Modification of Significant New Uses of Certain Chemical Substances (20-1.M), 67996-68001 [2020-21464]

Download as PDF 67996 Federal Register / Vol. 85, No. 208 / Tuesday, October 27, 2020 / Rules and Regulations direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. E. Unfunded Mandates Reform Act F. Environment We have analyzed this rule under Department of Homeland Security Directive 023–01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321–4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting for a total of 20 hours that will prohibit entry within 200 yards of a worksite crossing the Menominee River for the removal of overhead electrical cables crossing the river. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023–01–001–01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the ADDRESSES section of this preamble. G. Protest Activities jbell on DSKJLSW7X2PROD with RULES The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to call or email the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places, or vessels. Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways. VerDate Sep<11>2014 15:51 Oct 26, 2020 Jkt 253001 PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 1. The authority citation for part 165 continues to read as follows: ■ The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531–1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble. List of Subjects in 33 CFR Part 165 For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows: Authority: 46 U.S.C. 70034, 70051; 33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; Department of Homeland Security Delegation No. 0170.1. 2. Add § 165.T09–0642 to read as follows: ■ § 165.T09–0642 Safety Zone; Electrical Cable Removal, Menominee River, Menominee, MI and Marinette, WI. (a) Location. All navigable waters of the Menominee River within 200 yards of a line crossing the river from coordinates 45.096326° N, 087.602092° W to 45.097197° N, 087.600601° W. (b) Enforcement period. The regulated area described in paragraph (a) is effective from 7 a.m. through 5 p.m. on October 27 and October 28, 2020. (c) Regulations. (1) In accordance with the general regulations in section § 165.23, entry into, transiting, or anchoring within this safety zone is prohibited unless authorized by the Captain of the Port Lake Michigan (COTP) or a designated representative. (2) This safety zone is closed to all vessel traffic, except as may be permitted by the COTP or a designated representative. (3) The ‘‘designated representative’’ of the COTP is any Coast Guard commissioned, warrant, or petty officer who has been designated by the COTP to act on his or her behalf. (4) Persons and vessel operators desiring to enter or operate within the safety zone must contact the COTP or designated representative to obtain permission to do so. The COTP or designated representative may be contacted via VHF Channel 16. Vessel operators given permission to enter or operate in the safety zone must comply with all directions given to them by the COTP or designated representative. Dated: October 20, 2020. D.P. Montoro, Captain, U.S. Coast Guard, Captain of the Port Lake Michigan. [FR Doc. 2020–23650 Filed 10–26–20; 8:45 am] BILLING CODE 9110–04–P PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 721 [EPA–HQ–OPPT–2019–0614; FRL–10013– 53] RIN 2070–AB27 Modification of Significant New Uses of Certain Chemical Substances (20– 1.M) Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: EPA is amending significant new use rules (SNURs) issued under the Toxic Substances Control Act (TSCA) for certain chemical substances, which were the subject of premanufacture notices (PMNs) and significant new use notices (SNUNs). As a result of EPA’s review of SNUNs for these chemical substances and based on new and existing data, EPA is finalizing amendments to these SNURs. Specifically, this action amends the identified SNURs to allow certain new uses reported in the SNUNs without additional notification requirements and modify the significant new use notification requirements based on the actions and determinations for the SNUN submissions. DATES: This rule is effective on December 28, 2020. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on November 10, 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. SUMMARY: 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 E:\FR\FM\27OCR1.SGM 27OCR1 Federal Register / Vol. 85, No. 208 / Tuesday, October 27, 2020 / Rules and Regulations 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)) and 40 CFR 721.20, and must comply with the export notification requirements in 40 CFR part 707, subpart D. jbell on DSKJLSW7X2PROD with RULES 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–2019–0263, 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. VerDate Sep<11>2014 15:51 Oct 26, 2020 Jkt 253001 II. Background A. What action is the Agency taking? EPA is issuing amendments to the SNURs for certain chemical substances in 40 CFR part 721, subpart E. A SNUR for a chemical substance designates certain activities as a significant new use. Persons who intend to manufacture or process the chemical substance for the significant new use must notify EPA at least 90 days before commencing that activity. The required notification (i.e., a SNUN) initiates EPA’s evaluation of the intended use within the applicable review period. Manufacture and processing for the significant new use may not commence until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required with that determination. Previously, in the Federal Register of April 1, 2020 (85 FR 18173; FRL– 10004–51), EPA proposed amendments to the SNURs for these chemical substances and established the record for these SNUR amendments in the docket under docket ID number EPA– HQ–OPPT–2019–0614. 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 (i.e., a SNUR) after considering all relevant factors, including those listed in TSCA section 5(a)(2). EPA may also amend a SNUR promulgated under TSCA section 5(a)(2). Procedures and criteria for modifying or revoking SNUR requirements appear at 40 CFR 721.185. C. How do the general SNUR provisions apply to this action? General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the final rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the final rule. Provisions relating to user fees appear at 40 CFR part 700. According to 40 CFR 721.1(c), persons subject to these SNURs must comply with the same notice requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include the PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 67997 information submission requirements of TSCA sections 5(b) and 5(d)(1), the exemptions authorized by TSCA sections 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA must either determine that the significant new use is not likely to present an unreasonable risk of injury or take such regulatory action as is associated with an alternative determination before the manufacture or processing for the significant new use can commence. 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 A. Considerations for Significant New Use Determinations 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 whether and how to modify the significant new uses for the chemical substances that are the subject of these SNURs, and as described in the preamble to the proposed rule, EPA considered relevant information about the toxicity of the chemical substance, likely human exposures and environmental releases associated with possible uses, and the four TSCA section 5(a)(2) factors listed in this unit. B. Procedures for Significant New Uses Claimed as CBI 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 E:\FR\FM\27OCR1.SGM 27OCR1 67998 Federal Register / Vol. 85, No. 208 / Tuesday, October 27, 2020 / Rules and Regulations jbell on DSKJLSW7X2PROD with RULES procedure to deal with the situation where a specific significant new use is CBI, at 40 CFR 721.1725(b)(1) and has referenced it to apply to other SNURs. Under these procedures a manufacturer or processor may request EPA to determine whether a specific 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. IV. Public Comments on Proposed Rule and EPA Responses EPA received three public comments on the proposed amendments. The Agency’s responses to these comments are provided in a separate Response to Public Comments document that is available in the docket for this rule. EPA made one change to the final rule amending 40 CFR 721.10663 based on one comment. Specifically, EPA added language used in previous SNURs for other carbon nanotube chemicals identifying criteria where SNUR requirements do not apply. EPA agrees with the commenter that when the chemical substance meets any of these criteria, there is no unreasonable risk from exposure to the substance. VerDate Sep<11>2014 15:51 Oct 26, 2020 Jkt 253001 V. Rationale of the Final Rule These amendments are based on EPA’s determination under 40 CFR 721.185(a)(3) following review of significant new use notices (SNUNs) for the chemical substances submitted to EPA. After reviewing the SNUNs, EPA concluded that there is no need to require additional notice from persons who propose to engage in identical or similar activities. In those instances where EPA expanded the scope of the significant new use, the Agency identified concerns during review of the SNUNs, as discussed in Unit IV. of the proposed rule, associated with certain potential new uses. In addition to considering the factors discussed in Unit IV. of the proposed rule, EPA determined that those uses could result in changes in the type or form of exposure to the chemical substance, increased exposures to the chemical substance, and/or changes in the reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of the chemical substance. VI. Applicability of Rule to Uses Occurring Before Effective Date of the Final Rule To establish a significant new use, EPA must determine that the use is not ongoing. EPA made this determination in issuing the original final rule for each chemical substance, and solicited additional comments on the proposed modifications to provide an opportunity for members of the public to indicate whether any of the uses which are not significant new uses under the current rules, but which would be regulated as ‘‘significant new uses’’ if the proposed rule is finalized, are ongoing. EPA received no comments that these uses were ongoing. Therefore, EPA concludes that the uses are not ongoing and designated April 1, 2020 (the date of publication of the proposed rule) as the cutoff date for determining whether the new use is ongoing. In the unlikely event that a person began commercial manufacture or processing of the chemical substances for a significant new use identified as of the cutoff 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. PO 00000 Frm 00034 Fmt 4700 Sfmt 4700 VII. Development and Submission of Information EPA recognizes that TSCA section 5 generally 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, 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 an applicable rule, order or consent agreement under TSCA section 4, or a TSCA section 5(b)(4) listing 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 addressed in this final rule. Descriptions are provided for informational purposes. The information identified in Unit IV. of the proposed rule will be potentially useful to EPA’s evaluation of a chemical substance in the event that someone submits a SNUN for a significant new use pursuant to the SNURs addressed in this final rule. Companies who are considering submitting a SNUN are encouraged, but are not required, to develop the potentially useful 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 on 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 dialogue with Agency representatives to help determine how best the submitter can meet both the data needs and the objective of TSCA section 4(h). 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. 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 E:\FR\FM\27OCR1.SGM 27OCR1 Federal Register / Vol. 85, No. 208 / Tuesday, October 27, 2020 / Rules and Regulations submitters contact EPA early enough to provide time for conducting appropriate tests. SNUN submitters should be aware that EPA will be better able to evaluate SNUNs that provide detailed information on the following: • Human exposure and environmental release that may result from the significant new use of the chemical substances; and • Information on risks posed by the chemical substances compared to risks posed by potential substitutes. VIII. SNUN Submissions According to 40 CFR 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN under 40 CFR part 720, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710–25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 721.25 and 720.40. E– PMN software is available electronically at https://www.epa.gov/reviewing-newchemicals-under-toxic-substancescontrol-act-tsca. IX. Economic Analysis EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors of the chemical substances subject to this rule. EPA’s complete economic analysis is available in the docket under docket ID number EPA–HQ–OPPT– 2019–0614. X. 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. jbell on DSKJLSW7X2PROD with RULES A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulations and Regulatory Review This action modifies SNURs for several chemical substances that were the subject of PMNs and SNUNs. 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). VerDate Sep<11>2014 15:51 Oct 26, 2020 Jkt 253001 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) This action does not impose any new information collection burden under the PRA (44 U.S.C. 3501 et seq.). Burden is defined in 5 CFR 1320.3(b). The information collection activities associated with new chemical SNURs have already been approved under OMB control number 2070–0012 (EPA ICR No. 0574). This action does not impose any burden requiring additional OMB approval. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA’s regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable. 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. 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 SNUR modifications will not have a significant adverse economic impact on PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 67999 a substantial number of small entities. The requirement to submit a SNUN applies to any person (including small or large entities) who intends to engage in any activity described in the final rule as a ‘‘significant new use.’’ Because these uses are ‘‘new’’ based on all information currently available to EPA, EPA has concluded that no small or large entities presently engage in such activities. A SNUR requires that any person who intends to engage in such activity in the future must first notify EPA by submitting a SNUN. Although some small entities may decide to pursue a significant new use in the future, EPA cannot presently determine how many, if any, there may be. However, EPA’s experience to date is that, in response to the promulgation of SNURs covering over 1,000 chemicals, the Agency receives only a small number of notices per year. For example, EPA received 7 SNUNs in Federal fiscal year (FY) 2013, 13 in FY2014, 6 in FY2015, 10 in FY2016, 14 in FY2017, and 11 in FY2018 and only a fraction of these were from small businesses. In addition, the Agency currently offers relief to qualifying small businesses by reducing the SNUN submission fee from $16,000 to $2,800. This lower fee reduces the total reporting and recordkeeping of cost of submitting a SNUN to about $10,116 for qualifying small firms. Therefore, the potential economic impacts of complying with this SNUR are not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published in the Federal Register of June 2, 1997 (62 FR 29684) (FRL–5597–1), the Agency presented its general determination that final SNURs are not expected to have a significant economic impact on a substantial number of small entities, which was provided to the Chief Counsel for Advocacy of the Small Business Administration. E. Unfunded Mandates Reform Act (UMRA) Based on EPA’s experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this action. As such, EPA has determined that this action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.). E:\FR\FM\27OCR1.SGM 27OCR1 68000 Federal Register / Vol. 85, No. 208 / Tuesday, October 27, 2020 / Rules and Regulations 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, entitled ‘‘Federalism’’ (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 jbell on DSKJLSW7X2PROD with RULES 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 and is therefore not subject to considerations under NTTAA section 12(d) (15 U.S.C. 272 note). VerDate Sep<11>2014 15:51 Oct 26, 2020 Jkt 253001 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). XI. Congressional Review Act (CRA) 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 in 40 CFR Part 721 Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements. Dated: September 14, 2020. Tala Henry, Deputy Director, Office of Pollution Prevention and Toxics. Therefore, for the reasons stated in the preamble, EPA amends 40 CFR part 721 as follows: PART 721—SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES 1. The authority citation for part 721 continues to read as follows: ■ Authority: 15 U.S.C. 2604, 2607, and 2625(c). 2. Amend § 721.5185 by revising paragraphs (a)(1) and (a)(2)(i) and (iii) to read as follows: ■ § 721.5185 2-Propen-1-one, 1-(4morpholinyl)-. (a) * * * (1) The chemical substance identified as 2-propen-1-one, 1-(4-morpholinyl)(PMN P–95–169; SNUN S–08–7; SNUN S–14–1; and SNUN S–17–10; CAS No. 5117–12–4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this rule do not apply to quantities of the chemical substance after it has been completely reacted (cured) because 2-propen-1-one, 1-(4-morpholinyl)- will no longer exist. (2) * * * (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i) and (iv), (a)(3)(i) and (ii), (a)(6)(v), (b), and (c). (A) Safety 4/4H EVOH/PE laminate, Ansell Edmont Neoprene number 865, and Solvex Nitrile Rubber number 275 gloves have been tested in accordance with the American Society for Testing Materials (ASTM) F739 method and PO 00000 Frm 00036 Fmt 4700 Sfmt 4700 found by EPA to satisfy the consent orders and § 721.63(a)(2)(i) requirements for dermal protection to 100 percent PMN substance. Gloves and other dermal protection may not be used for a time period longer than they are actually tested and must be replaced at the end of each work shift. For additional dermal protection materials, a company must submit all test data to the Agency and must receive written Agency approval for each type of material tested prior to use of that material as worker dermal protection. However, for the purposes of determining the imperviousness of gloves, up to 1 year after the commencement of commercial manufacture or import, the employer may use the method described in § 721.63(a)(3)(ii), thereafter, they must use the method described in § 721.63(a)(3)(i). For purposes of § 721.63(b), the concentration is set at 1.0%. (B) Additional requirements for use as a monomer for stereolithography: Requirements as specified in § 721.63(a)(4) and (5), (a)(6)(v), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(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 assigned protection factor of at least 50. * * * * * (iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(y)(1). It is a significant new use to use the chemical substance for any use other than as a monomer for use in ultraviolet ink jet applications or stereolithography, unless the chemical substance is processed and used in an enclosed process. * * * * * ■ 3. Amend § 721.10371 by revising paragraphs (a)(1) and (a)(2)(i) to read as follows: § 721.10371 Butanoic acid, 3-mercapto,1,1′-[2-(hydroxymethyl)-2-(substituted-1oxoalkoxy)methyl)-1,3-propanediyl] ester (generic). (a) * * * (1) The chemical substance identified generically as butanoic acid, 3mercapto-,1,1′-[2-(hydroxymethyl)-2(substituted-1-oxoalkoxy)methyl)-1,3propanediyl] ester (PMN P–10–136 and E:\FR\FM\27OCR1.SGM 27OCR1 Federal Register / Vol. 85, No. 208 / Tuesday, October 27, 2020 / Rules and Regulations S–18–5, Chemical A) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) * * * (i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f). It is a significant new use to use the substance other than as a monomer for acryl-based ultraviolet (UV)-curing coatings, inks, and adhesives or the confidential use described in the significant new use notice S–18–5. * * * * * ■ 4. Amend § 721.10372 by revising paragraphs (a)(1) and (a)(2)(i) to read as follows: § 721.10372 Butanoic acid, 3-mercapto,1,1′-[2,2-bis[(substituted-1oxoalkoxy)methyl]-1,3-propanediyl] ester (generic). jbell on DSKJLSW7X2PROD with RULES (a) * * * (1) The chemical substance identified generically as butanoic acid, 3mercapto-,1,1′-[2,2-bis[(substituted-1oxoalkoxy)methyl]-1,3-propanediyl] ester (PMN P–10–136 and SNUN S–18– 5, Chemical B) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) * * * (i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f). It is a significant new use to use the substance other than as a monomer for acryl-based ultraviolet (UV)-curing coatings, inks, and adhesives, or the confidential use described in the SNUN S–18–5. * * * * * ■ 5. Amend § 721.10663 by revising paragraphs (a)(1), (a)(2)(i) and (ii), and (b)(1) to read as follows: (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1) and (3) through (6), (b), 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 of at least 50. For purposes of § 721.63(a)(6), the airborne form of the substance includes particulate. For purposes of § 721.63(b), concentration is set at 1.0%. (ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(v)(1), (w)(1), and (x)(1). It is a significant new use to use the substance other than as a chemical additive for use in epoxy compounds for transportation, marine and industrial coatings, paints and manufactured goods, for the confidential use described in PMN P–12–44, or for the confidential use described in SNUN S–19–5. (b) * * * (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (f), (i), and (k) are applicable to manufacturers, importers, and processors of this substance. * * * * * ■ 6. Amend § 721.10928 by revising paragraphs (a)(1) and (a)(2)(iii) to read as follows: § 721.10663 Functionalized multi-walled carbon nanotubes (generic). § 721.10928 Coke (coal), secondary pitch; a carbon-containing residue from the coking of air blown pitch coke oil and/or pitch distillate; composed primarily of isotropic carbon, it contains small amounts of sulfur and ash constituents. (a) * * * (1) The chemical substance identified generically as functionalized multiwalled carbon nanotubes (PMN P–12– 44; SNUN S–18–4; and SNUN S–19–5) 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 completely reacted (cured); incorporated or embedded into a polymer matrix that itself has been completely reacted (cured); embedded in a permanent solid polymer form that is not intended to undergo further processing except for mechanical process; or incorporated into an article. (2) * * * (a) * * * (1) The chemical substance identified as coke (coal), secondary pitch. Definition: A carbon-containing residue from the coking of air blown pitch coke oil and/or pitch distillate; composed primarily of isotropic carbon, it contains small amounts of sulfur and ash constituents (PMN P–12–292, PMN P– 17–217, and SNUN S–19–4; CAS No. 94113–91–4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) * * * (iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (p), and (y)(1) and (2). It is a significant new use to use the substance other than for the VerDate Sep<11>2014 15:51 Oct 26, 2020 Jkt 253001 PO 00000 Frm 00037 Fmt 4700 Sfmt 4700 68001 confidential use permitted by the Order for P–12–292, as a lubricating agent used in the production of automotive disc brakes, or to process as an additive for the manufacture of diesel particulate filters to increase the porosity of the filter. It is a significant new use to use the substance in an additive formulation to produce diesel particulate filters within the United States. For purposes of § 721.80, the aggregate volume is 2,500,000 kilograms. * * * * * [FR Doc. 2020–21464 Filed 10–26–20; 8:45 am] BILLING CODE 6560–50–P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 660 [Docket No. 201021–0276] RIN 0648–BK15 Fisheries Off West Coast States; Emergency Action To Temporarily Extend the Primary Sablefish Fishery Season National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Temporary rule; emergency action; request for comments. AGENCY: This emergency rule temporarily extends the 2020 sablefish primary fishery from October 31, 2020 to December 31, 2020. This action is necessary to provide operational flexibility so that vessels in the sablefish primary fishery are able to fully harvest their tier limits despite high economic uncertainty in 2020. This action would also extend the incidental halibut retention allowance provision for the sablefish primary fishery from October 31, 2020 to November 15, 2020 and set the halibut retention limit during this time period at 250 pounds (113 kilograms) dressed weight of Pacific halibut for every 1,000 pounds (454 kilograms) dressed weight of sablefish landed and up to 2 additional Pacific halibut in excess of the 250-pounds-per1,000-pound limit per landing. DATES: Effective October 27, 2020 until December 31, 2020. Comments must be submitted by November 27, 2020. ADDRESSES: You may submit comments on this document, identified by NOAA– NMFS–2020–0133 by any of the following methods: • Electronic Submission: Submit all electronic public comments via the SUMMARY: E:\FR\FM\27OCR1.SGM 27OCR1

Agencies

[Federal Register Volume 85, Number 208 (Tuesday, October 27, 2020)]
[Rules and Regulations]
[Pages 67996-68001]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21464]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2019-0614; FRL-10013-53]
RIN 2070-AB27


Modification of Significant New Uses of Certain Chemical 
Substances (20-1.M)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is amending significant new use rules (SNURs) issued under 
the Toxic Substances Control Act (TSCA) for certain chemical 
substances, which were the subject of premanufacture notices (PMNs) and 
significant new use notices (SNUNs). As a result of EPA's review of 
SNUNs for these chemical substances and based on new and existing data, 
EPA is finalizing amendments to these SNURs. Specifically, this action 
amends the identified SNURs to allow certain new uses reported in the 
SNUNs without additional notification requirements and modify the 
significant new use notification requirements based on the actions and 
determinations for the SNUN submissions.

DATES: This rule is effective on December 28, 2020. For purposes of 
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on 
November 10, 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

[[Page 67997]]

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)) and 
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-2019-0263, 
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 issuing amendments to the SNURs for certain chemical 
substances in 40 CFR part 721, subpart E. A SNUR for a chemical 
substance designates certain activities as a significant new use. 
Persons who intend to manufacture or process the chemical substance for 
the significant new use must notify EPA at least 90 days before 
commencing that activity. The required notification (i.e., a SNUN) 
initiates EPA's evaluation of the intended use within the applicable 
review period. Manufacture and processing for the significant new use 
may not commence until EPA has conducted a review of the notice, made 
an appropriate determination on the notice, and taken such actions as 
are required with that determination.
    Previously, in the Federal Register of April 1, 2020 (85 FR 18173; 
FRL-10004-51), EPA proposed amendments to the SNURs for these chemical 
substances and established the record for these SNUR amendments in the 
docket under docket ID number EPA-HQ-OPPT-2019-0614. 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 (i.e., a SNUR) after 
considering all relevant factors, including those listed in TSCA 
section 5(a)(2). EPA may also amend a SNUR promulgated under TSCA 
section 5(a)(2). Procedures and criteria for modifying or revoking SNUR 
requirements appear at 40 CFR 721.185.

C. How do the general SNUR provisions apply to this action?

    General provisions for SNURs appear in 40 CFR part 721, subpart A. 
These provisions describe persons subject to the final rule, 
recordkeeping requirements, exemptions to reporting requirements, and 
applicability of the rule to uses occurring before the effective date 
of the final rule. Provisions relating to user fees appear at 40 CFR 
part 700. According to 40 CFR 721.1(c), persons subject to these SNURs 
must comply with the same notice 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, 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 before the manufacture or 
processing for the significant new use can commence. 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

A. Considerations for Significant New Use Determinations

    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 whether and how to modify the significant new uses 
for the chemical substances that are the subject of these SNURs, and as 
described in the preamble to the proposed rule, EPA considered relevant 
information about the toxicity of the chemical substance, likely human 
exposures and environmental releases associated with possible uses, and 
the four TSCA section 5(a)(2) factors listed in this unit.

B. Procedures for Significant New Uses Claimed as CBI

    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

[[Page 67998]]

procedure to deal with the situation where a specific significant new 
use is CBI, at 40 CFR 721.1725(b)(1) and has referenced it to apply to 
other SNURs.
    Under these procedures a manufacturer or processor may request EPA 
to determine whether a specific 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.

IV. Public Comments on Proposed Rule and EPA Responses

    EPA received three public comments on the proposed amendments. The 
Agency's responses to these comments are provided in a separate 
Response to Public Comments document that is available in the docket 
for this rule. EPA made one change to the final rule amending 40 CFR 
721.10663 based on one comment. Specifically, EPA added language used 
in previous SNURs for other carbon nanotube chemicals identifying 
criteria where SNUR requirements do not apply. EPA agrees with the 
commenter that when the chemical substance meets any of these criteria, 
there is no unreasonable risk from exposure to the substance.

V. Rationale of the Final Rule

    These amendments are based on EPA's determination under 40 CFR 
721.185(a)(3) following review of significant new use notices (SNUNs) 
for the chemical substances submitted to EPA. After reviewing the 
SNUNs, EPA concluded that there is no need to require additional notice 
from persons who propose to engage in identical or similar activities. 
In those instances where EPA expanded the scope of the significant new 
use, the Agency identified concerns during review of the SNUNs, as 
discussed in Unit IV. of the proposed rule, associated with certain 
potential new uses. In addition to considering the factors discussed in 
Unit IV. of the proposed rule, EPA determined that those uses could 
result in changes in the type or form of exposure to the chemical 
substance, increased exposures to the chemical substance, and/or 
changes in the reasonably anticipated manner and methods of 
manufacturing, processing, distribution in commerce, and disposal of 
the chemical substance.

VI. Applicability of Rule to Uses Occurring Before Effective Date of 
the Final Rule

    To establish a significant new use, EPA must determine that the use 
is not ongoing. EPA made this determination in issuing the original 
final rule for each chemical substance, and solicited additional 
comments on the proposed modifications to provide an opportunity for 
members of the public to indicate whether any of the uses which are not 
significant new uses under the current rules, but which would be 
regulated as ``significant new uses'' if the proposed rule is 
finalized, are ongoing. EPA received no comments that these uses were 
ongoing. Therefore, EPA concludes that the uses are not ongoing and 
designated April 1, 2020 (the date of publication of the proposed rule) 
as the cutoff date for determining whether the new use is ongoing.
    In the unlikely event that a person began commercial manufacture or 
processing of the chemical substances for a significant new use 
identified as of the cutoff 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.

VII. Development and Submission of Information

    EPA recognizes that TSCA section 5 generally 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, 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 an applicable rule, order or consent agreement 
under TSCA section 4, or a TSCA section 5(b)(4) listing 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 addressed in this final rule. Descriptions are provided 
for informational purposes. The information identified in Unit IV. of 
the proposed rule will be potentially useful to EPA's evaluation of a 
chemical substance in the event that someone submits a SNUN for a 
significant new use pursuant to the SNURs addressed in this final rule. 
Companies who are considering submitting a SNUN are encouraged, but are 
not required, to develop the potentially useful 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 on 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 dialogue with Agency representatives to help determine how 
best the submitter can meet both the data needs and the objective of 
TSCA section 4(h).
    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. 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

[[Page 67999]]

submitters contact EPA early enough to provide time for conducting 
appropriate tests.
    SNUN submitters should be aware that EPA will be better able to 
evaluate SNUNs that provide detailed information on the following:
     Human exposure and environmental release that may result 
from the significant new use of the chemical substances; and
     Information on risks posed by the chemical substances 
compared to risks posed by potential substitutes.

VIII. SNUN Submissions

    According to 40 CFR 721.1(c), persons submitting a SNUN must comply 
with the same notification requirements and EPA regulatory procedures 
as persons submitting a PMN under 40 CFR part 720, including submission 
of test data on health and environmental effects as described in 40 CFR 
720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated 
using e-PMN software, and submitted to the Agency in accordance with 
the procedures set forth in 40 CFR 721.25 and 720.40. E-PMN software is 
available electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.

IX. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN 
requirements for potential manufacturers and processors of the chemical 
substances subject to this rule. EPA's complete economic analysis is 
available in the docket under docket ID number EPA-HQ-OPPT-2019-0614.

X. Statutory and Executive Order Reviews

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

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

    This action modifies SNURs for several chemical substances that 
were the subject of PMNs and SNUNs. 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)

    This action does not impose any new information collection burden 
under the PRA (44 U.S.C. 3501 et seq.). Burden is defined in 5 CFR 
1320.3(b). The information collection activities associated with new 
chemical SNURs have already been approved under OMB control number 
2070-0012 (EPA ICR No. 0574). This action does not impose any burden 
requiring additional OMB approval.
    An agency may not conduct or sponsor, and a person is not required 
to respond to a collection of information that requires OMB approval 
under PRA, unless it has been approved by OMB and displays a currently 
valid OMB control number. The OMB control numbers for EPA's regulations 
in title 40 of the CFR, after appearing in the Federal Register, are 
listed in 40 CFR part 9, and included on the related collection 
instrument or form, if applicable. 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.
    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 SNUR modifications 
will not have a significant adverse economic impact on a substantial 
number of small entities. The requirement to submit a SNUN applies to 
any person (including small or large entities) who intends to engage in 
any activity described in the final rule as a ``significant new use.'' 
Because these uses are ``new'' based on all information currently 
available to EPA, EPA has concluded that no small or large entities 
presently engage in such activities. A SNUR requires that any person 
who intends to engage in such activity in the future must first notify 
EPA by submitting a SNUN. Although some small entities may decide to 
pursue a significant new use in the future, EPA cannot presently 
determine how many, if any, there may be. However, EPA's experience to 
date is that, in response to the promulgation of SNURs covering over 
1,000 chemicals, the Agency receives only a small number of notices per 
year. For example, EPA received 7 SNUNs in Federal fiscal year (FY) 
2013, 13 in FY2014, 6 in FY2015, 10 in FY2016, 14 in FY2017, and 11 in 
FY2018 and only a fraction of these were from small businesses. In 
addition, the Agency currently offers relief to qualifying small 
businesses by reducing the SNUN submission fee from $16,000 to $2,800. 
This lower fee reduces the total reporting and recordkeeping of cost of 
submitting a SNUN to about $10,116 for qualifying small firms. 
Therefore, the potential economic impacts of complying with this SNUR 
are not expected to be significant or adversely impact a substantial 
number of small entities. In a SNUR that published in the Federal 
Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency 
presented its general determination that final SNURs are not expected 
to have a significant economic impact on a substantial number of small 
entities, which was provided to the Chief Counsel for Advocacy of the 
Small Business Administration.

E. Unfunded Mandates Reform Act (UMRA)

    Based on EPA's experience with proposing and finalizing SNURs, 
State, local, and Tribal governments have not been impacted by these 
rulemakings, and EPA does not have any reasons to believe that any 
State, local, or Tribal government will be impacted by this action. As 
such, EPA has determined that this action does not impose any 
enforceable duty, contain any unfunded mandate, or otherwise have any 
effect on small governments subject to the requirements of UMRA 
sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).

[[Page 68000]]

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, entitled 
``Federalism'' (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 and is 
therefore not subject to considerations under 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).

XI. Congressional Review Act (CRA)

    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 in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances, 
Reporting and recordkeeping requirements.

    Dated: September 14, 2020.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.

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

PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES

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

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


0
2. Amend Sec.  721.5185 by revising paragraphs (a)(1) and (a)(2)(i) and 
(iii) to read as follows:


Sec.  721.5185  2-Propen-1-one, 1-(4-morpholinyl)-.

    (a) * * *
    (1) The chemical substance identified as 2-propen-1-one, 1-(4-
morpholinyl)- (PMN P-95-169; SNUN S-08-7; SNUN S-14-1; and SNUN S-17-
10; CAS No. 5117-12-4) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section. 
The requirements of this rule do not apply to quantities of the 
chemical substance after it has been completely reacted (cured) because 
2-propen-1-one, 1-(4-morpholinyl)- will no longer exist.
    (2) * * *
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) and (iv), (a)(3)(i) and (ii), (a)(6)(v), (b), 
and (c).
    (A) Safety 4/4H EVOH/PE laminate, Ansell Edmont Neoprene number 
865, and Solvex Nitrile Rubber number 275 gloves have been tested in 
accordance with the American Society for Testing Materials (ASTM) F739 
method and found by EPA to satisfy the consent orders and Sec.  
721.63(a)(2)(i) requirements for dermal protection to 100 percent PMN 
substance. Gloves and other dermal protection may not be used for a 
time period longer than they are actually tested and must be replaced 
at the end of each work shift. For additional dermal protection 
materials, a company must submit all test data to the Agency and must 
receive written Agency approval for each type of material tested prior 
to use of that material as worker dermal protection. However, for the 
purposes of determining the imperviousness of gloves, up to 1 year 
after the commencement of commercial manufacture or import, the 
employer may use the method described in Sec.  721.63(a)(3)(ii), 
thereafter, they must use the method described in Sec.  
721.63(a)(3)(i). For purposes of Sec.  721.63(b), the concentration is 
set at 1.0%.
    (B) Additional requirements for use as a monomer for 
stereolithography: Requirements as specified in Sec.  721.63(a)(4) and 
(5), (a)(6)(v), and (c). When determining which persons are reasonably 
likely to be exposed as required for Sec.  721.63(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 assigned protection factor of at least 
50.
* * * * *
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(y)(1). It is a significant new use to use 
the chemical substance for any use other than as a monomer for use in 
ultraviolet ink jet applications or stereolithography, unless the 
chemical substance is processed and used in an enclosed process.
* * * * *

0
3. Amend Sec.  721.10371 by revising paragraphs (a)(1) and (a)(2)(i) to 
read as follows:


Sec.  721.10371  Butanoic acid, 3-mercapto-,1,1'-[2-(hydroxymethyl)-2-
(substituted-1-oxoalkoxy)methyl)-1,3-propanediyl] ester (generic).

    (a) * * *
    (1) The chemical substance identified generically as butanoic acid, 
3-mercapto-,1,1'-[2-(hydroxymethyl)-2-(substituted-1-oxoalkoxy)methyl)-
1,3-propanediyl] ester (PMN P-10-136 and

[[Page 68001]]

S-18-5, Chemical A) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) * * *
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f). It is a significant new use to use the 
substance other than as a monomer for acryl-based ultra-violet (UV)-
curing coatings, inks, and adhesives or the confidential use described 
in the significant new use notice S-18-5.
* * * * *

0
4. Amend Sec.  721.10372 by revising paragraphs (a)(1) and (a)(2)(i) to 
read as follows:


Sec.  721.10372  Butanoic acid, 3-mercapto-,1,1'-[2,2-bis[(substituted-
1-oxoalkoxy)methyl]-1,3-propanediyl] ester (generic).

    (a) * * *
    (1) The chemical substance identified generically as butanoic acid, 
3-mercapto-,1,1'-[2,2-bis[(substituted-1-oxoalkoxy)methyl]-1,3-
propanediyl] ester (PMN P-10-136 and SNUN S-18-5, Chemical B) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) * * *
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f). It is a significant new use to use the 
substance other than as a monomer for acryl-based ultra-violet (UV)-
curing coatings, inks, and adhesives, or the confidential use described 
in the SNUN S-18-5.
* * * * *

0
5. Amend Sec.  721.10663 by revising paragraphs (a)(1), (a)(2)(i) and 
(ii), and (b)(1) to read as follows:


Sec.  721.10663  Functionalized multi-walled carbon nanotubes 
(generic).

    (a) * * *
    (1) The chemical substance identified generically as functionalized 
multi-walled carbon nanotubes (PMN P-12-44; SNUN S-18-4; and SNUN S-19-
5) 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 completely reacted (cured); incorporated or embedded into a 
polymer matrix that itself has been completely reacted (cured); 
embedded in a permanent solid polymer form that is not intended to 
undergo further processing except for mechanical process; or 
incorporated into an article.
    (2) * * *
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1) and (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 (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 of at least 50. For purposes of Sec.  
721.63(a)(6), the airborne form of the substance includes particulate. 
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(v)(1), (w)(1), and (x)(1). It is a 
significant new use to use the substance other than as a chemical 
additive for use in epoxy compounds for transportation, marine and 
industrial coatings, paints and manufactured goods, for the 
confidential use described in PMN P-12-44, or for the confidential use 
described in SNUN S-19-5.
    (b) * * *
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (f), (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
* * * * *

0
6. Amend Sec.  721.10928 by revising paragraphs (a)(1) and (a)(2)(iii) 
to read as follows:


Sec.  721.10928  Coke (coal), secondary pitch; a carbon-containing 
residue from the coking of air blown pitch coke oil and/or pitch 
distillate; composed primarily of isotropic carbon, it contains small 
amounts of sulfur and ash constituents.

    (a) * * *
    (1) The chemical substance identified as coke (coal), secondary 
pitch. Definition: A carbon-containing residue from the coking of air 
blown pitch coke oil and/or pitch distillate; composed primarily of 
isotropic carbon, it contains small amounts of sulfur and ash 
constituents (PMN P-12-292, PMN P-17-217, and SNUN S-19-4; CAS No. 
94113-91-4) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) * * *
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (p), and (y)(1) and (2). It is a 
significant new use to use the substance other than for the 
confidential use permitted by the Order for P-12-292, as a lubricating 
agent used in the production of automotive disc brakes, or to process 
as an additive for the manufacture of diesel particulate filters to 
increase the porosity of the filter. It is a significant new use to use 
the substance in an additive formulation to produce diesel particulate 
filters within the United States. For purposes of Sec.  721.80, the 
aggregate volume is 2,500,000 kilograms.
* * * * *
[FR Doc. 2020-21464 Filed 10-26-20; 8:45 am]
BILLING CODE 6560-50-P
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