CCLME.ORG - 40 CFR PART 721—SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES
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(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.
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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.
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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.
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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:




number of kilograms/day/site released
----------------------------------------
receiving stream flow (million liters/ X 1000 = N parts per billion
day)
------------------------------------------------------------------------



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:




number of kilograms/day/site released
----------------------------------------
receiving stream flow (million liters/ X 1000 = N parts per billion
day)
------------------------------------------------------------------------



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:




number of kilograms/day/site released
----------------------------------------
receiving stream flow (million liters/ X 1000 = N parts per billion
day)
------------------------------------------------------------------------



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.
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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.

Subpart C—Recordkeeping Requirements
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§ 721.100 Applicability.
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This subpart C identifies certain additional recordkeeping requirements applicable to manufacturers, importers, and processors of substances identified in subpart E of this part for each specific substance. The provisions of this subpart C apply only when referenced in subpart E of this part for a substance and significant new use identified in that subpart E. If the provisions in this subpart C conflict with general provisions of subpart A of this part, the provisions of this subpart C shall apply.

[54 FR 31313, July 27, 1989]

§ 721.125 Recordkeeping requirements.
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At the time EPA adds a substance to subpart E of this part, EPA will specify appropriate recordkeeping requirements which correspond to the significant new use designations for the substance selected from subpart B of this part. Each manufacturer, importer, and processor of the substance shall maintain the records for 5 years from the date of their creation. In addition to the records specified in §721.40, the records whose maintenance this section requires may include the following:

(a) Records documenting the manufacture and importation volume of the substance and the corresponding dates of manufacture and import.

(b) Records documenting volumes of the substance purchased in the United States by processors of the substance, names and addresses of suppliers, and corresponding dates of purchase.

(c) Records documenting the names and addresses (including shipment destination address, if different) of all persons outside the site of manufacture, importation, or processing to whom the manufacturer, importer, or processor directly sells or transfers the substance, the date of each sale or transfer, and the quantity of the substance sold or transferred on such date.

(d) Records documenting establishment and implementation of a program for the use of any applicable personal protective equipment required under §721.63.

(e) Records documenting the determinations required by § 721.63(a)(3) that chemical protective clothing is impervious to the substance.

(f) Records documenting establishment and implementation of the hazard communication program required under §721.72.

(g) Copies of labels required under §721.72(b).

(h) Copies of material safety data sheets required under § 721.72(c).

(i) Records documenting compliance with any applicable industrial, commercial, and consumer use limitations under § 721.80.

(j) Records documenting compliance with any applicable disposal requirements under §721.85, including the method of disposal, location of disposal sites, dates of disposal, and volume of the substance disposed. Where the estimated disposal volume is not known to or reasonably ascertainable by the manufacturer, importer, or processor, that person must maintain other records which demonstrate establishment and implementation of a program that ensures compliance with any applicable disposal requirements.

(k) Records documenting establishment and implementation of procedures that ensure compliance with any applicable water discharge limitations under §721.90.

[54 FR 31313, July 27, 1989]

Subpart D—Expedited Process for Issuing Significant New Use Rules for Selected Chemical Substances and Limitation or Revocation of Selected Significant New Use Rules
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Source: 54 FR 31314, July 27, 1989, unless otherwise noted.

§ 721.160 Notification requirements for new chemical substances subject to section 5(e) orders.
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(a) Selection of substances. (1) In accordance with the expedited process specified in this section, EPA will issue significant new use notification requirements and other specific requirements for each new chemical substance that is the subject of a final order issued under section 5(e) of the Act, except for an order that prohibits manufacture and import of the substance, unless EPA determines that significant new use notification requirements are not needed for the substance.

(2) If EPA determines that significant new use notification requirements are not needed for a substance that is subject to a final order issued under section 5(e) of the Act, except for an order that prohibits manufacture or import of the substance, EPA will issue a notice in the Federal Register explaining why the significant new use requirements are not needed.

(b) Designation of requirements. (1) The significant new use notification and other specific requirements will be based on and be consistent with the provisions included in the final order issued for the substance under section 5(e) of the Act. EPA may also designate additional activities as significant new uses which will be subject to notification. Designation of additional activities as significant new uses will be done in accordance with the criteria and procedures under §721.170, or through a separate rulemaking proceeding.

(2) Significant new use requirements and other specific requirements designated under this section will be listed in subpart E of this part. For each substance, subpart E will identify:

(i) The chemical name.

(ii) The activities designated as significant new uses.

(iii) Other specific requirements applicable to the substance, including recordkeeping requirements or any other requirements included in the final section 5(e) order.

(c) Procedures for issuing significant new use rules. (1) EPA will issue significant new use rules under this section by one of the following three processes: direct final rulemaking, interim final rulemaking, or notice and comment rulemaking. EPA will use the direct final rulemaking process to issue significant new use rules unless it determines that, in a particular case, one of the other processes is more appropriate.

(2) Federal Register documents issued to propose or establish significant new uses under this section will contain the following:

(i) The chemical identity of the substance or, if its specific identity is claimed confidential, an appropriate generic chemical name and an accession number assigned by EPA.

(ii) The premanufacture notice number.

(iii) The CAS number, where available and not claimed confidential.

(iv) A summary of EPA's findings under section 5(e)(1)(A) of the Act for the final order issued under section 5(e).

(v) Designation of the significant new uses subject to, or proposed to be subject to, notification and any other applicable requirements.

(vi) Any modifications of subpart A of this part applicable to the specific substance and significant new uses.

(vii) If the Federal Register document establishes a final rule, or notifies the public that a final rule will not be issued after public comment has been received, the document will describe comments received and EPA's response.

(3) Direct final rulemaking. (i) When EPA uses the direct final rulemaking procedure to issue a significant new use rule, it will issue a final rule in the Federal Register following its decision to develop a significant new use rule under this section for a specific new chemical substance.

(ii) The Federal Register document will state that, unless written notice is received by EPA within 30 days of publication that someone wishes to submit adverse or critical comments, the rule will be effective 60 days from the date of publication. The written notice of intent to submit adverse or critical comments should state which SNUR(s) will be the subject of the adverse or critical comments, if several SNURs are established through the direct final rule. If notice is received within 30 days that someone wishes to submit adverse or critical comments, the section(s) of the direct final rule containing the SNUR(s) for which a notice of intent to comment was received will be withdrawn by EPA issuing a document in the final rule section of the Federal Register, and a proposal will be published in the proposed rule section of the Federal Register. The proposal will establish a 30-day comment period.

(iii) If EPA, having considered any timely comments submitted in response to the proposal, decides to establish notification requirements under this section, EPA will issue a final rule adding the substance to subpart E of this part and designating the significant new uses subject to notification.

(4) Notice and comment rulemaking. (i) When EPA uses a notice and comment procedure to issue a significant new use rule, EPA will issue a proposal in the Federal Register following its decision to develop a significant new use rule under this section for a specific new chemical substance. Persons will be given 30 days to comment on whether EPA should establish notification requirements for the substance under this part.

(ii) If EPA, having considered any timely comments, decides to establish notification requirements under this section, EPA will issue a final rule adding the substance to subpart E of this part and designating the significant new uses subject to notification.

(5) Interim final rulemaking. (i) When EPA uses the interim final rulemaking procedure to issue a significant new use rule, EPA will issue an interim final rule in the final rule section of the Federal Register following its decision to develop a significant new use rule for a specific new chemical substance. The document will state EPA's reasons for using the interim final rulemaking procedure.

(A) The significant new use rule will take effect on the date of publication.

(B) Persons will be given 30 days from the date of publication to submit comments.

(ii) Interim final rules issued under this section shall cease to be in effect 180 days after publication unless, within the 180-day period, EPA issues a final rule in the Federal Register responding to any written comments received during the 30-day comment period specified in paragraph (c)(5)(i)(B) of this section and promulgating final significant new use notification requirements and other requirements for the substance.

(d) Schedule for issuing significant new use rules. (1) Unless EPA determines that a significant new use rule should not be issued under this section, EPA will issue a proposed rule, a direct final rule, or an interim final rule within 180 days of receipt of a valid notice of commencement under §720.102 of this chapter for any substance for which the notice of commencement was received on or after October 10, 1989.

(2) Unless EPA determines that a significant new use rule should not be issued under this section, EPA will issue a proposed rule, a direct final rule, or an interim final rule within 1 year of October 10, 1989, for any substance for which the valid notice of commencement under §720.102 of this chapter was received before October 10, 1989.

(3) If EPA receives adverse or critical significant comments following publication of a proposed or interim final rule, EPA will either withdraw the rule or issue a final rule addressing the comments received.

§ 721.170 Notification requirements for selected new chemical substances that have completed premanufacture review.
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(a) Selection of substances. In accordance with the expedited process specified in this section, EPA may issue significant new use notification and recordkeeping requirements for any new chemical substance for which a premanufacture notice has been submitted under part 720 of this chapter if EPA determines that activities other than those described in the premanufacture notice may result in significant changes in human exposure or environmental release levels and/or that concern exists about the substance's health or environmental effects.

(b) Concern criteria. EPA may determine that concern exists about a substance's health or environmental effects if EPA makes any one of the following findings:

(1)(i) The substance may cause carcinogenic effects because the substance:

(A) Has been shown by valid test data to cause carcinogenic effects in humans or in at least one species of laboratory animal.

(B) Has been shown to be a possible carcinogen based on the weight of the evidence in short-term tests indicative of the potential to cause carcinogenic effects.

(C) Is closely analogous, based on toxicologically relevant similarities in molecular structure and physical properties, to another substance that has been shown by test data to cause carcinogenic effects in humans or in at least one species of laboratory animal, provided that if there is more than one such analogue, the greatest weight will be given to the relevant data for the most appropriate analogues.

(D) Is known or can reasonably be anticipated, based on valid scientific data or established scientific principles, to be metabolized in humans or transformed in the environment to a substance which may have the potential to cause carcinogenic effects under the criteria in paragraphs (b)(1)(i) (A), (B), or (C) of this section.

(ii) No substance may be regulated based on a finding under paragraph (b)(1) of this section unless EPA has also made the finding under §721.170(c)(2)(ii).

(2) The substance has been shown by valid test data to cause acutely toxic effects in at least one species of laboratory animal or is closely analogous, based on toxicologically relevant similarities in molecular structure and physical properties, to another substance that has been shown by valid test data to cause acutely toxic effects in at least one species of laboratory animal, provided that if there is more than one such analogue, the greatest weight will be given to the relevant data for the most appropriate analogues.

(3) The substance may cause serious chronic effects, serious acute effects, or developmentally toxic effects under reasonably anticipated conditions of exposure because the substance:

(i) Has been shown by valid test data to cause serious chronic effects, serious acute effects, or developmentally toxic effects in humans or in at least one species of laboratory animal at dose levels that could be of concern under reasonably anticipated conditions of exposure.

(ii) Is closely analogous, based on toxicologically relevant similarities in molecular structure and physical properties, to another chemical substance that has been shown by valid test data to cause serious chronic effects, serious acute effects, or developmentally toxic effects in humans or in at least one species of laboratory animal at dose levels that could be of concern under reasonably anticipated conditions of exposure, provided that if there is more than one such analogue, the greatest weight will be given to the relevant data for the most appropriate analogues.

(iii) Is known or can reasonably be anticipated, based on valid scientific data or established scientific principles, to be metabolized in humans or transformed in the environment to a substance which may have the potential to cause serious chronic effects, serious acute effects, or developmentally toxic effects under the criteria in paragraph (b)(3) (i) and (ii) of this section.

(iv) Has been shown to potentially cause developmentally toxic effects based on the weight of the evidence in short-term tests indicative of the potential to cause developmentally toxic effects.

(4) The substance may cause significant adverse environmental effects under reasonably anticipated conditions of release because the substance:

(i) Has been shown by valid test data to cause significant adverse environmental effects at dose levels that could be of concern under reasonably anticipated conditions of release.

(ii) Is closely analogous, based on toxicologically relevant similarities in molecular structure and physical properties, to another substance that has been shown by valid test data to cause significant adverse environmental effects at dose levels that could be of concern under reasonably anticipated conditions of release, provided that if there is more than one such analogue, the greatest weight will be given to the relevant data for the most appropriate analogues.

(iii) Has been determined, based on calculations using the substance's physical and chemical properties, to be potentially able to cause significant adverse environmental effects at dose levels that could be of concern under reasonably anticipated conditions of release.

(iv) Is known or can reasonably be anticipated, based on valid scientific data or established scientific principles, to be environmentally transformed to a substance which may have the potential to cause significant adverse environmental effects under the criteria in paragraph (b)(4) (i), (ii), and (iii) of this section.

(5) Concern exists about the health or environmental effects of one or more impurities or byproducts of the substance because the impurity or byproduct meets one or more of the criteria in paragraph (b) (1) through (4) of this section and either:

(i) The impurity or byproduct is a new chemical substance and may be present in concentrations that could cause adverse health or environmental effects under reasonably anticipated conditions of exposure or release.

(ii) Reasonably anticipated manufacture, processing, or use activities involving the substance for which a premanufacture notice has been submitted may result in significantly increased human exposure to or environmental release of the impurity or byproduct compared to exposure or release levels resulting from existing activities involving the impurity or byproduct.

(c) Designation of requirements. (1) When EPA decides to establish significant new use reporting requirements under this section, EPA may designate as a significant new use any one or more of the activities set forth in subpart B of this part. In addition, EPA may designate specific recordkeeping requirementsdescribed under subpart C of this part that are applicable to the substance. (continued)