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. 28, July 12, 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 ½ inches wide by 1 ¼ 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 ½ inch by 1 ¼ 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:
Subpopulation
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.
# 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)
Chemical
								  Name
Level
									 micrograms/day
Acrylonitrile
								  ..............................................................................
0.7
Aldrin
								  ........................................................................................
0.04
Asbestos
								  ..................................................................................
100
								  fibers inhaled/day*
Benzene
								  ...................................................................................
7
Benzidine
								  .................................................................................
0.001
Bis(2-chloroethyl) ether
								  ..........................................................
0.3
Bis(chloromethyl) ether
								  ...........................................................
0.02
Carbon tetrachloride
								  ...............................................................
5
DDT, DDE and DDD (in combination)
								  .................................
2
1,2-Dibromo-3-chloropropane (DBCP)
								  ................................
0.1
para-Dichlorobenzene
								  ............................................................
20
3,3'-Dichlorobenzidine
								  ............................................................
0.6
Dieldrin
								  .....................................................................................
0.04
1,4-Dioxane
								  .............................................................................
30
Epichlorohydrin
								  ........................................................................
9
Ethylene dibromide
								  .................................................................
0.2
								  (ingestion)
3 (inhalation)
								  ............................................................................
Ethylene dichloride
								  ..................................................................
10
Ethylene oxide
								  .........................................................................
2
Hexachlorobenzene
								  ................................................................
0.4
Hexachlorocyclohexane (technical
								  grade).............................
0.2
N-Nitroso-n-dibutylamine
								  ........................................................
0.06
N-Nitrosodiethylamine
								  ............................................................
0.02
N-Nitrosodimethylamine
								  .........................................................
0.04
N-Nitrosodiphenylamine
								  .........................................................
80
N-Nitrosodi-n-propylamine
								  .....................................................
0.1
N-Nitroso-N-ethylurea
								  .............................................................
0.03
N-Nitroso-N-methylurea
								  ..........................................................
0.006
Polybrominated biphenyls
								  ......................................................
0.02
Toxaphene
								  ...............................................................................
0.6
2,4,6-Trichlorophenol
								  ..............................................................
10
Urethane
								  ...................................................................................
0.7
* 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)
Element
No Significant Risk
									 Level in micrograms per day
Arsenic (inorganic)
								  ..........................
10
Beryllium
								  ..........................
0.1
Cadmium ..........................
1
# 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:
Chemical
									 Name
Level
									 micrograms/day
Acetaldehyde
								  .....................................................................................
90
Acrylamide
								  .........................................................................................
0.2
Allyl chloride
								  .......................................................................................
30
Aniline
								  .................................................................................................
100
Azobenzene
								  .......................................................................................
6
Benzo (a) pyrene
								  ...............................................................................
0.06
Beryllium oxide
								  ..................................................................................
0.1
Beryllium sulfate
								  .................................................................................
0.0002
1,3-Butadiene
								  ....................................................................................
0.4
Chlordane
								  ...........................................................................................
0.5
Chloroform
								  .........................................................................................
9
Chromium (hexavalent)
								  .....................................................................
0.001
Coke oven emissions
								  .......................................................................
0.3
DDVP (Dichlorvos)
								  ...........................................................................
2
Dichloromethane (Methylene Chloride)
								  ..........................................
50
Di (2-ethylhexyl) phthalate
								  .................................................................
80
2,4-Dinitrotoluene
								  ..............................................................................
2
Folpet
								  ..................................................................................................
200
Formaldehyde (gas)
								  ..........................................................................
15
Furmecyclox
								  .......................................................................................
20
Heptachlor
								  ..........................................................................................
0.2
Heptachlor epoxide
								  ...........................................................................
0.08
Hexachlorocyclohexane
alpha
								  isomer.....................................................................................
0.3
beta
								  isomer.......................................................................................
0.5
gamma
								  isomer.................................................................................
0.6
Hydrazine
								  ............................................................................................
0.04
Hydrazine sulfate
								  ...............................................................................
0.2
4,4'-Methylene bis
								  (N,N-dimethyl)benzeneamine............................
20
Nickel refinery dust
								  ............................................................................
0.8
Nickel subsulfide
								  ................................................................................
0.4
N-Nitrosodiethanolamine
								  ..................................................................
0.3
N-nitrosomethylethylamine
								  ................................................................
0.03
N-nitrosopyrrolidine
								  ..........................................................................
0.3
Pentachlorophenol
								  .............................................................................
40
Polychlorinated Biphenyls (PCBs)
								  ...................................................
0.09
Tetrachlorodibenzo-p-dioxin (TCDD)
								  ..............................................
0.000005
Tetrachloroethylene
								  ...........................................................................
14
Trichlorethylene
								  ..................................................................................
60
Vinyl chloride
								  ......................................................................................
0.3
..............................................................................................
(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:
Subpopulation
Water
									 liters/day
Air cubic
									 meters/day
Man (18+ years of age)
								  .........................................
2
								  ...............................................
..........................
								  20
Woman (18+ years of age)
								  ...................................
2
								  ...............................................
..........................
								  20
Woman with conceptus
								  .........................................
2
								  ...............................................
..........................
								  20
Adolescent (10-18 years of
								  age)..........................
2
								  ...............................................
..........................
								  20
Child (2-10 years of age)
								  ......................................
2
								  ...............................................
..........................
								  15
Infant (0-2 years of
								  age).........................................
1
								  ...............................................
..........................
								  4
(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)
Chemical Name
Level
									 Micrograms/day
Ethylene Oxide..............................
.......................... 20.0
Lead
								  ..............................................
..........................
								  0.5
(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).