AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Proposed rule.

SUMMARY:

EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for chemical substances that were the subject of premanufacture notices (PMNs) and are subject to Orders issued by EPA pursuant TSCA. The SNURs require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is proposed as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA's evaluation of the use, under the conditions of use for that chemical substance, within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required by that determination.

DATES:

Comments must be received on or before June 3, 2020.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2019-0596, by one of the following methods:

• Federal eRulemaking Portal: http://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.
• Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001.
• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/​dockets/​contacts.html.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/​dockets.

FOR FURTHER INFORMATION CONTACT:

For technical information contact: Kenneth Moss, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-9232; email address: moss.kenneth@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. General Information

A. Does this action apply to me?

You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this proposed rule. 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.

This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and Orders under TSCA. Importers of chemicals subject to final SNURs must certify compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this proposed rule on or after June 3, 2020 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see 40 CFR 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.

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

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as 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 http://www.epa.gov/​dockets/​comments.html.

II. Background

A. What action is the agency taking?

EPA is proposing these SNURs under TSCA section 5(a)(2) for chemical substances that were the subject of PMNs. These proposed SNURs would require persons to notify EPA at least 90 days before commencing the manufacture or processing of a chemical substance for any activity proposed as a significant new use. Receipt of such notices would allow EPA to assess risks and, if appropriate, to regulate the significant new use before it may occur. Additional background regarding SNURs is more fully set out in the preamble to EPA's first direct final SNUR published in the Federal Register issue of April 24, 1990 (55 FR 17376). Consult that preamble for further general information on the objectives, rationale, and procedures for SNURs and on the basis for significant new use designations, including provisions for developing test data.

B. 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 the four TSCA section 5(a)(2) factors listed in Unit III. Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture or process the chemical substance for that use (15 U.S.C. 2604(a)(1)(B)(i)). TSCA furthermore prohibits such manufacturing or processing from commencing until EPA has conducted a review of the notice, made an appropriate determination, and taken such actions as are required in association with that determination (15 U.S.C. 2604(a)(1)(B) ii)). In the case of a determination other than not likely to present unreasonable risk, the applicable review period must also expire before manufacturing or processing for the new use may commence.

C. Applicability of General Provisions

General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the proposed rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. According to 40 CFR 721.1(c), persons subject to these SNURs must comply with the same SNUN requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). These requirements include the information submission requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 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 use is not likely to present an unreasonable risk of injury under the conditions of use for the chemical substance or take such regulatory action as is associated with an alternative determination before the manufacture or processing for the significant new use can commence. In the case of a determination other than not likely to present unreasonable risk, the applicable review period must also expire before manufacturing or processing for the new use may commence. If EPA determines that the use 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 findings.

III. Significant New Use Determination

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 determining what would constitute a significant new use for the chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances, likely human exposures and environmental releases associated with possible uses, and the four TSCA section 5(a)(2) factors listed in this unit. These proposed rules include PMN substances that are subject to Orders issued under TSCA section 5(e)(1)(A), as required by the determinations made under TSCA section 5(a)(3)(B). Those Orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The proposed SNURs would identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying Orders, consistent with TSCA section 5(f)(4).

IV. Substances Subject to This Proposed Rule

EPA is proposing significant new use and recordkeeping requirements for certain chemical substances in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each chemical substance:

• PMN number.
• Chemical name (generic name, if the specific name is claimed as CBI).
• Chemical Abstracts Service (CAS) Registry number (if assigned for non-confidential chemical identities).
• Effective date of and basis for the TSCA section 5(e) Order.
• Potentially Useful Information.
• CFR citation assigned in the regulatory text section of the proposed rule.

These proposed rules include PMN substances that are subject to Orders issued under TSCA section 5(e)(1)(A), as required by the determinations made under TSCA section 5(a)(3)(B). Those Orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The proposed SNURs would identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying Orders, consistent with TSCA section 5(f)(4).

Where EPA determined that the PMN substance may present an unreasonable risk of injury to human health via inhalation exposure, the underlying TSCA section 5(e) Order usually requires that potentially exposed employees wear specified respirators unless actual measurements of the workplace air show that air-borne concentrations of the PMN substance are below a New Chemical Exposure Limit (NCEL), include requirements addressing performance criteria for sampling and analytical methods, periodic monitoring, respiratory protection, and recordkeeping. No comparable NCEL provisions currently exist in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases, the individual SNURs in 40 CFR part 721, subpart E, will state that persons subject to the SNUR who wish to pursue NCELs as an alternative to the 40 CFR 721.63 respirator requirements may request to do so under 40 CFR 721.30. EPA expects that persons whose 40 CFR 721.30 requests to use the NCELs approach for SNURs that are approved by EPA will be required to comply with NCELs provisions that are comparable to those contained in the corresponding TSCA section 5(e) Order for the same chemical substance.

The chemicals subject to these proposed SNURs are as follows:

PMN Number: P-14-865

Chemical Name: Aromatic amide oxime (generic).

CAS Number: Not available.

Effective date of TSCA section 5(e) Order: September 6, 2018.

Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the PMN substance will be as an intermediate. EPA identified concerns for mutagenicity based on analysis of test data on analogs. EPA also identified concerns for toxicity to fish based on analysis of test data on the PMN substance. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(I)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the TSCA Order requires:

• Use of personal protective equipment (where there is potential for dermal exposure);
• Use of the PMN substance only as a chemical intermediate; and
• No predictable or purposeful release of a manufacturing, processing, or use stream associated with any use of the PMN substance into the waters of the United States exceeding a surface water concentration of 30 parts per billion (ppb).

The SNUR designates as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information may be potentially useful to characterize the effects of the PMN substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. EPA has also determined that the results of specific reproductive/developmental testing and chronic aquatic toxicity testing would help characterize the potential human and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or relevant information.

CFR citation: 40 CFR 721.11466.

PMN Number: P-15-54

Chemical Name: Carbon nanotubes (generic).

CAS Number: Not available.

Effective Date of TSCA section 5(e) Order: December 17, 2019.

Basis for TSCA section 5(e) Order: The PMN states that the use of the PMN substance will be as a chemical intermediate to manufacture functionalized carbon nanotubes by oxidation with nitric acid; an additive in rubber polymers to improve mechanical/physical/chemical/electrical properties; an additive in resin polymers to improve mechanical/physical/chemical/electrical properties; an additive in metals to improve electrical/thermal properties; an additive in ceramics to improve mechanical/electrical/thermal properties; a semi-conductor, conductive, or resistive element in electronic circuitry and devices; an electric collector element or electrode in energy devices; a photoelectric or thermoelectric conversion elements in energy devices; a catalyst support element or catalytic electrode for use in energy devices; an additive for transparency and conductivity in electronic devices; and an electro-mechanical element in actuator, sensor, or switching devices. Based on carbon nanotube analogues, data submitted for the PMN substance, and comparison to analogous respirable, poorly soluble particulates, EPA identified concerns for pulmonary toxicity and oncogenicity. A direct final SNUR was issued for this PMN substance on November 17, 2016 (81 FR 81250), and withdrawn on January 19, 2017 (82 FR 6277) in response to the PMN submitter's intent to submit adverse comments, which was a request to modify the original 5(e) Order to add more uses. The Order (as modified) was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the TSCA Order requires:

• Use of personal protective equipment where there is a potential for dermal exposure;
• Use of a National Institute for Occupational Safety and Health (NIOSH)-certified respirator with an Assigned Protection Factor (APF) of at least 50 where there is a potential for inhalation exposure;
• Use of the PMN substance other than as allowed in the TSCA Order;
• Waste streams from manufacture, processing, and use must be disposed of only by incineration or landfill; and
• No predictable or purposeful release of a manufacturing, processing, or use stream associated with any use of the PMN substance into the waters of the United States.

The proposed SNUR would designate as a “significant new use” in the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the environmental effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the TSCA Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. EPA has determined that the results of chronic aquatic toxicity testing, with NOM (natural organic matter) as the dispersant, may be potentially useful to characterize the environmental effects of the PMN substance. Although the TSCA Order does not require these tests, the TSCA Order's restrictions remain in effect until the TSCA Order is modified or revoked by EPA based on submission of this or other relevant information.

CFR citation: 40 CFR 721.11467.

PMN Number: P-16-583

Chemical Name: Aromatic hydrocarbon resin (generic).

CAS Number: Not available.

Effective date of TSCA section 5(e) Order: October 17, 2018.

Basis for TSCA section 5(e) Order: The PMN states that the use of the PMN substance will be as a sealant for head lamps of cars. EPA identified concern for hydrocarbon pneumonia if the PMN substance is manufactured with a higher proportion of lower molecular weight species during heating. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(I)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to human health. To protect against these risks, the TSCA Order requires:

• Manufacture of the PMN substance such that the number average molecular weight is at least 1,000 grams per mole; and
• Use of the PMN substance only as a hot-melt sealant for motor vehicle lamps.

The SNUR designates as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the TSCA Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. EPA has also determined that the results of specific organ toxicity testing would help characterize the potential human health effects of the PMN substance. Although the Order does not require these tests, the TSCA Order's restrictions remain in effect until the TSCA Order is modified or revoked by EPA based on submission of this or relevant information.

CFR citation: 40 CFR 721.11468.

PMN Number: P-17-193

Chemical Names: Pentaerythritol ester of mixed linear and branched carboxylic acids (generic) (P-17-193, chemical A) and Dipentaerythritol ester of mixed linear and branched carboxylic acids (generic) (P-17-193, chemical B).

CAS Numbers: Not available.

Effective Date of TSCA section 5(e) Order: January 8, 2020.

Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the PMN substances will be as a synthetic lubricant for contained use and as an industrial lubricant. Based on analogue data, EPA has identified concerns for reproductive/developmental effects, systemic toxicity, and kidney effects. Based on comparison to analogous esters, EPA predicts drinking water toxicity may occur at concentrations that exceed 330 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the TSCA Order requires:

• No predictable or purposeful release of a manufacturing, processing, or use stream associated with any use of the PMN substances into the waters of the United States exceeding a surface water concentration of 330 ppb.

The proposed SNUR would designate as a “significant new use” in the absence this protective measure.

Potentially Useful Information: EPA has determined that certain information about the human health effects of the PMN substances may be potentially useful in support of a request by the PMN submitter to modify the TSCA Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of in vitro toxicokinetics/metabolism information, specific target organ toxicity, and reproductive/development toxicity testing may be potentially useful to characterize the human health effects of the PMN substances. Although the TSCA Order does not require these tests, the TSCA Order's restrictions remain in effect until the TSCA Order is modified or revoked by EPA based on submission of this or other relevant information.

CFR citations: 40 CFR 721.11469 (P-17-193, chemical A) and 40 CFR 721.11470 (P-17-193, chemical B).

PMN Number: P-17-221

Chemical name: Alkylheterocyclic amine blocked isocyanate, alkoxysilane polymer (generic).

CAS number: Not available.

Effective date of TSCA section 5(e) Order: October 17, 2018.

Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the PMN substance will be as a coating polymer. Based on analysis of test data on reactivity of the methoxy and ethoxy silane moieties as well as the release of methanol, EPA identified concerns for ocular toxicity, irritation to eyes, skin, lung, and mucous membranes. The TSCA Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the in the absence of sufficient information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the TSCA Order requires:

• Use of personal protective equipment including chemically impervious gloves and eye goggles, (where there is potential for dermal exposure);
• No use of the PMN substance at a concentration greater than 10% in formulation;
• Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the Safety Data Sheet (SDS); and
• Use of the PMN substance only for the confidential use allowed in the TSCA Order.

The SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the TSCA Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. EPA has also determined that the results of specific irritation and lung effect testing would help characterize the potential human effects of the PMN substance. Although the TSCA Order does not require these tests, the TSCA Order's restrictions remain in effect until the TSCA Order is modified or revoked by EPA based on submission of this or relevant information.

CFR citation: 40 CFR 721.11471.

PMN Number: P-17-282

Chemical Name: Isocyanic acid, polymethylenepolyphenylene ester, caprolactam- and phenol-blocked.

CAS Number: 2093945-13-0.

Effective Date of TSCA section 5(e) Order: January 13, 2020.

Basis for TSCA section 5(e) Order: The PMN states that the use of the PMN substance will be as a blocked crosslinker for electrical insulation coating used on stators and motors. Based on the release of phenol, EPA has identified concerns for irritation to membranes, blood toxicity, and developmental toxicity. Based on the release of caprolactam, EPA has also identified concerns for eye, skin, and respiratory irritation, skin and respiratory sensitization, lung effects, kidney toxicity, and developmental toxicity. Based on comparison to analogous carbamate esters-phenyl and carbonyl ureas, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb. The TSCA Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the TSCA Order requires:

• No modification of the manufacture, processing, or use of the PMN substance in any manner that generates inhalation exposure to phenol or caprolactam; and
• No predictable or purposeful release of a manufacturing, processing, or use stream associated with any use of the PMN substance into the waters of the United States exceeding a surface water concentration of 1 ppb.

The proposed SNUR would designate as a “significant new use” in the absence of these protective measures.

Potentially Useful Information: EPA has determined that certain information about the human health and environmental effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the TSCA Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of aquatic toxicity, developmental toxicity, pulmonary effects, eye damage, skin irritation/corrosion, and skin sensitization testing may be potentially useful to characterize the human health and environmental effects of the PMN substance. Although the Order does not require these tests, the TSCA Order's restrictions remain in effect until the TSCA Order is modified or revoked by EPA based on submission of this or other relevant information.

CFR citation: 40 CFR 721.11472.

PMN Number: P-17-334

Chemical Name: Benzamide, 2-(trifluoromethyl)-.

CAS Number: 360-64-5.

Effective date of TSCA section 5(e) Order: August 20, 2018.

Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the PMN substance will be as a chemical precursor. EPA has identified concerns for neurotoxic effects based on analog data. There are concerns for oncogenicity based on test data. To the extent the chemical substance is metabolized, there are concerns for reproductive, developmental and neurotoxicity, lung, neurotoxicity, liver, and kidney effects based on analog data for the potential derivative metabolite. Based on analogous amides, EPA predicts environmental effects may occur at surface water concentrations that exceed 39 parts per billion. The TSCA Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) based on a finding that the substances may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the TSCA Order requires:

• No domestic manufacture of the PMN substance;
• Use of personal protective equipment (where there is potential for dermal exposure); Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS;
• Import for processing and use only as a chemical intermediate, as required by the Order, with no alteration of processes that result in the generation of a dust, mist or aerosol; and
• No predictable or purposeful release of a manufacturing, processing, or use stream associated with any use of the PMN substance into the waters of the United States exceeding a surface water concentration of 39 ppb.

The SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the health and environmental effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the TSCA Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. EPA has also determined that the results of specific absorption and metabolism testing and chronic aquatic toxicity testing would help characterize the potential human and environmental effects of the PMN substance. Although the TSCA Order does not require these tests, the TSCA Order's restrictions remain in effect until the TSCA Order is modified or revoked by EPA based on submission of this or relevant information.

CFR citation: 40 CFR 721.11473.

PMN Number: P-17-386

Chemical Name: Cashew, nutshell liq. polymer with formaldehyde, phenol and resorcinol.

CAS Number: 2044014-81-3.

Effective date of TSCA section 5(e) Order: October 19, 2018.

Basis for TSCA section 5(e) Order: The PMN states that the use of the substance will be as an additive as a processing aid for automotive tire stock (tackifier for synthetic automotive tire stock). EPA identified concerns for sensitization based on resorcinol and cashew nutshell oil. The TSCA Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(I)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to human health. The TSCA Order was also issued under TSCA sections 5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding that the substance is or will be produced in substantial quantities and that the substance either enters or may reasonably be anticipated to enter the environment in substantial quantities, or there is or may be significant (or substantial) human exposure to the substance. To protect against these risks, the TSCA Order requires:

• Submission to EPA of certain toxicity testing within 12 months of submission of a Notice of Commencement or Manufacture or Import (NOC) for the PMN substance;
• Use of personal protective equipment (where there is potential for dermal exposure);
• Use of a NIOSH-certified respirator with an APF of at least 50 (where there is a potential for inhalation exposure); and
• No use of the PMN substance in a consumer product.

The SNUR designates as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. EPA has also determined that the results of specific sensitization testing would help characterize the potential human effects of the PMN substance. The submitter has agreed not to exceed a certain production volume limit without performing an acute aquatic toxicity testing. Although the TSCA Order does not require these tests, the TSCA Order's restrictions remain in effect until the TSCA Order is modified or revoked by EPA based on submission of this or relevant information.

CFR citation: 40 CFR 721.11474.

PMN Number: P-18-12

Chemical Name: Polyester polyol (generic).

CAS Number: Not available.

Effective Date of TSCA section 5(e) Order: January 30, 2020.

Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use will be as adhesives. Based on the chelation of calcium to form calculi, EPA has identified concern for bladder toxicity. Based on comparison to analogous esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the TSCA Order requires:

• No predictable or purposeful release of a manufacturing, processing, or use stream associated with any use of the PMN substance into the waters of the United States exceeding a surface water concentration of 1 ppb.

The proposed SNUR would designate as a “significant new use” in the absence of this protective measure.

Potentially Useful Information: EPA has determined that certain information about the human health and environmental effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of acute ecotoxicity base set, chronic ecotoxicity base set, and specific target organ toxicity testing may be potentially useful to characterize the human health and environmental effects of the PMN substance. Although the TSCA Order does not require these tests, the TSCA Order's restrictions remain in effect until the TSCA Order is modified or revoked by EPA based on submission of this or other relevant information.

CFR citation: 40 CFR 721.11475.

PMN Number: P-18-18

Chemical Name: Fluorinated acrylate, polymer with alkyloxirane homopolymer monoether with alkanediol mono(2-methyl-2-propenoate), tert-Bu 2-ethylhexaneperoxoate-initiated (generic).

CAS Number: Not available.

Effective date of TSCA section 5(e) Order: October 3, 2019.

Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the PMN substance will be as a lubricant. Based on estimated physical/chemical properties of the PMN substance, comparison to structurally analogous chemical substances, and structural alerts for perfluoro compounds, EPA has identified lung effects and systemic effects. Based on structural alerts for peroxides and acrylates, EPA has also identified skin sensitization. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of specific information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the TSCA Order requires:

• No manufacture (including import) of the PMN substance beyond the confidential annual production volume;
• Refrain from domestic manufacture of the PMN substance (i.e., import only);
• Refrain from manufacturing, processing, distributing in commerce or using the PMN substance in a manner that would result in the generation of respirable forms (i.e., mist, vapor, or aerosol); and
• No predictable or purposeful release of a manufacturing, processing, or use stream associated with any use of the PMN substance into the waters of the United States.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information may be potentially useful to characterize the human health effects of the PMN substance in support of a request by the PMN submitter to modify the TSCA Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of skin sensitization and specific target organ toxicity testing would help characterize the potential health effects of the PMN substance. Although the TSCA Order does not require these tests, the TSCA Order's restrictions remain in effect until the TSCA Order is modified or revoked by EPA based on submission of this or relevant information.

CFR citation: 40 CFR 721.11476.

PMN Number: P-18-42

Chemical name: 2,5-Furandione, polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-5(or 6)-yl ester, ester with 2,3-dihydroxypropyl neodecanoate, polymer with 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane, 2-hydroxyethyl acrylate- and 2-hydroxyethyl methacrylate-blocked.

CAS number: 2245262-16-0.

Effective date of TSCA section 5(e) Order: September 19, 2018.

Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the PMN substance will be as an industrial coating. Based on analysis of test data on analogous acrylates, EPA identified concerns for mutagenicity, oncogenicity, developmental toxicity, liver toxicity, kidney toxicity, sensitization, and irritation. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) based on a finding that the substances may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the TSCA Order requires:

• Use of personal protective equipment (where there is potential for dermal exposure);
• No use of the PMN substance involving an application method that generates a dust, mist, spray or aerosol;
• Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS;
• Use of the PMN substance only for the confidential use allowed in the TSCA Order; and
• No use of the PMN substance in a consumer product.

The SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the TSCA Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. EPA has also determined that the results of specific sensitization and developmental toxicity testing would help characterize the potential human effects of the PMN substance. Although the TSCA Order does not require these tests, the TSCA Order's restrictions remain in effect until the TSCA Order is modified or revoked by EPA based on submission of this or relevant information.

CFR citation: 40 CFR 721.11477.

PMN Numbers: P-18-52 and P-18-53

Chemical Names: Perfluoroalkyl ethyl- and vinyl-modified organopolysiloxane (generic).

CAS Numbers: Not available.

Effective date of TSCA section 5(e) Order: January 14, 2020.

Basis for TSCA section 5(e) Order: The PMNs state that the generic (non-confidential) use of the PMN substances will be as coating agents. Based on high molecular weight insoluble polymers and polymers with perfluorinated tails, EPA has identified concern for lung effects (lung waterproofing and lung overload). Based on analogue data for the low molecular weight fraction, EPA has also identified concerns for thyroid, liver, and developmental toxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substances may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the TSCA Order requires:

• Use of personal protective equipment to prevent dermal exposure where there is a potential for dermal exposure;
• Use of a NIOSH-certified respirator with an APF of at least 1,000 where there is a potential for inhalation exposure or compliance with a NCEL of 0.0015 mg/m³ as an 8-hour time-weighted average (TWA) to prevent inhalation exposure;
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS;
• No domestic manufacture of the PMN substances (i.e., import only);
• No import of the PMN substances beyond the annual production volumes of 420 kg for P-18-52 and 336 kg for P-18-53; and

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially Useful Information: EPA has determined that certain information about the human health effects of the PMN substances may be potentially useful in support of a request by the PMN submitter to modify the TSCA Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. EPA has determined that the results of specific target organ toxicity, pulmonary effects, and reproductive toxicity testing may be potentially useful to characterize the human health effects of the PMN substances. Although the TSCA Order does not require these tests, the TSCA Order's restrictions remain in effect until the TSCA Order is modified or revoked by EPA based on submission of this or other relevant information.

CFR citations: 40 CFR 721.11478 (P-18-52) and 40 CFR 721.11479 (P-18-53).

PMN Number: P-18-62

Chemical Name: Oxirane, 2,2′-[cyclohexylidenebis(4,1-phenyleneoxymethylene)]bis-.

CAS Number: 13446-84-9.

Effective Date of TSCA section 5(e) Order: January 29, 2020.

Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use will be for open, non-dispersive use in coatings specifically for the electronics fields. Based on structural alerts for epoxides, EPA has identified concerns for carcinogenicity and reproductive effects. Based on submitted test data on the PMN substance and comparison to structurally analogous chemical substances, EPA has also identified concerns for mutagenicity and kidney effects. Based on QSAR predictions for analogous epoxides and neutral organics, EPA also predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these ricks, the TSCA Order requires:

• Use of personal protective equipment to prevent dermal exposure where there is a potential for dermal exposure;
• Use of a NIOSH-certified respirator with an APF of at least 1,000 where there is a potential for inhalation exposure;
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS;
• No manufacture or processing of the PMN substance in any manner which generates inhalation exposures;
• No use of the PMN substance other than as described in the PMN; and
• No predictable or purposeful release of a manufacturing, processing, or use stream associated with any use of the PMN substance into the waters of the United States exceeding a surface water concentration of 1 ppb.

The proposed SNUR would designate as a “significant new use” in the absence of these protective measures.

Potentially Useful Information: EPA has determined that certain information about the human health and environmental effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the TSCA Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of aquatic toxicity, specific target organ toxicity, reproductive toxicity, and carcinogenicity testing may be potentially useful to characterize the human health and environmental effects of the PMN substance. Although the TSCA Order does not require these tests, the TSCA Order's restrictions remain in effect until the TSCA Order is modified or revoked by EPA based on submission of this or other relevant information.

CFR citation: 40 CFR 721.11480.

PMN Numbers: P-18-74 and P-18-75

Chemical Names: Saturated fatty acid, reaction products with cadmium zinc selenide sulfide and polymeric amine (generic) (P-18-74) and Saturated fatty acid, reaction products with cadmium zinc selenide sulfide, alkylamine and polymeric amine (generic) (P-18-75).

CAS Numbers: Not available.

Effective Date of TSCA section 5(e) Order: January 31, 2020.

Basis for TSCA section 5(e) Order: The PMN for P-18-74 states that use will be as a chemical intermediate for a quantum dot used as an optical down-converter (50%), and quantum dot in an optical down-converter (50%). The PMN for P-18-75 states that use will be as a quantum dot used in an optical down-converter. Based on the physical/chemical properties of the PMN substances and comparison to structurally analogous chemical substances, EPA has identified concerns for carcinogenicity, immunotoxicity, lung effects, dermal, ocular and respiratory irritation, and undesignated sensitization. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substances may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the TSCA Order requires:

• No manufacture of the PMN substances with a cadmium percentage greater than the confidential value stated in the Order;
• No use of the PMN substance P-18-74 other than as a chemical intermediate for a quantum dot used as an optical down-converter or as a quantum dot in an optical down-converter;
• No use of the PMN substance P-18-75 other than as a quantum dot used in an optical down-converter;
• No manufacture, processing, or use of the PMN substances in any manner which results in inhalation exposure;
• Manufacture, process, or use the PMN substances only in liquid formulation;
• Only dispose of the PMN substances by incineration in a permitted hazardous waste incinerator;
• No predictable or purposeful release of a manufacturing, processing, or use stream associated with any use of the PMN substance into the waters of the United States;
• Use of dermal personal protective equipment where there is a potential for dermal exposure; and
• Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” in the absence of these protective measures.

Potentially Useful Information: EPA has determined that certain information about the human health and environmental effects of the PMN substances may be potentially useful in support of a request by the PMN submitter to modify the TSCA Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of eye damage, skin irritation, skin sensitization, pulmonary toxicity, specific target organ toxicity, carcinogenicity, and acute and chronic aquatic toxicity testing may be potentially useful to characterize the human health and environmental effects of the PMN substances. Although the TSCA Order does not require these tests, the TSCA Order's restrictions remain in effect until the TSCA Order is modified or revoked by EPA based on submission of this or other relevant information.

CFR citations: 40 CFR 721.11481 (P-18-74) and 40 CFR 721.11482 (P-18-75).

PMN Number: P-18-160

Chemical name: Heteropolycyclic, halo substituted alkyl substituted- diaromatic amino substituted carbomonocycle, halo substituted alkyl substituted heteropolycyclic, tetraaromatic metalloid salt (1:1) (generic).

CAS number: Not available.

Effective date of TSCA section 5(e) Order: December 10, 2019.

Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be as a coating component. EPA identified concerns for acute toxicity, neurotoxicity, eye irritation, and photosensitization based on physical/chemical properties and comparison to analogous chemical substances. EPA has also identified concerns for aquatic toxicity based on comparison to analogous cationic dyes. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the TSCA Order requires:

Submission to EPA of certain toxicity testing before manufacturing the chemical for more than 18 months;

• Use of personal protective equipment where there is a potential for dermal exposure;
• Use of a NIOSH-certified respirator with an APF of at least 50 to prevent inhalation exposure where there is a potential for inhalation exposure;
• Establishment of a hazard communication program, including health precautionary statements on each label and in the SDS;
• Refraining from domestic manufacture in the United States (i.e., import only);
• Refraining from manufacturing the PMN substance beyond the confidential annual manufacture (which includes import) production volume specified in the TSCA Order;
• Refraining from manufacturing the PMN substance in the form of a powder, liquid or gas (i.e., solid only); and
• No predictable or purposeful release of a manufacturing, processing, or use stream associated with any use of the PMN substance into the waters of the United States.

The proposed SNUR would designate as a “significant new use” the absence protective measures.

Potentially useful information: EPA has determined that certain information about the environmental and health effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the TSCA Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. The submitter has agreed not to exceed certain production volume limits without performing the combined repeated dose toxicity with reproduction/developmental toxicity screening test with functional observation battery test. EPA has also determined that the results of chronic aquatic toxicity, acute toxicity, eye irritation, specific target organ toxicity, and photosensitization testing may be potentially useful to characterize the environmental and human health effects of the PMN substance. Although the TSCA Order does not require these tests, the TSCA Order's restrictions remain in effect until the TSCA Order is modified or revoked by EPA based on submission of this or other relevant information.

CFR citation: 40 CFR 721.11483

PMN Numbers: P-18-237 and P-18-292

Chemical Names: Alkanediol, polymer with 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane, alkylaminoalkyl methacrylate- and dialkylheteromonocycle-blocked (generic) (P-18-237) and Alkanediol, polymer with 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane, alkylaminoalkyl methacrylate-blocked (generic) (P-18-292).

CAS Numbers: Not available.

Effective date of TSCA section 5(e) Order: September 17, 2019.

Basis for TSCA section 5(e) Order: The PMNs state that the generic (non-confidential) use of the PMN substances will be for use in print resins. Based on estimated physical/chemical properties of the PMN substances, comparison to structurally analogous chemical substances, and structural alerts for methacrylates, EPA has identified eye and skin irritation, skin sensitization, and systemic effects. Based on the comparison to structurally analogous acrylates/methacrylates, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of specific information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the TSCA Order requires:

• No manufacturing, processing, or use of the PMN substances in any manner or method that generates dust, spray, vapor, mist, or aerosol; and
• No predictable or purposeful release of a manufacturing, processing, or use stream associated with any use of the PMN substance into the waters of the United States exceeding a surface water concentration of 1 ppb.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information may be potentially useful to characterize the human health and environmental effects of the PMN substances if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of chronic aquatic toxicity, eye irritation, skin irritation, skin sensitization, and specific target organ toxicity testing would help characterize the potential health and environmental effects of the PMN substances.

CFR citations: 40 CFR 721.11484 (P-18-237) and 40 CFR 721.11485 (P-18-292).

PMN Number: P-18-287

Chemical Name: Synthetic oil from tires (generic).

CAS Number: Not available.

Effective Date of TSCA section 5(e) Order: December 17, 2019.

Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be to produce “tires, wastes, pyrolyzed, condensate oil fraction” (CASRN 1312024-02-4) from scrap tire materials. The synthetic oil fraction from tire waste pyrolysis can be used in a variety of industries. Some examples of use of synthetic oil include use as a fuel, upgraded for use as a higher quality fuel, as an additive for asphalt or other complex mixtures, used to manufacture other chemicals, etc. EPA has identified concerns for irritation and neurotoxicity based on structural alerts for solvents, and systemic toxicity, developmental/reproductive toxicity, and carcinogenicity based on a constituent of the new chemical, benzene. EPA has also identified aspiration hazard based on measured kinematic viscosity. Based on SAR analysis of analogous neutral organics, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 5 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the TSCA Order requires:

• No manufacture of the PMN substance other than as described in the PMN;
• No manufacturing, processing, or use of the PMN substance for consumer or “commercial uses” (as the term is defined at 40 CFR 721.3) when the saleable goods or service could introduce the PMN substance into a “consumer” setting (as that term is defined in 40 CFR 721.3); and
• Waste streams from manufacture, processing, and use must be disposed of only by incineration.

The proposed SNUR would designate as a “significant new use” in the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the environmental and health effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the TSCA Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. EPA has determined that the results of aquatic toxicity, skin irritation, eye irritation, specific target organ toxicity, reproductive toxicity (developmental effects), and carcinogenicity testing may be potentially useful to characterize the environmental and human health effects of the PMN substance. Although the TSCA Order does not require these tests, the TSCA Order's restrictions remain in effect until the TSCA Order is modified or revoked by EPA based on submission of this or other relevant information.

CFR citation: 40 CFR 721.11486.

PMN Number: P-19-51

Chemical name: 1,3-Propanediamine, N1,N1-dimethyl-, polymers with alkylene glycol ether with alkyltriol (3:1) mixed acrylates and adipates, and alkylene glycol monoacrylate ether with alkyltriol (3:1) (generic).

CAS number: Not available.

Effective date of TSCA section 5(e) Order: October 22, 2019.

Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be as a UV curable ink. EPA has identified concerns for skin and respiratory sensitization and skin and eye irritation based on the methacrylate/acrylate composition. EPA also identified liver effects based on the extent the low molecular weight fractions are bioavailable. Based on comparison to analogous polycationic polymers, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 3 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the TSCA Order requires:

• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS;
• No domestic manufacture of the PMN substance (i.e., import only);
• No use of the PMN substance other than for the confidential use specified in the TSCA Order; and
• No predictable or purposeful release of a manufacturing, processing, or use stream associated with any use of the PMN substance into the waters of the United States exceeding a surface water concentration of 3 ppb.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the human health and environmental effects of the PMN substance in support of a request by the PMN submitter to modify the TSCA Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. EPA has determined that the results of acute and chronic aquatic toxicity, specific target organ toxicity, skin sensitization, skin irritation, and eye irritation testing would help EPA determine the potential human and environmental effects of the PMN substance. Although the TSCA Order does not require this information, the TSCA Order's restrictions remain in effect until the TSCA Order is modified or revoked by EPA based on submission of this or other relevant information.

CFR citation: 40 CFR 721.11487.

PMN Number: P-19-55

Chemical Name: 1,3-Propanediol, 2-ethyl-2-(hydroxymethyl)-, polymer with oxirane, 4-(dimethylamino)benzoate.

CAS Number: 2067275-86-7.

Effective Date of TSCA section 5(e) Order: January 14, 2020.

Basis for TSCA section 5(e) Order: The PMN states that the use of the substance will be as a photo initiator within UV curable coating/ink formulations. Based on submitted test data, EPA has identified concerns for sensitization, reproductive, and systemic effects. Based on submitted acute and chronic toxicity data, EPA has also identified concern for toxicity to aquatic organisms may occur at concentrations that exceed 12 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the TSCA Order requires:

• No manufacturing, processing, or use of the PMN substance in any manner that results in inhalation exposure;
• No use of the PMN substance other than as a photo initiator within UV curable coating/ink formulations; and
• No predictable or purposeful release of a manufacturing, processing, or use stream associated with any use of the PMN substance into the waters of the United States exceeding a surface water concentration of 12 ppb.

The proposed SNUR would designate as a “significant new use” in the absence of these protective measures.

Potentially Useful Information: EPA has determined that certain information about the environmental effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the TSCA Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. EPA has determined that the results of developmental/reproductive toxicity testing may be potentially useful to characterize the human health effects of the PMN substance. Although the TSCA Order does not require these tests, the TSCA Order's restrictions remain in effect until the TSCA Order is modified or revoked by EPA based on submission of this or other relevant information.

CFR citation: 40 CFR 721.11488.

PMN Number: P-19-159

Chemical Name: Titanium (4+) hydroxyl-alkylcarboxylate salt complex (generic).

CAS Number: Not available.

Effective Date of TSCA section 5(e) Order: January 10, 2020.

Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be as a catalyst in the industrial sector. Based on the reactive nature of the PMN substance, presence of acid moieties, titanium (to the extent it is bioavailable), and information in the SDS, EPA has identified concerns for irritation to the eyes, skin, and respiratory tract, severe skin burns and eye damage, and skin and respiratory sensitization. Based on test data available on the PMN substance and comparison to analogous substances, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the TSCA Order requires:

• No manufacture, processing, or use of the PMN substance in any manner or method that generates inhalation exposure; and
• No predictable or purposeful release of a manufacturing, processing, or use stream associated with any use of the PMN substance into the waters of the United States exceeding a surface water concentration of 1 ppb.

The proposed SNUR would designate as a “significant new use” in the absence of these protective measures.

Potentially Useful Information: EPA has determined that certain information about the human health effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the TSCA Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. EPA has determined that the results of pulmonary effects, skin irritation, eye irritation, skin sensitization, and specific target organ toxicity testing may be potentially useful to characterize the human health effects of the PMN substance. Although the TSCA Order does not require these tests, the TSCA Order's restrictions remain in effect until the TSCA Order is modified or revoked by EPA based on submission of this or other relevant information.

CFR citation: 40 CFR 721.11489.

V. Rationale and Objectives of the Proposed Rule

A. Rationale

During review of the PMNs submitted for the chemical substances that are subject to these proposed SNURs, EPA concluded that regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. The basis for such findings is outlined in Unit IV. Based on these findings, TSCA section 5(e) Orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. As a general matter, EPA believes it is necessary to follow TSCA section 5(e) Orders with a SNUR that identifies the absence of those protective measures as Significant New Uses to ensure that all manufacturers and processors—not just the original submitter—are held to the same standard.

B. Objectives

EPA is proposing these SNURs for specific chemical substances which have undergone premanufacture review because the Agency wants:

• To identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying TSCA Orders, consistent with TSCA section 5(f)(4).
• To have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use.
• To be able to either determine that the prospective manufacture or processing is not likely to present an unreasonable risk, or to take necessary regulatory action associated with any other determination, before the described significant new use of the chemical substance occurs.

VI. Applicability of the Proposed Significant New Use Designation

To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substances subject to this proposed rule have undergone premanufacture review. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the TSCA Inventory, no person may commence such activities without first submitting a PMN. Therefore, for chemical substances for which an NOC has not been submitted EPA concludes that the designated significant new uses are not ongoing.

When chemical substances identified in this proposed rule are added to the TSCA Inventory, EPA recognizes that, before the rule is effective, other persons might engage in a use that has been identified as a significant new use. However, TSCA section 5(e) Orders have been issued for these chemical substances, and the PMN submitters are prohibited by the TSCA section 5(e) Orders from undertaking activities which would be designated as significant new uses. The identities of 18 of the 24 chemical substances subject to this proposed rule have been claimed as confidential (per 40 CFR 720.85) for a chemical substance covered by this action. Based on this, the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this proposed rule are ongoing.

Therefore, EPA designates May 4, 2020 as the cutoff date for determining whether the new use is ongoing. The objective of EPA's approach is to ensure that a person cannot defeat a SNUR by initiating a significant new use before the effective date of the final rule.

In the unlikely event that a person began commercial manufacture or processing of the chemical substances for a significant new use identified as of that date 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 EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination.

Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Chemical Substance Inventory (TSCA Inventory). Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the internet at http://www.epa.gov/​opptintr/​existingchemicals/​pubs/​tscainventory/​index.html.

VII. Development and Submission of Information

EPA recognizes that TSCA section 5 does not require developing any particular new information (e.g., generating test data) before submission of a SNUN. There is an exception: If a person is required to submit information for a chemical substance pursuant to a rule, Order or consent agreement under TSCA section 4 (15 U.S.C. 2603), then TSCA section 5(b)(1)(A) (15 U.S.C. 2604(b)(1)(A)) requires such information to be submitted to EPA at the time of submission of the SNUN.

In the absence of a rule, Order, or consent agreement under TSCA section 4 covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information known or reasonably ascertainable (40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. Unit IV. lists potentially useful information for all SNURs listed here. Descriptions of this information is provided for informational purposes. The potentially useful information identified in Unit IV of the proposed rule will be useful to EPA's evaluation in the event that someone submits a SNUN for the significant new use. Companies who are considering submitting a SNUN are encouraged, but not required, to develop the information on the substance, which may assist with EPA's analysis of the SNUN. EPA strongly encourages persons, before performing any testing, to consult with the Agency. Furthermore, pursuant to TSCA section 4(h), which pertains to reduction of testing on vertebrate animals, EPA encourages dialog with the Agency on the use of alternative test methods and strategies (also called New Approach Methodologies, or NAMs), if available, to generate the potentially useful information. EPA encourages dialogue with Agency representatives to help determine how best the submitter can meet both the data needs and the objective of TSCA section 4(h). To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/​ocspp and select “Test Methods and Guidelines.” The Organisation for Economic Co-operation and Development test guidelines are available from the OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org.

The potentially useful information listed in Unit IV. 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 section 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 substances.
• Information on risks posed by the chemical substances compared to risks posed by potential substitutes.

VIII. SNUN Submissions

According to 40 CFR 721.1(c), persons submitting a SNUN must comply with the same notification 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 720.40. E-PMN software is available electronically at http://www.epa.gov/​opptintr/​newchems.

IX. Economic Analysis

EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors of the chemical substances subject to this proposed rule. EPA's complete economic analysis is available in the docket under docket ID number EPA-HQ-OPPT-2019-0596.

X. Statutory and Executive Order Reviews

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

A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulations and Regulatory Review

This proposed rule would establish SNURs for 3 new chemical substances that were the subject of PMNs. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act (PRA)

According to the PRA, 44 U.S.C. 3501 et seq., 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 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.

The information collection requirements related to this action have already been approved by OMB pursuant to PRA under OMB control number 2070-0012 (EPA ICR No. 574). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN.

Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, Regulatory Support Division, Office of Mission Support (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.

C. Regulatory Flexibility Act (RFA)

Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq., the Agency hereby certifies that promulgation of this proposed SNUR would not have a significant adverse economic impact on a substantial number of small entities. 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, it appears 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. Although some small entities may decide to pursue a significant new use in the future, EPA cannot presently determine how many, if any, there may be. However, 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 seven in Federal fiscal year (FY) 2013, 13 in FY2014, six in FY2015, 12 in FY2016, 13 in FY2017, and 11 in FY2018, 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 $16,000 to $2,800. This lower fee reduces the total reporting and recordkeeping of cost of submitting a SNUN to about $10,116 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)

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 proposed rule. As such, EPA has determined that this proposed rule does 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. 1531-1538 et seq.).

E. Executive Order 13132: Federalism

This action would not have a substantial direct effect on 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, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999).

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

This proposed rule would not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This proposed rule would not significantly nor uniquely affect the communities of Indian Tribal governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175 (65 FR 67249, November 9, 2000), do not apply to this proposed rule.

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

This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children.

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

This proposed rule is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use and because this action is not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

In addition, since this action does not involve any technical standards, NTTAA section 12(d), 15 U.S.C. 272 note, does not apply to this action.

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

This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898 (59 FR 7629, February 16, 1994).

List of Subjects

40 CFR Part 721

• Environmental protection
• Chemicals
• Hazardous substances
• Reporting and recordkeeping requirements

Therefore, it is proposed that 40 CFR chapter I be amended as follows:

PARTS 721—[AMENDED]

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

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

2. Add §§ 721.11466 through 721.11489 to subpart E to read as follows:

Subpart E—Significant New Uses for Specific Chemical Substances