13 Carcinogens Standard 2008 (e-CFR)

§ 1910.1003 13 Carcinogens (4-Nitrobiphenyl, etc.).
(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;
alpha-Naphthylamine, CAS No. 134327;
methyl chloromethyl ether, CAS No. 107302;
3,′-Dichlorobenzidine (and its salts) CAS No. 91941;
bis-Chloromethyl ether, CAS No. 542881;
beta-Naphthylamine, CAS No. 91598;
Benzidine, CAS No. 92875;
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:
(i) Solid or liquid mixtures containing less than 0.1 percent by weight or volume of 4–Nitrobiphenyl; methyl
chloromethyl ether; bis-chloromethyl ether; beta-Naphthylamine; 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; beta-Propiolactone; 2-Acetylaminofluorene; 4Dimethylaminoazobenzene, or N-Nitrosodimethylamine.
(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, non-regulated 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 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); betaNaphthylamine; benzidine; 4–Aminodiphenyl; 2–Acetylaminofluorene; 4–Dimethylaminoazo-benzene; and
N-Nitrosodimethylamine 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 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) Employees engaged in handling operations involving the carcinogens addressed by this section must be
provided with, and required to wear and use a half-face filter-type respirator with filters for dusts, mists, and
fumes, or air-purifying canisters or cartridges. A respirator affording higher levels of protection than this
respirator may be substituted.
(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 N-Nitrosodimethylamine 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) Respirator program. The employer must implement a
respiratory protection program in accordance with 29 CFR 1910.134 (b), (c), (d) (except (d)(1)(iii) and (iv),
and (d)(3)), and (e) through (m).
(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 betaPropiolactone 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.
(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; alpha-Naphthylamine; 3,′Dichlorobenzidine (and its salts); beta-Naphthylamine; Benzidine; 4–Aminodiphenyl; 2–Acetylaminofluorene;
4–Dimethylaminoazo-benzene 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 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 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. 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.
(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]