§ 702.37 - Evaluation requirements.

§ 702.37 Submission of manufacturer requests for risk evaluationsEvaluation requirements.

pursuant to

(a) General provision. Any request that EPA conduct a risk evaluation pursuant to this part must comply with all the procedures and criteria in this section to be eligible to be granted by EPA.

(b) Method for submission. One or more manufacturers of a chemical substance may request that EPA conduct a risk evaluation. All requests submitted to EPA under this subpart must be submitted via the EPA Central Data Exchange (CDX) found at http://cdx.epa.gov. Requests must include all of the following information:

(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 A request for risk evaluations of a category of chemical substances must include an explanation of why the category is appropriate under 15 U.S.C. 2625(c), and EPA will grant such request only upon determining that the requested category is appropriate for risk evaluation.

(3) The manufacturer must identify the circumstances on which they are requesting that EPA conduct a risk evaluation and include a rationale for why these circumstances constitute conditions of use under § 702.33.

(4) The request must also include a list of all the existing information that is relevant to whether the chemical substance, under the circumstances identified by the manufacturer(s), presents an unreasonable risk of injury to health or the environment. The list must be accompanied by an explanation as to why such information is adequate to permit EPA to complete a risk evaluation addressing the circumstances identified by the manufacturer(s), The request need not include copies of the information; citations are sufficient, if the information is publically available. The request must include or reference all available information on the health and environmental hazard(s) of the chemical substance, human and environmental exposure(s), and exposed population(s), as relevant to the circumstances identified in the request. At a minimum, this must include all the following, as relevant to the circumstances identified:

(i) The chemical substance's hazard and exposure potential;

(ii) The chemical substance's persistence and bioaccumulation;

(iii) Potentially exposed or susceptible subpopulations which the manufacturer(s) believes to be relevant to the EPA risk evaluation;

(iv) 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);

(v) The chemical substance's production volume or significant changes in production volume; and

(vi) Any other information relevant to the potential risks of the chemical substance under the circumstances identified in the request.

(5) The request must include a commitment to provide to EPA any referenced information upon request.

(6) Scientific information submitted must be consistent with the scientific standards in 15 U.S.C. 2625(h).

(7) A signed certification that all information contained in the request is accurate and complete, as follows:

(i) I certify that to the best of my knowledge and belief:

(A) The company named in this request manufacturers the chemical substance identified for risk evaluation.

(B) All information provided in the notice is complete and accurate as of the date of the request.

(C) I have either identified or am submitting all information in my possession, control, and a description of all other data known to or reasonably ascertainable by me as required for this request 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.

(ii) [Reserved]

(c) Optional elements. A manufacturer may provide 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

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 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)(

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2)(E)

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d

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Confidential business

Information and information

. Claims of confidentiality must be made in accordance with the procedures described in 40 CFR part 703.

(e) EPA process for evaluating manufacturer requests —

(1) Review for completeness. Upon receipt of the request, EPA will verify that the request is facially complete, i.e., that information has been submitted that appears to be consistent with the requirements in paragraphs (b) through (d) of this section. EPA will inform the submitting manufacturer(s) if EPA has determined that the request is incomplete, and cannot be processed. Facially complete requests will be processed as described in this subpart.

(2) Public notification of receipt of request. Within 15 business days of receipt of a facially complete submission, EPA will notify the public of receipt of the manufacturer request. This notification will include any information submitted by the manufacturer that is not CBI, including the condition(s) of use for which the evaluation is requested.

(3) Conditions of use to be evaluated. EPA will assess whether the circumstances identified in the request constitute condition of use under § 702.33, and whether those conditions of use warrant inclusion within the scope of a risk evaluation for the chemical substance. EPA will also assess what, if any, additional conditions of use that warrant inclusion within the scope of a risk evaluation for the chemical substance. EPA will conduct these assessments and make proposed determinations based on the same considerations applied in the same manner as it would for a risk evaluation for a high-priority substance.

(4) Public notice and comment. No later than 60 business days of receiving a request that EPA has determined to be complete under paragraph (e)(1) of this section, EPA will submit for publication the receipt of the request in the Federal Register, open a docket for that request and provide no less than a 45 calendar day public comment period. The docket will contain the manufacturer request (excluding information claimed as CBI) and EPA' proposed additions of conditions of use as described in paragraph (e)(3) of this section, and the basis for these proposed additions. During the comment period the public may submit comments and information relevant to the requested risk evaluation, in particular, commenters are encouraged to identify any information not included in the request or the proposed determinations that the commenters believe would be needed to conduct a risk evaluation, and to provide any other information relevant to EPA's proposed determinations of the conditions of use, such as information on other conditions of use of the chemical than those included in the request or in EPA's proposed determinations

(5) Supplementation of original request.

(i) At any time prior to the end of the comment period, the requesting manufacturer(s) may supplement the original request with any new information it receives.

(ii) At any point prior to the completion of a risk evaluation pursuant to this section, manufacturer(s) must supplement the original request with any information that meets the criteria in 15 U.S.C. 2607(e) and this section, or with any other information that has the potential to change EPA's risk evaluation with respect to the conditions of use as requested by the manufacturer. Such information must be submitted consistent with section 8(e) if the information is subject to that section or otherwise within 30 calendar days of the manufacturer's obtaining the information.

(6) EPA's decision.

(i) Within 60 days of the end of the comment period provided in paragraph (e)(4) of this section, EPA will review the request along with any additional information received during the comment period to determine whether the request meets the criteria and requirements of this section.

(ii) EPA will grant the request if it determines that all of the following have been met:

(A) That the circumstances identified in the request constitute conditions of use that warrant inclusion in a risk evaluation for the chemical substance;

(B) That EPA has all of the information needed to conduct such risk evaluation on the conditions of use that were the subject of the request; and

(C) All other criteria and requirements of this section have been met.

(iii) At the end of this 60-day period, EPA will notify the submitting manufacturer(s) of its decision and include the basis for granting or denying the request. Bases for a denial, include the manufacturer has not provided sufficient information to complete the risk evaluation on the condition(s) of use requested, or that the circumstances identified in the request either do not constitute conditions of use, or the conditions of use do not warrant inclusion in a risk evaluation for the chemical substance. This notification will also identify any additional conditions of use, as determined by the Administrator, that will be included in this risk evaluation.

(iv) Within 30 days of receipt of EPA's notification the requester(s) may withdraw the request.

(7) Public notice of decision. EPA will make public EPA's decision to grant or deny the request at the time that EPA notifies the manufacturer.

(8) Compliant request. EPA will initiate a risk evaluation for all requests for non-TSCA Work Plan Chemicals that meet the criteria in this subpart, until EPA determines that the number of manufacturer-requested chemical substances undergoing risk evaluation is equal to 25% of the High-Priority Substances identified in subpart A as undergoing risk evaluation. Once that level has been reached, EPA will initiate at least one new manufacturer-requested risk evaluation for each manufacturer-requested risk evaluation completed so long as there are sufficient requests that meet the criteria of this subpart, as needed to ensure that the number of manufacturer-requested risk evaluations is equal to at least 25% of the High-Priority substances risk evaluation and not more than 50%.

(9) Preferences. In conformance with § 702.35(c), in evaluating requests for TSCA Work Plan Chemicals and requests for non-TSCA Work Plan chemicals in excess of the 25% threshold in § 702.35(b), EPA will first give preference to requests for risk evaluations on chemical substances:

(i) First, for which the Agency 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.

(10) No preferential treatment. Once granted, EPA will initiate the risk evaluation and thereafter will conduct the risk evaluation following the procedures in §§ 702.39 through 702.51. EPA will not expedite or otherwise provide special treatment to a risk evaluation conducted as a result of a manufacturer's request.

(11) Fees. Manufacturers must pay fees to support risk evaluations as specified under 15 U.S.C. 2605(b)(4)(E)(ii).

[82 FR 33747, July 20, 2017, as amended at 88 FR 37166, June 7, 2023]

sources.

(1) EPA will base each risk evaluation on reasonably available information.

(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).