California Code of Regulations
Title 8 - Industrial Relations
Division 1 - Department of Industrial Relations
Chapter 4 - Division of Industrial Safety
Subchapter 7 - General Industry Safety Orders
Group 16 - Control of Hazardous Substances
Article 109 - Hazardous Substances and Processes
Appendix G to Section 5194 - Terms and Provisions for Subsection (b)(6)

Current through Register 2024 Notice Reg. No. 38, September 20, 2024

The following Sections from Title 22 of the California Code of Regulations (22 CCR) in effect on May 9, 1991 are printed in this Appendix because they provide terms and provisions referred to in subsection (b)(6):

See Title 29 Code of Federal Regulations section 1910.1200 Appendix E.

The following Sections from Title 22 of the California Code of Regulations (22 CCR) in effect on May 9, 1991 are printed in this Appendix because they provide terms and provisions referred to in subsection (b)(6):

# 12201. Definitions.

(a) In The Course of doing Business.

For purposes of Health and Safety Code Sections 25249.5 and 25249.6, "in the course of doing business" means any act or omission, whether or not for profit, except:

(1) as excluded by subdivision (b) of Section 25249.11 of the Health and Safety Code; or

(2) when caused by acts of war or grave and irresistible natural disasters such that no reasonable amount of resistance or advance preparation would be sufficient to avoid the discharge, release or exposure.

(b) In the Course of Doing Business, Acts of Employees.

"In the course of doing business" includes any act or omission of any employee which furthers the purpose or operation of the business, or which is expressly or implicitly authorized, except for the personal use, consumption or production of listed chemicals by an employee on the business premises or while performing activities for the business, unless the employer knows or should know of such use, consumption or production and knows or should know that such use, consumption or production will expose other individuals within the meaning of Health and Safety Code Section 25249.6 to a listed chemical.

(c) Employee.

The term "employee" shall have the same meaning as it does in Unemployment Insurance Code Section 621 and in Labor Code Section 3351. Generally, and without limiting the applicability of the definitions in these two statutes, this means than an employee is a person who performs services for remuneration under any appointment or contract of hire or apprenticeship, express or implied, oral or written, whether lawfully or unlawfully employed. In computing whether a person employs ten or fewer employees in his business, all full-time and part-time employees on the date on which the discharge, release or exposure occurs must be counted. Thus, the prohibitions on discharge or release and exposures to certain chemicals will apply to any person who has ten or more full-time or part-time employees on the date in question.

(d) Knowingly.

"Knowingly" refers only to knowledge of the fact that a discharge of, release of, or exposure to a chemical listed pursuant to Health and Safety Code Section 25249.8(a) is occurring. No knowledge that the discharge, release or exposure is unlawful is required. However, a person in the course of doing business who, through misfortune or accident and without evil design, intention or negligence, commits an act or omits to do something which results in a discharge, release or exposure has not violated Health and Safety Code Sections 25249.5 or 25249.6.

(e) ED NOTE: Cal-OSHA Standards Board did not incorporate subsection (e) into 5194(b)(6).

(f) Expose.

The term "expose" means to cause to ingest, inhale, contact via body surfaces or otherwise come into contact with a chemical. An individual may come into contact with a chemical through water, air, food, consumer products and any other environmental exposure as well as occupational or workplace exposures.

(g) - (j) ED NOTE: Cal-OSHA Standards Board did not incorporate subsections (g), (h), (i), and (j) into 5194(b)(6).

(k) For purposes of this chapter, "listed chemical" means a chemical listed pursuant to Health and Safety Code Section 25249.8, subsection (a).

# 12502. Exposure to a Listed Chemical in Drinking Water.

(a) A person otherwise responsible for an exposure to a listed chemical which involves the use of drinking water, including the use of drinking water in food or any other consumer product, does not "expose" an individual within the meaning of Section 25249.6 to the extent that the person can show that the listed chemical was contained in drinking water which was received from:

(1) a public water system, as defined in Section 4010.1 of the Health and Safety Code;

(2) a commercial supplier of drinking water; or

(3) a source of drinking water in compliance with all applicable primary drinking water standards for all listed chemicals and the chemical in question is the result of treatment of the water in order to achieve compliance with primary drinking water standards.

Where the source of the listed chemical is in part from such drinking water and in part from other sources, "exposure" can occur only as to that portion of the listed chemical from sources other than such drinking water.

(b) For purposes of subdivision (a), the amount of a listed chemical contained in drinking water shall be determined by sampling of the drinking water at the point of delivery and by testing pursuant to Section 12901. If sampling and testing is impractical, the amount of a listed chemical shall be based on test results of the most recent sample of the drinking water taken by the public water system or the commercial drinking water supplier, provided that all sampling and testing has been conducted at the frequency and in the manner required by law, or alternatively, such amount shall be calculated at five percent of the maximum contaminant level set forth in the primary drinking water standard for the listed chemical.

# 12601. Clear and Reasonable Warnings.

(a) Whenever a clear and reasonable warning is required under Section 25249.6 of the Health and Safety Code, the method employed to transmit the warning must be reasonably calculated, considering the alternative methods available under the circumstances, to make the warning message available to the individual prior to exposure. The message must clearly communicate that the chemical in question is known to the state to cause cancer, or birth defects or other reproductive harm. Nothing in this section shall be construed to preclude a person from providing warnings other than those specified in subdivisions (b), (c), and (d) which satisfy the requirements of this subdivision, or to require that warnings be provided separately to each exposed individual.

(b) Warnings for consumer products exposures which include the methods of transmission and the warning messages as specified by this subdivision shall be deemed to be clear and reasonable. A "consumer products exposure" is an exposure which results from a person's acquisition, purchase, storage, consumption, or other reasonably foreseeable use of a consumer good, or any exposure that results from receiving a consumer service.

(1) The warning may be provided by using one or more of the following methods singly or in combination:

(A) A warning that appears on a product's label or other labeling. The term "label" means a display of written, printed or graphic matter upon a product or its immediate container. The term "labeling" means any label or other written, printed or graphic matter affixed to or accompanying a product or its container or wrapper.

(B) Identification of the product at the retail outlet in a manner which provides a warning. Identification may be through shelf labeling, signs, menus, or a combination thereof.

(C) A system of signs, public advertising identifying the system and toll-free information services, or any other system, that provides clear and reasonable warnings.

(D) For alcoholic beverages, including, without limitation, beer, malt beverages, wine and distilled spirits:

1. Primarily intended for consumption off the premises where sold or distributed:

(i) at least one notice or sign, no smaller than 10 inches wide by 10 inches high, and bearing the warning message set forth in paragraph (4) (E) of this subsection; or

(ii) at least one horizontal strip marker no smaller than 10 1/2 inches wide by 1 1/4 inches high, and bearing the warning message set forth in paragraph (4)(E) of this subsection; or

(iii) a notice no smaller than 5 inches by 5 inches, and bearing the warning message set forth in (4)(E) of this subsection.

(iv) If signs 10 inches high by 10 inches wide are used, the word "warning" shall be centered, three-quarters of an inch from the top of the sign in ITC Garamond bold condensed type face all in one-inch capital letters. Three-sixteenths of an inch from the base of the word "warning" shall be a line extending from left to right across the width of the sign one-sixteenth of an inch in thickness. Centered one-half inch below the line shall be the body of the warning message in 36/50 ITC Garamond bold condensed type face with the initial letter of each word, other than the conjunctive "and," capitalized. For the body of the warning message, left and right margins of at least one-half of an inch, and a bottom margin of at least one-half inch shall be observed. Larger signs shall bear substantially the same proportions of type size and spacing to sign dimension as the sign 10 inches high by 10 inches wide.

(v) If the 10 1/2 inch by 1 1/4 inch horizontal strip markers are used, the word "WARNING," punctuated by a colon, shall be justified left and located three-sixteenths of an inch from the top of the strip notice in ITC Garamond bold condensed type face all in capital letters measuring eleven sixteenth of an inch in height.

Three thirty-seconds of an inch from the base of the word "WARNING" shall be a line extending from left to right across the width of the word "WARNING" and the punctuation colon one thirty-second of an inch in thickness. Located one-fourth of an inch from the top and one-fourth of an inch from the bottom of the strip notice, and to the immediate right of the word "WARNING," shall be the body of the warning message in 12/16 point ITC Garamond bold condensed type face with the initial letter of each word, other than the conjunctive "and," capitalized. The word "WARNING" shall be one-half inch from the left edge of the strip notice and the requisite warning message shall extend to within one-half inch from the right edge.

(vi) If the 5 inch by 5 inch signs are used, they shall bear substantially the same proportions of type size and spacing to sign dimension as the sign 10 inches high by 10 inches wide, with both the word "WARNING" and the warning text set in white on a contrasting red background.

(vii) Such sign or notice shall be placed in the retail establishment so as to assure that it is readable and likely to be read either at each retail point of sale or each point of display. Such sign or notice shall be placed either at all retail points of sale or all points of display, but need not be placed at both. If 10 inch by 10 inch signs or notices are placed at the point of display, each shall be placed no more than ten feet from any alcoholic beverage container and in a manner associating the sign or notice with the display. If horizontal strip notices are used, they shall be placed at ten foot intervals horizontally along the display. If a 5 inch by 5 inch sign is used, it shall be conspicuously placed at each retail point of sale (e.g., check-out counter, cash register, cash box) so that it is likely to be read and understood during the sales transaction.

(viii) All measurements specified or referred to in paragraphs (iv), (v) and (vi), above, are not required to be precisely accurate.

2. Provided for consumption on the premises at tables served by food or beverage persons, or sold or distributed through over the counter service;

(i) a notice or sign displayed at each of the tables where alcoholic beverages are served or may be consumed at least 5 inches high by 5 inches wide bearing substantially the same type face and substantially the same proportion of type size and spacing to sign dimension as described in paragraph (D)1. (vi); or

(ii) the warning message set forth in paragraph (4)(E) of this subdivision, placed upon a menu or list in association with the alcoholic beverages listed thereon and served at such premises, or if alcoholic beverages are not listed thereon, on any menu or list provided to patrons in association with the listing of food or beverage offerings, in type size and design, such that the text is conspicuous and likely to be read prior to consumption of alcoholic beverages or,

(iii) at least one 10 inch by 10 inch sign, meeting the specifications set forth in paragraph (D)1. (iv) of this subsection, placed so that it is readable and likely to be read by patrons as they enter each public entrance to the establishment. If the establishment does not have clearly defined physical boundaries delineating those areas where, by permit or license, alcoholic beverages are served, the 10 inch by 10 inch sign shall be posted so that it is readable and likely to be read by patrons as they enter the area or areas where, by permit or license, alcoholic beverages are served; and

(iv) If sold or distributed through over-the-counter service, at least one sign, meeting the specifications set forth in paragraph (D)1., (iv) of this subsection, placed in the retail establishment so that the warning message is, prior to the consumption of alcoholic beverages, readable and likely to be read from all counter locations available to the public. Therefore, a retail establishment providing a warning pursuant to the preceding sentence, also would be required to provide a warning in accordance with either paragraph 2.(i), 2.(ii) or 2.(iii) of this subsection.

3. For premises which are specially licensed to sell and serve alcoholic beverages both on and off the licensed premises (e.g., in facilities that offer both "tasting" and retail sales), the off-sale portion of the premises shall comply with the provisions of subsection (D)1., above, and the portion of the premises where alcoholic beverages are served shall comply with the provisions of subsection (D)2., above.

4. For alcoholic beverages sold or distributed to consumers through the mail or package delivery services, warnings may be provided by incorporating or placing the warning message set forth in paragraph (4)(E) on or in the shipping container or delivery package in such a manner so that the warning message is likely to be read by the recipient prior to consumption of the alcoholic beverage(s).

5. All signs or notices referred to in subsections (D)1., (D)2. and (D)3., above, shall be displayed so that they are clearly visible under all lighting conditions normally encountered during business hours.

(2) To the extent practicable, warning materials such as signs, notices, menu stickers,or labels shall be provided by the manufacturer, producer, or packager of the consumer product, rather than by the retail seller. For alcoholic beverages, the placement and maintenance of the warning shall be the responsibility of the manufacturer or its distributor at no cost to the retailer, and any consequences for failure to do the same shall rest solely with the manufacturer or its distributor, provided that the retailer does not remove, deface, or obscure the requisite signs or notices, or obstruct, interfere with, or otherwise frustrate the manufacturer's reasonable efforts to post, maintain, or periodically replace said materials. For prescription drugs, the labeling approved or otherwise provided under federal law and the prescriber's accepted practice of obtaining a patient's informed consent shall be deemed to be a clear and reasonable warning.

(3) The warnings provided pursuant to paragraphs (1)(A) and (1)(B) shall be prominently placed upon a product's label or other labeling or displayed at the retail outlet with such conspicuousness, as compared with other words, statements, designs, or devices in the label, labeling or display as to render it likely to be read and understood by an ordinary individual under customary conditions of purchase or use.

(4) The warning message must include the following language:

(A) For consumer products that contain a chemical known to the state to cause cancer:

"WARNING: This product contains a chemical known to the State of California to cause cancer."

(B) For consumer products that contain a chemical known to the state to cause reproductive toxicity:

"WARNING: This product contains a chemical known to the State of California to cause birth defects or other reproductive harm."

(C) For food, other than alcoholic beverages, sold, served, or otherwise provided in food facilities, as defined in Health and Safety Code Section 27521(a), which is intended for immediate consumption:

"WARNING: Chemicals known to the State of California to cause cancer, or birth defects or other reproductive harm may be present in foods or beverages sold or served here."

(D) For fresh fruits, nuts and vegetables:

"WARNING: This product may contain a chemical known to the State of California to cause cancer, or birth defects or other reproductive harm."

(E) For alcoholic beverages, including, without limitation, beer, malt beverages, wine and distilled spirits:

"WARNING: Drinking Distilled Spirits, Beer, Coolers, Wine and Other Alcoholic Beverages May Increase Cancer Risk, and, During Pregnancy, Can Cause Birth Defects."

(5) A person in the course of doing business, who manufactures, produces, assembles, processes, handles, distributes, stores, sells or otherwise transfers a consumer product which he or she knows to contain a chemical known to the state to cause cancer or reproductive toxicity in an amount which requires a warning shall provide a warning to any person to whom the product is sold or transferred unless the product is packaged or labeled with a clear and reasonable warning.

(c) Warnings for occupational exposures which include the methods of transmission and the warning messages as specified by this subdivision shall be deemed clear and reasonable. An "occupational exposure" is an exposure, in the workplace of the employer causing the exposure, to any employee.

(1) The method employed to transmit the warning must include one of the following alternative methods:

(A) A warning that appears on the label or labeling of a product or substance present or used in the workplace. The label or labeling shall be prominently displayed on the product or substance and the product or substance shall be used under circumstances which make it likely that the warnings will be read and understood by employees or other individuals prior to the exposure for which the warning is given.

(B) A warning that appears on a sign in the workplace posted in a conspicuous place and under conditions that make it likely to be read and understood by employees and other individuals prior to the exposure for which the warning is given.

(C) A warning to the exposed employee about the chemical in question which complies with all information, training and labeling requirements of the federal Hazard Communication Standard (29 CFR Section 1910.1200, as amended and filed September 30, 1986), the California Hazard Communication Standard (Cal. Code Regs., Title 8, Section 5194, as amended and filed May 26, 1987), or, for pesticides, the Pesticides and Worker Safety requirements (Cal. Code Regs., Title 3, Ch. 6, Subch. 3, Group 3, Section 6700 et seq., in effect on February 16, 1988) authorized in Food and Agricultural Code Section 12981 (as amended by Statutes of 1980, Ch. 926, P. 2945, Section 1).

(2) For purposes of paragraph (1)(A) of this subdivision, the warning shall be provided in terms which would provide a clear warning for a consumer product as specified above.

(3) For purposes of paragraph (1)(B) of this subdivision, the following specific warning messages shall be deemed to clearly communicate that an individual is being exposed to a chemical known to the state to cause cancer, or birth defects or other reproductive harm.

(A) For exposure to a chemical known to the state to cause cancer:

"WARNING: This area contains a chemical known to the State of California to cause cancer."

(B) For exposure to a chemical known to the state to cause reproductive toxicity:

"WARNING: This area contains a chemical known to the State of California to cause birth defects or other reproductive harm."

(d) Warnings for environmental exposures which include the methods of transmission and the warning messages as specified by this subdivision shall be deemed clear and reasonable. An "environmental exposure" is an exposure which may foreseeably occur as the result of contact with an environmental medium, including, but not limited to, ambient air, indoor air, drinking water, standing water, running water, soil, vegetation, or manmade or natural substances, either through inhalation, ingestion, skin contact or otherwise. Environmental exposures include all exposures which are not consumer products exposures, or occupational exposures.

(1) The method employed to transmit the warning must include the most appropriate of the following alternative methods under the circumstances:

(A) A warning that appears on a sign in the affected area. The term "sign" means a presentation of written, printed or graphic matter. The term "affected area" means the area in which an exposure to a chemical known to the state to cause cancer or reproductive toxicity is at a level that requires a warning. A posting of signs in the manner described in Section 6776, (e)(1) of Title 3 of the California Code of Regulations, (as amended and filed August 15, 1986) shall be sufficient for purposes of this paragraph.

(B) A warning which is in a notice mailed or otherwise delivered to each occupant in the affected area. Such notice shall be provided at least once in any three-month period.

(C) A warning provided by public media announcements which target the affected area. Such announcements shall be made at least once in any three-month period.

(2) Environmental exposure warnings shall 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.

(3) For purposes of paragraph (1)(A) of this subdivision, the following specific warning messages shall be deemed to clearly communicate that an individual is being exposed to a chemical known to the state to cause caner, or birth defects or other reproductive harm.

(A) For exposure to a chemical known to the state to cause cancer:

"WARNING: This area contains a chemical known to the State of California to cause cancer."

(B) For exposure to a chemical known to the state to cause reproductive toxicity:

"WARNING: This area contains a chemical known to the State of California to cause birth defects or other reproductive harm."

# 12701. General.

(a) The determination of whether a level of exposure to a chemical known to the state to cause cancer poses no significant risk for purpose of Health and Safety Code Section 25249.10(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 the chemical as known to the state to cause cancer. Nothing in this article shall preclude a person from using evidence, standards, risk assessment methodologies, principles, assumptions or levels not described in this article to establish that a level of exposure to a listed chemical poses no significant risk.

(b) A level of exposure to a listed chemical, assuming daily exposure at that level, shall be deemed to pose no significant risk provided that the level is determined:

(1) By means of a quantitative risk assessment that meets the standards described in Section 12703;

(2) By application of Section 12707 (Routes of Exposure); or

(3) By one of the following, as applicable:

(A) If a specific regulatory level has been established for the chemical in question in Section 12705, by application of that level.

(B) If no specific level is established for the chemical in question in Section 12705, by application of Section 12709 (Exposure to Trace Elements), 12711 (Levels Based on State or Federal Standards) or 12713 (Exposure to Food, Drugs, Cosmetics and Medical Devices), unless otherwise provided.

(c) ED NOTE: Cal-OSHA Standards Board did not incorporate subsection (c) into 5194(b)(6).

(d) This article establishes exposure levels posing no significant risk solely for purposes of Health and Safety Code Section 25249.10(c). Nothing in this article shall be construed to establish exposure or risk levels for other regulatory purposes.

# 12703. 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 date 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 date 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 surface area scaling factor equivalent to the ratio of human to animal bodyweight, taken to the one-third power. This is equivalent to a scaling factor of 14 when extrapolating from mouse data, and a scaling factor of 6.5 when extrapolating from rat data.

(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:

(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.

# 12705. 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 subsection (b) for such chemical shall be deemed to pose no significant risk within the meaning of Health and Safety Code section 25249.10(c).

(b)

* 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) Whenever the lead agency proposes to formally adopt, pursuant to this section, a level which shall be deemed to pose no significant risk of cancer, assuming daily exposure at that level, the lead agency shall provide to each member of the Scientific Advisory Panel notice of the proposed action, a copy of the proposed level, and a copy of initial statement of reasons supporting the proposal. The close of the public comment period for any such proposal shall be scheduled by the lead agency so as to permit the Scientific Advisory Panel the opportunity to review such proposal and provide comment to the lead agency. Any such comment by the Scientific Advisory Panel shall become a part of the formal rulemaking file. Nothing in this subdivision shall be construed to prevent members of the Scientific Advisory Panel from providing comments individually on any such proposal, or to require the Scientific Advisory Panel to submit any comment.

# 12707. 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) Chromium (hexavalent compounds)

(5) Nickel and nickel compounds

# 12709. Exposure to Trace Elements.

(a) Except where a specific regulatory level is established in Section 12705, exposure to a trace element listed in (b) shall be deemed to pose no significant cancer risk so long as the reasonably anticipated level of exposure to the chemical does not exceed the level set forth in (b).

(b)

# 12711. Levels Based on State or Federal Standards.

(a) Except as otherwise provided in section 12705, 12707, 12709, or 12713, 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) The following levels based on state or federal risk assessments shall be deemed to pose no significant risk:

(3) 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.

# 12721. Level of Exposure to Carcinogens.

(a) For the 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 the Act, "lifetime exposure" means the reasonably anticipated rate of exposure for an individual to a given medium of exposure measured over a lifetime of seventy years.

(c) For purposes of Health and Safety Code Section 25249.10(c), the level of exposure to a listed carcinogen, assuming lifetime exposure at the level in question, 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 the given medium of exposure measured over a lifetime of seventy years.

(d) The following assumptions shall be used to calculate the reasonably anticipated rate of exposure to a listed carcinogen, unless more specific and scientifically appropriate date are available:

(1) For an exposure reasonably expected to affect the general population in any geographic area:

(A) The exposed individual ingests two liters of drinking water per day.

(B) The exposed individual inhales twenty cubic meters of air per day.

(C) The exposed individual has a lifespan of seventy years.

(2) For an exposure reasonably anticipated to affect a certain subpopulation of the general population in any geographic area, specific date (if available) relating to that subpopulation shall be used to determine the level of exposure.

(A) In the absence of more specific and scientifically appropriate data, the following assumptions should be made as appropriate:

(B) For an exposure reasonably expected to affect the conceptus (embryo or fetus), the gestation period for the exposed conceptus is nine months.

(3) For workplace exposures, the exposed worker inhales ten cubic meters of workplace air per eight-hour day, forty hours per week, fifty weeks per year over a forty-year period. The exposed individual from the general population who occasionally enters a workplace inhales 1.25 cubic meters of workplace air for one hour per month for a seventy-year lifetime.

(4) For exposures to consumer products, lifetime exposure shall be calculated using the average rate of intake or exposure for average users of the consumer product, and not on a per capita basis for the general population. The average 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.

# 12801. 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 Health and Safety Code Section 25249.10(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. 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 12803 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 12805.

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

(d) The chemicals specifically contained in this article do not include all listed reproductive toxicants 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 Health and Safety Code Section 25249.10(c). Nothing in this article shall be construed to establish exposure levels for other regulatory purposes.

# 12803. 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 has no observable effect, assuming exposure at one thousand times the level in question. 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 reproductive toxicity. 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) Only studies producing the reproductive effect which provides the basis for the determination that a chemical is known to the state to cause reproductive toxicity shall be utilized for the determination of the NOEL. Where multiple reproductive effects provide the basis for the determination that a chemical is known to the state to cause reproductive toxicity, the reproductive effect for which studies produce the lowest NOEL shall be utilized for the determination of the NOEL. The NOEL shall be the highest dose level which results in no observable reproductive effect, expressed in milligrams of chemical per kilogram of bodyweight per day.

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

(3) Animal bioassay studies for 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, and the route of exposure and the extent of occurrence of effects.

(4) The NOEL shall be based on the most sensitive study deemed to be of sufficient quality.

(5) 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.

(6) When available data are of such quality that anatomic, physiologic, pharmacokinetics and metabolic considerations can be taken into account with confidence, they may be used in the assessment.

(7) When data do not allow the determination of a NOEL, the lowest observable effect level (LOEL) shall be divided by 10 to establish a NOEL for purposes of assessment.

(b) The NOEL shall be converted to a milligram per day dose level by multiplying the assumed human body weight by the NOEL. When the applicable reproductive effect is upon the male, human body weight of 70 kilograms shall be assumed. When the applicable reproductive effect is upon the female or conceptus, human body weight of 58 kilograms shall be assumed.

# 12805. Specific Regulatory Levels: Reproductive Toxicants.

(a) Exposure to a chemical at a level which does not exceed the level set forth in subsection (b) for such chemical has no observable effect assuming exposure at one thousand (1,000) times that level.

(b)

(c) Unless a specific level is otherwise provided in this section, an assessment by an agency of the state or federal government that is the substantial equivalent of the assessment described in subdivision (a) of Section 12803, and establishes a maximum allowable daily dose level in the manner provided in paragraph (b)(1) of Section 12801, shall constitute the allowable daily dose level having no observable effect within the meaning of Health and Safety Code Section 25249.10(c).

# 12821. Level of Exposure to Reproductive Toxicants.

(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 Health and Safety Code Section 25249.10(c), the level of exposure to a listed reproductive toxicant 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 listed reproductive toxicant, unless more specific and scientifically appropriate data are available:

(1) The assumptions set forth in subdivision (d) of Section 12721 shall be used to calculate the reasonably anticipated rate of exposure to a listed reproductive toxicant, 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 listed reproductive toxicant 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.

# 12901. Methods of Detection.

(a) For purposes of Section 25249.11, subdivision (c), of the Health and Safety Code, the term "any detectable amount" means a level detected using a method of analysis referred to in this section. For purposes of this section, "method of analysis" refers to the method of detection or detection and calculation for a listed chemical in a specific medium, including, but not limited to, water, air, food, or soil, and shall include methods and procedures concerning the number of samples and the frequency and site of sampling that are specific for the listed chemical in question.

(b) Where the California Department of Health Services, the California Department of Food and Agriculture, the Air Resources Board, a local air pollution control district, the State Water Resources Control Board, or a Regional Water Quality Control Board has adopted or employs a method of analysis for a listed chemical in a specific medium, such method shall be the method of analysis for that chemical in that medium. Where more than one method of analysis has been so adopted or is so employed, each may be utilized as the method of analysis.

(c) Where no state or local agency identified in subdivision (b) has adopted or employs a method of analysis, a method of analysis, a method of analysis for a listed chemical in a specific medium adopted or employed by a federal agency shall be the method of analysis for that chemical in that medium. When more than one method of analysis has been so adopted or is so employed, each may be utilized as the method of analysis.

(d) Where no regulatory agency identified in subdivision (b) or (c) has adopted or employs a method of analysis, a method of analysis for a listed chemical in a specific medium which is generally accepted by the scientific community, as evidenced by its publication in compilations by professional and scientific associations or societies, such as the Association of Official Analytical Chemists, or in peer-reviewed technical journals published by such associations or societies, such method shall be the method of analysis for that chemical in that medium. When more than one method of analysis is generally accepted, each may be utilized as the method of analysis.

(e) Where no method of analysis as described in subsections (b) or (c) has been adopted or is employed, or is generally accepted by the scientific community as described in subsection (d), and a scientifically valid method of analysis has been developed for a listed chemical in a specific medium, such method shall be the method of analysis for that chemical in that medium. Where more than one method of analysis has been developed for a chemical in a specific medium, each may be utilized as the method of analysis.

(f) In performing an analysis to determine the concentration of a chemical known to the state to cause cancer or reproductive toxicity in a given medium, generally accepted standards and practice for sampling, collection, storage, preparation, chemical analysis, statistical analysis of data, interpretation of results and modeling shall be observed.

(g) For purposes of Health and Safety Code Sections 25249.5 and 25249.6, no discharge, release or exposure occurs unless a listed chemical is detectable as provided in this section.

1. New appendix E filed 5-31-91 as an emergency; operative 5-31-91 (Register 91, No. 33). A Certificate of Compliance must be transmitted to OAL by 9-30-91 or emergency appendix E language will be repealed by operation of law on the following day.
2. Amendment of section filed 9-30-91 as an emergency; operative 9-30-91 (Register 92, No. 2). A Certificate of Compliance must be transmitted to OAL 1-28-92 or emergency language will be repealed by operation of law on the following day.
3. Certificate of Compliance as to 9-30-91 order transmitted to OAL 11-22-91 and filed 12-17-91 (Register 92, No. 12).
4. Editorial correction of HISTORY 3 and 4 (Register 94, No. 50).
5. Editorial correction of #12502 and #12601 (c)(1)(C) (Register 95, No. 24).
6. Redesignation of former Appendix E to Appendix G, addition of cross-reference to CFR and amendment of NOTE filed 5-6-2013; operative 5-6-2013 pursuant to Labor Code section 142.3(a)(4)(C). Submitted to OAL for printing only pursuant to Labor Code section 142.3(a)(4) (Register 2013, No. 19).
7. Redesignation of former Appendix E to Appendix G, addition of cross-reference to CFR and amendment of NOTE refiled 11-6-2013; operative 11-6-2013 pursuant to Labor Code section 142.3(a)(4)(C). Submitted to OAL for printing only pursuant to Labor Code section 142.3(a)(4) (Register 2013, No. 45).
8. Repealer of 11-6-2013 order by operation of law 5-6-2014 pursuant to Labor Code 142.3 (Register 2014, No. 19).
9. Redesignation of former Appendix E to Appendix G, addition of cross-reference to CFR and amendment of NOTE filed 5-5-2014; operative 5-6-2014 pursuant to Government Code section 11343.4(b)(3) (Register 2014, No. 19).

Note: Authority cited: Sections 50.7 and 142.3, Labor Code. Reference: Sections 50.7 and 142.3, Labor Code; Sections 25249.6, 25249.7, 25249.8, 25249.10, 25249.11, 25249.12 and 25249.13, Health and Safety Code; California Lab. Federation v. Occupational Safety and Health Stds. Bd. (1990) 221 Cal.App.3d 1547 [271 Cal. Rptr. 310]; and Federal Register Volume 77, Number 58 (Monday, March 26, 2012) Pages 17574-17896).