Section 721.63 - Protection in the workplace(a) Whenever a substance is identified in subpart E of this part as being subject to this section, any manner or method of manufacturing (including importing) or processing associated with any use of the substance is considered a significant new use unless a program is established whereby: (1) Each person who is reasonably likely to be dermally exposed in the work area to the chemical substance through direct handling of the substance or through contact with equipment on which the substance may exist, or because the substance becomes airborne in the form listed in paragraph (a)(6) of this section, and cited in subpart E of this part for the chemical substance, is provided with, and is required to wear, personal protective equipment that provides a barrier to prevent dermal exposure to the substance in the specific work area where it is selected for use. Each such item of personal protective equipment must be selected and used in accordance with 29 CFR 1910.132 and 1910.133 .(2) In addition to any other personal protective equipment selected in paragraph (a)(1) of this section, the following items are required:(ii) Full body chemical protective clothing.(iii) Chemical goggles or equivalent eye protection.(iv) Clothing which covers any other exposed areas of the arms, legs, and torso. Clothing provided under this paragraph need not be tested or evaluated under the requirements of paragraph (a)(3) of this section.(3) The employer is able to demonstrate that each item of chemical protective clothing, including gloves, selected provides an impervious barrier to prevent dermal exposure during normal and expected duration and conditions of exposure within the work area by any one or a combination of the following: (i) Testing the material used to make the chemical protective clothing and the construction of the clothing to establish that the protective clothing will be impervious for the expected duration and conditions of exposure. The testing must subject the chemical protective clothing to the expected conditions of exposure, including the likely combinations of chemical substances to which the clothing may be exposed in the work area.(ii) Evaluating the specifications from the manufacturer or supplier of the chemical protective clothing, or of the material used in construction of the clothing, to establish that the chemical protective clothing will be impervious to the chemical substance alone and in likely combination with other chemical substances in the work area.(4) Each person who is reasonably likely to be exposed to the chemical substance by inhalation in the work area in one or more of the forms listed in paragraph (a)(6) of this section and cited in subpart E of this part for the chemical substance, is provided with, and is required to wear, at a minimum, a NIOSH-approved respirator from one of the categories listed in paragraph (a)(5) of this section, and the respirator is used in accordance with 29 CFR 1910.134 and 42 CFR part 84 .(5) The following NIOSH-certified respirators meet the requirements for paragraph (a)(4) of this section: (i) Category 19C Type C supplied-air respirator operated in pressure demand or other positive pressure mode and equipped with a full facepiece.(ii) Category 19C Type C supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a tight-fitting facepiece.(iii) Category 19C Type C supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a hood or helmet or tight-fitting facepiece.(iv) Category 21C air-purifying respirator equipped with a full facepiece and high efficiency particulate filters.(v) Category 21C powered air-purifying respirator equipped with a tight-fitting facepiece and high efficiency particulate filters.(vi) Category 21C powered air-purifying respirator equipped with a loose-fitting hood or helmet and high efficiency particulate filters.(vii) Category 21C air-purifying respirator equipped with a high efficiency particulate filter including disposable respirators.(viii) Category 23C air-purifying respirator equipped with a full facepiece and combination cartridges approved for paints, lacquers, and enamels. (Approval label may preclude use for some paints, lacquers, or enamels.)(ix) Category 23C powered air-purifying respirator equipped with a tight-fitting facepiece and combination cartridges approved for paints, lacquers, and enamels. (Approval label may preclude use for some paints, lacquers, or enamels.)(x) Category 23C powered air-purifying respirator equipped with a loose-fitting hood or helmet and combination cartridges approved for paints, lacquers, and enamels. (Approval label may preclude use for some paints, lacquers, or enamels.)(xi) Category 23C air-purifying respirator equipped with combination cartridges approved for paints, lacquers, and enamels, including disposable respirators. (Approval label may preclude use for some paints, lacquers, or enamels.)(xii) Category 23C air-purifying respirator equipped with a full facepiece and organic gas/vapor cartridges.(xiii) Category 23C powered air-purifying respirator equipped with a tight-fitting facepiece and organic gas/vapor cartridges.(xiv) Category 23C powered air-purifying respirator equipped with a loose-fitting hood or helmet and organic gas/vapor cartridges.(xv) Category 23C air-purifying respirator equipped with organic gas/vapor cartridges, including disposable respirators.(xvi) NIOSH-certified N100 (if oil aerosols absent), R100, or P100 filtering facepiece respirator. (APF =10).(xvii) NIOSH-certified air-purifying half-mask respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters. (APF =10).(xviii) NIOSH-certified air-purifying half mask respirator equipped with appropriate gas/vapor cartridges. (APF =10).(xix) NIOSH-certified air-purifying half-mask respirator equipped with appropriate gas/vapor cartridges in combination with N100, R100, or P100 filters or an appropriate canister incorporating N100, R100, or P100 filters. (APF =10).(xx) NIOSH-certified negative pressure (demand) supplied-air respirator equipped with a half-mask. (APF =10).(xxi) NIOSH-certified negative pressure (demand) self-contained breathing apparatus (SCBA) equipped with a half mask. (APF =10).(xxii) NIOSH-certified powered air-purifying respirator equipped with a hood or helmet and HEPA filters. (APF =25).(xxiii) NIOSH-certified powered air-purifying respirator with a hood or helmet equipped with appropriate gas/vapor cartridges. (APF =25).(xxiv) NIOSH-certified powered air-purifying respirator with a hood or helmet and with appropriate gas/vapor cartridges in combination with HEPA filters. (APF =25).(xxv) NIOSH-certified powered air-purifying respirator equipped with a loose fitting facepiece and HEPA filters. (APF =25).(xxvi) NIOSH-certified powered air-purifying respirator equipped with a loose fitting facepiece with appropriate gas/vapor cartridges. (APF =25).(xxvii) NIOSH-certified powered air-purifying respirator equipped with a loose fitting facepiece with appropriate gas/vapor cartridges in combination with HEPA filters. (APF =25).(xxviii) NIOSH-certified continuous flow supplied-air respirator equipped with a hood or helmet. (APF =25).(xxix) NIOSH-certified continuous flow supplied-air respirator equipped with a loose fitting facepiece. (APF =25).(xxx) NIOSH-certified air-purifying full facepiece respirator equipped with N100, R-100, or P-100 filter(s). (APF =50).(xxxi) NIOSH-certified air-purifying full facepiece respirator equipped with appropriate gas/vapor cartridges or canisters. (APF =50).(xxxii) NIOSH-certified air-purifying full facepiece respirator equipped with appropriate gas/vapor cartridges in combination with N100, R100, or P100 filters or an appropriate canister incorporating N100, R100, or P100 filters. (APF =50).(xxxiii) NIOSH-certified powered air-purifying respirator equipped with a tight-fitting half mask and HEPA filters. (APF =50).(xxxiv) NIOSH-certified powered air-purifying respirator equipped with a tight-fitting half mask and appropriate gas/vapor cartridges or canisters. (APF =50).(xxxv) NIOSH-certified powered air-purifying respirator with a tight-fitting half mask and appropriate gas/vapor cartridges in combination with HEPA filters. (APF =50).(xxxvi) NIOSH-certified pressure-demand or other positive pressure mode supplied-air respirator equipped with a half-mask. (APF =50).(xxxvii) NIOSH-certified negative pressure (demand) supplied-air respirator equipped with a full facepiece. (APF =50).(xxxviii) NIOSH-certified continuous flow supplied-air respirator equipped with a tight-fitting half mask. (APF =50).(xxxix) NIOSH-certified negative pressure (demand) self-contained breathing apparatus (SCBA) equipped with a hood or helmet or a full facepiece. (APF =50).(xl) NIOSH-certified powered air purifying full facepiece respirator equipped with HEPA filters. (APF =1,000).(xli) NIOSH-certified powered air purifying full facepiece respirator equipped with appropriate gas/vapor cartridges. (APF =1,000).(xlii) NIOSH-certified powered air purifying fill facepiece respirator equipped with appropriate gas/vapor cartridges in combination with HEPA filters. (APF =1,000).(xliii) NIOSH-certified powered air-purifying respirator equipped with a hood or helmet and N100, R100, or P100 filters with evidence demonstrating protection level of 1,000 or greater. See 40 CFR 721.63(a)(5)(li) . (APF =1,000).(xliv) NIOSH-certified powered air-purifying respirator equipped with a hood or helmet and appropriate gas/vapor cartridges with evidence demonstrating protection level of 1,000 or greater. See 40 CFR 721.63(a)(5)(li) . (APF =1,000).(xlv) NIOSH-certified powered air-purifying respirator with a loose-fitting hood or helmet that is equipped with an appropriate gas/vapor cartridge in combination with HEPA filters with evidence demonstrating protection level of 1,000 or greater. See 40 CFR 721.63(a)(5)(li) . (APF =1,000).(xlvi) NIOSH-certified continuous flow supplied-air respirator equipped with a full facepiece. (APF =1,000).(xlvii) NIOSH-certified continuous flow supplied-air respirator equipped with a hood or helmet with evidence demonstrating protection level of 1,000 or greater. See 40 CFR 721.63(a)(5)(li) . (APF =1,000).(xlviii) NIOSH-certified pressure-demand supplied-air respirator equipped with a full facepiece. (APF =1,000).(xlix) NIOSH-certified pressure-demand or other positive-pressure mode (e.g., open/closed circuit) self-contained breathing apparatus (SCBA) equipped with a hood or helmet or a full facepiece. (APF =10,000).(l) If one of the respirators in paragraph (a)(5)(i) through (a)(5)(xv) is cited for a substance identified in subpart E an employer may substitute a respirator from paragraphs (a)(5)(xvi) through (a)(5)(xlix) as long as its assigned protection factor is equal to or greater than the respirator cited in subpart E for that substance.(li) Without testing data that demonstrates a level of protection of 1,000 or greater, all air purifying respirators and supplied air respirators with helmets/hoods are to be treated as loose-fitting facepiece respirators with an APF of 25.(6) When cited in subpart E of this part for a substance, the following airborne form(s) of the substance, in combination or alone, are referenced by paragraphs (a)(1) and (4) of this section: (vii) Particulate or aerosol (solids or liquid droplets suspended in a gas, e.g., dust, fume, mist, smoke).(ix) Combination particulate and gas/vapor (gas and liquid/solid physical forms are both present, e.g., particulates and acid gases or particulates and organic vapors).(7) Where people are reasonably likely to have dermal or eye exposure to the chemical substance in the work area, either through direct handling of the substance, or through contact with surfaces on which the substance may exist, or because the substance becomes airborne in the form listed in paragraph (a)(6) of this section, and the form is cited in subpart E of this part for the chemical substance, engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be implemented to prevent exposure, where feasible. Where engineering, work practice, and administrative controls are not feasible or dermal or eye exposure is still reasonably likely, each person who is reasonably likely to be exposed to the chemical substance by dermal or eye exposure must be provided with, and is required to wear, personal protective equipment (PPE) to prevent dermal or eye exposure to the substance. Refer to 29 CFR 1910.132 and 29 CFR 1910.133 for requirements on selection and use of PPE.(8) Where each person who is reasonably likely to be exposed to the chemical substance by inhalation in the work area in one or more of the forms listed in paragraph (a)(6) of this section and cited in subpart E of this part for the chemical substance, engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. When engineering, work practice, and administrative controls are not feasible or inhalation exposure is still reasonably likely, each person who is reasonably likely to be exposed to the chemical substance by inhalation in the work area in one or more of the forms listed in paragraph (a)(6) of this section and cited in subpart E of this part for the chemical substance, must be provided with, and is required to wear, a NIOSH- certified respirator from one of the categories listed in paragraph (a)(5) of this section. Refer to 29 CFR 1910.134 and 42 CFR part 84 for requirements on the selection, use, and maintenance of respirators, including establishing respiratory protection program, medical determination, and other administrative and programmatic requirements for respiratory protection.(b) If a substance identified in subpart E of this part is present in the work area only as a mixture, an employer is exempt from the provisions of this section if the concentration of the substance in the mixture does not exceed a concentration set in subpart E of this part. The exemption does not apply if the employer has reason to believe that during intended use or processing in the work area, the substance in the mixture may be concentrated above the level set in subpart E of this part.(c)(1) If at any time after commencing distribution in commerce of a chemical substance that is identified in subpart E of this part as subject to this section, the person has knowledge that a recipient of the substance is engaging in an activity that is not consistent with the implementation of a program specified in paragraph (a) of this section, the person is considered to have knowledge that the recipient is engaging in a significant new use and is required to follow the procedures in § 721.5(d) unless the person is able to document the following: (i) That the person has notified the recipient in writing within 15 working days of the time the person first has knowledge that the recipient is engaging in an activity that is not consistent with the implementation of a program specified in paragraph (a) of this section, and that the person has knowledge of the failure of implementation.(ii) That within 15 working days of notifying the recipient that the recipient is engaging in an activity that is not consistent with the implementation of a program specified in paragraph (a) of this section the person has received from the recipient, in writing, a statement of assurance that the recipient has established the program required under paragraph (a) of this section, and will take appropriate measures to avoid activities that are inconsistent with implementation of the program required under paragraph (a) of this section.(2) If, after receiving a statement of assurance from a recipient under paragraph (c)(1)(ii) of this section, a manufacturer or processor has knowledge that the recipient is engaging in an activity that is not consistent with the implementation of the program specified in paragraph (a) of this section, that person is considered to have knowledge that the person is engaging in a significant new use and is required to follow the procedures in § 721.5(d) .54 FR 31308, July 27, 1989, as amended at 87 FR 39765, July 5, 2022