cfr_sections
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23 rows where part_number = 702 and title_number = 40 sorted by section_id
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| section_id ▼ | title_number | title_name | chapter | subchapter | part_number | part_name | subpart | subpart_name | section_number | section_heading | agency | authority | source_citation | amendment_citations | full_text |
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| 40:40:33.0.1.1.2.1.1.1 | 40 | Protection of Environment | I | R | 702 | PART 702—GENERAL PRACTICES AND PROCEDURES | A | Subpart A—Procedures for Prioritization of Chemical Substances for Risk Evaluation | § 702.1 General provisions. | EPA | (a) Purpose. This regulation establishes the risk-based screening process for designating chemical substances as a High-Priority Substance or a Low-Priority Substance for risk evaluation as required under section 6(b) of the Toxic Substances Control Act, as amended (15 U.S.C. 2605(b)). (b) Scope of designations. EPA will make priority designations pursuant to these procedures for a chemical substance, not for a specific condition or conditions of uses of a chemical substance. (c) Categories of chemical substances. Nothing in this subpart shall be interpreted as a limitation on EPA's authority under 15 U.S.C. 2625(c) to take action, including the actions contemplated in this subpart, on a category of chemical substances. (d) Prioritization timeframe. The Agency will publish a final priority designation for a chemical substance in no fewer than 9 months and no longer than 1 year following initiation of prioritization pursuant to § 702.7. (e) Metals or metal compounds. EPA will identify priorities for chemical substances that are metals or metal compounds in accordance with 15 U.S.C. 2605(b)(2)(E). (f) Applicability. These regulations do not apply to any chemical substance for which a manufacturer requests a risk evaluation under 15 U.S.C. 2605(b)(4)(C). (g) Scientific standards and weight of the scientific evidence. EPA's proposed priority designations under § 702.9 and final priority designations under § 702.11 will be consistent with the scientific standards provision in 15 U.S.C. 2625(h) and the weight of the scientific evidence provision in 15 U.S.C. 2625(i). (h) Interagency collaboration. EPA will consult with other relevant Federal Agencies during the administration of this subpart. | ||||
| 40:40:33.0.1.1.2.1.1.10 | 40 | Protection of Environment | I | R | 702 | PART 702—GENERAL PRACTICES AND PROCEDURES | A | Subpart A—Procedures for Prioritization of Chemical Substances for Risk Evaluation | § 702.17 Effect of designation as a high-priority substance. | EPA | Final designation of a chemical substance as a High-Priority Substance under § 702.11 initiates a risk evaluation pursuant to subpart B of this part. Designation as a High-Priority Substance is not a final agency action and is not subject to judicial review until the date of promulgation of the associated final rule under section 6(a). Designation as a High-Priority Substance is not a finding that the chemical substance presents an unreasonable risk. | ||||
| 40:40:33.0.1.1.2.1.1.2 | 40 | Protection of Environment | I | R | 702 | PART 702—GENERAL PRACTICES AND PROCEDURES | A | Subpart A—Procedures for Prioritization of Chemical Substances for Risk Evaluation | § 702.3 Definitions. | EPA | For purposes of this subpart, the following definitions apply: Act means the Toxic Substances Control Act, as amended (15 U.S.C. 2601 et seq. ). Conditions of use means the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of. EPA means the U.S. Environmental Protection Agency. High-priority substance means a chemical substance that EPA determines, without consideration of costs or other non-risk factors, may present an unreasonable risk of injury to health or the environment because of a potential hazard and a potential route of exposure under the conditions of use, including an unreasonable risk to potentially exposed or susceptible subpopulations identified as relevant by EPA. Low-priority substance means a chemical substance that EPA concludes, based on information sufficient to establish, without consideration of costs or other non-risk factors, does not meet the standard for a High-Priority Substance. Potentially exposed or susceptible subpopulation means a group of individuals within the general population identified by the Administrator who, due to either greater susceptibility or greater exposure, may be at greater risk than the general population of adverse health effects from exposure to a chemical substance or mixture, such as infants, children, pregnant women, workers, or the elderly. Reasonably available information means information that EPA possesses or can reasonably generate, obtain and synthesize for use, considering the deadlines specified in 15 U.S.C. 2605(b) for prioritization and risk evaluation. Information that meets such terms is reasonably available information whether or not the information is confidential business information that is protected from public disclosure under 15 U.S.C. 2613. | ||||
| 40:40:33.0.1.1.2.1.1.3 | 40 | Protection of Environment | I | R | 702 | PART 702—GENERAL PRACTICES AND PROCEDURES | A | Subpart A—Procedures for Prioritization of Chemical Substances for Risk Evaluation | § 702.4 [Reserved] | EPA | |||||
| 40:40:33.0.1.1.2.1.1.4 | 40 | Protection of Environment | I | R | 702 | PART 702—GENERAL PRACTICES AND PROCEDURES | A | Subpart A—Procedures for Prioritization of Chemical Substances for Risk Evaluation | § 702.5 Candidate selection. | EPA | (a) General objective. In selecting candidates for a High-Priority Substance designation, it is EPA's general objective to select those chemical substances with the greatest hazard and exposure potential first, considering reasonably available information on the relative hazard and exposure of potential candidates. In selecting candidates for Low-Priority Substance designation, it is EPA's general objective to select those chemical substances with hazard and/or exposure characteristics under the conditions of use such that a risk evaluation is not warranted at the time to determine whether the chemical substance presents an unreasonable risk of injury to health or the environment, including an unreasonable risk to potentially exposed or susceptible subpopulations identified as relevant by EPA. (b) Available information. EPA expects to ensure that there is reasonably available information to meet the deadlines for prioritization under the Act. (c) Preferences and TSCA work plan. In selecting a candidate for prioritization as a High-Priority Substance, EPA will: (1) Give preference to: (i) Chemical substances that are listed in the 2014 update of the TSCA Work Plan for Chemical Assessments as having a persistence and bioaccumulation score of 3; and (ii) Chemical substances that are listed in the 2014 update of the TSCA Work Plan for Chemical Assessments that are known human carcinogens and have high acute and chronic toxicity; and (2) Identify a sufficient number of candidates from the 2014 update of the TSCA Work Plan for Chemical Assessments to ensure that, at any given time, at least 50 percent of risk evaluations being conducted by EPA are drawn from that list until all substances on the list have been designated as either a High-Priority Substance or Low-Priority Substance pursuant to § 702.11. (d) Purpose. The purpose of the preferences and criteria in paragraphs (a) through (c) of this section is to inform EPA's decision whether or not to initiate the prioritization process pursuant to § 702.7… | ||||
| 40:40:33.0.1.1.2.1.1.5 | 40 | Protection of Environment | I | R | 702 | PART 702—GENERAL PRACTICES AND PROCEDURES | A | Subpart A—Procedures for Prioritization of Chemical Substances for Risk Evaluation | § 702.7 Initiation of prioritization process. | EPA | (a) EPA generally expects to initiate the prioritization process for a chemical substance only when it believes that the information necessary to prioritize the substance is reasonably available. (b) EPA will initiate prioritization by publishing a notice in the Federal Register identifying a chemical substance for prioritization. EPA will include a general explanation in this notice for why it chose to initiate the process on the chemical substance. (c) The prioritization timeframe in § 702.1(d) begins upon EPA's publication of the notice described in paragraph (b) of this section. (d) Publication of the notice in the Federal Register pursuant to paragraph (b) of this section will initiate a period of 90 days during which interested persons may submit relevant information on that chemical substance. Relevant information might include, but is not limited to, any information that may inform the screening review conducted pursuant to § 702.9(a). EPA will open a separate docket for each chemical substance to facilitate receipt of information. (e) EPA may, in its discretion, extend the public comment period in paragraph (d) of this section for up to three months in order to receive or evaluate information submitted under 15 U.S.C. 2603(a)(2)(B). The length of the extension will be based upon EPA's assessment of the time necessary for EPA to receive and/or evaluate information submitted under 15 U.S.C. 2603(a)(2)(B). | ||||
| 40:40:33.0.1.1.2.1.1.6 | 40 | Protection of Environment | I | R | 702 | PART 702—GENERAL PRACTICES AND PROCEDURES | A | Subpart A—Procedures for Prioritization of Chemical Substances for Risk Evaluation | § 702.9 Screening review and proposed priority designation. | EPA | (a) Screening review. Following the close of the comment period described in § 702.7(d), including any extension pursuant to paragraph (e) of that section, EPA will generally use reasonably available information to screen the candidate chemical substance against the following criteria and considerations: (1) The chemical substance's hazard and exposure potential; (2) The chemical substance's persistence and bioaccumulation; (3) Potentially exposed or susceptible subpopulations; (4) Storage of the chemical substance near significant sources of drinking water; (5) The chemical substance's conditions of use or significant changes in conditions of use; (6) The chemical substance's production volume or significant changes in production volume; and (7) Other risk-based criteria that EPA determines to be relevant to the designation of the chemical substance's priority. (b) Information sources. In conducting the screening review in paragraph (a) of this section, EPA expects to consider sources of information relevant to the listed criteria and consistent with the scientific standards provision in 15 U.S.C. 2625(h), including, as appropriate, sources for hazard and exposure data listed in Appendices A and B of the TSCA Work Plan Chemicals: Methods Document (February 2012). (c) Proposed designation. Based on the results of the screening review in paragraph (a) of this section, relevant information received from the public as described in § 702.7(d), and other information as appropriate and consistent with 15 U.S.C. 2625(h) and (i), EPA will propose to designate the chemical substance as either a High-Priority Substance or Low-Priority Substance, along with an identification of the information, analysis, and basis used to support the proposed designation. (d) Costs and non-risk factors. EPA will not consider costs or other non-risk factors in making a proposed priority designation. (e) Insufficient information. If information remains insufficient to enable the proposed designation of the chemical substa… | ||||
| 40:40:33.0.1.1.2.1.1.7 | 40 | Protection of Environment | I | R | 702 | PART 702—GENERAL PRACTICES AND PROCEDURES | A | Subpart A—Procedures for Prioritization of Chemical Substances for Risk Evaluation | § 702.11 Final priority designation. | EPA | (a) After considering any additional information collected from the proposed designation process in § 702.9, as appropriate, EPA will finalize its designation of a chemical substance as either a High-Priority Substance or a Low-Priority Substance consistent with 15 U.S.C. 2625(h) and (i). (b) EPA will not consider costs or other non-risk factors in making a final priority designation. (c) EPA will publish each final priority designation in the Federal Register, along with an identification of the information, analysis, and basis used to support a final designation consistent with 15 U.S.C. 2625(h), (i) and (j). For High-Priority Substance designations, EPA generally expects to indicate which condition(s) of use were the primary basis for such designations. (d) As required in 15 U.S.C. 2605(b)(3)(C), EPA will finalize a designation for at least one High-Priority Substance for each risk evaluation it completes, other than a risk evaluation that was requested by a manufacturer pursuant to subpart B of this part. The obligation in 15 U.S.C. 2605(b)(3)(C) will be satisfied by the designation of at least one High-Priority Substance where such designation specifies the risk evaluation that the designation corresponds to, and where the designation occurs within a reasonable time before or after the completion of the risk evaluation. | ||||
| 40:40:33.0.1.1.2.1.1.8 | 40 | Protection of Environment | I | R | 702 | PART 702—GENERAL PRACTICES AND PROCEDURES | A | Subpart A—Procedures for Prioritization of Chemical Substances for Risk Evaluation | § 702.13 Revision of designation. | EPA | EPA may revise a final designation of a chemical substance from Low-Priority to High-Priority Substance at any time based on reasonably available information. To revise such a designation, EPA will re-initiate the prioritization process on that chemical substance in accordance with § 702.7, re-screen the chemical substance and propose a priority designation pursuant to § 702.9, and finalize the priority designation pursuant to § 702.11. | ||||
| 40:40:33.0.1.1.2.1.1.9 | 40 | Protection of Environment | I | R | 702 | PART 702—GENERAL PRACTICES AND PROCEDURES | A | Subpart A—Procedures for Prioritization of Chemical Substances for Risk Evaluation | § 702.15 Effect of designation as a low-priority substance. | EPA | Designation of a chemical substance as a Low-Priority Substance under § 702.11 means that a risk evaluation of the chemical substance is not warranted at the time, but does not preclude EPA from later revising the designation pursuant to § 702.13, if warranted. Designation as a Low-Priority Substance is not a finding that the chemical substance does not present an unreasonable risk, but rather that it does not meet the High-Priority Substance definition. | ||||
| 40:40:33.0.1.1.2.2.1.1 | 40 | Protection of Environment | I | R | 702 | PART 702—GENERAL PRACTICES AND PROCEDURES | B | Subpart B—Procedures for Chemical Substance Risk Evaluations | § 702.31 General provisions. | EPA | (a) Purpose. This subpart establishes the EPA process for conducting a risk evaluation to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment as required under TSCA section 6(b)(4)(B) (15 U.S.C. 2605(b)(4)(B)). (b) Scope. These regulations establish the general procedures, key definitions, and timelines EPA will use in a risk evaluation conducted pursuant to TSCA section 6(b) (15 U.S.C. 2605(b)). (c) Applicability. The requirements of this part apply to all chemical substance risk evaluations initiated pursuant to TSCA section 6(b) (15 U.S.C. 2605(b)) beginning June 3, 2024. For risk evaluations initiated prior to this date, but not yet finalized, EPA will seek to apply the requirements in this subpart to the extent practicable. These requirements shall not apply retroactively to risk evaluations already finalized. (d) Categories of chemical substances. Consistent with EPA's authority to take action with respect to categories of chemicals under 15 U.S.C. 2625(c), all references in this part to “chemical” or “chemical substance” shall also apply to “a category of chemical substances.” | ||||
| 40:40:33.0.1.1.2.2.1.10 | 40 | Protection of Environment | I | R | 702 | PART 702—GENERAL PRACTICES AND PROCEDURES | B | Subpart B—Procedures for Chemical Substance Risk Evaluations | § 702.49 Publicly available information. | EPA | For each risk evaluation, EPA will maintain a public docket at https://www.regulations.gov to provide public access to the following information, as applicable for that risk evaluation: (a) The draft scope, final scope, draft risk evaluation, and final risk evaluation; (b) All notices, determinations, findings, consent agreements, and orders; (c) Any information required to be provided to EPA under 15 U.S.C. 2603; (d) A nontechnical summary of the risk evaluation; (e) A list of the studies, with the results of the studies, considered in carrying out each risk evaluation; (f) Any final peer review report, including the response to peer review and public comments received during peer review; (g) Response to public comments received on the draft scope and the draft risk evaluation; and (h) Where unreasonable risk to workers is identified via inhalation, EPA's calculation of a risk-based occupational exposure value. | ||||
| 40:40:33.0.1.1.2.2.1.2 | 40 | Protection of Environment | I | R | 702 | PART 702—GENERAL PRACTICES AND PROCEDURES | B | Subpart B—Procedures for Chemical Substance Risk Evaluations | § 702.33 Definitions. | EPA | All definitions in TSCA apply to this subpart. In addition, the following definitions apply: Act means the Toxic Substances Control Act (TSCA), as amended (15 U.S.C. 2601 et seq. ). Aggregate exposure means the combined exposures from a chemical substance across multiple routes and across multiple pathways. Conditions of use means the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of. EPA means the U.S. Environmental Protection Agency. Pathways means the physical course a chemical substance takes from the source to the organism exposed. Potentially exposed or susceptible subpopulation means a group of individuals within the general population identified by EPA who, due to either greater susceptibility or greater exposure, may be at greater risk than the general population of adverse health effects from exposure to a chemical substance or mixture, such as infants, children, pregnant women, workers, the elderly, or overburdened communities. Reasonably available information means information that EPA possesses or can reasonably generate, obtain, and synthesize for use in risk evaluations, considering the deadlines specified in TSCA section 6(b)(4)(G) for completing such evaluation. Information that meets the terms of the preceding sentence is reasonably available information whether or not the information is confidential business information, that is protected from public disclosure under TSCA section 14. Routes means the ways a chemical substance enters an organism after contact, e.g., by ingestion, inhalation, or dermal absorption. Sentinel exposure means the exposure from a chemical substance that represents the plausible upper bound of exposure relative to all other exposures within a broad category of similar or related exposures. Uncertainty means the imperfect knowledge or lack of precise knowledge of the real world either for specific… | ||||
| 40:40:33.0.1.1.2.2.1.3 | 40 | Protection of Environment | I | R | 702 | PART 702—GENERAL PRACTICES AND PROCEDURES | B | Subpart B—Procedures for Chemical Substance Risk Evaluations | § 702.35 Chemical substances subject to risk evaluation. | EPA | (a) Chemical substances undergoing risk evaluation. A risk evaluation for a chemical substance designated by EPA as a High-Priority Substance pursuant to the prioritization process described in subpart A or initiated at the request of a manufacturer or manufacturers under § 702.45, will be conducted in accordance with this part, subject to § 702.31(c). (b) Percentage requirements. Pursuant to 15 U.S.C. 2605(b)(4)(E)(i) and in accordance with § 702.45(j)(1), EPA will ensure that the number of chemical substances for which a manufacturer-requested risk evaluation is initiated pursuant to § 702.45(e)(9) is not less than 25%and not more than 50% of the number of chemical substances for which a risk evaluation was initiated upon designation as a High-Priority Substance under subpart A. (c) Manufacturer-requested risk evaluations for work plan chemical substances. Manufacturer requests for risk evaluations, described in paragraph (a) of this section, for chemical substances that are drawn from the 2014 update of the TSCA Work Plan for Chemical Assessments will be granted at the discretion of EPA. Such evaluations are not subject to the percentage requirements in paragraph (b) of this section. | ||||
| 40:40:33.0.1.1.2.2.1.4 | 40 | Protection of Environment | I | R | 702 | PART 702—GENERAL PRACTICES AND PROCEDURES | B | Subpart B—Procedures for Chemical Substance Risk Evaluations | § 702.37 Evaluation requirements. | EPA | (a) Considerations. (1) EPA will use applicable EPA guidance when conducting risk evaluations, as appropriate and where it represents the best available science. (2) EPA will document that the risk evaluation is consistent with the best available science and based on the weight of the scientific evidence. In determining best available science, EPA shall consider as applicable: (i) The extent to which the scientific information, technical procedures, measures, methods, protocols, methodologies, or models employed to generate the information are reasonable for and consistent with the intended use of the information; (ii) The extent to which the information is relevant for the Administrator's use in making a decision about a chemical substance or mixture; (iii) The degree of clarity and completeness with which the data, assumptions, methods, quality assurance, and analyses employed to generate the information are documented; (iv) The extent to which the variability and uncertainty in the information, or in the procedures, measures, methods, protocols, methodologies, or models, are evaluated and characterized; and (v) The extent of independent verification or peer review of the information or of the procedures, measures, methods, protocols, methodologies or models. (3) EPA will ensure that all supporting analyses and components of the risk evaluation are suitable for their intended purpose, and tailored to the problems and decision at hand, in order to inform the development of a technically sound determination as to whether a chemical substance presents an unreasonable risk of injury to health or the environment under the conditions of use, based on the weight of the scientific evidence. (4) EPA will not exclude conditions of use from the scope of the risk evaluation, but a fit-for-purpose approach may result in varying types and levels of analysis and supporting information for certain conditions of use, consistent with paragraph (b) of this section. The extent to which EPA will refine its evaluations for… | ||||
| 40:40:33.0.1.1.2.2.1.5 | 40 | Protection of Environment | I | R | 702 | PART 702—GENERAL PRACTICES AND PROCEDURES | B | Subpart B—Procedures for Chemical Substance Risk Evaluations | § 702.39 Components of risk evaluation. | EPA | (a) In general. Each risk evaluation will include all of the following components: (1) A Scope; (2) A Hazard Assessment; (3) An Exposure Assessment; (4) A Risk Characterization; and (5) A Risk Determination. (b) Scope of the risk evaluation. The scope of the risk evaluation will include all the following: (1) The condition(s) of use the EPA expects to consider in the risk evaluation. (2) The potentially exposed populations, including any potentially exposed or susceptible subpopulations as identified as relevant to the risk evaluation by EPA under the conditions of use that EPA plans to evaluate. (3) The ecological receptors that EPA plans to evaluate. (4) The hazards to health and the environment that EPA plans to evaluate. (5) A description of the reasonably available information and scientific approaches EPA plans to use in the risk evaluation. (6) A conceptual model that describes the actual or predicted relationships between the chemical substance, its associated conditions of use through predicted exposure scenarios, and the identified human and environmental receptors and human and ecological health hazards. (7) An analysis plan that includes hypotheses and descriptions about the relationships identified in the conceptual model and the approaches and strategies EPA intends to use to assess exposure and hazard effects, and to characterize risk; and a description, including quality, of the data, information, methods, and models, that EPA intends to use in the analysis and how uncertainty and variability will be characterized. (8) EPA's plan for peer review consistent with § 702.41. (c) Hazard assessment. (1) The hazard assessment process includes the identification, evaluation, and synthesis of information to describe the potential health and environmental hazards of the chemical substance under the conditions of use. (2) Hazard information related to potential health and environmental hazards of the chemical substance will be reviewed in a manner consistent with best available science … | ||||
| 40:40:33.0.1.1.2.2.1.6 | 40 | Protection of Environment | I | R | 702 | PART 702—GENERAL PRACTICES AND PROCEDURES | B | Subpart B—Procedures for Chemical Substance Risk Evaluations | § 702.41 Peer review. | EPA | EPA will conduct peer review activities on risk evaluations conducted pursuant to 15 U.S.C. 2605(b)(4)(A). EPA expects such activities, including decisions regarding the appropriate scope and type of peer review, to be consistent with the applicable peer review policies, procedures, and methods in guidance promulgated by the Office of Management and Budget and EPA, and in accordance with 15 U.S.C. 2625(h) and (i). | ||||
| 40:40:33.0.1.1.2.2.1.7 | 40 | Protection of Environment | I | R | 702 | PART 702—GENERAL PRACTICES AND PROCEDURES | B | Subpart B—Procedures for Chemical Substance Risk Evaluations | § 702.43 Risk evaluation actions and timeframes. | EPA | (a) Draft scope. (1) For each risk evaluation to be conducted, EPA will publish a document that specifies the draft scope of the risk evaluation EPA plans to conduct and publish a notice of availability in the Federal Register. The document will address the elements in § 702.39(b). (2) EPA generally expects to publish the draft scope during the prioritization process concurrent with publication of a proposed designation as a High-Priority Substance pursuant to § 702.9(g), but no later than 3 months after the initiation of the risk evaluation process for the chemical substance. (3) EPA will allow a public comment period of no less than 45 calendar days during which interested persons may submit comment on EPA's draft scope. EPA will open a docket to facilitate receipt of public comments. (b) Final scope. (1) EPA will, no later than 6 months after the initiation of a risk evaluation, publish a document that specifies the final scope of the risk evaluation EPA plans to conduct, and publish a notice of availability in the Federal Register. The document shall address the elements in § 702.39(b). (2) For a chemical substance designated as a High-Priority Substance under subpart A of this part, EPA will not publish the final scope of the risk evaluation until at least 12 months have elapsed from the initiation of the prioritization process for the chemical substance. (c) Draft risk evaluation. EPA will publish a draft risk evaluation, publish a notice of availability in the Federal Register, open a docket to facilitate receipt of public comment, and provide no less than a 60-day comment period, during which time the public may submit comment on EPA's draft risk evaluation. The document shall include the elements in § 702.39(c) through (f). (d) Final risk evaluation. (1) EPA will complete and publish a final risk evaluation for the chemical substance under the conditions of use as soon as practicable, but not later than 3 years after the date on which EPA initiates the risk evaluation. The document sh… | ||||
| 40:40:33.0.1.1.2.2.1.8 | 40 | Protection of Environment | I | R | 702 | PART 702—GENERAL PRACTICES AND PROCEDURES | B | Subpart B—Procedures for Chemical Substance Risk Evaluations | § 702.45 Submission of manufacturer requests for risk evaluations. | EPA | (a) General provisions. (1) One or more manufacturers of a chemical substance may request that EPA conduct a risk evaluation on a chemical substance. (2) Such requests must comply with all the requirements, procedures, and criteria in this section. (3) Subject to limited exceptions in paragraph (e)(7)(iii) of this section, it is the burden of the requesting manufacturer(s) to provide EPA with the information necessary to carry out the risk evaluation. (4) In determining whether there is sufficient information to support a manufacturer-requested risk evaluation, EPA expects to apply the same standard as it would for EPA-initiated risk evaluations, including but not limited to the considerations and requirements in § 702.37. (5) EPA may identify data needs at any time during the process described in this section, and, by submitting a request for risk evaluation under this section, the requesting manufacturer(s) agrees to provide, or develop and provide, EPA with information EPA deems necessary to carry out the risk evaluation, consistent with the provisions described in this subpart. (6) EPA will not expedite or otherwise provide special treatment to a manufacturer-requested risk evaluation pursuant to 15 U.S.C. 2605(b)(4)(E)(ii). (7) Once initiated in accordance with paragraph (e)(9) of this section, EPA will conduct manufacturer-requested risk evaluations following the procedures in §§ 702.37 through 702.43 and §§ 702.47 through 702.49 of this subpart. (8) For purposes of this section, information that is “known to or reasonably ascertainable by” the requesting manufacturer(s) would include all information in the requesting manufacturer's possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know. Meeting this standard requires an exercise and documentation of due diligence that may vary depending on the circumstances and parties involved. At a minimum, due diligence requires: (i) A thorough search and collection of publicly ava… | ||||
| 40:40:33.0.1.1.2.2.1.9 | 40 | Protection of Environment | I | R | 702 | PART 702—GENERAL PRACTICES AND PROCEDURES | B | Subpart B—Procedures for Chemical Substance Risk Evaluations | § 702.47 Interagency collaboration. | EPA | During the risk evaluation process, not to preclude any additional, prior, or subsequent collaboration, EPA will consult with other relevant Federal agencies. | ||||
| 40:40:33.0.1.1.2.3.1.1 | 40 | Protection of Environment | I | R | 702 | PART 702—GENERAL PRACTICES AND PROCEDURES | C | Subpart C—Citizen Suit | § 702.60 Purpose. | EPA | Section 20 of the Toxic Substances Control Act (TSCA) authorizes any person to begin a civil action to compel performance by the Environmental Protection Agency (EPA) of TSCA non-discretionary acts or duties (section 20(a)(2)) or to restrain any violation of TSCA, or of any rule promulgated under sections 4, 5, or 6, or of any order issued under section 5 of TSCA (section 20(a)(1)). The purpose of this regulation is to prescribe procedures governing the giving of a notice of intent to file suit required by section 20(b) of TSCA as a prerequisite to beginning such civil actions. | ||||
| 40:40:33.0.1.1.2.3.1.2 | 40 | Protection of Environment | I | R | 702 | PART 702—GENERAL PRACTICES AND PROCEDURES | C | Subpart C—Citizen Suit | § 702.61 Service of notice. | EPA | (a) Notice as a prerequisite to suit. Under section 20 of TSCA, no civil action may be commenced by a citizen to restrain a violation of TSCA, or a rule or order thereunder, unless at least 60 days in advance the citizen has given notice of the intent to file suit to the Administrator and to the person who is alleged to have committed the violation. No civil action may be commenced by a citizen to compel the Administrator to perform any non-discretionary act or duty under TSCA, unless at least 60 days in advance the citizen has given notice of the intent to file suit to the Administrator. However, in the case of an alleged failure by the Administrator to file an action under section 7 of TSCA, the citizen must give notice to the Administrator only 10 days in advance of filing the civil action. (b) Method of service. Notice of intent to file suit can be either personally served or served by certified mail—return receipt requested—to persons identified in paragraph (d) of this section. (c) Date of service. The effective date of service of a notice given in accordance with this rule shall be the date of the return receipt, if served by mail, or the date of receipt if personally served. (d) Persons to be served —(1) Violations of TSCA rules or TSCA order. (i) If the alleged violator is a private individual or a corporation, notice of intent to file suit shall be served on the individual or the owner or managing agent of the plant, facility, or activity alleged to be in violation. If the alleged violator is a corporation, a copy of the notice shall also be sent to the registered agent, if any, of such corporation in the State in which such violation is alleged to have occurred. Notice shall also be served on the Administrator of the EPA. (ii) If the alleged violator is a State or local government entity, notice of intent to file suit shall be served on the head of the agency. Notice shall also be served on the Administrator of the EPA, and a copy shall be sent to the Attorney General of the United States.… | ||||
| 40:40:33.0.1.1.2.3.1.3 | 40 | Protection of Environment | I | R | 702 | PART 702—GENERAL PRACTICES AND PROCEDURES | C | Subpart C—Citizen Suit | § 702.62 Contents of notice. | EPA | (a) Violation of TSCA rule or TSCA order. Notice of intent to file suit regarding an alleged violation of TSCA or any rule promulgated under sections 4, 5, or 6, or an order issued under section 5, shall include sufficient information to permit the recipient to identify: (1) The specific provision of TSCA or of the rule or order under TSCA alleged to have been violated. (2) The activity alleged to constitute a violation. (3) The person or persons responsible for the alleged violation. (4) The location of the alleged violation. (5) The date or dates of the alleged violation as closely as the citizen is able to specify them. (6) The full name, address, and telephone number of the citizen giving notice. (b) Failure to act. Notice regarding an alleged failure of the Administrator to perform any act or duty which is not discretionary shall: (1) Identify the specific provision of TSCA which requires an act or creates a duty. (2) Describe with reasonable specificity the action taken or not taken by the Administrator which is alleged to constitute a failure to perform the act or duty. (3) State the full name, address, and telephone number of the citizen giving the notice. (c) Identification of Counsel. The notice shall state the name, address, and telephone number of the Legal Counsel, if any, representing the citizen giving the notice. |
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CREATE TABLE cfr_sections (
section_id TEXT PRIMARY KEY,
title_number INTEGER,
title_name TEXT,
chapter TEXT,
subchapter TEXT,
part_number TEXT,
part_name TEXT,
subpart TEXT,
subpart_name TEXT,
section_number TEXT,
section_heading TEXT,
agency TEXT,
authority TEXT,
source_citation TEXT,
amendment_citations TEXT,
full_text TEXT
);
CREATE INDEX idx_cfr_title ON cfr_sections(title_number);
CREATE INDEX idx_cfr_part ON cfr_sections(part_number);
CREATE INDEX idx_cfr_agency ON cfr_sections(agency);