Flame Retardants; Significant New Uses Rules for Certain Non-Ongoing Uses

Federal RegisterJun 22, 2023

88 Fed. Reg. 40728 (Jun. 22, 2023)

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Proposed rule.

SUMMARY:

Under the Toxic Substances Control Act (TSCA), EPA is proposing significant new use rules (SNURs) for three flame retardants, tris(2-chloroethyl) phosphate (TCEP), 4,4′-(1-methylethylidene)bis[2, 6-dibromophenol], also known as “tetrabromobisphenol A,” (TBBPA), and triphenyl phosphate (TPP), which are all undergoing TSCA risk evaluations. The proposed significant new uses are manufacture (including import) or processing for any use, with the exception that the conditions of use the Agency expects to consider within the scope of the TSCA section 6 risk evaluations are not proposed as significant new uses. Persons subject to the SNUR would be required to notify EPA at least 90 days before commencing any manufacturing (including import) or processing of the chemical substance for a significant new use. Once EPA receives a notification, EPA must review and make an affirmative determination on the notification, and take such action as is required by any such determination before the manufacture (including import) or processing for the significant new use can commence.

DATES:

Comments must be received on or before August 7, 2023.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA–HQ–OPPT–2023–0012, using the Federal eRulemaking Portal at https://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:

For technical information contact: Thomas Groeneveld, Office of Pollution Prevention and Toxics (7404M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; telephone number: (202) 566–1188; email address: existing.chemical.SNUR@epa.gov.

For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554–1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. What is the Agency's authority for taking this action?

TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including those listed in TSCA section 5(a)(2) (see Unit II.A.). Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture (including import) or process the chemical substance for that use (15 U.S.C. 2604(a)(1)(B)(i)). TSCA further provides that such manufacturing (including import) or processing may not commence until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination (15 U.S.C. 2604(a)(1)(B)(ii)). EPA has long interpreted the statutory term “significant new use” to include the resumption of a use that had ceased prior to promulgation of the proposed SNUR, for example see, April 25, 2019 (84 FR 17345) (FRL–9991–33)); March 8, 2016 (81 FR 20535 (FRL–9943–83)); December 29, 2014 (79 FR 77891 (FRL–9915–60)) and October 22, 2013 (78 FR 62443 (FRL–9397–1)), and EPA will not determine that a use is a “significant new use” if information reasonably available to the Agency, including that received during the period for public comment, establishes that the use is ongoing at the time the proposed rule is published in the Federal Register .

B. What action is the Agency taking?

EPA is proposing SNURs for the following three flame retardants undergoing TSCA section 6 risk evaluations:

Tris(2-chloroethyl) phosphate (TCEP), CASRN 115–96–8 (Ref. 1);
4,4′-(1-methylethylidene)bis[2, 6-dibromophenol], also known as “tetrabromobisphenol A,” (TBBPA), CASRN 79–94–7 (Ref. 2); and
Triphenyl phosphate (TPP), CASRN 115–86–6 (Ref. 3).

The proposed significant new uses are manufacture (including import) or processing for any use, with the exception that the conditions of use that EPA expects to consider within the scope of the TSCA section 6 risk evaluations are not proposed as significant new uses (Refs. 1, 2, and 3). The conditions of use that EPA identified for the TSCA section 6 risk evaluations include all manufacture, processing, and use the Agency believes to be ongoing, as well as legacy uses and associated disposal, in the United States based on reasonably available information. The proposed significant new uses include manufacture and processing for uses that have ceased; manufacture and processing for uses that have not yet ceased but for which all manufacture and processing has ceased; and manufacture and processing for uses for which EPA has no information demonstrating that the use has previously commenced in the United States. EPA will consider any information received during the period for public comment suggesting that particular uses had commenced in the United States and not ceased prior to publication date of this notice of proposed rulemaking.

EPA is not proposing to make inapplicable the general exemptions from SNUR notice requirements that are described in 40 CFR 721.45. These include, for example, exemptions from notification requirements for persons manufacturing or processing the chemical substance only as an impurity or certain byproduct, and persons importing or processing the chemical substance as part of an article. (See also the request for comment in Unit II.D.).

EPA is requesting public comment on all aspects of this proposal and specifically on the Agency's description of the significant new uses for the chemicals identified, including specific documentation of ongoing uses not identified by the Agency, if any (see details discussed in Unit III.). Please note that the Agency has listed the exempted conditions of use from the significant new use proposed designation as these conditions of use appear in the risk evaluation scope documents, including both manufacturing and processing for specific uses and the uses themselves in the same list of exceptions. EPA is interested in comments on how these conditions of use are presented as exemptions from the significant new use.

C. Why is the Agency taking this action?

The Agency is proposing these SNURs to ensure that EPA receives timely advanced notice of any future manufacturing (including importing) or processing of the chemical substances subject to these proposed SNURs for uses identified as significant new uses that may produce changes in human and environmental exposures, and to ensure that an appropriate determination (relevant to the risks associated with such manufacturing (including importing), processing, distribution in commerce, use and disposal) has been issued prior to the commencement of such manufacturing (including importing) or processing. The proposed SNURs are necessary to ensure that manufacturing (including import) or processing for significant new uses cannot proceed until EPA has responded to the planned new use circumstances by taking the required actions under TSCA sections 5(e) or 5(f) in the event that EPA determines under section 5(a)(3) that: (1) The significant new use presents an unreasonable risk under the conditions of use (without consideration of costs or other nonrisk factors, and including an unreasonable risk to a potentially exposed or susceptible subpopulation (PESS) identified as relevant by EPA); (2) The information available to EPA is insufficient to permit a reasoned evaluation of the health and environmental effects of the significant new use; (3) In the absence of sufficient information, the manufacturing (including importing), processing, distribution in commerce, use, or disposal of the substance, or any combination of such activities, may present an unreasonable risk (without consideration of costs or other nonrisk factors, and including an unreasonable risk to a PESS identified as relevant by EPA); or (4) There is substantial production and sufficient potential for environmental release or human exposure (as defined in TSCA section 5(a)(3)(B)(ii)(II)). In order for manufacturing (including importing) or processing for the significant new use to proceed after EPA has made one of these four determinations, EPA must take actions under TSCA sections 5(e) or 5(f) to protect health and the environment. However, EPA may also determine that the significant new use is not likely to present an unreasonable risk under TSCA section 5(a)(3)(C), after which manufacturing (including importing) or processing for the significant new use may proceed.

EPA is separately conducting risk evaluations for the chemical substances subject to this proposed rule under their respective conditions of use, pursuant to TSCA section 6(b)(4)(A) (15 U.S.C. 2605(b)(4)(A)). The term “conditions of use” is defined in TSCA section 3(4) to mean 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. Through scoping and subsequent information gathering activity for the risk evaluations, EPA identified conditions of use to consider in the TSCA section 6 risk evaluations for these chemical substances. The conditions of use identified by EPA for the TSCA section 6 risk evaluations are listed for each chemical substance in Unit III.D. These conditions of use include (but are not limited to) all manufacture, processing, and use that the information available to the Agency demonstrates to be ongoing in the United States. EPA is not proposing to designate these conditions of use as significant new uses.

Additionally, as part of the information gathering activity associated with the risk evaluations for these chemical substances, EPA identified certain prior uses that have ceased, as well as industrial, commercial, or consumer conditions of use that are ongoing but for which manufacturing (including import) and processing have ceased. EPA is proposing to determine that manufacture and processing for these two categories of uses are no longer ongoing. These uses are also listed for each chemical substance in Unit III.D. Manufacture (including import) and processing of these chemical substances for these uses, as well as for any other potential use of these chemical substances not identified as a condition of use for the TSCA section 6 risk evaluations, are within the scope of this proposed SNUR.

The rationale and objectives for this proposed SNUR are further explained in Unit II.B.

D. Does this action apply to me?

1. General applicability.

You may be potentially affected by this action if you manufacture (including import), process, or distribute in commerce chemical substances and mixtures. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Manufacturers or processors of one or more subject chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries.

Textile manufacturing (NAICS code 313).
Fabric coating mills (NAICS code 313320).
All other leather good and allied product manufacturing (NAICS code 316998).
All other miscellaneous wood product manufacturing (NAICS code 321999).
Paper bag and coated treated paper manufacturing (NAICS code 322220).
Coated and laminated paper manufacturing (NAICS code 322222).
All other converted paper product manufacturing (NAICS code 322299).
Other basic inorganic chemical manufacturing (NAICS code 325180).
Alkalies and chlorine manufacturing (NAICS code 325181).
All other basic inorganic chemical manufacturing (NAICS code 325188).
All other basic organic chemical manufacturing (NAICS code 325199).
Plastics material and resin manufacturing (NAICS code 325211).

• Artificial and synthetic fibers and filaments manufacturing (NAICS code 325220).

Noncellulosic organic fiber manufacturing (NAICS code 325222).
Paint and coating manufacturing (NAICS code 325510).
Adhesive manufacturing (NAICS code 325520).
Custom compounding of purchased resins (NAICS code 325991).
Photographic film, paper, plate, and chemical manufacturing (NAICS code 325992).
All other miscellaneous chemical product and preparation manufacturing (NAICS code 325998).
Plastics and rubber products manufacturing (NAICS code 326).
Unlaminated plastics film and sheet (except packaging) manufacturing (NAICS code 326113).
Laminated plastics plate, sheet (except packaging), and shape manufacturing (NAICS code 326130).
Polystyrene foam product manufacturing (NAICS code 326140).
Urethane and other foam product (except polystyrene) manufacturing ((NAICS code 326150).
All other plastics product manufacturing (NAICS code 326199).
Other concrete product manufacturing (NAICS code 327390).
Other industrial machinery manufacturing (NAICS code 333249).
Computer and electronic product manufacturing (NAICS code 334).
Bare printed circuit board manufacturing (NAICS code 334412).
Semiconductor and related device manufacturing (NAICS code 334413).
Electronic connector manufacturing (NAICS code 334417).
Other electronic component manufacturing (NAICS code 334419).
Current-carrying wiring device manufacturing (NAICS code 335931).
Carbon and graphite product manufacturing (NAICS code 335991).
Automobile manufacturing (NAICS code 336111).
Other motor vehicle parts manufacturing (NAICS code 336390).
All other motor vehicle parts manufacturing (NAICS code 336399).
Aerospace product and parts manufacturing (NAICS code 336400).
Aircraft manufacturing (NAICS code 336411).
Other aircraft parts and auxiliary equipment manufacturing (NAICS code 336413).
Furniture and related product manufacturing (NAICS code 337).
Gasket, packing, and sealing device manufacturing (NAICS code 339991).
Other chemical and allied products merchant wholesalers (NAICS code 424690).
All other pipeline transportation (NAICS code 486990).
Testing laboratories and services (NAICS code 541380).
Hazardous waste treatment and disposal (NAICS code 562211).
Solid waste landfill (NAICS code 562212).
Other nonhazardous waste treatment and disposal (NAICS code 562219).
Materials recovery facilities (NAICS code 562920).
All other miscellaneous waste management services (NAICS code 562998).
National security (NAICS code 928110).

2. Applicability to importers and exporters.

This action may also affect certain entities through pre-existing import, including import certification, and export notification rules under TSCA. Chemical importers are subject to the import provision of TSCA section 13 (15 U.S.C. 2612), which requires that the Secretary of the Treasury “refuse entry into the customs territory of the United States” of any substance, mixture, or article containing a chemical substance or mixture that fails to comply with any rule issued under TSCA or that “is offered for entry in violation” of TSCA or certain rules or orders issued under TSCA, including rules issued under TSCA section 5. Persons who import any chemical substance in bulk form, as part of a mixture, or as part of an article (if required by rule) are also subject to TSCA section 13 import certification requirements and the corresponding regulations promulgated at 19 CFR 12.118 through 12.127 (see also 19 CFR 127.28). Chemical importers of the chemical substances in bulk form, as part of a mixture, or as part of an article (if required by rule) must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA, including regulations issued under TSCA sections 5, 6, 7 and Title IV. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B.

In addition, pursuant to 40 CFR 721.20, any persons who export or intend to export a chemical substance that is the subject of this proposed rule on or after July 24, 2023 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) and must comply with the export notification requirements in 40 CFR part 707, subpart D.

E. What are the estimated incremental impacts of this action?

EPA has evaluated the potential costs of establishing SNUR reporting requirements for potential manufacturers (including importers) and processors of the chemical substances included in this proposed rule. This analysis (Ref. 4), which is available in the docket, is briefly summarized here.

1. Estimated costs for SNUN submissions.

In the event that a SNUN is submitted, costs are an estimated $26,894 per SNUN submission for large business submitters and $11,204 for small business submitters. These estimates include the cost to prepare and submit the SNUN (including registration for EPA's Central Data Exchange (CDX)), and the payment of a user fee. Businesses that submit a SNUN would be subject to either a $19,020 user fee required by 40 CFR 700.45(c)(2)(ii) and (d), or, if they are a small business as defined at 13 CFR 121.201, a reduced user fee of $3,300 (40 CFR 700.45(c)(1)(ii) and (d)) per fiscal year 2022. The costs of submission of SNUNs will not be incurred by any company unless a company decides to pursue a significant new use as defined in this proposed SNUR. Additionally, these estimates reflect the costs and fees as they are known at the time this rulemaking.

2. Estimated costs for export notifications.

EPA has also evaluated the potential costs associated with the export notification requirements under TSCA section 12(b) and the implementing regulations at 40 CFR part 707, subpart D, which require exporters to notify EPA if they export or intend to export a chemical substance or mixture for which, among other things, a rule has been proposed or promulgated under TSCA section 5. For persons exporting a substance that is the subject of a SNUR, a one-time notice to EPA must be provided for the first export or intended export to a particular country. The total costs of export notification will vary by chemical, depending on the number of required notifications ( i.e., the number of countries to which the chemical is exported). While EPA is unable to make any estimate of the likely number of export notifications for the chemical substances covered by the proposed SNURs, as stated in the accompanying economic analysis, the estimated cost of the export notification requirement on a per unit basis is approximately $66.

F. What should I consider as I prepare my comments for EPA?

1. Submitting CBI. Do not submit this information to EPA through https://www.regulations.gov or email. If you wish to include CBI in your comment, please follow the instructions at https:// www.epa.gov/dockets and clearly mark the part or all the information that you claim to be CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets. EPA welcomes comment on all aspects of this proposed rule. In providing comments on an identified condition of use or a use that EPA proposes to determine is a significant new use for the chemical substances subject to this rule, please provide sufficient information for EPA to substantiate any assertions of an ongoing use for the specific chemical substance(s). EPA has identified in this notice the conditions of use that it plans to consider in the TSCA section 6 risk evaluation. It also has sought to identify uses that the information available to EPA demonstrates have been discontinued in the United States in Unit III. These lists are intended to provide examples and may not be exhaustive. Please note requests for comment related to specific aspects of this proposed rule in sections that follow (see Units III.B. (impurities and byproducts) and IV. (regulatory alternatives considered)).

II. Background

A. Significant New Use Determination

1. Determination factors.

TSCA section 5(a)(2) states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:

The projected volume of manufacturing and processing of a chemical substance.
The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.
The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

In addition to the factors enumerated in TSCA section 5(a)(2), the statute authorizes EPA to consider any other relevant factors.

2. Scientific standards, evidence, and available information.

EPA has used reasonably available information, as well as technical procedures, measures, methods, protocols, methodologies, and models consistent with the best available science, as applicable. These information sources supply information relevant to whether a particular use would be a significant new use, based on relevant factors including those listed under TSCA section 5(a)(2).

The clarity and completeness of the data, assumptions, methods, quality assurance, and analyses employed in EPA's decision are documented, as applicable and to the extent necessary for purposes of this proposed significant new use rule, in Units III.D. and V. and in the references cited throughout the preamble of this proposed rule. The extent to which the various information, procedures, measures, methods, protocols, methodologies or models used in EPA's decision have been subject to independent verification or peer review is adequate to justify their use, collectively, in the record for a significant new use rule.

3. Determination for these chemical substances.

To determine what would constitute a significant new use of TCEP, TBBPA and TPP, EPA considered relevant information about the toxicity or expected toxicity of these substances, likely human exposures and environmental releases associated with possible uses, and the four factors listed in TSCA section 5(a)(2). If any entity were to commence a new use, including to resume a use of TCEP, TBBPA, and TPP that had been phased out, that use could both change the type and form and increase the magnitude and duration of human and environmental exposure to the substances, and thus EPA believes such uses should be identified as significant new uses. Based on consideration of the statutory factors discussed herein, EPA is proposing to determine that the following uses constitute significant new uses: manufacturing (including importing) or processing of TCEP, TBBPA, and TPP for any use, with the exception that the conditions of use the Agency expects to consider within the scope of the TSCA section 6 risk evaluations are not proposed as significant new uses, as discussed in Unit III.D.

B. Rationale and Objectives of This Proposed Rule

1. Rationale.

Under TSCA, no person may manufacture a new chemical substance or manufacture or process a chemical substance for a significant new use until EPA makes a determination as described in TSCA section 5(a) and takes any required action. The issuance of a SNUR is not a risk determination itself, only a notification requirement for “significant new uses,” so that the Agency has the opportunity to review the SNUN for the significant new use and make a TSCA section 5(a)(3) risk determination.

Consistent with EPA's past practice for issuing SNURs under TSCA section 5(a)(2), EPA's decision to propose a SNUR for a particular chemical use need not be based on an extensive evaluation of the hazard, exposure, or potential risk associated with that use. If a person decides to begin manufacturing (including importing) or processing any of these chemicals for the use, the submission of the SNUN to EPA allows the Agency to evaluate the conditions of use.

EPA has identified the potential for adverse environmental and health effects from the conditions of use of TCEP, TBBPA, and TPP based on data and information sources already described in the proposed designation of TCEP, TBBPA, and TPP as high priority substances for TSCA section 6 risk evaluation and the final scopes of the risk evaluations for TCEP, TBBPA, and TPP (Refs. 1, 2, and 3). EPA will evaluate risk under TSCA section 6 from the conditions of use of TCEP, TBBPA, and TPP.

As discussed in this unit and Unit III.D., based on an extensive review of reasonably available information, EPA is proposing to determine that significant new uses of TCEP, TBBPA, and TPP are manufacture (including import) or processing for any use, with the exception that the conditions of use the Agency expects to consider within the scope of the TSCA section 6 risk evaluations are not proposed as significant new uses. The conditions of use that EPA identified for the TSCA section 6 risk evaluations include all manufacture, processing, and use that the information available to the Agency demonstrates to be ongoing in the United States. The proposed significant new uses include manufacture and processing for uses that have ceased; manufacture and processing for uses that have not yet ceased but for which all manufacture and processing has ceased; and manufacture and processing for uses for which EPA has no information demonstrating that the use has previously commenced in the United States. Among other things, EPA has identified certain uses of TCEP, TBBPA, and TPP that have ceased as well as industrial, commercial, or consumer conditions of use that are ongoing but for which manufacturing (including import) or processing have ceased. In the absence of a SNUR, the manufacturing (including importing) or processing of TCEP, TBBPA, and TPP for the significant new uses proposed in this rule could begin at any time, without prior notice to EPA under section 5 and without providing EPA an opportunity to review and address potential risks associated with the new use. EPA is concerned that commencement of manufacturing (including importing) or processing TCEP, TBBPA, and TPP for the proposed significant new uses, could significantly increase the volume of manufacturing (including importing) and processing of these chemicals, as well as the magnitude and duration of exposure to humans and the environment over that which would otherwise exist currently, particularly to the potentially exposed or susceptible subpopulations identified by EPA in the final scopes for risk evaluation or during risk evaluation. Given the concerns associated with the conditions of use as described in Unit III.D., EPA believes that notification and EPA's required review are warranted for these chemicals prior to the commencement of a significant new use.

2. Objectives.

Based on the considerations discussed in Unit III.D., EPA wants to achieve the following objectives with regard to the significant new use(s) designated in this proposed rule:

EPA would receive notice of any person's intent to manufacture (including import) or process the chemical substances for the described significant new use before that activity begins.
EPA would have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing (including importing) or processing the chemical substances for the described significant new use.
EPA would be able to either determine that the significant new use is not likely to present an unreasonable risk of injury, or to take such regulatory action as is associated with any other determination under TSCA section 5, before the manufacture or processing for the significant new use could commence.

C. Applicability of General Provisions to These Proposed SNURs

General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to SNURs, recordkeeping requirements, and exemptions to reporting requirements, among other things.

Provisions relating to user fees appear at 40 CFR part 700. Pursuant to 40 CFR 721.1(c), persons subject to SNURs must comply with the same requirements and EPA regulatory procedures as submitters of Premanufacture Notices (PMNs) under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA sections 5(b) and 5(d)(1), the exemptions authorized by TSCA sections 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720.

Once EPA receives a SNUN, EPA must either determine that the significant new use is not likely to present an unreasonable risk of injury or take such regulatory action as is associated with an alternative determination under TSCA section 5 before the manufacture (including import) or processing for the significant new use can commence. If EPA determines that the significant new use of the chemical substance is not likely to present an unreasonable risk, EPA is required under TSCA section 5(g) to make public, and submit for publication in the Federal Register , a statement of EPA's finding.

D. Applicability of General Exemptions to These Proposed SNURs

The general exemptions from SNUR notice requirements that are described in 40 CFR 721.45 apply to these proposed SNURs.

EPA is requesting public comment on the alternative of making inapplicable the article exemption at 40 CFR 721.45(f). Under this alternative, the import and processing of articles containing TCEP, TBBPA, and TPP would not be exempt from significant new use notification requirements. As EPA collects and reviews information about the importing or processing of TCEP, TBBPA, and TPP as part of articles and the potential exposure to these chemical substances through articles, EPA may consider whether to make inapplicable the articles exemption at 40 CFR 721.45(f).

EPA also seeks comment on the potential impact of making inapplicable the articles exemption on firms that plan to import or process articles containing TCEP, TBBPA, and TPP, because, while not required by the proposed SNUR, these parties may take additional steps to determine whether TCEP, TBBPA, and TPP are part of the articles that they are considering for importing or processing.

E. Applicability of the Proposed SNURs to Uses Occurring Before the Effective Date of the Final Rule

Any use that EPA determines, in the final rule, was ongoing as of the date of publication of this proposal and did not cease prior to issuance of the final rule, will not be designated as a significant new use in the final rule.

As discussed in the Federal Register of April 24, 1990 (55 FR 17376 (FRL–3658–5)), EPA has decided that the intent of the TSCA section 5(a)(1)(B) is best served by designating a use as a significant new use as of the date of publication of the proposed rule rather than as of the effective date of the final rule. The objective of EPA's approach is to ensure that a person cannot defeat a SNUR by initiating a significant new use after publication of the proposed rule but before the effective date of the final rule. Uses arising after the publication of the proposed rule are distinguished from uses that are identified in the final rule as having been ongoing on the date of publication of the proposed rule. The former would be new uses, the latter ongoing uses, except that uses that are identified as ongoing as of the publication of the proposed rule would not be considered ongoing uses if they have ceased by the date of issuance of a final rule.

Any person who begins commercial manufacturing (including importing) or processing of the chemical substances for a use that is designated as a significant new use in the final rule would have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons would have to first comply with all applicable SNUR notification requirements and wait until all TSCA prerequisites for the commencement of manufacture or processing have been satisfied.

F. Important Information About SNUN Submissions

1. SNUN submissions.

According to 40 CFR 721.1(c), persons submitting a SNUN must comply with the same notice requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710–25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 721.25 and 40 CFR 720.40. E–PMN software is available electronically at https://www.epa.gov/chemicals-under-tsca.

EPA recommends that SNUN submitters consult with the Agency if, for instance, the chemical substance is also subject to a rule, order, or consent agreement under TSCA section 4. Prior to submitting a SNUN, submitters should consider what information may be useful in evaluating a SNUN. Discussions with the Agency prior to submission can afford ample time to conduct any tests that might be helpful in evaluating risks posed by the substance.

2. Development and submission of information with the SNUN.

EPA recognizes that TSCA section 5 does not usually require developing new information ( e.g., generating test data) before submission of a SNUN. There is an exception: If a person is otherwise required to submit information for a chemical substance subject to the SNUR pursuant to a rule, TSCA Order or consent agreement under TSCA section 4, then TSCA section 5(b)(1)(A) requires such information to be submitted to EPA at the time of submission of the SNUN.

In the absence of a TSCA section 4 test rule, order, or consent agreement covering the chemical substance, persons are required to submit only information in their possession or control and to describe any other information known to or reasonably ascertainable by them (15 U.S.C. 2604(d); 40 CFR 721.25, and 40 CFR 720.50). However, as a general matter, EPA recommends that SNUN submitters include information that would permit a reasoned evaluation of risks posed by the chemical substance during its manufacture (including import), processing, distribution in commerce, use, or disposal. EPA encourages persons to consult with the Agency before submitting a SNUN. As part of this optional pre-notice consultation, EPA would discuss specific information it believes may be useful in evaluating a significant new use.

Submitting a SNUN that does not include information sufficient to permit a reasoned evaluation may increase the likelihood that EPA will either respond with a determination that the information available to the Agency is insufficient to permit a reasoned evaluation of the health and environmental effects of the significant new use or, alternatively, that in the absence of sufficient information, the manufacture, processing, distribution in commerce, use, or disposal of the chemical substance may present an unreasonable risk of injury.

EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. Furthermore, pursuant to TSCA section 4(h), which pertains to reduction of testing in vertebrate animals, EPA encourages consultation with the Agency on the use of alternative test methods and strategies (also called New Approach Methodologies, or NAMs), if available, to generate the recommended test data. EPA encourages dialog with Agency representatives to help determine how best the submitter can meet both the data needs and the objective of TSCA section 4(h). For more information on alternative test methods and strategies to reduce vertebrate animal testing, visit https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce.

The potentially useful information listed in Unit III. may not be the only means of addressing the potential risks of the chemical substance. However, submitting a SNUN without any test data or other information may increase the likelihood that EPA will take action under TSCA sections 5(e) or 5(f). EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.

SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following:

Human exposure and environmental release that may result from the significant new use of the chemical substance.
Information on risks posed by the chemical substances compared to risks posed by potential substitutes.

III. Chemical Substances Subject to This Proposed Rule

The proposed SNURs would apply to manufacturing (including import) or processing for certain uses of TCEP, TBBPA, and TPP as described in this unit.

A. What is the designated cutoff date for determining whether the use is new or ongoing for these chemical substances?

As explained in Unit II.D. EPA proposes to base its determination on whether a use is an ongoing use, as opposed to a new use, on information available to the agency (including information received during the public comment period) on whether the use was ongoing as of June 22, 2023. This is referred to as the cutoff date for determining whether a use is ongoing.

B. Do the proposed SNURs apply to impurities or byproducts?

In accordance with the impurity exemption at 40 CFR 721.45(d), the proposed SNURs would not apply to persons who manufacture (including import) or process TCEP, TBBPA, or TPP only as an impurity. EPA is not proposing to lift the impurities exemption for these SNURs. EPA is requesting public comment on any ongoing manufacturing (including import) or processing of TCEP, TBBPA, or TPP as an impurity.

There is no broad exemption for byproducts in EPA's general SNUR regulations at 40 CFR 721.45. Rather, EPA has only exempted byproducts from SNUR notification requirements in the limited circumstances where the person manufactures (including imports) or processes the substance only as a byproduct which is used only by public or private organizations that (1) burn it as a fuel; (2) dispose of it as a waste, including in a landfill or for enriching soil; or (3) extract component chemical substances from it for commercial purposes. See 40 CFR 721.45(e). Therefore, without a broader exemption in the proposed regulatory text of the SNURs, any other manufacturing (including importing) or processing of TCEP, TBBPA, or TPP as a byproduct that does not fall within a proposed exemption from the significant new use designations would be a significant new use subject to reporting requirements.

EPA is aware of ongoing activities that produce TBBPA and TPP as byproducts and continues to research such occurrences. EPA is requesting public comment on any ongoing manufacturing (including import) or processing of TCEP, TBBPA, or TPP as a byproduct that may not fall within the scope of the byproduct exemption at 40 CFR 721.45(e) and whether to include a broader exemption for manufacturing (including import) or processing as a byproduct in the final SNUR for these chemicals.

C. What information is provided for each chemical substance?

1. Chemical specific information.

For each chemical substance, EPA provides the following information in Unit III.D.:

Chemical name and Chemical Abstracts Service Registry Number (CASRN);
Uses EPA proposes to determine are significant new uses;
Conditions of use and production volumes;
Potential environmental and health effects; and
Potential routes and sources of exposure.

2. Background.

a. Conditions of use and production volumes.

In the draft scopes of the risk evaluations under TSCA section 6 for these chemicals, EPA identified and described the categories and subcategories of conditions of use that EPA expects to consider in the TSCA risk evaluations based on information reported to EPA through the Chemical Data Reporting (CDR) and Toxics Release Inventory (TRI) reporting, published literature, public comments and consultation with stakeholders for both uses currently in production and uses for which production may have ceased. EPA revised the conditions of use in the final scope of each risk evaluation based on additional information and public comments (Refs. 1, 2, and 3). TCEP, TBBPA, and TPP have conditions of use based on research conducted by the Agency that identified circumstances under which these chemical substances are intended, known or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of.

In conducting additional research on the conditions of use described in this proposed rule, EPA assembled information from the CDR and TRI programs, including production volumes and uses of TCEP, TBBPA, and TPP. Using this information EPA identified and described the categories and subcategories of conditions of use for the following lifecycle stages: manufacturing (including import); processing; distribution in commerce; industrial, commercial and consumer use; and disposal. EPA also consulted a variety of other sources to identify uses of TCEP, TBBPA, and TPP, including published literature, company websites, government and commercial trade databases and publications. To identify formulated products, including articles, EPA searched for safety data sheets (SDS) using internet searches, EPA Chemical and Product Categories (CPCat) data, and other resources in which SDSs could be found. SDSs were cross-checked with company websites to ensure that each product's SDS was current. In addition, EPA considered communications with companies, industry groups and public comments to supplement EPA's understanding of the conditions of use information. Production volume is based on data reported to EPA during the 2020 CDR submission period for calendar years 2016–2019 and described here as a range to protect production volumes that were claimed as CBI.

Finally, the Agency provides lists of identified conditions of use and uses proposed to be determined are significant new uses. In these lists, EPA specifies where such uses are among industrial, commercial, or consumer categories based on information in the final scopes for each chemical (Refs. 1, 2, and 3). In instances where such uses would include all three categories, EPA only lists the identified conditions of use and uses proposed to be determined as significant new uses.

b. Potential effects and routes of exposure.

As previously mentioned, certain phrasings of text and headings used in the proposed SNURs is identical to that used in the scope documents for each chemical. For example, comparable headings in the scope documents identify “Hazards (Effects),” “Environmental Hazards,” and “Human Health Hazards.” In this unit, the Agency is retaining traditional headings used in SNURs and will discuss such “effects” and “hazards” using text transferred from the scope documents.

D. Which chemical substances are subject to this proposed rule?

1. Tris(2-chloroethyl) phosphate (TCEP), CASRN 115–96–8.

a. Uses EPA proposes to determine are significant new uses.

EPA is proposing to designate as a significant new use manufacture (including import) or processing TCEP for any use, with the exception that the conditions of use the Agency expects to consider within the scope of the TSCA section 6 risk evaluation are not proposed as significant new uses. The conditions of use that EPA identified for the TSCA section 6 risk evaluation include all manufacture, processing, and use that the information available to the Agency demonstrates to be ongoing, as well as legacy uses and associated disposal, in the United States. At this time, EPA is aware that manufacture and processing for the following uses of TCEP have been discontinued and thus they are among the uses EPA proposes to determine are significant new uses:

Domestic manufacturing for any use;
Manufacturing (including import) for use in building and construction materials (insulation);
Processing for use in building and construction materials (insulation);
Manufacturing (including import) for use in wood and engineered wood products (wood resin composites);
Processing for use in wood and engineered wood products (wood resin composites);
Manufacturing (including import) for use in fabric and textile products;
Processing for use in fabric and textile products;
Manufacturing (including import) for use in foam seating and bedding products, except for foam used in aerospace equipment and products;
Processing for use in foam seating and bedding products, except for foam used in aerospace equipment and products;
Processing for incorporation into formulation, mixture, or reaction products, except for industrial and commercial use in polymers used in aerospace equipment and products; and
Processing for incorporation into article, except for industrial or commercial use in articles used in aerospace equipment and products.

b. Conditions of use and production volumes.

EPA is proposing to determine that the conditions of use of TCEP that EPA expects to consider in the TSCA section 6 risk evaluation include (but are not limited to) all ongoing manufacture, processing, and use of TCEP. EPA is proposing that the conditions of use that EPA expects to consider in the risk evaluation would not be significant new uses, even if they are not necessarily “ongoing” but are intended, known, or reasonably foreseen.

According to information reasonably available to the Agency, TCEP is imported into the United States and processed for commercial use in paints and coatings, which may be present in unoccupied spaces of consumer homes, and for industrial or commercial use in polymers for use in aerospace equipment and products (Ref. 1). In addition, TCEP is imported for commercial use as a laboratory chemical (Ref. 1). Historically, TCEP was incorporated into building and construction materials, such as roofing insulation and wood resin composites (Ref. 1). Some of these products may still be present in consumers' homes and in commercial infrastructure and, therefore, are still listed among the commercial and consumer conditions of use EPA has identified for risk evaluation (Ref. 1). Data reported to EPA during the 2020 CDR submission period indicate there is no reported production volume of 25,000 lbs. or more of TCEP domestically manufactured or imported into the United States. Because data reported to EPA during the 2016 CDR submission period indicated that TCEP was being imported, EPA concluded it is reasonably foreseen that TCEP continues to be imported below CDR production volume thresholds.

EPA has identified conditions of use of TCEP that are undergoing TSCA section 6 risk evaluation and are described in this unit in the same format that appears in the final scope document (Ref. 1), with minor edits for readability, supported by Agency research being conducted during TSCA risk evaluation of TCEP and for this SNUR. Please note that the following list contains conditions of use for all lifecycle stages of the chemical substance considered by TSCA section 6 risk evaluations. The proposed SNUR is directed at manufacture (including import) and processing for particular uses, but not other lifecycle stages such as distribution in commerce or disposal. The full list of conditions of use are included here to provide a comprehensive scope of conditions of use identified by the Agency. The conditions of use of TCEP that EPA has identified are:

Import for commercial use as a laboratory chemical;
Import for commercial use in paints and coatings;
Import for industrial or commercial use in polymers used in aerospace equipment and products;
Import for industrial or commercial use in articles used in aerospace equipment and products;
Processing for commercial use in paints and coatings;
Processing for industrial or commercial use in polymers used in aerospace equipment and products;
Processing for industrial or commercial use in articles used in aerospace equipment and products;
Recycling of articles;
Distribution in commerce;
Commercial use as a laboratory chemical;
Industrial or commercial use in aerospace equipment and products;
Commercial use in fabric and textile products;
Consumer use in fabric and textile products;
Commercial use in building and construction materials (insulation);
Consumer use in building and construction materials (insulation);
Commercial use in foam seating and bedding products;
Consumer use in foam seating and bedding products;
Commercial use in wood and engineered wood products (wood resin composites);
Consumer use in wood and engineered wood products (wood resin composites);
Commercial use in paints and coatings;
Consumer use in paints and coatings; and
Disposal.

c. Potential environmental and health effects.

During prioritization for TSCA section 6(b) risk evaluation, EPA identified environmental hazard effects for aquatic and terrestrial organisms, and also identified the following potential human health effects associated with TCEP: acute, repeated dose, genetic, reproductive, developmental, toxicokinetic, cancer, and neurological effects (Ref. 1). Since prioritization and as captured in the final scope, EPA applied automated techniques during the data screening phase of systematic review to identify the following additional potential human health hazards and related information that may be considered for the risk evaluation: cardiovascular, endocrine, gastrointestinal, hematological and immune, hepatic, mortality, musculoskeletal, nutritional and metabolic, ocular and sensory, renal, respiratory, skin and connective tissue, absorption, distribution, metabolism and excretion (ADME), and physiological based pharmacokinetic modeling and simulation (Ref. 1). Additional human health and environmental hazards may be considered during TSCA section 6(b) risk evaluation based on results from systematic review, as explained in Appendix A of the TCEP Final Scope (Ref. 1).

d. Potential routes and sources of exposure.

As previously mentioned, certain phrasings of text and headings in this unit are identical to that used in the scope documents for each chemical. In this unit, the Agency notes that certain discussions of environmental and general population exposures may list similar routes and sources of exposure; however, instead of modifying or synthesizing such discussions, the Agency is using text transferred from the scope documents. In addition, new or resumed uses would present potential routes and sources of exposure that could create concerns and, therefore, necessitate EPA review.

i. Environmental exposures.

The manufacturing (including import), processing, distribution, use and disposal of TCEP can result in releases to the environment and exposure to aquatic and terrestrial receptors (biota) via surface water, sediment, soil and ambient air. Environmental exposures to biota are informed by releases into the environment, overall persistence, degradation, bioaccumulation and partitioning across different media (Ref. 1). Concentrations of chemical substances in biota provide evidence of exposure (Ref. 1). TCEP has been identified in surface water, ground water and sediment, fish samples, seabird samples, and herring gull eggs (Ref. 1).

ii. Occupational exposures.

There is a potential for occupational exposure under various conditions of use of TCEP (Ref. 1). There is potential exposure from the processing of the chemical as it is incorporated into formulations and products and release from article components during their manufacture and industrial/commercial use, including handling and disposal of waste during manufacturing, processing (including recycling), and use (Ref. 1).

iii. Consumer exposures.

TCEP was previously incorporated into consumer products that may still be used, specifically fabric, textile, and leather products, and foam seating and bedding products, as well as building/construction materials including roofing insulation and wood and engineered wood products (Ref. 1). The main exposure routes for these uses where consumers interact with products and articles containing TCEP are dermal, inhalation, and dust ingestion, including children's mouthing of articles ( e.g., plastics, textiles, wood products) containing TCEP (Ref. 1).

iv. General population exposures.

Releases of TCEP from certain conditions of use, such as import, processing or disposal activities, may result in general population exposures (Ref. 1).

2. 4,4′-(1-methylethylidene)bis[2, 6-dibromophenol] (TBBPA), CASRN 79–94–7.

a. Uses EPA proposes to determine are significant new uses.

EPA is proposing to designate as a significant new use manufacture (including import) or processing TBBPA for any use, with the exception that the conditions of use the Agency expects to consider within the scope of the TSCA section 6 risk evaluation are not proposed as significant new uses. The conditions of use that EPA identified for the TSCA section 6 risk evaluation include all manufacture, processing, and use that the information available to the Agency demonstrates to be ongoing in the United States. At this time, EPA is aware that manufacture and processing for the following uses of TBBPA have been discontinued and thus they are among the uses EPA proposes to determine are significant new uses:

• Manufacturing (including import) for use in batteries ( e.g., adhesive in lead-acid battery casing and in lithium-ion batteries);

• Processing for use in batteries ( e.g., adhesive in lead-acid battery casing and in lithium-ion batteries);

• Manufacturing (including import) for use in fabric, leather, and textile products ( e.g., carpets, office furniture); and

• Processing for use in fabric, leather, and textile products ( e.g., carpets, office furniture).

b. Conditions of use and production volumes.

EPA is proposing to determine that the conditions of use of TBBPA that EPA expects to consider in the TSCA section 6 risk evaluation include (but are not limited to) all ongoing manufacture, processing, and use of TBBPA. EPA is proposing that the conditions of use that EPA expects to consider in the risk evaluation would not be significant new uses, even if they are not necessarily “ongoing” but are intended, known, or reasonably foreseen.

According to information reasonably available to the Agency, TBBPA is manufactured (including imported) in the United States (Ref. 2). The chemical is processed as a reactant or intermediate to create other flame retardants; incorporated into formulation, mixture or reaction products; and incorporated into articles (Ref. 2). Processing also includes the recycling of TBBPA and TBBPA-containing products (Ref. 2). The predominant uses for TBBPA are as a reactive flame retardant in electrical and electronic products ( e.g., printed circuit boards and semiconductor packages) and as an additive flame retardant in electrical and electronic products ( e.g., plastic enclosures) (Ref. 2). The epoxy resin containing TBBPA can also be used in adhesives, laminate for aviation and automobile interiors and building/construction materials (Ref. 2). Data reported to EPA during the 2020 CDR submission period indicate the reported production volume is between 20 million and 100 million pounds per year (Ref. 2).

EPA has identified conditions of use of TBBPA (Ref. 2), which are undergoing TSCA section 6 risk evaluation and are described in this unit in the same format that appears in the final scope document, with minor edits for readability, supported by Agency research being conducted during TSCA risk evaluation of TBBPA and for this SNUR. Please note that the following list contains conditions of use for all lifecycle stages of the chemical substance considered by TSCA section 6 risk evaluations. The proposed SNUR is directed at manufacture (including import) and processing for particular uses, but not other lifecycle stages such as distribution in commerce or disposal. The full list of conditions of use are included here to provide a comprehensive scope of conditions of use identified by the Agency. The conditions of use of TBBPA that EPA has identified are:

Domestic manufacturing;
Import;
Processing for use in adhesive manufacturing;
Processing for use in plastic material and resin manufacturing;
Processing for use in chemical product and preparation manufacturing;
Processing for use in electrical equipment, appliance and component manufacturing;
Processing for use in plastics product manufacturing;
Processing for use in computer and electronic product manufacturing;
Processing for use in electrical and electronic products;
Processing for use in printed circuit boards and semiconductor packages;
Processing for use in interior material for transportation equipment;
Processing for use in plastic electronic enclosures;
Recycling of electronic products;
Distribution in commerce;
Industrial or commercial use in electrical and electronic products;
Consumer use in electrical and electronic products;
Industrial or commercial use in prepreg material for automotive and aviation interiors;
Industrial or commercial use in building and construction materials;

• Industrial or commercial use in fabric, textile and leather products ( e.g., carpets, office furniture);

• Consumer use in fabric, textile and leather products ( e.g., carpets, office furniture);

Industrial or commercial use as a laboratory chemical;
Disposal.

c. Potential environmental and health effects.

During prioritization for TSCA section 6(b) risk evaluation, EPA identified environmental hazard effects from TBBPA for aquatic and terrestrial organisms, and also identified the following potential human health effects: immunological, neurological, carcinogenic, and developmental (Ref. 2). Since prioritization and as captured in the final scope, EPA applied automated techniques during the data screening phase of systematic review to identify the following additional potential human health hazards and related information that may be considered for the risk evaluation: cardiovascular, endocrine, gastrointestinal, hematological, hepatic, mortality, nutritional and metabolic ocular and sensory, renal, reproductive, respiratory, skin and connective tissue, and ADME (Ref. 2). Additional human health and environmental hazards may be considered during TSCA section 6(b) risk evaluation based on results from systematic review, as explained in Appendix A of the TBBPA Final Scope (Ref. 2).

d. Potential routes and sources of exposure.

i. Environmental exposures.

The manufacturing, processing, distribution, use and disposal of TBBPA can result in releases to the environment and exposure to aquatic and terrestrial receptors (biota) (Ref. 2). Environmental exposures to biota are informed by releases into the environment, overall persistence, degradation and bioaccumulation within the environment and partitioning across different media (Ref. 2). Concentrations of chemical substances in biota provide evidence of exposure (Ref. 2).

ii. Occupational exposures.

Releases of TBBPA from certain conditions of use, such as manufacturing, processing, industrial/commercial uses, and disposal may result in occupational exposures (Ref. 2). Examples of occupational activities associated with the conditions of use identified for TBBPA include, but are not limited to: unloading and transferring TBBPA to and from storage containers to process vessels during manufacturing; processing and use; handling and disposing of waste containing TBBPA during manufacturing, processing (including recycling), and use; cleaning and maintaining equipment during manufacturing, processing (including recycling), and use; sampling chemicals, formulations or products containing TBBPA for quality control during manufacturing, processing (including recycling), and use; and performing other work activities in or near areas where TBBPA is used (Ref. 2).

EPA anticipates inhalation of dust and other respirable particles as an exposure pathway during the manufacture and processing of various articles containing TBBPA ( e.g., particulate generated during handling of plastic resins, finishing operations associated with the manufacture and finishing of plastics and plastic articles and incorporation of plastics and other article components into finished products) (Ref. 2). Dermal exposures for workers are possible during conditions of use (Ref. 2).

iii. Consumer exposures.

According to CDR reports, TBBPA appears to be used in consumer products used in indoor environments, specifically fabric, textile, and leather products, electrical and electronic products (including in the plastic enclosures), children's products, and building/construction materials (Ref. 2). Several of these products have the potential to be mouthed by children (Ref. 2). In addition, handling TBBPA-containing materials during disposal can lead to consumer and bystander exposures (Ref. 2). The main exposure routes where consumers interact with products and articles containing TBBPA are dermal, inhalation and dust ingestion, including children's mouthing of articles ( e.g., electronics, plastics, textiles) containing TBBPA (Ref. 2).

iv. General population exposures.

Releases of TBBPA from certain conditions of use, such as manufacturing, processing or disposal, may result in general population exposures (Ref. 2). TBBPA has been found in drinking water, ground water, ambient air, indoor air, fish, human breast milk and dust and soil (Ref. 2).

3. Triphenyl phosphate (TPP), CASRN 115–86–6.

a. Uses EPA proposes to determine are significant new uses.

EPA is proposing to designate as a significant new use manufacture (including import) or processing TPP for any use, with the exception that the conditions of use the Agency expects to consider within the scope of the TSCA section 6 risk evaluation are not proposed as significant new uses. The conditions of use that EPA identified for the TSCA section 6 risk evaluation include all manufacture, processing, and uses that the information available to the Agency demonstrates to be ongoing in the United States. At this time, EPA is aware that manufacture and processing for the following uses of TPP have been discontinued and thus they are among the uses EPA proposes to determine are significant new uses:

Manufacturing (including import) for use in photographic applications; and
Processing for use in photographic applications.

b. Conditions of use and production volumes.

EPA is proposing to determine that the conditions of use of TPP that EPA expects to consider in the TSCA section 6 risk evaluation include (but are not limited to) all ongoing manufacture, processing, and use of TPP. EPA is proposing that the conditions of use that EPA expects to consider in the risk evaluation would not be significant new uses, even if they are not necessarily “ongoing” but are intended, known, or reasonably foreseen.

According to information reasonably available to the Agency, TPP is manufactured (including imported) in the United States (Ref. 3). The chemical is processed as a reactant; incorporated into formulation, mixture, or reaction products; and incorporated into articles (Ref. 3). Several commercial uses were identified, mainly in plastic and rubber products, and in paints and coatings (Ref. 3). Other uses reported include use in lubricants and greases. Consumer uses were reported in foam seating and bedding products (Ref. 3). Data reported to EPA during the 2020 CDR submission period indicate the reported production volume is between 1 million and 10 million pounds per year (Ref. 3).

EPA has identified conditions of use of TPP (Ref. 3), which are undergoing TSCA section 6 risk evaluation and are described in this unit in the same format that appears in the final scope document, with minor edits for readability, supported by Agency research being conducted during TSCA risk evaluation of TPP and for this SNUR. Please note that the following list contains conditions of use for all lifecycle stages of the chemical substance considered by TSCA section 6 risk evaluations. The proposed SNUR is directed at manufacture (including import) and processing for particular uses, but not other lifecycle stages such as distribution in commerce or disposal. The full list of conditions of use are included here to provide a comprehensive scope of conditions of use identified by the Agency. The conditions of use of TPP that EPA has identified are:

Domestic manufacturing;
Import (including repackaging);
Processing for use in plastics material and resin manufacturing;
Processing for use in plastic product manufacturing;
Processing for use in computer and electronic product manufacturing;
Processing for use in rubber product manufacturing;
Processing for use in textiles, apparel, and leather manufacturing;
Processing for use in furniture and related product manufacturing;
Processing for use in paint and coating manufacturing;
Processing for use in all other chemical product and preparation manufacturing;
Processing for use in adhesives, sealants, lubricants, and greases;
Processing for use in operational fluids, maintenance fluids and semisolids, reactive fluids, and solids used in aerospace industry;
Processing for use in turbine engine oils in aviation;
Processing for use in turbine engine oils in non-aviation industries;
Processing for use in furniture and related product manufacturing;
Recycling;
Distribution in commerce;
Industrial or commercial use in paints and coatings;
Industrial or commercial use in plastic and rubber products;
Consumer use in plastic and rubber products;
Industrial or commercial use as a laboratory chemical;
Industrial or commercial use in lubricants and greases;
Consumer use in lubricants and greases;
Industrial or commercial use in operational fluids, maintenance fluids and semisolids, reactive fluids, and solids used in aerospace industry;
Industrial or commercial use in turbine engine oils used in aviation;
Industrial or commercial use in turbine engine oils used in non-aviation industries;
Industrial or commercial use in electrical and electronic products;
Consumer use in electrical and electronic products;
Industrial or commercial use in foam seating and bedding products;
Consumer use in foam seating and bedding products;
Industrial or commercial use in furniture and furnishings;
Industrial or commercial use in building and construction materials; and
Disposal.

c. Potential environmental and health effects.

During prioritization for TSCA section 6(b) risk evaluation, EPA identified potential environmental hazard effects from TPP for aquatic and terrestrial organisms, and also identified the following potential human health effects and related information: developmental, irritation, corrosion, and repeated dose (Ref. 3). Since prioritization and as captured in the final scope, EPA applied automated techniques during the data screening phase of systematic review to identify the following additional potential human health hazards and related information that may be considered for the risk evaluation: cancer, cardiovascular, endocrine, gastrointestinal, hematological and immune, hepatic, mortality, musculoskeletal, neurological, nutritional and metabolic, ocular and sensory, renal, reproductive, skin and connective tissue, and ADME (Ref. 3). Additional human health and environmental hazards may be considered during TSCA section 6(b) risk evaluation based on results from systematic review, as explained in Appendix A of the TPP Final Scope (Ref. 3).

d. Potential routes and sources of exposure.

i. Environmental exposures.

The manufacturing, processing, distribution, use and disposal of TPP can result in releases to the environment and exposure to aquatic and terrestrial receptors (biota) (Ref. 3). TPP was detected in wastewater effluent, landfill leachate, sediment, soil, ambient air, as well as in fish (including shellfish) and dolphins (Ref. 3).

ii. Occupational exposures.

There is a potential for occupational exposure under the various conditions of use (manufacturing (including import), processing, industrial/commercial uses, and disposal) (Ref. 3). Also, there are potential exposures from the processing of TPP as it is incorporated into formulations and products (Ref. 3). There is also potential for exposure from additive flame retardants due to release from article components during their manufacture and industrial/commercial use (Ref. 3).

EPA anticipates inhalation of mist, dust, and other respirable particles as an occupational exposure pathway during the manufacture, processing, and commercial/industrial use of various products containing TPP ( e.g., particulate generated during manufacture and handling of foam and plastics and incorporation of foam and plastics into finished products, and mist generated during application to textiles and application of paints and coatings) (Ref. 3). For the oral route, workers and occupational non-users may inadvertently ingest inhaled particles that deposit in the upper respiratory tract or may transfer chemicals from their hands to their mouths (Ref. 3). Also, there is potential dermal exposure from contact with solids during packaging and repackaging operations at manufacturing and import sites when TPP is handled as a dry powder (Ref. 3). EPA also anticipates dermal exposure to liquid if TPP is formulated with liquid chemical and handled as a liquid (Ref. 3).

iii. Consumer exposures.

TPP is used in consumer products used in indoor environments, including foam seating and bedding products, and plastic and rubber products (Ref. 3). TPP use has also been reported in electrical and electronic products (Ref. 3). Several of these products have the potential to be mouthed by children. In addition, handling during the disposal of TPP-containing materials can lead to consumer and bystander exposures (Ref. 3). The main exposure routes for these uses where consumers interact with products and articles containing TPP are dermal, inhalation, and dust ingestion, including children's mouthing of articles ( e.g., textiles, wood products and plastics) containing TPP (Ref. 3). Therefore, potential sources and pathways of exposure to consumers include oral, dermal and inhalation; for bystanders, only the inhalation route may result from the conditions of use of TPP (Ref. 3).

iv. General population exposures.

Releases of TPP from certain conditions of use, such as manufacturing, processing, or disposal activities, may result in general population exposures (Ref. 3). TPP was detected in surface water, ground water, soil, ambient air, indoor air, indoor dust, as well as in fish (including shellfish) (Ref. 3).

V. References

The following is a listing of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not physically located in the docket. For assistance in locating these other documents, please consult the technical person listed under FOR FURTHER INFORMATION CONTACT .

1. EPA. Final Scope of the Risk Evaluation for Tris(2-chloroethyl) Phosphate (TCEP); CASRN 115–96–8. August 2020. EPA Document # EPA–740–R–20–009. Available at: https://www.epa.gov/sites/default/files/2020-09/documents/casrn_115-96-8_tris2-chloroethyl_phosphate_tcep_final_scope.pdf.

2. EPA. Final Scope of the Risk Evaluation for 4,4′-(1-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA); CASRN 79–94–7. August 2020. EPA Document # EPA–740–R–20–008. Available at: https://www.epa.gov/sites/default/files/2020-09/documents/casrn_79-94-7_44-1-methylethylidenebis2_6-dibromophenol_tbbpa_finalscope.pdf.

3. EPA. Final Scope of the Risk Evaluation for Triphenyl Phosphate (TPP); CASRN 115–86–6. August 2020. EPA Document # EPA–740–R–20–010. Available at: https://www.epa.gov/sites/default/files/2020-09/documents/casrn_115-86-6_triphenyl_phosphate_tpp_final_scope.pdf.

4. EPA. Economic Analysis of the Proposed Significant New Use Rules for Flame Retardants Undergoing TSCA Section 6 Risk Evaluation. May 9, 2023.

VI. Statutory and Executive Order Reviews

Additional information about these statutes and Executive Orders can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and 14094: Modernizing Regulatory Review

This action is not a significant regulatory action as defined in Executive Order 12866 (58 FR 51735, October 4, 1993), as amended by Executive Order 14094 (88 FR 21879, April 11, 2023), and was therefore not subject to a requirement for Executive Order 12866 review.

B. Paperwork Reduction Act (PRA)

This action does not impose any new information collection burden under the PRA, 44 U.S.C. 3501 et seq. OMB has previously approved the information collection activities contained in the existing SNUR regulations under OMB Control No. 2070–0038 (EPA ICR No. 1188.13). If an entity were to submit a SNUN to the Agency, the annual burden is estimated to be less than 100 hours per response, and the estimated burden for export notifications is less than 1.5 hours per notification. In both cases, if the firm submitting either a SNUN or export notification is already registered in CDX, the burden would be lower than the presented estimates.

An agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under the PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register , are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable.

Consistent with the PRA, EPA is interested in comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden or improving the automated collection techniques.

C. Regulatory Flexibility Act (RFA)

I certify this action will not have a significant economic impact on a substantial number of small entities under the RFA, 5 U.S.C. 601 et seq. The small entities subject to the requirements of this action are potential future manufacturers (defined by statute to include importers), processors, and exporters of one or more subject chemical substances for a significant new use designated in the proposed SNURs. The requirement to submit a SNUN applies to any person (including small or large entities) who intends to engage in any activity described in the final rule as a “significant new use.” Because these uses are “new,” based on all information currently available to EPA, the Agency has determined that no small or large entities presently engage in such activities. A SNUR requires that any person who intends to engage in such activity in the future must first notify EPA by submitting a SNUN. EPA's experience to date is that, in response to the promulgation of SNURs covering over 1,000 chemicals, the Agency receives only a small number of notices per year. For example, the number of SNUNs received was 10 in federal fiscal year (FY) FY2016, 14 in FY2017, 16 in FY2018, five in FY2019, seven in FY2020, and 13 in FY2021, and only a fraction of these were from small businesses. In addition, the Agency currently offers relief to qualifying small businesses by reducing the SNUN submission fee from $19,020 to $3,330. This lower fee reduces the total reporting and recordkeeping of cost of submitting a SNUN to about $11,204 for qualifying small firms. Therefore, the potential economic impacts of complying with this proposed SNUR are not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published in the Federal Register of June 2, 1997 (62 FR 29684) (FRL–5597–1), the Agency presented its general determination that final SNURs are not expected to have a significant economic impact on a substantial number of small entities, which was provided to the Chief Counsel for Advocacy of the Small Business Administration.

D. Unfunded Mandates Reform Act (UMRA)

This action does not contain any unfunded mandates as described in UMRA, 2 U.S.C. 1531–1538, and does not significantly or uniquely affect small governments. Based on EPA's experience with proposing and finalizing SNURs, state, local, and tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any state, local, or tribal government will be impacted by this action. As such, EPA has determined that this proposed rule would not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).

E. Executive Order 13132: Federalism

This action does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it will not have substantial direct effect on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments

This action does not have tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000), because it will not have substantial direct effects on tribal governments, on the relationship between the federal government and the Indian tribes, or on the distribution of power and responsibilities between the federal government and Indian tribes. This action will not significantly nor uniquely affect the communities of tribal governments, nor would it involve or impose any requirements that affect Indian tribes.

G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks

EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997), as applying only to those regulatory actions that concern environmental health or safety risks that EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2–202 of Executive Order 13045. Since this is not a “covered regulatory action,” Executive Order 13045 does not apply, and since this action does not address human health concerns, EPA's policy on Children's Health also does not apply to this SNUR. However, the EPA Policy on Children's Health will apply to the consideration of the SNUNs submitted to EPA in response to a SNUR.

Although this action does not concern an environmental health or safety risk, the designation of certain uses of the subject chemicals as significant new uses ensures the Agency has an opportunity to review and address potential risks associated with such uses before an entity begins commencing any manufacture (including import) or processing of the chemical substance for that use. Once EPA receives a notification, EPA must review and make an affirmative determination on the notification, and take such action as is required by any such determination before the manufacture (including import) or processing for the significant new use can commence. Such a review will assess whether the use identified in the SNUN may present unreasonable risk to health or the environment and ensure that EPA can prevent future unsafe environmental releases of the chemical substances subject to the SNUR. As discussed previously, EPA is concerned about the potential for adverse health effects from the conditions of use of TCEP, TBBPA, and TPP for children and will evaluate the risk under TSCA section 6.

H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use

This action is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not a “significant regulatory action” under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

This rulemaking does not involve any technical standards under the NTTAA section 12(d) (15 U.S.C. 272 note).

J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations

Executive Order 12898 (59 FR 7629, February 16, 1994) directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations (people of color and/or indigenous peoples) and low-income populations.

EPA believes that it is not practicable to assess whether the human health or environmental conditions that exist prior to this action result in disproportionate and adverse effects on people of color, low-income populations and/or indigenous peoples. The SNURs do not address any human health or environmental risks or affect the level of protection provided to human health or the environment. Although this action does not concern human health or environmental conditions, the designation of certain uses as significant new uses subject to this proposed SNUR ensures the Agency has an opportunity to review and address potential risks associated with such uses. As noted previously, EPA is concerned about the potential for adverse health effects from the conditions of use of TCEP, TBBPA, and TPP and will evaluate those conditions of use under TSCA section 6, including health effects associated with those conditions of use affecting potentially exposed or susceptible subpopulations that may be at greater risk of adverse health effects due to biological susceptibility based on factors such as race/ethnicity, life stage, lifestyle factors, and nutrition status. The SNUR would require the submission of a SNUN before the manufacture (including import) or processing for the significant new use can commence. EPA would then review the SNUN submission to assess whether the use identified in the SNUN may present unreasonable risk to health or the environment and take appropriate action to prevent unreasonable risk from the chemical substances subject to the SNUR. Furthermore, information submitted under TSCA can also be used by others to identify potential problems, set priorities, and take appropriate steps to reduce any potential risks to human health and the environment and may make more information available to the public and interested communities that they can use to better assess potential exposures and risks to minority, low-income or indigenous populations, or tribes. For example, EPA provides public access to the information EPA receives and develops about chemical substances regulated under TSCA via ChemView ( https://chemview.epa.gov/chemview ).

List of Subjects in 40 CFR Part 721

Environmental protection
Chemicals
Hazardous substances
Reporting and recordkeeping requirements

Dated: June 15, 2023.

Denise Keehner,

Director, Office of Pollution Prevention and Toxics.

Therefore, for the reasons set forth in the preamble, it is proposed that 40 CFR chapter I be amended as follows:

PART 721—SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES

1. The authority citation for part 721 continues to read as follows:

Authority: 15 U.S.C. 2604, 2607, and 2625(c).

2. Add §§ 721.11778 through 721.11780 to subpart E to read as follows:

§ 721.11778

Tris(2-chloroethyl) phosphate.

(a) Chemical substance and significant new use subject to reporting.

(1) The chemical substance identified as tris(2-chloroethyl) phosphate (TCEP) (CASRN 115–96–8) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses for the chemical substance identified in paragraph (a)(1) of this section are:

(i) Any manner or method of manufacture (excluding import) of the substance associated with any use; and

(ii) Import or processing of the substance for any use, except for:

(A) Commercial use as a laboratory chemical;

(B) Commercial use in paints and coatings;

(C) Industrial or commercial use in polymers used in aerospace equipment and products and in articles in aerospace equipment and products; or

(D) Recycling of articles.

(b) Specific requirements. The provisions of subpart A of this part apply to this section.

§ 721.11779

4,4′-(1-methylethylidene)bis[2, 6-dibromophenol].

(a) Chemical substance and significant new uses subject to reporting.

(1) The chemical substance identified as 4,4′-(1-methylethylidene)bis[2, 6-dibromophenol], also known as “tetrabromobisphenol A,” (TBBPA) (CASRN 79–94–7) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses for the chemical substance identified in paragraph (a)(1) of this section are manufacture (including import) or processing for any use except in:

(i) Adhesive manufacturing;

(ii) Plastic material and resin manufacturing;

(iii) Chemical product and preparation manufacturing;

(iv) Electrical equipment, appliance and component manufacturing;

(v) Plastics product manufacturing;

(vi) Computer and electronic product manufacturing;

(vii) Electrical and electronic products;

(viii) Printed circuit boards and semiconductor packages;

(ix) Interior material for transportation equipment;

(x) Plastic electronic enclosures;

(xi) Industrial or commercial use in prepreg material for automotive and aviation interiors for;

(xii) Industrial or commercial use as a laboratory chemical for; or

(xiii) Recycling of electronic products.

(b) Specific requirements. The provisions of subpart A of this part apply to this section.

§ 721.11780

Triphenyl phosphate.

(a) Chemical substance and significant new uses subject to reporting.

(1) The chemical substance identified as Triphenyl phosphate (TPP) (CASRN 115–86–6) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses for the chemical substance identified in paragraph (a)(1) of this section are manufacture (including import) or processing for any use except in:

(i) Plastics material and resin manufacturing;

(ii) Plastic product manufacturing;

(iii) Computer and electronic product manufacturing;

(iv) Rubber product manufacturing;

(v) Textiles, apparel, and leather manufacturing;

(vi) Furniture and related product manufacturing;

(vii) Paint and coating manufacturing;

(viii) Chemical product and preparation manufacturing;

(ix) Adhesives, sealants, lubricants, and greases;

(x) Electrical and electronic products;

(xi) Plastic and rubber products;

(xii) Industrial or commercial use in paints and coatings;

(xii) Industrial use in hydraulic fluid;

(xiii) Industrial or commercial use in turbine engine oils in aviation industries;

(xiv) Industrial or commercial use in turbine engine oils in non-aviation industries;

(xv) Industrial or commercial use in operational fluids, maintenance fluids and semisolids, reactive fluids, and solids used in aerospace industries;

(xvi) Industrial or commercial use in laboratory chemicals;

(xvii) Foam seating and bedding products;

(xviii) Industrial or commercial use in furniture and furnishings;

(xix) Industrial or commercial use in building and construction materials; or

(xx) Recycling.

(b) Specific requirements. The provisions of subpart A of this part apply to this section.

[FR Doc. 2023–13250 Filed 6–21–23; 8:45 am]

BILLING CODE 6560–50–P