PART 702—GENERAL PRACTICES AND PROCEDURES Authority: 15 U.S.C. 2605 and 2619. Source: 47 FR 2773, Jan. 19, 1982, unless otherwise noted. Subpart A—Procedures for Prioritization of Chemical Substances for Risk Evaluation Source: 82 FR 33762, July 20, 2017, unless otherwise noted. § 702.1 General provisions. (a) Purpose. (b) Scope of designations. (c) Categories of chemical substances. (d) Prioritization timeframe. (e) Metals or metal compounds. (f) Applicability. (g) Scientific standards and weight of the scientific evidence. (h) Interagency collaboration. § 702.3 Definitions. For purposes of this subpart, the following definitions apply: Act et seq. Conditions of use EPA High-priority substance Low-priority substance Potentially exposed or susceptible subpopulation Reasonably available information § 702.4 [Reserved] § 702.5 Candidate selection. (a) General objective. (b) Available information. (c) Preferences and TSCA work plan. (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. (e) Insufficient information. § 702.7 Initiation of prioritization process. (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 (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 (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). § 702.9 Screening review and proposed priority designation. (a) Screening review. (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. (c) Proposed designation. (d) Costs and non-risk factors. (e) Insufficient information. (f) Conditions of use. (g) Publication. Federal Register, § 702.11 Final priority designation. (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, (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. § 702.13 Revision of designation. 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. § 702.15 Effect of designation as a low-priority substance. 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. § 702.17 Effect of designation as a high-priority substance. 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. Subpart B—Procedures for Chemical Substance Risk Evaluations Source: 82 FR 33747, July 20, 2017 as amended at 89 FR 37052, May 3, 2024, unless otherwise noted. § 702.31 General provisions. (a) Purpose. (b) Scope. (c) Applicability. (d) Categories of chemical substances. § 702.33 Definitions. All definitions in TSCA apply to this subpart. In addition, the following definitions apply: Act et seq. Aggregate exposure Conditions of use EPA Pathways Potentially exposed or susceptible subpopulation Reasonably available information Routes e.g., Sentinel exposure Uncertainty Variability § 702.35 Chemical substances subject to risk evaluation. (a) Chemical substances undergoing risk evaluation. (b) Percentage requirements. (c) Manufacturer-requested risk evaluations for work plan chemical substances. § 702.37 Evaluation requirements. (a) Considerations. (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 one or more condition of use in any risk evaluation will vary as necessary to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment. (5) EPA will evaluate chemical substances that are metals or metal compounds in accordance with 15 U.S.C. 2605(b)(2)(E). (b) Information and information sources. (2) EPA will apply systematic review methods to assess reasonably available information, as needed to carry out risk evaluations that meet the requirements in TSCA section 26(h) and (i), in a manner that is objective, unbiased, and transparent. (3) EPA may determine that certain information gaps can be addressed through application of assumptions, uncertainty factors, models, and/or screening to conduct its analysis with respect to the chemical substance, consistent with 15 U.S.C. 2625. The approaches used will be determined by the quality of reasonably available information, the deadlines specified in TSCA section 6(b)(4)(G) for completing the risk evaluation, and the extent to which the information reduces uncertainty. (4) EPA expects to use its authorities under the Act, and other information gathering authorities, when necessary to obtain the information needed to perform a risk evaluation for a chemical substance before initiating the risk evaluation for such substance. EPA will also use such authorities during the performance of a risk evaluation to obtain information as needed and on a case-by-case basis to ensure that EPA has adequate, reasonably available information to perform the evaluation. Where appropriate, to the extent practicable, and scientifically justified, EPA will require the development of information generated without the use of new testing on vertebrates. (5) Among other sources of information, EPA will also consider information and advice provided by the Science Advisory Committee on Chemicals established pursuant to 15 U.S.C. 2625(o). § 702.39 Components of risk evaluation. (a) In general. (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. (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. (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 based on the weight of scientific evidence and all assessment methods will be documented. (3) Consistent with § 702.37(b), information evaluated may include, but would not be limited to: Human epidemiological studies, in vivo and/or in vitro laboratory studies, biomonitoring and/or human clinical studies, ecological field data, read across, mechanistic and/or kinetic studies in a variety of test systems. These may include but are not limited to: toxicokinetics and toxicodynamics ( e.g., e.g., (4) The hazard information relevant to the chemical substance will be evaluated for identified human and environmental receptors, including all identified potentially exposed or susceptible subpopulation(s) determined to be relevant, for the exposure scenarios relating to the conditions of use. (5) The relationship between the dose of the chemical substance and the occurrence of health and environmental effects or outcomes will be evaluated. (6) Hazard identification will include an evaluation of the strengths, limitations, and uncertainties associated with the reasonably available information. (d) Exposure assessment. (2) Exposure information related to potential human health or ecological hazards of the chemical substance will be reviewed in a manner consistent with best available science based on the weight of scientific evidence and all assessment methods will be documented. (3) Consistent with § 702.37(b), information evaluated may include, but would not be limited to: chemical release reports, release or emission scenarios, data and information collected from monitoring or reporting, release estimation approaches and assumptions, biological monitoring data, workplace monitoring data, chemical exposure health data, industry practices with respect to occupational exposure control measures, and exposure modeling. (4) Chemical-specific factors, including, but not limited to physical-chemical properties and environmental fate and transport parameters, will be examined. (5) The human health exposure assessment will consider all potentially exposed or susceptible subpopulation(s) determined to be relevant. (6) Environmental health exposure assessment will characterize and evaluate the interaction of the chemical substance with the ecological receptors and the exposures considered, including populations and communities, depending on the chemical substance and the ecological characteristic involved. (7) EPA will describe whether sentinel exposures under the conditions of use were considered and the basis for their consideration. (8) EPA will consider aggregate exposures to the chemical substance, and, when supported by reasonably available information, consistent with the best available science and based on the weight of scientific evidence, include an aggregate exposure assessment in the risk evaluation, or will otherwise explain in the risk evaluation the basis for not including such an assessment. (9) EPA will assess all exposure routes and pathways relevant to the chemical substance under the conditions of use, including those that are regulated under other federal statutes. (e) Risk characterization. Requirements. (i) Integrate the hazard and exposure assessments into quantitative and/or qualitative estimates relevant to specific risks of injury to health or the environment, including any potentially exposed or susceptible subpopulations identified, under the conditions of use; (ii) Not consider costs or other non-risk factors; and (iii) Describe the weight of the scientific evidence for the identified hazards and exposures. (2) Summary of considerations. (i) Considerations regarding uncertainty and variability. e.g., (ii) Considerations of data quality. e.g., (iii) Considerations of alternative interpretations. (iv) Additional considerations for environmental risk. (f) Risk determination. (2) In determining whether unreasonable risk is presented, EPA's consideration of occupational exposure scenarios will take into account reasonably available information, including known and reasonably foreseen circumstances where subpopulations of workers are exposed due to the absence or ineffective use of personal protective equipment. EPA will not consider exposure reduction based on assumed use of personal protective equipment as part of the risk determination. (3) EPA will determine whether a chemical substance does or does not present an unreasonable risk after considering the risks posed under the conditions of use and, where EPA makes a determination of unreasonable risk, EPA will identify the conditions of use that significantly contribute to such determination. § 702.41 Peer review. 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). § 702.43 Risk evaluation actions and timeframes. (a) Draft scope. Federal Register. (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. Federal Register. (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. Federal Register, (d) Final risk evaluation. Federal Register (2) EPA may extend the deadline for a risk evaluation for not more than 6 months. The total time elapsed between initiation of the risk evaluation and completion of the risk evaluation may not exceed 3- and one-half years. (e) Final determination of unreasonable risk. (f) Final determination of no unreasonable risk. (g) Substantive revisions to scope documents and risk evaluations. (1) Draft documents. (2) Final scope. Federal Register (3) Final risk evaluation. (4) Process for revisions to final risk evaluations. § 702.45 Submission of manufacturer requests for risk evaluations. (a) General provisions. (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 available information; (ii) A reasonable inquiry within the requesting manufacturer's entire organization; and (iii) A reasonably inquiry outside of the requesting manufacturer's organization, including inquiries to upstream suppliers; downstream users; and employees or other agents of the manufacturer, including persons involved in research and development, import or production, or marketing. (9) In the event that a group of manufacturers of a chemical substance submit a request for risk evaluation under this section, the term “requesting manufacturer” in paragraphs (a), (c), and (i) of this section shall apply to all manufacturers in the group. EPA will otherwise coordinate with the primary contact named in the request for purposes of communication, payment of fees, and other actions as needed. (b) Method for submission. https://cdx.epa.gov. (c) Content of request. (1) Name, mailing address, and contact information of the entity (or entities) submitting the request. If more than one manufacturer submits the request, all individual manufacturers must provide their contact information. (2) The chemical identity of the chemical substance that is the subject of the request. At a minimum, this includes: all known names of the chemical substance, including common or trades names, CAS number, and molecular structure of the chemical substance. (3) For requests pertaining to a category of chemical substances, an explanation of why the category is appropriate under 15 U.S.C. 2625(c). EPA will determine whether the category is appropriate for risk evaluation as part of reviewing the request in paragraph (e) of this section. (4) A description of the circumstances under which the chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of, and all information known to or reasonably ascertainable by the requesting manufacturer that supports the identification of the circumstances described in this paragraph (c)(4). (5) All information known to or reasonably ascertainable by the requesting manufacturer(s) on the health and environmental hazard(s) of the chemical substance, human and environmental exposure(s), and exposed population(s), including but not limited to: (i) The chemical substance's exposure potential, including occupational, general population and consumer exposures, and facility release information; (ii) The chemical substance's hazard potential, including all potential environmental and human health hazards; (iii) The chemical substance's physical and chemical properties; (iv) The chemical substance's fate and transport properties including persistence and bioaccumulation; (v) Industrial and commercial locations where the chemical is used or stored; (vi) Whether there is any storage of the chemical substance near significant sources of drinking water, including the storage facility location and the nearby drinking water source(s); (vii) Consumer products containing the chemical; (viii) The chemical substance's production volume or significant changes in production volume; and (ix) Any other information relevant to the hazards, exposures and/or risks of the chemical substance. (6) Where information described in paragraph (c)(4) or (5) of this section is unavailable, an explanation as to why, and the rationale for why, in the requester's view, the provided information is nonetheless sufficient to allow EPA to complete a risk evaluation on the chemical substance. (7) Copies of all information referenced in paragraph (c)(5) of this section, or citations if the information is readily available from public sources. (8) A signed certification from the requesting manufacturer(s) that all information contained in the request is accurate and complete, as follows: I certify that to the best of my knowledge and belief: (A) The company named in this request manufactures the chemical substance identified for risk evaluation. (B) All information provided in the request is complete and accurate as of the date of the request. (C) I have either identified or am submitting all information in my possession and control, and a description of all other data known to or reasonably ascertainable by me as required under this part. I am aware it is unlawful to knowingly submit incomplete, false and/or misleading information in this request and there are significant criminal penalties for such unlawful conduct, including the possibility of fine and imprisonment. (9) Where appropriate, information that will inform EPA's determination as to whether restrictions imposed by one or more States have the potential to have a significant impact on interstate commerce or health or the environment, and that as a consequence the request is entitled to preference pursuant to 15 U.S.C. 2605(b)(4)(E)(iii). (d) Confidential business information. (e) EPA process for reviewing requests. Public notification of receipt of request. (2) Initial review for completeness. i.e., i.e., (3) Public notice and comment. Federal Register, (4) Secondary review for sufficiency. (5) Grant. (6) Publication of draft conditions of use and request for information. Federal Register (7) Identification of information needs. (i) Provide the necessary information. (ii) Withdraw the risk evaluation request. (iii) Request that EPA obtain the information using authorities under TSCA sections 4, 8 or 11. (8) Unfulfilled information needs. (9) Initiation of the risk evaluation. (f) Incomplete or insufficient request. (g) Withdrawal of request. (h) Data needs identified post-initiation. (i) Supplementation of original request. (j) Limitations on manufacturer-requested risk evaluations. In general. (2) Preferences. (i) First, for which EPA determines that restrictions imposed by one or more States have the potential to have a significant impact on interstate commerce, health or the environment; and then (ii) Second, based on the order in which the requests are received. (k) Fees. § 702.47 Interagency collaboration. During the risk evaluation process, not to preclude any additional, prior, or subsequent collaboration, EPA will consult with other relevant Federal agencies. § 702.49 Publicly available information. For each risk evaluation, EPA will maintain a public docket at https://www.regulations.gov (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. Subpart C—Citizen Suit § 702.60 Purpose. 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. § 702.61 Service of notice. (a) Notice as a prerequisite to suit. (b) Method of service. (c) Date of service. (d) Persons to be served Violations of TSCA rules or TSCA order. (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. (iii) If the alleged violator is a Federal agency, 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. (2) Performance of non-discretionary TSCA acts or duties. (3) Address of persons to be served. § 702.62 Contents of notice. (a) Violation of TSCA rule or TSCA order. (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. (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.