Significant New Use Rules on Certain Chemical Substances, 47004-47025 [2018-19950]

Download as PDF 47004 Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Rules and Regulations ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 9 and 721 [EPA–HQ–OPPT–2018–0567; FRL–9983–14] RIN 2070–AB27 Significant New Use Rules on Certain Chemical Substances Environmental Protection Agency (EPA). ACTION: Direct final rule. AGENCY: EPA is promulgating significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 28 chemical substances which were the subject of premanufacture notices (PMNs). The chemical substances are subject to Orders issued by EPA pursuant to the TSCA. This action requires persons who intend to manufacture (defined by statute to include import) or process any of these 28 chemical substances for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA’s evaluation of the 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 with that determination. DATES: This rule is effective on November 16, 2018. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on October 1, 2018. Written adverse comments on one or more of these SNURs must be received on or before October 17, 2018 (see Unit VI. of the SUPPLEMENTARY INFORMATION). If EPA receives written adverse comments, on one or more of these SNURs before October 17, 2018, EPA will withdraw the relevant sections of this direct final rule before its effective date. For additional information on related reporting requirement dates, see Units I.A., VI., and VII. of the SUPPLEMENTARY INFORMATION. ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA–HQ–OPPT–2018–0567, by one of the following methods: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) daltland on DSKBBV9HB2PROD with RULES2 SUMMARY: VerDate Sep<11>2014 18:34 Sep 14, 2018 Jkt 244001 or other information whose disclosure is restricted by statute. • Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460–0001. • Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http:// www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http:// www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: For technical information contact: Kenneth Moss, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460–0001; telephone number: (202) 564–9232; email address: moss.kenneth@epa.gov. For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554– 1404; email address: TSCA-Hotline@ epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this 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 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 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 October 17, 2018 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. B. What should I consider as I prepare my comments for EPA? 1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark part or all of the information that you claim to be CBI. For CBI information in a disk or CD–ROM that you mail to EPA, mark the outside of the disk or CD–ROM as CBI and then identify electronically within the disk or CD–ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/ comments.html. II. Background A. What action is the Agency taking? 1. Direct Final Rule. EPA is promulgating these SNURs using direct final rule procedures. These SNURs will require persons to notify EPA at least 90 days before commencing the manufacture or processing of a chemical substance for any activity designated by these SNURs as a significant new use. Receipt of such notices obligates EPA to assess risks that may be associated with the significant new uses under the conditions of use and, if appropriate, to regulate the proposed uses before they occur. 2. Proposed Rule. In addition to this Direct Final Rule, elsewhere in this issue of the Federal Register, EPA is issuing a Notice of Proposed Rulemaking for this rule. If EPA receives no adverse comment, the Agency will not take further action on the proposed rule and the direct final rule will become effective as provided in this action. If EPA receives adverse comment on one or more of SNURs in this action by October 2, 2018 (see Unit VI. of the SUPPLEMENTARY INFORMATION), the Agency will publish in the Federal E:\FR\FM\17SER2.SGM 17SER2 Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Rules and Regulations Register a timely withdrawal of the specific SNURs that the adverse comments pertain to, informing the public that the actions will not take effect. EPA would then address all adverse public comments in a response to comments document in a subsequent final rule, based on the proposed rule. daltland on DSKBBV9HB2PROD with RULES2 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 § 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 VerDate Sep<11>2014 18:34 Sep 14, 2018 Jkt 244001 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 28 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. Substances Subject to This Rule EPA is establishing significant new use and recordkeeping requirements for 28 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 TSCA section 5(e) Order. • Information identified by EPA that would help characterize the potential health and/or environmental effects of the chemical substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use designated by the SNUR. This information may include testing required in a TSCA section 5(e) Order PO 00000 Frm 00003 Fmt 4701 Sfmt 4700 47005 to be conducted by the PMN submitter, as well as testing not required to be conducted but which would also help characterize the potential health and/or environmental effects of the PMN substance. 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. See Unit VIII. for more information. • CFR citation assigned in the regulatory text section of this rule. The regulatory text section of these rules specifies the activities designated as significant new uses. Certain new uses, including exceedance of production volume limits (i.e., limits on manufacture volume) and other uses designated in this rule, may be claimed as CBI. Unit IX. discusses a procedure companies may use to ascertain whether a proposed use constitutes a significant new use. These rules include 28 PMN substances that are subject to Orders under TSCA section 5(e)(1)(A). Each Order is based on one or more of the findings in TSCA section 5(a)(3)(B): There is insufficient information to permit a reasoned evaluation; in the absence of sufficient information to permit a reasoned evaluation, the activities associated with the PMN substances may present unreasonable risk to human health or the environment; the substance is or will be produced in substantial quantities, and enters or may reasonably be anticipated to enter the environment in substantial quantities or there is or may be significant (substantial) human exposure to the substance. Those Orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The SNURs identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying Orders, consistent with TSCA section 5(f)(4). Where EPA determined that the PMN substance may present an unreasonable E:\FR\FM\17SER2.SGM 17SER2 47006 Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Rules and Regulations risk of injury to human health via inhalation exposure, the underlying TSCA section 5(e) Order required, among other things, that potentially exposed employees wear specified respirators unless actual measurements of the workplace air show that air-borne concentrations of the PMN substance are below a New Chemical Exposure Limit (NCEL) that is established by EPA to provide adequate protection to human health. In addition to the actual NCEL concentration, the comprehensive NCELs provisions in TSCA section 5(e) Orders, which are modeled after Occupational Safety and Health Administration (OSHA) Permissible Exposure Limits (PELs) provisions, include requirements addressing performance criteria for sampling and analytical methods, periodic monitoring, respiratory protection, and recordkeeping. However, no comparable NCEL provisions currently exist in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases, the individual SNURs in 40 CFR part 721, subpart E, will state that persons subject to the SNUR who wish to pursue NCELs as an alternative to the § 721.63 respirator requirements may request to do so under § 721.30. EPA expects that persons whose § 721.30 requests to use the NCELs approach for SNURs that are approved by EPA will be required to comply with NCELs provisions that are comparable to those contained in the corresponding TSCA section 5(e) Order for the same chemical substance. daltland on DSKBBV9HB2PROD with RULES2 PMN Number: P–14–758 Chemical name: 2-Propenenitrile, polymer with methanamine, hydrogenated, 3aminopropylterminated, ethoxylated propoxylated. CAS number: 2055838–16–7. Effective date of TSCA section 5(e) Order: September 15, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic (nonconfidential) use of the substance will be as urethane foam. Based on physical/ chemical properties, EPA has identified concern for lung toxicity. Based on SAR analysis of polycationic polymers, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 416 parts per billion (ppb). The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires: VerDate Sep<11>2014 18:34 Sep 14, 2018 Jkt 244001 1. Refraining from manufacturing the PMN substance in the United States (i.e. import only); 2. Use of personal protective equipment where there is a potential for dermal exposure; 3. Use of a National Institute of Occupational Safety and Health (NIOSH)-certified respirator with an APF of at least 50 where there is a potential for inhalation exposure; 4. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS; 5. No application method of the PMN substance that results in greater worker inhalation exposures to vapor, mist, or aerosol than those encountered in roller coating application; 6. Use of the PMN substance only for the confidential uses specified in the Order; and 7. No release of the PMN substance into the waters of the United States. 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 physical-chemical properties, fate, ecotoxicity and pulmonary effects of the PMN substance may be potentially useful to characterize the effects of the PMN substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. EPA has determined that the results of physical-chemical property testing, fate, acute and chronic aquatic toxicity testing, and pulmonary toxicity testing would help characterize the potential environmental and health effects of the PMN substance. Although the Order does not require these tests, the Order’s restrictions will remain in effect until the Order is modified or revoked by EPA based on submission of this or other information that EPA determines is relevant and needed to evaluate a modification request. CFR citation: 40 CFR 721.11124. PMN Number: P–16–493 Chemical Name: Dicarboxylic acids, polymers with alkyl prop-2-enoate, alkyl 2- ethylprop-2-enoate, alkyl[(alkenyl)alkyl]alkanediol, alkanediol, alkanedioic acid, alkyl 2rnethylprop-2-enoate, alkyl prop-2enoic acid, alkylene [isocyanatocarbomonocyte] and alkanediol, alkanolamine-blocked, compds with 2-(alkylamino)alkanol (generic). CAS Number: Not available. PO 00000 Frm 00004 Fmt 4701 Sfmt 4700 Effective date of TSCA section 5(e) Order: September 18, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic (nonconfidential) use of the substance will be as paint. Based on physical/chemical properties of the PMN substance and test data on analogous diisocyanates, EPA identified concerns for dermal sensitization, respiratory sensitization, lung effects, neurotoxicity, and developmental toxicity, as well as skin irritation, and a potential for cancer to workers due to the possibility of isocyanate residuals. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires: 1. Refraining from manufacturing or processing the PMN substance in the United States (i.e., import only); 2. Import of the PMN substance to contain no more than 0.1% residual isocyanate by weight; and 3. Import of the PMN substance to contain no more than 1% of a confidential component by weight. The SNUR designates as a ‘‘significant new use’’ the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful to characterize the effects of the PMN substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. EPA has determined that the results of sensitization and pulmonary toxicity testing would help characterize the potential health effects of the PMN substance. Although the Order does not require these tests, the Order’s restrictions will remain in effect until the Order is modified or revoked by EPA based on submission of this or other information that EPA determines is relevant and needed to evaluate a modification request. CFR citation: 40 CFR 721.11125. PMN Number: P–16–514 Chemical Name: Mixed metal oxide (generic). CAS Number: Not available. Effective date of TSCA section 5(e) Order: August 7, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic (non- E:\FR\FM\17SER2.SGM 17SER2 daltland on DSKBBV9HB2PROD with RULES2 Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Rules and Regulations confidential) use of the substance will be as a catalyst. Based on SAR analysis of test data on analogous mixed metal oxides, EPA identified concerns for lung effects, systemic effects, eye irritation and allergic skin reaction. EPA also identified risk to workers for lung toxicity based on lung overload for respirable, poorly soluble particulates. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health. To protect against these risks, the Order requires: 1. Submission to EPA of certain toxicity testing before exceeding the confidential production volume limit specified in the Order; 2. Use of personal protective equipment where there is a potential for dermal exposure; 3. Use of a NIOSH-certified respirator with an APF of at least 1,000 where there is a potential for inhalation exposure or compliance with a NCEL of 0.04 mg/m3 as an 8-hour time-weighted average to prevent inhalation exposure; 4. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the Safety Data Sheet (SDS); 5. Refraining from manufacturing or processing the PMN substance in the United States (i.e., import only); 6. Use of the PMN substance only for the confidential use stated in the Order; and 7. Disposal of the PMN substance only by recycling as described in the PMN. The SNUR designates as a ‘‘significant new use’’ the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful to characterize the effects of the PMN substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. The submitter has agreed not to exceed a certain production volume limit without performing specific pulmonary and internal organ toxicity testing. CFR citation: 40 CFR 721.11126. PMN Numbers: P–16–576 and P–16–577 Chemical names: Modified alkyl polyamine (generic) (P–16–576) and alkyl polyamine (generic) (P–16–577). CAS numbers: Not available. VerDate Sep<11>2014 18:34 Sep 14, 2018 Jkt 244001 Effective date of TSCA section 5(e) Order: September 18, 2017. Basis for TSCA section 5(e) Order: The PMNs state that the generic (nonconfidential) use of the substances will be as an intermediate (P–16–576) and an oil lubricant additive (P–16–577). Based on the physical/chemical properties of the PMN substances, analogue toxicity data, and data on the PMN substances, EPA has identified concerns for irritation to the skin, eyes, mucous membranes, and lungs; effects to the GI tract, adrenal glands, and blood; immunotoxicity; and reproductive toxicity. Based on Structure Activity Relationship (SAR) predictions for polycationic polymers and aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 parts per billion. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substances may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires: 1. Use of the PMN substances only for the confidential uses stated in the Order; 2. Use of personal protective equipment where there is a potential for dermal exposure; 3. Submission to EPA of certain toxicity testing for P–16–577 no later than 9 months and 12 months from the date of the Notice of Commencement (NOC) of either substance; 4. Refraining from manufacture, processing or use for consumer use or in commercial use where there is use in a consumer setting; and 5. No release of P–16–577 resulting in surface water concentrations that exceed 2 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 environmental and health effects of the PMN substances may be potentially useful to characterize the effects of the PMN substances in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. The submitter has agreed not to exceed certain time limits without performing specific pharmacokinetic and developmental toxicity testing. Additionally, EPA has determined that the results of chronic PO 00000 Frm 00005 Fmt 4701 Sfmt 4700 47007 aquatic toxicity testing on P–16–577 would help characterize the potential environmental effects caused by the PMN substances. Although the Order does not require this test, the Order’s restrictions will remain in effect until the Order is modified or revoked by EPA based on submission of this or other information that EPA determines is relevant and needed to evaluate a modification request. CFR citations: 40 CFR 721.11127 (P– 16–576) and 40 CFR 721.11128 (P–16– 577). PMN Number: P–16–590 Chemical Name: Silica gel, reaction products with chromium oxide (CrO3) and ethoxydiethyl aluminum. CAS Number: 932384–12–8. Effective date of TSCA section 5(e) Order: September 13, 2017. Basis for TSCA section 5(e) Order: The PMN states that the use of the substance will be as a catalyst for polyethylene polymerization. Based on the reactivity of the PMN substance and the presence of chromium VI, EPA identified concerns for oncogenicity, reproductive toxicity, respiratory sensitization, and severe irritation to skin, eyes, lung and mucous membranes. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to health. To protect against these risks, the Order requires: 1. Handling the PMN substance under an inert atmosphere using containers and systems designed not to be exposed to the air; 2. Use of personal protective equipment where there is a potential for dermal exposure; 3. Use of a NIOSH-certified respirator with an APF of 10 to 1,000 depending on monitoring results from the methods required in the Order; and 4. Disposal of all waste streams containing the PMN substance and the constituent breakdown products of the PMN substance in a Resource Conservation and Recovery Act (RCRA) hazardous waste landfill. The SNUR designates as a ‘‘significant new use’’ the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful to characterize the effects of the PMN substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a E:\FR\FM\17SER2.SGM 17SER2 47008 Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Rules and Regulations daltland on DSKBBV9HB2PROD with RULES2 significant new use that would be designated by this SNUR. EPA has determined that the results of a pulmonary toxicity study and a carcinogenicity study would help characterize the potential health effects of the PMN substance. Although the Order does not require these tests, the Order’s restrictions will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citation: 40 CFR 721.11129. PMN Number: P–16–593 Chemical Name: Carboxylic acids, C618 and C5-15-di-, polymers with diethyleneglycol, glycerol, sorbitol and terephthalic acid. CAS Number: 1967778–37–5. Effective date of TSCA section 5(e) Order: August 7, 2017. Basis for TSCA section 5(e) Order: The PMN states that the use of the substance will be as an aromatic polyester polyol for rigid foam. EPA identified concerns for lung effects and irritation to the eyes and mucous membranes based on the physical/ chemical properties of the PMN substance. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires: 1. Use of personal protective equipment where there is a potential for dermal exposure; 2. Use of the PMN substance only as an aromatic polyester polyol for rigid foam; 3. No manufacture, processing, or use of the PMN substance to result in inhalation exposures to a vapor, mist or aerosol; and 4. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS. 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 physical-chemical properties and health effects of the PMN substance may be potentially useful to characterize the effects of the PMN substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. EPA has determined that the results of physical- VerDate Sep<11>2014 18:34 Sep 14, 2018 Jkt 244001 chemical property testing and pulmonary toxicity testing would help characterize the potential health effects of the PMN substance. Although the Order does not require these tests, the Order’s restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citation: 40 CFR 721.11130. PMN Number: P–17–5 Chemical name: 1-tetradecene homopolymer hydrogenated. CAS number: 1857296–89–9. Effective date of TSCA section 5(e) Order: August 9, 2017. Basis for TSCA section 5(e) Order: The PMN states that the use of the substance will be as a base fluid/carrier fluid for additives in motor oil, automatic transmission fluid, and industrial lubricants. Based on analysis of test data on an analogous chemical substance, EPA has identified concerns for irritation to mucous membranes and hydrocarbon pneumonia. The Order was issued under TSCA section 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to human health. The Order was also issued under TSCA section 5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding that the substance is or will be produced in substantial quantities and that the substance either enters or may reasonably be anticipated to enter the environment in substantial quantities, or there is or may be significant (or substantial) human exposure to the substance. To protect against these risks, the Order requires: 1. Submission to EPA of certain toxicity testing no later than 9 months after the NOC; 2. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS; 3. No manufacture, processing, or use of the PMN substance to result in inhalation exposure to a vapor, mist, or aerosol; and 4. Not process the PMN substance for use other than as a base fluid/carrier fluid for additives in motor oil, automatic transmission fluid, and industrial lubricants. The SNUR designates as a ‘‘significant new use’’ the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful to characterize the effects of the PMN PO 00000 Frm 00006 Fmt 4701 Sfmt 4700 substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. The submitter has agreed not to exceed a certain production volume limit without performing specific pulmonary toxicity testing. CFR citation: 40 CFR 721.11131. PMN Numbers: P–17–149, P–17–150, P– 17–151, and P–17–165 Chemical Name: Fluorocyanophenyl alkylbenzoate (generic) CAS Numbers: Not available. Effective date of TSCA section 5(e) Order: August 10, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic (nonconfidential) use of the substances will be for electronic device use. Based on analysis of test data on analogous chemicals, EPA identified concerns for reproductive toxicity, developmental toxicity, neurotoxicity, and lung and skin effects. Based on SAR analysis of test data on analogous esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 ppb for P–17–165 and 4 ppb for the other PMN substances. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substances may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires: 1. Submission to EPA of certain toxicity testing before exceeding the confidential production volume limit specified in the Order; 2. Use of personal protective equipment where there is a potential for dermal exposure; 3. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS; 4. Use of the PMN substances only for the confidential use specified in the Order; 5. No modification of the manufacture, processing or use of the PMN substances to result in inhalation exposure to vapor, dust, mist, or aerosol; and 6. No release of the PMN substances resulting in surface water concentrations that exceed 2 ppb for P– 17–165 and 4 ppb for the other PMN substances. The SNUR designates as a ‘‘significant new use’’ the absence of these protective measures. E:\FR\FM\17SER2.SGM 17SER2 Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Rules and Regulations daltland on DSKBBV9HB2PROD with RULES2 Potentially useful information: EPA has determined that certain information about the environmental and health effects of the PMN substances may be potentially useful to characterize the effects of the PMN substances in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. The submitter has agreed not to exceed a certain production volume limit without performing specific reproductive/ developmental toxicity testing and acute and chronic aquatic toxicity testing. CFR citation: 40 CFR 721.11132. PMN Number: P–17–175 Chemical Name: Fluorinated propenoic poly alkyl ether ester (generic). CAS Number: Not available. Effective date of TSCA section 5(e) Order: September 1, 2017. Basis for TSCA section 5(e) Order: The PMN states that the use of the PMN substance will be as a leveling agent for coatings applied to aluminum printing plates. Based on analysis of test data on the analogue perfluorohexanoic acid, EPA identified concerns for liver toxicity, blood toxicity, and male reproductive toxicity for the potential incomplete incineration product. Based on SAR predictions for polyanionic polymers for the potential degradation product, EPA also identified concern for effects of the potential degradation products to terrestrial wild animals and birds based on test data for analogous perfluoro chemicals in mammals. EPA has concerns that these degradation products will persist in the environment, could bioaccumulate or biomagnify, and could be toxic (PBT) to people, wild mammals, and birds. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires: 1. Refraining from domestic manufacture in the United States (i.e., import only); 2. No manufacture (including import) beyond a maximum annual production volume of 60 kg; and 3. Use of the PMN substance only as a leveling agent for coatings applied to aluminum printing plates. The SNUR designates as a ‘‘significant new use’’ the absence of these protective measures. VerDate Sep<11>2014 18:34 Sep 14, 2018 Jkt 244001 Potentially useful information: EPA has determined that certain information about the physical-chemical properties and fate of the PMN substance may be potentially useful to characterize the effects of the PMN substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. EPA has determined that the results of specific physical-chemical properties, environmental fate, and bioaccumulation testing would help characterize the potential health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order’s restrictions will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citation: 40 CFR 721.11133. PMN number: P–17–199 Chemical name: Oxyalkylene urethane polyolefin (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: September 14, 2017. Basis for TSCA section 5(e) Order: The PMN states that the use of the substance will be as a binder in sealant. Based on the physical/chemical properties of the PMN substance, EPA identified concerns for oncogenicity, male reproductive effects, developmental toxicity and sensitization if the PMN substance were manufactured differently. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to human health. To protect against these risks, the Order requires: 1. Manufacture of the PMN substance at no less than the average molecular weight specified in the Order; and 2. Manufacture of the PMN substance with no more than 1% of the molecular weight content below 1,000 Daltons. The SNUR designates as a ‘‘significant new use’’ the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful to characterize the effects of the PMN substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. EPA has PO 00000 Frm 00007 Fmt 4701 Sfmt 4700 47009 determined that the results of specific developmental toxicity, internal organ toxicity, and sensitization testing would help characterize the potential health effects of the PMN substance. Although the Order does not require these tests, the Order’s restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citation: 40 CFR 721.11134. PMN Number: P–17–206 Chemical Name: Imino alkane amine phosphate (generic). CAS Number: Not available. Effective date of TSCA section 5(e) Order: August 9, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic (nonconfidential) use of the substance will be as a flame retardant for textiles. EPA identified concerns for irritation to eyes, mucous membranes, and lungs based on the pH of the PMN substance being 5. Also based on SAR analysis of test data on the nearest analogue inorganic phosphates EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires: 1. Refraining from domestic manufacture in the United States (i.e., import only); 2. Use of personal protective equipment where there is a potential for dermal exposure; 3. No modification of the processing or use of the PMN substance to result in inhalation exposures to vapor, dust, mist, or aerosol; 4. Use of the PMN substance only for the confidential use specified in the Order; 5. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS; 6. No release of the PMN substance into the waters of the United States; and 7. Disposal of the PMN substance and waste streams containing the PMN substance by incineration. 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 environmental effects of the PMN substance may be potentially useful in support of a request by the E:\FR\FM\17SER2.SGM 17SER2 47010 Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Rules and Regulations daltland on DSKBBV9HB2PROD with RULES2 PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. EPA has determined that the results of specific acute aquatic toxicity testing would help characterize the potential environmental effects of the PMN substance. Although the Order does not require these tests, the Order’s restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citations: 40 CFR 721.11135 (P– 17–206). PMN Number: P–17–223 Chemical Name: Fatty acids, tall-oil, reaction products with 2-[(2aminoalkyl)amino]alkanol, compds. with alkylene oxide-glycidyl o-tolyl ether polymer dihydrogenphosphate alkyl ether (generic). CAS Number: Not available. Effective date of TSCA section 5(e) Order: September 12, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic (nonconfidential) use of the substance will be as an additive for open, nondispersive use. EPA identified concerns for developmental toxicity based on Nheterocyclic compounds and concerns for possible irritation to mucous membranes and lung toxicity based on potential surfactancy properties. Also based on SAR analysis of test data on nearest analogue of soluble forms of inorganic phosphates, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 15 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires: 1. Submission to EPA of certain toxicity testing before exceeding the confidential production volume limit specified in the Order; 2. Refraining from manufacture, processing, or use for consumer use or in commercial use where there is use in a consumer setting; 3. Refrain from domestic manufacture in the United States (i.e., import only); 4. Use of the PMN substance only for the confidential use specified in the Order; 5. Use of the PMN substance in the confidential formulation at a concentration not greater than 1 percent by weight or volume; VerDate Sep<11>2014 18:34 Sep 14, 2018 Jkt 244001 6. Use of personal protective equipment where there is a potential for dermal exposure; 7. Refraining from modifying the processing if such modification would result in inhalation exposures to the PMN substance by vapor, dust, mist, or aerosol at a concentration of greater than 1 percent by weight or volume; 8. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS; and 9. No release of the PMN substance resulting in surface water concentrations that exceed 15 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 physical-chemical properties, environmental effects, and health effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. The submitter has agreed not to exceed a certain production volume limit without performing specific reproductive/ developmental toxicity testing and acute aquatic toxicity testing. EPA has also determined that the results of specific physical-chemical property and pulmonary toxicity testing would help characterize the potential human and environmental effects of the PMN substance. Although the Order does not require these tests, the Order’s restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citation: 40 CFR 721.11136. PMN Number: P–17–230 Chemical Name: Oxirane, 2-alkyl-, polymer with oxirane, mono[N-[3(carboxyamino)-4(or 6)alkylphenyl]carbamate], alkyl ether, ester with 2,2′,2″-nitrilotris-[alkanol] (generic). CAS Number: Not available. Effective date of TSCA section 5(e) Order: September 12, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic (nonconfidential) use of the substance will be as an additive for open, nondispersive use. Based on the potential surfactant properties, cationic binding to lung tissues, EPA identified concerns for lung toxicity and skin irritation. Based SAR analysis of test data on analogous polycationic polymers, EPA predicts toxicity to aquatic organisms PO 00000 Frm 00008 Fmt 4701 Sfmt 4700 may occur at concentrations that exceed 65 parts per billion. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires: 1. Submission to EPA of certain toxicity testing before exceeding the confidential production volume limit specified in the Order; 2. Refraining from manufacture, processing, or use for consumer use or in commercial use where there is use in a consumer setting; 3. Refraining from domestic manufacture in the United States (i.e., import only); 4. Use of the PMN substance only for the confidential use specified in the Order; 5. Use of the PMN substance in the confidential formulation at a concentration not greater than 1 percent by weight or volume; 6. Use of personal protective equipment where there is a potential for dermal exposure; 7. Refraining from modifying the processing method if such modification would result in inhalation exposures to the PMN substance by vapor, dust, mist, or aerosol, at a concentration of greater than 1 percent by weight or volume; 8. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS; and 9. No release of the PMN substance resulting in surface water concentrations that exceed 65 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 physical-chemical properties, environmental effects, and health effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. The submitter has agreed not to exceed a certain production volume limit without performing specific acute aquatic and sediment toxicity testing. EPA has also determined that the results of specific physical-chemical property and pulmonary toxicity testing would help characterize the potential health effects of the PMN substance. Although the E:\FR\FM\17SER2.SGM 17SER2 Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Rules and Regulations daltland on DSKBBV9HB2PROD with RULES2 Order does not require these tests, the Order’s restrictions will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citation: 40 CFR 721.11137. PMN Number: P–17–236 Chemical Name: Formaldehyde, polymer with (chloromethyl) oxirane and substituted aromatic compounds (generic). CAS Number: Not available. Effective date of TSCA section 5(e) Order: September 11, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic (nonconfidential) use of the substance will be as matrix resin for composite materials and binder resin for electronic materials. Based on analysis of test data on the PMN substance, analysis of data on analogous chemicals, and on the epoxide chemical category of concern, EPA identified concerns for skin and lung sensitization, oncogenicity, developmental toxicity, and male reproductive toxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to health. To protect against these risks, the Order requires: 1. Submission to EPA of certain toxicity testing before exceeding the confidential production volume limit specified in the Order; 2. Use of personal protective equipment where there is a potential for dermal exposure; 3. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS; 4. Refraining from domestic manufacture in the United States (i.e., import only); 5. Use of the PMN substance only as described in the PMN; and 6. No manufacture, processing, or use that results in inhalation exposure to vapor, dust, mist, or aerosol. The SNUR designates as a ‘‘significant new use’’ the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. The submitter has agreed not to exceed a certain VerDate Sep<11>2014 18:34 Sep 14, 2018 Jkt 244001 production volume limit without performing sensitization testing. EPA has also determined that the results of specific internal organ toxicity and carcinogenicity testing would help characterize the potential health effects of the PMN substance. Although the Order does not require these tests, the Order’s restrictions will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citation: 40 CFR 721.11138. PMN numbers: P–17–241, P–17–242, P– 17–243, P–17–244 Chemical names: Acid, reaction products with cadmium selenide (CdSe), trioctylphosphine and trioctylphosphine oxide (generic) (P– 17–241), Acid, reaction products with cadmium selenide sulfide, acid, trioctylphosphine and trioctylphosphine oxide (generic) (P– 17–242), Acid, reaction products with cadmium metal selenide sulfide, trioctylphosphine and trioctylphosphine oxide (generic) (P– 17–243), Metal oxide reaction products with cadmium metal selenide sulfide, and amine (generic) (P–17–244). CAS numbers: Not available. Effective date of TSCA section 5(e) Order: September 20, 2017. Basis for TSCA section 5(e) Order: The PMNs state that the generic (nonconfidential) use of P–17–241, P–17– 242, and P–17–243 will be as chemical intermediates, and the specific use of P– 17–244 will be as a down converting phosphor particle for use in conjunction with optoelectronic components. Based on analogy to respirable poor soluble particulates and the presence of cadmium, EPA identified concerns for lung effects, kidney effects, and oncogenicity for the PMN substances. EPA also identified concerns for neurotoxicity, developmental toxicity, and kidney toxicity for PMN P–17–244 based on the presence of other chemicals. Based on analysis of test data for cadmium and selenium core components, there is high hazard for acute and chronic environmental toxicity for PMNs P–17–241, P–17–242, and P–17–243. There is potential chronic environmental toxicity for PMN P–17–244 based on the presence of cadmium. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substances may present an unreasonable risk of injury to health and the environment. To protect against these risks, the Order requires: PO 00000 Frm 00009 Fmt 4701 Sfmt 4700 47011 1. Submission to EPA of certain testing for P–17–244 before exceeding the confidential production volume limit specified in the Order; 2. Use of personal protective equipment where there is potential for dermal exposure; 3. Manufacture, processing, and use P–17–241, P–17–242, and P–17–243 only as chemical intermediates as required in the Order; 4. Manufacture, processing, and use P–17–241, P–17–242, and P–17–243 only in liquid formulations; 5. No use of P–17–241, P–17–242, and P–17–243 in applications that generate a dust, mist, or aerosol; 6. Manufacture, processing and use of P–17–244, only as a down-converter for use in conjunction with optoelectronic components; 7. For workers potentially exposed to the solid form of P–17–244, use of a laminar-flow fume hood or glove box to reduce or eliminate inhalation exposure, and workers who may still be exposed by inhalation will use a NIOSH-certified full-faced respirator with an APF of at least 50; and 8. Disposal of the PMN substances only by incineration in a permitted hazardous waste incinerator. 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 fate and health effects of the PMN substances may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. The submitter has agreed not to exceed a certain production volume limit without performing certain fate and internal organ toxicity testing on P–17–244. EPA has also determined that the results of specific fate testing would help characterize the potential health and environmental effects of the PMN substances. Although the Order does not require these tests, the Order’s restrictions will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citations: 40 CFR.11139 (P–17– 241), 40 CFR.11140 (P–17–242), 40 CFR.11141 (P–17–243), and 40 CFR.11142 (P–17–244). PMN number: P–17–265 Chemical name: Alkanoic acid, 2alkyl-, substituted alkyl ester, polymer with alkyl alkenoate, substituted carbomonocycle, substituted alkyl E:\FR\FM\17SER2.SGM 17SER2 daltland on DSKBBV9HB2PROD with RULES2 47012 Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Rules and Regulations alkenoate and alkyl substituted alkenoate, substituted alkanenitrileinitiated (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: August 16, 2017. Basis for TSCA section 5(e) Order: The PMN states that the use of the substance will be as a coating resin intermediate. Based on physical/ chemical properties EPA identified concerns for lung toxicity, systemic toxicity, reproductive toxicity, corrosion, and irritation for the PMN substance when it has an acid concentration greater than 20% or an amine concentration greater than 5%. Based on SAR analysis for anionic polymers and physical/chemical properties, EPA has identified concern for environmental effects when it has an acid concentration greater than 20%. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to health and the environment. To protect against these risks, the Order requires: 1. Refraining from manufacturing the PMN substance with an acid concentration greater than 20%; and 2. Refraining from manufacturing the PMN substance with an amine concentration greater than 5%. 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 substance may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. EPA has determined that the results of specific physical-chemical property testing, pulmonary toxicity testing, irritation testing, and acute and chronic aquatic toxicity testing would help characterize the potential health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order’s restrictions will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citation: 40 CFR 721.11143. CAS number: Not available. Effective date of TSCA section 5(e) Order: September 22, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic use of the PMN substance will be as a surface drier in clear and pigmented coatings systems. Based on the physical/ chemical properties of the PMN substance and analysis of analogue test data, EPA identified concerns for neurotoxicity, developmental toxicity, and eye and skin irritation. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to health and the environment. The Order was also issued under TSCA sections 5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding that the substance is or will be produced in substantial quantities and that the substance either enters or may reasonably be anticipated to enter the environment in substantial quantities. To protect against these risks, the Order requires: 1. Submission to EPA of certain testing before exceeding an aggregate total production of 430,000 kilograms of the PMN substance; 2. Use of personal protective equipment where there is a potential for dermal exposure; 3. Use of a NIOSH-certified respirator with an APF of at least 10 where there is potential for inhalation exposure; 4. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS; and 5. No use of the PMN substance other than as a surface drier in clear and pigmented coatings systems. The SNUR designates as a ‘‘significant new use’’ the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. The submitter has agreed not to exceed the production limit without performing specific reproductive/developmental toxicity testing. CFR citation: 40 CFR 721.11144. PMN number: P–17–301 Chemical name: Manganese heterocyclic-amine carboxylate complexes (generic). PMN number: P–17–318 Chemical name: Sulfuric acid mixed salt (generic). CAS number: Not available. VerDate Sep<11>2014 18:34 Sep 14, 2018 Jkt 244001 PO 00000 Frm 00010 Fmt 4701 Sfmt 4700 Effective date of TSCA section 5(e) Order: September 25, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic (nonconfidential) use of the substance will be as a component in nutrient solutions. Based on analogue data and information provided in the SDS, EPA has identified concerns for skin, eye, respiratory, and GI tract irritation, corrosion and acute toxicity. Also, based on SAR predictions for analogue inorganic salts, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 760 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to human health and the environment. The Order was also issued under TSCA sections 5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding that the substance is or will be produced in substantial quantities and that the substance either enters or may reasonably be anticipated to enter the environment in substantial quantities. To protect against these risks, the Order requires: 1. Submission of certain toxicity testing on the PMN substance prior to exceeding the confidential production volume limit specified in the Order. 2. Use of personal protective equipment where there is a potential for dermal exposure. 3. Use of the PMN substance only for the confidential use specified in the Order. 4. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS. 5. Manufacture of the PMN substance to contain no more than 1% free ammonia. 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 substance may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. The submitter has agreed not to exceed the production limit without performing specific acute aquatic toxicity testing. EPA has also determined that the results of specific reproductive/developmental toxicity testing would help characterize the potential health and environmental E:\FR\FM\17SER2.SGM 17SER2 Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Rules and Regulations daltland on DSKBBV9HB2PROD with RULES2 effects of the PMN substance. Although the Order does not require these tests, the Order’s restrictions will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citation: 40 CFR 721.11145. PMN number: P–17–323 Chemical name: 2-Propenoic acid, branched alkyl ester (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: September 26, 2017. Basis for TSCA section 5(e) Order: The PMN states that the use of the substance will be as a reactive monomer for use in producing polymers. Based on the physical/chemical properties of the PMN substance (as described in the New Chemical Program’s PBT category at 64 FR 60194; November 4, 1999) and test data on structurally similar substances, the PMN substance is a potentially persistent, bioaccumulative, and toxic (PBT) chemical. EPA estimates that the PMN substance will persist in the environment more than 2 months and estimates a bioaccumulation factor of greater than or equal to 1,000. Based on SAR analysis of test data on analogous acrylates and from the branched acid that may be formed after ester hydrolysis, EPA has identified concerns for eye and skin irritation, oncogenicity, developmental toxicity, liver toxicity, kidney toxicity, and sensitization. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires: 1. Submission of certain toxicity testing on the PMN substance prior to exceeding the confidential production volume limit as specified in the Order; 2. Use of personal protective equipment where there is a potential for dermal exposure; 3. No use of the PMN substance other than as a reactive monomer for use in producing polymers; 4. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS; 5. Refraining from domestic manufacture in the United States (i.e., import only); and 6. No release of the PMN substance to the waters of the United States. The SNUR designates as a ‘‘significant new use’’ the absence of these protective measures. VerDate Sep<11>2014 18:34 Sep 14, 2018 Jkt 244001 Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. The submitter has agreed not to exceed the production limit without performing specific developmental/reproductive toxicity and sensitization testing. EPA has also determined that the results of specific fate testing would help characterize the potential health effects of the PMN substance. Although the Order does not require these tests, the Order’s restrictions will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citation: 40 CFR 721.11146. PMN number: P–17–326 Chemical name: Allyloxymethylacrylate (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: September 5, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic (nonconfidential) use of the substance will be as an ultraviolet curable monomer. Based on analysis of test data on the PMN substance and the physical/ chemical properties of the PMN substance, EPA identified concerns for oncogenicity, developmental and reproductive effects, liver and kidney toxicity, sensitization, and irritation. Additionally, the SDS indicates concerns for severe skin and eye damage and allergic skin reaction. Based on analysis of acute aquatic toxicity data, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 26 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the PMN substance may present an unreasonable risk of injury to health and the environment. To protect against these risk, the Order requires: 1. Submission of certain toxicity testing on the PMN substance prior to exceeding the confidential production volume limit as specified in the Order; 2. Use of personal protective equipment where there is potential for dermal exposure; 3. Use of NIOSH certified respirators with an APF of 10 to prevent inhalation exposure where there is potential for inhalation exposure; PO 00000 Frm 00011 Fmt 4701 Sfmt 4700 47013 4. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS; 5. Refraining from domestic manufacture in the United States (i.e., import only); 6. Use of the PMN substance only as specified in the Order; and 7. No release of the PMN substance into the waters of the United States. 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 substance may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. The submitter has agreed not to exceed the production limit without performing specific developmental/reproductive toxicity and sensitization testing. EPA has also determined that the results of specific chronic aquatic toxicity testing would help characterize the potential environmental effects of the PMN substance. Although the Order does not require these tests, the Order’s restrictions will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citation: 40 CFR 721.11147. PMN number: P–17–345 Chemical name: Polyurethane, methacrylate blocked (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: September 6, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic (nonconfidential) use of the substance will be as a resin intermediate. Based on physical/chemical properties of the PMN substance, EPA identified concerns for irritation to skin, eye, lung, mucous membranes, and potential neurotoxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to health and the environment. To protect against these risks, the Order requires: 1. Submission of certain toxicity testing within six months from the date of the NOC; 2. Use of personal protective equipment where there is potential for dermal exposure; E:\FR\FM\17SER2.SGM 17SER2 47014 Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Rules and Regulations 3. Establishment and use of a hazard communication program, including human health precautionary statements on each label and SDS; 4. No manufacturing, processing, or use of the PMN substance in a manner that would result in inhalation exposure to vapor, mist, aerosol, or dust; and 5. Use the PMN substance only as specified in the Order. The SNUR designates as a ‘‘significant new use’’ the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. The submitter has agreed not to exceed the production limit without performing specific eye irritation testing. CFR citation: 40 CFR 721.11148. V. Rationale and Objectives of the Rule A. Rationale daltland on DSKBBV9HB2PROD with RULES2 During review of the PMNs submitted for the chemical substances that are subject to these SNURs, EPA concluded that for all 28 chemical substances, regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. The basis for such findings is outlined in Unit IV. Based on these findings, TSCA section 5(e) Orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. The SNURs identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying Orders, consistent with TSCA section 5(f)(4). SNUN before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use. • EPA will be able to either determine that the prospective manufacture or processing is not likely to present an unreasonable risk, or to take necessary regulatory action associated with any other determination, before the described significant new use of the chemical substance occurs. • EPA will identify as significant new uses any manufacturing, processing, use, distribution in commerce, use, 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. VI. Direct Final Procedures EPA is issuing these SNURs as a direct final rule. The effective date of this rule is November 16, 2018 without further notice, unless EPA receives written adverse comments before October 17, 2018. If EPA receives written adverse comments on one or more of these SNURs before October 17, 2018, EPA will withdraw the relevant sections of this direct final rule before its effective date. This rule establishes SNURs for a number of chemical substances. Any person who submits adverse comments must identify the chemical substance and the new use to which it applies. EPA will not withdraw a SNUR for a chemical substance not identified in the comment. B. Objectives VII. Applicability of the Significant New Use Designation 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 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 an 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. VerDate Sep<11>2014 18:34 Sep 14, 2018 Jkt 244001 PO 00000 Frm 00012 Fmt 4701 Sfmt 4700 When chemical substances identified in this rule are added to the TSCA Inventory, EPA recognizes that, before the rule is effective, other persons might engage in a use that has been identified as a significant new use. However, TSCA section 5(e) Orders have been issued for all of the chemical substances, and the PMN submitters are prohibited by the TSCA section 5(e) Orders from undertaking activities which will be designated as significant new uses. The identities of 24 of the 28 chemical substances subject to this rule have been claimed as confidential and EPA has received no post-PMN bona fide submissions (per §§ 720.25 and 721.11) for a chemical substance covered by this action. Based on this, the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this rule are ongoing. Therefore, EPA designates September 17, 2018 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 direct final rule. Persons who begin commercial manufacture or processing of the chemical substances for a significant new use identified as of that date will have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons will 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 developing any particular new information (e.g., generating test data) before submission of a SNUN. There is an exception: development of test data is required where the chemical substance subject to the SNUR is also subject to a rule, order or consent agreement under TSCA section 4 (see TSCA section 5(b)(1)). In the absence of a TSCA section 4 test rule covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information known to or reasonably ascertainable by them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. Unit IV. lists required or recommended E:\FR\FM\17SER2.SGM 17SER2 daltland on DSKBBV9HB2PROD with RULES2 Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Rules and Regulations testing for all of the listed SNURs. Descriptions of tests are provided for informational purposes. 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). To access the OCSPP test guidelines referenced in this document electronically, please go to http:// www.epa.gov/ocspp and select ‘‘Test Methods and Guidelines.’’ The Organisation for Economic Co-operation and Development (OECD) test guidelines are available from the OECD Bookshop at http://www.oecdbookshop. org or SourceOECD at http:// www.sourceoecd.org. In certain of the TSCA section 5(e) Orders for the chemical substances regulated under this rule, EPA has established production volume limits in view of the lack of data on the potential health and environmental risks that may be posed by the significant new uses or increased exposure to the chemical substances. These limits cannot be exceeded unless the PMN submitter first submits the results of toxicity tests that would permit a reasoned evaluation of the potential risks posed by these chemical substances. Listings of the tests specified in the TSCA section 5(e) Orders are included in Unit IV. The SNURs contain the same production volume limits as the TSCA section 5(e) Orders. Exceeding these production limits is defined as a significant new use. Persons who intend to exceed the production limit must notify the Agency by submitting a SNUN at least 90 days in advance of commencement of nonexempt commercial manufacture or processing. Any request by EPA for the triggered and pended testing described in the Orders was made based on EPA’s consideration of available screeninglevel data, if any, as well as other available information on appropriate testing for the PMN substances. Further, any such testing request on the part of EPA that includes testing on vertebrates was made after consideration of available toxicity information, computational toxicology and bioinformatics, and high-throughput VerDate Sep<11>2014 18:34 Sep 14, 2018 Jkt 244001 screening methods and their prediction models. Potentially useful information identified in Unit IV. may not be the only means of addressing the potential risks of the chemical substance. However, submitting a SNUN without any test data may increase the likelihood that EPA will take action under TSCA section 5(e), particularly if satisfactory test results have not been obtained from a prior PMN or SNUN submitter. 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., PO 00000 Frm 00013 Fmt 4701 Sfmt 4700 47015 the use does not meet the criteria specified in the rule for a significant new use, that person can manufacture or process the chemical substance so long as the significant new use trigger is not met. In the case of a production volume trigger, this means that the aggregate annual production volume does not exceed that identified in the bona fide submission to EPA. Because of confidentiality concerns, EPA does not typically disclose the actual production volume that constitutes the use trigger. Thus, if the person later intends to exceed that volume, a new bona fide submission would be necessary to determine whether that higher volume would be a significant new use. X. SNUN Submissions According to § 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– 2018–0567. 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, or TSCA section 5(e) 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 E:\FR\FM\17SER2.SGM 17SER2 47016 Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Rules and Regulations daltland on DSKBBV9HB2PROD with RULES2 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) On February 18, 2012, EPA certified pursuant to RFA section 605(b) (5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a significant economic impact on a substantial number of small entities where the following are true: 1. A significant number of SNUNs would not be submitted by small entities in response to the SNUR. 2. The SNUR submitted by any small entity would not cost significantly more than $8,300. VerDate Sep<11>2014 18:34 Sep 14, 2018 Jkt 244001 A copy of that certification is available in the docket for this action. This action is within the scope of the February 18, 2012 certification. Based on the Economic Analysis discussed in Unit XI. and EPA’s experience promulgating SNURs (discussed in the certification), EPA believes that the following are true: • A significant number of SNUNs would not be submitted by small entities in response to the SNUR. • Submission of the SNUN would not cost any small entity significantly more than $8,300. Therefore, the promulgation of the SNUR would not have a significant economic impact on a substantial number of small entities. 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). 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 PO 00000 Frm 00014 Fmt 4701 Sfmt 4700 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: September 5, 2018. Jeffery T. Morris, Director, Office of Pollution Prevention and Toxics. Therefore, 40 CFR parts 9 and 721 are amended as follows: E:\FR\FM\17SER2.SGM 17SER2 Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Rules and Regulations 4. Add § 14;721.11124 to subpart E to read 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 § 14;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 * 721.11124 721.11125 721.11126 721.11127 721.11128 721.11129 721.11130 721.11131 721.11132 721.11133 721.11134 721.11135 721.11136 721.11137 721.11138 721.11139 721.11140 721.11141 721.11142 721.11143 721.11144 721.11145 721.11146 721.11147 721.11148 * * ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. * daltland on DSKBBV9HB2PROD with RULES2 * * * * * * * * 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 * * * PART 721—[AMENDED] 3. The authority citation for part 721 continues to read as follows: ■ Authority: 15 U.S.C. 2604, 2607, and 2625(c). VerDate Sep<11>2014 18:34 Sep 14, 2018 Jkt 244001 § 721.11124 2-Propenenitrile, polymer with methanamine, hydrogenated, 3aminopropylterminated, ethoxylated propoxylated. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2-Propenenitrile, polymer with methanamine, hydrogenated, 3aminopropylterminated, ethoxylated propoxylated (PMN P–14–758; CAS No. 2055838–16–7) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the PMN substance after they have been completely reacted (cured). (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(3) through (5) (respirators must provide a National Institute for Occupational Safety and Health assigned protection factor of at least 50), and (a)(6)(v), (particulate), (when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures (e.g. enclosure or confinement of operation, general and local ventilation) or administrative control measures (e.g. workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible), § 721.63(b) (concentration set at 1.0%), and § 721.63(c). (ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (e) (concentration set at 1.0%), (f), (g)(1)(ii), (g)(2)(ii), (g)(4)(iii), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f) and (k). A significant new use is any spray application method that results in greater worker inhalation exposures to vapor, mist, or aerosol than the roller coating application. (iv) Release to water. Requirements as specified in § 721.90(b)(1), and (c)(1). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i), and (k) are applicable to manufacturers and processors of this substance. PO 00000 Frm 00015 Fmt 4701 Sfmt 4700 47017 (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. ■ 5. Add § 14;721.11125 to subpart E to read as follows: § 721.11125 Dicarboxylic acids, polymers with alkyl prop-2-enoate, alkyl 2-ethylprop2-enoate, alkyl[(alkenyl)alkyl]alkanediol, alkanediol, alkanedioic acid, alkyl 2rnethylprop-2-enoate, alkyl prop-2-enoic acid, alkylene [isocyanatocarbomonocyte] and alkanediol, alkanolamine-blocked, compds with 2-(alkylamino)alkanol (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as dicarboxylic acids, polymers with alkyl prop-2-enoate, alkyl 2-ethylprop-2-enoate, alkyl[(alkenyl)alkyl]alkanediol, alkanediol, alkanedioic acid, alkyl 2methylprop-2-enoate, alkyl prop-2-enoic acid, alkylene [isocyanatocarbomonocyte] and alkanediol, alkanolamine-blocked, compds with 2-(alkylamino)alkanol (P– 16–493) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been reacted (cured). (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f). It is a significant new use to import the PMN substance to contain more than 0.1% residual isocyanate by weight. It is a significant new use to import the PMN substance to contain more than 1% of a confidential component by weight. (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. (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. ■ 6. Add § 721.11126 to subpart E to read as follows: E:\FR\FM\17SER2.SGM 17SER2 daltland on DSKBBV9HB2PROD with RULES2 47018 Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Rules and Regulations § 721.11126 Mixed metal oxide (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as a mixed metal oxide (P–16–514) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(3) through (5) (respirators must provide a National Institute for Occupational Safety and Health assigned protection factor of at least 1,000), and (a)(6) (particulate), (when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures (e.g., enclosure or confinement of operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible), § 721.63(b) (concentration set at 1.0%), and § 721.63(c). (A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA section 5(e) Order for this substance. The NCEL is 0.04 mg/m3 as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to § 721.63 respirator requirements may request to do so under § 721.30. Persons whose § 721.30 requests to use the NCELs approach are approved by EPA will be required to follow NCELs provisions comparable to those contained in the corresponding TSCA section 5(e) Order. (B) [Reserved] (ii) Hazard communication. Requirements as specified in § 721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(iv), (lung toxicity if inhaled), (eye irritation), (allergic skin reaction), (g)(2)(i) through (iii) and (v) (use respiratory protection or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 0.04 mg/m3), (g)(4)(i), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used. (iii) Industrial, Commercial, and consumer activities. Requirements as specified in § 721.80(e), (f), (k), and (q). (iv) Disposal. Requirements as specified in § 721.85. It is a significant new use to dispose of the PMN VerDate Sep<11>2014 18:34 Sep 14, 2018 Jkt 244001 substance other than by recycling as described in the Order. (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 (j) 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. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraphs (a)(2)(iii) and (iv) of this section. ■ 7. Add § 721.11127 to subpart E to read as follows: § 721.11127 (generic). Modified alkyl polyamine (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as modified alkyl polyamine (PMN P–16–576) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (a)(6) (particulate), (vapor), (when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible), § 721.63(b) (concentration set at 1.0%), and § 721.63(c). (ii) Hazard communication. Requirements as specified in § 721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), (ii), (vi), (viii), (g)(2)(i) through (iii) and (v), (g)(3)(i) and (ii), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k). It is a significant new use to manufacture the chemical substance more than 9 months. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). PO 00000 Frm 00016 Fmt 4701 Sfmt 4700 (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i), are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. ■ 8. Add § 721.11128 to subpart E to read as follows: § 721.11128 Alkyl polyamine (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as alkyl polyamine (PMN P–16–577) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i)(iii), (a)(3), (a)(6)(v), (a)(6) (particulate), (when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible), § 721.63(b) (concentration set at 1.0%), and § 721.63(c). (ii) Hazard communication. Requirements as specified in § 721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), (ii), (vi), (viii), (g)(2)(i) through (iii) and (v), (g)(3)(i) and (ii), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k). It is a significant new use to manufacture the chemical substance more than 9 months. (iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N = 2. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) and (k) are E:\FR\FM\17SER2.SGM 17SER2 Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Rules and Regulations applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. ■ 9. Add § 721.11129 to subpart E to read as follows: daltland on DSKBBV9HB2PROD with RULES2 § 721.11129 Silica gel, reaction products with chromium oxide (CrO3) and ethoxydiethyl aluminum. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as silica gel, reaction products with chromium oxide (CrO3) and ethoxydiethyl aluminum is (P–16–590, CAS No. 932384–12–8) 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) Protection in the workplace. Requirements as specified in § 721.63(a)(1) and (a)(3) through (5) (respirators must provide a National Institute for Occupational Safety and Health assigned protection factor of 10 to 1,000 depending on the results of the exposure monitoring as described in the Order for P16–590 and required by this section (a)(2)(i), (a)(6) (particulate), and (a)(6) (vapor), (when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4) engineering control measures (e.g. enclosure or confinement of operation, general and local ventilation) or administrative control measures (e.g. workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible), § 721.63(b) (concentration set at 0.1%), and § 721.63(c). It is a significant new use to not conduct the exposure monitoring required in the Order for P16–590 when workers are reasonably likely to be exposed by inhalation. (ii) Industrial, Commercial, and consumer activities. Requirements as specified in § 721.80. It is a significant new use to manufacture, process, or use the PMN substance other than in a system where the PMN substance is handled in an inert atmosphere and is not designed to be exposed to air. (iii) Disposal. Requirements as specified in § 721.85. It is a significant new use to dispose of all waste streams containing the PMN substance and the constituent breakdown products of the PMN substance other than in a Resource Conservation and Recovery Act hazardous waste landfill. VerDate Sep<11>2014 18:34 Sep 14, 2018 Jkt 244001 (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (e), (i), and (j) 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. ■ 10. Add § 14;721.11130 to subpart E to read as follows: § 721.11130 Carboxylic acids, C6–18 and C5–15-di-, polymers with diethylene glycol, glycerol, sorbitol and terephthalic acid. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as carboxylic acids, C6–18 and C5–15-di-, polymers with diethylene glycol, glycerol, sorbitol and terephthalic acid (P–16–593, CAS No. 1967778–37–5) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been reacted (cured). (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i) and (iii), and (a)(3), (when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g. enclosure or confinement of operation, general and local ventilation) or administrative control measures (e.g. workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible), § 721.63(b) (concentration set at 1.0%), and § 721.63(c). (ii) Hazard communication. Requirements as specified in § 721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(ii), (irritation), (g)(2)(i) through (iii) and (v), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used. (iii) Industrial, Commercial, and consumer activities. Requirements as specified in § 721.80(k)(aromatic polyester polyol for rigid foam). It is a significant new use to manufacture, process, or use the PMN substance to result in inhalation exposure to a vapor, mist or aerosol. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. PO 00000 Frm 00017 Fmt 4701 Sfmt 4700 47019 (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (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. ■ 11. Add § 14;721.11131 to subpart E to read as follows: § 721.11131 1-tetradecene homopolymer hydrogenated. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1-tetradecene homopolymer hydrogenated (PMN P–17–5, CAS No. 1857296–89–9) 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) Hazard communication. Requirements as specified in § 721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(ii), (g)(2)(ii), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used. (ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k)(base fluid/ carrier fluid for additives in motor oil, automatic transmission fluid, and industrial lubricants). It is a significant new use to manufacture the chemical substance more than 9 months. It is a significant new use to manufacture, process, or use the PMN substance to resuls in inhalation exposure to a vapor, mist or aerosol. (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 (f) through (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. ■ 12. Add § 14;721.11132 to subpart E to read as follows: § 721.11132 Fluorocyanophenyl alkylbenzoate (generic) (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances generically identified as fluorocyanophenyl alkylbenzoate (P–17–149), (P–17–150), (P–17–151), and (P–17–165) are subject E:\FR\FM\17SER2.SGM 17SER2 47020 Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Rules and Regulations daltland on DSKBBV9HB2PROD with RULES2 to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (iii), and (iv), (a)(3), and (a)(6)(v), (particulate), (when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g. enclosure or confinement of operation, general and local ventilation) or administrative control measures (e.g. workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible), § 721.63(b) (concentration set at 1.0%) and § 721.63(c). (ii) Hazard communication. Requirements as specified in § 721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i) through (iii), (iv), (vi), and (ix), (g)(2)(i), (ii), (iii), and (v), (g)(3)(i) and (ii), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used. (iii) Industrial, Commercial, and consumer activities. Requirements as specified in § 721.80(k) and (q). It is a significant new use to manufacture, process, or use the PMN substance to result in inhalation exposures to vapor, dust, mist, or aerosols to the substance. (iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N = 2 for P–17–165 and N = 4 for P–17–149, P–17–150, and P–17– 151. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) and (k) are applicable to manufacturers, importers, and processors of these substances. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. ■ 13. Add § 14;721.11133 to subpart E to read as follows: § 721.11133 Fluorinated propenoic poly alkyl ether ester (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as fluorinated propenoic poly alkyl ether ester (P–17–175) is subject to VerDate Sep<11>2014 18:34 Sep 14, 2018 Jkt 244001 reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been reacted (cured). (2) The significant new uses are: (i) Industrial, Commercial, and consumer activities. Requirements as specified in § 721.80(f) and (t)(60 kilograms). It is a significant new use to use the substance other than as a leveling agent for coatings applied to aluminum printing plates. (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 significant new use rule. ■ 14. Add § 14;721.11134 to subpart E to read as follows: § 721.11134 Oxyalkylene urethane polyolefin (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as oxyalkylene urethane polyolefin (PMN P–17–199) 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. It is a new use the manufacture (including import) the PMN substance with an average molecular weight greater than specified in the Order or with more than 1% of the molecular weight content below 1,000 Daltons. (ii) [Reserved] (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (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. (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. PO 00000 Frm 00018 Fmt 4701 Sfmt 4700 15. Add § 14;721.11135 to subpart E to read as follows: ■ § 721.11135 (generic). Imino alkane amine phosphate (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as imino alkane amine phosphate (P–17–206) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been reacted (cured). (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (a)(6)(v), (particulate), (when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g. enclosure or confinement of operation, general and local ventilation) or administrative control measures (e.g. workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible), § 721.63(b) (concentration set at 1.0%) and § 721.63(c). (ii) Hazard communication. Requirements as specified in § 721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), (g)(2)(i) and (v), (g)(3)(i) and (ii), (g)(4)(iii), and (g)(5), Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used. (iii) Industrial, Commercial, and consumer activities. Requirements as specified in § 721.80(f) and (k). It is a significant new use to modify processing or use if it results in inhalation exposure to vapor, dust, mist, or aerosols to the substance. (iv) Disposal. Requirements as specified in § 721.85(a)(1), (b)(1), and (c)(1). (v) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (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. E:\FR\FM\17SER2.SGM 17SER2 Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Rules and Regulations (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. ■ 16. Add § 14;721.11136 to subpart E to read as follows: daltland on DSKBBV9HB2PROD with RULES2 § 721.11136 Fatty acids, tall-oil, reaction products with 2-[(2aminoalkyl)amino]alkanol, compds. with alkylene oxide-glycidyl o-tolyl ether polymer dihydrogen phosphate alkyl ether (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as fatty acids, tall-oil, reaction products with 2-[(2aminoalkyl)amino]alkanol, compds. with alkylene oxide-glycidyl o-tolyl ether polymer dihydrogen phosphate alkyl ether (P–17–223) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been reacted (cured). (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(3), and (a)(6)(v), (particulate), (when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and, engineering control measures (e.g. enclosure or confinement of operation, general and local ventilation) or administrative control measures (e.g. workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible), § 721.63(b) (concentration set at 1.0%) and § 721.63(c). (ii) Hazard communication. Requirements as specified in § 721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i) and (ii), (g)(2)(i), (ii), and (v), (g)(3)(i) and (ii), and (g)(5), Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used. (iii) Industrial, Commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (q). It is a significant new use to modify any processing if such modification would result in inhalation exposures to the PMN substance by vapor, dust, mist, or aerosol, at a concentration of greater than 1 percent by weight or volume. It is a significant new use to use the PMN substance in the confidential formulation identified in the Order at concentration greater than 1 percent by weight or volume. It is a significant new use to manufacture, process, or use the VerDate Sep<11>2014 19:08 Sep 14, 2018 Jkt 244001 substance for consumer use or for commercial uses that could introduce the substance into a consumer setting. (iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N = 15. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) 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. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. ■ 17. Add § 14;721.11137 to subpart E to read as follows: § 721.11137 Oxirane, 2-alkyl-, polymer with oxirane, mono[N-[3-(carboxyamino)-4(or 6)alkylphenyl]carbamate], alkyl ether, ester with 2,2′,2″-nitrilotris-[alkanol] (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as oxirane, 2-alkyl-, polymer with oxirane, mono[N-[3(carboxyamino)-4(or 6)alkylphenyl]carbamate], alkyl ether, ester with 2,2′,2″-nitrilotris-[alkanol] (P– 17–230) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been reacted (cured). (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (a)(6)(v), (particulate), (when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g. enclosure or confinement of operation, general and local ventilation) or administrative control measures (e.g. workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible), § 721.63(b) (concentration set at 1.0%) and § 721.63(c). (ii) Hazard communication. Requirements as specified in § 721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i) and (ii), (eye irritation), (g)(2)(i), (ii), and (v), (g)(3)(i) and (ii), and (g)(5). Alternative hazard and warning statements that meet the PO 00000 Frm 00019 Fmt 4701 Sfmt 4700 47021 criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used. (iii) Industrial, Commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (q). It is a significant new use to modify processing methods if such modification would result in inhalation exposures to the PMN substance by vapor, dust, mist, or aerosol, at a concentration of greater than 1 percent by weight or volume. It is a significant new use to use the PMN substance in the confidential formulation at a concentration greater than 1 percent by weight or volume. It is a significant new use to manufacture, process, or use the substance for consumer use or for commercial uses that could introduce the substance into a consumer setting. (iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N = 65. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) 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. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. ■ 18. Add § 14;721.11138 to subpart E to read as follows: § 721.11138 Formaldehyde, polymer with (chloromethyl) oxirane and substituted aromatic compounds (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as formaldehyde, polymer with (chloromethyl) oxirane and substituted aromatic compounds (P–17– 236) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to the PMN substance after it has been incorporated into the confidential forms identified in the Order. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (iii), and (iv), (a)(3), and (a)(6) (particulate), (when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering E:\FR\FM\17SER2.SGM 17SER2 47022 Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Rules and Regulations control measures (e.g. enclosure or confinement of operation, general and local ventilation) or administrative control measures (e.g. workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible), § 721.63(b) (concentration set at 1.0%), and § 721.63(c). (ii) Hazard communication. Requirements as specified in § 721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(ii), (vi), (vii), and (ix), (skin sensitization), (g)(2)(i), (ii), (iii), and (v), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used. (iii) Industrial, Commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (q). It is a significant new use to modify manufacture, processing, or use if it results in inhalation exposure to vapor, dust, mist, or aerosols to the substance. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers, importers, 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 paragraphs (a)(1) and (a)(2)(iii) of this section. ■ 19. Add § 14;721.11139 to subpart E to read as follows: daltland on DSKBBV9HB2PROD with RULES2 § 721.11139 Acid, reaction products with cadmium selenide (CdSe), trioctylphosphine and trioctylphosphine oxide (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as acid, reaction products with cadmium selenide (CdSe), trioctylphosphine and trioctylphosphine oxide (PMN P–17– 241) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), and (a)(3) and (6) (particulate), (when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g., VerDate Sep<11>2014 18:34 Sep 14, 2018 Jkt 244001 enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible), and § 721.63(c). (ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(g) and (y)(1). It is a significant new use to manufacture, process, or use the substance other than in a liquid formulation. (iii) Disposal. Requirements as specified in § 721.85. It is a significant new use to dispose of the substance and any waste stream containing the substance other than in a permitted hazardous waste incinerator. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (e), (i), and (j) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. ■ 20. Add § 14;721.11140 to subpart E to read as follows: § 721.11140 Acid, reaction products with cadmium selenide sulfide, acid, trioctylphosphine and trioctylphosphine oxide (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as acid, reaction products with cadmium selenide sulfide, acid, trioctylphosphine and trioctylphosphine oxide (PMN P–17– 242), is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), and (a)(3) and (6) (particulate), (when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible), and § 721.63(c). (ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(g) and (y)(1). It is a significant new use to manufacture, PO 00000 Frm 00020 Fmt 4701 Sfmt 4700 process, or use the substance other than in a liquid formulation. (iii) Disposal. Requirements as specified in § 721.85. It is a significant new use to dispose of the substance and any waste stream containing the substance other than in a permitted hazardous waste incinerator. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (e), (i), and (j) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. ■ 21. Add § 721.11141 to subpart E to read as follows: § 721.11141 Acid, reaction products with cadmium metal selenide sulfide, trioctylphosphine and trioctylphosphine oxide (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as acid, reaction products with cadmium metal selenide sulfide, trioctylphosphine and trioctylphosphine oxide (PMN P–17– 243), is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), and (a)(3) and (6) (particulate), (when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible), and § 721.63(c). (ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(g) and (y)(1). It is a significant new use to manufacture, process, or use the substance other than in a liquid formulation. (iii) Disposal. Requirements as specified in § 721.85. It is a significant new use to dispose of the substance and any waste stream containing the substance other than in a permitted hazardous waste incinerator. (b) Specific requirements. The provisions of subpart A of this part E:\FR\FM\17SER2.SGM 17SER2 Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Rules and Regulations apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (e), (i), and (j) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. ■ 22. Add § 721.11142 to subpart E to read as follows: daltland on DSKBBV9HB2PROD with RULES2 § 721.11142 Metal oxide reaction products with cadmium metal selenide sulfide, and amine (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as metal oxide reaction products with cadmium metal selenide sulfide, and amine (PMN P–17–244) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(3) through (5) (respirators must provide a National Institute for Occupational Safety and Health assigned protection factor (APF) of at least 50), and (a)(6)(particulate), (when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible), and § 721.63(c). It is a significant new use to handle the solid form of the substance without use of a fume hood or glove box. (ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(q), (k) (down converting phosphor particle for use in conjunction with optoelectronic components), and (y)(1) and (2). (iii) Disposal. Requirements as specified in § 721.85. It is a significant new use to dispose of the substance and any waste stream containing the substance other than in a permitted hazardous waste incinerator. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (e), (i), and (j) are applicable to manufacturers and processors of this substance. VerDate Sep<11>2014 18:34 Sep 14, 2018 Jkt 244001 (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. (3) Determining whether a specific use us subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section. ■ 23. Add § 721.11143 to subpart E to read as follows: § 721.11143 Alkanoic acid, 2-alkyl-, substituted alkyl ester, polymer with alkyl alkenoate, substituted carbomonocycle, substituted alkyl alkenoate and alkyl substituted alkenoate, substituted alkanenitrile-initiated (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as alkanoic acid, 2-alkyl-, substituted alkyl ester, polymer with alkyl alkenoate, substituted carbomonocycle, substituted alkyl alkenoate and alkyl substituted alkenoate, substituted alkanenitrileinitiated (PMN P–17–265) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or cured. (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80. It is a significant new use to manufacture the PMN substance with an acid concentration greater than 20%. It is a significant new use to manufacture the PMN substance with an amine concentration greater than 5%. (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), (b), (c), and (i). (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. ■ 24. Add § 721.11144 to subpart E to read as follows: § 721.11144 Manganese heterocyclicamine carboxylate complexes (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as manganese heterocyclicamine carboxylate complexes (PMN P– 17–301) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this PO 00000 Frm 00021 Fmt 4701 Sfmt 4700 47023 section. The requirements of this Order do not apply to quantities of the PMN substance after they have been entrained in cured coating or ink. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(3) through (5) (respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 10), and (a)(6) (particulate), (when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures (e.g. enclosure or confinement of operation, general and local ventilation) or administrative control measures (e.g. workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible), § 721.63(b) (concentration set at 1.0%), and § 721.63(c). (ii) Hazard communication. Requirements as specified in § 721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i) through (iii) and (ix), (eye irritation), (g)(2)(ii) through (iv), (avoid skin and eye contact), (use skin and eye protection), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) (surface drier in clear and pigmented coatings systems) and (p) (430,000 kilograms). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i). (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. ■ 25. Add § 721.11145 to subpart E to read as follows: § 721.11145 (generic). Sulfuric acid mixed salt (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as sulfuric acid mixed salt (PMN P–17–318) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(3), and (a)(6)(v), (particulate), (when E:\FR\FM\17SER2.SGM 17SER2 47024 Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Rules and Regulations determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g. enclosure or confinement of operation, general and local ventilation) or administrative control measures (e.g. workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible), § 721.63(b) (concentration set at 1.0%), and § 721.63(c). (ii) Hazard communication. Requirements as specified in § 721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), (irritation to eye, respiratory, and GI tract), (corrosion), (acute toxicity), (g)(2)(i) and (iii), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) and (q). It is a significant new use to manufacture of the PMN substance with more than 1% free ammonia content. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i). (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. ■ 26. Add § 721.11146 to subpart E to read as follows: daltland on DSKBBV9HB2PROD with RULES2 § 721.11146 2-Propenoic acid, branched alkyl ester (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as 2-propenoic acid, branched alkyl ester (PMN P–17–323) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been reacted (cured). (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (iii), and (iv), (a)(3), and (a)(6)(v), (particulate), (when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g. enclosure or VerDate Sep<11>2014 18:34 Sep 14, 2018 Jkt 244001 confinement of operation, general and local ventilation) or administrative control measures (e.g. workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible), § 721.63(b) (concentration set at 1.0%), and § 721.63(c). (ii) Hazard communication. Requirements as specified in § 721.72(a) through (e) (concentration set at 1.0%), (f), and (g)(1)(iv) and (ix), (skin and eye irritation), (oncogenicity), (sensitization), (g)(2)(i), (iii), and (v), (use eye protection), (g)(4)(iii), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k) (reactive monomer for use in producing polymers), and (q). (iv) Release to water. Release to water requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) and (k). (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. ■ 27. Add § 721.11147 to subpart E to read as follows: § 721.11147 (generic). Allyloxymethylacrylate (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as allyloxymethylacrylate (PMN P–17–326) is subject to reporting under this section for the significant new uses as described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted (cured). (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (iii), and (iv), (a)(3) through (5) (respirators must provide a National Institute for Occupational Safety and Health assigned protection factor of at least 10), and (a)(6)(v), (particulate), (when determining which persons are PO 00000 Frm 00022 Fmt 4701 Sfmt 4700 reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measure (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible), § 721.63(b) (concentration set at 1.0%), and § 721.63(c). (ii) Hazard communication. Requirements as specified in § 721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), (iv), (vi), and (ix), (sensitization), (g)(2)(i) through (v), (g)(3)(i) and (ii), (g)(4)(iii), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (q). (iv) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Requirements as specified in § 721.125(a) through (i), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. ■ 28. Add § 721.11148 to subpart E to read as follows: § 721.11148 Polyurethane, methacrylate blocked (generic). (a) Chemical substance and significant new sues subject to reporting. (1) The chemical substance generically identified as polyurethane, methacrylate blocked (PMN P–17–345) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted (cured). (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i)(iii), (a)(3), and (a)(6)(v), (particulate), (when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering E:\FR\FM\17SER2.SGM 17SER2 Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Rules and Regulations daltland on DSKBBV9HB2PROD with RULES2 control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measure (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible), § 721.63(b) (concentration set at 1.0%), and § 721.63(c). (ii) Hazard communication. Requirements as specified in § 721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(irritation to skin, eyes, lungs, and mucous membranes), (g)(2)(i) through (iii) and (v), and (g)(5). Alternative hazard and warning statements that meet the criteria of the VerDate Sep<11>2014 18:34 Sep 14, 2018 Jkt 244001 Globally Harmonized System and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k). It is a significant new use to manufacture the chemical substance more than 6 months. It is a significant new use to modify manufacture, processing, or use if it results in inhalation exposure to vapor, dust, mist, or aerosols to the substance. (b) Specific requirements. The provisions of subpart A of this part apply to this section except ss modified by this paragraph (b). PO 00000 Frm 00023 Fmt 4701 Sfmt 9990 47025 (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. [FR Doc. 2018–19950 Filed 9–14–18; 8:45 am] BILLING CODE 6560–50–P E:\FR\FM\17SER2.SGM 17SER2

Agencies

[Federal Register Volume 83, Number 180 (Monday, September 17, 2018)]
[Rules and Regulations]
[Pages 47004-47025]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19950]



[[Page 47003]]

Vol. 83

Monday,

No. 180

September 17, 2018

Part II





Environmental Protection Agency





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40 CFR Parts 9 and 721





Significant New Use Rules on Certain Chemical Substances; Final Rule 
and Proposed Rule

Federal Register / Vol. 83 , No. 180 / Monday, September 17, 2018 / 
Rules and Regulations

[[Page 47004]]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2018-0567; FRL-9983-14]
RIN 2070-AB27


Significant New Use Rules on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is promulgating significant new use rules (SNURs) under 
the Toxic Substances Control Act (TSCA) for 28 chemical substances 
which were the subject of premanufacture notices (PMNs). The chemical 
substances are subject to Orders issued by EPA pursuant to the TSCA. 
This action requires persons who intend to manufacture (defined by 
statute to include import) or process any of these 28 chemical 
substances for an activity that is designated as a significant new use 
by this rule to notify EPA at least 90 days before commencing that 
activity. The required notification initiates EPA's evaluation of the 
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 
with that determination.

DATES: This rule is effective on November 16, 2018. For purposes of 
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on 
October 1, 2018.
    Written adverse comments on one or more of these SNURs must be 
received on or before October 17, 2018 (see Unit VI. of the 
SUPPLEMENTARY INFORMATION). If EPA receives written adverse comments, 
on one or more of these SNURs before October 17, 2018, EPA will 
withdraw the relevant sections of this direct final rule before its 
effective date.
    For additional information on related reporting requirement dates, 
see Units I.A., VI., and VII. of the SUPPLEMENTARY INFORMATION.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2018-0567, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW, Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
Kenneth Moss, Chemical Control Division (7405M), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW, Washington, DC 20460-0001; telephone number: 
(202) 564-9232; email address: [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 October 17, 2018 
are subject to the export notification provisions of TSCA section 12(b) 
(15 U.S.C. 2611(b)) (see Sec.  [emsp14]721.20), and must comply with 
the export notification requirements in 40 CFR part 707, subpart D.

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

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark part or all of the information 
that you claim to be CBI. For CBI information in a disk or CD-ROM that 
you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then 
identify electronically within the disk or CD-ROM the specific 
information that is claimed as CBI. In addition to one complete version 
of the comment that includes information claimed as CBI, a copy of the 
comment that does not contain the information claimed as CBI must be 
submitted for inclusion in the public docket. Information so marked 
will not be disclosed except in accordance with procedures set forth in 
40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Background

A. What action is the Agency taking?

    1. Direct Final Rule. EPA is promulgating these SNURs using direct 
final rule procedures. These SNURs will require persons to notify EPA 
at least 90 days before commencing the manufacture or processing of a 
chemical substance for any activity designated by these SNURs as a 
significant new use. Receipt of such notices obligates EPA to assess 
risks that may be associated with the significant new uses under the 
conditions of use and, if appropriate, to regulate the proposed uses 
before they occur.
    2. Proposed Rule. In addition to this Direct Final Rule, elsewhere 
in this issue of the Federal Register, EPA is issuing a Notice of 
Proposed Rulemaking for this rule. If EPA receives no adverse comment, 
the Agency will not take further action on the proposed rule and the 
direct final rule will become effective as provided in this action. If 
EPA receives adverse comment on one or more of SNURs in this action by 
October 2, 2018 (see Unit VI. of the SUPPLEMENTARY INFORMATION), the 
Agency will publish in the Federal

[[Page 47005]]

Register a timely withdrawal of the specific SNURs that the adverse 
comments pertain to, informing the public that the actions will not 
take effect. EPA would then address all adverse public comments in a 
response to comments document in a subsequent final rule, based on the 
proposed rule.

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.  [emsp14]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 28 
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. Substances Subject to This Rule

    EPA is establishing significant new use and recordkeeping 
requirements for 28 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 TSCA section 5(e) Order.
     Information identified by EPA that would help characterize 
the potential health and/or environmental effects of the chemical 
substance in support of a request by the PMN submitter to modify the 
Order, or if a manufacturer or processor is considering submitting a 
SNUN for a significant new use designated by the SNUR.
    This information may include testing required in a TSCA section 
5(e) Order to be conducted by the PMN submitter, as well as testing not 
required to be conducted but which would also help characterize the 
potential health and/or environmental effects of the PMN substance. 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. See Unit VIII. for more information.
     CFR citation assigned in the regulatory text section of 
this rule.
    The regulatory text section of these rules specifies the activities 
designated as significant new uses. Certain new uses, including 
exceedance of production volume limits (i.e., limits on manufacture 
volume) and other uses designated in this rule, may be claimed as CBI. 
Unit IX. discusses a procedure companies may use to ascertain whether a 
proposed use constitutes a significant new use.
    These rules include 28 PMN substances that are subject to Orders 
under TSCA section 5(e)(1)(A). Each Order is based on one or more of 
the findings in TSCA section 5(a)(3)(B): There is insufficient 
information to permit a reasoned evaluation; in the absence of 
sufficient information to permit a reasoned evaluation, the activities 
associated with the PMN substances may present unreasonable risk to 
human health or the environment; the substance is or will be produced 
in substantial quantities, and enters or may reasonably be anticipated 
to enter the environment in substantial quantities or there is or may 
be significant (substantial) human exposure to the substance. Those 
Orders require protective measures to limit exposures or otherwise 
mitigate the potential unreasonable risk. The SNURs identify as 
significant new uses any manufacturing, processing, use, distribution 
in commerce, or disposal that does not conform to the restrictions 
imposed by the underlying Orders, consistent with TSCA section 5(f)(4). 
Where EPA determined that the PMN substance may present an unreasonable

[[Page 47006]]

risk of injury to human health via inhalation exposure, the underlying 
TSCA section 5(e) Order required, among other things, that potentially 
exposed employees wear specified respirators unless actual measurements 
of the workplace air show that air-borne concentrations of the PMN 
substance are below a New Chemical Exposure Limit (NCEL) that is 
established by EPA to provide adequate protection to human health. In 
addition to the actual NCEL concentration, the comprehensive NCELs 
provisions in TSCA section 5(e) Orders, which are modeled after 
Occupational Safety and Health Administration (OSHA) Permissible 
Exposure Limits (PELs) provisions, include requirements addressing 
performance criteria for sampling and analytical methods, periodic 
monitoring, respiratory protection, and recordkeeping. However, no 
comparable NCEL provisions currently exist in 40 CFR part 721, subpart 
B, for SNURs. Therefore, for these cases, the individual SNURs in 40 
CFR part 721, subpart E, will state that persons subject to the SNUR 
who wish to pursue NCELs as an alternative to the Sec.  721.63 
respirator requirements may request to do so under Sec.  
[emsp14]721.30. EPA expects that persons whose Sec.  721.30 requests to 
use the NCELs approach for SNURs that are approved by EPA will be 
required to comply with NCELs provisions that are comparable to those 
contained in the corresponding TSCA section 5(e) Order for the same 
chemical substance.

PMN Number: P-14-758

    Chemical name: 2-Propenenitrile, polymer with methanamine, 
hydrogenated, 3-aminopropylterminated, ethoxylated propoxylated.
    CAS number: 2055838-16-7.
    Effective date of TSCA section 5(e) Order: September 15, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as urethane foam. Based 
on physical/chemical properties, EPA has identified concern for lung 
toxicity. Based on SAR analysis of polycationic polymers, EPA predicts 
toxicity to aquatic organisms may occur at concentrations that exceed 
416 parts per billion (ppb). The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation, the 
substance may present an unreasonable risk of injury to human health 
and the environment. To protect against these risks, the Order 
requires:
    1. Refraining from manufacturing the PMN substance in the United 
States (i.e. import only);
    2. Use of personal protective equipment where there is a potential 
for dermal exposure;
    3. Use of a National Institute of Occupational Safety and Health 
(NIOSH)-certified respirator with an APF of at least 50 where there is 
a potential for inhalation exposure;
    4. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS;
    5. No application method of the PMN substance that results in 
greater worker inhalation exposures to vapor, mist, or aerosol than 
those encountered in roller coating application;
    6. Use of the PMN substance only for the confidential uses 
specified in the Order; and
    7. No release of the PMN substance into the waters of the United 
States.

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 physical-chemical properties, fate, ecotoxicity 
and pulmonary effects of the PMN substance may be potentially useful to 
characterize the effects of the PMN substance in support of a request 
by the PMN submitter to modify the Order, or if a manufacturer or 
processor is considering submitting a SNUN for a significant new use 
that would be designated by this SNUR. EPA has determined that the 
results of physical-chemical property testing, fate, acute and chronic 
aquatic toxicity testing, and pulmonary toxicity testing would help 
characterize the potential environmental and health effects of the PMN 
substance. Although the Order does not require these tests, the Order's 
restrictions will remain in effect until the Order is modified or 
revoked by EPA based on submission of this or other information that 
EPA determines is relevant and needed to evaluate a modification 
request.
    CFR citation: 40 CFR 721.11124.

PMN Number: P-16-493

    Chemical Name: Dicarboxylic acids, polymers with alkyl prop-2-
enoate, alkyl 2- ethylprop-2-enoate, alkyl[(alkenyl)alkyl]alkanediol, 
alkanediol, alkanedioic acid, alkyl 2-rnethylprop-2-enoate, alkyl prop-
2-enoic acid, alkylene [isocyanatocarbomonocyte] and alkanediol, 
alkanolamine-blocked, compds with 2-(alkylamino)alkanol (generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: September 18, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as paint. Based on 
physical/chemical properties of the PMN substance and test data on 
analogous diisocyanates, EPA identified concerns for dermal 
sensitization, respiratory sensitization, lung effects, neurotoxicity, 
and developmental toxicity, as well as skin irritation, and a potential 
for cancer to workers due to the possibility of isocyanate residuals. 
The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(l)(A)(ii)(I), based on a finding that in the absence of sufficient 
information to permit a reasoned evaluation, the substance may present 
an unreasonable risk of injury to human health and the environment. To 
protect against these risks, the Order requires:
    1. Refraining from manufacturing or processing the PMN substance in 
the United States (i.e., import only);
    2. Import of the PMN substance to contain no more than 0.1% 
residual isocyanate by weight; and
    3. Import of the PMN substance to contain no more than 1% of a 
confidential component by weight.

The SNUR designates as a ``significant new use'' the absence of these 
protective measures.
    Potentially useful information: EPA has determined that certain 
information about the health effects of the PMN substance may be 
potentially useful to characterize the effects of the PMN substance in 
support of a request by the PMN submitter to modify the Order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use that would be designated by this SNUR. EPA has 
determined that the results of sensitization and pulmonary toxicity 
testing would help characterize the potential health effects of the PMN 
substance. Although the Order does not require these tests, the Order's 
restrictions will remain in effect until the Order is modified or 
revoked by EPA based on submission of this or other information that 
EPA determines is relevant and needed to evaluate a modification 
request.
    CFR citation: 40 CFR 721.11125.

PMN Number: P-16-514

    Chemical Name: Mixed metal oxide (generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: August 7, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-

[[Page 47007]]

confidential) use of the substance will be as a catalyst. Based on SAR 
analysis of test data on analogous mixed metal oxides, EPA identified 
concerns for lung effects, systemic effects, eye irritation and 
allergic skin reaction. EPA also identified risk to workers for lung 
toxicity based on lung overload for respirable, poorly soluble 
particulates. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation, the 
substance may present an unreasonable risk of injury to human health. 
To protect against these risks, the Order requires:
    1. Submission to EPA of certain toxicity testing before exceeding 
the confidential production volume limit specified in the Order;
    2. Use of personal protective equipment where there is a potential 
for dermal exposure;
    3. Use of a NIOSH-certified respirator with an APF of at least 
1,000 where there is a potential for inhalation exposure or compliance 
with a NCEL of 0.04 mg/m\3\ as an 8-hour time-weighted average to 
prevent inhalation exposure;
    4. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the Safety Data Sheet (SDS);
    5. Refraining from manufacturing or processing the PMN substance in 
the United States (i.e., import only);
    6. Use of the PMN substance only for the confidential use stated in 
the Order; and
    7. Disposal of the PMN substance only by recycling as described in 
the PMN.

The SNUR designates as a ``significant new use'' the absence of these 
protective measures.
    Potentially useful information: EPA has determined that certain 
information about the health effects of the PMN substance may be 
potentially useful to characterize the effects of the PMN substance in 
support of a request by the PMN submitter to modify the Order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use that would be designated by this SNUR. The 
submitter has agreed not to exceed a certain production volume limit 
without performing specific pulmonary and internal organ toxicity 
testing.
    CFR citation: 40 CFR 721.11126.

PMN Numbers: P-16-576 and P-16-577

    Chemical names: Modified alkyl polyamine (generic) (P-16-576) and 
alkyl polyamine (generic) (P-16-577).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: September 18, 2017.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic 
(non-confidential) use of the substances will be as an intermediate (P-
16-576) and an oil lubricant additive (P-16-577). Based on the 
physical/chemical properties of the PMN substances, analogue toxicity 
data, and data on the PMN substances, EPA has identified concerns for 
irritation to the skin, eyes, mucous membranes, and lungs; effects to 
the GI tract, adrenal glands, and blood; immunotoxicity; and 
reproductive toxicity. Based on Structure Activity Relationship (SAR) 
predictions for polycationic polymers and aliphatic amines, EPA 
predicts toxicity to aquatic organisms may occur at concentrations that 
exceed 2 parts per billion. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation, the 
substances may present an unreasonable risk of injury to human health 
and the environment. To protect against these risks, the Order 
requires:
    1. Use of the PMN substances only for the confidential uses stated 
in the Order;
    2. Use of personal protective equipment where there is a potential 
for dermal exposure;
    3. Submission to EPA of certain toxicity testing for P-16-577 no 
later than 9 months and 12 months from the date of the Notice of 
Commencement (NOC) of either substance;
    4. Refraining from manufacture, processing or use for consumer use 
or in commercial use where there is use in a consumer setting; and
    5. No release of P-16-577 resulting in surface water concentrations 
that exceed 2 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 environmental and health effects of the PMN 
substances may be potentially useful to characterize the effects of the 
PMN substances in support of a request by the PMN submitter to modify 
the Order, or if a manufacturer or processor is considering submitting 
a SNUN for a significant new use that would be designated by this SNUR. 
The submitter has agreed not to exceed certain time limits without 
performing specific pharmacokinetic and developmental toxicity testing. 
Additionally, EPA has determined that the results of chronic aquatic 
toxicity testing on P-16-577 would help characterize the potential 
environmental effects caused by the PMN substances. Although the Order 
does not require this test, the Order's restrictions will remain in 
effect until the Order is modified or revoked by EPA based on 
submission of this or other information that EPA determines is relevant 
and needed to evaluate a modification request.
    CFR citations: 40 CFR 721.11127 (P-16-576) and 40 CFR 721.11128 (P-
16-577).

PMN Number: P-16-590

    Chemical Name: Silica gel, reaction products with chromium oxide 
(CrO3) and ethoxydiethyl aluminum.
    CAS Number: 932384-12-8.
    Effective date of TSCA section 5(e) Order: September 13, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the use of 
the substance will be as a catalyst for polyethylene polymerization. 
Based on the reactivity of the PMN substance and the presence of 
chromium VI, EPA identified concerns for oncogenicity, reproductive 
toxicity, respiratory sensitization, and severe irritation to skin, 
eyes, lung and mucous membranes. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I), based on a finding 
that in the absence of sufficient information to permit a reasoned 
evaluation, the substance may present an unreasonable risk of injury to 
health. To protect against these risks, the Order requires:
    1. Handling the PMN substance under an inert atmosphere using 
containers and systems designed not to be exposed to the air;
    2. Use of personal protective equipment where there is a potential 
for dermal exposure;
    3. Use of a NIOSH-certified respirator with an APF of 10 to 1,000 
depending on monitoring results from the methods required in the Order; 
and
    4. Disposal of all waste streams containing the PMN substance and 
the constituent breakdown products of the PMN substance in a Resource 
Conservation and Recovery Act (RCRA) hazardous waste landfill.

The SNUR designates as a ``significant new use'' the absence of these 
protective measures.
    Potentially useful information: EPA has determined that certain 
information about the health effects of the PMN substance may be 
potentially useful to characterize the effects of the PMN substance in 
support of a request by the PMN submitter to modify the Order, or if a 
manufacturer or processor is considering submitting a SNUN for a

[[Page 47008]]

significant new use that would be designated by this SNUR. EPA has 
determined that the results of a pulmonary toxicity study and a 
carcinogenicity study would help characterize the potential health 
effects of the PMN substance. Although the Order does not require these 
tests, the Order's restrictions will remain in effect until the Order 
is modified or revoked by EPA based on submission of this or other 
relevant information.
    CFR citation: 40 CFR 721.11129.

PMN Number: P-16-593

    Chemical Name: Carboxylic acids, C6-18 and C5-15-di-, polymers with 
diethyleneglycol, glycerol, sorbitol and terephthalic acid.
    CAS Number: 1967778-37-5.
    Effective date of TSCA section 5(e) Order: August 7, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the use of 
the substance will be as an aromatic polyester polyol for rigid foam. 
EPA identified concerns for lung effects and irritation to the eyes and 
mucous membranes based on the physical/chemical properties of the PMN 
substance. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) 
and 5(e)(l)(A)(ii)(I), based on a finding that in the absence of 
sufficient information to permit a reasoned evaluation the substance 
may present an unreasonable risk of injury to human health and the 
environment. To protect against these risks, the Order requires:
    1. Use of personal protective equipment where there is a potential 
for dermal exposure;
    2. Use of the PMN substance only as an aromatic polyester polyol 
for rigid foam;
    3. No manufacture, processing, or use of the PMN substance to 
result in inhalation exposures to a vapor, mist or aerosol; and
    4. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.

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 physical-chemical properties and health effects 
of the PMN substance may be potentially useful to characterize the 
effects of the PMN substance in support of a request by the PMN 
submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that would be 
designated by this SNUR. EPA has determined that the results of 
physical-chemical property testing and pulmonary toxicity testing would 
help characterize the potential health effects of the PMN substance. 
Although the Order does not require these tests, the Order's 
restrictions remain in effect until the Order is modified or revoked by 
EPA based on submission of this or other relevant information.
    CFR citation: 40 CFR 721.11130.

PMN Number: P-17-5

    Chemical name: 1-tetradecene homopolymer hydrogenated.
    CAS number: 1857296-89-9.
    Effective date of TSCA section 5(e) Order: August 9, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the use of 
the substance will be as a base fluid/carrier fluid for additives in 
motor oil, automatic transmission fluid, and industrial lubricants. 
Based on analysis of test data on an analogous chemical substance, EPA 
has identified concerns for irritation to mucous membranes and 
hydrocarbon pneumonia. The Order was issued under TSCA section 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation the 
substance may present an unreasonable risk of injury to human health. 
The Order was also issued under TSCA section 5(a)(3)(B)(ii)(II) and 
5(e)(1)(A)(ii)(II), based on a finding that the substance is or will be 
produced in substantial quantities and that the substance either enters 
or may reasonably be anticipated to enter the environment in 
substantial quantities, or there is or may be significant (or 
substantial) human exposure to the substance. To protect against these 
risks, the Order requires:
    1. Submission to EPA of certain toxicity testing no later than 9 
months after the NOC;
    2. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS;
    3. No manufacture, processing, or use of the PMN substance to 
result in inhalation exposure to a vapor, mist, or aerosol; and
    4. Not process the PMN substance for use other than as a base 
fluid/carrier fluid for additives in motor oil, automatic transmission 
fluid, and industrial lubricants.

The SNUR designates as a ``significant new use'' the absence of these 
protective measures.
    Potentially useful information: EPA has determined that certain 
information about the health effects of the PMN substance may be 
potentially useful to characterize the effects of the PMN substance in 
support of a request by the PMN submitter to modify the Order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use that would be designated by this SNUR. The 
submitter has agreed not to exceed a certain production volume limit 
without performing specific pulmonary toxicity testing.
    CFR citation: 40 CFR 721.11131.

PMN Numbers: P-17-149, P-17-150, P-17-151, and P-17-165

    Chemical Name: Fluorocyanophenyl alkylbenzoate (generic)
    CAS Numbers: Not available.
    Effective date of TSCA section 5(e) Order: August 10, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substances will be for electronic device 
use. Based on analysis of test data on analogous chemicals, EPA 
identified concerns for reproductive toxicity, developmental toxicity, 
neurotoxicity, and lung and skin effects. Based on SAR analysis of test 
data on analogous esters, EPA predicts toxicity to aquatic organisms 
may occur at concentrations that exceed 2 ppb for P-17-165 and 4 ppb 
for the other PMN substances. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation the 
substances may present an unreasonable risk of injury to human health 
and the environment. To protect against these risks, the Order 
requires:
    1. Submission to EPA of certain toxicity testing before exceeding 
the confidential production volume limit specified in the Order;
    2. Use of personal protective equipment where there is a potential 
for dermal exposure;
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS;
    4. Use of the PMN substances only for the confidential use 
specified in the Order;
    5. No modification of the manufacture, processing or use of the PMN 
substances to result in inhalation exposure to vapor, dust, mist, or 
aerosol; and
    6. No release of the PMN substances resulting in surface water 
concentrations that exceed 2 ppb for P-17-165 and 4 ppb for the other 
PMN substances.

The SNUR designates as a ``significant new use'' the absence of these 
protective measures.

[[Page 47009]]

    Potentially useful information: EPA has determined that certain 
information about the environmental and health effects of the PMN 
substances may be potentially useful to characterize the effects of the 
PMN substances in support of a request by the PMN submitter to modify 
the Order, or if a manufacturer or processor is considering submitting 
a SNUN for a significant new use that would be designated by this SNUR. 
The submitter has agreed not to exceed a certain production volume 
limit without performing specific reproductive/developmental toxicity 
testing and acute and chronic aquatic toxicity testing.
    CFR citation: 40 CFR 721.11132.

PMN Number: P-17-175

    Chemical Name: Fluorinated propenoic poly alkyl ether ester 
(generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: September 1, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the use of 
the PMN substance will be as a leveling agent for coatings applied to 
aluminum printing plates. Based on analysis of test data on the 
analogue perfluorohexanoic acid, EPA identified concerns for liver 
toxicity, blood toxicity, and male reproductive toxicity for the 
potential incomplete incineration product. Based on SAR predictions for 
polyanionic polymers for the potential degradation product, EPA also 
identified concern for effects of the potential degradation products to 
terrestrial wild animals and birds based on test data for analogous 
perfluoro chemicals in mammals. EPA has concerns that these degradation 
products will persist in the environment, could bioaccumulate or 
biomagnify, and could be toxic (PBT) to people, wild mammals, and 
birds. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(l)(A)(ii)(I), based on a finding that in the absence of sufficient 
information to permit a reasoned evaluation the substance may present 
an unreasonable risk of injury to human health and the environment. To 
protect against these risks, the Order requires:
    1. Refraining from domestic manufacture in the United States (i.e., 
import only);
    2. No manufacture (including import) beyond a maximum annual 
production volume of 60 kg; and
    3. Use of the PMN substance only as a leveling agent for coatings 
applied to aluminum printing plates.

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 physical-chemical properties and fate of the PMN 
substance may be potentially useful to characterize the effects of the 
PMN substance in support of a request by the PMN submitter to modify 
the Order, or if a manufacturer or processor is considering submitting 
a SNUN for a significant new use that would be designated by this SNUR. 
EPA has determined that the results of specific physical-chemical 
properties, environmental fate, and bioaccumulation testing would help 
characterize the potential health and environmental effects of the PMN 
substance. Although the Order does not require these tests, the Order's 
restrictions will remain in effect until the Order is modified or 
revoked by EPA based on submission of this or other relevant 
information.
    CFR citation: 40 CFR 721.11133.

PMN number: P-17-199

    Chemical name: Oxyalkylene urethane polyolefin (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: September 14, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the use of 
the substance will be as a binder in sealant. Based on the physical/
chemical properties of the PMN substance, EPA identified concerns for 
oncogenicity, male reproductive effects, developmental toxicity and 
sensitization if the PMN substance were manufactured differently. The 
Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient 
information to permit a reasoned evaluation the substance may present 
an unreasonable risk of injury to human health. To protect against 
these risks, the Order requires:
    1. Manufacture of the PMN substance at no less than the average 
molecular weight specified in the Order; and
    2. Manufacture of the PMN substance with no more than 1% of the 
molecular weight content below 1,000 Daltons.

The SNUR designates as a ``significant new use'' the absence of these 
protective measures.
    Potentially useful information: EPA has determined that certain 
information about the health effects of the PMN substance may be 
potentially useful to characterize the effects of the PMN substance in 
support of a request by the PMN submitter to modify the Order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use that would be designated by this SNUR. EPA has 
determined that the results of specific developmental toxicity, 
internal organ toxicity, and sensitization testing would help 
characterize the potential health effects of the PMN substance. 
Although the Order does not require these tests, the Order's 
restrictions remain in effect until the Order is modified or revoked by 
EPA based on submission of this or other relevant information.
    CFR citation: 40 CFR 721.11134.

PMN Number: P-17-206

    Chemical Name: Imino alkane amine phosphate (generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: August 9, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as a flame retardant 
for textiles. EPA identified concerns for irritation to eyes, mucous 
membranes, and lungs based on the pH of the PMN substance being 5. Also 
based on SAR analysis of test data on the nearest analogue inorganic 
phosphates EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 2 ppb. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I), based on a finding 
that in the absence of sufficient information to permit a reasoned 
evaluation the substance may present an unreasonable risk of injury to 
human health and the environment. To protect against these risks, the 
Order requires:
    1. Refraining from domestic manufacture in the United States (i.e., 
import only);
    2. Use of personal protective equipment where there is a potential 
for dermal exposure;
    3. No modification of the processing or use of the PMN substance to 
result in inhalation exposures to vapor, dust, mist, or aerosol;
    4. Use of the PMN substance only for the confidential use specified 
in the Order;
    5. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS;
    6. No release of the PMN substance into the waters of the United 
States; and
    7. Disposal of the PMN substance and waste streams containing the 
PMN substance by incineration.

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 environmental effects of the PMN substance may be 
potentially useful in support of a request by the

[[Page 47010]]

PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that would be 
designated by this SNUR. EPA has determined that the results of 
specific acute aquatic toxicity testing would help characterize the 
potential environmental effects of the PMN substance. Although the 
Order does not require these tests, the Order's restrictions remain in 
effect until the Order is modified or revoked by EPA based on 
submission of this or other relevant information.
    CFR citations: 40 CFR 721.11135 (P-17-206).

PMN Number: P-17-223

    Chemical Name: Fatty acids, tall-oil, reaction products with 2-[(2-
aminoalkyl)amino]alkanol, compds. with alkylene oxide-glycidyl o-tolyl 
ether polymer dihydrogenphosphate alkyl ether (generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: September 12, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as an additive for 
open, non-dispersive use. EPA identified concerns for developmental 
toxicity based on N-heterocyclic compounds and concerns for possible 
irritation to mucous membranes and lung toxicity based on potential 
surfactancy properties. Also based on SAR analysis of test data on 
nearest analogue of soluble forms of inorganic phosphates, EPA predicts 
toxicity to aquatic organisms may occur at concentrations that exceed 
15 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(l)(A)(ii)(I), based on a finding that in the absence of sufficient 
information to permit a reasoned evaluation the substance may present 
an unreasonable risk of injury to human health and the environment. To 
protect against these risks, the Order requires:
    1. Submission to EPA of certain toxicity testing before exceeding 
the confidential production volume limit specified in the Order;
    2. Refraining from manufacture, processing, or use for consumer use 
or in commercial use where there is use in a consumer setting;
    3. Refrain from domestic manufacture in the United States (i.e., 
import only);
    4. Use of the PMN substance only for the confidential use specified 
in the Order;
    5. Use of the PMN substance in the confidential formulation at a 
concentration not greater than 1 percent by weight or volume;
    6. Use of personal protective equipment where there is a potential 
for dermal exposure;
    7. Refraining from modifying the processing if such modification 
would result in inhalation exposures to the PMN substance by vapor, 
dust, mist, or aerosol at a concentration of greater than 1 percent by 
weight or volume;
    8. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS; and
    9. No release of the PMN substance resulting in surface water 
concentrations that exceed 15 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 physical-chemical properties, environmental 
effects, and health effects of the PMN substance may be potentially 
useful in support of a request by the PMN submitter to modify the 
Order, or if a manufacturer or processor is considering submitting a 
SNUN for a significant new use that would be designated by this SNUR. 
The submitter has agreed not to exceed a certain production volume 
limit without performing specific reproductive/developmental toxicity 
testing and acute aquatic toxicity testing. EPA has also determined 
that the results of specific physical-chemical property and pulmonary 
toxicity testing would help characterize the potential human and 
environmental effects of the PMN substance. Although the Order does not 
require these tests, the Order's restrictions remain in effect until 
the Order is modified or revoked by EPA based on submission of this or 
other relevant information.
    CFR citation: 40 CFR 721.11136.

PMN Number: P-17-230

    Chemical Name: Oxirane, 2-alkyl-, polymer with oxirane, mono[N-[3-
(carboxyamino)-4(or 6)-alkylphenyl]carbamate], alkyl ether, ester with 
2,2',2''-nitrilotris-[alkanol] (generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: September 12, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as an additive for 
open, non-dispersive use. Based on the potential surfactant properties, 
cationic binding to lung tissues, EPA identified concerns for lung 
toxicity and skin irritation. Based SAR analysis of test data on 
analogous polycationic polymers, EPA predicts toxicity to aquatic 
organisms may occur at concentrations that exceed 65 parts per billion. 
The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(l)(A)(ii)(I), based on a finding that in the absence of sufficient 
information to permit a reasoned evaluation the substance may present 
an unreasonable risk of injury to human health and the environment. To 
protect against these risks, the Order requires:
    1. Submission to EPA of certain toxicity testing before exceeding 
the confidential production volume limit specified in the Order;
    2. Refraining from manufacture, processing, or use for consumer use 
or in commercial use where there is use in a consumer setting;
    3. Refraining from domestic manufacture in the United States (i.e., 
import only);
    4. Use of the PMN substance only for the confidential use specified 
in the Order;
    5. Use of the PMN substance in the confidential formulation at a 
concentration not greater than 1 percent by weight or volume;
    6. Use of personal protective equipment where there is a potential 
for dermal exposure;
    7. Refraining from modifying the processing method if such 
modification would result in inhalation exposures to the PMN substance 
by vapor, dust, mist, or aerosol, at a concentration of greater than 1 
percent by weight or volume;
    8. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS; and
    9. No release of the PMN substance resulting in surface water 
concentrations that exceed 65 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 physical-chemical properties, environmental 
effects, and health effects of the PMN substance may be potentially 
useful in support of a request by the PMN submitter to modify the 
Order, or if a manufacturer or processor is considering submitting a 
SNUN for a significant new use that would be designated by this SNUR. 
The submitter has agreed not to exceed a certain production volume 
limit without performing specific acute aquatic and sediment toxicity 
testing. EPA has also determined that the results of specific physical-
chemical property and pulmonary toxicity testing would help 
characterize the potential health effects of the PMN substance. 
Although the

[[Page 47011]]

Order does not require these tests, the Order's restrictions will 
remain in effect until the Order is modified or revoked by EPA based on 
submission of this or other relevant information.
    CFR citation: 40 CFR 721.11137.

PMN Number: P-17-236

    Chemical Name: Formaldehyde, polymer with (chloromethyl) oxirane 
and substituted aromatic compounds (generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: September 11, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as matrix resin for 
composite materials and binder resin for electronic materials. Based on 
analysis of test data on the PMN substance, analysis of data on 
analogous chemicals, and on the epoxide chemical category of concern, 
EPA identified concerns for skin and lung sensitization, oncogenicity, 
developmental toxicity, and male reproductive toxicity. The Order was 
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I), 
based on a finding that in the absence of sufficient information to 
permit a reasoned evaluation the substance may present an unreasonable 
risk of injury to health. To protect against these risks, the Order 
requires:
    1. Submission to EPA of certain toxicity testing before exceeding 
the confidential production volume limit specified in the Order;
    2. Use of personal protective equipment where there is a potential 
for dermal exposure;
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS;
    4. Refraining from domestic manufacture in the United States (i.e., 
import only);
    5. Use of the PMN substance only as described in the PMN; and
    6. No manufacture, processing, or use that results in inhalation 
exposure to vapor, dust, mist, or aerosol.

The SNUR designates as a ``significant new use'' the absence of these 
protective measures.
    Potentially useful information: EPA has determined that certain 
information about the health effects of the PMN substance may be 
potentially useful in support of a request by the PMN submitter to 
modify the Order, or if a manufacturer or processor is considering 
submitting a SNUN for a significant new use that would be designated by 
this SNUR. The submitter has agreed not to exceed a certain production 
volume limit without performing sensitization testing. EPA has also 
determined that the results of specific internal organ toxicity and 
carcinogenicity testing would help characterize the potential health 
effects of the PMN substance. Although the Order does not require these 
tests, the Order's restrictions will remain in effect until the Order 
is modified or revoked by EPA based on submission of this or other 
relevant information.
    CFR citation: 40 CFR 721.11138.

PMN numbers: P-17-241, P-17-242, P-17-243, P-17-244

    Chemical names: Acid, reaction products with cadmium selenide 
(CdSe), trioctylphosphine and trioctylphosphine oxide (generic) (P-17-
241), Acid, reaction products with cadmium selenide sulfide, acid, 
trioctylphosphine and trioctylphosphine oxide (generic) (P-17-242), 
Acid, reaction products with cadmium metal selenide sulfide, 
trioctylphosphine and trioctylphosphine oxide (generic) (P-17-243), 
Metal oxide reaction products with cadmium metal selenide sulfide, and 
amine (generic) (P-17-244).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: September 20, 2017.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic 
(non-confidential) use of P-17-241, P-17-242, and P-17-243 will be as 
chemical intermediates, and the specific use of P-17-244 will be as a 
down converting phosphor particle for use in conjunction with 
optoelectronic components. Based on analogy to respirable poor soluble 
particulates and the presence of cadmium, EPA identified concerns for 
lung effects, kidney effects, and oncogenicity for the PMN substances. 
EPA also identified concerns for neurotoxicity, developmental toxicity, 
and kidney toxicity for PMN P-17-244 based on the presence of other 
chemicals. Based on analysis of test data for cadmium and selenium core 
components, there is high hazard for acute and chronic environmental 
toxicity for PMNs P-17-241, P-17-242, and P-17-243. There is potential 
chronic environmental toxicity for PMN P-17-244 based on the presence 
of cadmium. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) 
and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of 
sufficient information to permit a reasoned evaluation the substances 
may present an unreasonable risk of injury to health and the 
environment. To protect against these risks, the Order requires:
    1. Submission to EPA of certain testing for P-17-244 before 
exceeding the confidential production volume limit specified in the 
Order;
    2. Use of personal protective equipment where there is potential 
for dermal exposure;
    3. Manufacture, processing, and use P-17-241, P-17-242, and P-17-
243 only as chemical intermediates as required in the Order;
    4. Manufacture, processing, and use P-17-241, P-17-242, and P-17-
243 only in liquid formulations;
    5. No use of P-17-241, P-17-242, and P-17-243 in applications that 
generate a dust, mist, or aerosol;
    6. Manufacture, processing and use of P-17-244, only as a down-
converter for use in conjunction with optoelectronic components;
    7. For workers potentially exposed to the solid form of P-17-244, 
use of a laminar-flow fume hood or glove box to reduce or eliminate 
inhalation exposure, and workers who may still be exposed by inhalation 
will use a NIOSH-certified full-faced respirator with an APF of at 
least 50; and
    8. Disposal of the PMN substances only by incineration in a 
permitted hazardous waste incinerator.

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 fate and health effects of the PMN substances may 
be potentially useful in support of a request by the PMN submitter to 
modify the Order, or if a manufacturer or processor is considering 
submitting a SNUN for a significant new use that would be designated by 
this SNUR. The submitter has agreed not to exceed a certain production 
volume limit without performing certain fate and internal organ 
toxicity testing on P-17-244. EPA has also determined that the results 
of specific fate testing would help characterize the potential health 
and environmental effects of the PMN substances. Although the Order 
does not require these tests, the Order's restrictions will remain in 
effect until the Order is modified or revoked by EPA based on 
submission of this or other relevant information.
    CFR citations: 40 CFR.11139 (P-17-241), 40 CFR.11140 (P-17-242), 40 
CFR.11141 (P-17-243), and 40 CFR.11142 (P-17-244).

PMN number: P-17-265

    Chemical name: Alkanoic acid, 2-alkyl-, substituted alkyl ester, 
polymer with alkyl alkenoate, substituted carbomonocycle, substituted 
alkyl

[[Page 47012]]

alkenoate and alkyl substituted alkenoate, substituted alkanenitrile-
initiated (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: August 16, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the use of 
the substance will be as a coating resin intermediate. Based on 
physical/chemical properties EPA identified concerns for lung toxicity, 
systemic toxicity, reproductive toxicity, corrosion, and irritation for 
the PMN substance when it has an acid concentration greater than 20% or 
an amine concentration greater than 5%. Based on SAR analysis for 
anionic polymers and physical/chemical properties, EPA has identified 
concern for environmental effects when it has an acid concentration 
greater than 20%. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation the 
substance may present an unreasonable risk of injury to health and the 
environment. To protect against these risks, the Order requires:
    1. Refraining from manufacturing the PMN substance with an acid 
concentration greater than 20%; and
    2. Refraining from manufacturing the PMN substance with an amine 
concentration greater than 5%.

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 
substance may be potentially useful in support of a request by the PMN 
submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that would be 
designated by this SNUR. EPA has determined that the results of 
specific physical-chemical property testing, pulmonary toxicity 
testing, irritation testing, and acute and chronic aquatic toxicity 
testing would help characterize the potential health and environmental 
effects of the PMN substance. Although the Order does not require these 
tests, the Order's restrictions will remain in effect until the Order 
is modified or revoked by EPA based on submission of this or other 
relevant information.
    CFR citation: 40 CFR 721.11143.

PMN number: P-17-301

    Chemical name: Manganese heterocyclic-amine carboxylate complexes 
(generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: September 22, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
use of the PMN substance will be as a surface drier in clear and 
pigmented coatings systems. Based on the physical/chemical properties 
of the PMN substance and analysis of analogue test data, EPA identified 
concerns for neurotoxicity, developmental toxicity, and eye and skin 
irritation. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) 
and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of 
sufficient information to permit a reasoned evaluation the substance 
may present an unreasonable risk of injury to health and the 
environment. The Order was also issued under TSCA sections 
5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding that the 
substance is or will be produced in substantial quantities and that the 
substance either enters or may reasonably be anticipated to enter the 
environment in substantial quantities. To protect against these risks, 
the Order requires:
    1. Submission to EPA of certain testing before exceeding an 
aggregate total production of 430,000 kilograms of the PMN substance;
    2. Use of personal protective equipment where there is a potential 
for dermal exposure;
    3. Use of a NIOSH-certified respirator with an APF of at least 10 
where there is potential for inhalation exposure;
    4. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS; and
    5. No use of the PMN substance other than as a surface drier in 
clear and pigmented coatings systems.

The SNUR designates as a ``significant new use'' the absence of these 
protective measures.
    Potentially useful information: EPA has determined that certain 
information about the health effects of the PMN substance may be 
potentially useful in support of a request by the PMN submitter to 
modify the Order, or if a manufacturer or processor is considering 
submitting a SNUN for a significant new use that would be designated by 
this SNUR. The submitter has agreed not to exceed the production limit 
without performing specific reproductive/developmental toxicity 
testing.
    CFR citation: 40 CFR 721.11144.

PMN number: P-17-318

    Chemical name: Sulfuric acid mixed salt (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: September 25, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as a component in 
nutrient solutions. Based on analogue data and information provided in 
the SDS, EPA has identified concerns for skin, eye, respiratory, and GI 
tract irritation, corrosion and acute toxicity. Also, based on SAR 
predictions for analogue inorganic salts, EPA predicts toxicity to 
aquatic organisms may occur at concentrations that exceed 760 ppb. The 
Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient 
information to permit a reasoned evaluation the substance may present 
an unreasonable risk of injury to human health and the environment. The 
Order was also issued under TSCA sections 5(a)(3)(B)(ii)(II) and 
5(e)(1)(A)(ii)(II), based on a finding that the substance is or will be 
produced in substantial quantities and that the substance either enters 
or may reasonably be anticipated to enter the environment in 
substantial quantities. To protect against these risks, the Order 
requires:
    1. Submission of certain toxicity testing on the PMN substance 
prior to exceeding the confidential production volume limit specified 
in the Order.
    2. Use of personal protective equipment where there is a potential 
for dermal exposure.
    3. Use of the PMN substance only for the confidential use specified 
in the Order.
    4. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    5. Manufacture of the PMN substance to contain no more than 1% free 
ammonia.

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 
substance may be potentially useful in support of a request by the PMN 
submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that would be 
designated by this SNUR. The submitter has agreed not to exceed the 
production limit without performing specific acute aquatic toxicity 
testing. EPA has also determined that the results of specific 
reproductive/developmental toxicity testing would help characterize the 
potential health and environmental

[[Page 47013]]

effects of the PMN substance. Although the Order does not require these 
tests, the Order's restrictions will remain in effect until the Order 
is modified or revoked by EPA based on submission of this or other 
relevant information.
    CFR citation: 40 CFR 721.11145.

PMN number: P-17-323

    Chemical name: 2-Propenoic acid, branched alkyl ester (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: September 26, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the use of 
the substance will be as a reactive monomer for use in producing 
polymers. Based on the physical/chemical properties of the PMN 
substance (as described in the New Chemical Program's PBT category at 
64 FR 60194; November 4, 1999) and test data on structurally similar 
substances, the PMN substance is a potentially persistent, 
bioaccumulative, and toxic (PBT) chemical. EPA estimates that the PMN 
substance will persist in the environment more than 2 months and 
estimates a bioaccumulation factor of greater than or equal to 1,000. 
Based on SAR analysis of test data on analogous acrylates and from the 
branched acid that may be formed after ester hydrolysis, EPA has 
identified concerns for eye and skin irritation, oncogenicity, 
developmental toxicity, liver toxicity, kidney toxicity, and 
sensitization. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation the 
substance may present an unreasonable risk of injury to human health 
and the environment. To protect against these risks, the Order 
requires:
    1. Submission of certain toxicity testing on the PMN substance 
prior to exceeding the confidential production volume limit as 
specified in the Order;
    2. Use of personal protective equipment where there is a potential 
for dermal exposure;
    3. No use of the PMN substance other than as a reactive monomer for 
use in producing polymers;
    4. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS;
    5. Refraining from domestic manufacture in the United States (i.e., 
import only); and
    6. No release of the PMN substance to the waters of the United 
States.

The SNUR designates as a ``significant new use'' the absence of these 
protective measures.
    Potentially useful information: EPA has determined that certain 
information about the health effects of the PMN substance may be 
potentially useful in support of a request by the PMN submitter to 
modify the Order, or if a manufacturer or processor is considering 
submitting a SNUN for a significant new use that would be designated by 
this SNUR. The submitter has agreed not to exceed the production limit 
without performing specific developmental/reproductive toxicity and 
sensitization testing. EPA has also determined that the results of 
specific fate testing would help characterize the potential health 
effects of the PMN substance. Although the Order does not require these 
tests, the Order's restrictions will remain in effect until the Order 
is modified or revoked by EPA based on submission of this or other 
relevant information.
    CFR citation: 40 CFR 721.11146.

PMN number: P-17-326

    Chemical name: Allyloxymethylacrylate (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: September 5, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as an ultraviolet 
curable monomer. Based on analysis of test data on the PMN substance 
and the physical/chemical properties of the PMN substance, EPA 
identified concerns for oncogenicity, developmental and reproductive 
effects, liver and kidney toxicity, sensitization, and irritation. 
Additionally, the SDS indicates concerns for severe skin and eye damage 
and allergic skin reaction. Based on analysis of acute aquatic toxicity 
data, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 26 ppb. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding 
that in the absence of sufficient information to permit a reasoned 
evaluation the PMN substance may present an unreasonable risk of injury 
to health and the environment. To protect against these risk, the Order 
requires:
    1. Submission of certain toxicity testing on the PMN substance 
prior to exceeding the confidential production volume limit as 
specified in the Order;
    2. Use of personal protective equipment where there is potential 
for dermal exposure;
    3. Use of NIOSH certified respirators with an APF of 10 to prevent 
inhalation exposure where there is potential for inhalation exposure;
    4. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS;
    5. Refraining from domestic manufacture in the United States (i.e., 
import only);
    6. Use of the PMN substance only as specified in the Order; and
    7. No release of the PMN substance into the waters of the United 
States.

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 
substance may be potentially useful in support of a request by the PMN 
submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that would be 
designated by this SNUR. The submitter has agreed not to exceed the 
production limit without performing specific developmental/reproductive 
toxicity and sensitization testing. EPA has also determined that the 
results of specific chronic aquatic toxicity testing would help 
characterize the potential environmental effects of the PMN substance. 
Although the Order does not require these tests, the Order's 
restrictions will remain in effect until the Order is modified or 
revoked by EPA based on submission of this or other relevant 
information.
    CFR citation: 40 CFR 721.11147.

PMN number: P-17-345

    Chemical name: Polyurethane, methacrylate blocked (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: September 6, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as a resin 
intermediate. Based on physical/chemical properties of the PMN 
substance, EPA identified concerns for irritation to skin, eye, lung, 
mucous membranes, and potential neurotoxicity. The Order was issued 
under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a 
finding that in the absence of sufficient information to permit a 
reasoned evaluation the substance may present an unreasonable risk of 
injury to health and the environment. To protect against these risks, 
the Order requires:
    1. Submission of certain toxicity testing within six months from 
the date of the NOC;
    2. Use of personal protective equipment where there is potential 
for dermal exposure;

[[Page 47014]]

    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and SDS;
    4. No manufacturing, processing, or use of the PMN substance in a 
manner that would result in inhalation exposure to vapor, mist, 
aerosol, or dust; and
    5. Use the PMN substance only as specified in the Order.

The SNUR designates as a ``significant new use'' the absence of these 
protective measures.
    Potentially useful information: EPA has determined that certain 
information about the health effects of the PMN substance may be 
potentially useful in support of a request by the PMN submitter to 
modify the Order, or if a manufacturer or processor is considering 
submitting a SNUN for a significant new use that would be designated by 
this SNUR. The submitter has agreed not to exceed the production limit 
without performing specific eye irritation testing.
    CFR citation: 40 CFR 721.11148.

V. Rationale and Objectives of the Rule

A. Rationale

    During review of the PMNs submitted for the chemical substances 
that are subject to these SNURs, EPA concluded that for all 28 chemical 
substances, regulation was warranted under TSCA section 5(e), pending 
the development of information sufficient to make reasoned evaluations 
of the health or environmental effects of the chemical substances. The 
basis for such findings is outlined in Unit IV. Based on these 
findings, TSCA section 5(e) Orders requiring the use of appropriate 
exposure controls were negotiated with the PMN submitters.
    The SNURs identify as significant new uses any manufacturing, 
processing, use, distribution in commerce, or disposal that does not 
conform to the restrictions imposed by the underlying Orders, 
consistent with TSCA section 5(f)(4).

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 listed chemical substance for the described significant 
new use.
     EPA will be able to either determine that the prospective 
manufacture or processing is not likely to present an unreasonable 
risk, or to take necessary regulatory action associated with any other 
determination, before the described significant new use of the chemical 
substance occurs.
     EPA will identify as significant new uses any 
manufacturing, processing, use, distribution in commerce, use, 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.

VI. Direct Final Procedures

    EPA is issuing these SNURs as a direct final rule. The effective 
date of this rule is November 16, 2018 without further notice, unless 
EPA receives written adverse comments before October 17, 2018.
    If EPA receives written adverse comments on one or more of these 
SNURs before October 17, 2018, EPA will withdraw the relevant sections 
of this direct final rule before its effective date.
    This rule establishes SNURs for a number of chemical substances. 
Any person who submits adverse comments must identify the chemical 
substance and the new use to which it applies. EPA will not withdraw a 
SNUR for a chemical substance not identified in the comment.

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 an 
NOC and the chemical substance has not been added to the TSCA 
Inventory, no person may commence such activities without first 
submitting a PMN. Therefore, for chemical substances for which an NOC 
has not been submitted EPA concludes that the designated significant 
new uses are not ongoing.
    When chemical substances identified in this rule are added to the 
TSCA Inventory, EPA recognizes that, before the rule is effective, 
other persons might engage in a use that has been identified as a 
significant new use. However, TSCA section 5(e) Orders have been issued 
for all of the chemical substances, and the PMN submitters are 
prohibited by the TSCA section 5(e) Orders from undertaking activities 
which will be designated as significant new uses. The identities of 24 
of the 28 chemical substances subject to this rule have been claimed as 
confidential and EPA has received no post-PMN bona fide submissions 
(per Sec. Sec.  720.25 and 721.11) for a chemical substance covered by 
this action. Based on this, the Agency believes that it is highly 
unlikely that any of the significant new uses described in the 
regulatory text of this rule are ongoing.
    Therefore, EPA designates September 17, 2018 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 
direct final rule.
    Persons who begin commercial manufacture or processing of the 
chemical substances for a significant new use identified as of that 
date will have to cease any such activity upon the effective date of 
the final rule. To resume their activities, these persons will 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 developing any 
particular new information (e.g., generating test data) before 
submission of a SNUN. There is an exception: development of test data 
is required where the chemical substance subject to the SNUR is also 
subject to a rule, order or consent agreement under TSCA section 4 (see 
TSCA section 5(b)(1)).
    In the absence of a TSCA section 4 test rule covering the chemical 
substance, persons are required only to submit information in their 
possession or control and to describe any other information known to or 
reasonably ascertainable by them (see 40 CFR 720.50). However, upon 
review of PMNs and SNUNs, the Agency has the authority to require 
appropriate testing. Unit IV. lists required or recommended

[[Page 47015]]

testing for all of the listed SNURs. Descriptions of tests are provided 
for informational purposes. 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). To 
access the OCSPP test guidelines referenced in this document 
electronically, please go to http://www.epa.gov/ocspp and select ``Test 
Methods and Guidelines.'' The Organisation for Economic Co-operation 
and Development (OECD) test guidelines are available from the OECD 
Bookshop at http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org.
    In certain of the TSCA section 5(e) Orders for the chemical 
substances regulated under this rule, EPA has established production 
volume limits in view of the lack of data on the potential health and 
environmental risks that may be posed by the significant new uses or 
increased exposure to the chemical substances. These limits cannot be 
exceeded unless the PMN submitter first submits the results of toxicity 
tests that would permit a reasoned evaluation of the potential risks 
posed by these chemical substances. Listings of the tests specified in 
the TSCA section 5(e) Orders are included in Unit IV. The SNURs contain 
the same production volume limits as the TSCA section 5(e) Orders. 
Exceeding these production limits is defined as a significant new use. 
Persons who intend to exceed the production limit must notify the 
Agency by submitting a SNUN at least 90 days in advance of commencement 
of non-exempt commercial manufacture or processing.
    Any request by EPA for the triggered and pended testing described 
in the Orders was made based on EPA's consideration of available 
screening-level data, if any, as well as other available information on 
appropriate testing for the PMN substances. Further, any such testing 
request on the part of EPA that includes testing on vertebrates was 
made after consideration of available toxicity information, 
computational toxicology and bioinformatics, and high-throughput 
screening methods and their prediction models.
    Potentially useful information identified in Unit IV. may not be 
the only means of addressing the potential risks of the chemical 
substance. However, submitting a SNUN without any test data may 
increase the likelihood that EPA will take action under TSCA section 
5(e), particularly if satisfactory test results have not been obtained 
from a prior PMN or SNUN submitter. 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.  
[emsp14]721.1725(b)(1) with that under Sec.  [emsp14]721.11 into a 
single step.
    If EPA determines that the use identified in the bona fide 
submission would not be a significant new use, i.e., the use does not 
meet the criteria specified in the rule for a significant new use, that 
person can manufacture or process the chemical substance so long as the 
significant new use trigger is not met. In the case of a production 
volume trigger, this means that the aggregate annual production volume 
does not exceed that identified in the bona fide submission to EPA. 
Because of confidentiality concerns, EPA does not typically disclose 
the actual production volume that constitutes the use trigger. Thus, if 
the person later intends to exceed that volume, a new bona fide 
submission would be necessary to determine whether that higher volume 
would be a significant new use.

X. SNUN Submissions

    According to Sec.  [emsp14]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-2018-0567.

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, or TSCA section 5(e) 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

[[Page 47016]]

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)

    On February 18, 2012, EPA certified pursuant to RFA section 605(b) 
(5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a 
significant economic impact on a substantial number of small entities 
where the following are true:
    1. A significant number of SNUNs would not be submitted by small 
entities in response to the SNUR.
    2. The SNUR submitted by any small entity would not cost 
significantly more than $8,300.
    A copy of that certification is available in the docket for this 
action.
    This action is within the scope of the February 18, 2012 
certification. Based on the Economic Analysis discussed in Unit XI. and 
EPA's experience promulgating SNURs (discussed in the certification), 
EPA believes that the following are true:
     A significant number of SNUNs would not be submitted by 
small entities in response to the SNUR.
     Submission of the SNUN would not cost any small entity 
significantly more than $8,300.

    Therefore, the promulgation of the SNUR would not have a 
significant economic impact on a substantial number of small entities.

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).

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: September 5, 2018.
Jeffery T. Morris,
Director, Office of Pollution Prevention and Toxics.
    Therefore, 40 CFR parts 9 and 721 are amended as follows:

[[Page 47017]]

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.  14;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
 
------------------------------------------------------------------------
                                * * * * *
721.11124...............................................       2070-0012
721.11125...............................................       2070-0012
721.11126...............................................       2070-0012
721.11127...............................................       2070-0012
721.11128...............................................       2070-0012
721.11129...............................................       2070-0012
721.11130...............................................       2070-0012
721.11131...............................................       2070-0012
721.11132...............................................       2070-0012
721.11133...............................................       2070-0012
721.11134...............................................       2070-0012
721.11135...............................................       2070-0012
721.11136...............................................       2070-0012
721.11137...............................................       2070-0012
721.11138...............................................       2070-0012
721.11139...............................................       2070-0012
721.11140...............................................       2070-0012
721.11141...............................................       2070-0012
721.11142...............................................       2070-0012
721.11143...............................................       2070-0012
721.11144...............................................       2070-0012
721.11145...............................................       2070-0012
721.11146...............................................       2070-0012
721.11147...............................................       2070-0012
721.11148...............................................       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.  14;721.11124 to subpart E to read as follows:


Sec.  721.11124  2-Propenenitrile, polymer with methanamine, 
hydrogenated, 3-aminopropylterminated, ethoxylated propoxylated.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2-Propenenitrile, 
polymer with methanamine, hydrogenated, 3-aminopropylterminated, 
ethoxylated propoxylated (PMN P-14-758; CAS No. 2055838-16-7) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section. The requirements of this 
section do not apply to quantities of the PMN substance after they have 
been completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(3) through (5) (respirators must provide a 
National Institute for Occupational Safety and Health assigned 
protection factor of at least 50), and (a)(6)(v), (particulate), (when 
determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(1) and (4), engineering control measures 
(e.g. enclosure or confinement of operation, general and local 
ventilation) or administrative control measures (e.g. workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible), Sec.  721.63(b) (concentration set at 1.0%), 
and Sec.  721.63(c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (e) (concentration set at 1.0%), (f), 
(g)(1)(ii), (g)(2)(ii), (g)(4)(iii), and (g)(5). Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (k). A significant new use is any 
spray application method that results in greater worker inhalation 
exposures to vapor, mist, or aerosol than the roller coating 
application.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

0
5. Add Sec.  14;721.11125 to subpart E to read as follows:


Sec.  721.11125  Dicarboxylic acids, polymers with alkyl prop-2-enoate, 
alkyl 2-ethylprop-2-enoate, alkyl[(alkenyl)alkyl]alkanediol, 
alkanediol, alkanedioic acid, alkyl 2-rnethylprop-2-enoate, alkyl prop-
2-enoic acid, alkylene [isocyanatocarbomonocyte] and alkanediol, 
alkanolamine-blocked, compds with 2-(alkylamino)alkanol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
dicarboxylic acids, polymers with alkyl prop-2-enoate, alkyl 2-
ethylprop-2-enoate, alkyl[(alkenyl)alkyl]alkanediol, alkanediol, 
alkanedioic acid, alkyl 2-methylprop-2-enoate, alkyl prop-2-enoic acid, 
alkylene [isocyanatocarbomonocyte] and alkanediol, alkanolamine-
blocked, compds with 2-(alkylamino)alkanol (P-16-493) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section. The requirements of this section do 
not apply to quantities of the substance after they have been reacted 
(cured).
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f). It is a significant new use to import 
the PMN substance to contain more than 0.1% residual isocyanate by 
weight. It is a significant new use to import the PMN substance to 
contain more than 1% of a confidential component by weight.
    (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.
    (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.

0
6. Add Sec.  721.11126 to subpart E to read as follows:

[[Page 47018]]

Sec.  721.11126  Mixed metal oxide (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as a mixed 
metal oxide (P-16-514) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(3) through (5) (respirators must provide a National 
Institute for Occupational Safety and Health assigned protection factor 
of at least 1,000), and (a)(6) (particulate), (when determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or 
confinement of operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible), Sec.  721.63(b) (concentration set at 1.0%), and Sec.  
721.63(c).
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA section 5(e) Order for this substance. The NCEL is 0.04 mg/m\3\ as 
an 8-hour time weighted average. Persons who wish to pursue NCELs as an 
alternative to Sec.  721.63 respirator requirements may request to do 
so under Sec.  721.30. Persons whose Sec.  721.30 requests to use the 
NCELs approach are approved by EPA will be required to follow NCELs 
provisions comparable to those contained in the corresponding TSCA 
section 5(e) Order.
    (B) [Reserved]
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(iv), 
(lung toxicity if inhaled), (eye irritation), (allergic skin reaction), 
(g)(2)(i) through (iii) and (v) (use respiratory protection or maintain 
workplace airborne concentrations at or below an 8-hour time-weighted 
average of 0.04 mg/m\3\), (g)(4)(i), and (g)(5). Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, Commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(e), (f), (k), and (q).
    (iv) Disposal. Requirements as specified in Sec.  721.85. It is a 
significant new use to dispose of the PMN substance other than by 
recycling as described in the Order.
    (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 (j) 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.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraphs (a)(2)(iii) 
and (iv) of this section.

0
7. Add Sec.  721.11127 to subpart E to read as follows:


Sec.  721.11127  Modified alkyl polyamine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
modified alkyl polyamine (PMN P-16-576) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (a)(6) (particulate), 
(vapor), (when determining which persons are reasonably likely to be 
exposed as required for Sec.  721.63(a)(1), engineering control 
measures (e.g., enclosure or confinement of the operation, general and 
local ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible), Sec.  721.63(b) (concentration set at 1.0%), 
and Sec.  721.63(c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), 
(ii), (vi), (viii), (g)(2)(i) through (iii) and (v), (g)(3)(i) and 
(ii), and (g)(5). Alternative hazard and warning statements that meet 
the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k). It is a significant new use to 
manufacture the chemical substance more than 9 months.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i), are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

0
8. Add Sec.  721.11128 to subpart E to read as follows:


Sec.  721.11128  Alkyl polyamine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as alkyl 
polyamine (PMN P-16-577) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i)(iii), (a)(3), (a)(6)(v), (a)(6) (particulate), 
(when determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(1), engineering control measures (e.g., 
enclosure or confinement of the operation, general and local 
ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible), Sec.  721.63(b) (concentration set at 1.0%), 
and Sec.  721.63(c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), 
(ii), (vi), (viii), (g)(2)(i) through (iii) and (v), (g)(3)(i) and 
(ii), and (g)(5). Alternative hazard and warning statements that meet 
the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k). It is a significant new use to 
manufacture the chemical substance more than 9 months.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 2.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) and (k) are

[[Page 47019]]

applicable to manufacturers and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

0
9. Add Sec.  721.11129 to subpart E to read as follows:


Sec.  721.11129  Silica gel, reaction products with chromium oxide 
(CrO3) and ethoxydiethyl aluminum.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as silica gel, 
reaction products with chromium oxide (CrO3) and ethoxydiethyl aluminum 
is (P-16-590, CAS No. 932384-12-8) 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) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1) and (a)(3) through (5) (respirators must provide a 
National Institute for Occupational Safety and Health assigned 
protection factor of 10 to 1,000 depending on the results of the 
exposure monitoring as described in the Order for P16-590 and required 
by this section (a)(2)(i), (a)(6) (particulate), and (a)(6) (vapor), 
(when determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(1) and (4) engineering control measures 
(e.g. enclosure or confinement of operation, general and local 
ventilation) or administrative control measures (e.g. workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible), Sec.  721.63(b) (concentration set at 0.1%), 
and Sec.  721.63(c). It is a significant new use to not conduct the 
exposure monitoring required in the Order for P16-590 when workers are 
reasonably likely to be exposed by inhalation.
    (ii) Industrial, Commercial, and consumer activities. Requirements 
as specified in Sec.  721.80. It is a significant new use to 
manufacture, process, or use the PMN substance other than in a system 
where the PMN substance is handled in an inert atmosphere and is not 
designed to be exposed to air.
    (iii) Disposal. Requirements as specified in Sec.  721.85. It is a 
significant new use to dispose of all waste streams containing the PMN 
substance and the constituent breakdown products of the PMN substance 
other than in a Resource Conservation and Recovery Act hazardous waste 
landfill.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (e), (i), and (j) 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.

0
10. Add Sec.  14;721.11130 to subpart E to read as follows:


Sec.  721.11130  Carboxylic acids, C6-18 and C5-15-di-, polymers with 
diethylene glycol, glycerol, sorbitol and terephthalic acid.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as carboxylic acids, 
C6-18 and C5-15-di-, polymers with diethylene glycol, glycerol, 
sorbitol and terephthalic acid (P-16-593, CAS No. 1967778-37-5) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section. The requirements of this 
section do not apply to quantities of the substance after they have 
been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) and (iii), and (a)(3), (when determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1), engineering control measures (e.g. enclosure or 
confinement of operation, general and local ventilation) or 
administrative control measures (e.g. workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible), Sec.  721.63(b) (concentration set at 1.0%), and Sec.  
721.63(c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(ii), 
(irritation), (g)(2)(i) through (iii) and (v), and (g)(5). Alternative 
hazard and warning statements that meet the criteria of the Globally 
Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, Commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k)(aromatic polyester polyol for rigid 
foam). It is a significant new use to manufacture, process, or use the 
PMN substance to result in inhalation exposure to a vapor, mist or 
aerosol.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
11. Add Sec.  14;721.11131 to subpart E to read as follows:


Sec.  721.11131   1-tetradecene homopolymer hydrogenated.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1-tetradecene 
homopolymer hydrogenated (PMN P-17-5, CAS No. 1857296-89-9) 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) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(ii), 
(g)(2)(ii), and (g)(5). Alternative hazard and warning statements that 
meet the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k)(base fluid/carrier fluid for additives 
in motor oil, automatic transmission fluid, and industrial lubricants). 
It is a significant new use to manufacture the chemical substance more 
than 9 months. It is a significant new use to manufacture, process, or 
use the PMN substance to resuls in inhalation exposure to a vapor, mist 
or aerosol.
    (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 (f) through (i) are applicable to 
manufacturers and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
12. Add Sec.  14;721.11132 to subpart E to read as follows:


Sec.  721.11132   Fluorocyanophenyl alkylbenzoate (generic)

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances generically identified as 
fluorocyanophenyl alkylbenzoate (P-17-149), (P-17-150), (P-17-151), and 
(P-17-165) are subject

[[Page 47020]]

to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (iii), and (iv), (a)(3), and (a)(6)(v), 
(particulate), (when determining which persons are reasonably likely to 
be exposed as required for Sec.  721.63(a)(1), engineering control 
measures (e.g. enclosure or confinement of operation, general and local 
ventilation) or administrative control measures (e.g. workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible), Sec.  721.63(b) (concentration set at 1.0%) 
and Sec.  721.63(c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i) 
through (iii), (iv), (vi), and (ix), (g)(2)(i), (ii), (iii), and (v), 
(g)(3)(i) and (ii), and (g)(5). Alternative hazard and warning 
statements that meet the criteria of the Globally Harmonized System and 
OSHA Hazard Communication Standard may be used.
    (iii) Industrial, Commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) and (q). It is a significant new use to 
manufacture, process, or use the PMN substance to result in inhalation 
exposures to vapor, dust, mist, or aerosols to the substance.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 2 for P-17-165 and N = 4 for 
P-17-149, P-17-150, and P-17-151.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) and (k) are applicable to manufacturers, 
importers, and processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

0
13. Add Sec.  14;721.11133 to subpart E to read as follows:


Sec.  721.11133   Fluorinated propenoic poly alkyl ether ester 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
fluorinated propenoic poly alkyl ether ester (P-17-175) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section. The requirements of this section do 
not apply to quantities of the substance after they have been reacted 
(cured).
    (2) The significant new uses are:
    (i) Industrial, Commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (t)(60 kilograms). It is a 
significant new use to use the substance other than as a leveling agent 
for coatings applied to aluminum printing plates.
    (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 significant new use rule.

0
14. Add Sec.  14;721.11134 to subpart E to read as follows:


Sec.  721.11134   Oxyalkylene urethane polyolefin (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
oxyalkylene urethane polyolefin (PMN P-17-199) 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. It is a new use the manufacture 
(including import) the PMN substance with an average molecular weight 
greater than specified in the Order or with more than 1% of the 
molecular weight content below 1,000 Daltons.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (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.
    (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.

0
15. Add Sec.  14;721.11135 to subpart E to read as follows:


Sec.  721.11135   Imino alkane amine phosphate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as imino 
alkane amine phosphate (P-17-206) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section. The requirements of this section do not apply to 
quantities of the substance after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (a)(6)(v), 
(particulate), (when determining which persons are reasonably likely to 
be exposed as required for Sec.  721.63(a)(1), engineering control 
measures (e.g. enclosure or confinement of operation, general and local 
ventilation) or administrative control measures (e.g. workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible), Sec.  721.63(b) (concentration set at 1.0%) 
and Sec.  721.63(c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), 
(g)(2)(i) and (v), (g)(3)(i) and (ii), (g)(4)(iii), and (g)(5), 
Alternative hazard and warning statements that meet the criteria of the 
Globally Harmonized System and OSHA Hazard Communication Standard may 
be used.
    (iii) Industrial, Commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (k). It is a significant new use to 
modify processing or use if it results in inhalation exposure to vapor, 
dust, mist, or aerosols to the substance.
    (iv) Disposal. Requirements as specified in Sec.  721.85(a)(1), 
(b)(1), and (c)(1).
    (v) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (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.

[[Page 47021]]

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

0
16. Add Sec.  14;721.11136 to subpart E to read as follows:


Sec.  721.11136   Fatty acids, tall-oil, reaction products with 2-[(2-
aminoalkyl)amino]alkanol, compds. with alkylene oxide-glycidyl o-tolyl 
ether polymer dihydrogen phosphate alkyl ether (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as fatty 
acids, tall-oil, reaction products with 2-[(2-aminoalkyl)amino]alkanol, 
compds. with alkylene oxide-glycidyl o-tolyl ether polymer dihydrogen 
phosphate alkyl ether (P-17-223) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section. The requirements of this section do not apply to 
quantities of the substance after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(3), and (a)(6)(v), (particulate), (when 
determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(1) and, engineering control measures (e.g. 
enclosure or confinement of operation, general and local ventilation) 
or administrative control measures (e.g. workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible), Sec.  721.63(b) (concentration set at 1.0%) and Sec.  
721.63(c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i) and 
(ii), (g)(2)(i), (ii), and (v), (g)(3)(i) and (ii), and (g)(5), 
Alternative hazard and warning statements that meet the criteria of the 
Globally Harmonized System and OSHA Hazard Communication Standard may 
be used.
    (iii) Industrial, Commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k), and (q). It is a significant new 
use to modify any processing if such modification would result in 
inhalation exposures to the PMN substance by vapor, dust, mist, or 
aerosol, at a concentration of greater than 1 percent by weight or 
volume. It is a significant new use to use the PMN substance in the 
confidential formulation identified in the Order at concentration 
greater than 1 percent by weight or volume. It is a significant new use 
to manufacture, process, or use the substance for consumer use or for 
commercial uses that could introduce the substance into a consumer 
setting.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 15.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) 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.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

0
17. Add Sec.  14;721.11137 to subpart E to read as follows:


Sec.  721.11137   Oxirane, 2-alkyl-, polymer with oxirane, mono[N-[3-
(carboxyamino)-4(or 6)-alkylphenyl]carbamate], alkyl ether, ester with 
2,2',2''-nitrilotris-[alkanol] (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
oxirane, 2-alkyl-, polymer with oxirane, mono[N-[3-(carboxyamino)-4(or 
6)-alkylphenyl]carbamate], alkyl ether, ester with 2,2',2''-
nitrilotris-[alkanol] (P-17-230) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section. The requirements of this section do not apply to 
quantities of the substance after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (a)(6)(v), 
(particulate), (when determining which persons are reasonably likely to 
be exposed as required for Sec.  721.63(a)(1), engineering control 
measures (e.g. enclosure or confinement of operation, general and local 
ventilation) or administrative control measures (e.g. workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible), Sec.  721.63(b) (concentration set at 1.0%) 
and Sec.  721.63(c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i) and 
(ii), (eye irritation), (g)(2)(i), (ii), and (v), (g)(3)(i) and (ii), 
and (g)(5). Alternative hazard and warning statements that meet the 
criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, Commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k), and (q). It is a significant new 
use to modify processing methods if such modification would result in 
inhalation exposures to the PMN substance by vapor, dust, mist, or 
aerosol, at a concentration of greater than 1 percent by weight or 
volume. It is a significant new use to use the PMN substance in the 
confidential formulation at a concentration greater than 1 percent by 
weight or volume. It is a significant new use to manufacture, process, 
or use the substance for consumer use or for commercial uses that could 
introduce the substance into a consumer setting.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 65.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) 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.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

0
18. Add Sec.  14;721.11138 to subpart E to read as follows:


Sec.  721.11138   Formaldehyde, polymer with (chloromethyl) oxirane and 
substituted aromatic compounds (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
formaldehyde, polymer with (chloromethyl) oxirane and substituted 
aromatic compounds (P-17-236) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section. The requirements of this section do not apply to the PMN 
substance after it has been incorporated into the confidential forms 
identified in the Order.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (iii), and (iv), (a)(3), and (a)(6) 
(particulate), (when determining which persons are reasonably likely to 
be exposed as required for Sec.  721.63(a)(1), engineering

[[Page 47022]]

control measures (e.g. enclosure or confinement of operation, general 
and local ventilation) or administrative control measures (e.g. 
workplace policies and procedures) shall be considered and implemented 
to prevent exposure, where feasible), Sec.  721.63(b) (concentration 
set at 1.0%), and Sec.  721.63(c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(ii), 
(vi), (vii), and (ix), (skin sensitization), (g)(2)(i), (ii), (iii), 
and (v), and (g)(5). Alternative hazard and warning statements that 
meet the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, Commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k), and (q). It is a significant new 
use to modify manufacture, processing, or use if it results in 
inhalation exposure to vapor, dust, mist, or aerosols to the substance.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, 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 paragraphs (a)(1) and 
(a)(2)(iii) of this section.

0
19. Add Sec.  14;721.11139 to subpart E to read as follows:


Sec.  721.11139   Acid, reaction products with cadmium selenide (CdSe), 
trioctylphosphine and trioctylphosphine oxide (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as acid, 
reaction products with cadmium selenide (CdSe), trioctylphosphine and 
trioctylphosphine oxide (PMN P-17-241) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), and (a)(3) and (6) (particulate), (when 
determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(1), engineering control measures (e.g., 
enclosure or confinement of the operation, general and local 
ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible), and Sec.  721.63(c).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(g) and (y)(1). It is a significant new use 
to manufacture, process, or use the substance other than in a liquid 
formulation.
    (iii) Disposal. Requirements as specified in Sec.  721.85. It is a 
significant new use to dispose of the substance and any waste stream 
containing the substance other than in a permitted hazardous waste 
incinerator.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (e), (i), and (j) are applicable to manufacturers 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
20. Add Sec.  14;721.11140 to subpart E to read as follows:


Sec.  721.11140   Acid, reaction products with cadmium selenide 
sulfide, acid, trioctylphosphine and trioctylphosphine oxide (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as acid, 
reaction products with cadmium selenide sulfide, acid, 
trioctylphosphine and trioctylphosphine oxide (PMN P-17-242), is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), and (a)(3) and (6) (particulate), (when 
determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(1), engineering control measures (e.g., 
enclosure or confinement of the operation, general and local 
ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible), and Sec.  721.63(c).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(g) and (y)(1). It is a significant new use 
to manufacture, process, or use the substance other than in a liquid 
formulation.
    (iii) Disposal. Requirements as specified in Sec.  721.85. It is a 
significant new use to dispose of the substance and any waste stream 
containing the substance other than in a permitted hazardous waste 
incinerator.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (e), (i), and (j) are applicable to manufacturers 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
21. Add Sec.  721.11141 to subpart E to read as follows:


Sec.  721.11141   Acid, reaction products with cadmium metal selenide 
sulfide, trioctylphosphine and trioctylphosphine oxide (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as acid, 
reaction products with cadmium metal selenide sulfide, 
trioctylphosphine and trioctylphosphine oxide (PMN P-17-243), is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), and (a)(3) and (6) (particulate), (when 
determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(1), engineering control measures (e.g., 
enclosure or confinement of the operation, general and local 
ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible), and Sec.  721.63(c).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(g) and (y)(1). It is a significant new use 
to manufacture, process, or use the substance other than in a liquid 
formulation.
    (iii) Disposal. Requirements as specified in Sec.  721.85. It is a 
significant new use to dispose of the substance and any waste stream 
containing the substance other than in a permitted hazardous waste 
incinerator.
    (b) Specific requirements. The provisions of subpart A of this part

[[Page 47023]]

apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (e), (i), and (j) are applicable to manufacturers 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
22. Add Sec.  721.11142 to subpart E to read as follows:


Sec.  721.11142   Metal oxide reaction products with cadmium metal 
selenide sulfide, and amine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as metal 
oxide reaction products with cadmium metal selenide sulfide, and amine 
(PMN P-17-244) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(3) through (5) (respirators must provide a 
National Institute for Occupational Safety and Health assigned 
protection factor (APF) of at least 50), and (a)(6)(particulate), (when 
determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(1) and (4), engineering control measures 
(e.g., enclosure or confinement of the operation, general and local 
ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible), and Sec.  721.63(c). It is a significant new 
use to handle the solid form of the substance without use of a fume 
hood or glove box.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(q), (k) (down converting phosphor particle 
for use in conjunction with optoelectronic components), and (y)(1) and 
(2).
    (iii) Disposal. Requirements as specified in Sec.  721.85. It is a 
significant new use to dispose of the substance and any waste stream 
containing the substance other than in a permitted hazardous waste 
incinerator.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (e), (i), and (j) are applicable to manufacturers 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use us subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(ii) of 
this section.

0
23. Add Sec.  721.11143 to subpart E to read as follows:


Sec.  721.11143   Alkanoic acid, 2-alkyl-, substituted alkyl ester, 
polymer with alkyl alkenoate, substituted carbomonocycle, substituted 
alkyl alkenoate and alkyl substituted alkenoate, substituted 
alkanenitrile-initiated (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
alkanoic acid, 2-alkyl-, substituted alkyl ester, polymer with alkyl 
alkenoate, substituted carbomonocycle, substituted alkyl alkenoate and 
alkyl substituted alkenoate, substituted alkanenitrile-initiated (PMN 
P-17-265) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section. The 
requirements of this section do not apply to quantities of the 
substance after they have been completely reacted or cured.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80. It is a significant new use to 
manufacture the PMN substance with an acid concentration greater than 
20%. It is a significant new use to manufacture the PMN substance with 
an amine concentration greater than 5%.
    (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), (b), (c), and (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
24. Add Sec.  721.11144 to subpart E to read as follows:


Sec.  721.11144  Manganese heterocyclic-amine carboxylate complexes 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
manganese heterocyclic-amine carboxylate complexes (PMN P-17-301) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section. The requirements of this 
Order do not apply to quantities of the PMN substance after they have 
been entrained in cured coating or ink.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(3) through (5) (respirators must provide a National 
Institute for Occupational Safety and Health (NIOSH) assigned 
protection factor (APF) of at least 10), and (a)(6) (particulate), 
(when determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(1) and (4), engineering control measures 
(e.g. enclosure or confinement of operation, general and local 
ventilation) or administrative control measures (e.g. workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible), Sec.  721.63(b) (concentration set at 1.0%), 
and Sec.  721.63(c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i) 
through (iii) and (ix), (eye irritation), (g)(2)(ii) through (iv), 
(avoid skin and eye contact), (use skin and eye protection), and 
(g)(5). Alternative hazard and warning statements that meet the 
criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (surface drier in clear and pigmented 
coatings systems) and (p) (430,000 kilograms).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
25. Add Sec.  721.11145 to subpart E to read as follows:


Sec.  721.11145   Sulfuric acid mixed salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
sulfuric acid mixed salt (PMN P-17-318) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(3), and (a)(6)(v), (particulate), (when

[[Page 47024]]

determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(1), engineering control measures (e.g. 
enclosure or confinement of operation, general and local ventilation) 
or administrative control measures (e.g. workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible), Sec.  721.63(b) (concentration set at 1.0%), and Sec.  
721.63(c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), 
(irritation to eye, respiratory, and GI tract), (corrosion), (acute 
toxicity), (g)(2)(i) and (iii), and (g)(5). Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) and (q). It is a significant new use to 
manufacture of the PMN substance with more than 1% free ammonia 
content.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

0
26. Add Sec.  721.11146 to subpart E to read as follows:


Sec.  721.11146   2-Propenoic acid, branched alkyl ester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 2-
propenoic acid, branched alkyl ester (PMN P-17-323) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section. The requirements of this section do 
not apply to quantities of the substance after they have been reacted 
(cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (iii), and (iv), (a)(3), and (a)(6)(v), 
(particulate), (when determining which persons are reasonably likely to 
be exposed as required for Sec.  721.63(a)(1), engineering control 
measures (e.g. enclosure or confinement of operation, general and local 
ventilation) or administrative control measures (e.g. workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible), Sec.  721.63(b) (concentration set at 1.0%), 
and Sec.  721.63(c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), and (g)(1)(iv) 
and (ix), (skin and eye irritation), (oncogenicity), (sensitization), 
(g)(2)(i), (iii), and (v), (use eye protection), (g)(4)(iii), and 
(g)(5). Alternative hazard and warning statements that meet the 
criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k) (reactive monomer for use in 
producing polymers), and (q).
    (iv) Release to water. Release to water requirements as specified 
in Sec.  721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) and (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

0
27. Add Sec.  721.11147 to subpart E to read as follows:


Sec.  721.11147  Allyloxymethylacrylate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
allyloxymethylacrylate (PMN P-17-326) is subject to reporting under 
this section for the significant new uses as described in paragraph 
(a)(2) of this section. The requirements of this section do not apply 
to quantities of the substance after they have been completely reacted 
(cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (iii), and (iv), (a)(3) through (5) 
(respirators must provide a National Institute for Occupational Safety 
and Health assigned protection factor of at least 10), and (a)(6)(v), 
(particulate), (when determining which persons are reasonably likely to 
be exposed as required for Sec.  721.63(a)(1) and (4), engineering 
control measures (e.g., enclosure or confinement of the operation, 
general and local ventilation) or administrative control measure (e.g., 
workplace policies and procedures) shall be considered and implemented 
to prevent exposure, where feasible), Sec.  721.63(b) (concentration 
set at 1.0%), and Sec.  721.63(c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), 
(iv), (vi), and (ix), (sensitization), (g)(2)(i) through (v), (g)(3)(i) 
and (ii), (g)(4)(iii), and (g)(5). Alternative hazard and warning 
statements that meet the criteria of the Globally Harmonized System and 
OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k), and (q).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Requirements as specified in Sec.  721.125(a) 
through (i), and (k) are applicable to manufacturers and processors of 
this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

0
28. Add Sec.  721.11148 to subpart E to read as follows:


Sec.  721.11148   Polyurethane, methacrylate blocked (generic).

    (a) Chemical substance and significant new sues subject to 
reporting. (1) The chemical substance generically identified as 
polyurethane, methacrylate blocked (PMN P-17-345) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section. The requirements of this section do 
not apply to quantities of the substance after they have been 
completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i)(iii), (a)(3), and (a)(6)(v), (particulate), 
(when determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(1), engineering

[[Page 47025]]

control measures (e.g., enclosure or confinement of the operation, 
general and local ventilation) or administrative control measure (e.g., 
workplace policies and procedures) shall be considered and implemented 
to prevent exposure, where feasible), Sec.  721.63(b) (concentration 
set at 1.0%), and Sec.  721.63(c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), 
(g)(1)(irritation to skin, eyes, lungs, and mucous membranes), 
(g)(2)(i) through (iii) and (v), and (g)(5). Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k). It is a significant new use to 
manufacture the chemical substance more than 6 months. It is a 
significant new use to modify manufacture, processing, or use if it 
results in inhalation exposure to vapor, dust, mist, or aerosols to the 
substance.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except ss modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

[FR Doc. 2018-19950 Filed 9-14-18; 8:45 am]
 BILLING CODE 6560-50-P