13 Carcinogens Standard (29 CFR 1910.1003)

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Title 29: Labor
PART 1910—OCCUPATIONAL SAFETY AND HEALTH STANDARDS (CONTINUED)
Subpart Z—Toxic and Hazardous Substances

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§ 1910.1003 13 Carcinogens (4-Nitrobiphenyl, etc.).

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(a) Scope and application. (1) This section applies to any area in which the 13
carcinogens addressed by this section are manufactured, processed, repackaged,
released, handled, or stored, but shall not apply to transshipment in sealed
containers, except for the labeling requirements under paragraphs (e)(2), (3) and (4)
of this section. The 13 carcinogens are the following:
4-Nitrobiphenyl, Chemical Abstracts Service Register Number (CAS No.) 92933;

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alpha-Naphthylamine, CAS No. 134327;
methyl chloromethyl ether, CAS No. 107302;
3,'-Dichlorobenzidine (and its salts) CAS No. 91941;

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bis-Chloromethyl ether, CAS No. 542881;

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beta-Naphthylamine, CAS No. 91598;
Benzidine, CAS No. 92875;

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4-Aminodiphenyl, CAS No. 92671;
Ethyleneimine, CAS No. 151564;
beta-Propiolactone, CAS No. 57578;
2-Acetylaminofluorene, CAS No. 53963;
4-Dimethylaminoazo-benezene, CAS No. 60117; and
N-Nitrosodimethylamine, CAS No. 62759.

(2) This section shall not apply to the following:

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(i) Solid or liquid mixtures containing less than 0.1 percent by weight or volume of
4–Nitrobiphenyl; methyl chloromethyl ether; bis-chloromethyl ether; betaNaphthylamine; benzidine or 4–Aminodiphenyl; and
(ii) Solid or liquid mixtures containing less than 1.0 percent by weight or volume of
alpha-Naphthylamine; 3,'-Dichlorobenzidine (and its salts); Ethyleneimine; betaPropiolactone; 2-Acetylaminofluorene; 4-Dimethylaminoazobenzene, or NNitrosodimethylamine.
(b) Definitions. For the purposes of this section:
Absolute filter is one capable of retaining 99.97 percent of a mono disperse aerosol
of 0.3 µm particles.
Authorized employee means an employee whose duties require him to be in the
regulated area and who has been specifically assigned by the employer.
Clean change room means a room where employees put on clean clothing and/or
protective equipment in an environment free of the 13 carcinogens addressed by
this section. The clean change room shall be contiguous to and have an entry from
a shower room, when the shower room facilities are otherwise required in this
section.
Closed system means an operation involving a carcinogen addressed by this section
where containment prevents the release of the material into regulated areas, nonregulated areas, or the external environment.
Decontamination means the inactivation of a carcinogen addressed by this section
or its safe disposal.
Director means the Director, National Institute for Occupational Safety and Health,
or any person directed by him or the Secretary of Health and Human Services to
act for the Director.
Disposal means the safe removal of the carcinogens addressed by this section from
the work environment.
Emergency means an unforeseen circumstance or set of circumstances resulting in
the release of a carcinogen addressed by this section that may result in exposure to
or contact with the material.
External environment means any environment external to regulated and
nonregulated areas.
Isolated system means a fully enclosed structure other than the vessel of
containment of a carcinogen addressed by this section that is impervious to the
passage of the material and would prevent the entry of the carcinogen addressed by
this section into regulated areas, nonregulated areas, or the external environment,
should leakage or spillage from the vessel of containment occur.
Laboratory-type hood is a device enclosed on the 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
addressed by this section within the hood does not require the insertion of any

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portion of any employee's body other than his hands and arms.
Nonregulated area means any area under the control of the employer where entry
and exit is neither restricted nor controlled.
Open-vessel system means an operation involving a carcinogen addressed by this
section in an open vessel that is not in an isolated system, a laboratory-type hood,
nor in any other system affording equivalent protection against the entry of the
material into regulated areas, non-regulated areas, or the external environment.
Protective clothing means clothing designed to protect an employee against contact
with or exposure to a carcinogen addressed by this section.
Regulated area means an area where entry and exit is restricted and controlled.
(c) Requirements for areas containing a carcinogen addressed by this section. A
regulated area shall be established by an employer where a carcinogen addressed
by this section is manufactured, processed, used, repackaged, released, handled or
stored. 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 addressed by this
section 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 operation. (i) Within regulated areas where the carcinogens
addressed by this section are stored in sealed containers, or contained in a closed
system, including piping systems, with any sample ports or openings closed while
the carcinogens addressed by this section are contained within, access shall be
restricted to authorized employees only.
(ii) Employees exposed to 4–Nitrobiphenyl; alpha-Naphthylamine; 3,'Dichlorobenzidine (and its salts); beta-Naphthylamine; benzidine; 4–
Aminodiphenyl; 2–Acetylaminofluorene; 4–Dimethylaminoazo-benzene; and NNitrosodimethylamine 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 involving “laboratory-type
hoods,” or in locations where the carcinogens addressed by this section are
contained in an otherwise “closed system,” but is transferred, charged, or
discharged into other normally closed containers, the provisions of this paragraph
shall apply.
(i) Access shall be restricted to authorized employees only.
(ii) Each operation shall be provided with 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

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sufficient volume to maintain the correct operation of the local exhaust system.
(iii) Employees shall be provided with, and required to wear, clean, full body
protective clothing (smocks, coveralls, or long-sleeved shirt and pants), shoe covers
and gloves prior to entering the regulated area.
(iv) Employers must provide each employee engaged in handling operations
involving the carcinogens 4-Nitrobiphenyl, alpha-Naphthylamine, 3,3'Dichlorobenzidine (and its salts), beta-Naphthylamine, Benzidine, 4Aminodiphenyl, 2-Acetylaminofluorene, 4-Dimethylaminoazo-benzene, and NNitrosodimethylamine, addressed by this section, with, and ensure that each of
these employees wears and uses, a NIOSH-certified air-purifying, half-mask
respirator with particulate filters. Employers also must provide each employee
engaged in handling operations involving the carcinogens methyl chloromethyl
ether, bis-Chloromethyl ether, Ethyleneimine, and beta-Propiolactone, addressed by
this section, with, and ensure that each of these employees wears and uses any selfcontained 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 positivepressure mode in combination with an auxiliary self-contained positive-pressure
breathing apparatus. Employers may substitute a respirator affording employees
higher levels of protection than these respirators.
(v) 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. The contents of such
impervious containers shall be identified, as required under paragraphs (e) (2), (3),
and (4) of this section.
(vi) Drinking fountains are prohibited in the regulated area.
(vii) 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 and employees exposed to 4–Nitrobiphenyl; alpha-Naphthylamine; 3,'Dichlorobenzidine (and its salts); beta-Naphthylamine; Benzidine; 4–
Aminodiphenyl; 2–Acetylaminofluorene; 4–Dimethylaminoazo-benzene; and NNitrosodimethylamine shall be required to shower after the last exit of the day.
(5) Maintenance and decontamination activities. In cleanup of leaks of spills,
maintenance, or repair operations on contaminated systems or equipment, or any
operations involving work in an area where direct contact with a carcinogen
addressed by this section could result, each authorized employee entering that area
shall:
(i) Be provided with and required to wear clean, impervious garments, including
gloves, boots, and continuous-air supplied hood in accordance with §1910.134;
(ii) Be decontaminated before removing the protective garments and hood;
(iii) Be required to shower upon removing the protective garments and hood.
(d) General regulated area requirements —(1) Respiratory program . The
employer must implement a respiratory protection program in accordance with
§1910.134 (b), (c), (d) (except (d)(1)(iii) and (iv), and (d)(3)), and (e) through (m),
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which covers each employee required by this section to use a respirator.
(2) Emergencies. In an emergency, immediate measures including, but not limited
to, the requirements of paragraphs (d)(2) (i) through (v) of this section shall be
implemented.
(i) The potentially affected area shall be evacuated as soon as the emergency has
been determined.
(ii) Hazardous conditions created by the emergency shall be eliminated and the
potentially affected area shall be decontaminated prior to the resumption of normal
operations.
(iii) 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 any treatment shall be included in the
incident report, in accordance with paragraph (f)(2) of this section.
(iv) Where an employee has a known contact with a carcinogen addressed by this
section, such employee shall be required to shower as soon as possible, unless
contraindicated by physical injuries.
(v) An incident report on the emergency shall be reported as provided in paragraph
(f)(2) of this section.
(vi) 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 to Ethyleneimine or beta-Propiolactone only
would be most likely as a result of equipment failure or improper work practice.
(3) Hygiene facilities and practices. (i) 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.
(ii) Where employees are required by this section to wash, washing facilities shall
be provided in accordance with §1910.141(d) (1) and (2) (ii) through (vii).
(iii) Where employees are required by this section to shower, shower facilities shall
be provided in accordance with §1910.141(d)(3).
(iv) Where employees wear protective clothing and equipment, clean change rooms
shall be provided for the number of such employees required to change clothes, in
accordance with §1910.141(e).
(v) Where toilets are in regulated areas, such toilets shall be in a separate room.
(4) Contamination control. (i) Except for outdoor systems, regulated areas 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.
(ii) 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.

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(iii) Decontamination procedures shall be established and implemented to remove
carcinogens addressed by this section from the surfaces of materials, equipment,
and the decontamination facility.
(iv) Dry sweeping and dry mopping are prohibited for 4–Nitrobiphenyl; alphaNaphthylamine; 3,'-Dichlorobenzidine (and its salts); beta-Naphthylamine;
Benzidine; 4–Aminodiphenyl; 2–Acetylaminofluorene; 4–Dimethylaminoazobenzene and N-Nitrosodimethylamine.
(e) Signs, information and training —(1) Signs —(i) Entrances to regulated areas
shall be posted with signs bearing the legend:
CANCER-SUSPECT AGENT
AUTHORIZED PERSONNEL ONLY

(ii) Entrances to regulated areas containing operations covered in paragraph (c)(5)
of this section shall be posted with signs bearing the legend:
CANCER-SUSPECT AGENT EXPOSED IN THIS AREA
IMPERVIOUS SUIT INCLUDING GLOVES, BOOTS, AND AIR-SUPPLIED HOOD REQUIRED
AT ALL TIMES
AUTHORIZED PERSONNEL ONLY

(iii) 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.
(2) Container contents identification. (i) Containers of a carcinogen addressed by
this section and containers required under paragraphs (c)(4)(v) and (c)(6) (vii)(B)
and (viii)(B) of this section that are accessible only to and handled only by
authorized employees, or by other employees trained in accordance with paragraph
(e)(5) of this section, may have contents identification limited to a generic or
proprietary name or other proprietary identification of the carcinogen and percent.
(ii) Containers of a carcinogen addressed by this section and containers required
under paragraphs (c)(4)(v) and (c)(6) (vii)(B) and (viii)(B) of this section that are
accessible to or handled by employees other than authorized employees or
employees trained in accordance with paragraph (e)(5) of this section shall have
contents identification that includes the full chemical name and Chemical Abstracts
Service Registry number as listed in paragraph (a)(1) of this section.
(iii) Containers shall have the warning words “CANCER-SUSPECT AGENT”
displayed immediately under or adjacent to the contents identification.
(iv) Containers whose contents are carcinogens addressed by this section with
corrosive or irritating properties shall have label statements warning of such
hazards noting, if appropriate, particularly sensitive or affected portions of the
body.
(3) Lettering. Lettering on signs and instructions required by paragraph (e)(1) shall
be a minimum letter height of 2 inches (5 cm). Labels on containers required under
this section shall not be less than one-half the size of the largest lettering on the
package, and not less than 8-point type in any instance. Provided, That no such

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required lettering need be more than 1 inch (2.5 cm) in height.
(4) Prohibited statements. No statement shall appear on or near any required sign,
label, or instruction that contradicts or detracts from the effect of any required
warning, information, or instruction.
(5) Training and indoctrination. (i) Each employee prior to being authorized to
enter a regulated area, shall receive a training and indoctrination program
including, but not necessarily limited to:
(A) The nature of the carcinogenic hazards of a carcinogen addressed by this
section, including local and systemic toxicity;
(B) The specific nature of the operation involving a carcinogen addressed by this
section that 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 purposes;
(E) The purpose for and significance of emergency practices and procedures;
(F) The employee's specific role in 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 addressed
by this section;
(H) The purpose for and application of specific first aid procedures and practices;
(I) A review of this section at the employee's first training and indoctrination
program and annually thereafter.
(ii) Specific emergency procedures shall be prescribed, and posted, and employees
shall be familiarized with their terms, and rehearsed in their application.
(iii) All materials relating to the program shall be provided upon request to
authorized representatives of the Assistant Secretary and the Director.
(f) [Reserved]
(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. (i) Before an employee is assigned to enter a regulated area, a
preassignment physical examination by a physician shall be provided. The
examination shall include the personal history of the employee, family and
occupational background, including genetic and environmental factors.
(ii) Authorized employees shall be provided periodic physical examinations, not
less often than annually, following the preassignment examination.
(iii) In all physical examinations, the examining physician shall consider whether
there exist conditions of increased risk, including reduced immunological
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competence, those undergoing treatment with steroids or cytotoxic agents,
pregnancy, and cigarette smoking.
(2) Records. (i) Employers of employees examined pursuant to this paragraph 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.
(ii) Records required by this paragraph shall be provided upon request to
employees, designated representatives, and the Assistant Secretary in accordance
with 29 CFR 1910.1020 (a) through (e) and (g) through (i). These records shall also
be provided upon request to the Director.
(iii) 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.
[61 FR 9242, Mar. 7, 1996, as amended at 63 FR 1286, Jan. 8, 1998; 63 FR 20099,
Apr. 23, 1998; 70 FR 1141, Jan. 5, 2005; 71 FR 16672, Apr. 3, 2006; 73 FR 75584,
Dec. 2, 2008; 76 FR 33608, June 8, 2011]
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