This subpart B identifies certain significant new uses of chemical substances identified in subpart E of this part. The provisions of this subpart B apply only when referenced as applying to a chemical substance identified in subpart E of this part.

(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:

(i) Gloves.

(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:

(i) Dust.

(ii) Mist.

(iii) Fume.

(iv) Smoke.

(v) Vapor.

(vi) Gas.

(vii) Particulate or aerosol (solids or liquid droplets suspended in a gas, e.g., dust, fume, mist, smoke).

(viii) Gas/vapor.

(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).

Whenever a substance is identified in subpart E of this part as being subject to this section, a significant new use of that substance is any manner or method of manufacture (including import) or processing associated with any use of that substance without establishing a hazard communication program as described in this section. Paragraphs (a) through (h) of this section apply to SNURs issued July 5, 2022. Paragraphs (i) and (j) of his section apply to SNURs issued on or after July 5, 2022. Any person subject to the requirements of paragraphs (a) through (h) of this section have the option of following the requirements of paragraph (i) of this section or using the statements specified in paragraphs (g) or (h) of this section.

(a) Written hazard communication program. Each employer shall develop and implement a written hazard communication program for the substance in each workplace. The written program will, at a minimum, describe how the requirements of this section for labels, SDSs, and other forms of warning material will be satisfied. The employer must make the written hazard communication program available, upon request, to all employees, contractor employees, and their designated representatives. The employer may rely on an existing hazard communication program, including an existing program established under the Occupational Health and Safety Administration (OSHA) Hazard Communication Standard in 29 CFR 1910.1200 of 2012 to comply with this paragraph provided that the existing hazard communication program satisfies the requirements of this paragraph. The written program shall include the following:

(1) A list of each substance identified in subpart E of this part as subject to this section known to be present in the work area. The list must be maintained in the work area and must use the identity provided on the appropriate SDS for each substance required under paragraph (c) of this section. The list may be compiled for the workplace or for individual work areas.

(2) The methods the employer will use to inform employees of the hazards of non-routine tasks involving the substance, for example, the cleaning of reactor vessels, and the hazards associated with the substance contained in unlabeled pipes in their work area.

(3) The methods the employer will use to inform contractors of the presence of the substance in the employer's workplace and of the provisions of this part applicable to the substance if employees of the contractor work in the employer's workplace and are reasonably likely to be exposed to the substance while in the employer's workplace.

(b) Labeling. (1) Each employer shall ensure that each container of the substance in the workplace is labeled in accordance with this paragraph (b)(1).

(i) The label shall, at a minimum, contain the following information:

(A) A statement of health hazard(s) and precautionary measure(s) for the substance, if any, identified in subpart E of this part or by the employer.

(B) The identity by which the substance may be commonly recognized.

(C) A statement of environmental hazard(s) and precautionary measure(s) for the substance, if any, identified in subpart E of this part or by the employer.

(D) A statement of exposure and precautionary measure(s), if any, identified in subpart E of this part or by the employer.

(ii) The employer may use signs, placards, process sheets, batch tickets, operating procedures, or other such written materials in lieu of affixing labels to individual stationary process containers, as long as the alternative method identifies the containers to which it is applicable and conveys information specified by paragraph (b)(1)(i) of this section. Any written materials must be readily accessible to the employees in their work areas throughout each work shift.

(iii) The employer need not label portable containers into which the substance is transferred from labeled containers, and which are intended only for the immediate use of the employee who performs the transfer.

(iv) The employer shall not remove or deface an existing label on incoming containers of the substance unless the container is immediately relabeled with the information specified in paragraph (b)(1)(i) of this section.

(2) Each employer shall ensure that each container of the substance leaving its workplace for distribution in commerce is labeled in accordance with this paragraph.

(i) The label shall, at a minimum, contain the following information:

(A) The information required under paragraph (b)(1)(i) of this section.

(B) The name and address of the manufacturer or a responsible party who can provide additional information on the substance for hazard evaluation and any appropriate emergency procedures.

(ii) The label shall not conflict with the requirements of the Hazardous Materials Transportation Act (18 U.S.C. 1801 et. seq.) and regulations issued under that Act by the Department of Transportation.

(3) The label, or alternative forms of warning, shall be legible and prominently displayed.

(4) The label, or alternative forms of warning, shall be in English; however, the information may be repeated in other languages.

(5) If the label or alternative form of warning is to be applied to a mixture containing a substance identified in subpart E of this part as subject to this section in combination with another substance identified in subpart E of this part and/or a substance defined as a “hazardous chemical” under the Occupational Safety and Health Administration (OSHA) Hazard Communication Standard (29 CFR 1910.1200), the employer may prescribe on the label, SDS, or alternative form of warning, the measures to control worker exposure or environmental release which the employer determines provide the greatest degree of protection. However, should these control measures differ from the applicable measures required under subpart E of this part, the employer must seek a determination of equivalency for such alternative control measures pursuant to § 721.30 before prescribing them under this paragraph (b)(5).

(c) Safety data sheets. (1) Each employer must obtain or develop a SDS for the substance.

(2) Each SDS shall contain, at a minimum, the following information:

(i) The identity used on the container label of the substance under this section, and, if not claimed confidential, the chemical and common name of the substance. If the chemical and common name are claimed confidential, a generic chemical name must be used.

(ii) Physical and chemical characteristics of the substance known to the employer (such as vapor pressure, flash point).

(iii) The physical hazards of the substance known to the employer, including the potential for fire, explosion, and reactivity.

(iv) The potential human and environmental hazards as specified in subpart E of this part for the substance.

(v) Signs and symptoms of exposure, and any medical conditions which are expected to be aggravated by exposure to the substance known to the employer.

(vi) The primary routes of exposure to the substance.

(vii) Precautionary measures to control worker exposure and/or environmental release identified in subpart E of this part for the substance, or alternative control measures which EPA has determined under § 721.30 provide substantially the same degree of protection as the identified control measures.

(viii) Any generally applicable precautions for safe handling and use of the substance which are known to the employer, including appropriate hygienic practices, protective measures during repair and maintenance of contaminated equipment, and procedures for response to spills and leaks.

(ix) Any generally applicable control measures which are known to the employer, such as appropriate engineering controls, work practices, or personal protective equipment.

(x) Emergency first aid procedures known to the employer.

(xi) The date of preparation of the SDS or of its last revision.

(xii) The name, address, and telephone number of the individual preparing or distributing the SDS, or a responsible party who can provide additional information on the substance for hazard evaluation and any appropriate emergency procedures.

(3) If no relevant information is found or known for any given category on the SDS, the employer must mark the SDS to indicate that no applicable information was found.

(4) Where multiple mixtures containing the substance have similar compositions (i.e., the chemical ingredients are essentially the same, but the specific composition varies from mixture to mixture) and similar hazards, the employer may prepare one SDS to apply to all of these multiple mixtures.

(5) If the employer becomes aware of any significant new information regarding the hazards of the substance or ways to protect against the hazards, this new information must be added to the SDS within 3 months from the time the employer becomes aware of the new information. If the substance is not currently being manufactured, processed, or used in the employer's workplace, the employer must add the new information to the SDS before the substance is reintroduced into the workplace.

(6) The employer must ensure that persons receiving the substance from the employer are provided an appropriate SDS with their initial shipment and with the first shipment after an SDS is revised. The employer may either provide the SDS with the shipped containers or send it to the person prior to or at the time of shipment.

(7) The employer must maintain a copy of the SDS in its workplace, and must ensure that it is readily accessible during each work shift to employees when they are in their work areas. (Easy and immediate electronic access and other alternatives to maintaining paper copies of the safety data sheets are permitted as long as complete and accurate versions of the SDS are available immediately to employees in each workplace by such options.)

(8) The SDS may be kept in any form, including as operating procedures, and may be designed to cover groups of substances in a work area where it may be more appropriate to address the potential hazards of a process rather than individual substances. However, in all cases, the required information must be provided for each substance and must be readily accessible during each work shift to employees when they are in their work areas.

(9) The SDS must be in English; however, the information may be repeated in other languages.

(d) Employee information and training. Each employer must ensure that employees are provided with information and training on the substance identified in subpart E of this part. This information and training must be provided at the time of each employee's initial assignment to a work area containing the substance and whenever the substance subject to this section is introduced into the employee's work area for the first time.

(1) Information provided to employees under this paragraph shall include:

(i) The requirements of this section.

(ii) Any operations in the work area where the substance is present.

(iii) The location and availability of the written hazard communication program required under paragraph (a) of this section, including the list of substances identified in subpart E of this part as subject to this section, and SDSs required by paragraph (c) of this section.

(2) Training provided to employees shall include:

(i) Methods and observations that may be used to detect the presence or release of the substance in or from an employee's work area (such as monitoring conducted by the employer, continuous monitoring devices, visual appearance, or odor of the substance when being released).

(ii) The potential human health and environmental hazards of the substance as specified in subpart E of this part.

(iii) The measures employees can take to protect themselves and the environment from the substance, including specific procedures the employer has implemented to protect employees and the environment from exposure to the substance, including appropriate work practices, emergency procedures, personal protective equipment, engineering controls, and other measures to control worker exposure and/or environmental release required under subpart E of the part, or alternative control measures which EPA has determined under § 721.30 provide substantially the same degree of protection as the specified control measures.

(iv) The requirements of the hazard communication program developed by the employer under this section, including an explanation of the labeling system and the SDS required by this section and guidance on obtaining and using appropriate hazard information.

(e) Low concentrations in mixtures. 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.

(f) Existing hazard communication program. The employer need not take additional actions if existing programs and procedures satisfy the requirements of this section.

(g) Human health, environmental hazard, exposure, and precautionary statements. Whenever referenced in subpart E of this part for a substance, the following human health and environmental hazard, exposure, and precautionary statements shall appear on each label as specified in paragraph (b) of this section and the SDS as specified in paragraph (c) of this section. Additional statements may be included as long as they are true and do not alter the meaning of the required statements.

(1) Human health hazard statements:

(i) Causes skin irritation.

(ii) Respiratory complications. (You may also use paragraph (g)(1)(x) of this section for this designation.).

(iii) Central nervous system effects. (You may also use paragraph (g)(1)(xi) of this section for this designation but you must include this specific effect.)

(iv) Internal organ effects. (You may also use paragraph (g)(1)(xi) of this section for this designation.)

(v) Birth defects. (You may also use paragraph (g)(1)(xii) of this section for this designation but you must include this specific effect.)

(vi) Reproductive effects. (You may also use paragraph (g)(1)(xii) of this section for this designation but you must include this specific effect.)

(vii) May cause cancer.

(viii) Immune system effects. (You may also use paragraph (g)(1)(xi) of this section for this designation but you must include this specific effect.)

(ix) Developmental effects. (You may also use paragraph (g)(1)(xii) of this section for this designation but you must include this specific effect.)

(x) May cause allergy or asthma symptoms or breathing difficulties if inhaled.

(xi) May cause damage to organs (state all organs identified in subpart E of this part for this substance) through prolonged or repeated exposure.

(xii) May damage fertility or the unborn child (state specific effect identified in subpart E of this part for this substance).

(xiii) May cause an allergic skin reaction.

(xiv) Causes eye irritation.

(2) Human health hazard precautionary statements:

(i) Avoid skin contact. (You may also use paragraph (g)(2)(vi) of this section for this designation.)

(ii) Avoid breathing substance. (You may also use paragraph (g)(2)(viii) of this section for this designation.)

(iii) Avoid ingestion.

(iv) Use respiratory protection. (You may also use paragraph (g)(2)(vii) of this section for this designation.)

(v) Use skin protection. (You may also use paragraph (g)(2)(vi) of this section for this designation.)

(vi) Wear protective gloves/protective clothing/eye protection/face protection. (Chemical manufacturer or distributor to specify type of equipment, as required.)

(vii) Wear respiratory protection. (Chemical manufacturer or distributor to specify equipment as required.)

(viii) Avoid breathing dust/fume/gas/mist/vapors/spray. (Chemical manufacturer or distributor to specify applicable conditions.)

(3) Environmental hazard statements: This substance may be:

(i) Toxic to fish. (You may also use paragraph (g)(3)(iii) of this section for this designation.)

(ii) Toxic to aquatic organisms. (You may also use paragraph (g)(3)(iii) of this section for this designation.)

(iii) Toxic to aquatic life.

(4) Environmental hazard precautionary statements: Notice to users:

(i) Disposal restrictions apply. (You may also use paragraph (g)(4)(iv) of this section for this designation.)

(ii) Spill clean-up restrictions apply. (You may also use paragraph (g)(4)(iv) of this section for this designation.)

(iii) Do not release to water. (You may also use paragraph (g)(4)(iv) of this section for this designation.)

(iv) Dispose of contents/container to . . . (Specify disposal requirements in subpart E of this part and whether they apply to contents, container or both.)

(5) Each human health or environmental hazard precautionary statement identified in subpart E of this part for the label on the substance container must be followed by the statement, “See SDS for details.”

(h) Human health, environmental hazard exposure and precautionary statements. (1) Whenever referenced in subpart E of this part for a substance, the following human health, environmental hazard, exposure, and precautionary statements shall appear on each label as specified in paragraph (b) of this section. Additional statements may be included as long as they are true and do not alter the meaning of the required statements.

(i) Precautionary statements. (A) The health effects of this chemical substance have not been determined.

(B) When using this substance, use skin protection.

(C) Use respiratory protection when there is a reasonable likelihood of exposure in the work area from dust, mist, or smoke from spray application.

(D) Chemicals similar in structure to this substance have been found to cause cancer in laboratory animals.

(ii) Human health hazard statements. (A) Causes skin irritation.

(B) Respiratory complications. (You may also use paragraph (h)(1)(ii)(J) of this section for this designation.)

(C) Central nervous system effects. (You may also use paragraph (h)(1)(ii)(K) of this section for this designation but you must include this specific effect.)

(D) Internal organ effects. (You may also use paragraph (h)(1)(ii)(K) of this section for this designation.)

(E) Birth defects. (You may also use paragraph (h)(1)(ii)(L) of this section for this designation but you must include this specific effect.)

(F) Reproductive effects. (You may also use paragraph (h)(1)(ii)(L) of this section for this designation but you must include this specific effect.)

(G) Cancer.

(H) Immune system effects. (You may also use paragraph (h)(1)(ii)(K) of this section for this designation but you must include this specific effect.)

(I) Developmental effects. (You may also use paragraph (h)(1)(ii)(L) of this section for this designation but you must include this specific effect.)

(J) May cause allergy or asthma symptoms or breathing difficulties if inhaled.

(K) May cause damage to organs (state all organs identified in subpart E of this part for this substance) through prolonged or repeated exposure.

(L) May damage fertility or the unborn child (state specific effect identified in subpart E of this part for this substance).

(M) May cause an allergic skin reaction.

(N) Causes eye irritation.

(iii) Human health hazard precautionary statements. When using this substance:

(A) Avoid skin contact. (You may also use paragraph (h)(1)(iii)(F) of this section for this designation.)

(B) Avoid breathing substance. (You may also use paragraph (h)(1)(iii)(H) of this section for this designation.)

(C) Avoid ingestion.

(D) Use respiratory protection. (You may also use paragraph (h)(1)(iii)(G) of this section for this designation.)

(E) Use skin protection. (You may also use paragraph (h)(1)(iii)(F) of this section for this designation.)

(F) Wear protective gloves/protective clothing/eye protection/face protection. (Chemical manufacturer or distributor to specify type of equipment, as required.)

(G) Wear respiratory protection. (Chemical manufacturer or distributor to specify equipment as required.)

(H) Avoid breathing dust/fume/gas/mist/vapors/spray. (Chemical manufacturer or distributor to specify applicable conditions.)

(iv) Environmental hazard statements. (A) Toxic to fish. (You may also use paragraph (h)(1)(iv)(C) of this section for this designation.)

(B) Toxic to aquatic organisms. (You may also use paragraph (h)(1)(iv)(C) of this section for this designation.)

(C) Toxic to aquatic life.

(v) Environmental hazard precautionary statements. Notice to Users:

(A) Disposal restrictions apply. (You may also use paragraph (h)(1)(v)(D) of this section for this designation)

(B) Spill clean-up restrictions apply. (You may also use paragraph (h)(1)(v)(D) of this section for this designation)

(C) Do not release to water. (You may also use paragraph (h)(1)(v)(D) of this section for this designation.)

(D) Dispose of contents/container to . . . (Specify disposal requirements in subpart E of this part and whether they apply to contents, container or both.)

(vi) Additional statements. Each human health or environmental precautionary statement identified in subpart E of this part for the label on the substance container must be followed by the statement, “See SDS for details.”

(2) Whenever referenced in subpart E of this part for a substance, the following human health, environmental hazard, exposure, and precautionary statements shall appear on each SDS as specified in paragraph (c) of this section. Additional statements may be included as long as they are true and do not alter the meaning of the required statements.

(i) Precautionary statements. (A) The health effects of this chemical substance have not been determined.

(B) When using this substance, use skin protection.

(C) Use respiratory protection when there is a reasonable likelihood of exposure in the work area from dust, mist, or smoke from spray application.

(D) Chemicals similar in structure to this substance have been found to cause cancer in laboratory animals.

(ii) Human health hazard statements. (A) Causes skin irritation.

(B) Respiratory complications. (You may also use paragraph (h)(2)(ii)(J) of this section for this designation.)

(C) Central nervous system effects. (You may also use paragraph (h)(2)(ii)(K) of this section for this designation but you must include this specific effect.)

(D) Internal organ effects. (You may also use paragraph (h)(2)(ii)(K) of this section for this designation.)

(E) Birth defects. (You may also use paragraph (h)(2)(ii)(L) of this section for this designation but you must include this specific effect.)

(F) Reproductive effects. (You may also use paragraph (h)(2)(ii)(L) of this section for this designation but you must include this specific effect.)

(G) May cause cancer.

(H) Immune system effects. (You may also use paragraph (h)(2)(ii)(K) of this section for this designation but you must include this specific effect.)

(I) Developmental effects. (You may also use paragraph (h)(2)(ii)(L) of this section for this designation but you must include this specific effect.)

(J) May cause allergy or asthma symptoms or breathing difficulties if inhaled.

(K) May cause damage to organs (state all organs identified in subpart E of this part for this substance.) through prolonged or repeated exposure.

(L) May damage fertility or the unborn child (state specific effect identified in subpart E of this part for this substance).

(M) May cause an allergic skin reaction.

(N) Causes eye irritation.

(iii) Human health hazard precautionary statements. (A) Avoid skin contact. (You may also use paragraph (h)(2)(iii)(F) of this section for this designation.)

(B) Avoid breathing substance. (You may also use paragraph (h)(2)(iii)(H) of this section for this designation.)

(C) Avoid ingestion.

(D) Use respiratory protection. (You may also use paragraph (h)(2)(iii)(G) of this section for this designation.)

(E) Use skin protection. (You may also use paragraph (h)(2)(iii)(F) of this section for this designation.)

(F) Wear protective gloves/protective clothing/eye protection/face protection. (Chemical manufacturer or distributor to specify type of equipment, as required.)

(G) Wear respiratory protection. (Chemical manufacturer or distributor to specify equipment as required.)

(H) Avoid breathing dust/fume/gas/mist/vapors/spray. (Chemical manufacturer or distributor to specify applicable conditions.)

(iv) Environmental hazard statements. (A) Toxic to fish. (You may also use paragraph (h)(2)(iv)(C) of this section for this designation.)

(B) Toxic to aquatic organisms. (You may also use paragraph (h)(2)(iv)(C) of this section for this designation.)

(C) Toxic to aquatic life.

(v) Environmental hazard precautionary statements. Notice to Users:

(A) Disposal restrictions apply. (You may also use paragraph (h)(2)(v)(D) of this section for this designation.)

(B) Spill clean-up restrictions apply. (You may also use paragraph (h)(2)(v)(D) of this section for this designation.)

(C) Do not release to water. (You may also use paragraph (h)(2)(v)(D) of this section for this designation.)

(D) Dispose of contents/container to . . . (Specify disposal requirements in subpart E of this part and whether they apply to contents, container or both.)

(i) Written hazard communication program. Each employer shall develop and implement a written hazard communication program for the substance in each workplace in accordance with 29 CFR 1910.1200.

(j) Human health, environmental hazard, exposure, and precautionary statements. In addition to the requirements for the hazard communication program specified in paragraph (i) of this section, whenever referenced in subpart E of this part for a substance, the following human health and environmental hazard, exposure, and precautionary statements shall appear as specified in paragraph (i) of this section.

(1) Human health hazard statements:

(i) Causes skin irritation.

(ii) May cause cancer.

(iii) Immune system effects.

(iv) Developmental effects.

(v) May cause allergy or asthma symptoms or breathing difficulties if inhaled.

(vi) May cause damage to organs (state all organs identified in subpart E of this part for this substance) through prolonged or repeated exposure.

(vii) May damage fertility or the unborn child (state specific effect identified in subpart E of this part for this substance).

(viii) May cause an allergic skin reaction.

(ix) Causes eye irritation.

(2) Human health hazard precautionary statements:

(i) Avoid ingestion.

(ii) Wear protective gloves/protective clothing/eye protection/face protection. (Chemical manufacturer or distributor to specify type of equipment, as required.)

(iii) Wear respiratory protection. (Chemical manufacturer or distributor to specify equipment as required.)

(iv) Avoid breathing dust/fume/gas/mist/vapors/spray. (Chemical manufacturer or distributor to specify applicable conditions.)

(3) Environmental hazard statements: This substance may be:

(i) Toxic to aquatic life.

(ii) Very toxic to aquatic life.

(iii) Harmful to aquatic life.

(iv) Very toxic to aquatic life with long term effects.

(v) Toxic to aquatic life with long lasting effects.

(vi) Harmful to aquatic life with long lasting effects.

(vii) May cause long lasting harmful effects to aquatic life.

(4) Environmental hazard precautionary statements: Notice to users:

(i) Avoid release to the environment (if this is not the intended use.)

(ii) Collect spillage.

(iii) Dispose of contents/container to . . . (Specify disposal requirements in subpart E of this part and whether they apply to contents, container or both.)

Whenever a substance is identified in subpart E of this part as being subject to this section, a significant new use of the substance is:

(a) Use in non-enclosed processes.

(b) Any manner or method of manufacture in non-enclosed processes associated with any use.

(c) Any manner or method of processing in non-enclosed processes associated with any use.

(d) Use beyond the site of manufacture.

(e) Processing beyond the site of manufacture.

(f) Any manner or method of manufacture (excluding import) of the substance associated with any use.

(g) Use other than as an intermediate.

(h) Use other than as a site-limited intermediate.

(i) Use as an intermediate where the concentration of the intermediate substance in the product intended for distribution in commerce exceeds the concentration specified in subpart E of this part for the substance.

(j) Use other than as described in the premanufacture notice referenced in subpart E of this part for the substance.

(k) Use other than allowed by the section 5(e) consent order referenced in subpart E of this part for the substance.

(l) Non-industrial use.

(m) Commercial use.

(n) Non-commercial use.

(o) Use in a consumer product.

(p) Aggregate manufacturing volume for any use greater than that specified in subpart E of this part for the substance.

(q) Aggregate manufacturing volume for any use greater than that allowed by the section 5(e) consent order referenced in subpart E of this part for the substance.

(r) Aggregate manufacturing volume for any use greater than that specified in subpart E of this part for the substance unless the manufacturer has submitted the results of the health or environmental effects studies identified in subpart E of this part for the substance and those studies comply with the procedures and criteria for developing and evaluating data identified in subpart E of this part for the substance.

(s) Annual manufacturing volume for any use greater than that specified in subpart E of this part for the substance.

(t) Annual manufacturing volume for any use greater than that allowed by the section 5(e) consent order referenced in subpart E of this part for the substance.

(u) Annual manufacturing volume for any use greater than that specified in subpart E of this part for the substance unless the manufacturer has submitted the results of the health or environmental effects studies identified in subpart E of this part for the substance and those studies comply with the procedures and criteria for developing and evaluating data identified in subpart E of this part for the substance.

(v) Use in the form of:

(1) A powder.

(2) A solid.

(3) A liquid.

(4) A gas.

(w) Any manner or method of manufacture of the substance in the following form associated with any use:

(1) A powder.

(2) A solid.

(3) A liquid.

(4) A gas.

(x) Any manner or method of processing of the substance in the following form associated with any use:

(1) A powder.

(2) A solid.

(3) A liquid.

(4) A gas.

(y) Use involving an application method that generates:

(1) A vapor, mist, or aerosol.

(2) A dust.

Whenever a substance is identified in subpart E of this part as being subject to this section, a significant new use of the substance is any method of:

(a) Disposal of the process stream associated with any use of the substance or with any manner or method of manufacturing associated with any use of the substance other than by the following. This provision does not supersede any applicable Federal, State, or local laws and regulations.

(1) Incineration.

(2) Landfill.

(3) Deep well injection.

(b) Disposal of the process stream associated with any use or with any manner or method of processing associated with any use other than by the following. This provision does not supersede any applicable Federal, State, or local laws and regulations.

(1) Incineration.

(2) Landfill.

(3) Deep well injection.

(c) Disposal of the use stream associated with any use, other than by the following. This provision does not supersede any applicable Federal, State, or local laws and regulations.

(1) Incineration.

(2) Landfill.

(3) Deep well injection.

(d) Disposal of the substance associated with any use of the substance, or with any manner or method of manufacture or processing in association with any use. This provision does not supersede any applicable Federal, State, or local laws and regulations.

Whenever a substance is identified in subpart E of this part as being subject to this section, a significant new use of the substance is:

(a) Any predictable or purposeful release of a manufacturing stream associated with any use of the substance, from any site:

(1) Into the waters of the United States.

(2) Into the waters of the United States without application of one or more of the following treatment technologies as specified in subpart E of this part either by the discharger or, in the case of a release through publicly-owned treatment works, by a combination of treatment by the discharger and the publicly-owned treatment works:

(i) Chemical precipitation and settling.

(ii) Biological treatment (activated sludge or equivalent) plus clarification.

(iii) Steam stripping.

(iv) Resin or activated carbon adsorption.

(v) Chemical destruction or conversion.

(vi) Primary wastewater treatment.

(3) Into the waters of the United States without primary wastewater treatment, and secondary wastewater treatment as defined in 40 CFR part 133.

(4) Into the waters of the United States if the quotient from the following formula:

(b) Any predictable or purposeful release of a process stream containing the substance associated with any use of the substance from any site:

(1) Into the waters of the United States.

(2) Into the waters of the United States without application of one or more of the following treatment technologies as specified in subpart E of this part either by the discharger or, in the case of a release through publicly-owned treatment works, by a combination of treatment by the discharger and the publicly-owned treatment works:

(i) Chemical precipitation and settling.

(ii) Biological treatment (activated sludge or equivalent) plus clarification.

(iii) Steam stripping.

(iv) Resin or activated carbon adsorption.

(v) Chemical destruction or conversion.

(vi) Primary wastewater treatment.

(3) Into the waters of the United States without primary wastewater treatment, and secondary wastewater treatment as defined in 40 CFR part 133.

(4) Into the waters of the United States if the quotient from the following formula:

(c) Any predictable or purposeful release of a use stream containing the substance associated with any use of the substance from any site:

(1) Into the waters of the United States.

(2) Into the waters of the United States without application of one or more of the following treatment technologies as specified in subpart E of this part either by the discharger or, in the case of a release through publicly-owned treatment works, by a combination of treatment by the discharger and the publicly-owned treatment works:

(i) Chemical precipitation and settling.

(ii) Biological treatment (activated sludge or equivalent) plus clarification.

(iii) Steam stripping.

(iv) Resin or activated carbon adsorption.

(v) Chemical destruction or conversion.

(vi) Primary wastewater treatment.

(3) Into the waters of the United States without primary wastewater treatment, and secondary wastewater treatment as defined in 40 CFR part 133.

(4) Into the waters of the United States if the quotient from:

These instructions describe the use of the equation specified in § 721.90(a)(4), (b)(4), and (c)(4) to compute estimated surface water concentrations which will result from release of a substance identified in subpart E of this part. The equation shall be computed for each site using the stream flow rate appropriate for the site according to paragraph (b) of this section, and the highest number of kilograms calculated to be released for that site on a given day according to paragraph (a) of this section. Two variables shall be considered in computing the equation, the number of kilograms released, and receiving stream flow.

(a) Number of kilograms released. (1) To calculate the number of kilograms of substance to be released from manufacturing, processing, or use operations, as specified in the numerator of the equation, develop a process description diagram which describes each manufacturing, processing, or use operation involving the substance. The process description must include the major unit operation steps and chemical conversions. A unit operation is a functional step in a manufacturing, processing, or use operation where substances undergo chemical changes and/or changes in location, temperature, pressure, physical state, or similar characteristics. Include steps in which the substance is formulated into mixtures, suspensions, solutions, etc.

(2) Indicate on each diagram the entry point of all feedstocks (e.g., reactants, solvents, and catalysts) used in the operation. Identify each feedstock and specify its approximate weight regardless of whether the process is continuous or batch.

(3) Identify all release points from which the substance or wastes containing the substance will be released into air, land, or water. Indicate these release points on the diagram. Do not include accidental releases or fugitive emissions.

(4) For releases identified in the diagram that are destined for water, estimate the amount of substance that will be released before the substance enters control technology. The kilograms of substance released may be estimated based on:

(i) The mass balance of the operation, i.e., totaling inputs and outputs, including wastes for each part of the process such that outputs equal inputs. The amount released to water may be the difference between the amount of the substance in the starting material (or formed in a reaction) minus the amount of waste material removed from each part of the process and not released to water and the amount of the substance in the final product.

(ii) Physical properties such as water solubility where a known volume of water being discharged is assumed to contain the substance at concentrations equal to its solubility in water. This approach is particularly useful where the waste stream results from separation of organic/water phases or filtration of the substance from an aqueous stream to be discharged.

(iii) Measurements of flow rates of the process/use stream and known concentrations of the substance in the stream.

(5) After releases of a substance to water are estimated for each operation on a site, total the releases of the substance to water from all operations at that site. The value (number of kilograms) specified in the numerator of the equation should reflect total kilograms of substance released to water per day from all operations at a single site.

(6) Use the highest expected daily release of the substance for each site.

(7) When a substance is designated in subpart E of this part with a specific control technology and a percentage removal of the substance from wastewater resulting from use of the specified control technology, you may subtract that percentage from the highest expected daily release if that control technology is applied.

(b) Receiving stream flow. (1) The receiving stream flow shall be expressed in million liters per day (MLD). The flow rate data to be used must be for the point of release on the water body that first receives release of the substance whether by direct discharge from a site, or by indirect discharge through a Publicly-Owned Treatment Works (POTW) for each site. The flow rate reported shall be the lowest 7-day average stream flow with a recurrence interval of 10 years (7-Q-10). If the 7-Q-10 flow rate is not available for the actual point of release, the stream flow rate should be used from the U.S. Geological Survey (USGS) gauging station that is nearest the point of release that is expected to have a flow rate less than or equal to the receiving stream flow at the point of release.

(2) Receiving stream flow data may be available from the National Pollutant Discharge Elimination System (NPDES) permit for the site or the POTW releasing the substance to surface water, from the NPDES permit-writing authority for the site or the POTW, or from USGS publications, such as the water-data report series.

(3) If receiving stream flow data are not available for a stream, either the value of 10 MLD or the daily flow of wastewater from the site or the POTW releasing the substance must be used as an assumed minimum stream flow. Similarly, if stream flow data are not available because the location of the point of release of the substance to surface water is a lake, estuary, bay, or ocean, then the flow rate to be used must be the daily flow of wastewater from the site or the POTW releasing the substance to surface water. Wastewater flow data may be available from the NPDES permit or NPDES authority for the site or the POTW releasing the substance to water.