29 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:
(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; 4-Dimethylaminoazobenzene, 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.
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.
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.
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.
(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 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.
(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) 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, 4-Aminodiphenyl, 2-Acetylaminofluorene, 4-Dimethylaminoazo-benzene, and N-Nitrosodimethylamine, 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 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. 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 paragraph (e) 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:
(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), which covers each employee required by this section to use a respirator.
(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.
(v) 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.
(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.
(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) Communication of hazards -
(1) Hazard communication.
(i) Chemical manufacturers, importers, distributors and employers shall comply with all requirements of the Hazard Communication Standard (HCS) (§ 1910.1200) for each carcinogen listed in paragraph (e)(1)(iv) of this section.
(iii) Employers shall include the carcinogens listed in paragraph (e)(1)(iv) of this section in the hazard communication program established to comply with the HCS (§ 1910.1200). Employers shall ensure that each employee has access to labels on containers of the carcinogens listed in paragraph (e)(1)(iv) and to safety data sheets, and is trained in accordance with the requirements of HCS and paragraph (e)(4) of this section.
(iv) List of Carcinogens:
(A) 4-Nitrobiphenyl: Cancer.
(B) alpha-Naphthylamine: Cancer; skin irritation; and acute toxicity effects.
(C) Methyl chloromethyl ether: Cancer; skin, eye and respiratory effects; acute toxicity effects; and flammability.
(D) 3,3′-Dichlorobenzidine (and its salts): Cancer and skin sensitization.
(E) bis-Chloromethyl ether: Cancer; skin, eye, and respiratory tract effects; acute toxicity effects; and flammability.
(F) beta-Naphthylamine: Cancer and acute toxicity effects.
(G) Benzidine: Cancer and acute toxicity effects.
(H) 4-Aminodiphenyl: Cancer.
(I) Ethyleneimine: Cancer; mutagenicity; skin and eye effects; liver effects; kidney effects; acute toxicity effects; and flammability.
(J) beta-Propiolactone: Cancer; skin irritation; eye effects; and acute toxicity effects.
(K) 2-Acetylaminofluorene: Cancer.
(L) 4-Dimethylaminoazo-benzene: Cancer; skin effects; and respiratory tract irritation.
(M) N-Nitrosodimethylamine: Cancer; liver effects; and acute toxicity effects.
(v) 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.
(3) 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.
(4) Training and indoctrination.
(C) The purpose for and application of the medical surveillance program, including, as appropriate, methods of self-examination;
(E) The purpose for and significance of emergency practices and procedures;
(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.
(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.
(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.
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