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Subchapter 7. General Industry Safety Orders
Group 16. Control of Hazardous Substances
Article 110. Regulated Carcinogens
(a) Scope and Application. This section applies to an area in which any of the substances listed below is manufactured, processed, used, repackaged, released, stored or otherwise handled but does not apply to solid or liquid mixtures with a content less than the percent specified below or to transshipment in sealed containers, except for the labeling requirements under paragraphs (e)(2), (e)(3) and (e)(4) of this section.
Benzidine (and its salts)
3,3'-Dichlorobenzidine (and its salts)
Methyl chloromethyl ether
* By weight or volume
** This section does not apply to these materials in operations involving the destructive distillation of carbonaceous materials, such as occurs in coke ovens.
(1) Absolute Filter. A filter capable of retaining 99.97 percent of a mono disperse aerosol of 0.3 micrometer particles.
(2) Authorized Employee. An employee whose duties require him to be in the regulated area and who has been specifically assigned by the employer.
(3) Chief. The Chief of the Division of Occupational Safety and Health, P.O. Box 420603, San Francisco, California 94142.
(4) Clean Change Room. A room where employees put on clean clothing and/or protective equipment in an environment free of carcinogens. This room shall be contiguous to, and have entry from, a shower room when shower facilities are otherwise required by this section.
(5) Closed System. Any operation involving a carcinogen where containment prevents release into regulated areas, nonregulated areas or the external environment.
(6) Decontamination. The inactivation of a carcinogen or its safe disposal.
(7) Disposal. The safe removal of a carcinogen from the work environment.
(8) Emergency. An unforeseen circumstance or set of circumstances resulting in the release of a carcinogen which may result in exposure to, or contact with, the carcinogen.
(9) External Environment. Any environment external to regulated and nonregulated areas.
(10) Isolated System. A fully enclosed structure, other than the vessel of containment of a carcinogen, which is impervious to the passage of the carcinogen and which would prevent the entry of the carcinogen into regulated areas, nonregulated areas or the external environment should leakage or spillage from the vessel of containment occur.
(11) Laboratory Type Hood. A device enclosed on three sides and the top and bottom, designed and maintained so as to draw air inward at an average linear face velocity of 150 feet per minute with a minimum of 125 feet per minute; designed, constructed and maintained in such a way that an operation involving a carcinogen within the enclosure does not require the insertion of any portion of any employee's body other than hands and arms.
(12) Nonregulated Area. Any area under the control of the employer where entry and exit is neither restricted nor controlled.
(13) Open Vessel System. An operation involving a carcinogen in an open vessel which is not in an isolated system, in a laboratory type hood or in any other system affording equivalent protection against the entry of a carcinogen into regulated areas, nonregulated areas or the external environment.
(14) Protective Clothing. Clothing designed to protect an employee against contact with, or exposure to, a carcinogen.
(15) Regulated Area. An area where entry and exit is restricted and controlled.
(c) Regulated Areas. A regulated area shall be established by an employer where a carcinogen is manufactured, processed, used, released, stored or otherwise handled. All such areas shall be controlled in accordance with the requirements for the following category or categories describing the operation involved:
(1) Isolated Systems. Employees working with a carcinogen within an isolated system such as a “glove box” shall wash their hands and arms upon completion of the assigned task and before engaging in other activities not associated with the isolated system.
(2) Closed System Operations. Within the regulated areas where a carcinogen is stored in sealed containers or is contained in a closed system, including piping systems with any sample ports or openings closed while a carcinogen is contained within:
(A) Access shall be restricted to authorized employees;
(B) With the exception of those cases in which the substance is beta-propiolactone, bis-chloromethyl ether, methyl chloromethyl ether, or ethyleneimine, employees shall be required to wash hands, forearms, face and neck upon each exit from the regulated areas, close to the point of exit, and before engaging in other activities.
(3) Open Vessel System Operations. Open vessel system operations as defined in paragraph (b)(13) of this section are prohibited.
(4) Transfer From a Closed System, Charging or Discharging Point Operations, or Otherwise Opening a Closed System. In operations where a carcinogen is contained in a “closed system” but is transferred, charged or discharged into other normally closed containers, the following provisions shall apply:
(A) Access shall be restricted to authorized employees.
(B) Each operation shall be provided with a “laboratory type hood” or with equivalent continuous local exhaust ventilation so that air movement is always from ordinary work areas to the operation. Exhaust air shall not be discharged to regulated areas, nonregulated areas or the external environment unless decontaminated. Clean makeup air shall be introduced in sufficient volume to maintain the correct operation of the local exhaust system.
(C) Employees shall be provided with, and be required to wear, clean, full body protective clothing (smocks, coveralls or long-sleeved shirts and pants), shoe covers and gloves prior to entering the regulated area. Shoe covers are not required when the substance is bis-chloromethyl ether, methyl chloromethyl ether, or ethyleneimine.
(D) Employees engaged in the handling of carcinogens shall be provided with, and be required to wear and use as minimum protection, a half-face, filter type respirator for dusts, mists and fumes, or air purifying canisters or cartridges. Those employees engaged in the handling of beta-propiolactone, bis-chloromethyl ether, methyl chloromethyl ether, N-nitrosodimethylamine, or ethyleneimine shall be provided with, and be required to wear and use any self-contained breathing apparatus that has a full facepiece and is operated in a pressure-demand or other positive-pressure mode, or any supplied-air respirator that has a full facepiece and is operated in a pressure-demand or other positive-pressure mode in combination with an auxiliary self-contained positive-pressure breathing apparatus. A respirator affording higher levels of protection than these respirators may be substituted.
(E) Prior to each exit from a regulated area, employees shall be required to remove and leave protective clothing and equipment at the point of exit and, at the last exit of the day, to place used clothing and equipment in impervious containers at the point of exit for purposes of subsequent decontamination or disposal. The contents of such impervious containers shall be identified as required under paragraphs (e)(2), (e)(3) and (e)(4) of this section.
(F) Employees shall be required to wash hands, forearms, face and neck on each exit from the regulated area, close to the point of exit, and before engaging in other activities. Exception to this requirement is permitted when the substance is beta-propiolactone, bis-chloromethyl ether, methyl chloromethyl ether, or ethyleneimine.
(G) Employees shall be required to shower after the last exit of the day except in those cases in which the substance is beta-propiolactone, bis-chloromethyl ether, methyl chloromethyl ether, or ethyleneimine.
(H) Drinking fountains are prohibited in the regulated area.
(5) Maintenance and Decontamination Activities. In cleanup of leaks or spills, maintenance or repair operations on contaminated systems or equipment, or any operations involving work in an area where direct contact with a carcinogen could result, each authorized employee entering that area shall:
(A) Be provided with, and be required to wear, clean, impervious garments including gloves, boots and continuous air-supplied hood in accordance with Section 5144.
(B) Be decontaminated before removing the protective garments and hood.
(C) Be required to shower, including washing of the hair, upon removing the protective garments and hood.
(6) Laboratory Activities. The requirements of this paragraph shall apply to research and quality control activities involving the use of a carcinogen.
(A) Mechanical pipetting aids shall be used for all pipetting procedures.
(B) Experiments, procedures and equipment which could produce aerosols shall be confined to laboratory type hoods or glove boxes.
(C) Laboratory work surfaces on which a carcinogen is handled shall be protected from contamination.
(D) Contaminated wastes and animal carcasses shall be collected in impervious containers which are closed and decontaminated prior to removal from the work area. Such wastes and carcasses shall be incinerated in such a manner that no carcinogenic products are released.
(E) All other forms of a carcinogen shall be inactivated prior to disposal.
(F) Laboratory vacuum systems shall be protected with high efficiency scrubbers or with disposable absolute filters except that only high efficiency scrubbers shall be used with beta-propiolactone, bis-chloromethyl ether, methyl chloromethyl ether, or ethyleneimine.
(G) Employees, other than those engaged in animal support activities, shall be provided with, and shall be required to wear, a daily change of clean, protective laboratory clothing, such as a solid-front gown, surgical scrub suit or fully buttoned laboratory coat. The required change of clean, protective clothing for employees engaged in animal support activities shall include coveralls or pants and shirt, foot covers, head covers, gloves, and appropriate protective respiratory equipment or devices.
(H) Prior to each exit from a regulated area, employees shall be required to remove and leave protective clothing and equipment at the point of exit and, at the last exit of the day, to place used clothing and equipment in impervious containers at the point of exit for purposes of decontamination or disposal. Such impervious containers shall be identified as to their contents by labeling according to paragraphs (e)(2), (e)(3) and (e)(4) of this section.
(I) Employees shall be required to wash hands, forearms, face and neck upon each exit from the regulated area, close to the point of exit, and before engaging in other activities.
(J) Employees engaged in animal support activities shall be required to shower, including washing of the hair, after the last exit of the day.
(K) Air pressure in laboratory areas and animal rooms where a carcinogen is handled and bio-assay studies are performed shall be negative in relation to the pressure in surrounding areas. Exhaust air shall not be discharged to regulated areas, nonregulated areas or the external environment unless decontaminated.
(L) There shall be no connection between regulated areas and any other areas through the ventilation system.
(M) A current inventory of carcinogens shall be maintained.
(N) Ventilated apparatus such as laboratory type hoods shall be tested at least semi-annually, or immediately after ventilation modification or maintenance operations, by personnel fully qualified to certify correct containment and operation.
(d) General Regulated Area Requirements.
(1) Emergencies. Specific emergency procedures shall be prescribed and posted. In an emergency, immediate measures including, but not limited to, the requirements of subparagraphs (A), (B), (C), (D) and (E) of this paragraph shall be implemented.
(A) The potentially affected areas shall be evacuated as soon as the emergency has been determined.
(B) Hazardous conditions created by the emergency shall be eliminated and the potentially affected area shall be decontaminated prior to the resumption of normal operations.
(C) Special medical surveillance by a physician shall be instituted within 24 hours for employees present in the potentially affected area at the time of the emergency. A report of the medical surveillance and of any medical treatment shall be included in the incident report, in accordance with paragraph (f)(2) of this section.
(D) Where an employee has a known contact with a carcinogen, such an employee shall be required to shower, including washing of the hair, as soon as possible unless contraindicated by physical injuries.
(E) An incident report on the emergency shall be reported as provided in paragraph (f)(2) of this section.
(F) In operations involving beta-propiolactone, or ethyleneimine, emergency deluge showers and eyewash fountains supplied with running potable water shall be located near, within sight of, and on the same level with locations where a direct exposure would be most likely to occur as a result of equipment failure or improper work practice.
(2) Hygiene Facilities and Practices.
(A) Storage or consumption of food, storage or use of containers of beverages, storage or application of cosmetics, smoking, storage of smoking materials, tobacco products or other products for chewing, or the chewing of such products, are prohibited in regulated areas.
(B) Where employees are required by this section to wash or shower, facilities shall be provided in accordance with Section 3366.
(C) Where employees wear protective clothing and equipment, clean change rooms shall be provided in accordance with Section 3367 for the number of such employees required to change clothes.
(D) Where toilets are in regulated areas, such toilets shall be in a separate room in accordance with Section 3365.
(3) Contamination Control.
(A) Regulated areas, except for outdoor systems, shall be maintained under pressure negative with respect to nonregulated areas. Local exhaust ventilation may be used to satisfy this requirement. Clean makeup air in equal volume shall replace air removed.
(B) Any equipment, material or other item taken into or removed from a regulated area shall be done so in a manner that does not cause contamination in nonregulated areas or the external environment.
(C) Decontamination procedures shall be established and implemented to remove a carcinogen from the surface of materials, equipment and the decontamination facility.
(D) Dry sweeping and dry mopping are prohibited.
(4) Respirator program. The employer must implement a respiratory protection program in accordance with section 5144 (b) through (d) (except (d)(1)(C) and (E), and (d)(3)), and (e) through (m).
(e) Communication of hazards.
(1) Hazard communication.
(A) Chemical manufacturers, importers, distributors and employers shall comply with all requirements of the Hazard Communication Standard (HCS) (Section 5194) for each carcinogen listed in paragraph (e)(1)(D) of this section.
(B) In classifying the hazards of carcinogens listed in paragraph (e)(1)(D) of this section, at least the hazards listed in paragraph (e)(1)(D) are to be addressed.
(C) Employers shall include the carcinogens listed in paragraph (e)(1)(D) of this section in the hazard communication program established to comply with the HCS (Section 5194). Employers shall ensure that each employee has access to labels on containers of the carcinogens listed in paragraph (e)(1)(D) and to safety data sheets, and is trained in accordance with the requirements of HCS and paragraph (e)(4) of this section.
(D) List of Carcinogens:
1. 4-Nitrobiphenyl: Cancer.
2. alpha-Naphthylamine: Cancer; skin irritation; and acute toxicity effects.
3. Methyl chloromethyl ether: Cancer; skin, eye and respiratory effects; acute toxicity effects; and flammability.
4. 3,3'-Dichlorobenzidine (and its salts): Cancer and skin sensitization.
5. bis-Chloromethyl ether: Cancer; skin, eye, and respiratory tract effects; acute toxicity effects; and flammability.
6. beta-Naphthylamine: Cancer and acute toxicity effects.
7. Benzidine: Cancer and acute toxicity effects.
8. 4-Aminodiphenyl: Cancer.
9. Ethyleneimine: Cancer; mutagenicity; skin and eye effects; liver effects; kidney effects; acute toxicity effects; and flammability.
12. 4-Dimethylaminoazo-benzene: Cancer; skin effects; and respiratory tract irritation.
13. N-Nitrosodimethylamine: Cancer; liver effects; and acute toxicity effects.
(A) The employer shall post entrances to regulated areas with signs bearing the legend:
MAY CAUSE CANCER
AUTHORIZED PERSONNEL ONLY
(B) The employer shall post signs at entrances to regulated areas containing operations covered in paragraph (c)(5) of this section. The signs shall bear the legend:
MAY CAUSE CANCER
WEAR AIR-SUPPLIED HOODS, IMPERVIOUS SUITS,
AND PROTECTIVE EQUIPMENT IN THIS AREA
AUTHORIZED PERSONNEL ONLY
(C) Prior to June 1, 2016, employers may use the following legend in lieu of that specified in paragraph (e)(2)(A) of this section:
AUTHORIZED PERSONNEL ONLY
(D) Prior to June 1, 2016, employers may use the following legend in lieu of that specified in paragraph (e)(2)(B) of this section:
CANCER-SUSPECT AGENT EXPOSED IN THIS AREA
IMPERVIOUS SUIT INCLUDING GLOVES, BOOTS AND
AIR-SUPPLIED HOOD REQUIRED AT ALL TIMES
AUTHORIZED PERSONNEL ONLY
(E) Appropriate signs and instructions shall be posted at the entrance to, and exit from, regulated areas informing employees of the procedures that must be followed in entering and leaving a regulated area.
(F) Prescribed emergency procedures shall be posted in an appropriate location.
(3) Prohibited Statements. No statement shall appear on or near any required sign, label or instruction which contradicts or detracts from the effect of any required warning, information or instruction.
(4) Training and Indoctrination. Each employee, prior to being authorized to enter a regulated area, shall receive a training and indoctrination program including, but not necessarily limited to, the information or requirements of this paragraph. (All materials relating to the training/indoctrination program shall be provided upon request to authorized representatives of the Chief and the Director of the Department of Health.)
(A) The nature of the carcinogenic hazards including local and systemic toxicity.
(B) The specific nature of the operation involving a carcinogen which could result in exposure.
(C) The purpose for, and application of, the medical surveillance program, including, as appropriate, methods of self examination.
(D) The purpose for, and application of, decontamination practices and procedures.
(E) The purpose for, and significance of, emergency practices and procedures.
(F) The employee's specific role in prescribed emergency procedures.
(G) Specific information to aid the employee in recognition and evaluation of conditions and situations which may result in the release of a carcinogen.
(H) The purpose for, and application of, specific first-aid procedures and practices.
(I) The employee shall be familiarized with the prescribed emergency procedures and rehearsed in their application.
(J) This section shall be reviewed at the employee's first training and indoctrination program and annually thereafter.
(f) Reports. See section 5203.
(g) Medical Surveillance. At no cost to the employee, a program of medical surveillance shall be established and implemented for employees considered for assignment to enter regulated areas, and for authorized employees.
(A) Before an employee is assigned to enter a regulated area, a preassignment medical examination by a licensed physician shall be provided. The examination shall include the employee's personal history and that of the employee's family insofar as these are related to pertinent genetic, occupational and environmental factors.
(B) Authorized employees shall be provided periodic medical examinations, not less often than annually, following the preassignment examination.
(C) In all medical examinations, the physician shall consider whether factors exist, which would predispose the employee to increase risk, such as reduced immunological competence, treatment with steroids or cytotoxic agents, pregnancy and cigarette smoking.
(A) Employers of employees examined pursuant to paragraph (g)(1), above, shall cause to be maintained complete and accurate records of all such medical examinations. Records shall be maintained for the duration of the employee's employment. Upon termination of the employee's employment, including retirement or death, or in the event that the employer ceases business without a successor, records, or notarized true copies thereof, shall be forwarded by registered mail to the Director, National Institute for Occupational Safety and Health. The employer shall also comply with any additional requirements involving the transfer of records set forth in Section 3204.
(B) Records required by this paragraph shall be provided upon request to employees, designated representatives, and authorized representatives of the Chief, in accordance with Section 3204, and the Director of the National Institute for Occupational Safety and Health.
(C) Any physician who conducts a medical examination required by this paragraph shall furnish to the employer a statement of the employee's suitability for employment in the specific exposure.
9. Amendment of subsection (c)(4)(D) filed 4-5-85; effective thirtieth day thereafter (Register 85, No. 14).
10. Change without regulatory effect amending subsection (b)(3) filed 3-4-92 pursuant to section 100, title 1, California Code of Regulations (Register 92, No. 19).
11. Amendment of subsections (c)(4)(D) and (d)(4) filed 8-25-98; operative 11-23-98 (Register 98, No. 35).
12. Amendment of subsection (f), repealer of subsections (f)(1)-(f)(2)(B)4. and amendment of Note filed 7-6-99; operative 8-5-99 (Register 99, No. 28).
13. Change without regulatory effect amending subsections (d)(2)(B)-(D) filed 6-11-2001 pursuant to section 100, title 1, California Code of Regulations (Register 2001, No. 24).
14. Amendment of subsection (c)(4)(D) filed 1-18-2012; operative 1-18-2012 pursuant to Labor Code section 142.3(a)(4)(C). Submitted to OAL for printing only pursuant to Labor Code section 142.3(a)(3) (Register 2012, No. 3).
15. Amendment of subsection (e) and subsections therein 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).
16. Amendment of subsection (e) and subsections therein 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).
17. Repealer of 11-6-2013 order by operation of law 5-6-2014 pursuant to Labor Code 142.3 (Register 2014, No. 19).
18. Amendment of subsection (e) and subsections therein filed 5-5-2014; operative 5-6-2014 pursuant to Government Code section 11343.4(b)(3) (Register 2014, No. 19).