)

        Chapter 6 Costs (§§ 1021 — 1039)

​

§ 1021.5. Attorney fees in cases resulting in public benefit

​

Upon motion, a court may award attorneys’ fees to a successful party against one or more opposing parties in any action which has resulted in the enforcement of an important right affecting the public interest if: (a) a significant benefit, whether pecuniary or nonpecuniary, has been conferred on the general public or a large class of persons, (b) the necessity and financial burden of private enforcement, or of enforcement by one public entity against another public entity, are such as to make the award appropriate, and (c) such fees should not in the interest of justice be paid out of the recovery, if any. With respect to actions involving public entities, this section applies to allowances against, but not in favor of, public entities, and no claim shall be required to be filed therefor, unless one or more successful parties and one or more opposing parties are public entities, in which case no claim shall be required to be filed therefor under Part 3 (commencing with Section 900) of Division 3.6 of Title 1 of the Government Code.

Attorney’s fees awarded to a public entity pursuant to this section shall not be increased or decreased by a multiplier based upon extrinsic circumstances, as discussed in Serrano v. Priest, 20 Cal. 3d 25, 49.

Code Civ. Proc., § 1021.5

​

California Code of Regulations

​​

Title 11 - Law

​ Division 4 - Proposition 65 Private Enforcement​

  Chapter 3 - Settlement Guidelines

​

Cal. Code Regs. Tit. 11, § 3200 - Authority and Scope

​​

This chapter contains the Attorney General's guidelines for review of settlements by persons proceeding "in the public interest" pursuant to Health and Safety Code section 25249.7(f)(4). The provisions of this chapter are guidelines, which are not binding on litigants or the courts, but provide the Attorney General's view as to the legality and appropriateness of various types of settlement provisions, and the type of evidence sufficient for the private plaintiff to sustain its burden of supporting the proposed settlement. The guidelines are not a comprehensive identification of all factors that should be considered in reviewing settlements, but identify particular issues that are likely to occur frequently. This should assist the parties in fashioning settlements to which the Attorney General is unlikely to object, and assist the courts in determining whether to approve settlements.

​

Cal. Code Regs. Tit. 11, § 3200

​

Cal. Code Regs. Tit. 11, § 3201 - Attorney's Fees

 

Code of Civil Procedure section 1021.5 permits an award of attorney's fees to a "successful party . . . in any action which has resulted in the enforcement of an important right affecting the public interest if: (a) a significant benefit . . . has been conferred on the general public or a large class of persons, (b) the necessity and financial burden of private enforcement . . . are such as to make the award appropriate, and (c) such fees should not in the interest of justice be paid out of the recovery, if any." These guidelines are intended to be consistent with existing law interpreting Code of Civil Procedure section 1021.5, but provide assistance to the litigants and the court in applying them to issues commonly arising under Proposition 65. These guidelines apply to settlements under which the basis for a fee award is provided by Code of Civil Procedure section 1021.5. Where there is a different or additional basis for an award of fees, parts of these guidelines may not apply. Since the Legislature has mandated that the court must determine that the attorney's fees in all settlements of Private Proposition 65 actions must be "reasonable under California law," the fact that the defendant agreed to pay the fee does not automatically render the fee reasonable. The fact that the fee award is part of a settlement, however, may justify applying a somewhat less exacting review of each element of the fee claim than would be applied in a contested fee application.

(a) Successful Party. The fact that a defendant changed its conduct prior to entry of a court order or judgment does not preclude a finding that the plaintiff was successful. If the plaintiff's action was the cause or "catalyst" of the change in conduct, the plaintiff may be deemed successful.

(b) Public Benefit.

(1) In a case alleging failure to warn, a settlement that provides for the giving of a clear and reasonable warning, where there had been no warning provided prior to the sixty-day notice, for an exposure that appears to require a warning, is presumed to confer a significant benefit on the public. If there is no evidence of an exposure for which a warning plausibly is required, there is no significant public benefit, even if a warning is given. If the relief consists of minor or technical changes in the language, appearance, or location of a warning in a manner that is not likely to significantly increase its visibility or effectiveness in communicating the warning to the exposed persons, there is no significant public benefit. Where a settlement sets forth a standard or formula for when a given product requires a warning, supporting evidence should show that at least some of the products in controversy in the action either are, or at some time were, above the warning level, or the existence of the standard or formula itself may not establish the existence of a significant public benefit.

(2) Reformulation of a product, changes in air emissions, or other changes in the defendant's practices that reduce or eliminate the exposure to a listed chemical, in lieu of the provision of a warning, are presumed to confer a significant benefit on the public. Where a settlement sets forth a standard or formula for reformulation, supporting evidence should show that at least some of the products in controversy in the action either are, or at some time relevant to the litigation were, above the agreed-upon reformulation standard or formula, or else the mere agreement to a reformulation standard or formula may not establish the existence of a significant public benefit. Similarly, where a settlement requires changes in air emissions or other changes in the defendant's practices, supporting evidence should show that the changes in air emissions or to the defendant's practices will result in emissions or exposures that are less than the emissions or exposures that either are present or were present at some time relevant to the litigation, or else the mere agreement to make the changes may not establish the existence of a significant public benefit.

(3) In a case alleging violations of Health and Safety Code section 25249.5, the reduction or elimination of the discharge of listed chemicals establishes a significant public benefit.

(c) Necessity of Private Enforcement. To establish necessity of private enforcement, the plaintiff should establish that its continued prosecution of the action was necessary to obtain the relief in the settlement. For example, where a defendant proposed in writing to provide certain relief, and the settlement or judgment does not provide any significant additional relief, additional fees incurred after the time that the offer was rejected may not be reasonable or necessary.

(d) Reasonable Fees. Hourly fees should be those reasonable for attorneys of similar skill and experience in the relevant market area. Once a lodestar fee is a calculated, a multiplier of that amount is not reasonable unless a showing is made that the case involved a substantial investment of time and resources with a high risk of an adverse result, and obtained a substantial public benefit. No fees should be awarded based on additional time spent in response to the Attorney General's inquiries or participation in the case, unless specifically identified and approved by the court.

(e) Documentation. All attorney's fees and any investigation costs sought to be recouped in a Settlement should be justified by contemporaneously kept records of actual time spent or costs incurred, which describe the nature of the work performed. Declarations relying on memory or recreated, non-contemporaneously kept records may raise an issue concerning the accuracy of the time estimate.

(f) "Contingent Fee" Awards. A "contingent" fee is an attorney's fee paid pursuant to an agreement between the plaintiff and the plaintiff's attorney under which the attorney will be paid a specified amount or percentage of the total recovery obtained for the plaintiff. Where a plaintiff obtains an award of funds that belong exclusively to the plaintiff without any restriction, these fees generally are not considered to have been awarded by the court, and are reviewed by courts only under specified circumstances (e.g., compromise of a claim of a minor). In Proposition 65 cases, however, there typically is no award of damages or other unrestricted funds to the plaintiff (other than the plaintiff's 25% of any civil penalty recovery). Accordingly, simply denominating a fee award as "contingent" and based on the total monetary recovery does not necessarily render the fee amount "reasonable under California law," and such fees should be justified under Code of Civil Procedure section 1021.5 or another applicable theory.

​

Cal. Code Regs. Tit. 11, § 3201

​

Cal. Code Regs. Tit. 11, § 3202 - Clear and Reasonable Warnings

​

Health and Safety Code section 25249.7(f)(4)(A) requires that, in order to approve a settlement, the court must find that "Any warning that is required by the settlement complies with" the clear and reasonable warning requirement of Proposition 65. This guideline provides additional information concerning the Attorney General's interpretation of the statute and existing regulations governing clear and reasonable warnings and factors that will be considered in the Attorney General's review of settlements. Nothing in this guideline shall be construed to authorize any warning that does not comply with the statute and regulations, or to preclude any warning that complies with the statute and regulations or to conflict with regulations adopted by the Office of Environmental Health Hazard Assessment. This guideline is intended to address some of the types of warnings commonly found in settlements, not to provide comprehensive standards.

(a) Supporting evidence. In order to sustain its burden of producing evidence sufficient to support the conclusion that the warning is legal, the plaintiff should provide (1) the text and appearance of the warning, along with a sufficient description of where the warning will appear in order to ascertain whether the warning will be "reasonably conspicuous" under the circumstances of purchase or use of the product; and (2) sufficient proof that the product causes exposure to a listed chemical to enable a finding that the warning would be truthful.

(b) Warning language. Where the settling parties agree to language other than the "safe harbor" language set forth in the governing regulations (22 CCR " 12601(b)) the warning language should be analyzed to determine whether it is clear and reasonable. Certain phrases or statements in warnings are not clear and reasonable, such as (1) use of the adverb "may" to modify whether the chemical causes cancer or reproductive toxicity (as distinguished from use of "may" to modify whether the product itself causes cancer or reproductive toxicity); (2) additional words or phrases that contradict or obfuscate otherwise acceptable warning language. Certain other deviations from the safe-harbor warnings are generally clear and reasonable, such as (1) Using the language "Using this product will expose you to a chemical . . ." in lieu of "This product contains a chemical . . ."; or (2) deleting the reference to "the state of California" from the safe-harbor language.

(c) Premises warnings for environmental tobacco smoke. A number of cases involve provision of warnings due to exposure to environmental tobacco smoke caused by entry of persons (other than employees) on premises where smoking is permitted at any location on the premises.

1. Location of signs.

(A) For hotels or apartment buildings in which entry to guest rooms or apartments is on an enclosed hallway and there is a common ventilation system, the sign should be posted at main and subsidiary entrances to the building (including any entrance from a parking structure), and at the registration counter or administrative office open to the public or guests.

(B) For hotels or apartment complexes in which entry to guest rooms or apartments is to areas open to ambient air; signs should be posted at a kiosk or gate where cars drive in, if any, and at the registration counter or other administrative office open to the public or guests.

2. Language of Signs. The following language is appropriate and legally sufficient:

"WARNING: This facility allows smoking in some areas. Tobacco smoke, and many of the chemicals in it, are known to the state of California to cause cancer, and birth defects or other reproductive harm. [Optional: Smoking is permitted only in the following areas of this facility: (identify areas, e.g., "swimming pool area," "foyers," "designated guest rooms," "outdoor patios."]"

3. Successful parties. The plaintiff is not successful and has not conferred a substantial public benefit if the defendant had posted signs substantially complying with subparagraphs (1) and (2); and the only additional relief obtained is the posting of additional signs in guest rooms or in hallways that lead to guest rooms in which smoking is permitted.

(d) Environmental Exposure Warnings. In determining whether environmental exposure warnings comply with the law, the parties should consider 22 CCR section 12601(d)(2), which requires, among other things, that the warning "be provided in a conspicuous manner and under such conditions as to make it likely to be read, seen or heard and understood by an ordinary individual in the course of normal daily activity, and reasonably associated with the location and source of the exposure." 22 CCR section 12601(d)(1) also requires that such warnings "target the affected area." Settlements meeting these requirements should:

(1) include a warning other than signs posted at the facility wherever the area for which the exposure occurs at a level requiring a warning extends beyond the boundaries of the facility to an area of persons who do not actually enter or walk by the facility.

(2) Use hand-delivered or mail-delivered notices rather than media advertisements unless the area of persons to be warned is so large as to make such delivery substantially more expensive than media advertisements;

(3) If newspaper notices are used, they should appear in the main news section of the newspaper with the largest circulation in the area for which a warning is given, be at least 1/4 page in size, and contain a graphic depiction of the location of the facility for which the warning is given and the area for which the warning is given.

​

Cal. Code Regs. Tit. 11, § 3202

​

Cal. Code Regs. Tit. 11, § 3203 - Reasonable Civil Penalty

​​

The reasonableness of civil penalties in a settlement will be evaluated based on the factors set forth in the Health and Safety Code section 25249.7(b)(2). The following factors are "[other factors] that justice may require" to be considered within the meaning of Health and Safety Code section 25249.7(b)(2)(G):

(a) A settlement with little or no penalty may be entirely appropriate or not, based on the facts or circumstances of a particular case.

(b) Recovery of civil penalties (75% of which must be provided to the Office of Environmental Health Hazard Assessment) serves the purpose and intent of Proposition 65. Accordingly, civil penalties shall not be "traded" for payments of attorney's fees.

(c) Where a settlement provides that certain civil penalties are assessed, but may be waived in exchange for certain conduct by the defendant, such as, for example, reformulating products to reduce or eliminate the listed chemical, the conduct must be related to the purposes of the litigation, provide environmental and public health benefits within California, and provide a clear mechanism for verification that the qualifying conditions have been satisfied.

(d) Where a settlement requires the alleged violator to make any Additional Settlement Payments to the plaintiff or to a third party, such Additional Settlement Payments are viewed as an "offset" to the civil penalty. The plaintiff must demonstrate to the satisfaction of the court that it is in the public interest to offset the civil penalty required by statute.

​

Cal. Code Regs. Tit. 11, § 3203

​

Cal. Code Regs. Tit. 11, § 3205 - Other Provisions

 

Certain other provisions of a settlement may either be unlawful or contrary to public policy, and could provide the basis for an objection by the Attorney General.

(a) Releases or other language describing the intended scope of claims resolved or barred by the settlement shall not purport to:

(1) Be on behalf of the People of the State of California. Appropriate language is that the plaintiffs are "suing 'in the public interest' pursuant to Health and Safety Code section 25249.7(d)" and "suing 'in the interest of . . . the general public' pursuant to Business and Professions Code section 17204" (whichever applies to the action).

(2) Release or resolve any claim by individuals with personal injuries, unless those claims were properly raised in the complaint and litigated in the action.

(3) Release or resolve any claim concerning listed chemicals that are not present in the product at the time of entry of judgment, or any claim concerning chemicals that are not on the list of chemicals known to the state to cause cancer or reproductive toxicity, but may become listed in the future.

(4) Release or resolve any claim concerning chemicals or exposures not set forth in the sixty-day notice of violation.

(5) Immunize any defendant from any duty caused by a change in law, or to impose a duty that is removed by a change in law.

​

Cal. Code Regs. Tit. 11, § 3205