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 110 - Regulated Carcinogens
Section 5209 - Carcinogens
Universal Citation: 8 CA Code of Regs 5209
Current through Register 2024 Notice Reg. No. 38, September 20, 2024
(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.
| Chemical | Chemical Abstracts Registry number | Percent * |
| 2-Acetylaminofluorene.......................... | ..........................53963 | 1.0 |
| 4-Aminodiphenyl.......................... | ..........................92671 | 0.1 |
| Benzidine (and its salts).......................... | ..........................92875 | 0.1 |
| 3,3'-Dichlorobenzidine (and its salts).......................... | ..........................91941 | 1.0 |
| 4-Dimethylaminoazobenzene.......................... | ..........................60117 | 1.0 |
| alpha-Naphthylamine **.......................... | ..........................134327 | 1.0 |
| beta-Naphthylamine **.......................... | ..........................91598 | 0.1 |
| 4-Nitrobiphenyl.......................... | ..........................92933 | 0.1 |
| N-Nitrosodimethylamine.......................... | ..........................62759 | 1.0 |
| beta-Propiolactone.......................... | ..........................57578 | 1.0 |
| bis-Chloromethyl ether.......................... | ..........................542881 | 0.1 |
| Methyl chloromethyl ether.......................... | ..........................107302 | 0.1 |
| Ethyleneimine.......................... | ..........................151564 | 1.0 |
* 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.
(b) Definitions.
(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.
10. beta-Propiolactone: Cancer; skin
irritation; eye effects; and acute toxicity effects.
11. 2-Acetylaminofluorene: Cancer.
12. 4-Dimethylaminoazo-benzene: Cancer; skin
effects; and respiratory tract irritation.
13. N-Nitrosodimethylamine: Cancer; liver
effects; and acute toxicity effects.
(2) Signs.
(A) The employer shall post entrances to
regulated areas with signs bearing the legend:
DANGER
(CHEMICAL IDENTIFICATION)
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:
DANGER
(CHEMICAL IDENTIFICATION)
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:
CANCER-SUSPECT AGENT
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.
(1)
Examinations.
(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.
(2) Records.
(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.
1. New
section filed 8-1-74; effective thirtieth day thereafter (Register 74, No. 31).
For former section and history, see Register 73, No. 43.
2.
Amendment of subsection (d) filed 9-20-74 as procedural; effective upon filing
(Register 74, No. 38).
3. Amendment filed 2-13-75; effective
thirtieth day thereafter (Register 75, No. 7).
4. Amendment of
subsections (a), (b)(3), and repealer of subsection (c)(7) filed 5-25-79;
effective thirtieth day thereafter (Register 79, No. 21).
5.
Amendment of subsection (f)(1) filed 6-15-79; effective thirtieth day
thereafter (Register 79, No. 24).
6. Repealer of subsection (d)(1)
and renumbering of subsections (d)(2)-(d)(4) filed 1-17-80; effective thirtieth
day thereafter (Register 80, No. 3).
7. Amendment of subsection
(g)(2) filed 3-20-81; effective thirtieth day thereafter (Register 81, No.
12).
8. Editorial correction of subsection (b)(3) filed 3-3-83
(Register 83, No. 10).
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).
Note: Authority cited: Sections 142.3, 9020, 9030 and 9040, Labor Code. Reference: Sections 142.3, 9004(d), 9009, 9020, 9030, 9031 and 9040, Labor Code.
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