Significant New Use Rules on Certain Chemical Substances (20-1.5e), 57968-57980 [2020-18883]

Download as PDF 57968 Federal Register / Vol. 85, No. 181 / Thursday, September 17, 2020 / Rules and Regulations Privacy Act programs and reducing costs to the public as explained in the preamble of the DoD-level Privacy rule published at 84 FR 14728. This rule is not significant under Executive Order (E.O.) 12866, ‘‘Regulatory Planning and Review.’’ Therefore, E.O. 13771, ‘‘Reducing Regulation and Controlling Regulatory Costs,’’ does not apply. List of Subjects in 32 CFR Part 327 Privacy. PART 327—[REMOVED] Accordingly, by the authority of 5 U.S.C. 301, 32 CFR part 327 is removed. ■ Dated: August 19, 2020. Aaron T. Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense. I. General Information [FR Doc. 2020–18522 Filed 9–16–20; 8:45 am] BILLING CODE 5001–06–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 9 and 721 [EPA–HQ–OPPT–2019–0596; FRL–10013– 34] RIN 2070–AB27 Significant New Use Rules on Certain Chemical Substances (20–1.5e) Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: 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. jbell on DSKJLSW7X2PROD with RULES SUMMARY: This rule is effective on November 16, 2020. For purposes of DATES: VerDate Sep<11>2014 15:54 Sep 16, 2020 Jkt 250001 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: (202) 564–4163; email address: wysong.william@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: 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 PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 identification (ID) number EPA–HQ– OPPT–2019–0596, is available at https:// 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 (202) 566–1744, and the telephone number for the OPPT Docket is (202) 566–0280. 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, P16-583, P-17-193, P-17-221, P-17-282, P17-334, P-17-386, P-18-12, P-18-18, P18-42, P-18-52, P-18-53, P-18-62, P-1874, P-18-75, P-18-160, P-18-237, P-18287, P-18-292, P-19-51, P-19-55, and P19-159. 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, E:\FR\FM\17SER1.SGM 17SER1 Federal Register / Vol. 85, No. 181 / Thursday, September 17, 2020 / Rules and Regulations jbell on DSKJLSW7X2PROD with RULES 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 VerDate Sep<11>2014 15:54 Sep 16, 2020 Jkt 250001 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 nonconfidential 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). PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 57969 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 E:\FR\FM\17SER1.SGM 17SER1 57970 Federal Register / Vol. 85, No. 181 / Thursday, September 17, 2020 / Rules and Regulations 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/tscainventory. jbell on DSKJLSW7X2PROD with RULES 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 VerDate Sep<11>2014 15:54 Sep 16, 2020 Jkt 250001 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 PO 00000 Frm 00034 Fmt 4700 Sfmt 4700 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 screeninglevel 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: E:\FR\FM\17SER1.SGM 17SER1 Federal Register / Vol. 85, No. 181 / Thursday, September 17, 2020 / Rules and Regulations • 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. jbell on DSKJLSW7X2PROD with RULES 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. VerDate Sep<11>2014 15:54 Sep 16, 2020 Jkt 250001 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-chemicalsunder-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/lawsregulations-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 PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 57971 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 E:\FR\FM\17SER1.SGM 17SER1 57972 Federal Register / Vol. 85, No. 181 / Thursday, September 17, 2020 / Rules and Regulations 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.). jbell on DSKJLSW7X2PROD with RULES 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). VerDate Sep<11>2014 15:54 Sep 16, 2020 Jkt 250001 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). 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. * * Frm 00036 Fmt 4700 Sfmt 4700 * * 40 CFR citation * * OMB control No. * * * Significant New Uses of Chemical Substances * 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 PO 00000 * E:\FR\FM\17SER1.SGM * * 721.11466 721.11467 721.11468 721.11469 721.11470 721.11471 721.11472 721.11473 721.11474 721.11475 721.11476 17SER1 * * 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 Federal Register / Vol. 85, No. 181 / Thursday, September 17, 2020 / Rules and Regulations 40 CFR citation OMB control No. 721.11477 721.11478 721.11479 721.11480 721.11481 721.11482 721.11483 721.11484 721.11485 721.11486 721.11487 721.11488 721.11489 * * * * 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 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: ■ jbell on DSKJLSW7X2PROD with RULES Subpart E—Significant New Uses for Specific Chemical Substances Sec. 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(2methyl-2-propenoate), tert-Bu 2ethylhexaneperoxoate-initiated (generic). 721.11477 2,5-Furandione, polymer with 2ethyl-2-(hydroxymethyl)-1,3propanediol, 3a,4,5,6,7,7a-hexahydro4,7-methano-1H-inden-5(or 6)-yl ester, ester with 2,3-dihydroxypropyl neodecanoate, polymer with 5isocyanato-1-(isocyanatomethyl)-1,3,3trimethylcyclohexane, 2-hydroxyethyl acrylate- and 2-hydroxyethyl methacrylate-blocked. 721.11478 Perfluoroalkyl ethyl- and vinylmodified organopolysiloxane (generic). 721.11479 Perfluoroalkyl ethyl- and vinylmodified organopolysiloxane (generic). VerDate Sep<11>2014 15:54 Sep 16, 2020 Jkt 250001 721.11480 Oxirane, 2,2’[cyclohexylidenebis(4,1phenyleneoxymethylene)]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 5isocyanato-1-(isocyanatomethyl)-1,3,3trimethylcyclohexane, alkylaminoalkyl methacrylate-, and dialkylheteromonocycle-blocked (generic). 721.11485 Alkanediol, polymer with 5isocyanato-1-(isocyanatomethyl)-1,3,3trimethylcyclohexane, alkylaminoalkyl methacrylate-blocked (generic). 721.11486 Synthetic oil from tires (generic). 721.11487 1,3-Propanediamine, N1,N1dimethyl-, 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+) hydroxylalkylcarboxylate salt complex (generic). * * * § 721.11466 (generic). * * Aromatic amide oxime (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. PO 00000 Frm 00037 Fmt 4700 Sfmt 4700 57973 (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 E:\FR\FM\17SER1.SGM 17SER1 jbell on DSKJLSW7X2PROD with RULES 57974 Federal Register / Vol. 85, No. 181 / Thursday, September 17, 2020 / Rules and Regulations 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. § 721.11469 Pentaerythritol ester of mixed linear and branched carboxylic acids (generic) (P-17-193, chemical A). § 721.11468 (generic). § 721.11470 Dipentaerythritol ester of mixed linear and branched carboxylic acids (generic) (P-17-193, chemical B). Aromatic hydrocarbon resin (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. VerDate Sep<11>2014 15:54 Sep 16, 2020 Jkt 250001 (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. (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 PO 00000 Frm 00038 Fmt 4700 Sfmt 4700 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 E:\FR\FM\17SER1.SGM 17SER1 Federal Register / Vol. 85, No. 181 / Thursday, September 17, 2020 / Rules and Regulations 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. jbell on DSKJLSW7X2PROD with RULES § 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 P17-334, 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 VerDate Sep<11>2014 15:54 Sep 16, 2020 Jkt 250001 57975 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. 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. § 721.11474 Cashew, nutshell liq. polymer with formaldehyde, phenol and resorcinol. § 721.11475 (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 PO 00000 Frm 00039 Fmt 4700 Sfmt 4700 Polyester polyol (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyester polyol (PMN P18-12) 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-2propenoate), tert-Bu 2ethylhexaneperoxoate-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-2propenoate), tert-Bu 2ethylhexaneperoxoate-initiated (PMN P18-18) 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: E:\FR\FM\17SER1.SGM 17SER1 57976 Federal Register / Vol. 85, No. 181 / Thursday, September 17, 2020 / Rules and Regulations (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. jbell on DSKJLSW7X2PROD with RULES § 721.11477 2,5-Furandione, polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, 3a,4,5,6,7,7ahexahydro- 4,7-methano-1Hinden-5(or 6)-yl ester, ester with 2,3dihydroxypropyl neodecanoate, polymer with 5-isocyanato-l-(isocyanatomethyl)-1,3, 3-trimethylcyclohexane, 2-hydroxyethyl acrylate- and 2-hydroxyethyl methacrylateblocked. (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-methano1H-inden-5(or 6)-yl ester, ester with 2,3dihydroxypropyl neodecanoate, polymer with 5-isocyanato-l(isocyanatomethyl)-1,3, 3trimethylcyclohexane, 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) VerDate Sep<11>2014 15:54 Sep 16, 2020 Jkt 250001 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 vinylmodified 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 PO 00000 Frm 00040 Fmt 4700 Sfmt 4700 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 vinylmodified 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 E:\FR\FM\17SER1.SGM 17SER1 jbell on DSKJLSW7X2PROD with RULES Federal Register / Vol. 85, No. 181 / Thursday, September 17, 2020 / Rules and Regulations 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. VerDate Sep<11>2014 15:54 Sep 16, 2020 Jkt 250001 § 721.11480 Oxirane, 2,2′[cyclohexylidenebis(4,1phenyleneoxymethylene)]bis-. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical identified as oxirane, 2,2′-[cyclohexylidenebis(4,1phenyleneoxymethylene)]bis- (PMN P18-62, 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 PO 00000 Frm 00041 Fmt 4700 Sfmt 4700 57977 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 downconverter (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. E:\FR\FM\17SER1.SGM 17SER1 57978 Federal Register / Vol. 85, No. 181 / Thursday, September 17, 2020 / Rules and Regulations (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. jbell on DSKJLSW7X2PROD with RULES § 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 VerDate Sep<11>2014 15:54 Sep 16, 2020 Jkt 250001 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 PO 00000 Frm 00042 Fmt 4700 Sfmt 4700 (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 5isocyanato-1-(isocyanatomethyl)-1,3,3trimethylcyclohexane, alkylaminoalkyl methacrylate-, and dialkylheteromonocycleblocked (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)-1,3,3trimethylcyclohexane, 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 E:\FR\FM\17SER1.SGM 17SER1 Federal Register / Vol. 85, No. 181 / Thursday, September 17, 2020 / Rules and Regulations 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. jbell on DSKJLSW7X2PROD with RULES § 721.11485 Alkanediol, polymer with 5isocyanato-1-(isocyanatomethyl)-1,3,3trimethylcyclohexane, 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)-1,3,3trimethylcyclohexane, 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. VerDate Sep<11>2014 15:54 Sep 16, 2020 Jkt 250001 § 721.11486 (generic). Synthetic oil from tires (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,N1dimethyl-, 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 PO 00000 Frm 00043 Fmt 4700 Sfmt 4700 57979 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. E:\FR\FM\17SER1.SGM 17SER1 57980 Federal Register / Vol. 85, No. 181 / Thursday, September 17, 2020 / Rules and Regulations § 721.11489 Titanium (4+) hydroxylalkylcarboxylate salt complex (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as titanium (4+) hydroxylalkylcarboxylate salt complex (PMN P19-159) 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. [FR Doc. 2020–18883 Filed 9–16–20; 8:45 am] BILLING CODE 6560–50–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 414 [CMS–5533–N] Medicare Program; Alternative Payment Model (APM) Incentive Payment Advisory for Clinicians— Request for Current Billing Information for Qualifying APM Participants Centers for Medicare & Medicaid Services (CMS), Health and Human Services (HHS). ACTION: Payment advisory. AGENCY: This advisory is to alert certain clinicians who are Qualifying APM participants (QPs) and eligible to receive an Alternative Payment Model (APM) Incentive Payment that CMS does not have the current billing information needed to disburse the jbell on DSKJLSW7X2PROD with RULES SUMMARY: VerDate Sep<11>2014 15:54 Sep 16, 2020 Jkt 250001 payment. This advisory provides information to these clinicians on how to update their billing information to receive this payment. DATES: This advisory is effective on September 14, 2020. FOR FURTHER INFORMATION CONTACT: Tanya Dorm, (410) 786–2206. SUPPLEMENTARY INFORMATION: Seema Verma, having reviewed and approved this document, authorizes Vanessa Garcia, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register. I. Background [FR Doc. 2020–20488 Filed 9–14–20; 11:15 am] Under the Medicare Quality Payment Program, an eligible clinician who participates in an Advanced Alternative Payment Model (APM) and meets the applicable payment amount or patient count thresholds for a performance year is a Qualifying APM Participant (QP) for that year. An eligible clinician who is a QP for a year based on their performance in a QP Performance Period earns a 5 percent lump sum APM Incentive Payment that is paid in a payment year that occurs 2 years after the QP Performance Period. The amount of the APM Incentive Payment is equal to 5 percent of the estimated aggregate payments for covered professional services furnished by the QP during the calendar year immediately preceding the payment year. II. Provisions of the Advisory The Centers for Medicare & Medicaid Services (CMS) has identified those eligible clinicians who earned an APM Incentive Payment in CY 2020 based on their CY 2018 QP status. When CMS disbursed the CY 2020 APM Incentive Payments, CMS was unable to verify current Medicare billing information for some QPs and was therefore unable to issue payment. In order to successfully disburse the APM Incentive Payment, CMS is requesting assistance in identifying current Medicare billing information for these QPs. CMS has compiled a list of QPs we have identified as having unverified billing information. These QPs, and any others who anticipated receiving an APM Incentive Payment but have not, should follow the instructions to provide CMS with updated billing information at the following web address: https://qpp-cm-prod-content. s3.amazonaws.com/uploads/1112/2020 %20APM%20Incentive%20Payment %20Notice.pdf. If you have any questions concerning submission of information through the website, please contact the QPP Help Desk at 1–866–288–8292. All submissions must be received no later than November 13, 2020. The Administrator of the Centers for Medicare & Medicaid Services (CMS), PO 00000 Frm 00044 Fmt 4700 Sfmt 4700 Vanessa Garcia, Federal Register Liaison, Centers for Medicare & Medicaid Services. BILLING CODE 4120–01–P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Parts 1, 2, 25, 27 and 101 [GN Docket No. 18–122; FCC 20–22; FRS 17048] Expanding Flexible Use of the 3.7 to 4.2 GHz Band Federal Communications Commission. ACTION: Final rule; corrections and announcement of compliance date. AGENCY: In this document, the Commission corrects a typographical error in the 3.7 GHz Report and Order, FCC 20–22, published on April 23, 2020, and announces that the Office of Management and Budget has approved the information collection requirements associated with the rules adopted in the Federal Communications Commission’s 3.7 GHz Report and Order, requiring the Relocation Payment Clearinghouse and the Relocation Coordinator to each make real-time, public disclosures of the content and timing of and the parties to communications, if any, from or to applicants in the Commission’s auction for overlay licenses in the 3.7 GHz Service, and that compliance with the new rules is now required. This document is consistent with the 3.7 GHz Report and Order, which states that the Commission will publish a document in the Federal Register announcing a compliance date for the new rule sections. SUMMARY: Effective date: The corrections are effective September 17, 2020. Compliance date: Compliance with 47 CFR 27.1413(c)(6) and 27.1414(b)(4)(i), published at 85 FR 22804 on April 23, 2020, is required on September 17, 2020. DATES: FOR FURTHER INFORMATION CONTACT: Anna Gentry, Mobility Division, Wireless Telecommunications Bureau, at (202) 418–7769 or Anna.Gentry@ fcc.gov. This document corrects a typographical error SUPPLEMENTARY INFORMATION: E:\FR\FM\17SER1.SGM 17SER1

Agencies

[Federal Register Volume 85, Number 181 (Thursday, September 17, 2020)]
[Rules and Regulations]
[Pages 57968-57980]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18883]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2019-0596; FRL-10013-34]
RIN 2070-AB27


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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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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: 
(202) 564-4163; email address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

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 https://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 (202) 566-1744, and the telephone number for the OPPT 
Docket is (202) 566-0280.
    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,

[[Page 57969]]

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

[[Page 57970]]

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:

[[Page 57971]]

     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 Sec.  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

[[Page 57972]]

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

0
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.


0
2. In Sec.  9.1, amend the table by adding entries for Sec. Sec.  
721.11466 through 721.11489 in numerical order under the undesignated 
center heading ``Significant New Uses of Chemical Substances'' to read 
as follows:


Sec.  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

[[Page 57973]]

 
                  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

0
3. The authority citation for part 721 continues to read as follows:

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


0
4. Add Sec. Sec.  721.11466 through 721.11489 to subpart E to read as 
follows:

Subpart E--Significant New Uses for Specific Chemical Substances

Sec.
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).
* * * * *


Sec.  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 Sec.  
721.63(a)(1) through (3), and (6), (b) and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
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 Sec.  721.63(b), concentration is set 
at 1.0%.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(g).
    (iii) Release to water. Requirements as specified in Sec.  
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 Sec.  
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 Sec.  721.185 apply to this section.


Sec.  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 Sec.  
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 Sec.  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 Sec.  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 Sec.  721.63(a)(6), particulate (including solids or liquid 
droplets).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  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

[[Page 57974]]

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 Sec.  721.85(a)(1) and 
(2), (b)(1) and (2), and (c)(1) and (2).
    (iv) Release to water. Requirements as specified in Sec.  
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 Sec.  
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 Sec.  721.185 apply to this section.


Sec.  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 Sec.  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 Sec.  
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 Sec.  721.185 apply to this section.


Sec.  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 Sec.  
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 Sec.  
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 Sec.  721.185 apply to this section.


Sec.  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 Sec.  
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 Sec.  
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 Sec.  721.185 apply to this section.


Sec.  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 Sec.  
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 Sec.  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 Sec.  721.63(b), 
concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1)(i) and (ii), (2)(i) through (iii) and 
(v), and (5). For purposes of Sec.  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 Sec.  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 Sec.  
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 Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii).


Sec.  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

[[Page 57975]]

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 Sec.  
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 Sec.  
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 Sec.  721.185 apply to this section.


Sec.  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 Sec.  
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 Sec.  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 Sec.  721.63(a)(6), 
particulate applies. For purposes of Sec.  721.63(b), the concentration 
is set at 0.1%.
    (ii) Hazard communication. Requirements as specified in Sec.  
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 Sec.  
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 Sec.  721.80(f), (g) and (y)(1).
    (iv) Release to water. Requirements as specified in Sec.  
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 Sec.  
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 Sec.  721.185 apply to this section.


Sec.  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 Sec.  
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 Sec.  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 Sec.  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 Sec.  721.63(a)(6), particulate (including combination gas/
vapor and particulate). For purposes of Sec.  721.63(b), concentration 
is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1)(i), (2)(i) and (ii), (iv) and (v), 
(4)(iii), and (5). For purposes of Sec.  721.72(e), concentration is 
set at 1.0%. For purposes of Sec.  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 Sec.  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 Sec.  
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 Sec.  721.185 apply to this section.


Sec.  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 Sec.  
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 Sec.  
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 Sec.  721.185 apply to this section.


Sec.  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:

[[Page 57976]]

    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (t) and (y)(1).
    (ii) Releases to water. Requirements as specified in Sec.  
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 Sec.  
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 Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.


Sec.  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 Sec.  
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 Sec.  
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 Sec.  
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 Sec.  
721.72(g)(1) eye irritation. For purposes of Sec.  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 Sec.  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 Sec.  
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 Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii).


Sec.  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 Sec.  
721.63(a)(1) through (6) and (c). When determining which persons are 
reasonably likely to be exposed as required by Sec.  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 
Sec.  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 Sec.  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 Sec.  721.63 respirator requirements may 
request to do so under Sec.  721.30. Persons whose Sec.  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 Sec.  
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 Sec.  721.72(g)(1) specific target organ 
toxicity. For purposes of Sec.  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 Sec.  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 Sec.  
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 Sec.  721.185 apply to this section.


Sec.  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 Sec.  
721.63(a)(1), (3) through (6), and (c). When determining which persons 
are reasonably likely to be exposed as

[[Page 57977]]

required by Sec.  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 Sec.  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 Sec.  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 Sec.  721.63 respirator requirements may 
request to do so under Sec.  721.30. Persons whose Sec.  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 Sec.  
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 Sec.  721.72(g)(1) specific target organ 
toxicity. For purposes of Sec.  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 Sec.  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 Sec.  
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 Sec.  1721.185 apply to this section.


Sec.  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 Sec.  
721.63(a)(1), (3) through (6), (b), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
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 Sec.  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 
Sec.  721.63(a)(6), particulate (including solids or liquid droplets). 
For purposes of Sec.  721.63(b), concentration is set at 0.1%.
    (ii) Hazard communication. Requirements as specified in Sec.  
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 Sec.  721.72(g)(1) 
specific target organ toxicity. For purposes of Sec.  721.72(e), 
concentration is set at 0.1%.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  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 Sec.  
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 Sec.  
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 Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725 (b)(1) apply to paragraph (a)(2)(iii) 
of this section.


Sec.  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 Sec.  
721.63(a)(1), (3) and (6), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  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 
Sec.  721.63(a)(6), particulate (including solids or liquid droplets).
    (ii) Hazard communication. Requirements as specified in Sec.  
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 Sec.  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 Sec.  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.

[[Page 57978]]

    (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 Sec.  
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 Sec.  
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 Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725 (b)(1) apply to paragraph (a)(2)(iii) 
of this section.


Sec.  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 Sec.  
721.63(a)(1), (3) and (6), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  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 
Sec.  721.63(a)(6), particulate (including solids or liquid droplets).
    (ii) Hazard communication. Requirements as specified in Sec.  
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 Sec.  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 Sec.  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 Sec.  
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 Sec.  
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 Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725 (b)(1) apply to paragraph (a)(2)(iii) 
of this section.


Sec.  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 Sec.  
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 Sec.  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 Sec.  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 Sec.  
721.63(a)(6), particulate (including solids or liquid droplets).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), (2)(i) through (v), (3)(i) and (ii) 
and (4)(iii). For purposes of Sec.  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 Sec.  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 Sec.  
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 Sec.  
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 Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725 (b)(1) apply to paragraph (a)(2)(iii) 
of this section.


Sec.  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

[[Page 57979]]

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 Sec.  
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 Sec.  
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 Sec.  721.185 apply to this section.


Sec.  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 Sec.  
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 Sec.  
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 Sec.  721.185 apply to this section.


Sec.  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 Sec.  721.80(k) and (o).
    (ii) Disposal. Requirements as specified in Sec.  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 Sec.  
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 Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.


Sec.  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 Sec.  
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 Sec.  
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 Sec.  721.72(e), 
concentration is set at 0.1%.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (k).
    (iii) Release to water. Requirements as specified in Sec.  
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 Sec.  
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 Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(ii) of 
this section.


Sec.  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 Sec.  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 Sec.  
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 Sec.  
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 Sec.  1721.185 apply to this section.

[[Page 57980]]

Sec.  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 Sec.  
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 Sec.  
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 Sec.  721.185 apply to this section.

[FR Doc. 2020-18883 Filed 9-16-20; 8:45 am]
BILLING CODE 6560-50-P


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