( 2) When the research and development activity is conducted solely in a laboratory and exposure to the chemical substance is controlled through the implementation of prudent laboratory practices for handling chemical substances of unknown toxicity, and any distribution, except for purposes of disposal, is to other such laboratories for further research and development activity, the information specified in paragraph ( b)( 1) of this section need not be reviewed and evaluated. ( For purposes of this paragraph ( b)( 2), a laboratory is defined as a contained research facility where relatively small quantities of chemical substances are used on a pro production basis, and where activities involve the use of containers for reactions, transfers, and other handling of substances designed to be easily manipulated by a single individual).

( c)( 1) The manufacturer, importer, or processor must notify the persons identified in paragraph ( a)( 2) of this section by means of a container labeling system, conspicuous placement of notices in areas where exposure may occur, written notification to each person potentially exposed, or any other method of notification which adequately informs persons of health risks which the manufacturer, importer, or processor has reason to believe may be associated with the substance, as determined under paragraph ( b)( 1) of this section.

( 2) If the manufacturer, importer, or processor distributes a chemical substance manufactured, imported, or processed under this section to persons not in its employ, the manufacturer, importer, or processor must in written form: ( i) Notify those persons that the substance is to be used only for research and development purposes. ( ii) Provide the notice of health risks specified in paragraph ( c)( 1) of this section.

( 3) The adequacy of any notification under this section is the responsibility of the manufacturer, importer, or processor.

( d) Quantities of the chemical substance, or of mixtures or articles containing the chemical substance, remaining after completion of research and development activities may be: ( 1) Disposed of as a waste in accordance with applicable Federal, State, and local regulations, to the extent the disposal activity is not identified as a significant new use for the substance in subpart E of this part, or ( 2) Used for a commercial purpose, to the extent the use is not identified as a significant new use of the substance in subpart E of this part. May 10, 2004 ( e)( 1) Persons who manufacture, import, or process a chemical substance under this section must retain the following records: ( i) Copies of or citations to information reviewed and evaluated under paragraph ( b)( 1) of this section to determine the need to make any notification of risk. ( ii) Documentation of the nature and method of notification under paragraph ( c)( 1) of this section including copies of any labels or written notices used. ( iii) Documentation of prudent laboratory practices used instead of notification and evaluation under paragraph ( b)( 2) of this section. ( iv) The names and addresses of any persons other than the manufacturer, importer, or processor to whom the substance is distributed, the identity of the substance, the amount distributed, and copies of the notifications required under paragraph ( c)( 2) of this section.

( 2) [ Reserved]

[ 53 FR 28361, July 27, 1988, as amended at 58 FR 34204, June 23, 1993]

Subpart B  Certain Significant New Uses 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. May 10, 2004 ( 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 May 10, 2004 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 May 10, 2004 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, May 10, 2004 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 May 10, 2004 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. May 10, 2004 ( 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 May 10, 2004 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 May 10, 2004 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. May 10, 2004 ( 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. May 10, 2004 ( 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. May 10, 2004 ( 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. May 10, 2004 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 May 10, 2004 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  1000 = N parts per receiving stream flow ( million liters/ X 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. May 10, 2004 ( 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.

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: May 10, 2004 ( 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 § 721.100 Applicability.

This subpart C identifies certain additional recordkeeping requirements applicable to May 10, 2004 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.

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 May 10, 2004 Substances and Limitation or Revocation of Selected Significant New Use Rules Source: 54 FR 31314, July 27, 1989, unless otherwise noted.

§ 721.160 Notification requirements for new chemical substances subject to section 5( e) orders.

( 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. May 10, 2004 ( 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. May 10, 2004 ( 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.

( 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 May 10, 2004 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 May 10, 2004 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 requirements described under subpart C of this part that are applicable to the substance.

( 2) EPA may designate as a significant new use only those activities that ( i) are different from those described in the premanufacture notice for the substance, including any amendments, deletions, and additions of activities to the premanufacture notice, and ( ii) may be accompanied by changes in exposure or release levels that are significant in relation to the health or environmental concerns identified under paragraph ( b) of this section.

( d) Procedures for issuing significant new use rules. ( 1) Significant new use requirements designated under this section will be listed in subpart E of this part. For each substance, subpart E of this part will identify: ( i) The chemical name. ( ii) The activities designated as significant new uses, which may include one or more of the activities described in paragraph ( c) of this section. ( iii) Other specific requirements applicable to the substance.

( 2) When EPA determines that a substance is a candidate for a significant new use rule under this section, it will notify the person that submitted the premanufacture notice for the substance no later than 7 calendar days before the expiration of the notice review period under § 720.75 of this chapter. In providing this notice, EPA will describe the health or environmental concerns identified under paragraph ( b) of this section and the activities under consideration for designation as significant new uses. Such notice may be by telephone, but in this event will be confirmed in writing no later than 30 days after completion of the notice review period.

( 3) 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 the basis for action under this section. ( 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 May 10, 2004 comments received and EPA's response.

( 4) 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. ( i)( A) When EPA uses the direct final rulemaking procedure to issue a significant new use rule it will issue a direct final rule in the final rule section of the FEDERAL REGISTER following its decision to develop a significant new use rule under this section for a specific new chemical substance. ( B) The FEDERAL REGISTER document will state that, unless written notice is received by EPA within 30 days after the date of publication that someone wishes to submit adverse or critical comments, the SNUR will be effective 60 days from 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 after the date of publication 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 EPA will issue a proposed rule in the proposed rule section of the FEDERAL REGISTER. The proposed rule will establish a 30 day comment period.

( C) 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.

( ii)( A) When EPA uses a notice and comment procedure to issue a significant new use rule, EPA will issue a proposed rule 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. ( B) 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. ( iii)( A) 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. ( 1) The significant new use rule will take effect on the date of publication. ( 2) Persons will be given 30 days from the date of publication to submit comments. ( B) An interim final rule 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 ( d)( 4)( iii)( A)( 2) of this section and promulgating final significant new use notification requirements and other requirements for the substance. May 10, 2004 ( e) Schedule for issuing significant new use rules. ( 1) EPA will issue a proposed rule, an interim final rule, or a direct final rule within 270 days of receipt of the 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) If EPA receives adverse or critical comments within the designated comment period following publication of a proposed rule or an interim final rule, EPA will either withdraw the rule or issue a final rule addressing the comments received.

[ 54 FR 31314, July 27, 1989, as amended at 60 FR 16316, Mar. 29, 1995]

§ 721.185 Limitation or revocation of certain notification requirements.

( a) Criteria for modification or revocation. EPA may at any time modify or revoke significant new use notification requirements for a chemical substance which has been added to subpart E of this part using the procedures under § 721.160 or § 721.170. Such action may be taken under this section if EPA makes one of the following determinations, unless other information shows that the requirements should be retained:

( 1) Test data or other information obtained by EPA provide a reasonable basis for concluding that activities designated as significant new uses of the substance will not present an unreasonable risk of injury to human health or the environment.

( 2) EPA has promulgated a rule under section 4 or 6 of the Act, or EPA or another agency has taken action under another law for the substance that eliminates the need for significant new use notification under section 5( a)( 2) of the Act.

( 3) EPA has received significant new use notices for some or all of the activities designated as significant new uses of the substance and, after reviewing such notices, concluded that there is no need to require additional notice from persons who propose to engage in identical or similar activities.

( 4) EPA has examined new information, or has reexamined the test data or other information or analysis supporting its decision to add the substance to subpart E of this part under § 721.170 and has concluded that the substance does not meet the criteria under § 721.170( b).

( 5) For a substance added to subpart E of this part under § 721.160, EPA has examined new information, or has reexamined the test data or other information or analysis supporting its finding under section 5( e)( 1)( A)( ii)( I) of the Act, and has concluded that a rational basis no longer exists for the findings that activities involving the substance may present an unreasonable risk of injury to human health or the environment required under section 5( e)( 1)( A) of the Act.

( 6) For a substance added to subpart E of this part under § 721.160, certain activities involving the substance have been designated as significant new uses pending the completion of testing, and adequate test data developed in accordance with applicable procedures and criteria have been submitted to EPA. May 10, 2004 ( b) Procedures for limitation or revocation. Modification or revocation of significant new use notification requirements for a substance that has been added to subpart E of this part using the procedures described under § 721.160 or § 721.170 may occur either at EPA's initiative or in response to a written request.

( 1) Any affected person may request modification or revocation of significant new use notification requirements for a substance that has been added to subpart E of this part using the procedures described in § 721.160 or § 721.170 by writing to the Director of the Office of Pollution Prevention and Toxics and stating the basis for such request. All requests should be sent to the Document Control Office ( 7407), Office of Pollution Prevention and Toxics, U. S. Environmental Protection Agency, Room G 099, 1200 Pennsylvania Ave., NW., Washington, DC 20460. ATTN: Request to amend significant new use rule. The request must be accompanied by information sufficient to support the request.

( 2) The Director of the Office of Pollution Prevention and Toxics will consider the request, make a determination whether to initiate rulemaking to modify the requirements, and notify the requester of that determination by certified letter. If the request is denied, the letter will explain why EPA has concluded that the significant new use notification requirements for that substance should remain in effect.

( 3) If EPA concludes that significant new use notification requirements for a substance should be limited or revoked, EPA will propose the changes in the FEDERAL REGISTER, briefly describe the grounds for the action, and provide interested parties an opportunity to comment.

[ 54 FR 31314, July 27, 1989, as amended at 58 FR 34204, June 23, 1993; 60 FR 34464, July 3, 1995] May 10, 2004 Attachment E 40 CFR Part 723 May 10, 2004 40 CFR Protection of Environment CHAPTER I ENVIRONMENTAL PROTECTION AGENCY ( CONTINUED)

SUBCHAPTER R  TOXIC SUBSTANCES CONTROL ACT PART 723  PREMANUFACTURE NOTIFICATION EXEMPTIONS Subpart A [ Reserved]

Subpart B  Specific Exemptions Sec. 723.50 Chemical substances manufactured in quantities of 10,000 kilograms or less per year, and chemical substances with low environmental releases and human exposures. 723.175 Chemical substances used in or for the manufacture or processing of instant photographic and peel apart film articles. 723.250 Polymers.

Authority: 15 U. S. C. 2604.

Subpart A [ Reserved]

Subpart B  Specific Exemptions § 723.50 Chemical substances manufactured in quantities of 10,000 kilograms or less per year, and chemical substances with low environmental releases and human exposures.

( a) Purpose and scope. ( 1) This section grants an exemption from the premanufacture notice requirements of section 5( a)( 1)( A) of the Toxic Substances Control Act ( 15 U. S. C. 2604( a)( 1)( A)) for the manufacture of: ( i) Chemical substances manufactured in quantities of 10,000 kilograms or less per year. ( ii) Chemical substances with low environmental releases and human exposures.

( 2) To manufacture a new chemical substance under the terms of this exemption a manufacturer must: ( i) Submit a notice of intent to manufacture 30 days before manufacture begins, as required under paragraph ( e) of this section. ( ii) Comply with all other provisions of this section.

( 3) This section does not apply to microorganisms subject to part 725 of this chapter.

( b) Definitions. The following definitions apply to this subpart.

( 1) Act means the Toxic Substances Control Act ( 15 U. S. C. 2601 et seq).

( 2) Consumer means a private individual who uses a chemical substance or any product May 10, 2004 containing the chemical substance in or around a permanent or temporary household or residence, during recreation, or for any personal use or enjoyment.

( 3) Environment has the same meaning as in section 3 of the Act ( 15 U. S. C. 2602).

( 4) Environmental transformation product means any chemical substance resulting from the action of environmental processes on a parent compound that changes the molecular identity of the parent compound.

( 5) Metabolite means a chemical entity produced by one or more enzymatic or nonenzymatic reactions as a result of exposure of an organism to a chemical substance.

( 6) Serious acute effects means human disease processes or other adverse effects that have short latency periods for development, result from short term exposure, or are a combination of these factors and that are likely to result in death, severe or prolonged incapacitation, disfigurement, or severe or prolonged loss of the ability to use a normal bodily or intellectual function with a consequent impairment of normal activities.

( 7) Serious chronic effects means human disease processes or other adverse effects that have long latency periods for development, result from long term exposure, are long term illnesses, or are a combination of these factors and that are likely to result in death, severe or prolonged incapacitation, disfigurement, or severe or prolonged loss of the ability to use a normal bodily or intellectual function with a consequent impairment of normal activities.

( 8) Significant environmental effects means: ( i) Any irreversible damage to biological, commercial, or agricultural resources of importance to society; ( ii) Any reversible damage to biological, commercial, or agricultural resources of importance to society if the damage persists beyond a single generation of the damaged resource or beyond a single year; or ( iii) Any known or reasonably anticipated loss of members of an endangered or threatened species. Endangered or threatened species are those species identified as such by the Secretary of the Interior in accordance with the Endangered Species Act, as amended ( 16 U. S. C. 1531).

( 9) Site means a contiguous property unit. Property divided only by a public right of way is one site. There may be more than one manufacturing plant on a single site.

( 10) The terms byproduct, EPA, importer, impurity, known to or reasonably ascertainable, manufacture, manufacturer, new chemical substance, person, possession or control, and test data have the same meanings as in § 720.3 of this chapter.

( c) Exemption categories. Except as provided in paragraph ( d) of this section, this exemption applies to:

( 1) Any manufacturer of a new chemical substance manufactured in quantities of 10,000 kilograms or less per year under the terms of this exemption. May 10, 2004 ( 2) Any manufacturer of a new chemical substance satisfying all of the following low environmental release and low human exposure eligibility criteria: ( i) Consumers and the general population. For exposure of consumers and the general population to the new chemical substance during all manufacturing, processing, distribution in commerce, use, and disposal of the substance: ( A) No dermal exposure. ( B) No inhalation exposure ( except as described in paragraph ( c)( 2)( iv) of this section. ( C) Exposure in drinking water no greater than a 1 milligram per year ( estimated average dosage resulting from drinking water exposure in streams from the maximum allowable concentration level from ambient surface water releases established under paragraph ( c)( 2)( iii) of this section or a higher concentration authorized by EPA under paragraph ( c)( 2)( iii) of this section).

( ii) Workers. For exposure of workers to the new chemical substance during all manufacturing, processing, distribution in commerce, use and disposal of the substance: ( A) No dermal exposure ( this criterion is met if adequate dermal exposure controls are used in accordance with applicable EPA guidance). ( B) No inhalation exposure ( this criterion is considered to be met if adequate inhalation exposure controls are used in accordance with applicable EPA guidance).

( iii) Ambient surface water. For ambient surface water releases, no releases resulting in surface water concentrations above 1 part per billion, calculated using the methods prescribed in § § 721.90 and 721.91, unless EPA has approved a higher surface water concentration supported by relevant and scientifically valid data submitted to EPA in a notice under paragraph ( e) of this section on the substance or a close structural analogue of the substance which demonstrates that the new substance will not present an unreasonable risk of injury to aquatic species or human health at the higher concentration.

( iv) Incineration. For ambient air releases from incineration, no releases of the new chemical substance above 1 microgram per cubic meter maximum annual average concentration, calculated using the formula:

( kg/ day of release after treatment) multiplied by ( number of release days per year) multiplied by ( 9.68 × 10 6) micrograms per cubic meter.

( v) Land or groundwater. For releases to land or groundwater, no releases to groundwater, to land, or to a landfill unless the manufacturer has demonstrated to EPA's satisfaction in a notice under paragraph ( e) of this section that the new substance has negligible groundwater migration potential.

( d) Chemical substances that cannot be manufactured under this exemption. A new chemical substance cannot be manufactured under this section, notwithstanding satisfaction of the criterion of paragraphs ( c)( 1) or ( c)( 2) of this section, if EPA determines, in accordance with paragraph ( g) of this section, that the substance, any reasonably anticipated metabolites, environmental transformation products, or byproducts of the substance, or any reasonably anticipated impurities in the substance may cause, under anticipated conditions of manufacture, processing, distribution in commerce, use, or disposal of the new chemical substance: May 10, 2004 ( 1) Serious acute ( lethal or sublethal) effects.

( 2) Serious chronic ( including carcinogenic and teratogenic) effects.

( 3) Significant environmental effects.

( e) Exemption notice. ( 1) A manufacturer applying for an exemption under either paragraph ( c)( 1) or ( c)( 2) of this section must submit an exemption notice to the EPA at least 30 days before manufacture of the new chemical substance begins. The notice must be sent in writing to: TSCA Document Control Officer ( 7407), Office of Pollution Prevention and Toxics, U. S. Environmental Protection Agency, Room G 099, 1200 Pennsylvania Ave., NW., Washington, DC 20460. The date of submission will be the date on which the notice is received by the TSCA Document Control Officer. EPA will acknowledge the receipt of the notice by letter. The letter will identify the date on which the review period begins. The notice shall be submitted using EPA Form No. 7710 25 (" the PMN form"), which may be obtained from EPA by writing the Environmental Assistance Division, ( 7408), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460, or by calling the TSCA Assistance Information Service at ( 202) 554 1404; TDD ( 202) 554 0551; online service modem ( 202) 554 5603.

( 2) The notice shall contain the information described below, pursuant to the referenced provisions of § 720.45. ( i) Manufacturer identity. ( ii) Chemical identity ( § 720.45( a)). ( iii) Impurities ( § 720.45( b)). ( iv) Known synonyms or trade names ( § 720.45( c)). ( v) Byproducts ( § 720.45( d)). ( vi) Production volume ( § 720.45( e)). ( A) Manufacturers submitting an exemption application under paragraph ( c)( 1) of this section will be assumed to be manufacturing at an annual production volume of 10,000 kilograms. Manufacturers who intend to manufacture an exempted substance at annual volumes of less than 10,000 kilograms and wish EPA to conduct its risk assessment based upon such lesser annual production level rather than a 10,000 kilograms level, may so specify by writing the lesser annual production volume in the appropriate box on the PMN form and marking the adjacent binding option box. Manufacturers who opt to specify annual production levels below 10,000 kilograms and who mark the production volume binding option box shall not manufacture more than the specific annual amount of the exempted substance unless a new exemption notice for a higher ( up to 10,000 kgs) manufacturing volume is submitted and approved pursuant to this section.

( B) Manufacturers submitting an exemption under paragraph ( c)( 2) of this section shall list the estimated maximum amount to be manufactured during the first year of production and the estimated maximum amount to be manufactured during any 12 month period during the first 3 years of production. ( vii) Description of intended categories of use ( § 720.45( f)). ( viii) For manufacturer controlled sites, the manufacturer shall supply identity of manufacturing sites, process descriptions, and worker exposure and environmental release information ( § 720.45( g)); for sites not controlled by the manufacturer, processing and use operation descriptions, estimated number of processing and use sites, and worker exposure/ environmental May 10, 2004 release information ( § 720.45( h)). A manufacturer applying for an exemption under paragraph ( c)( 1) of this section need not provide information on worker exposure and environmental release referenced in paragraphs ( e)( 2)( viii) of this section if such information is not known or not readily available to the manufacturer. To assist in reporting this information, manufacturers may obtain a copy of EPA's Guidance for Reporting Occupational Exposure and Environmental Release Information under 40 CFR 723.50, available from the Environmental Assistance Division at the address listed in paragraph ( e)( 1) of this section. Where worker exposure and environmental release information is not supplied by the manufacturer, EPA will generally apply " bounding estimates" ( i. e., exposure estimates higher than those incurred by persons in the population with the highest exposure) to account for uncertainties in actual exposure and release scenarios. ( ix) Type and category of notice. The manufacturer must clearly indicate on the first page of the PMN form that the submission is a " TSCA section 5( h)( 4) exemption notice," and must indicate whether the notice is being submitted under paragraph ( c)( 1) or ( c)( 2) of this section. Manufacturers of chemical substances that qualify for an exemption under both paragraph ( c)( 1) and ( c)( 2) of this section may apply for either exemption, but not both. ( x) Test data ( § 720.50). ( xi) Certification. In addition to the certifications required in EPA form 7710 25, the following certifications shall be included in notices under this section. The manufacturer must certify that:

( A) The manufacturer intends to manufacture or import the new chemical substance for commercial purposes, other than in small quantities solely for research and development, under the terms of this section. ( B) The manufacturer is familiar with the terms of this section and will comply with those terms. ( C) The new chemical substance for which the notice is submitted meets all applicable exemption conditions. ( D) For substances manufactured under paragraph ( c)( 1) of this section, the manufacturer intends to commence manufacture of the exempted substance for commercial purposes within 1 year of the date of the expiration of the 30 day review period.

( xii) Sanitized copy of notice.

( A) The manufacturer must make all claims of confidentiality in accordance with paragraph ( l) of this section. If any information is claimed confidential, the manufacturer must submit a second copy of the notice, with all information claimed as confidential deleted, in accordance with paragraph ( l)( 3) of this section. ( B) If the manufacturer does not provide the second copy, the submission will be considered incomplete.

( 3) Incomplete notices. If EPA receives a submission which does not include all of the information required under this paragraph ( e) of this section, the submission will be determined to be incomplete by EPA. When a submission for a new chemical substance has been determined to be incomplete, a manufacturer reapplying for an exemption for the new chemical substance must submit a new exemption notice containing all the information required under this paragraph ( e) of this section including a certification page containing an original dated signature; partial submissions sent to EPA to supplement notices declared incomplete will not be accepted. Photocopied pages from previously submitted exemption forms will be accepted provided that the May 10, 2004 certifications page contains an original dated signature.

( f) Multiple exemption holders. ( 1) A manufacturer who intends to manufacture a substance for which an exemption under this section was previously approved may apply for an exemption under paragraph ( c)( 1) or ( c)( 2) of this section; however, EPA will not approve any subsequent exemption application under paragraph ( c)( 1) of this section unless it can determine that the potential human exposure to, and environmental release of, the new chemical substance at the higher aggregate production volume will not present an unreasonable risk of injury to human health or the environment.

( 2)( i) If EPA proposes to deny an exemption application for a substance for which another manufacturer currently holds an exemption, and that proposed denial is based exclusively on the cumulative human exposure or environmental release of the substance which precludes the EPA from determining that the subsequent applicant's activities will not present an unreasonable risk of injury to human health or the environment, the EPA will notify the first exemption holder that it must, within 21 days of its receipt of EPA's notice, either:

( A) Provide a new certification that it has commenced, or that it will commence, manufacture of the new chemical substance under this section within 1 year of the expiration of its exemption review period; or ( B) Withdraw its exemption for the new chemical substance.

( ii) If the first exemption holder does not respond to the EPA's notice under paragraph ( f)( 2)( i) of this section within the prescribed time period, EPA shall issue a notice of ineligibility to the first exemption holder under the provisions of paragraph ( h)( 2) of this section.

( g) Review period. ( 1) EPA will review the notice submitted under paragraph ( e) of this section to determine whether manufacture of the new chemical substance is eligible for the exemption. The review period will end 30 days after receipt of the notice by the TSCA Document Control Officer. To provide additional time to address any unresolved issues concerning an exemption application, the exemption applicant may, at any time during the review period, request a suspension of the review period pursuant to the provisions of § 720.75( b) of this chapter.

( 2) Upon expiration of the 30 day review period, if EPA has taken no action, the manufacturer may consider its exemption approved and begin to manufacture the new chemical substance under the terms described in its notice and in this section.

( h) Notice of ineligibility  ( 1) During the review period. If the EPA determines during the review period that manufacture of the new chemical substance does not meet the terms of this section or that there are issues concerning toxicity or exposure that require further review which cannot be accomplished within the 30 day review period, EPA will notify the manufacturer by telephone that the substance is not eligible. This telephone notification will subsequently be confirmed by certified letter that identifies the reasons for the ineligibility determination. The manufacturer may not begin manufacture of the new chemical substance without complying with section 5( a)( 1) of the Act or submitting a new notice under paragraph ( e) of this section that satisfies EPA's concerns. May 10, 2004 ( 2) After the review period. ( i)( A) If at any time after the review period specified in paragraph ( g) of this section the Assistant Administrator for the Office of Prevention, Pesticides, and Toxic Substances (" the Assistant Administrator") makes a preliminary determination that manufacture of the new chemical substance does not meet the terms of this section, the Assistant Administrator will notify the manufacturer by certified letter that EPA believes that the new chemical substance does not meet the terms of the section.

( B) The manufacturer may continue to manufacture, process, distribute in commerce, and use the substance after receiving the notice under paragraph ( h)( 2)( i)( A) of this section if the manufacturer was manufacturing, processing, distributing in commerce, or using the substance at the time of the notification and if the manufacturer submits objections or an explanation under paragraph ( h)( 2)( ii) of this section. Manufacturers not manufacturing, processing, distributing in commerce, or using the substance at the time of the notification may not begin manufacture until EPA makes its final determination under paragraph ( h)( 2)( iii) of this section.

( ii) A manufacturer who has received notice under paragraph ( h)( 2)( i)( A) of this section may submit, within 15 days of receipt of written notification, detailed objections to the determination or an explanation of its diligence and good faith efforts in attempting to comply with the terms of this section.

( iii) The Assistant Administrator will consider any objections or explanation submitted under paragraph ( h)( 2)( ii) of this section and will make a final determination. The Assistant Administrator will notify the manufacturer of the final determination by telephone within 15 days of receipt of the objections or explanation, and subsequently by certified letter.

( iv) If the Assistant Administrator determines that manufacture of the new chemical substance meets the terms of this section, the manufacturer may continue or resume manufacture, processing, distribution in commerce, and use in accordance with the terms of this section.

( v) If the Assistant Administrator determines that manufacture of the new chemical substance does not meet the terms of this section and that the manufacturer did not act with due diligence and in good faith to meet the terms of this section, the manufacturer must cease any continuing manufacture, processing, distribution in commerce, and use of the new chemical substance within 7 days of the written notification under paragraph ( h)( 2)( iii) of this section. The manufacturer may not resume manufacture, processing, distribution in commerce, and use of the new chemical substance until it submits a notice under section 5( a)( 1) of the Act and part 720 of this chapter and the notice review period has ended.

( vi) If the Assistant Administrator determines that manufacture of the new chemical substance does not meet the terms of this section and that the manufacturer acted with due diligence and in good faith to meet the terms of this section, the manufacturer may continue manufacture, processing, distribution in commerce, and use of the new chemical substance if:

( A) It was actually manufacturing, processing, distributing in commerce, or using the chemical substance at the time it received the notification specified in paragraph ( h)( 2)( i)( A) of this section.

( B) It submits a notice on the new chemical substance under section 5( a)( 1) of the Act and part May 10, 2004 720 of this chapter within 15 days of receipt of the written notification under paragraph ( h)( 2)( iii) of this section. Such manufacture, processing, distribution in commerce, and use may continue unless EPA takes action under section 5( e) or 5( f) of the Act.

( 3) Action under this paragraph does not preclude action under sections 7, 15, 16, or 17 of the Act.

( i) Additional information. If the manufacturer of a new chemical substance under the terms of this exemption obtains test data or other information indicating that the new chemical substance may not qualify under terms of this section, the manufacturer must submit these data or information to EPA within 15 working days of receipt of the information. If, during the notice review period specified in paragraph ( g) of this section, the submitter obtains possession, control, or knowledge of new information that materially adds to, changes, or otherwise makes significantly more complete the information included in the notice, the submitter must send that information to the address listed on the notice form within 10 days of receiving the new information, but no later than 5 days before the end of the notice review period. The new submission must clearly identify the submitter and the exemption notice to which the new information is related. If the new information becomes available during the last 5 days of the notice review period, the submitter must immediately inform its EPA contact for that notice by telephone.

( j) Changes in manufacturing site, use, human exposure and environmental release controls, and certain manufacturing volumes. ( 1) Except as provided in paragraph ( j)( 6) of this section, chemical substances manufactured under this section must be manufactured at the site or sites described, for the uses described, and under the human exposure and environmental release controls described in the exemption notice under paragraph ( e) of this section.

( 2) Where the manufacturer lists a specific physical form in which the new chemical substance will be manufactured, processed, and/ or used, the manufacturer must continue manufacturing, processing, and/ or using the new chemical substance in either the same physical form described in the notice under paragraph ( e), or in a physical form which will not increase the human exposure to or environmental release of the new chemical substance over those exposures or releases resulting from the specified physical form ( e. g., a manufacturer which specifies that the new chemical substance will be produced in a non volatile liquid form generally may not change to a respirable powder form).

( 3) The annual production volume of chemical substances manufactured under paragraph ( c)( 1) of this section for which the manufacturer designated a binding annual production volume pursuant to paragraph ( e)( 2)( vi) of this section must not exceed that designated volume.

( 4) Any person who manufactures a new chemical substance under paragraph ( c)( 1) or ( c)( 2) of this section must comply with the provisions of this section, including submission of a new notice under paragraph ( e) of this section, before:

( i) Manufacturing the new chemical substance at a site that was not approved in a previous exemption notice for the substance, except as provided in paragraph ( j)( 6) of this section. ( ii) Manufacturing the new chemical substance for a use that was not approved in a previous May 10, 2004 exemption notice for the substance. ( iii) Manufacturing the new chemical substance without employing the human exposure and environmental release controls approved in a previous exemption notice for the substance. ( iv) Manufacturing the new chemical substance in a physical form different than that physical form approved in a previous exemption notice for the substance and which form may increase the human exposure to, or environmental release of, the new chemical substance over those exposures or releases resulting from the physical form approved in the previous notice. ( v) Manufacturing the chemical substance in annual production volumes above any volume designated by the manufacturer as binding under paragraph ( e)( 2)( vi) of this section in a previous exemption notice for the substance.

( 5) In an exemption notice informing EPA of a change in site, use, or worker protection, or environmental release controls, the manufacturer is not required to provide all of the same information submitted to EPA in a previous exemption notice for that chemical substance. The new exemption notice, however, must indicate the identity of the new chemical substance; the manufacturer's name; the name and telephone number of a technical contact; and location of the new site, new worker protection or environmental release controls, and new use information. The notice must also include the EPA designated exemption number assigned to the previous notice and a new certification by the manufacturer, as described in paragraph ( e)( 2)( xi) of this section.

( 6)( i) A manufacturer may, without submitting a new notice, manufacture the new chemical substance at a site not listed in its exemption application under the following conditions:

( A) the magnitude, frequency, and duration of exposure of individual workers to the new chemical substance at the new manufacturing site is equal to, or less than, the magnitude, frequency, and duration of exposure of the individual workers to the new chemical substance at the manufacturing site for which the EPA performed its original risk assessment pursuant to the original exemption notice; and ( B) Either ( 1) at the new manufacturing site, the manufacturer does not release to surface waters any of the new chemical substance, or any waste streams containing the new chemical substance; or ( 2) at the new manufacturing site, the manufacturer maintains surface water concentrations of the chemical substance, resulting from direct or indirect discharges from the manufacturing site, at or below 1 part per billion, or at or below an alternative concentration level approved by the Agency in writing or under the procedures described in paragraph ( c)( 2)( iii) of this section, using the water concentration calculation method described at § § 721.90 and 721.91.

( ii) The manufacturer shall notify EPA of any new manufacturing site no later than 30 days after the commencement of manufacture of the new chemical substance under the exemption at the new manufacturing site as follows:

( A) The notification must contain the EPA designated exemption number to which the notification applies, manufacturer identity, the street address of the new manufacturing site, the date on which manufacture commenced at the new site, the name and telephone number of a technical contact at the new site, any claim of confidentiality, and a statement that the notification is an amendment to the original exemption application under the terms of this section. May 10, 2004 ( B) The notification may be submitted on EPA form 7710 56 " Notice of Commencement of Manufacture;" however, the manufacturer must add the statement required under paragraph ( j)( 6)( ii)( A) of this section that the notification is an amendment to the original exemption.

( C) The notification must contain an original signature of an authorized official of the manufacturer.

( k) Customer notification. ( 1) Manufacturers of new chemical substances described in paragraphs ( c)( 1) and ( c)( 2) of this section must notify processors and industrial users that the substance can be used only for the uses specified in the exemption notice at paragraph ( e) of this section. The manufacturer must also inform processors and industrial users of any controls specified in the exemption notice. The manufacturer may notify processors and industrial users by means of a container labeling system, written notification, or any other method that adequately informs them of use restrictions or controls.

( 2) A manufacturer of a new chemical substance described in paragraph ( c)( 2) of this section may distribute the chemical substance only to other persons who agree in writing to not further distribute the substance until it has been reacted, incorporated into an article, or otherwise rendered into a physical form or state in which environmental releases and human exposures above the eligibility criteria in paragraph ( c)( 2) of this section are not likely to occur.

( 3) If the manufacturer learns that a direct or indirect customer is processing or using the new substance in violation of use restrictions or without imposing prescribed worker protection or environmental release controls, the manufacturer must cease distribution of the substance to the customer or the customer's supplier immediately unless the manufacturer is able to document each of the following:

( i) That the manufacturer has, within 5 working days, notified the customer in writing that the customer has failed to comply with the conditions specified in this section and the exemption notice under paragraph ( e) of this section. ( ii) That, within 15 working days of notifying the customer of the noncompliance, the manufacturer received from the customer, in writing, a statement of assurance that the customer is aware of the terms of this section and the exemption notice and will comply with those terms.

( 4) If, after receiving a statement of assurance from a customer under paragraph ( k)( 3)( ii) of this section, the manufacturer obtains knowledge that the customer has again failed to comply with any of the conditions specified in this section or the exemption notice, the manufacturer shall cease supplying the new chemical substance to that customer and shall report the failure to comply to EPA within 15 days of obtaining this knowledge. Within 30 days of its receipt of the report, EPA will notify the manufacturer whether, and under what conditions, distribution of the chemical substance to the customer may resume.

( l) Confidentiality. ( 1) If the manufacturer submits information to EPA under this section which the manufacturer claims to be confidential business information, the manufacturer must clearly identify the information at the time of submission to EPA by bracketing, circling, or underlining it and stamping it with " CONFIDENTIAL" or some other appropriate designation. Any information so identified will be treated in accordance with the procedures in part 2 of this chapter. Any May 10, 2004 information not claimed confidential at the time of submission may be made available to the public without further notice.

( 2)( i) Any person who asserts a claim of confidentiality for chemical identity under this paragraph ( l) must provide a generic chemical name that is only as generic as necessary to protect the confidential chemical identity of the particular chemical substance. The name should reveal the specific chemical identity to the maximum extent possible.

( ii) The generic name provided by the manufacturer will be subject to EPA review and approval in accordance with the procedures specified in § 720.85( b)( 6) of this chapter. The generic name provided by the submitter or an alternative selected by EPA under these procedures will be placed on a public list of substances exempt under this section.

( 3) If any information is claimed confidential, the manufacturer must submit a second copy of the notice with all information claimed as confidential deleted. EPA will place the second copy in the public file.

( m) Exemptions granted under superseded regulations. Manufacturers holding exemptions granted under the superseded requirements of this section ( as in effect on May 26, 1995) shall either continue to comply with those requirements ( including the production volume limit) or apply for a new exemption pursuant to this section. EPA will not accept requests to amend exemptions granted under the superseded requirements; manufacturers wishing to amend such exemptions must submit a new exemption under paragraph ( e) of this section. If a new exemption for a new chemical substance is granted under this exemption to the manufacturer holding an exemption under the superseded requirements, the exemption under the superseded requirements for such substance shall be void.

( n) Recordkeeping. ( 1) A manufacturer of a new chemical substance under paragraph ( c) of this section must maintain the records described in this paragraph at the manufacturing site or site of importation for a period of 5 years after their preparation.

( 2) The records must include the following to demonstrate compliance with this section:

( i) Records of annual production volume and import volume. ( ii) Records documenting compliance with the applicable requirements and restrictions of paragraphs ( c), ( e), ( f), ( h), ( i), ( j), and ( k) of this section.

( 3) Any person who manufactures a new chemical substance under the terms of this section must, upon request of a duly designated representative of EPA, permit such person at all reasonable times to have access to and to copy records kept under paragraph ( n)( 2) of this section.

( 4) The manufacturer must submit the records listed in paragraph ( n)( 2) of this section to EPA upon request. Manufacturers must provide these records within 15 working days of receipt of such request.

( o) Compliance. ( 1) Failure to comply with any provision of this section is a violation of section 15 of the Act ( 15 U. S. C. 2614). May 10, 2004 ( 2) Submitting materially misleading or false information in connection with the requirements of any provision of this section is a violation of this section and therefore a violation of section 15 of the Act ( 15 U. S. C. 2614).

( 3) Violators may be subject to the civil and criminal penalties in section 16 of the Act ( 15 U. S. C. 2615) for each violation.

( 4) EPA may seek to enjoin the manufacture or processing of a chemical substance in violation of this section, or act to seize any chemical substance manufactured or processed in violation of this section, or take other action under the authority of section 7 of the Act ( 15 U. S. C. 2606) or section 17 of the Act ( 15 U. S. C. 1616).

[ 60 FR 16346, Mar. 29, 1995, as amended at 60 FR 34465, July 3, 1995; 62 FR 17932, April 11, 1997; 64 FR 31989, June 15, 1999]

§ 723.175 Chemical substances used in or for the manufacture or processing of instant photographic and peel apart film articles.

( a) Purpose and scope. ( 1) This section grants an exemption from the premanufacture notice requirements of section 5( a)( 1)( A) of the Toxic Substances Control Act ( 15 U. S. C. 2604( a)( 1)( A)) for the manufacture and processing of new chemical substances used in or for the manufacture or processing of instant photographic and peel apart film articles. This section does not apply to microorganisms subject to part 725 of this chapter.

( 2) To manufacture a new chemical substance under the terms of this exemption, a manufacturer of instant photographic or peel apart film articles must:

( i) Submit an exemption notice when manufacture begins under paragraph ( i) of this section. ( ii) Comply with certain requirements to limit exposure to the new chemical substance under paragraphs ( e), ( f), ( g), and ( h) of this section. ( iii) Comply with all recordkeeping requirements under paragraph ( j) of this section.

( b) Definitions. ( 1) Act means the Toxic Substances Control Act ( 15 U. S. C. 2601 et seq.).

( 2) An article is a manufactured item ( i) which is formed to a specific shape or design during manufacture, ( ii) which has end use function( s) dependent in whole or in part upon its shape or design during end use, and ( iii) which has either no change of chemical composition during its end use or only those changes of composition which have no commercial purpose separate from that of the article and that may occur as described in § 710.2 of this chapter except that fluids and particles are not considered articles regardless of shape or design.

( 3) The terms byproduct, EPA, impurities, person, and site have the same meanings as in § 710.3 of this chapter.

( 4) The term category of chemical substances has the same meaning as in section 26( c)( 2) of the Act ( 15 U. S. C. 2625). May 10, 2004 ( 5) The terms chemical substance, distribute in commerce, distribution in commerce, environment, manufacture, new chemical substance, and process have the same meanings as in section 3 of the Act ( 15 U. S. C. 2602).

( 6) Director of the Office of Pollution Prevention and Toxics means the Director of the EPA Office of Pollution Prevention and Toxics or any EPA employee designated by the Office Director to carry out the Office Director's functions under this section.

( 7) The term exemption category means a category of chemical substances for which a person( s) has applied for or been granted an exemption under section 5( h)( 4) of the Act ( 15 U. S. C. 2604).

( 8) The term instant photographic film article means a self developing photographic film article designed so that all the chemical substances contained in the article, including the chemical substances required to process the film, remain sealed during distribution and use.

( 9) Intermediate means any chemical substance which is consumed in whole or in part in a chemical reaction( s) used for the intentional manufacture of another chemical substance.

( 10) Known to or reasonably ascertainable means all information in a person's possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know, our could obtain without unreasonable burden or cost.

( 11) The term peel apart film article means a self developing photographic film article consisting of a positive image receiving sheet, a light sensitive negative sheet, and a sealed reagent pod containing a developer reagent and designed so that all the chemical substances required to develop or process the film will not remain sealed within the article during and after the development of the film.

( 12) Photographic article means any article which will become a component of an instant photographic or peel apart film article.

( 13) Special production area means a demarcated area within which all manufacturing, processing, and use of a new chemical substance takes place, except as provided in paragraph ( f) of this section, in accordance with the requirements of paragraph ( e) of this section.

( 14) Test data means:

( i) Data from a formal or informal study, test, experiment, recorded observation, monitoring, or measurement. ( ii) Information concerning the objectives, experimental methods and materials, protocols, results, data analyses ( including risk assessments), and conclusions from a study, test, experiment, recorded observation, monitoring, or measurement.

( 15) Used in or for the manufacturing or processing of an instant photographic or peel apart film article, when used to describe activities involving a new chemical substance, means the new chemical substance ( i) is included in the article, or ( ii) is an intermediate to a chemical substance included in the article or is one of a series of intermediates used to manufacture a chemical May 10, 2004 substance included in the article.

( 16) Wet mixture means a water or organic solvent based suspension, solution, dispersion, or emulsion used in the manufacture of an instant photographic or peel apart film article.

( c) Exemption category. The exemption category includes new chemical substances used in or for the manufacture or processing of instant photographic or peel apart film articles which are manufactured and processed under the terms of this section.

( d) Applicability. This exemption applies only to manufacturers of instant photographic or peel apart film articles who:

( 1) Manufacture the new chemical substances used in or for the manufacture or processing of the instant photographic or peel apart film articles.

( 2) Limit manufacture and processing of a new chemical substance to the site( s) listed in the exemption notice for that new chemical substance submitted under paragraph ( i) of this section.

( 3) Comply with the requirements of paragraphs ( e), ( f), ( g), ( h), and ( j) of this section.

( 4) Do not distribute in commerce or use a peel apart film article containing a new chemical substance until submission of a premanufacture notice under section 5( a)( 1)( A) of the Act ( 15 U. S. C. 2604) and until the review period for the notice has ended without EPA action to prevent distribution or use.

( e) Conditions of manufacture and processing in the special production area. All manufacturing, processing, and use operations involving the new chemical substance must be performed in a special production area under the conditions set forth in this paragraph until the new chemical substance has been incorporated into a wet mixture, photographic article, or instant photographic or peel apart film article.

( 1) Exposure limits. In the special production area, the ambient air concentration of the new chemical substance during manufacture, processing, and use cannot exceed an 8 hour time weighted average ( TWA) of 10 ppm for gases and vapors and 50 & mu; g/ m 3 for particulates, with an allowable TWA excursion of 50 percent above those concentrations for a duration of 30 minutes or less.

( 2) Respiratory protection  ( i) Respirator requirement. Except as specified in paragraph ( e)( 2)( ii) of this section, each person in the special production area must wear an appropriate respiratory protection device to protect against dusts, fumes, vapors, and other airborne contaminants, as described in 29 CFR 1910.134. Selection of an appropriate respirator must be made according to the guidance of American National Standard Practices for Respiratory Protection Z88.2 1969 and the NIOSH Certified Equipment List, U. S. Department of Health and Human Services, NIOSH publication No. 80 144.

( ii) Waiver of respirator requirement. Employees are not required to wear respirators if monitoring information collected and analyzed in accordance with paragraph ( e)( 3) of this section May 10, 2004 demonstrates that the ambient 8 hour TWA concentration of the new chemical substance in the area is less than 1 ppm for gases and vapors and 5 & mu; g/ m 3 for particulates with an allowable TWA excursion of 50 percent above these concentrations for a duration of 30 minutes or less.

( iii) Quantitative fit test. Each respirator must be issued to a specific individual for personal use. A quantitative fit test must be performed for each respirator before its first use by that person in a special production area.

( 3) Monitoring  ( i) When to monitor. ( A) When suitable sampling and analytic methods exist, periodic monitoring in accordance with this paragraph must be done to ensure compliance with the exposure limits of paragraphs ( e)( 1) and ( 2)( ii) of this section.

( B) When suitable sampling and analytic methods do not exist, compliance with the exposure limits of paragraph ( e)( 1) and the requirements of paragraph ( e)( 10) of this section must be determined by an evaluation of monitoring data developed for a surrogate chemical substance possessing comparable physical chemical properties under similar manufacturing and processing conditions.

( ii) Monitoring methods. A suitable air sampling method must permit personal or fixed location sampling by conventional collection methods. A suitable analytic method must have adequate sensitivity for the volume of sample available and be specific for the new chemical substance being monitored. If chemical specific monitoring methods are not available, nonspecific methods may be used if the concentration of the new chemical substance is assumed to be the total concentration of chemical substances monitored.

( iii) Monitoring frequency. ( A) When suitable air sampling and analytical procedures are available, monitoring must be done in each special production area during the first three 8 hour work shifts involving the manufacture or processing of each new chemical substance. Thereafter, monitoring must be done in each special production area for at least one 8 hour period per month, during a production run in which the new chemical substance is manufactured or processed. Samples must be of such frequency and pattern as to represent with reasonable accuracy the mean level and maximum 30 minute level of employee exposure during an 8 hour work shift. In monitoring for an 8 hour work shift or the equivalent, samples must be collected periodically or continuously for the duration of the 8 hour work shift. Samples must be taken during a period which is likely to represent the maximum employee exposure.

( B) If the manufacturer demonstrates compliance with the exposure limits for 3 consecutive months, further monitoring of the identical process must be performed only every 6 months thereafter, unless there is a significant change in the process, process design, or equipment. If there is such a change, the manufacturer must begin monitoring again according to the schedule in paragraph ( e)( 3)( iii)( A) of this section.

( iv) Location of monitoring. Air samples must be taken so as to ensure that the samples adequately represent the ambient air concentration of a new chemical substance present in each worker's breathing zone. May 10, 2004 ( 4) Engineering controls and exposure safeguards. Engineering controls such as, but not limited to, isolation, enclosure, local exhaust ventilation, and dust collection must be used to ensure compliance with the exposure limits prescribed in paragraphs ( e)( 1) or ( e)( 2)( ii) of this section.

( 5) Training, hygiene, and work practices  ( i) Training. No employee may enter a special production area before the completion of a training program. The training program must be adapted to the individual circumstances of the manufacturer and must address: The known physical chemical and toxicological properties of the chemical substances handled in the area; procedures for using and maintaining respirators and other personal safeguards; applicable principles of hygiene; special handling procedures designed to limit personal exposure to, and inadvertent release of, chemical substances; and procedures for responding to emergencies or spills.

( ii) Hygiene. Appropriate standards of hygiene must be observed by all employees handling a new chemical substance in manufacturing, processing, or transfer operations. The manufacturer must provide appropriate facilities for employee changing and wash up. Food, beverages, tobacco products, and cosmetics must not be allowed in special production areas.

( iii) Work practices. Operating procedures such as those related to chemical weighing and filtering, or the charging, discharging and clean up of process equipment, must be designed and conducted to ensure compliance with the exposure limits prescribed in paragraph ( e)( 1) or ( e)( 2)( ii) of this section. Written procedures and all materials necessary for responding to emergency situations must be immediately accessible to all employees in a special production area. Any spill or unanticipated emission must be controlled by specially trained personnel using the equipment and protective clothing described in paragraph ( e)( 6) of this section.

( 6) Personal protection devices. All workers engaged in the manufacture and processing of a new chemical substance in the special production area must wear suitable protective clothing or equipment, such as chemical resistant coveralls, protective eyewear, and gloves.

( 7) Caution signs. Each special production area must be clearly posted with signs identifying the area as a special production area where new chemical substances are manufactured and processed under controlled conditions. Each sign must clearly restrict entry into the special production area to qualified personnel who are properly trained and equipped with appropriate personal exposure safeguards.

( 8) Removal for storage or transportation. A new chemical substance that is not incorporated into a wet mixture, photographic article, or instant photographic or peel apart film article may be removed from the special production area for purposes of storage between operational steps or for purposes of transportation to another special production area. Such storage or transportation must be conducted in a manner that limits worker and environmental exposure through the use of engineering controls, training, hygiene, work practices, and personal protective devices appropriate to the chemical substance in question.

( 9) Labeling. ( i) Any new chemical substance removed from a special production area or stored or transported between operational steps must be clearly labeled. The label must show the identity of the new chemical substance or an appropriate identification code, a statement of any known May 10, 2004 hazards associated with it, a list of special handling instructions, first aid information, spill control directions, and where applicable, the appropriate U. S. Department of Transportation notations.

( ii) No label is required if the new chemical substance has been incorporated into a photographic article, or if it is contained in a sealed reaction vessel or pipeline, or if it has been incorporated into an instant photographic or peel apart film article.

( 10) Areas immediately adjacent to the special production area. The ambient air concentration of the new chemical substance in areas immediately adjacent to the special production area must not exceed the exposure limit established in paragraph ( e)( 2)( ii) of this section for waiver of respirator protection within the special production area. Periodic monitoring in accordance with paragraph ( e)( 3) of this section must be performed in immediately adjacent areas where it is reasonable to expect a risk of inhalation exposure.

( f) Conditions of processing outside the special production area. A wet mixture may be incorporated into a photographic article or an instant photographic or peel apart film article outside the special production area under the conditions listed in this paragraph:

( 1) Engineering controls and exposure safeguards. Engineering controls must limit the exposure to a new chemical substance contained in a wet mixture.

( 2) Training, hygiene and work practices  ( i) Training. Training of employees involved in the handling of wet mixtures containing a new chemical substance must be adapted to the individual circumstances of the employees' activities and must address: Procedures for using personal exposure safeguards, applicable principles of hygiene, handling procedures designed to limit personal exposure, and procedures for responding to emergencies and spills.

( ii) Hygiene. Appropriate standards of hygiene that limit exposure must be observed by all employees handling wet mixtures that contain new chemical substances.