2020-18883. Significant New Use Rules on Certain Chemical Substances (20-1.5e)

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

EPA is issuing 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 to TSCA. This action requires persons to notify EPA at least 90 days before commencing manufacture (defined by statute to include import) or processing of any of these chemical substances for an activity that is designated as a significant new use by this rule. The required notification initiates EPA's evaluation of the chemical under the conditions of use 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 as a result of that determination.

DATES:

This rule is effective on November 16, 2020. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (EST) on October 1, 2020.

FOR FURTHER INFORMATION CONTACT:

For technical information contact: William Wysong, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: [phone]; email address: [e-mail].

For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: [phone]; email address: [e-mail].

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 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 provisions 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, which would include 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 rule 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. How can I access the docket?

The docket includes information considered by the Agency in developing the proposed and final rules. The docket for this action, identified by docket identification (ID) number EPA-HQ-OPPT-2019-0596, is available at http://www.regulations.gov or at the Office of Pollution Prevention and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is [phone], and the telephone number for the OPPT Docket is [phone].

Due to the public health concerns related to COVID-19, the EPA Docket Center (EPA/DC) and Reading Room is closed to visitors with limited exceptions. The staff continues to provide remote customer service via email, phone, and webform. For the latest status information on EPA/DC services and docket access, visit https://www.epa.gov/​dockets.

II. Background

A. What action is the Agency taking?

EPA is finalizing SNURs under TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) for chemical substances which were the subject of PMNs P-14-865, P-15-54, P-16-583, P-17-193, P-17-221, P-17-282, P-17-334, P-17-386, P-18-12, P-18-18, P-18-42, P-18-52, P-18-53, P-18-62, P-18-74, P-18-75, P-18-160, P-18-237, P-18-287, P-18-292, P-19-51, P-19-55, and P-19-159.

Previously, in the Federal Register of May 4, 2020 (85 FR 26419) (FRL-10007-65), EPA proposed SNURs for these chemical substances and established the record for these SNURs in the docket under docket ID number EPA-HQ-OPPT-2019-0596. That docket includes information considered by the Agency in developing the proposed and final rules, including public comments and EPA's responses to the public comments received.

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 bulleted TSCA section 5(a)(2) factors listed in Unit III.

C. Applicability of General Provisions

General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the 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. Pursuant to 40 CFR 721.1(c), persons subject to these SNURs must comply with the significant new use notice (SNUN) requirements and EPA regulatory procedures as submitters of 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 and before the manufacture or processing for the significant new use can commence, 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. If EPA determines that the significant new 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

When the Agency issues an order under TSCA section 5(e), section 5(f)(4) requires that the Agency consider whether to promulgate a SNUR for any use not conforming to the restrictions of the TSCA Order or publish a statement describing the reasons for not initiating the rulemaking. 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, and potential human exposures and environmental releases that may be associated with possible uses of these chemical substances, in the context of the four bulleted TSCA section 5(a)(2) factors listed in this unit.

IV. Public Comments on Proposed Rule and EPA Responses

EPA received five comments on the proposed rule: Three from identifying entities and two that were anonymous. The Agency's responses are presented in the Response to Public Comments document that is available in the docket for this rule. EPA made no changes to the rule provisions based on these comments.

V. Substances Subject to This Rule

EPA is establishing significant new use and recordkeeping requirements for chemical substances in 40 CFR part 721, subpart E. In Unit IV. of the proposed SNUR, EPA provided the following information for each chemical substance:

• PMN number.
• Chemical name (generic name, if the specific name is claimed as confidential business information (CBI)).
• Chemical Abstracts Service (CAS) Registry number (if assigned for non-confidential chemical identities).
• Effective date of and basis for the TSCA Order.
• Potentially Useful Information. This is information identified by EPA that would help characterize the potential health and/or environmental effects of the chemical substances if a manufacturer or processor is considering submitting a SNUN for a significant new use designated by the SNUR.
• CFR citation assigned in the regulatory text section of these rules.

The regulatory text section of these rules specifies the activities designated as significant new uses. Certain new uses, including production volume limits and other uses designated in the rules, may be claimed as CBI.

These final 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 TSCA Orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The final SNURs 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).

Where EPA determined that the PMN substance may present an unreasonable risk of injury to human health via inhalation exposure, the underlying TSCA 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). The comprehensive NCELs provisions in TSCA Orders 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 Order.

VI. Rationale and Objectives of the Rule

A. Rationale

During review of the PMNs submitted for the chemical substances that are subject to these SNURs and as further discussed in Unit IV. of the proposed rule, 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. Based on such findings, TSCA 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 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 issuing these SNURs because the Agency wants to:

• Receive notice of any person's intent to manufacture or process a listed chemical substance for the described significant new use before that activity begins;
• 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; and
• Be obligated to make a determination under TSCA section 5(a)(3) regarding the use described in the SNUN, under the conditions of use. The Agency will either determine under TSCA section 5(a)(3)(C) that the significant new use is not likely to present an unreasonable risk, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, or make a determination under section TSCA 5(a)(3)(A) or (B) and take the required regulatory action associated with the determination, before manufacture or processing for the significant new use of the chemical substance can occur.

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 https://www.epa.gov/​tsca-inventory.

VII. Applicability of the 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 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 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 Orders have been issued for all the chemical substances that are the subject of this rule, and the PMN submitters are prohibited by the TSCA Orders from undertaking activities which will be designated as significant new uses. The identities of 18 of the 24 chemical substances subject to this rule have been claimed as confidential (per 40 CFR 720.85). 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 rule are ongoing.

Furthermore, EPA designated May 4, 2020 (the date of public release of the proposed rule) as the cutoff date for determining whether the new use is ongoing. The objective of EPA's approach has been to ensure that a person could not 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, that person will have to cease any such activity upon the effective date of the final rule. To resume their activities, that person 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.

VIII. Development and Submission of Information

EPA recognizes that TSCA section 5 does not require development of 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, 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 rule, TSCA 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 to or reasonably ascertainable by them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. Unit IV. of the proposed rule lists potentially useful information for all SNURs listed in this document. Descriptions are provided for informational purposes. The information identified in Unit IV. of the proposed rule will be potentially 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.

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 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).

In some of the TSCA Orders for the chemical substances identified in this rule, EPA has established production volume limits in view of the lack of data on the potential health and environmental risks that may be posed by the significant new uses or increased exposure to the chemical substances. These limits cannot be exceeded unless the PMN submitter first submits the results of specified tests that would permit a reasoned evaluation of the potential risks posed by these chemical substances. The SNURs contain the same production volume limits as the TSCA Orders. Exceeding these production limits is defined as a significant new use. Persons who intend to exceed the production limit must notify the Agency by submitting a SNUN at least 90 days in advance of commencement of non-exempt commercial manufacture or processing.

Any request by EPA for the triggered and pended testing described in the TSCA Orders was made based on EPA's consideration of available screening-level data, if any, as well as other available information on appropriate testing for the PMN substances. Further, any such testing request on the part of EPA that includes testing on vertebrates was made after consideration of available toxicity information, computational toxicology and bioinformatics, and high-throughput screening methods and their prediction models.

The potentially useful information identified in Unit IV. of the proposed rule may not be the only means of addressing the potential risks of the chemical substance associated with the designated significant new uses. 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 that 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.

IX. Procedural Determinations

By this rule, EPA is establishing certain significant new uses which have been claimed as CBI subject to Agency confidentiality regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a final determination or other disposition of the confidentiality claim under 40 CFR part 2 procedures, EPA is required to keep this information confidential. EPA promulgated a procedure to deal with the situation where a specific significant new use is CBI, at 40 CFR 721.1725(b)(1).

Under these procedures, a manufacturer or processor may request EPA to determine whether a proposed use would be a significant new use under the rule. The manufacturer or processor must show that it has a bona fide intent to manufacture or process the chemical substance and must identify the specific use for which it intends to manufacture or process the chemical substance. If EPA concludes that the person has shown a bona fide intent to manufacture or process the chemical substance, EPA will tell the person whether the use identified in the bona fide submission would be a significant new use under the rule. Since most of the chemical identities of the chemical substances subject to these SNURs are also CBI, manufacturers and processors can combine the bona fide submission under the procedure in 40 CFR 721.1725(b)(1) with that under 40 CFR 721.11 into a single step.

If EPA determines that the use identified in the bona fide submission would not be a significant new use, i.e., the use does not meet the criteria specified in the rule for a significant new use, that person can manufacture or process the chemical substance so long as the significant new use trigger is not met. In the case of a production volume trigger, this means that the aggregate annual production volume does not exceed that identified in the bona fide submission to EPA. Because of confidentiality concerns, EPA does not typically disclose the actual production volume that constitutes the use trigger. Thus, if the person later intends to exceed that volume, a new bona fide submission would be necessary to determine whether that higher volume would be a significant new use.

X. 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 and § 721.25. E-PMN software is available electronically at https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca.

XI. Economic Analysis

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

XII. 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 action establishes SNURs for several 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 Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011).

B. Executive Order 13771: Reducing Regulations and Controlling Regulatory Costs

This action is not subject to Executive Order 13771 (82 FR 9339, February 3, 2017), because this action is not a significant regulatory action under Executive Order 12866.

C. Paperwork Reduction Act (PRA)

According to 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 information collection requirements associated with SNURs have already been approved by OMB under the PRA under OMB control number 2070-0012 (EPA ICR No. 574). This rule does not impose any burden requiring additional OMB approval.

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. EPA is amending the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this action. This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the display requirements of PRA and OMB's implementing regulations at 5 CFR part 1320. The Information Collection Request (ICR) covering the SNUR activities was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table, EPA finds that further notice and comment to amend it is unnecessary. As a result, EPA finds that there is “good cause” under section 553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)) to amend this table without further notice and comment.

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.

D. Regulatory Flexibility Act (RFA)

Pursuant to the RFA section 605(b) (5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation of these SNURs 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, EPA has concluded 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, EPA received 7 SNUNs in Federal fiscal year (FY) 2013, 13 in FY2014, 6 in FY2015, 10 in FY2016, 14 in FY2017, and 11 in FY2018 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 $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 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.

E. 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 action. As such, EPA has determined that this action 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. 1501 et seq.).

F. Executive Order 13132: Federalism

This action will 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).

G. Executive Order 13175: Consultation and Coordination With Indian Tribe Governments

This action does not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This action does 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 action.

H. Executive Order 13045: Protection of Children From Environmental Health Risks 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. EPA interprets Executive Order 13045 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 the Executive Order.

I. 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 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.

J. National Technology Transfer and Advancement Act (NTTAA)

This action does not involve any technical standards subject to NTTAA section 12(d) (15 U.S.C. 272 note).

K. 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).

XIII. Congressional Review Act

This action is subject to the CRA (5 U.S.C. 801 et seq.), and EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

List of Subjects

40 CFR Part 9

• Environmental protection
• Reporting and recordkeeping requirements

40 CFR Part 721

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

Dated: August 20, 2020.

Tala Henry,

Deputy Director, Office of Pollution Prevention and Toxics.

Therefore, for the reasons stated in the preamble, EPA amends 40 CFR parts 9 and 721 as follows:

PART 9—OMB APPROVALS UNDER THE PAPERWORK REDUCTION ACT

1. The authority citation for part 9 continues to read as follows:

Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 9601-9657, 11023, 11048.

2. In § 9.1, amend the table by adding entries for §§ 721.11466 through 721.11489 in numerical order under the undesignated center heading “Significant New Uses of Chemical Substances” to read as follows:

§ 9.1

OMB approvals under the Paperwork Reduction Act.

* * * * *

40 CFR citation	OMB control No.
*    *    *    *    *
Significant New Uses of Chemical Substances
*    *    *    *    *
721.11466	2070-0012
721.11467	2070-0012
721.11468	2070-0012
721.11469	2070-0012
721.11470	2070-0012
721.11471	2070-0012
721.11472	2070-0012
721.11473	2070-0012
721.11474	2070-0012
721.11475	2070-0012
721.11476	2070-0012
721.11477	2070-0012
721.11478	2070-0012
721.11479	2070-0012
721.11480	2070-0012
721.11481	2070-0012
721.11482	2070-0012
721.11483	2070-0012
721.11484	2070-0012
721.11485	2070-0012
721.11486	2070-0012
721.11487	2070-0012
721.11488	2070-0012
721.11489	2070-0012

* * * * *

PART 721—SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES

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

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

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

Subpart E—Significant New Uses for Specific Chemical Substances

721.11466

Aromatic amide oxime (generic).

721.11467

Carbon nanotubes (generic).

721.11468

Aromatic hydrocarbon resin (generic).

721.11469

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

721.11470

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

721.11471

Alkylheterocyclic amine blocked isocyanate, alkoxysilane polymer (generic).

721.11472

Isocyanic acid, polymethylenepolyphenylene ester, caprolactam- and phenol-blocked.

721.11473

Benzamide, 2-(trifluoromethyl)-.

721.11474

Cashew, nutshell liq. polymer with formaldehyde, phenol and resorcinol.

721.11475

Polyester polyol (generic).

721.11476

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

721.11477

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.

721.11478

Perfluoroalkyl ethyl- and vinyl-modified organopolysiloxane (generic).

721.11479

Perfluoroalkyl ethyl- and vinyl-modified organopolysiloxane (generic).

721.11480

Oxirane, 2,2'-[cyclohexylidenebis(4,1-phenyleneoxymethylene)]bis-.

721.11481

Saturated fatty acid, reaction products with cadmium zinc selenide sulfide and polymeric amine (generic).

721.11482

Saturated fatty acid, reaction products with cadmium zinc selenide sulfide, alkylamine and polymeric amine (generic).

721.11483

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

721.11484

Alkanediol, polymer with 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane, alkylaminoalkyl methacrylate-, and dialkylheteromonocycle-blocked (generic).

721.11485

Alkanediol, polymer with 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane, alkylaminoalkyl methacrylate-blocked (generic).

721.11486

Synthetic oil from tires (generic).

721.11487

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).

721.11488

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

721.11489

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

* * * * *

§ 721.11466

Aromatic amide oxime (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aromatic amide oxime (PMN P-14-865) 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 are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1) through (3), and (6), (b) and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(b), concentration is set at 1.0%.

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(g).

(iii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4) and (c)(4) where N=30.

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (e), (i) and (k) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

§ 721.11467

Carbon nanotubes (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as carbon nanotubes (PMN P-15-54) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the PMN substance that have been (i) embedded or incorporated into a polymer matrix that itself has been reacted (cured) or (ii) embedded in a permanent solid polymer form that is not intended to undergo further processing, except mechanical processing.

(2) The significant new uses are:

(i) Workplace protection. Requirements as specified in § 721.63(a)(1), (2)(i) and (ii), and (3) through (6), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 50. For purposes of § 721.63(a)(6), particulate (including solids or liquid droplets).

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) (chemical intermediate to manufacture functionalized carbon nanotubes by oxidation with nitric acid; additive in rubber polymers to improve mechanical/physical/chemical/electrical properties; additive in resin polymers to improve mechanical/physical/chemical/electrical properties; additive in metals to improve electrical/thermal properties; additive in ceramics to improve mechanical/electrical/thermal properties; semi-conductor, conductive, or resistive element in electronic circuitry and devices; electric collector element or electrode in energy devices; photoelectric or thermoelectric conversion elements in energy devices; catalyst support element or catalytic electrode for use in energy devices; additive for transparency and conductivity in electronic devices; and electro-mechanical element in actuator, sensor, or switching devices).

(iii) Disposal. Requirements as specified in § 721.85(a)(1) and (2), (b)(1) and (2), and (c)(1) and (2).

(iv) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1) and (c)(1).

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (e) and (i) through (k) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

§ 721.11468

Aromatic hydrocarbon resin (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aromatic hydrocarbon resin (PMN P-16-583) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been reacted (cured).

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) (hot-melt sealant for motor vehicle lamps). It is a significant new use to manufacture the PMN substance with an average number molecular weight of less than 1000 grams per mole.

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c) and (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

§ 721.11469

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

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as pentaerythritol ester of mixed linear and branched carboxylic acids (PMN P-17-193, chemical A) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.

(2) The significant new use is:

(i) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4) and (c)(4) where N=330.

(ii) [Reserved]

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c) and (k) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

§ 721.11470

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

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as dipentaerythritol ester of mixed linear and branched carboxylic acids (PMN P-17-193, chemical B) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.

(2) The significant new use is:

(i) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4) and (c)(4) where N=330.

(ii) [Reserved]

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c) and (k) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

§ 721.11471

Alkylheterocyclic amine blocked isocyanate, alkoxysilane polymer (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkylheterocyclic amine blocked isocyanate, alkoxysilane polymer (PMN P-17-221) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of the TSCA Order do not apply to quantities of the PMN substance after they have been completely reacted (cured).

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) and (iii), (3) and (6) (particulate), (b), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(b), concentration is set at 1.0%.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (f), (g)(1)(i) and (ii), (2)(i) through (iii) and (v), and (5). For purposes of § 721.72(e), concentration is set at 1.0%. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k). It is a significant new use to formulate the PMN to a concentration greater than 10%.

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii).

§ 721.11472

Isocyanic acid, polymethylenepolyphenylene ester, caprolactam- and phenol-blocked.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as isocyanic acid, polymethylenepolyphenylene ester, caprolactam- and phenol-blocked (PMN P-17-282, CAS No. 2093945-13-0) is subject to reporting under this section for the significant new uses described paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted (cured).

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the PMN substance in any manner or method that generates inhalation exposure to phenol or caprolactam.

(ii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4) and (c)(4) where N=1.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c), (i), and (k) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

§ 721.11473

Benzamide, 2-(trifluoromethyl)-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as benzamide, 2-(trifluoromethyl)- (PMN P-17-334, CAS No. 360-64-5) 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 are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) and (iv), (3), (4), (6)(v) and (vi), (b) and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(a)(6), particulate applies. For purposes of § 721.63(b), the concentration is set at 0.1%.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (f), (g)(1)(iii) through (v), and (ix), (2)(i) through (iii) and (v), (3)(i) and (ii), and (5). For purposes of § 721.72(e), concentration is set at 0.1%. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (g) and (y)(1).

(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4) and (c)(4) where N=39.

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) and (k) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

§ 721.11474

Cashew, nutshell liq. polymer with formaldehyde, phenol and resorcinol.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as cashew nutshell liq. polymer with formaldehyde, phenol and resorcinol (PMN P-17-386, CAS No. 2044014-81-3) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been reacted (cured).

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (3) through (5), (6)(v) and (vi), (b), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 50. For purposes of § 721.63(a)(6), particulate (including combination gas/vapor and particulate). For purposes of § 721.63(b), concentration is set at 1.0%.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (f), (g)(1)(i), (2)(i) and (ii), (iv) and (v), (4)(iii), and (5). For purposes of § 721.72(e), concentration is set at 1.0%. For purposes of § 721.72(g)(1) skin and respiratory sensitization. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(o). It is a significant new use to manufacture the substance for more than one year.

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

§ 721.11475

Polyester polyol (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyester polyol (PMN P-18-12) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4) and (c)(4) where N=1.

(ii) [Reserved]

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c) and (k) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

§ 721.11476

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

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as fluorinated acrylate, polymer with alkyloxirane homopolymer monoether with alkanediol mono(2-methyl-2-propenoate), tert-Bu 2-ethylhexaneperoxoate-initiated (PMN P-18-18) 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 are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (t) and (y)(1).

(ii) Releases to water. Requirements as specified in § 721.90(a)(1), (b)(1) and (c)(1).

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c), (i), and (k) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(i) of this section.

§ 721.11477

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

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2,5-furandione, polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, 3a,4,5,6,7,7ahexahydro- 4,7-methano-1H-inden-5(or 6)-yl ester, ester with 2,3-dihydroxypropyl neodecanoate, polymer with 5-isocyanato-l-(isocyanatomethyl)-1,3, 3-trimethylcyclohexane, 2-hydroxyethyl acrylate- and 2-hydroxyethyl methacrylate-blocked (PMN P-18-42, CAS No. 2245262-16-0) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the PMN substance after they have been completely reacted (cured).

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) through (iv) and (3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (f), (g)(1)(i) and (ii), (iv), (vii) and (ix), (2)(i) through (iii) and (v), and (5). For purposes of § 721.72(g)(1) eye irritation. For purposes of § 721.72(g)(2) avoid eye contact. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k), (o) and (y)(1).

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii).

§ 721.11478

Perfluoroalkyl ethyl- and vinyl-modified organopolysiloxane (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as perfluoroalkyl ethyl- and vinyl-modified organopolysiloxane (PMN P-18-52) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted (cured).

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1) through (6) and (c). When determining which persons are reasonably likely to be exposed as required by § 721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 1,000). For purposes of § 721.63(a)(6) combination gas/vapor and particulate.

(A) As an alternative to respirator requirements in paragraph (a)(2)(i) of this section, manufacturer or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA section 5(e) consent order for this substance. The NCEL is 0.0015 mg/m3 as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to § 721.63 respirator requirements may request to do so under § 721.30. Persons whose § 721.30 requests to use the NCELs approach are approved by EPA will be required to follow NCELs provisions comparable to those contained in the corresponding TSCA section 5(e) consent order.

(B) [Reserved]

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (f), (g)(1)(vi), (2)(i) through (v), and (5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used. For purposes of § 721.72(g)(1) specific target organ toxicity. For purposes of § 721.72(g)(2)(iv), use respiratory protection or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 0.0015 mg/m3.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f) and (t) (420 kilograms).

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

§ 721.11479

Perfluoroalkyl ethyl- and vinyl-modified organopolysiloxane (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as perfluoroalkyl ethyl- and vinyl-modified organopolysiloxane (PMN P-18-53) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted (cured).

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (3) through (6), and (c). When determining which persons are reasonably likely to be exposed as required by § 721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 1,000. For purposes of § 721.63(a)(6), combination gas/vapor and particulate.

(A) As an alternative to respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA section 5(e) consent order for this substance. The NCEL is 0.0015 mg/m3 as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to § 721.63 respirator requirements may request to do so under § 721.30. Persons whose § 721.30 requests to use the NCELs approach are approved by EPA will be required to follow NCELs provisions comparable to those contained in the corresponding TSCA section 5(e) consent order.

(B) [Reserved]

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (f), (g)(1)(vi), (2)(i) through (v), and (5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used. For purposes of § 721.72(g)(1) specific target organ toxicity. For purposes of § 721.72(g)(2)(iv), use respiratory protection or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 0.0015 mg/m3.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f) and (t) (336 kilograms).

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 1721.185 apply to this section.

§ 721.11480

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

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical identified as oxirane, 2,2′-[cyclohexylidenebis(4,1-phenyleneoxymethylene)]bis- (PMN P-18-62, CAS No. 13446-84-9) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the PMN substance after they have been completely reacted (cured).

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (3) through (6), (b), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 1,000. For purposes of § 721.63(a)(6), particulate (including solids or liquid droplets). For purposes of § 721.63(b), concentration is set at 0.1%.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (f), and (g)(1)(vi), (vii), (2)(i) through (iii) (use respiratory protection when spraying), (v), (3)(i) and (ii), (4)(i), and (5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used. For purposes of § 721.72(g)(1) specific target organ toxicity. For purposes of § 721.72(e), concentration is set at 0.1%.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k). It is a significant new use to manufacture or process the PMN substance in any manner which generates inhalation exposures.

(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4) and (c)(4) where N=1.

(b) Specific requirements. The provision of subpart A of this part apply to this section as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) and (k) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725 (b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11481

Saturated fatty acid, reaction products with cadmium zinc selenide sulfide and polymeric amine (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical identified generically as saturated fatty acid, reaction products with cadmium zinc selenide sulfide and polymeric amine (PMN P-18-74) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (3) and (6), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(a)(6), particulate (including solids or liquid droplets).

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (f), and (g)(1)(i) and (vii), (2)(i) through (iii), and (v), (3)(i) and (ii), (4)(i) and (iii) and (5). For purposes of § 721.72(g)(1) pulmonary toxicity, eye damage, specific target organ toxicity, and skin sensitization. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) (chemical intermediate for a quantum dot used as an optical down-converter (50%), and quantum dot in an optical down-converter (50%)). It is a significant new use to manufacture, process, or use the PMN substance in other than a liquid formulation. It is a significant new use to manufacture or process the PMN substance in any manner which generates inhalation exposures. It is a significant new use to manufacture the PMN substance with a cadmium percentage greater than the confidential level identified in the TSCA Order.

(iv) Disposal. It is a significant new use to dispose of the PMN substance in any manner other than by incineration in a permitted hazardous waste incinerator.

(v) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1) and (c)(1).

(b) Specific requirements. The provision of subpart A of this part apply to this section as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (d), and (f) through (k) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725 (b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11482

Saturated fatty acid, reaction products with cadmium zinc selenide sulfide, alkylamine and polymeric amine (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical identified generically as saturated fatty acid, reaction products with cadmium zinc selenide sulfide, alkylamine and polymeric amine (PMN P-18-75) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (3) and (6), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(a)(6), particulate (including solids or liquid droplets).

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (f), and (g)(1)(i) and (vii), (2)(i) through (iii), and (v), (3)(i) and (ii), (4)(i) and (iii) and (5). For purposes of § 721.72(g)(1) pulmonary toxicity, eye damage, specific target organ toxicity, and skin sensitization. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80 (k)(quantum dot in an optical down-converter). It is a significant new use to manufacture, process, or use the PMN substance in other than a liquid formulation. It is a significant new use to manufacture or process the PMN substance in any manner which generates inhalation exposures. It is a significant new use to manufacture the PMN substance with a cadmium percentage greater than the confidential value stated in the TSCA Order.

(iv) Disposal. It is a significant new use to dispose of the PMN substance in any manner other than by incineration in a permitted hazardous waste incinerator.

(v) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1) and (c)(1).

(b) Specific requirements. The provision of subpart A of this part apply to this section as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (d) and (f) through (k) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725 (b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11483

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

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as heteropolycyclic, halo substituted alkyl substituted- diaromatic amino substituted carbomonocycle, halo substituted alkyl substituted heteropolycyclic, tetraaromatic metalloid salt (1:1) (PMN P-18-160) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted (cured).

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) through (iv), and (3) through (6). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 50. For purposes of § 721.63(a)(6), particulate (including solids or liquid droplets).

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (f), (g)(1), (2)(i) through (v), (3)(i) and (ii) and (4)(iii). For purposes of § 721.72(g)(1) acute toxicity, neurotoxicity, photosensitization, and eye irritation. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (t), and (w)(1), (3) and (4). It is a significant new use to manufacture the substance for more than 18 months.

(iv) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1) and (c)(1).

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c), (i), and (k) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725 (b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11484.

Alkanediol, polymer with 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane, alkylaminoalkyl methacrylate-, and dialkylheteromonocycle-blocked (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkanediol, polymer with 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane, alkylaminoalkyl methacrylate-, and dialkylheteromonocycle-blocked (PMN P-18-237) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been reacted (cured).

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the PMN substance in any manner or method that generates dust, spray, vapor, mist, or aerosol.

(ii) Releases to water. Requirements as specified in § 721.90(a)(4), (b)(4) and (c)(4) where N=1.

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c), (i), and (k) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

§ 721.11485

Alkanediol, polymer with 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane, alkylaminoalkyl methacrylate-blocked (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkanediol, polymer with 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane, alkylaminoalkyl methacrylate-blocked (PMN P-18-292) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been reacted (cured).

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the PMN substance in any manner or method that generates dust, spray, vapor, mist, or aerosol.

(ii) Releases to water. Requirements as specified in § 721.90(a)(4), (b)(4) and (c)(4) where N = 1.

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c), (i), and (k) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

§ 721.11486

Synthetic oil from tires (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as synthetic oil from tires (PMN P-18-287) 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 are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) and (o).

(ii) Disposal. Requirements as specified in § 721.85(a)(1), (b)(1) and (c)(1).

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c), (i) and (j) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(i) of this section.

§ 721.11487

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).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as 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) (PMN P-19-51) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the PMN substance after they have been completely reacted (cured).

(2) The significant new uses are:

(i) Hazard communication. Requirements as specified in § 721.72(a) through (f), and (g)(1)(i) and (iv), (2)(i) through (v), (3)(i) and (ii), (4)(i) and (ii) and (5). For purposes of § 721.72(g)(1) eye irritation, skin sensitization, and respiratory sensitization. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used. For purposes of § 721.72(e), concentration is set at 0.1%.

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f) and (k).

(iii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4) and (c)(4) where N=3.

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (d), (f) through (i), and (k) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section.

§ 721.11488

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

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1,3-propanediol, 2-ethyl-2-(hydroxymethyl)-, polymer with oxirane, 4-(dimethylamino)benzoate (PMN P-19-55, CAS No. 2067275-86-7) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) if this section. The requirements of this section do not apply to quantities of the PMN substance after they have been completely reacted (cured).

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k)(photo initiator within UV curable coating/ink formulations). It is a significant new use to manufacture, process, or use the PMN substance in any manner that results in inhalation exposure.

(ii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4) and (c)(4) where N = 12.

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c), (i), and (k) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 1721.185 apply to this section.

§ 721.11489

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

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as titanium (4+) hydroxyl-alkylcarboxylate salt complex (PMN P-19-159) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted (cured).

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the PMN substance in any manner or method that generates inhalation exposure.

(ii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4) and (c)(4) where N = 1.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c), (i), and (k) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.