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Electronic Code of Federal Regulations

e-CFR Data is current as of April 16, 2014

Title 40: Protection of Environment
PART 721—SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES


Subpart B—Certain Significant New Uses


Contents
§721.50   Applicability.
§721.63   Protection in the workplace.
§721.72   Hazard communication program.
§721.80   Industrial, commercial, and consumer activities.
§721.85   Disposal.
§721.90   Release to water.
§721.91   Computation of estimated surface water concentrations: Instructions.

Source: 54 FR 31308, July 27, 1989, unless otherwise noted.

§721.50   Applicability.

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.

§721.63   Protection in the workplace.

(a) 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 manner or method of manufacturing, importing, or processing associated with any use of the substance without establishing a program 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 30 CFR part 11.

(5) The following NIOSH approved respirators meet the minimum 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.

(6) When cited in subpart E of this part for a substance, the following airborne form(s) of the substance apply to paragraphs (a) (1) and (4) of this section:

(i) Dust.

(ii) Mist.

(iii) Fume.

(iv) Smoke.

(v) Vapor.

(vi) Gas.

(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, importer, 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).

§721.72   Hazard communication program.

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, import, or processing associated with any use of that substance without establishing a hazard communication program as described in 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, MSDSs, 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 (29 CFR 1900.1200), 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 MSDS 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 1900.1200), the employer may prescribe on the label, MSDS, 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.

(c) Material safety data sheets. (1) Each employer must obtain or develop a MSDS for the substance.

(2) Each MSDS 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 MSDS or of its last revision.

(xii) The name, address, and telephone number of the individual preparing or distributing the MSDS, 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 MSDS, the employer must mark the MSDS 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 MSDS 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 MSDS within 3 months from the time the employer becomes aware of the new information. If the substance is not currently being manufactured, imported, processed, or used in the employer's workplace, the employer must add the new information to the MSDS 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 MSDS with their initial shipment and with the first shipment after an MSDS is revised. The employer may either provide the MSDS 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 MSDS in its workplace, and must ensure that it is readily accessible during each work shift to employees when they are in their work areas.

(8) The MSDS 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 MSDS must be printed 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 MSDSs 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 MSDS 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 MSDS 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: This substance may cause:

(i) Skin irritation.

(ii) Respiratory complications.

(iii) Central nervous system effects.

(iv) Internal organ effects.

(v) Birth defects.

(vi) Reproductive effects.

(vii) Cancer.

(viii) Immune system effects.

(ix) Developmental effects.

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

(i) Avoid skin contact.

(ii) Avoid breathing substance.

(iii) Avoid ingestion.

(iv) Use respiratory protection.

(v) Use skin protection.

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

(i) Toxic to fish.

(ii) Toxic to aquatic organisms.

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

(i) Disposal restrictions apply.

(ii) Spill clean-up restrictions apply.

(iii) Do not release to water.

(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 MSDS 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. This substance may cause:

(A) Skin irritation

(B) Respiratory complications

(C) Central nervous system effects

(D) Internal organ effects

(E) Birth defects

(F) Reproductive effects

(G) Cancer

(H) Immune system effects

(I) Developmental effects

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

(A) Avoid skin contact

(B) Avoid breathing substance

(C) Avoid ingestion

(D) Use respiratory protection

(E) Use skin protection

(iv) Environmental hazard statements. This substance may be:

(A) Toxic to fish

(B) Toxic to aquatic organisms

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

(A) Disposal restrictions apply

(B) Spill clean-up restrictions apply

(C) Do not release to water.

(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 MSDS 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 MSDS 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. This substance may cause:

(A) Skin irritation

(B) Respiratory complications

(C) Central nervous system effects

(D) Internal organ effects

(E) Birth defects

(F) Reproductive effects

(G) Cancer

(H) Immune system effects

(I) Developmental effects

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

(A) Avoid skin contact

(B) Avoid breathing substance

(C) Avoid ingestion

(D) Use respiratory protection

(E) Use skin protection

(iv) Environmental hazard statements. This substance may be:

(A) Toxic to fish

(B) Toxic to aquatic organisms

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

(A) Disposal restrictions apply

(B) Spill clean-up restrictions apply

(C) Do not release to water.

[54 FR 31308, July 27, 1989, as amended at 55 FR 45996, Oct. 31, 1990; 58 FR 34204, June 23, 1993]

§721.80   Industrial, commercial, and consumer activities.

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 or import.

(e) Processing beyond the site of manufacture or import.

(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 manufacture and importation volume for any use greater than that specified in subpart E of this part for the substance.

(q) Aggregate manufacture and importation 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 manufacture and importation volume for any use greater than that specified in subpart E of this part for the substance unless the manufacturer or importer 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 manufacture and importation volume for any use greater than that specified in subpart E of this part for the substance.

(t) Annual manufacture and importation 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 manufacture and importation volume for any use greater than that specified in subpart E of this part for the substance unless the manufacturer or importer 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.

§721.85   Disposal.

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 supercede 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 supercede 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 supercede 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 supercede any applicable Federal, State, or local laws and regulations.

§721.90   Release to water.

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:

eCFR graphic er25se06.006.gif

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exceeds the level specified in subpart E of this part when calculated using the methods described in §721.91. In lieu of calculating the above quotient, monitoring or alternative calculations may be used to predict the surface water concentration which will result from the intended release of the substance, if the monitoring procedures or calculations have been approved for such purpose by EPA. EPA will review and act on written requests to approve monitoring procedures or alternative calculations within 90 days after such requests are received. EPA will inform submitters of the disposition of such requests in writing, and will explain the reasons therefor when they are denied.

(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:

eCFR graphic er25se06.006.gif

View or download PDF

exceeds the level specified in subpart E of this part when calculated using the methods described in §721.91. In lieu of calculating the above quotient, monitoring or alternative calculations may be used to predict the surface water concentration which will result from the intended release of the substance, if the monitoring procedures or calculations have been approved for such purpose by EPA. EPA will review and act on written requests to approve monitoring procedures or alternative calculations within 90 days after such requests are received. EPA will inform submitters of the disposition of such requests in writing, and will explain the reasons therefor when they are denied.

(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:

eCFR graphic er25se06.006.gif

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exceeds the level specified in subpart E of this part, when calculated using the methods described in §721.91. In lieu of calculating the above quotient, however, monitoring or alternative calculations may be used to predict the surface water concentration expected to result from intended release of the substance, if the monitoring procedures or calculations have been approved for such purpose by EPA. EPA will review and act on written requests to approve monitoring procedures or alternative calculations within 90 days after such requests are received. EPA will inform submitters of the disposition of such requests in writing, and will explain the reasons therefor when they are denied.

§721.91   Computation of estimated surface water concentrations: Instructions.

These instructions describe the use of the equation specified in §721.90(a)(4) and (b)(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.

(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.



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