Significant New Use Rules on Certain Chemical Substances, 13531-13543 [2019-06624]

Download as PDF Federal Register / Vol. 84, No. 66 / Friday, April 5, 2019 / Rules and Regulations The regulation in 33 CFR 165.929(e)(35) will be enforced as listed in Table 165.929 from 9 p.m. through 9:35 p.m. on July 4, 2019. ENVIRONMENTAL PROTECTION AGENCY If you have questions about this notice of enforcement, call or email LT John Ramos, Waterways Management Division, Marine Safety Unit Chicago, U.S. Coast Guard; telephone (630) 986– 2155, email D09-DG-MSUChicagoWaterways@uscg.mil. [EPA–HQ–OPPT–2017–0575; FRL–9991–19– OCSPP] DATES: FOR FURTHER INFORMATION CONTACT: The Coast Guard will enforce the Michigan City Summerfest safety zone listed as item (e)(35) in Table 165.929 of 33 CFR 165.929 from 9 p.m. through 9:35 p.m. on July 4, 2019. This action is being taken to provide for the safety of life on a navigable waterway during the fireworks display. This safety zone encompasses all waters of Michigan City Harbor and Lake Michigan within the arc of a circle with a 1,000 foot radius from the launch site located in position 41°43.700′ N, 086°54.617′ W. Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Lake Michigan or a designated on-scene representative. This notice of enforcement is issued under authority of 33 CFR 165.929, Safety Zones; Annual events requiring safety zones in the Captain of the Port Lake Michigan zone and 5 U.S.C. 552 (a). In addition to this notice in the Federal Register, the Captain of the Port Lake Michigan will provide the maritime community with advance notification of this safety zone enforcement period via Broadcast Notice to Mariners or Local Notice to Mariners. The Captain of the Port Lake Michigan, or a designated on-scene representative may be contacted via Channel 16, VHF–FM or at (414) 747– 7182. SUPPLEMENTARY INFORMATION: Dated: March 29, 2019. Thomas J. Stuhlreyer, Captain, U.S. Coast Guard, Captain of the Port Lake Michigan. [FR Doc. 2019–06655 Filed 4–4–19; 8:45 am] 40 CFR Parts 9 and 721 RIN 2070–AB27 Significant New Use Rules on Certain Chemical Substances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: EPA is issuing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 13 chemical substances which are the subject of premanufacture notices (PMNs). This action requires persons to notify EPA least 90 days before commencing manufacture (defined by statute to include import) or processing of any of these 13 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 intended 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 June 4, 2019. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on April 19, 2019. FOR FURTHER INFORMATION CONTACT: For technical information contact: Kenneth Moss, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; telephone number: (202) 564–9232; email address: moss.kenneth@epa.gov. For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554– 1404; email address: TSCA-Hotline@ epa.gov. SUMMARY: SUPPLEMENTARY INFORMATION: BILLING CODE 9110–04–P khammond on DSKBBV9HB2PROD with RULES 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 VerDate Sep<11>2014 15:56 Apr 04, 2019 Jkt 247001 PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 13531 provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include: • Manufacturers or processors of one or more subject chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries. This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importers of chemicals subject to these SNURs must certify their compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this rule on or after May 6, 2019 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see § 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D. II. Background A. What action is the Agency taking? EPA is finalizing a SNUR under TSCA section 5(a)(2) for 13 chemical substances which were the subject of PMNs P–16–192, P–16–354 and P–16– 355, P–16–380 through P–16–385, P–16–483 and P–16–484, P–16–575, and P–16–581. These SNURs require persons who intend to manufacture or process any of these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. Previously, in the Federal Register of October 16, 2018 (83 FR 52179) (FRL– 9984–93), EPA proposed a SNUR for these 13 chemical substances in 40 CFR part 721 subpart E. More information on the specific chemical substances subject to this final rule can be found in the Federal Register documents proposing the SNUR. The record for the SNUR was established in the docket under docket ID number EPA–HQ–OPPT–2017–0575. That docket includes information considered by the Agency in developing the proposed and final rules. EPA received a number of public comments on this rule. Those comments and EPA’s responses are found in Unit IV. E:\FR\FM\05APR1.SGM 05APR1 13532 Federal Register / Vol. 84, No. 66 / Friday, April 5, 2019 / Rules and Regulations B. What is the Agency’s authority for taking this action? Section 5(a)(2) of TSCA (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. Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture or process the chemical substance for that use (15 U.S.C. 2604(a)(1)(B)(i)). TSCA furthermore prohibits such manufacturing or processing from commencing until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination (15 U.S.C. 2604(a)(1)(B)(ii)). As described in Unit V., the general SNUR provisions are found at 40 CFR part 721, subpart A. khammond on DSKBBV9HB2PROD with RULES C. Applicability of General Provisions General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. According to § 721.1(c), persons subject to these SNURs must comply with the same SNUN requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA must either determine that the 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. VerDate Sep<11>2014 15:56 Apr 04, 2019 Jkt 247001 III. Significant New Use Determination Section 5(a)(2) of TSCA states that EPA’s determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including: • The projected volume of manufacturing and processing of a chemical substance. • The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance. • The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance. • The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance. In addition to these factors enumerated in TSCA section 5(a)(2), the statute authorizes EPA to consider any other relevant factors. To determine what would constitute a significant new use for the chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances, likely human exposures and environmental releases associated with possible uses, and the four bulleted TSCA section 5(a)(2) factors listed in this unit. IV. Public Comments on Proposed Rule and EPA Responses EPA received public comments from 15 entities on the proposed rule. The Agency’s responses are described below. Anonymous and Generally Supportive Comments EPA received a number of anonymous (and submitter-identified) comments in support of the Agency’s proposed Significant New Use Rules (SNURs). These comments were general in nature, citing the importance of Agency review of these 13 chemicals to protect human health and the environment. No response is required. Challenges to Underlying TSCA § 5(a)(3) Determinations Comment 1: EPA received multiple comments regarding the manner in which these proposed Significant New Use Rules (SNURs) operate. One comment requested that, in light of alleged legal and factual deficiencies, EPA withdraw both the proposed SNURs and the underlying ‘‘not likely’’ determinations and instead issue determinations, section 5(e) orders, and post-order section 5(f) SNURs based on a finding that the chemical substances ‘‘may present an unreasonable risk to PO 00000 Frm 00034 Fmt 4700 Sfmt 4700 health or the environment’’ under section 5(a)(3)(B). Another comment stated that EPA may not rely on ‘‘non5(e) SNURs’’ to make a ‘‘not likely’’ finding under section 5(a)(3)(C) and has failed to provide a legal and factual basis for its determination as required by section 5(g), but nevertheless supports the need to promulgate these SNURs at this time because otherwise there will be no protections at all in place for these chemical substances. The commenter stated that EPA found risks to workers for a number of the chemical substances subject to these proposed SNURs, absent protective measures that EPA expects will be implemented and will provide sufficient protection, and that EPA’s risk determination for these chemicals should not assume there will be full compliance with all of the controls recommended in an associated Safety Data Sheet and that such compliance would be adequate to protect workers. Response: These comments constitute challenges to certain TSCA § 5(a)(3) determinations rather than to the basis for or the content of the SNURs, which EPA has promulgated using its discretion to issue SNURs under TSCA § 5(a)(2). Because these comments are not germane to this rulemaking, EPA is not responding to these comments in this notice and declines to withdraw the SNURs on the basis of these comments. Regardless, EPA has already defended the legal and factual basis for the TSCA § 5(a)(3) determinations that these comments reference in a prior legal challenge. See Brief of U.S. Environmental Protection Agency in NRDC v. USEPA, 2d Cir. Docket No. 18– 25. Regulation of Workplace Risks Comment 2: Several commenters argued that where EPA finds unreasonable risks to workers in the absence of certain protective measures (e.g., personal protective equipment, engineering controls, etc.), EPA must identify as a significant new use any use of the chemical that occurs without those protections. Specifically, the commenters stated that, where EPA finds unreasonable risk to workers absent certain protective measures, the Agency must issue an order to address workplace risks—as well as consider promulgating a significant new use rule—because in these circumstances ‘‘the manufacture, processing, distribution in commerce, use, or disposal of such substance, or any combination of such activities, may present an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk E:\FR\FM\05APR1.SGM 05APR1 khammond on DSKBBV9HB2PROD with RULES Federal Register / Vol. 84, No. 66 / Friday, April 5, 2019 / Rules and Regulations factors, including an unreasonable risk to a potentially exposed subpopulation.’’ 15 U.S.C. 2604(e)(1)(A)(ii)(I). In following, the commenters state EPA ‘‘shall issue an order . . . to prohibit or limit the manufacture, processing, distribution in commerce, use, or disposal of such substance or to prohibit or limit any combination of such activities to the extent necessary to protect against an unreasonable risk of injury to health or the environment.’’ Id. § 2604(e)(1)(A). After issuing that order, EPA must consider whether to promulgate a significant new use rule ‘‘that identifies as a significant new use any manufacturing, processing, use, distribution in commerce, or disposal of the chemical substance that does not conform to the restrictions imposed by the * * * order’’ or publish a statement justifying the decision not to promulgate the SNUR. 15 U.S.C. 2604(f)(4). According to the commenters, Congress spoke clearly and required EPA to regulate unreasonable risks that a chemical substance ‘‘may present’’ under TSCA. The commenters contend that nothing in the text of TSCA allows EPA to simply assume that sufficient protective measures will be implemented to eliminate potential unreasonable risks; such an assumption essentially negates TSCA § 5(e), which could not be Congress’s intention. And, the commenters claim, EPA cannot find that a chemical is not likely to present an unreasonable risk based solely on EPA’s unjustified ‘‘expectation’’ that sufficient protective measures will be implemented . . . EPA effectively found risks to workers for several chemical substances subject to these proposed SNURs, absent protective measures that EPA simply ‘‘expects’’ will be implemented and will provide sufficient protection. Commenters assert that EPA’s risk determination for these chemicals should not assume there will be full compliance with all of the controls recommended in an associated Safety Data Sheet and that such compliance would be adequate to protect workers. Because EPA relied on these protective measures in its analysis of risk, commenters state that EPA should identify any condition of use without these protective measures to be a significant new use, meriting advance notification to EPA. Response: To the extent these comments argue that the Agency should have issued orders under Section 5(e) or 5(f) of TSCA, EPA believes they are beyond the scope of the SNUR for which EPA is specifically soliciting comments and are properly directed to VerDate Sep<11>2014 15:56 Apr 04, 2019 Jkt 247001 the Section 5(a)(3) determinations that pertain to the underlying PMNs for the SNUR. EPA is therefore not responding to these comments here. However, EPA is responding to comments that pertain specifically to the SNUR, i.e., those regarding the uses that should be subject to the SNUR, as well as the assertion that EPA must include certain worker protection provisions in the SNURs on the basis of TSCA Section 5(f)(4). EPA disagrees with the comment that, with respect to scenarios where EPA expects that worker protection requirements under other federal/state authorities would mitigate risks to workers, EPA must designate all uses without those protections as ‘‘significant new uses’’. Section 5(a)(2) of TSCA does not mandate that any specific uses be designated as significant. Instead, EPA has discretion as to which new uses to designate as significant. As mentioned in the ‘‘not likely’’ determination documents for the subject PMNs in this batch SNUR (see https://www.epa.gov/ reviewing-new-chemicals-under-toxicsubstances-control-act-tsca/chemicalsdetermined-not-likely), in exercising its discretion regarding which new uses should be designated as significant under section 5(a)(2), EPA expects compliance with federal and state laws, such as worker protection standards or disposal restrictions, unless casespecific facts indicate otherwise. Further, any workplace risks will be mitigated if exposures are appropriately controlled, and EPA expects that employers will require and workers will use the appropriate controls (e.g., personal protective equipment such as impervious gloves and/or respirators), consistent with the Safety Data Sheet prepared by the PMN submitter, in a manner adequate to protect them. With respect to comments regarding TSCA Section 5(f)(4), EPA notes that because no applicable TSCA Section 5(e) or 5(f) orders have been issued, the requirements of TSCA Section 5(f)(4) are not triggered. Therefore, EPA need not make changes in the proposed SNUR to correspond to Section 5(e) and 5(f) orders that have not been issued. SNURs Lack Provisions To Notify Downstream Processors and Users of Agency Concerns Comment 3: One commenter suggested that the proposed SNURs lack notification requirements for worker protection and hazard communication programs to ensure that risks to workers and the public from downstream activities are identified and addressed and fail to provide notice to downstream processors and users of the PMN substance’s environmental effects PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 13533 and EPA’s required limits on release to water. Response: 40 CFR 721.5 requires manufacturers and processors to either file a SNUN before distributing the chemical substance in commerce or notify downstream customers of the existence of a SNUR on a particular chemical substance (or determine that such users have notice). Thus, one of two possibilities will occur: (1) Downstream customers do receive notice of the SNUR, or (2) notification of downstream uses becomes unnecessary because the manufacturer or processors submits a SNUN to EPA, and the Agency either determines that such manufacture and processing is not likely to present unreasonable risk, or takes appropriate regulatory action to address the risks. Impact on Downstream Users Comment 4: One commenter similarly identified impacts of SNURs on downstream users who ‘‘often must struggle to figure out when a product they use is covered by a SNUR,’’ particularly when the proposed SNUR provides only the generic name of a confidential chemical substance, or when the proposed SNUR covers the use of a chemical substance in an article. The comment also notes that the burden and compliance risks are greatest when the proposed SNUR contains reporting requirements. The commenter indicates that downstream users may depend on voluntary disclosure by the supplier or a downstream formulator/distributor, in contrast to the mandatory reporting requirements in place under a 5(e) order. The comment concludes that EPA should take steps to close the gap between proposal and finalization of SNURs by finalizing SNURs expeditiously, by notifying submitters of EPA’s likelihood of promulgating a SNUR, and by requesting companies alert downstream users of impending SNURs. Response: The Agency is aware of the impacts of the issuance of a SNUR, including and beyond those specific to the actual TSCA notification requirement. EPA’s focus is to take appropriate action under TSCA to control potential risks to human health or the environment from exposure or release of a new chemical, including requiring notification of potential significant new uses. CBI and Disclosure of Health and Safety Information Comment 5: EPA received multiple comments critical of EPA’s process in promulgating the proposed SNURs. One E:\FR\FM\05APR1.SGM 05APR1 khammond on DSKBBV9HB2PROD with RULES 13534 Federal Register / Vol. 84, No. 66 / Friday, April 5, 2019 / Rules and Regulations comment requested that EPA extend the comment period and make CBI available for review with appropriate safeguards to avoid depriving the public of a meaningful opportunity to participate. The commenter stated that TSCA does not extend CBI protection to any health and safety study which is submitted under TSCA, including underlying information and occupational exposure studies. In addition to the scientific analyses developed by EPA (e.g., engineering reports, Structure Activity Team reports), which fall under this definition, other information that is generally required to be submitted with PMNs, such as toxicity studies, information on worker exposure, and the majority of information in Safety Data Sheets, also fall under this definition. EPA must disclose this information to the public. Despite these mandates, the commenter argues that EPA has failed to disclose this health and safety information. The comment states that EPA’s SAT reports, engineering reports, and exposure reports all constitute or contain health and safety information that EPA must disclose, yet for P–16–575 (as an example provided by the commenter) EPA has largely redacted these documents. Response: EPA recognizes that TSCA Section 14 does not protect from disclosure certain confidential information described in Section 14(b), including health and safety information. However, Section 14 does not require that EPA make a final confidentiality determination for all information submitted under TSCA and claimed as CBI as part of a PMN review, and EPA has not made a determination regarding the eligibility for confidential treatment of the information referenced in the comment. Here, EPA balanced the need for sufficient information in the public record to fully explain the bases for its decisions with the protections for CBI in section 14. With regard to EPA technical support reports underlying the section 5 determination, they are not covered by section 14(b)(2), which specifically refers to health and safety studies submitted to EPA. EPA provided sufficient information in the public record to fully explain the bases for its decisions while preserving the submitter’s confidentiality claims through generally accepted means, including the aggregation of certain data in the public docket, presentation of ranges of values, or masking of manufacturing site locations to prevent CBI disclosure. VerDate Sep<11>2014 15:56 Apr 04, 2019 Jkt 247001 Identifying ‘‘Significant New Uses’’ for SNURs Comment 6: The commenter considers the approach taken for these proposed SNURs that found ‘‘not likely to present an unreasonable risk’’ under the conditions of use described in the PMNs to be generally consistent with the requirements of the 2016 amendments to TSCA. To the extent that this approach also represents potential improvements in the Agency’s ability to provide more timely review of PMNs, the commenter supports the approach. The commenter encourages EPA to take a risk-based approach— with particular focus on changes occurring in the conditions of use of a substance that can affect exposure (i.e., human exposure and environmental releases)—in identifying what changes in the conditions of use that will constitute significant new uses, and to consider the potential burden on downstream users when designating potential new uses to be significant. The commenter further encouraged EPA to use its discretion to consider ‘‘all relevant factors,’’ including the cost of submitting SNUNs, the burden of compliance with SNUR reporting requirements such as Chemical Data Reporting (CDR) and TSCA section 12(b) export notification reporting, and the compliance risk caused by vague regulations, in promulgating 5(a)(2) SNURs to minimize regulatory burdens on downstream users. Response: EPA agrees that it should— and does—identify significant new uses only after consideration of the ‘‘relevant factors’’ identified in TSCA section (a)(2) ((1) the ‘‘projected manufacturing or processing volume of a chemical substance’’; (2) the ‘‘type or form of exposure of human beings or the environment’’ to the chemical substance; (3) the ‘‘magnitude and duration of exposure of human beings or the environment’’ to the environment; and (4) the ‘‘reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal’’ of the chemical substance). However, the Agency typically does not have all of the data specific enough for each of the aforementioned factors to support risk assessment(s) for anticipated changes that are not part of the PMN. Hence, such information would be provided if and when a SNUN is submitted that would provide such information for the significant new use. Another commenter supported this approach, explaining that future risks not contemplated in the PMN will be addressed by analysis of a significant new use notice (SNUN) PO 00000 Frm 00036 Fmt 4700 Sfmt 4700 which streamlines the current system which typically runs much longer than 90 days proscribed in TSCA. As to other regulatory requirements such as CDR or export notification, the Agency understands the impact and coordinates with those programs to eliminate inefficiencies. Furthermore, the Agency flags chemical substances on the TSCA Inventory that are regulated with a SNUR. For interpretation of SNUR notification requirements, the regulated community is encouraged to contact the Agency by using the options outlined in the ADDRESSES and FOR FURTHER INFORMATION CONTACT sections of the SNUR preamble. Catch-All Significant New ‘‘Use’’ Comment 7: One commenter suggested that EPA should generally designate as a significant new use any use of a chemical substance other than the uses EPA evaluated in its PMN review and determined are not likely to present an unreasonable risk. In particular, the commenter identified P– 16–192, P–16–380–385, and 16–575, as SNURs for which other types of triggers for notification (e.g., manufacture in a certain physical form, or manufacture, processing, or use to result in inhalation exposure) were used. Although the commenter supports inclusion of these triggers, it comments that EPA must also require notification for use other than that which EPA has reviewed. Response: Commenters suggested approach is overly broad. TSCA requires that EPA evaluate new chemicals under their conditions of use, including the intended, known and reasonably foreseen circumstances of manufacture, processing, distribution in commerce, use and disposal. Based upon EPA’s review of the relevant PMNs, the Agency identified uses that are appropriate for designation as ‘‘significant new uses’’ in order to ensure that EPA has an opportunity to review those uses in a SNUN submission at a later date and address any unreasonable risks at that time. TSCA § 5(a)(2) does not require EPA to take the catch-all approach advocated by commenters, and EPA believes a more tailored approach is warranted to avoid unduly burdensome regulations. Being More Specific in 40 CFR 721.80 Comment 8: One commenter suggested that EPA must clearly specify the cross references to EPA’s general regulations in the SNURs. A number of proposed SNURs state that the significant new uses are ‘‘requirements as specified in 721.80.’’ Since 40 CFR 721.80 contains 25 possible significant E:\FR\FM\05APR1.SGM 05APR1 Federal Register / Vol. 84, No. 66 / Friday, April 5, 2019 / Rules and Regulations khammond on DSKBBV9HB2PROD with RULES new use designations, this is misleading. Response: The Agency understands the confusion. Where one of the 25 specific significant new use designations in 721.80 is not being used, in the interest of transparency and clarity, the Agency generally lists ‘‘Industrial, commercial, and consumer activities. Requirements as specified in § 721.80’’ and follows with a complete sentence describing the actual activity. EPA will modify its approach so that where it is not citing a specific designation in 721.80, the Agency will drop the phrase ‘‘Requirements as specified in § 721.80.’’ For example, the SNUR at 40 CFR 721.11182 is finalized simply as: (i) Industrial, commercial, and consumer activities. It is a significant new use to manufacture the substance other than in an amorphous form. In response to this comment, the Agency is making a similar change to these 721.80 designations in all the final SNURs in this batch rule, except the SNURs at 721.11190 and 721.11191. Those two SNURs specifically cite 721.80(j), which is the confidential use identified in the associated PMN submission for those SNURs. Regulatory Burden of SNURs for Safer Chemicals Comment 9: One comment was regarding an enzyme used in the polymerization of glucose that would be subject to a proposed SNUR due to concerns with respiratory sensitization. The commenter stated that enzymes are recognized to have a positive and sustainable environmental profile and inherently low toxicity compared to other chemicals, and that this SNUR is a signal that it will be significantly more challenging to bring new enzymes to market and may decrease innovation that can address global challenges as highlighted by the UN Sustainable Development Goals. The commenter additionally voiced concern for the lengthy review time for PMN submissions. Response: To the extent commenter is disputing the outcome of a PMN review, these comments are more properly directed to the specific PMN determination and not this SNUR rulemaking. As mentioned previously in the response to Comment 1, this comment constitutes challenges to the corresponding TSCA § 5(a)(3) determinations rather than to the basis for or the content of the SNURs, which EPA has promulgated using its discretion to issue SNURs under TSCA § 5(a)(2). Nonetheless, the Agency is aware of, and working to remedy, the VerDate Sep<11>2014 15:56 Apr 04, 2019 Jkt 247001 increased length of time it has been taking to review and reach decision on section 5 notices as it implements the amendments to TSCA. Non-Animal Testing Comment 10: One commenter supports this approach of addressing potential risks that the subject chemicals may present under reasonably foreseen conditions of use, while finding that under the intended conditions of use, they are not likely to present unreasonable risks. In contrast, the commenter states, in its early implementation of the amended TSCA, EPA addressed such potential risks in consent agreements with PMN submitters. In these cases, the commenter notes, EPA frequently required health and ecotoxicity testing, including hundreds of vertebrate animal tests requiring tens of thousands of animals. The commenter therefore supports EPA’s new approach, which is consistent with TSCA’s requirements to reduce and replace the use of vertebrate animals in the testing of chemical substances and promote the development and timely incorporation of new test methods and strategies that are not based on vertebrate animals. In addition, it protects human health and the environment by addressing potential risks when the conditions of use under which they arise are intended, either as identified in PMNs or in SNUNs, while reducing the burden on PMN submitters and streamlining the review process. Response: As mentioned in the preamble to this SNUR, any recommendation for information identified by EPA 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 chemical substance. Further, any such testing identified by EPA that includes testing on vertebrates was made after consideration of available toxicity information, computational toxicology and bioinformatics, and highthroughput screening methods and their prediction models. EPA also recognizes that whether testing/further information is needed will depend on the specific exposure and use scenario in the SNUN. EPA encourages all SNUN submitters to contact EPA to discuss any potential future testing. 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. PO 00000 Frm 00037 Fmt 4700 Sfmt 4700 13535 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). Do Not Use SNURs as Information Gathering Tool, Tracking Tool Comment 11: One commenter urged EPA to not rely on SNURs as tools for tracking use and production of chemical or for otherwise gathering potentially useful information, but instead suggested that EPA rely on provisions like section 8 which specifically authorize such acts. Response: EPA is not issuing a requirement to develop any data or information as a result of these SNURs. It is the responsibility of a SNUN submitter to provide any such information as required by TSCA section 5 and SNUN regulations at 40 CFR part 721. Regarding potentially useful information, EPA encourages all SNUN submitters to contact EPA to discuss any potential future testing. 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). V. Substances Subject to This Rule EPA is establishing significant new use and recordkeeping requirements for 13 chemical substances in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each chemical substance: • PMN number. • Chemical name (generic name, if the specific name is claimed as CBI). • Chemical Abstracts Service (CAS) Registry number (if assigned for nonconfidential chemical identities). • Basis for the SNUR. • 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. This information may include testing not required to be conducted but which would help characterize the potential health and/or environmental effects of the PMN substance. Any recommendation for information E:\FR\FM\05APR1.SGM 05APR1 13536 Federal Register / Vol. 84, No. 66 / Friday, April 5, 2019 / Rules and Regulations khammond on DSKBBV9HB2PROD with RULES identified by EPA 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 chemical substance. Further, any such testing identified by EPA that includes testing on vertebrates was made after consideration of available toxicity information, computational toxicology and bioinformatics, and highthroughput screening methods and their prediction models. EPA also recognizes that whether testing/further information is needed will depend on the specific exposure and use scenario in the SNUN. EPA encourages all SNUN submitters to contact EPA to discuss any potential future testing. See Unit VIII. for more information. • 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. The chemical substances that are the subject of these SNURs completed premanufacture review. EPA has initially determined under TSCA section 5(a)(2), 15 U.S.C. 2604(a)(2), that certain changes from the conditions of use described in the PMNs could result in changes in the type or form of exposure to the chemical substances and/or increased exposures to the chemical substances and/or changes in the reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of the chemical substances. Consequently, EPA is designating these changes as significant new uses. PMN Number: P–16–192 Chemical Name: Silanized amorphous silica (generic). CAS Number: Not available. Basis for action: The PMN states that the use of the substance will be as a reinforcing filler for the production of rubber goods. Based on test data for crystalline silica, EPA identified concerns for lung effects if the chemical substance is not used following the limitations noted below. The conditions of use of the PMN substance as described in the PMN include the following protective measures: Manufacture of the PMN substance in an amorphous form. The SNUR designates as a ‘‘significant new use’’ the absence of this protective measure. Potentially useful information: EPA has determined that certain information about the physical-chemical properties VerDate Sep<11>2014 15:56 Apr 04, 2019 Jkt 247001 of the PMN substance may be potentially useful if a manufacturer or processor is considering submitting a SNUN for a significant new use designated by this SNUR. EPA has determined that information about the physical form, particle size, and water solubility would help characterize the potential health effects of the PMN substance. CFR citation: 40 CFR 721.11182. PMN Numbers: P–16–354 and P–16–355 Chemical name: Esteramine (generic). CAS number: Not available. Basis for action: The PMNs state that the generic (non-confidential) use of the substances will be as a chemical intermediate. Based on the physical/ chemical properties of the PMN substances and Structure Analysis Relationships (SAR) analysis of test data on analogous substances, EPA has identified concerns for irritation and developmental/reproductive toxicity, and aquatic toxicity at surface water concentrations exceeding 1 part per billion (ppb), if the chemical substances are not used following the limitations noted below. The conditions of use of the PMN substances as described in the PMNs include the following protective measures: 1. No release of a manufacturing, processing, or use stream associated with any use of the substances, other than the confidential chemical intermediate use described in the PMNs, into the waters of the United States exceeding a surface water concentration of 1 ppb; and 2. No manufacturing, processing or use of the PMN substances resulting in inhalation exposures to the substances. The SNUR designates as a ‘‘significant new use’’ the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the aquatic and human health toxicity of the PMN substances may be potentially useful to characterize the health and environmental effects of the PMN substances if a manufacturer or processor is considering submitting a SNUN for a significant new use designated by this SNUR. EPA has determined that the results of specific organ toxicity and aquatic toxicity testing would help characterize the potential health and environmental effects of the PMN substances. CFR citation: 40 CFR 721.11183. PMN Numbers: P–16–380, P–16–381, P–16–382, P–16–383, P–16–384, and P–16–385 Chemical Names: Formic acid, compds. with hydrolyzed bisphenol A- PO 00000 Frm 00038 Fmt 4700 Sfmt 4700 epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) polymerN1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-dimethylbutylidene)amino]ethyl]-1,2ethanediamine-dialdehyde-2(methylamino)ethanol reaction products acetates (salts), (generic) (P–16–380), propanoic acid, 2-hydroxy-, compds. with hydrolyzed bisphenol Aepichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) polymerN1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-dimethylbutylidene)amino]ethyl]-1,2ethanediamine-dialdehyde-2(methylamino)ethanol reaction products formates (salts), (generic) (P–16–381), formic acid, compds. with hydrolyzed bisphenol A-epichlorohydrinpolyethylene glycol ether with bisphenol A (2:1) polymer-N1-(1,3dimethylbutylidene)-N2-[2-[(1, 3dimethylbutylidene)amino] ethyl]-1,2ethanediamine-dialdehyde-2(methylamino)ethanol reaction products sulfamates (salts), (generic) (P–16–382), formic acid, compds. with hydrolyzed bisphenol A-epichlorohydrinpolyethylene glycol ether with bisphenol A (2:1) polymer-N1-(1,3dimethylbutylidene)-N2-[2-[(1, 3dimethylbutylidene)amino] ethyl]-1,2ethanediamine-dialdehyde-2(methylamino)ethanol reaction products acetates (salts), (generic) (P–16–383), propanoic acid, 2-hydroxy-, compds. with hydrolyzed bisphenol Aepichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) polymerN1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-dimethylbutylidene)amino]ethyl]-1,2ethanediamine-dialdehyde-2(methylamino)ethanol reaction products formates (salts), (generic) (P–16–384), formic acid, compds. with hydrolyzed bisphenol A-epichlorohydrinpolyethylene glycol ether with bisphenol A (2:1) polymer-N1-(1,3dimethylbutylidene)-N2-[2-[(1, 3dimethylbutylidene)amino]ethyl]-1,2ethanediamine-dialdehyde-2(methylamino)ethanol reaction products sulfamates (salts), (generic) (P–16–385). CAS Numbers: Not available. Basis for action: The PMNs state that the generic (non-confidential) use of the substances will be as a component of an electrocoat resin. Based on the physical/ chemical properties of the PMN substances and test data on analogous substances, EPA has identified concerns for lung effects and toxicity to aquatic organisms at concentrations that exceed 16 ppb if the chemical substances are not used following the limitations noted below. The conditions of use of the PMN substances as described in the PMNs include the following protective measures: E:\FR\FM\05APR1.SGM 05APR1 Federal Register / Vol. 84, No. 66 / Friday, April 5, 2019 / Rules and Regulations khammond on DSKBBV9HB2PROD with RULES 1. No manufacturing, processing or use of the PMN substances resulting in inhalation exposures to the substances; and 2. No release of a manufacturing, processing, or use stream associated with any use of the substances exceeding a surface water concentration of 16 ppb. The SNUR designates as a ‘‘significant new use’’ the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the health and environmental effects of the PMN substances may be potentially useful if a manufacturer or processor is considering submitting a SNUN for a significant new use designated by this SNUR. EPA has determined that the results of specific target organ, pulmonary, and acute aquatic toxicity testing would help characterize the potential health and environmental effects of the PMN substances. CFR citation: 40 CFR 721.11184 (P– 16–380); 40 CFR 721.11185 (P–16–381); 40 CFR 721.11186 (P–16–382); 40 CFR 721.11187 (P–16–383); 40 CFR 721.11188 (P–16–384); and 40 CFR 721.11189 (P–16–385). PMN Numbers: P–16–483 and P–16–484 Chemical names: Inorganic acids, metal salts, compds. with modified heteroaromatics, (generic) (P–16–483) and Inorganic acids, metal salts, compds. with substituted aromatic heterocycle, (generic) (P–16–484). CAS numbers: Not available. Basis for action: The PMNs state that the generic (non-confidential) use of P– 16–483 will be as a plastic additive and the generic (non-confidential) use of P– 16–484 will be as a chemical intermediate. Based on test data submitted on P–16–483 and data for analogous compounds, EPA has identified concerns for irritation, specific organ effects, and aquatic toxicity if the chemical is not used following the limitations noted below. The conditions of use of the PMN substances as described in the PMNs include the following protective measures: 1. No use of the substances other than the confidential use described in the PMNs; 2. No release of a manufacturing, processing, or use stream associated with any use of the substances exceeding a surface water concentration of 34 ppb; and 3. No manufacturing, processing or use of the PMN substances without the engineering controls described in the PMNs to limit exposure to dust. VerDate Sep<11>2014 15:56 Apr 04, 2019 Jkt 247001 The SNUR designates as a ‘‘significant new use’’ the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the human health and environmental toxicity of the PMN substances may be potentially useful to characterize the effects of the PMN substances if a manufacturer or processor is considering submitting a SNUN for a significant new use designated by this SNUR. EPA has determined that the results of aquatic toxicity and specific organ toxicity and aquatic toxicity testing would help characterize the potential health and environmental effects of the PMN substances. CFR citations: 40 CFR 721.11190 (P–16–683) and 40 CFR 721.11191 (P–16–684). PMN Number: P–16–575 Chemical name: Glucosyltransferase. International Union of Biochemistry and Molecular Biology Number: 2.4.1.5. CAS number: 9032–14–8. Basis for action: The PMN states that the use of the substance will be for polymerization of glucose. Based on the allergenic properties of proteins and review of surrogate enzymatic protein data submitted, EPA has identified concerns for respiratory sensitization if the chemical is not used following the limitations noted below. The conditions of use of the PMN substance as described in the PMN include the following protective measure: No manufacture, processing, or use of the PMN substance that results in inhalation exposures to the substance. The SNUR designates as a ‘‘significant new use’’ the absence of this protective measure. Potentially useful information: EPA has determined that certain information about the workplace exposure to the PMN substance may be potentially useful to characterize the health effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use designated by this SNUR. EPA has determined that the results of workplace air monitoring would help characterize the potential health effects of the PMN substance. CFR citation: 40 CFR 721.11192. PMN Number: P–16–581 Chemical name: Alpha 1,3polysaccharide (generic). CAS number: Not available. Basis for action: The PMN states that the uses of the substance will be as a polymer additive, paper coating component, composite component, and PO 00000 Frm 00039 Fmt 4700 Sfmt 4700 13537 fiber additive. Based on analogy to high molecular weight polymers, EPA has identified concerns for lung effects if the chemical is not used following the limitations noted below. The conditions of use of the PMN substance as described in the PMN include the following protective measures: 1. No use of the substance other than the uses described in the PMN; and 2. No manufacture, processing, or use with particle size less than 10 micrometers. The SNUR designates as a ‘‘significant new use’’ the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the toxicity of the PMN substance may be potentially useful to characterize the health effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use designated by this SNUR. EPA has determined that the results of pulmonary effects toxicity testing of the PMN substance may be potentially useful in characterizing the health effects of the PMN substance. CFR citation: 40 CFR 721.11193. VI. Rationale and Objectives of the Rule A. Rationale During review of the PMNs submitted for the chemical substances that are the subject of these SNURs and as further discussed in Unit IV, EPA identified certain reasonably foreseen conditions of use and other circumstances different from the intended conditions of use identified in the PMNs and determined that those changes could result in changes in the type or form of exposure to the chemical substances and/or increased exposures to the chemical substances and/or changes in the reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of the chemical substances. B. Objectives EPA is issuing these SNURs for specific chemical substances which have undergone premanufacture review because the Agency wants to achieve the following objectives with regard to the significant new uses designated in this rule: • EPA will 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. • EPA will have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing a E:\FR\FM\05APR1.SGM 05APR1 13538 Federal Register / Vol. 84, No. 66 / Friday, April 5, 2019 / Rules and Regulations khammond on DSKBBV9HB2PROD with RULES listed chemical substance for the described significant new use. • EPA is 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 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 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. • EPA will identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying Orders, consistent with TSCA section 5(f)(4). Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Chemical Substance Inventory (TSCA Inventory). Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the internet at http://www.epa.gov/opptintr/ existingchemicals/pubs/tscainventory/ index.html. VII. 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. EPA designated October 9, 2018 (the date of web posting 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 October 9, 2018, that person will have VerDate Sep<11>2014 15:56 Apr 04, 2019 Jkt 247001 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, order or consent agreement under TSCA section 4 (15 U.S.C. 2603), then TSCA section 5(b)(1)(A) (15 U.S.C. 2604(b)(1)(A)) requires such information to be submitted to EPA at the time of submission of the SNUN. In the absence of a rule, order, or consent agreement under TSCA section 4 covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information known to or reasonably ascertainable by them (see § 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. Unit IV. lists potentially useful information for all SNURs listed here. Descriptions are provided for informational purposes. The potentially useful information identified in Unit IV. will be useful to EPA’s evaluation in the event that someone submits a SNUN for the significant new use. Companies who are considering submitting a SNUN are encouraged, but not required, to develop the information on the substance, which may assist with EPA’s analysis of the SNUN. EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. Furthermore, pursuant to TSCA section 4(h), which pertains to reduction of testing in vertebrate animals, EPA encourages consultation with the Agency on the use of alternative test methods and strategies (also called New Approach Methodologies, or NAMs), if available, to generate the recommended test data. EPA encourages dialog with Agency representatives to help determine how best the submitter can meet both the data needs and the objective of TSCA section 4(h). The potentially useful information described in Unit IV. may not be the PO 00000 Frm 00040 Fmt 4700 Sfmt 4700 only means of providing information to evaluate the chemical substance associated with the significant new uses. However, submitting a SNUN without any test data may increase the likelihood that EPA will take action under TSCA section 5(e) or 5(f). EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests. SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following: • Human exposure and environmental release that may result from the significant new use of the chemical substances. • Information on risks posed by the chemical substances compared to risks posed by potential substitutes. 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 § 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 § 721.1725(b)(1) with that under § 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 E:\FR\FM\05APR1.SGM 05APR1 Federal Register / Vol. 84, No. 66 / Friday, April 5, 2019 / Rules and Regulations 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 § 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 http:// www.epa.gov/opptintr/newchems. 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– 2017–0366. XII. Statutory and Executive Order Reviews khammond on DSKBBV9HB2PROD with RULES A. Executive Order 12866 This action establishes SNURs for several new chemical substances that were the subject of PMNs and TSCA section 5(e) consent orders. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ‘‘Regulatory Planning and Review’’ (58 FR 51735, October 4, 1993). B. 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 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 VerDate Sep<11>2014 15:56 Apr 04, 2019 Jkt 247001 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. This Information Collection Request (ICR) 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. The information collection requirements related to this action have already been approved by OMB pursuant to PRA under OMB control number 2070–0012 (EPA ICR No. 574). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN. Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, Collection Strategies Division, Office of Environmental Information (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address. C. Regulatory Flexibility Act (RFA) Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation of this SNUR would not have a significant adverse economic impact on a substantial number of small entities. The requirement to submit a SNUN applies to any person (including small or large entities) who intends to engage in any activity described in the final rule as a ‘‘significant new use.’’ Because these uses are ‘‘new,’’ based on all information currently available to EPA, it appears that no small or large entities presently engage in such activities. A SNUR requires that any person who intends to engage in such activity in the PO 00000 Frm 00041 Fmt 4700 Sfmt 4700 13539 future must first notify EPA by submitting a SNUN. Although some small entities may decide to pursue a significant new use in the future, EPA cannot presently determine how many, if any, there may be. However, EPA’s experience to date is that, in response to the promulgation of SNURs covering over 1,000 chemicals, the Agency receives only a small number of notices per year. For example, the number of SNUNs received was seven in Federal fiscal year (FY) 2013, 13 in FY2014, six in FY2015, 10 in FY2016, and 14 in FY2017, 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. D. Unfunded Mandates Reform Act (UMRA) Based on EPA’s experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this 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. Executive Order 13132 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). E:\FR\FM\05APR1.SGM 05APR1 13540 Federal Register / Vol. 84, No. 66 / Friday, April 5, 2019 / Rules and Regulations F. Executive Order 13175 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, entitled ‘‘Consultation and Coordination with Indian Tribal Governments’’ (65 FR 67249, November 9, 2000), do not apply to this action. G. Executive Order 13045 This action is not subject to Executive Order 13045, entitled ‘‘Protection of Children from Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children. H. Executive Order 13211 This action is not subject to Executive Order 13211, entitled ‘‘Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use’’ (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use and because this action is not a significant regulatory action under Executive Order 12866. I. National Technology Transfer and Advancement Act (NTTAA) In addition, since this action does not involve any technical standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not apply to this action. khammond on DSKBBV9HB2PROD with RULES J. Executive Order 12898 This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898, entitled ‘‘Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations’’ (59 FR 7629, February 16, 1994). XIII. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). VerDate Sep<11>2014 15:56 Apr 04, 2019 Jkt 247001 List of Subjects PART 721—[AMENDED] 40 CFR Part 9 ■ Environmental protection, Reporting and recordkeeping requirements. 40 CFR Part 721 Dated: March 27, 2019. Tala Henry, Acting Deputy Director, Office of Pollution Prevention and Toxics. Therefore, 40 CFR parts 9 and 721 are amended as follows: PART 9—[AMENDED] 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, add the following sections 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. * * * * OMB control No. 40 CFR citation * * * * * Significant New Uses of Chemical Substances * 721.11182 721.11183 721.11184 721.11185 721.11186 721.11187 721.11188 721.11189 721.11190 721.11191 721.11192 721.11193 * * ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. * * PO 00000 * * * Frm 00042 Authority: 15 U.S.C. 2604, 2607, and 2625(c). 4. Add §§ 721.11182 through 721.11193 to subpart E to read as follows: ■ Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements. * 3. The authority citation for part 721 continues to read as follows: * * Fmt 4700 * * * Sfmt 4700 * 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 * Subpart E—Significant New Uses for Specific Chemical Substances Sec. * * * * * 721.11182 Silanized amorphous silica (generic). 721.11183 Esteramine (generic). 721.11184 Formic acid, compds. with hydrolyzed bisphenol Aepichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) polymerN1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-dimethylbutylidene)amino]ethyl]-1,2ethanediamine-dialdehyde-2(methylamino)ethanol reaction products acetates (salts), (generic). 721.11185 Propanoic acid, 2-hydroxy-, compds. with hydrolyzed bisphenol Aepichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) polymerN1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-dimethylbutylidene)amino]ethyl]-1,2ethanediamine-dialdehyde-2(methylamino)ethanol reaction products formates (salts), (generic). 721.11186 Formic acid, compds. with hydrolyzed bisphenol Aepichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) polymerN1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-dimethylbutylidene)amino]ethyl]-1,2ethanediamine-dialdehyde-2(methylamino)ethanol reaction products sulfamates (salts), (generic). 721.11187 Formic acid, compds. with hydrolyzed bisphenol Aepichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) polymerN1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-dimethylbutylidene)amino]ethyl]-1,2ethanediamine-dialdehyde-2(methylamino)ethanol reaction products acetates (salts), (generic). 721.11188 Propanoic acid, 2-hydroxy-, compds. with hydrolyzed bisphenol Aepichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) polymerN1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-dimethylbutylidene)amino]ethyl]-1,2ethanediamine-dialdehyde-2(methylamino)ethanol reaction products formates (salts), (generic). 721.11189 Formic acid, compds. with hydrolyzed bisphenol Aepichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) polymerN1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-dimethylbutylidene)amino]ethyl]-1,2ethanediamine-dialdehyde-2(methylamino)ethanol reaction products sulfamates (salts), (generic). 721.11190 Inorganic acids, metal salts, compds. with modified heteroaromatics, (generic). E:\FR\FM\05APR1.SGM 05APR1 Federal Register / Vol. 84, No. 66 / Friday, April 5, 2019 / Rules and Regulations 721.11191 Inorganic acids, metal salts, compds. with substituted aromatic heterocycle, (generic). 721.11192 Glucosyltransferase, International Union of Biochemistry and Molecular Biology Number: 2.4.1.5. 721.11193 Alpha 1,3-polysaccharide (generic). § 721.125(a) though (e), and (i) are applicable to manufacturers and processors of these substances. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. § 721.11182 (generic). § 721.11184 Formic acid, compds. with hydrolyzed bisphenol A-epichlorohydrinpolyethylene glycol ether with bisphenol A (2:1) polymer-N1-(1,3-dimethylbutylidene)N2-[2-[(1, 3dimethylbutylidene)amino]ethyl]-1,2ethanediamine-dialdehyde-2(methylamino)ethanol reaction products acetates (salts), (generic). Silanized amorphous silica (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as silanized amorphous silica (P–16–192) 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. It is a significant new use to manufacture the substance other than in an amorphous form. (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, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. khammond on DSKBBV9HB2PROD with RULES § 721.11183 Esteramine (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as esteramine (PMN P–16– 354 and P–16–355) are 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. It is a significant new use to manufacture, process, or use the substances in any manner that results in inhalation exposure. It is a significant new use to release a manufacturing, processing, or use stream associated with any use of the substances, other than the confidential chemical intermediate use described in the premanufacture notices, into the waters of the United States exceeding a surface water concentration of 1 part per billion (ppb) using the methods described in § 721.91. (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 VerDate Sep<11>2014 15:56 Apr 04, 2019 Jkt 247001 (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as formic acid, compds. with hydrolyzed bisphenol Aepichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) polymerN1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-dimethylbutylidene)amino]ethyl]-1,2ethanediamine-dialdehyde-2(methylamino)ethanol reaction products acetates (salts), (P–16–380) 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. It is a significant new use to manufacture, process, or use the 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=16. (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, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. § 721.11185 Propanoic acid, 2-hydroxy-, compds. with hydrolyzed bisphenol Aepichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) polymer-N1-(1,3dimethylbutylidene)-N2-[2-[(1, 3dimethylbutylidene)amino]ethyl]-1,2ethanediamine-dialdehyde-2(methylamino)ethanol reaction products formates (salts), (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically as propanoic acid, 2-hydroxy-, compds. with hydrolyzed bisphenol Aepichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) polymer- PO 00000 Frm 00043 Fmt 4700 Sfmt 4700 13541 N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-dimethylbutylidene)amino]ethyl]-1,2ethanediamine-dialdehyde-2(methylamino)ethanol reaction products formates (salts), (P–16–381) 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. It is a significant new use to manufacture, process, or use the 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=16. (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, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. § 721.1118 6 Formic acid, compds. with hydrolyzed bisphenol A-epichlorohydrinpolyethylene glycol ether with bisphenol A (2:1) polymer-N1-(1,3-dimethylbutylidene)N2-[2-[(1, 3dimethylbutylidene)amino]ethyl]-1,2ethanediamine-dialdehyde-2(methylamino)ethanol reaction products sulfamates (salts), (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as formic acid, compds. with hydrolyzed bisphenol Aepichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) polymerN1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-dimethylbutylidene)amino]ethyl]-1,2ethanediamine-dialdehyde-2(methylamino)ethanol reaction products sulfamates (salts), (P–16–382) 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. It is a significant new use to manufacture, process, or use the 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=16. (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 E:\FR\FM\05APR1.SGM 05APR1 13542 Federal Register / Vol. 84, No. 66 / Friday, April 5, 2019 / Rules and Regulations § 721.125(a) through (c), (i), and (k) are applicable to manufacturers, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. § 721.11187 Formic acid, compds. with hydrolyzed bisphenol A-epichlorohydrinpolyethylene glycol ether with bisphenol A (2:1) polymer-N1-(1,3-dimethylbutylidene)N2-[2-[(1, 3dimethylbutylidene)amino]ethyl]-1,2ethanediamine-dialdehyde-2(methylamino)ethanol reaction products acetates (salts), (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as formic acid, compds. with hydrolyzed bisphenol Aepichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) polymerN1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-dimethylbutylidene)amino]ethyl]-1,2ethanediamine-dialdehyde-2(methylamino)ethanol reaction products acetates (salts), (P–16–383) 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. It is a significant new use to manufacture, process, or use the 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=16. (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, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. khammond on DSKBBV9HB2PROD with RULES § 721.11188 Propanoic acid, 2-hydroxy-, compds. with hydrolyzed bisphenol A-epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) polymerN1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3dimethylbutylidene)amino]ethyl]-1,2ethanediamine-dialdehyde-2(methylamino)ethanol reaction products formates (salts), (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as propanoic acid, 2-hydroxy-, compds. with hydrolyzed bisphenol A-epichlorohydrinpolyethylene glycol ether with bisphenol A (2:1) polymer-N1-(1,3- VerDate Sep<11>2014 18:57 Apr 04, 2019 Jkt 247001 dimethylbutylidene)-N2-[2-[(1, 3dimethylbutylidene)amino] ethyl]-1,2ethanediamine-dialdehyde-2(methylamino)ethanol reaction products formates (salts), (P–16–384) 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. It is a significant new use to manufacture, process, or use the 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=16. (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, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. § 721.11189 Formic acid, compds. with hydrolyzed bisphenol A-epichlorohydrinpolyethylene glycol ether with bisphenol A (2:1) polymer-N1-(1,3-dimethylbutylidene)N2-[2-[(1, 3dimethylbutylidene)amino]ethyl]-1,2ethanediamine-dialdehyde-2(methylamino)ethanol reaction products sulfamates (salts), (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as formic acid, compds. with hydrolyzed bisphenol Aepichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) polymerN1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-dimethylbutylidene)amino]ethyl]-1,2ethanediamine-dialdehyde-2(methylamino)ethanol reaction products sulfamates (salts), (P–16–385) 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. It is a significant new use to manufacture, process, or use the 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=16. (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 PO 00000 Frm 00044 Fmt 4700 Sfmt 4700 applicable to manufacturers, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. § 721.11190 Inorganic acids, metal salts, compds. with modified heteroaromatics, (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as inorganic acids, metal salts, compds. with modified heteroaromatics, (PMN P–16–483) 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(j). It is a significant new use to manufacture, process, or use the substance without the engineering controls described in the premanufacture notice to limit exposure to dust. (ii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N=34. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c), (i), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(i) of this section. § 721.11191 Inorganic acids, metal salts, compds. with substituted aromatic heterocycle, (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as inorganic acids, metal salts, compds. with substituted aromatic heterocycle, (PMN P–16–484) 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(j). It is a significant new use to manufacture, process, or use the substance without the engineering controls described in the E:\FR\FM\05APR1.SGM 05APR1 Federal Register / Vol. 84, No. 66 / Friday, April 5, 2019 / Rules and Regulations premanufacture to limit exposure to dust. (ii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N=34. (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. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as glucosyltransferase, International Union of Biochemistry and Molecular Biology Number: 2.4.1.5 (PMN P–16–575, CAS No. 9032–14–8) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure. (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. khammond on DSKBBV9HB2PROD with RULES Alpha 1,3-polysaccharide (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as alpha 1,3-polysaccharide (generic) (PMN P–16–581) 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. It is a significant VerDate Sep<11>2014 15:56 Apr 04, 2019 Jkt 247001 [FR Doc. 2019–06624 Filed 4–4–19; 8:45 am] BILLING CODE 6560–50–P § 721.11192 Glucosyltransferase, International Union of Biochemistry and Molecular Biology Number: 2.4.1.5. § 721.11193 (generic). new use to use the substance other than as a polymer additive, paper coating component, composite component, or fiber additive. It is a significant new use to manufacture, process or use the PMN substance with particle size less than 10 micrometers. (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. ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA–R09–OAR–2017–0481; FRL–9991–53– Region 9] Air Quality State Implementation Plans: Arizona; Approval and Conditional Approval of State Implementation Plan Revisions; Maricopa County Air Quality Department; Stationary Source Permits Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: The Environmental Protection Agency (EPA) is finalizing revisions to the Maricopa County Air Quality Department’s (MCAQD) portion of the state implementation plan (SIP) for the State of Arizona. We are finalizing full approval of Rules 210, 220, 240, and 241, and conditional approval of Rules 100 and 200. The revisions update the MCAQD’s New Source Review (NSR) permitting program for new and modified sources of air pollution. DATES: This rule is effective on May 6, 2019. ADDRESSES: The EPA has established docket number EPA–R09–OAR–2017– 0481 for this action. Generally, documents in the docket for this action are available electronically at https:// www.regulations.gov or in hard copy at EPA Region IX, 75 Hawthorne Street (AIR–3), San Francisco, California 94105–3901. While all documents in the docket are listed at https:// www.regulations.gov, some information may be publicly available only at the SUMMARY: PO 00000 Frm 00045 Fmt 4700 Sfmt 4700 13543 hard copy location (e.g., copyrighted material, large maps, multi-volume reports), and some may not be available in either location (e.g., confidential business information (CBI)). To inspect the hard copy materials, please schedule an appointment during normal business hours with the contact listed in the FOR FURTHER INFORMATION CONTACT section. FOR FURTHER INFORMATION CONTACT: Shaheerah Kelly, EPA Region IX, 75 Hawthorne Street (AIR–3), San Francisco, CA 94105–3901, (415) 947– 4156, kelly.shaheerah@epa.gov. SUPPLEMENTARY INFORMATION: Throughout this document, the terms ‘‘we,’’ ‘‘us,’’ and ‘‘our’’ refer to the EPA. Table of Contents I. Proposed Action II. Summary of Public Comments and EPA Responses III. EPA Action IV. Incorporation by Reference V. Statutory and Executive Order Reviews Definitions For the purpose of this document, we are giving meaning to certain words or initials as follows: (i) The initials ADEQ mean or refer to the Arizona Department of Environmental Quality. (ii) The initials BACT mean or refer to Best Available Control Technology. (iii) The word or initials CAA or Act mean or refer to the Clean Air Act. (iv) The initials CFR mean or refer to Code of Federal Regulations. (v) The initials or words EPA, we, us or our mean or refer to the United States Environmental Protection Agency. (vi) The initials FR mean or refer to Federal Register. (vii) The word or initials MCAQD, ‘‘the County’’ or ‘‘Maricopa County’’ mean or refer to the Maricopa County Air Quality Department, the agency with jurisdiction over stationary sources within Maricopa County, Arizona. (viii) The phrase minor NSR means the permit program applicable to new or modified sources that do not result in a new major source or a major modification. (ix) The initials NAAQS mean or refer to the National Ambient Air Quality Standards. (x) The initials NSR mean or refer to New Source Review, which includes NNSR, PSD and minor NSR. (xi) The initials NNSR mean or refer to nonattainment New Source Review. (xii) The initials PM2.5 mean or refer to particulate matter less than 2.5 micrometers. (xiii) The initials PM10 mean or refer to particulate matter less than 10 micrometers. E:\FR\FM\05APR1.SGM 05APR1

Agencies

[Federal Register Volume 84, Number 66 (Friday, April 5, 2019)]
[Rules and Regulations]
[Pages 13531-13543]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06624]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2017-0575; FRL-9991-19-OCSPP]
RIN 2070-AB27


Significant New Use Rules on Certain Chemical Substances

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 13 chemical substances which 
are the subject of premanufacture notices (PMNs). This action requires 
persons to notify EPA least 90 days before commencing manufacture 
(defined by statute to include import) or processing of any of these 13 
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 intended 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 June 4, 2019. For purposes of judicial 
review, this rule shall be promulgated at 1 p.m. (e.s.t.) on April 19, 
2019.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Kenneth Moss, Chemical Control 
Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; telephone number: (202) 564-9232; email address: 
[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 
certification requirements promulgated at 19 CFR 12.118 through 12.127 
and 19 CFR 127.28. Chemical importers must certify that the shipment of 
the chemical substance complies with all applicable rules and orders 
under TSCA. Importers of chemicals subject to these SNURs must certify 
their compliance with the SNUR requirements. The EPA policy in support 
of import certification appears at 40 CFR part 707, subpart B. In 
addition, any persons who export or intend to export a chemical 
substance that is the subject of this rule on or after May 6, 2019 are 
subject to the export notification provisions of TSCA section 12(b) (15 
U.S.C. 2611(b)) (see Sec.  721.20), and must comply with the export 
notification requirements in 40 CFR part 707, subpart D.

II. Background

A. What action is the Agency taking?

    EPA is finalizing a SNUR under TSCA section 5(a)(2) for 13 chemical 
substances which were the subject of PMNs P-16-192, P-16-354 and P-16-
355, P-16-380 through P-16-385,
P-16-483 and P-16-484, P-16-575, and P-16-581. These SNURs require 
persons who intend to manufacture or process any of these chemical 
substances for an activity that is designated as a significant new use 
to notify EPA at least 90 days before commencing that activity.
    Previously, in the Federal Register of October 16, 2018 (83 FR 
52179) (FRL-9984-93), EPA proposed a SNUR for these 13 chemical 
substances in 40 CFR part 721 subpart E. More information on the 
specific chemical substances subject to this final rule can be found in 
the Federal Register documents proposing the SNUR. The record for the 
SNUR was established in the docket under docket ID number EPA-HQ-OPPT-
2017-0575. That docket includes information considered by the Agency in 
developing the proposed and final rules. EPA received a number of 
public comments on this rule. Those comments and EPA's responses are 
found in Unit IV.

[[Page 13532]]

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

    Section 5(a)(2) of TSCA (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. Once EPA determines that a use of a 
chemical substance is a significant new use, TSCA section 5(a)(1)(B) 
requires persons to submit a significant new use notice (SNUN) to EPA 
at least 90 days before they manufacture or process the chemical 
substance for that use (15 U.S.C. 2604(a)(1)(B)(i)). TSCA furthermore 
prohibits such manufacturing or processing from commencing until EPA 
has conducted a review of the notice, made an appropriate determination 
on the notice, and taken such actions as are required in association 
with that determination (15 U.S.C. 2604(a)(1)(B)(ii)). As described in 
Unit V., the general SNUR provisions are found at 40 CFR part 721, 
subpart A.

C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A. 
These provisions describe persons subject to the rule, recordkeeping 
requirements, exemptions to reporting requirements, and applicability 
of the rule to uses occurring before the effective date of the rule. 
Provisions relating to user fees appear at 40 CFR part 700. According 
to Sec.  721.1(c), persons subject to these SNURs must comply with the 
same SNUN requirements and EPA regulatory procedures as submitters of 
PMNs under TSCA section 5(a)(1)(A). In particular, these requirements 
include the information submission requirements of TSCA section 5(b) 
and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), 
(h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA 
receives a SNUN, EPA must either determine that the 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

    Section 5(a)(2) of TSCA states that EPA's determination that a use 
of a chemical substance is a significant new use must be made after 
consideration of all relevant factors, including:
     The projected volume of manufacturing and processing of a 
chemical substance.
     The extent to which a use changes the type or form of 
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and 
duration of exposure of human beings or the environment to a chemical 
substance.
     The reasonably anticipated manner and methods of 
manufacturing, processing, distribution in commerce, and disposal of a 
chemical substance.
    In addition to these factors enumerated in TSCA section 5(a)(2), 
the statute authorizes EPA to consider any other relevant factors.
    To determine what would constitute a significant new use for the 
chemical substances that are the subject of these SNURs, EPA considered 
relevant information about the toxicity of the chemical substances, 
likely human exposures and environmental releases associated with 
possible uses, and the four bulleted TSCA section 5(a)(2) factors 
listed in this unit.

IV. Public Comments on Proposed Rule and EPA Responses

    EPA received public comments from 15 entities on the proposed rule. 
The Agency's responses are described below.

Anonymous and Generally Supportive Comments

    EPA received a number of anonymous (and submitter-identified) 
comments in support of the Agency's proposed Significant New Use Rules 
(SNURs). These comments were general in nature, citing the importance 
of Agency review of these 13 chemicals to protect human health and the 
environment. No response is required.

Challenges to Underlying TSCA Sec.  5(a)(3) Determinations

    Comment 1: EPA received multiple comments regarding the manner in 
which these proposed Significant New Use Rules (SNURs) operate. One 
comment requested that, in light of alleged legal and factual 
deficiencies, EPA withdraw both the proposed SNURs and the underlying 
``not likely'' determinations and instead issue determinations, section 
5(e) orders, and post-order section 5(f) SNURs based on a finding that 
the chemical substances ``may present an unreasonable risk to health or 
the environment'' under section 5(a)(3)(B). Another comment stated that 
EPA may not rely on ``non-5(e) SNURs'' to make a ``not likely'' finding 
under section 5(a)(3)(C) and has failed to provide a legal and factual 
basis for its determination as required by section 5(g), but 
nevertheless supports the need to promulgate these SNURs at this time 
because otherwise there will be no protections at all in place for 
these chemical substances. The commenter stated that EPA found risks to 
workers for a number of the chemical substances subject to these 
proposed SNURs, absent protective measures that EPA expects will be 
implemented and will provide sufficient protection, and that EPA's risk 
determination for these chemicals should not assume there will be full 
compliance with all of the controls recommended in an associated Safety 
Data Sheet and that such compliance would be adequate to protect 
workers.
    Response: These comments constitute challenges to certain TSCA 
Sec.  5(a)(3) determinations rather than to the basis for or the 
content of the SNURs, which EPA has promulgated using its discretion to 
issue SNURs under TSCA Sec.  5(a)(2). Because these comments are not 
germane to this rulemaking, EPA is not responding to these comments in 
this notice and declines to withdraw the SNURs on the basis of these 
comments. Regardless, EPA has already defended the legal and factual 
basis for the TSCA Sec.  5(a)(3) determinations that these comments 
reference in a prior legal challenge. See Brief of U.S. Environmental 
Protection Agency in NRDC v. USEPA, 2d Cir. Docket No. 18-25.

Regulation of Workplace Risks

    Comment 2: Several commenters argued that where EPA finds 
unreasonable risks to workers in the absence of certain protective 
measures (e.g., personal protective equipment, engineering controls, 
etc.), EPA must identify as a significant new use any use of the 
chemical that occurs without those protections. Specifically, the 
commenters stated that, where EPA finds unreasonable risk to workers 
absent certain protective measures, the Agency must issue an order to 
address workplace risks--as well as consider promulgating a significant 
new use rule--because in these circumstances ``the manufacture, 
processing, distribution in commerce, use, or disposal of such 
substance, or any combination of such activities, may present an 
unreasonable risk of injury to health or the environment, without 
consideration of costs or other non-risk

[[Page 13533]]

factors, including an unreasonable risk to a potentially exposed 
subpopulation.'' 15 U.S.C. 2604(e)(1)(A)(ii)(I). In following, the 
commenters state EPA ``shall issue an order . . . to prohibit or limit 
the manufacture, processing, distribution in commerce, use, or disposal 
of such substance or to prohibit or limit any combination of such 
activities to the extent necessary to protect against an unreasonable 
risk of injury to health or the environment.'' Id. Sec.  2604(e)(1)(A). 
After issuing that order, EPA must consider whether to promulgate a 
significant new use rule ``that identifies as a significant new use any 
manufacturing, processing, use, distribution in commerce, or disposal 
of the chemical substance that does not conform to the restrictions 
imposed by the * * * order'' or publish a statement justifying the 
decision not to promulgate the SNUR. 15 U.S.C. 2604(f)(4). According to 
the commenters, Congress spoke clearly and required EPA to regulate 
unreasonable risks that a chemical substance ``may present'' under 
TSCA. The commenters contend that nothing in the text of TSCA allows 
EPA to simply assume that sufficient protective measures will be 
implemented to eliminate potential unreasonable risks; such an 
assumption essentially negates TSCA Sec.  5(e), which could not be 
Congress's intention. And, the commenters claim, EPA cannot find that a 
chemical is not likely to present an unreasonable risk based solely on 
EPA's unjustified ``expectation'' that sufficient protective measures 
will be implemented . . . EPA effectively found risks to workers for 
several chemical substances subject to these proposed SNURs, absent 
protective measures that EPA simply ``expects'' will be implemented and 
will provide sufficient protection. Commenters assert that EPA's risk 
determination for these chemicals should not assume there will be full 
compliance with all of the controls recommended in an associated Safety 
Data Sheet and that such compliance would be adequate to protect 
workers. Because EPA relied on these protective measures in its 
analysis of risk, commenters state that EPA should identify any 
condition of use without these protective measures to be a significant 
new use, meriting advance notification to EPA.
    Response: To the extent these comments argue that the Agency should 
have issued orders under Section 5(e) or 5(f) of TSCA, EPA believes 
they are beyond the scope of the SNUR for which EPA is specifically 
soliciting comments and are properly directed to the Section 5(a)(3) 
determinations that pertain to the underlying PMNs for the SNUR. EPA is 
therefore not responding to these comments here. However, EPA is 
responding to comments that pertain specifically to the SNUR, i.e., 
those regarding the uses that should be subject to the SNUR, as well as 
the assertion that EPA must include certain worker protection 
provisions in the SNURs on the basis of TSCA Section 5(f)(4).
    EPA disagrees with the comment that, with respect to scenarios 
where EPA expects that worker protection requirements under other 
federal/state authorities would mitigate risks to workers, EPA must 
designate all uses without those protections as ``significant new 
uses''. Section 5(a)(2) of TSCA does not mandate that any specific uses 
be designated as significant. Instead, EPA has discretion as to which 
new uses to designate as significant. As mentioned in the ``not 
likely'' determination documents for the subject PMNs in this batch 
SNUR (see https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/chemicals-determined-not-likely), in 
exercising its discretion regarding which new uses should be designated 
as significant under section 5(a)(2), EPA expects compliance with 
federal and state laws, such as worker protection standards or disposal 
restrictions, unless case-specific facts indicate otherwise. Further, 
any workplace risks will be mitigated if exposures are appropriately 
controlled, and EPA expects that employers will require and workers 
will use the appropriate controls (e.g., personal protective equipment 
such as impervious gloves and/or respirators), consistent with the 
Safety Data Sheet prepared by the PMN submitter, in a manner adequate 
to protect them.
    With respect to comments regarding TSCA Section 5(f)(4), EPA notes 
that because no applicable TSCA Section 5(e) or 5(f) orders have been 
issued, the requirements of TSCA Section 5(f)(4) are not triggered. 
Therefore, EPA need not make changes in the proposed SNUR to correspond 
to Section 5(e) and 5(f) orders that have not been issued.

SNURs Lack Provisions To Notify Downstream Processors and Users of 
Agency Concerns

    Comment 3: One commenter suggested that the proposed SNURs lack 
notification requirements for worker protection and hazard 
communication programs to ensure that risks to workers and the public 
from downstream activities are identified and addressed and fail to 
provide notice to downstream processors and users of the PMN 
substance's environmental effects and EPA's required limits on release 
to water.
    Response: 40 CFR 721.5 requires manufacturers and processors to 
either file a SNUN before distributing the chemical substance in 
commerce or notify downstream customers of the existence of a SNUR on a 
particular chemical substance (or determine that such users have 
notice). Thus, one of two possibilities will occur: (1) Downstream 
customers do receive notice of the SNUR, or (2) notification of 
downstream uses becomes unnecessary because the manufacturer or 
processors submits a SNUN to EPA, and the Agency either determines that 
such manufacture and processing is not likely to present unreasonable 
risk, or takes appropriate regulatory action to address the risks.

Impact on Downstream Users

    Comment 4: One commenter similarly identified impacts of SNURs on 
downstream users who ``often must struggle to figure out when a product 
they use is covered by a SNUR,'' particularly when the proposed SNUR 
provides only the generic name of a confidential chemical substance, or 
when the proposed SNUR covers the use of a chemical substance in an 
article. The comment also notes that the burden and compliance risks 
are greatest when the proposed SNUR contains reporting requirements. 
The commenter indicates that downstream users may depend on voluntary 
disclosure by the supplier or a downstream formulator/distributor, in 
contrast to the mandatory reporting requirements in place under a 5(e) 
order. The comment concludes that EPA should take steps to close the 
gap between proposal and finalization of SNURs by finalizing SNURs 
expeditiously, by notifying submitters of EPA's likelihood of 
promulgating a SNUR, and by requesting companies alert downstream users 
of impending SNURs.
    Response: The Agency is aware of the impacts of the issuance of a 
SNUR, including and beyond those specific to the actual TSCA 
notification requirement. EPA's focus is to take appropriate action 
under TSCA to control potential risks to human health or the 
environment from exposure or release of a new chemical, including 
requiring notification of potential significant new uses.

CBI and Disclosure of Health and Safety Information

    Comment 5: EPA received multiple comments critical of EPA's process 
in promulgating the proposed SNURs. One

[[Page 13534]]

comment requested that EPA extend the comment period and make CBI 
available for review with appropriate safeguards to avoid depriving the 
public of a meaningful opportunity to participate. The commenter stated 
that TSCA does not extend CBI protection to any health and safety study 
which is submitted under TSCA, including underlying information and 
occupational exposure studies. In addition to the scientific analyses 
developed by EPA (e.g., engineering reports, Structure Activity Team 
reports), which fall under this definition, other information that is 
generally required to be submitted with PMNs, such as toxicity studies, 
information on worker exposure, and the majority of information in 
Safety Data Sheets, also fall under this definition. EPA must disclose 
this information to the public. Despite these mandates, the commenter 
argues that EPA has failed to disclose this health and safety 
information. The comment states that EPA's SAT reports, engineering 
reports, and exposure reports all constitute or contain health and 
safety information that EPA must disclose, yet for P-16-575 (as an 
example provided by the commenter) EPA has largely redacted these 
documents.
    Response: EPA recognizes that TSCA Section 14 does not protect from 
disclosure certain confidential information described in Section 14(b), 
including health and safety information. However, Section 14 does not 
require that EPA make a final confidentiality determination for all 
information submitted under TSCA and claimed as CBI as part of a PMN 
review, and EPA has not made a determination regarding the eligibility 
for confidential treatment of the information referenced in the 
comment. Here, EPA balanced the need for sufficient information in the 
public record to fully explain the bases for its decisions with the 
protections for CBI in section 14. With regard to EPA technical support 
reports underlying the section 5 determination, they are not covered by 
section 14(b)(2), which specifically refers to health and safety 
studies submitted to EPA. EPA provided sufficient information in the 
public record to fully explain the bases for its decisions while 
preserving the submitter's confidentiality claims through generally 
accepted means, including the aggregation of certain data in the public 
docket, presentation of ranges of values, or masking of manufacturing 
site locations to prevent CBI disclosure.

Identifying ``Significant New Uses'' for SNURs

    Comment 6: The commenter considers the approach taken for these 
proposed SNURs that found ``not likely to present an unreasonable 
risk'' under the conditions of use described in the PMNs to be 
generally consistent with the requirements of the 2016 amendments to 
TSCA. To the extent that this approach also represents potential 
improvements in the Agency's ability to provide more timely review of 
PMNs, the commenter supports the approach. The commenter encourages EPA 
to take a risk-based approach--with particular focus on changes 
occurring in the conditions of use of a substance that can affect 
exposure (i.e., human exposure and environmental releases)--in 
identifying what changes in the conditions of use that will constitute 
significant new uses, and to consider the potential burden on 
downstream users when designating potential new uses to be significant. 
The commenter further encouraged EPA to use its discretion to consider 
``all relevant factors,'' including the cost of submitting SNUNs, the 
burden of compliance with SNUR reporting requirements such as Chemical 
Data Reporting (CDR) and TSCA section 12(b) export notification 
reporting, and the compliance risk caused by vague regulations, in 
promulgating 5(a)(2) SNURs to minimize regulatory burdens on downstream 
users.
    Response: EPA agrees that it should--and does--identify significant 
new uses only after consideration of the ``relevant factors'' 
identified in TSCA section (a)(2) ((1) the ``projected manufacturing or 
processing volume of a chemical substance''; (2) the ``type or form of 
exposure of human beings or the environment'' to the chemical 
substance; (3) the ``magnitude and duration of exposure of human beings 
or the environment'' to the environment; and (4) the ``reasonably 
anticipated manner and methods of manufacturing, processing, 
distribution in commerce, and disposal'' of the chemical substance). 
However, the Agency typically does not have all of the data specific 
enough for each of the aforementioned factors to support risk 
assessment(s) for anticipated changes that are not part of the PMN. 
Hence, such information would be provided if and when a SNUN is 
submitted that would provide such information for the significant new 
use. Another commenter supported this approach, explaining that future 
risks not contemplated in the PMN will be addressed by analysis of a 
significant new use notice (SNUN) which streamlines the current system 
which typically runs much longer than 90 days proscribed in TSCA. As to 
other regulatory requirements such as CDR or export notification, the 
Agency understands the impact and coordinates with those programs to 
eliminate inefficiencies. Furthermore, the Agency flags chemical 
substances on the TSCA Inventory that are regulated with a SNUR. For 
interpretation of SNUR notification requirements, the regulated 
community is encouraged to contact the Agency by using the options 
outlined in the ADDRESSES and FOR FURTHER INFORMATION CONTACT sections 
of the SNUR preamble.

Catch-All Significant New ``Use''

    Comment 7: One commenter suggested that EPA should generally 
designate as a significant new use any use of a chemical substance 
other than the uses EPA evaluated in its PMN review and determined are 
not likely to present an unreasonable risk. In particular, the 
commenter identified P-16-192, P-16-380-385, and 16-575, as SNURs for 
which other types of triggers for notification (e.g., manufacture in a 
certain physical form, or manufacture, processing, or use to result in 
inhalation exposure) were used. Although the commenter supports 
inclusion of these triggers, it comments that EPA must also require 
notification for use other than that which EPA has reviewed.
    Response: Commenters suggested approach is overly broad. TSCA 
requires that EPA evaluate new chemicals under their conditions of use, 
including the intended, known and reasonably foreseen circumstances of 
manufacture, processing, distribution in commerce, use and disposal. 
Based upon EPA's review of the relevant PMNs, the Agency identified 
uses that are appropriate for designation as ``significant new uses'' 
in order to ensure that EPA has an opportunity to review those uses in 
a SNUN submission at a later date and address any unreasonable risks at 
that time. TSCA Sec.  5(a)(2) does not require EPA to take the catch-
all approach advocated by commenters, and EPA believes a more tailored 
approach is warranted to avoid unduly burdensome regulations.

Being More Specific in 40 CFR 721.80

    Comment 8: One commenter suggested that EPA must clearly specify 
the cross references to EPA's general regulations in the SNURs. A 
number of proposed SNURs state that the significant new uses are 
``requirements as specified in 721.80.'' Since 40 CFR 721.80 contains 
25 possible significant

[[Page 13535]]

new use designations, this is misleading.
    Response: The Agency understands the confusion. Where one of the 25 
specific significant new use designations in 721.80 is not being used, 
in the interest of transparency and clarity, the Agency generally lists 
``Industrial, commercial, and consumer activities. Requirements as 
specified in Sec.  721.80'' and follows with a complete sentence 
describing the actual activity. EPA will modify its approach so that 
where it is not citing a specific designation in 721.80, the Agency 
will drop the phrase ``Requirements as specified in Sec.  721.80.'' For 
example, the SNUR at 40 CFR 721.11182 is finalized simply as:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture the substance other than in an 
amorphous form.
    In response to this comment, the Agency is making a similar change 
to these 721.80 designations in all the final SNURs in this batch rule, 
except the SNURs at 721.11190 and 721.11191. Those two SNURs 
specifically cite 721.80(j), which is the confidential use identified 
in the associated PMN submission for those SNURs.

Regulatory Burden of SNURs for Safer Chemicals

    Comment 9: One comment was regarding an enzyme used in the 
polymerization of glucose that would be subject to a proposed SNUR due 
to concerns with respiratory sensitization. The commenter stated that 
enzymes are recognized to have a positive and sustainable environmental 
profile and inherently low toxicity compared to other chemicals, and 
that this SNUR is a signal that it will be significantly more 
challenging to bring new enzymes to market and may decrease innovation 
that can address global challenges as highlighted by the UN Sustainable 
Development Goals. The commenter additionally voiced concern for the 
lengthy review time for PMN submissions.
    Response: To the extent commenter is disputing the outcome of a PMN 
review, these comments are more properly directed to the specific PMN 
determination and not this SNUR rulemaking. As mentioned previously in 
the response to Comment 1, this comment constitutes challenges to the 
corresponding TSCA Sec.  5(a)(3) determinations rather than to the 
basis for or the content of the SNURs, which EPA has promulgated using 
its discretion to issue SNURs under TSCA Sec.  5(a)(2). Nonetheless, 
the Agency is aware of, and working to remedy, the increased length of 
time it has been taking to review and reach decision on section 5 
notices as it implements the amendments to TSCA.

Non-Animal Testing

    Comment 10: One commenter supports this approach of addressing 
potential risks that the subject chemicals may present under reasonably 
foreseen conditions of use, while finding that under the intended 
conditions of use, they are not likely to present unreasonable risks. 
In contrast, the commenter states, in its early implementation of the 
amended TSCA, EPA addressed such potential risks in consent agreements 
with PMN submitters. In these cases, the commenter notes, EPA 
frequently required health and ecotoxicity testing, including hundreds 
of vertebrate animal tests requiring tens of thousands of animals. The 
commenter therefore supports EPA's new approach, which is consistent 
with TSCA's requirements to reduce and replace the use of vertebrate 
animals in the testing of chemical substances and promote the 
development and timely incorporation of new test methods and strategies 
that are not based on vertebrate animals. In addition, it protects 
human health and the environment by addressing potential risks when the 
conditions of use under which they arise are intended, either as 
identified in PMNs or in SNUNs, while reducing the burden on PMN 
submitters and streamlining the review process.
    Response: As mentioned in the preamble to this SNUR, any 
recommendation for information identified by EPA 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 chemical 
substance. Further, any such testing identified by 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. EPA also 
recognizes that whether testing/further information is needed will 
depend on the specific exposure and use scenario in the SNUN. EPA 
encourages all SNUN submitters to contact EPA to discuss any potential 
future testing. 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).

Do Not Use SNURs as Information Gathering Tool, Tracking Tool

    Comment 11: One commenter urged EPA to not rely on SNURs as tools 
for tracking use and production of chemical or for otherwise gathering 
potentially useful information, but instead suggested that EPA rely on 
provisions like section 8 which specifically authorize such acts.
    Response: EPA is not issuing a requirement to develop any data or 
information as a result of these SNURs. It is the responsibility of a 
SNUN submitter to provide any such information as required by TSCA 
section 5 and SNUN regulations at 40 CFR part 721. Regarding 
potentially useful information, EPA encourages all SNUN submitters to 
contact EPA to discuss any potential future testing. 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).

V. Substances Subject to This Rule

    EPA is establishing significant new use and recordkeeping 
requirements for 13 chemical substances in 40 CFR part 721, subpart E. 
In this unit, EPA provides the following information for each chemical 
substance:
     PMN number.
     Chemical name (generic name, if the specific name is 
claimed as CBI).
     Chemical Abstracts Service (CAS) Registry number (if 
assigned for non-confidential chemical identities).
     Basis for the SNUR.
     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.
    This information may include testing not required to be conducted 
but which would help characterize the potential health and/or 
environmental effects of the PMN substance. Any recommendation for 
information

[[Page 13536]]

identified by EPA 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 chemical substance. Further, any such 
testing identified by 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. EPA also recognizes that whether testing/
further information is needed will depend on the specific exposure and 
use scenario in the SNUN. EPA encourages all SNUN submitters to contact 
EPA to discuss any potential future testing. See Unit VIII. for more 
information.
     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.
    The chemical substances that are the subject of these SNURs 
completed premanufacture review. EPA has initially determined under 
TSCA section 5(a)(2), 15 U.S.C. 2604(a)(2), that certain changes from 
the conditions of use described in the PMNs could result in changes in 
the type or form of exposure to the chemical substances and/or 
increased exposures to the chemical substances and/or changes in the 
reasonably anticipated manner and methods of manufacturing, processing, 
distribution in commerce, and disposal of the chemical substances. 
Consequently, EPA is designating these changes as significant new uses.

PMN Number: P-16-192

    Chemical Name: Silanized amorphous silica (generic).
    CAS Number: Not available.
    Basis for action: The PMN states that the use of the substance will 
be as a reinforcing filler for the production of rubber goods. Based on 
test data for crystalline silica, EPA identified concerns for lung 
effects if the chemical substance is not used following the limitations 
noted below. The conditions of use of the PMN substance as described in 
the PMN include the following protective measures:
    Manufacture of the PMN substance in an amorphous form.
    The SNUR designates as a ``significant new use'' the absence of 
this protective measure.
    Potentially useful information: EPA has determined that certain 
information about the physical-chemical properties of the PMN substance 
may be potentially useful if a manufacturer or processor is considering 
submitting a SNUN for a significant new use designated by this SNUR. 
EPA has determined that information about the physical form, particle 
size, and water solubility would help characterize the potential health 
effects of the PMN substance.
    CFR citation: 40 CFR 721.11182.

PMN Numbers: P-16-354 and P-16-355

    Chemical name: Esteramine (generic).
    CAS number: Not available.
    Basis for action: The PMNs state that the generic (non-
confidential) use of the substances will be as a chemical intermediate. 
Based on the physical/chemical properties of the PMN substances and 
Structure Analysis Relationships (SAR) analysis of test data on 
analogous substances, EPA has identified concerns for irritation and 
developmental/reproductive toxicity, and aquatic toxicity at surface 
water concentrations exceeding 1 part per billion (ppb), if the 
chemical substances are not used following the limitations noted below. 
The conditions of use of the PMN substances as described in the PMNs 
include the following protective measures:
    1. No release of a manufacturing, processing, or use stream 
associated with any use of the substances, other than the confidential 
chemical intermediate use described in the PMNs, into the waters of the 
United States exceeding a surface water concentration of 1 ppb; and
    2. No manufacturing, processing or use of the PMN substances 
resulting in inhalation exposures to the substances.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the aquatic and human health toxicity of the PMN 
substances may be potentially useful to characterize the health and 
environmental effects of the PMN substances if a manufacturer or 
processor is considering submitting a SNUN for a significant new use 
designated by this SNUR. EPA has determined that the results of 
specific organ toxicity and aquatic toxicity testing would help 
characterize the potential health and environmental effects of the PMN 
substances.
    CFR citation: 40 CFR 721.11183.

PMN Numbers: P-16-380, P-16-381, P-16-382, P-16-383, P-16-384, and P-
16-385

    Chemical Names: Formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) 
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products acetates (salts), (generic) (P-
16-380), propanoic acid, 2-hydroxy-, compds. with hydrolyzed bisphenol 
A-epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) 
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products formates (salts), (generic) (P-
16-381), formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) 
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino] ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products sulfamates (salts), (generic) 
(P-16-382), formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) 
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino] ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products acetates (salts), (generic) (P-
16-383), propanoic acid, 2-hydroxy-, compds. with hydrolyzed bisphenol 
A-epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) 
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products formates (salts), (generic) (P-
16-384), formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) 
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products sulfamates (salts), (generic) 
(P-16-385).
    CAS Numbers: Not available.
    Basis for action: The PMNs state that the generic (non-
confidential) use of the substances will be as a component of an 
electrocoat resin. Based on the physical/chemical properties of the PMN 
substances and test data on analogous substances, EPA has identified 
concerns for lung effects and toxicity to aquatic organisms at 
concentrations that exceed 16 ppb if the chemical substances are not 
used following the limitations noted below. The conditions of use of 
the PMN substances as described in the PMNs include the following 
protective measures:

[[Page 13537]]

    1. No manufacturing, processing or use of the PMN substances 
resulting in inhalation exposures to the substances; and
    2. No release of a manufacturing, processing, or use stream 
associated with any use of the substances exceeding a surface water 
concentration of 16 ppb.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the health and environmental effects of the PMN 
substances may be potentially useful if a manufacturer or processor is 
considering submitting a SNUN for a significant new use designated by 
this SNUR. EPA has determined that the results of specific target 
organ, pulmonary, and acute aquatic toxicity testing would help 
characterize the potential health and environmental effects of the PMN 
substances.
    CFR citation: 40 CFR 721.11184 (P-16-380); 40 CFR 721.11185 (P-16-
381); 40 CFR 721.11186 (P-16-382); 40 CFR 721.11187 (P-16-383); 40 CFR 
721.11188 (P-16-384); and 40 CFR 721.11189 (P-16-385).

PMN Numbers: P-16-483 and P-16-484

    Chemical names: Inorganic acids, metal salts, compds. with modified 
heteroaromatics, (generic) (P-16-483) and Inorganic acids, metal salts, 
compds. with substituted aromatic heterocycle, (generic) (P-16-484).
    CAS numbers: Not available.
    Basis for action: The PMNs state that the generic (non-
confidential) use of P-16-483 will be as a plastic additive and the 
generic (non-confidential) use of P-16-484 will be as a chemical 
intermediate. Based on test data submitted on P-16-483 and data for 
analogous compounds, EPA has identified concerns for irritation, 
specific organ effects, and aquatic toxicity if the chemical is not 
used following the limitations noted below. The conditions of use of 
the PMN substances as described in the PMNs include the following 
protective measures:
    1. No use of the substances other than the confidential use 
described in the PMNs;
    2. No release of a manufacturing, processing, or use stream 
associated with any use of the substances exceeding a surface water 
concentration of 34 ppb; and
    3. No manufacturing, processing or use of the PMN substances 
without the engineering controls described in the PMNs to limit 
exposure to dust.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health and environmental toxicity of the 
PMN substances may be potentially useful to characterize the effects of 
the PMN substances if a manufacturer or processor is considering 
submitting a SNUN for a significant new use designated by this SNUR. 
EPA has determined that the results of aquatic toxicity and specific 
organ toxicity and aquatic toxicity testing would help characterize the 
potential health and environmental effects of the PMN substances.
    CFR citations: 40 CFR 721.11190
(P-16-683) and 40 CFR 721.11191
(P-16-684).

PMN Number: P-16-575

    Chemical name: Glucosyltransferase. International Union of 
Biochemistry and Molecular Biology Number: 2.4.1.5.
    CAS number: 9032-14-8.
    Basis for action: The PMN states that the use of the substance will 
be for polymerization of glucose. Based on the allergenic properties of 
proteins and review of surrogate enzymatic protein data submitted, EPA 
has identified concerns for respiratory sensitization if the chemical 
is not used following the limitations noted below. The conditions of 
use of the PMN substance as described in the PMN include the following 
protective measure:
    No manufacture, processing, or use of the PMN substance that 
results in inhalation exposures to the substance.
    The SNUR designates as a ``significant new use'' the absence of 
this protective measure.
    Potentially useful information: EPA has determined that certain 
information about the workplace exposure to the PMN substance may be 
potentially useful to characterize the health effects of the PMN 
substance if a manufacturer or processor is considering submitting a 
SNUN for a significant new use designated by this SNUR. EPA has 
determined that the results of workplace air monitoring would help 
characterize the potential health effects of the PMN substance.
    CFR citation: 40 CFR 721.11192.

PMN Number: P-16-581

    Chemical name: Alpha 1,3-polysaccharide (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the uses of the substance 
will be as a polymer additive, paper coating component, composite 
component, and fiber additive. Based on analogy to high molecular 
weight polymers, EPA has identified concerns for lung effects if the 
chemical is not used following the limitations noted below. The 
conditions of use of the PMN substance as described in the PMN include 
the following protective measures:
    1. No use of the substance other than the uses described in the 
PMN; and
    2. No manufacture, processing, or use with particle size less than 
10 micrometers.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the toxicity of the PMN substance may be potentially 
useful to characterize the health effects of the PMN substance if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use designated by this SNUR. EPA has determined that 
the results of pulmonary effects toxicity testing of the PMN substance 
may be potentially useful in characterizing the health effects of the 
PMN substance.
    CFR citation: 40 CFR 721.11193.

VI. Rationale and Objectives of the Rule

A. Rationale

    During review of the PMNs submitted for the chemical substances 
that are the subject of these SNURs and as further discussed in Unit 
IV, EPA identified certain reasonably foreseen conditions of use and 
other circumstances different from the intended conditions of use 
identified in the PMNs and determined that those changes could result 
in changes in the type or form of exposure to the chemical substances 
and/or increased exposures to the chemical substances and/or changes in 
the reasonably anticipated manner and methods of manufacturing, 
processing, distribution in commerce, and disposal of the chemical 
substances.

B. Objectives

    EPA is issuing these SNURs for specific chemical substances which 
have undergone premanufacture review because the Agency wants to 
achieve the following objectives with regard to the significant new 
uses designated in this rule:
     EPA will 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.
     EPA will have an opportunity to review and evaluate data 
submitted in a SNUN before the notice submitter begins manufacturing or 
processing a

[[Page 13538]]

listed chemical substance for the described significant new use.
     EPA is 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 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 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.
     EPA will identify as significant new uses any 
manufacturing, processing, use, distribution in commerce, or disposal 
that does not conform to the restrictions imposed by the underlying 
Orders, consistent with TSCA section 5(f)(4).
    Issuance of a SNUR for a chemical substance does not signify that 
the chemical substance is listed on the TSCA Chemical Substance 
Inventory (TSCA Inventory). Guidance on how to determine if a chemical 
substance is on the TSCA Inventory is available on the internet at 
http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

VII. 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.
    EPA designated October 9, 2018 (the date of web posting 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 October 9, 2018, 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, order 
or consent agreement under TSCA section 4 (15 U.S.C. 2603), then TSCA 
section 5(b)(1)(A) (15 U.S.C. 2604(b)(1)(A)) requires such information 
to be submitted to EPA at the time of submission of the SNUN.
    In the absence of a rule, order, or consent agreement under TSCA 
section 4 covering the chemical substance, persons are required only to 
submit information in their possession or control and to describe any 
other information known to or reasonably ascertainable by them (see 
Sec.  720.50). However, upon review of PMNs and SNUNs, the Agency has 
the authority to require appropriate testing. Unit IV. lists 
potentially useful information for all SNURs listed here. Descriptions 
are provided for informational purposes. The potentially useful 
information identified in Unit IV. will be useful to EPA's evaluation 
in the event that someone submits a SNUN for the significant new use. 
Companies who are considering submitting a SNUN are encouraged, but not 
required, to develop the information on the substance, which may assist 
with EPA's analysis of the SNUN.
    EPA strongly encourages persons, before performing any testing, to 
consult with the Agency pertaining to protocol selection. Furthermore, 
pursuant to TSCA section 4(h), which pertains to reduction of testing 
in vertebrate animals, EPA encourages consultation with the Agency on 
the use of alternative test methods and strategies (also called New 
Approach Methodologies, or NAMs), if available, to generate the 
recommended test data. EPA encourages dialog with Agency 
representatives to help determine how best the submitter can meet both 
the data needs and the objective of TSCA section 4(h).
    The potentially useful information described in Unit IV. may not be 
the only means of providing information to evaluate the chemical 
substance associated with the significant new uses. However, submitting 
a SNUN without any test data may increase the likelihood that EPA will 
take action under TSCA section 5(e) or 5(f). EPA recommends that 
potential SNUN submitters contact EPA early enough so that they will be 
able to conduct the appropriate tests.
    SNUN submitters should be aware that EPA will be better able to 
evaluate SNUNs which provide detailed information on the following:
     Human exposure and environmental release that may result 
from the significant new use of the chemical substances.
     Information on risks posed by the chemical substances 
compared to risks posed by potential substitutes.

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 Sec.  
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 Sec.  
721.1725(b)(1) with that under Sec.  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

[[Page 13539]]

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 Sec.  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 http://www.epa.gov/opptintr/newchems.

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-2017-0366.

XII. Statutory and Executive Order Reviews

A. Executive Order 12866

    This action establishes SNURs for several new chemical substances 
that were the subject of PMNs and TSCA section 5(e) consent orders. The 
Office of Management and Budget (OMB) has exempted these types of 
actions from review under Executive Order 12866, entitled ``Regulatory 
Planning and Review'' (58 FR 51735, October 4, 1993).

B. 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 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. This 
Information Collection Request (ICR) 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.
    The information collection requirements related to this action have 
already been approved by OMB pursuant to PRA under OMB control number 
2070-0012 (EPA ICR No. 574). This action does not impose any burden 
requiring additional OMB approval. If an entity were to submit a SNUN 
to the Agency, the annual burden is estimated to average between 30 and 
170 hours per response. This burden estimate includes the time needed 
to review instructions, search existing data sources, gather and 
maintain the data needed, and complete, review, and submit the required 
SNUN.
    Send any comments about the accuracy of the burden estimate, and 
any suggested methods for minimizing respondent burden, including 
through the use of automated collection techniques, to the Director, 
Collection Strategies Division, Office of Environmental Information 
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, 
Washington, DC 20460-0001. Please remember to include the OMB control 
number in any correspondence, but do not submit any completed forms to 
this address.

C. Regulatory Flexibility Act (RFA)

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation 
of this SNUR would not have a significant adverse economic impact on a 
substantial number of small entities. The requirement to submit a SNUN 
applies to any person (including small or large entities) who intends 
to engage in any activity described in the final rule as a 
``significant new use.'' Because these uses are ``new,'' based on all 
information currently available to EPA, it appears that no small or 
large entities presently engage in such activities. A SNUR requires 
that any person who intends to engage in such activity in the future 
must first notify EPA by submitting a SNUN. Although some small 
entities may decide to pursue a significant new use in the future, EPA 
cannot presently determine how many, if any, there may be. However, 
EPA's experience to date is that, in response to the promulgation of 
SNURs covering over 1,000 chemicals, the Agency receives only a small 
number of notices per year. For example, the number of SNUNs received 
was seven in Federal fiscal year (FY) 2013, 13 in FY2014, six in 
FY2015, 10 in FY2016, and 14 in FY2017, 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.

D. Unfunded Mandates Reform Act (UMRA)

    Based on EPA's experience with proposing and finalizing SNURs, 
State, local, and Tribal governments have not been impacted by these 
rulemakings, and EPA does not have any reasons to believe that any 
State, local, or Tribal government will be impacted by this 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. Executive Order 13132

    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).

[[Page 13540]]

F. Executive Order 13175

    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, entitled ``Consultation and Coordination with 
Indian Tribal Governments'' (65 FR 67249, November 9, 2000), do not 
apply to this action.

G. Executive Order 13045

    This action is not subject to Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997), because this is not an 
economically significant regulatory action as defined by Executive 
Order 12866, and this action does not address environmental health or 
safety risks disproportionately affecting children.

H. Executive Order 13211

    This action is not subject to Executive Order 13211, entitled 
``Actions Concerning Regulations That Significantly Affect Energy 
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001), because 
this action is not expected to affect energy supply, distribution, or 
use and because this action is not a significant regulatory action 
under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

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

J. Executive Order 12898

    This action does not entail special considerations of environmental 
justice related issues as delineated by Executive Order 12898, entitled 
``Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations'' (59 FR 7629, February 16, 
1994).

XIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. 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: March 27, 2019.
Tala Henry,
Acting Deputy Director, Office of Pollution Prevention and Toxics.

    Therefore, 40 CFR parts 9 and 721 are amended as follows:

PART 9--[AMENDED]

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, add the following sections 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.

* * * * *

------------------------------------------------------------------------
                                                            OMB control
                     40 CFR citation                            No.
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
Significant New Uses of Chemical Substances.............................
------------------------------------------------------------------------
 
                                * * * * *
721.11182...............................................       2070-0012
721.11183...............................................       2070-0012
721.11184...............................................       2070-0012
721.11185...............................................       2070-0012
721.11186...............................................       2070-0012
721.11187...............................................       2070-0012
721.11188...............................................       2070-0012
721.11189...............................................       2070-0012
721.11190...............................................       2070-0012
721.11191...............................................       2070-0012
721.11192...............................................       2070-0012
721.11193...............................................       2070-0012
 
                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 721--[AMENDED]

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.  721.11182 through 721.11193 to subpart E to read as 
follows:

Subpart E--Significant New Uses for Specific Chemical Substances

Sec.
* * * * *
721.11182 Silanized amorphous silica (generic).
721.11183 Esteramine (generic).
721.11184 Formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) 
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products acetates (salts), (generic).
721.11185 Propanoic acid, 2-hydroxy-, compds. with hydrolyzed 
bisphenol A-epichlorohydrin-polyethylene glycol ether with bisphenol 
A (2:1) polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products formates (salts), (generic).
721.11186 Formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) 
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products sulfamates (salts), 
(generic).
721.11187 Formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) 
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products acetates (salts), (generic).
721.11188 Propanoic acid, 2-hydroxy-, compds. with hydrolyzed 
bisphenol A-epichlorohydrin-polyethylene glycol ether with bisphenol 
A (2:1) polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products formates (salts), (generic).
721.11189 Formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) 
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products sulfamates (salts), 
(generic).
721.11190 Inorganic acids, metal salts, compds. with modified 
heteroaromatics, (generic).

[[Page 13541]]

721.11191 Inorganic acids, metal salts, compds. with substituted 
aromatic heterocycle, (generic).
721.11192 Glucosyltransferase, International Union of Biochemistry 
and Molecular Biology Number: 2.4.1.5.
721.11193 Alpha 1,3-polysaccharide (generic).


Sec.  721.11182   Silanized amorphous silica (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
silanized amorphous silica (P-16-192) 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. It is a 
significant new use to manufacture the substance other than in an 
amorphous form.
    (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, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11183   Esteramine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
esteramine (PMN P-16-354 and P-16-355) are 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. It is a 
significant new use to manufacture, process, or use the substances in 
any manner that results in inhalation exposure. It is a significant new 
use to release a manufacturing, processing, or use stream associated 
with any use of the substances, other than the confidential chemical 
intermediate use described in the premanufacture notices, into the 
waters of the United States exceeding a surface water concentration of 
1 part per billion (ppb) using the methods described in Sec.  721.91.
    (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) though (e), and (i) are applicable to manufacturers and 
processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11184  Formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) 
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products acetates (salts), (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as formic 
acid, compds. with hydrolyzed bisphenol A-epichlorohydrin-polyethylene 
glycol ether with bisphenol A (2:1) polymer-N1-(1,3-
dimethylbutylidene)-N2-[2-[(1, 3-dimethylbutylidene)amino]ethyl]-1,2-
ethanediamine-dialdehyde-2-(methylamino)ethanol reaction products 
acetates (salts), (P-16-380) 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. It is a 
significant new use to manufacture, process, or use the 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=16.
    (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, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11185   Propanoic acid, 2-hydroxy-, compds. with hydrolyzed 
bisphenol A-epichlorohydrin-polyethylene glycol ether with bisphenol A 
(2:1) polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products formates (salts), (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically as propanoic acid, 2-
hydroxy-, compds. with hydrolyzed bisphenol A-epichlorohydrin-
polyethylene glycol ether with bisphenol A (2:1) polymer-N1-(1,3-
dimethylbutylidene)-N2-[2-[(1, 3-dimethylbutylidene)amino]ethyl]-1,2-
ethanediamine-dialdehyde-2-(methylamino)ethanol reaction products 
formates (salts), (P-16-381) 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. It is a 
significant new use to manufacture, process, or use the 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=16.
    (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, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.1118  6 Formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) 
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products sulfamates (salts), (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as formic 
acid, compds. with hydrolyzed bisphenol A-epichlorohydrin-polyethylene 
glycol ether with bisphenol A (2:1) polymer-N1-(1,3-
dimethylbutylidene)-N2-[2-[(1, 3-dimethylbutylidene)amino]ethyl]-1,2-
ethanediamine-dialdehyde-2-(methylamino)ethanol reaction products 
sulfamates (salts), (P-16-382) 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. It is a 
significant new use to manufacture, process, or use the 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=16.
    (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

[[Page 13542]]

Sec.  721.125(a) through (c), (i), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11187   Formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) 
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products acetates (salts), (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as formic 
acid, compds. with hydrolyzed bisphenol A-epichlorohydrin-polyethylene 
glycol ether with bisphenol A (2:1) polymer-N1-(1,3-
dimethylbutylidene)-N2-[2-[(1, 3-dimethylbutylidene)amino]ethyl]-1,2-
ethanediamine-dialdehyde-2-(methylamino)ethanol reaction products 
acetates (salts), (P-16-383) 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. It is a 
significant new use to manufacture, process, or use the 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=16.
    (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, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11188   Propanoic acid, 2-hydroxy-, compds. with hydrolyzed 
bisphenol A-epichlorohydrin-polyethylene glycol ether with bisphenol A 
(2:1) polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products formates (salts), (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
propanoic acid, 2-hydroxy-, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) 
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino] ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products formates (salts), (P-16-384) 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. It is a 
significant new use to manufacture, process, or use the 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=16.
    (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, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11189   Formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) 
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products sulfamates (salts), (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as formic 
acid, compds. with hydrolyzed bisphenol A-epichlorohydrin-polyethylene 
glycol ether with bisphenol A (2:1) polymer-N1-(1,3-
dimethylbutylidene)-N2-[2-[(1, 3-dimethylbutylidene)amino]ethyl]-1,2-
ethanediamine-dialdehyde-2-(methylamino)ethanol reaction products 
sulfamates (salts), (P-16-385) 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. It is a 
significant new use to manufacture, process, or use the 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=16.
    (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, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11190   Inorganic acids, metal salts, compds. with modified 
heteroaromatics, (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
inorganic acids, metal salts, compds. with modified heteroaromatics, 
(PMN P-16-483) 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(j). It is a significant new use to 
manufacture, process, or use the substance without the engineering 
controls described in the premanufacture notice to limit exposure to 
dust.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=34.
    (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.  721.11191   Inorganic acids, metal salts, compds. with 
substituted aromatic heterocycle, (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
inorganic acids, metal salts, compds. with substituted aromatic 
heterocycle, (PMN P-16-484) 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(j). It is a significant new use to 
manufacture, process, or use the substance without the engineering 
controls described in the

[[Page 13543]]

premanufacture to limit exposure to dust.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=34.
    (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.  721.11192   Glucosyltransferase, International Union of 
Biochemistry and Molecular Biology Number: 2.4.1.5.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 
glucosyltransferase, International Union of Biochemistry and Molecular 
Biology Number: 2.4.1.5 (PMN P-16-575, CAS No. 9032-14-8) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture, process, or use the substance in 
any manner that results in inhalation exposure.
    (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.  721.11193   Alpha 1,3-polysaccharide (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as alpha 
1,3-polysaccharide (generic) (PMN P-16-581) 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. It is a 
significant new use to use the substance other than as a polymer 
additive, paper coating component, composite component, or fiber 
additive. It is a significant new use to manufacture, process or use 
the PMN substance with particle size less than 10 micrometers.
    (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.

[FR Doc. 2019-06624 Filed 4-4-19; 8:45 am]
 BILLING CODE 6560-50-P