83 FR 47004 - Significant New Use Rules on Certain Chemical Substances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 83, Issue 180 (September 17, 2018)
Federal Register Volume 83, Issue 180 (September 17, 2018)
| Page Range | 47004-47025 | |
| FR Document | 2018-19950 |
[Federal Register Volume 83, Number 180 (Monday, September 17, 2018)] [Rules and Regulations] [Pages 47004-47025] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-19950] [[Page 47003]] Vol. 83 Monday, No. 180 September 17, 2018 Part II Environmental Protection Agency ----------------------------------------------------------------------- 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]] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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
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ENVIRONMENTAL PROTECTION or other information whose disclosure is at 40 CFR part 707, subpart B. In
AGENCY restricted by statute. addition, any persons who export or
• Mail: Document Control Office intend to export a chemical substance
40 CFR Parts 9 and 721 (7407M), Office of Pollution Prevention that is the subject of this rule on or after
and Toxics (OPPT), Environmental October 17, 2018 are subject to the
[EPA–HQ–OPPT–2018–0567; FRL–9983–14]
Protection Agency, 1200 Pennsylvania export notification provisions of TSCA
RIN 2070–AB27 Ave., NW, Washington, DC 20460–0001. section 12(b) (15 U.S.C. 2611(b)) (see
• Hand Delivery: To make special § 721.20), and must comply with the
Significant New Use Rules on Certain arrangements for hand delivery or export notification requirements in 40
Chemical Substances delivery of boxed information, please CFR part 707, subpart D.
AGENCY: Environmental Protection follow the instructions at http://
www.epa.gov/dockets/contacts.html. B. What should I consider as I prepare
Agency (EPA). my comments for EPA?
Additional instructions on
ACTION: Direct final rule.
commenting or visiting the docket, 1. Submitting CBI. Do not submit this
SUMMARY: EPA is promulgating along with more information about information to EPA through
significant new use rules (SNURs) under dockets generally, is available at http:// regulations.gov or email. Clearly mark
the Toxic Substances Control Act www.epa.gov/dockets. part or all of the information that you
(TSCA) for 28 chemical substances FOR FURTHER INFORMATION CONTACT: For claim to be CBI. For CBI information in
which were the subject of technical information contact: Kenneth a disk or CD–ROM that you mail to EPA,
premanufacture notices (PMNs). The Moss, Chemical Control Division mark the outside of the disk or CD–ROM
chemical substances are subject to (7405M), Office of Pollution Prevention as CBI and then identify electronically
Orders issued by EPA pursuant to the and Toxics, Environmental Protection within the disk or CD–ROM the specific
TSCA. This action requires persons who Agency, 1200 Pennsylvania Ave., NW, information that is claimed as CBI. In
intend to manufacture (defined by Washington, DC 20460–0001; telephone addition to one complete version of the
statute to include import) or process any number: (202) 564–9232; email address: comment that includes information
of these 28 chemical substances for an moss.kenneth@epa.gov. claimed as CBI, a copy of the comment
activity that is designated as a For general information contact: The that does not contain the information
significant new use by this rule to notify TSCA-Hotline, ABVI-Goodwill, 422 claimed as CBI must be submitted for
EPA at least 90 days before commencing South Clinton Ave., Rochester, NY inclusion in the public docket.
that activity. The required notification 14620; telephone number: (202) 554– Information so marked will not be
initiates EPA’s evaluation of the 1404; email address: TSCA-Hotline@ disclosed except in accordance with
intended use within the applicable epa.gov. procedures set forth in 40 CFR part 2.
review period. Persons may not SUPPLEMENTARY INFORMATION: 2. Tips for preparing your comments.
commence manufacture or processing When preparing and submitting your
for the significant new use until EPA I. General Information comments, see the commenting tips at
has conducted a review of the notice, A. Does this action apply to me? http://www.epa.gov/dockets/
made an appropriate determination on comments.html.
You may be potentially affected by
the notice, and has taken such actions this action if you manufacture, process, II. Background
as are required with that determination. or use the chemical substances
DATES: This rule is effective on A. What action is the Agency taking?
contained in this rule. The following list
November 16, 2018. For purposes of of North American Industrial 1. Direct Final Rule. EPA is
judicial review, this rule shall be Classification System (NAICS) codes is promulgating these SNURs using direct
promulgated at 1 p.m. (e.s.t.) on October not intended to be exhaustive, but rather final rule procedures. These SNURs will
1, 2018. provides a guide to help readers require persons to notify EPA at least 90
Written adverse comments on one or determine whether this document days before commencing the
more of these SNURs must be received applies to them. Potentially affected manufacture or processing of a chemical
on or before October 17, 2018 (see Unit entities may include: substance for any activity designated by
VI. of the SUPPLEMENTARY INFORMATION). • Manufacturers or processors of one these SNURs as a significant new use.
If EPA receives written adverse or more subject chemical substances Receipt of such notices obligates EPA to
comments, on one or more of these (NAICS codes 325 and 324110), e.g., assess risks that may be associated with
SNURs before October 17, 2018, EPA chemical manufacturing and petroleum the significant new uses under the
will withdraw the relevant sections of refineries. conditions of use and, if appropriate, to
this direct final rule before its effective This action may also affect certain regulate the proposed uses before they
date. entities through pre-existing import occur.
For additional information on related certification and export notification 2. Proposed Rule. In addition to this
reporting requirement dates, see Units rules under TSCA. Chemical importers Direct Final Rule, elsewhere in this
I.A., VI., and VII. of the SUPPLEMENTARY are subject to the TSCA section 13 (15 issue of the Federal Register, EPA is
INFORMATION. U.S.C. 2612) import certification issuing a Notice of Proposed
ADDRESSES: Submit your comments, requirements promulgated at 19 CFR Rulemaking for this rule. If EPA receives
identified by docket identification (ID) 12.118 through 12.127 and 19 CFR no adverse comment, the Agency will
number EPA–HQ–OPPT–2018–0567, by 127.28. Chemical importers must certify not take further action on the proposed
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one of the following methods: that the shipment of the chemical rule and the direct final rule will
• Federal eRulemaking Portal: http:// substance complies with all applicable become effective as provided in this
www.regulations.gov. Follow the online rules and orders under TSCA. Importers action. If EPA receives adverse comment
instructions for submitting comments. of chemicals subject to these SNURs on one or more of SNURs in this action
Do not submit electronically any must certify their compliance with the by October 2, 2018 (see Unit VI. of the
information you consider to be SNUR requirements. The EPA policy in SUPPLEMENTARY INFORMATION), the
Confidential Business Information (CBI) support of import certification appears Agency will publish in the Federal
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risk of injury to human health via 1. Refraining from manufacturing the Effective date of TSCA section 5(e)
inhalation exposure, the underlying PMN substance in the United States (i.e. Order: September 18, 2017.
TSCA section 5(e) Order required, import only); Basis for TSCA section 5(e) Order:
among other things, that potentially 2. Use of personal protective The PMN states that the generic (non-
exposed employees wear specified equipment where there is a potential for confidential) use of the substance will
respirators unless actual measurements dermal exposure; be as paint. Based on physical/chemical
of the workplace air show that air-borne 3. Use of a National Institute of properties of the PMN substance and
concentrations of the PMN substance Occupational Safety and Health test data on analogous diisocyanates,
are below a New Chemical Exposure (NIOSH)-certified respirator with an EPA identified concerns for dermal
Limit (NCEL) that is established by EPA APF of at least 50 where there is a sensitization, respiratory sensitization,
to provide adequate protection to potential for inhalation exposure; lung effects, neurotoxicity, and
human health. In addition to the actual 4. Establishment and use of a hazard developmental toxicity, as well as skin
NCEL concentration, the comprehensive communication program, including irritation, and a potential for cancer to
NCELs provisions in TSCA section 5(e) human health precautionary statements workers due to the possibility of
Orders, which are modeled after on each label and in the SDS; isocyanate residuals. The Order was
Occupational Safety and Health 5. No application method of the PMN issued under TSCA sections
Administration (OSHA) Permissible substance that results in greater worker 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I), based
Exposure Limits (PELs) provisions, inhalation exposures to vapor, mist, or on a finding that in the absence of
include requirements addressing aerosol than those encountered in roller sufficient information to permit a
performance criteria for sampling and coating application; reasoned evaluation, the substance may
analytical methods, periodic 6. Use of the PMN substance only for present an unreasonable risk of injury to
monitoring, respiratory protection, and the confidential uses specified in the human health and the environment. To
recordkeeping. However, no comparable Order; and protect against these risks, the Order
7. No release of the PMN substance requires:
NCEL provisions currently exist in 40
into the waters of the United States. 1. Refraining from manufacturing or
CFR part 721, subpart B, for SNURs.
Therefore, for these cases, the The SNUR designates as a ‘‘significant processing the PMN substance in the
individual SNURs in 40 CFR part 721, new use’’ the absence of these protective United States (i.e., import only);
subpart E, will state that persons subject measures. 2. Import of the PMN substance to
to the SNUR who wish to pursue NCELs Potentially useful information: EPA contain no more than 0.1% residual
as an alternative to the § 721.63 has determined that certain information isocyanate by weight; and
respirator requirements may request to about the physical-chemical properties, 3. Import of the PMN substance to
do so under § 721.30. EPA expects that fate, ecotoxicity and pulmonary effects contain no more than 1% of a
persons whose § 721.30 requests to use of the PMN substance may be confidential component by weight.
the NCELs approach for SNURs that are potentially useful to characterize the The SNUR designates as a ‘‘significant
approved by EPA will be required to effects of the PMN substance in support new use’’ the absence of these protective
comply with NCELs provisions that are of a request by the PMN submitter to measures.
comparable to those contained in the modify the Order, or if a manufacturer Potentially useful information: EPA
corresponding TSCA section 5(e) Order or processor is considering submitting a has determined that certain information
for the same chemical substance. SNUN for a significant new use that about the health effects of the PMN
would be designated by this SNUR. EPA substance may be potentially useful to
PMN Number: P–14–758 has determined that the results of characterize the effects of the PMN
Chemical name: 2-Propenenitrile, physical-chemical property testing, fate, substance in support of a request by the
polymer with methanamine, acute and chronic aquatic toxicity PMN submitter to modify the Order, or
hydrogenated, 3- testing, and pulmonary toxicity testing if a manufacturer or processor is
aminopropylterminated, ethoxylated would help characterize the potential considering submitting a SNUN for a
propoxylated. environmental and health effects of the significant new use that would be
PMN substance. Although the Order designated by this SNUR. EPA has
CAS number: 2055838–16–7.
does not require these tests, the Order’s determined that the results of
Effective date of TSCA section 5(e) restrictions will remain in effect until
Order: September 15, 2017. sensitization and pulmonary toxicity
the Order is modified or revoked by testing would help characterize the
Basis for TSCA section 5(e) Order: EPA based on submission of this or potential health effects of the PMN
The PMN states that the generic (non- other information that EPA determines substance. Although the Order does not
confidential) use of the substance will is relevant and needed to evaluate a require these tests, the Order’s
be as urethane foam. Based on physical/ modification request. restrictions will remain in effect until
chemical properties, EPA has identified CFR citation: 40 CFR 721.11124. the Order is modified or revoked by
concern for lung toxicity. Based on SAR
PMN Number: P–16–493 EPA based on submission of this or
analysis of polycationic polymers, EPA
other information that EPA determines
predicts toxicity to aquatic organisms Chemical Name: Dicarboxylic acids, is relevant and needed to evaluate a
may occur at concentrations that exceed polymers with alkyl prop-2-enoate, modification request.
416 parts per billion (ppb). The Order alkyl 2- ethylprop-2-enoate, CFR citation: 40 CFR 721.11125.
was issued under TSCA sections alkyl[(alkenyl)alkyl]alkanediol,
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), alkanediol, alkanedioic acid, alkyl 2- PMN Number: P–16–514
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based on a finding that in the absence rnethylprop-2-enoate, alkyl prop-2- Chemical Name: Mixed metal oxide
of sufficient information to permit a enoic acid, alkylene (generic).
reasoned evaluation, the substance may [isocyanatocarbomonocyte] and CAS Number: Not available.
present an unreasonable risk of injury to alkanediol, alkanolamine-blocked, Effective date of TSCA section 5(e)
human health and the environment. To compds with 2-(alkylamino)alkanol Order: August 7, 2017.
protect against these risks, the Order (generic). Basis for TSCA section 5(e) Order:
requires: CAS Number: Not available. The PMN states that the generic (non-
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PMN submitter to modify the Order, or 6. Use of personal protective may occur at concentrations that exceed
if a manufacturer or processor is equipment where there is a potential for 65 parts per billion. The Order was
considering submitting a SNUN for a dermal exposure; issued under TSCA sections
significant new use that would be 7. Refraining from modifying the 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I), based
designated by this SNUR. EPA has processing if such modification would on a finding that in the absence of
determined that the results of specific result in inhalation exposures to the sufficient information to permit a
acute aquatic toxicity testing would PMN substance by vapor, dust, mist, or reasoned evaluation the substance may
help characterize the potential aerosol at a concentration of greater than present an unreasonable risk of injury to
environmental effects of the PMN 1 percent by weight or volume; human health and the environment. To
substance. Although the Order does not 8. Establishment and use of a hazard protect against these risks, the Order
require these tests, the Order’s communication program, including requires:
restrictions remain in effect until the human health precautionary statements 1. Submission to EPA of certain
Order is modified or revoked by EPA on each label and in the SDS; and toxicity testing before exceeding the
based on submission of this or other 9. No release of the PMN substance confidential production volume limit
relevant information. resulting in surface water specified in the Order;
CFR citations: 40 CFR 721.11135 (P– concentrations that exceed 15 ppb. 2. Refraining from manufacture,
17–206). The SNUR designates as a ‘‘significant processing, or use for consumer use or
new use’’ the absence of these protective in commercial use where there is use in
PMN Number: P–17–223 measures. a consumer setting;
Chemical Name: Fatty acids, tall-oil, Potentially useful information: EPA 3. Refraining from domestic
reaction products with 2-[(2- has determined that certain information manufacture in the United States (i.e.,
aminoalkyl)amino]alkanol, compds. about the physical-chemical properties, import only);
with alkylene oxide-glycidyl o-tolyl environmental effects, and health effects 4. Use of the PMN substance only for
ether polymer dihydrogenphosphate of the PMN substance may be the confidential use specified in the
alkyl ether (generic). potentially useful in support of a Order;
CAS Number: Not available. request by the PMN submitter to modify 5. Use of the PMN substance in the
Effective date of TSCA section 5(e) the Order, or if a manufacturer or confidential formulation at a
Order: September 12, 2017. processor is considering submitting a concentration not greater than 1 percent
Basis for TSCA section 5(e) Order: SNUN for a significant new use that by weight or volume;
The PMN states that the generic (non- would be designated by this SNUR. The 6. Use of personal protective
confidential) use of the substance will submitter has agreed not to exceed a equipment where there is a potential for
be as an additive for open, non- certain production volume limit without dermal exposure;
dispersive use. EPA identified concerns performing specific reproductive/ 7. Refraining from modifying the
for developmental toxicity based on N- developmental toxicity testing and acute processing method if such modification
heterocyclic compounds and concerns aquatic toxicity testing. EPA has also would result in inhalation exposures to
for possible irritation to mucous determined that the results of specific the PMN substance by vapor, dust, mist,
membranes and lung toxicity based on physical-chemical property and or aerosol, at a concentration of greater
potential surfactancy properties. Also pulmonary toxicity testing would help than 1 percent by weight or volume;
based on SAR analysis of test data on characterize the potential human and 8. Establishment and use of a hazard
nearest analogue of soluble forms of environmental effects of the PMN communication program, including
inorganic phosphates, EPA predicts substance. Although the Order does not human health precautionary statements
toxicity to aquatic organisms may occur require these tests, the Order’s on each label and in the SDS; and
at concentrations that exceed 15 ppb. restrictions remain in effect until the 9. No release of the PMN substance
The Order was issued under TSCA Order is modified or revoked by EPA resulting in surface water
sections 5(a)(3)(B)(ii)(I) and based on submission of this or other concentrations that exceed 65 ppb.
5(e)(l)(A)(ii)(I), based on a finding that relevant information.
in the absence of sufficient information CFR citation: 40 CFR 721.11136. The SNUR designates as a ‘‘significant
to permit a reasoned evaluation the new use’’ the absence of these protective
substance may present an unreasonable PMN Number: P–17–230 measures.
risk of injury to human health and the Chemical Name: Oxirane, 2-alkyl-, Potentially useful information: EPA
environment. To protect against these polymer with oxirane, mono[N-[3- has determined that certain information
risks, the Order requires: (carboxyamino)-4(or 6)- about the physical-chemical properties,
1. Submission to EPA of certain alkylphenyl]carbamate], alkyl ether, environmental effects, and health effects
toxicity testing before exceeding the ester with 2,2′,2″-nitrilotris-[alkanol] of the PMN substance may be
confidential production volume limit (generic). potentially useful in support of a
specified in the Order; CAS Number: Not available. request by the PMN submitter to modify
2. Refraining from manufacture, Effective date of TSCA section 5(e) the Order, or if a manufacturer or
processing, or use for consumer use or Order: September 12, 2017. processor is considering submitting a
in commercial use where there is use in Basis for TSCA section 5(e) Order: SNUN for a significant new use that
a consumer setting; The PMN states that the generic (non- would be designated by this SNUR. The
3. Refrain from domestic manufacture confidential) use of the substance will submitter has agreed not to exceed a
in the United States (i.e., import only); be as an additive for open, non- certain production volume limit without
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4. Use of the PMN substance only for dispersive use. Based on the potential performing specific acute aquatic and
the confidential use specified in the surfactant properties, cationic binding sediment toxicity testing. EPA has also
Order; to lung tissues, EPA identified concerns determined that the results of specific
5. Use of the PMN substance in the for lung toxicity and skin irritation. physical-chemical property and
confidential formulation at a Based SAR analysis of test data on pulmonary toxicity testing would help
concentration not greater than 1 percent analogous polycationic polymers, EPA characterize the potential health effects
by weight or volume; predicts toxicity to aquatic organisms of the PMN substance. Although the
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PART 9—[AMENDED] ■ 4. Add § 14;721.11124 to subpart E to (2) Limitations or revocation of
read as follows: certain notification requirements. The
■ 1. The authority citation for part 9 provisions of § 721.185 apply to this
§ 721.11124 2-Propenenitrile, polymer with section.
continues to read as follows: methanamine, hydrogenated, 3- (3) Determining whether a specific use
Authority: 7 U.S.C. 135 et seq., 136–136y; aminopropylterminated, ethoxylated
15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671; propoxylated.
is subject to this section. The provisions
21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 of § 721.1725(b)(1) apply to paragraph
(a) Chemical substance and (a)(2)(iii) of this section.
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, significant new uses subject to reporting.
1321, 1326, 1330, 1342, 1344, 1345(d) and ■ 5. Add § 14;721.11125 to subpart E to
(e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
(1) The chemical substance identified as
read as follows:
1971–1975 Comp. p. 973; 42 U.S.C. 241, 2-Propenenitrile, polymer with
242b, 243, 246, 300f, 300g, 300g–1, 300g–2, methanamine, hydrogenated, 3- § 721.11125 Dicarboxylic acids, polymers
300g–3, 300g–4, 300g–5, 300g–6, 300j–1, aminopropylterminated, ethoxylated with alkyl prop-2-enoate, alkyl 2-ethylprop-
300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq., propoxylated (PMN P–14–758; CAS No. 2-enoate, alkyl[(alkenyl)alkyl]alkanediol,
6901–6992k, 7401–7671q, 7542, 9601–9657, 2055838–16–7) is subject to reporting alkanediol, alkanedioic acid, alkyl 2-
11023, 11048. under this section for the significant rnethylprop-2-enoate, alkyl prop-2-enoic
acid, alkylene [isocyanatocarbomonocyte]
■ 2. In § 14;9.1, add the following new uses described in paragraph (a)(2) and alkanediol, alkanolamine-blocked,
sections in numerical order under the of this section. The requirements of this compds with 2-(alkylamino)alkanol
undesignated center heading section do not apply to quantities of the (generic).
‘‘Significant New Uses of Chemical PMN substance after they have been (a) Chemical substance and
Substances’’ to read as follows: completely reacted (cured). significant new uses subject to reporting.
(2) The significant new uses are: (1) The chemical substance generically
§ 9.1 OMB approvals under the Paperwork (i) Protection in the workplace.
Reduction Act. identified as dicarboxylic acids,
Requirements as specified in polymers with alkyl prop-2-enoate,
* * * * * § 721.63(a)(1), (a)(2)(i), (a)(3) through (5) alkyl 2-ethylprop-2-enoate,
(respirators must provide a National alkyl[(alkenyl)alkyl]alkanediol,
OMB control Institute for Occupational Safety and
40 CFR citation alkanediol, alkanedioic acid, alkyl 2-
No. Health assigned protection factor of at methylprop-2-enoate, alkyl prop-2-enoic
least 50), and (a)(6)(v), (particulate), acid, alkylene
* * * * * (when determining which persons are [isocyanatocarbomonocyte] and
Significant New Uses of Chemical reasonably likely to be exposed as alkanediol, alkanolamine-blocked,
Substances required for § 721.63(a)(1) and (4), compds with 2-(alkylamino)alkanol (P–
engineering control measures (e.g. 16–493) is subject to reporting under
enclosure or confinement of operation, this section for the significant new uses
* * * * * general and local ventilation) or
721.11124 ............................. 2070–0012 described in paragraph (a)(2) of this
administrative control measures (e.g. section. The requirements of this section
721.11125 ............................. 2070–0012
721.11126 ............................. 2070–0012
workplace policies and procedures) do not apply to quantities of the
721.11127 ............................. 2070–0012 shall be considered and implemented to substance after they have been reacted
721.11128 ............................. 2070–0012 prevent exposure, where feasible), (cured).
721.11129 ............................. 2070–0012 § 721.63(b) (concentration set at 1.0%), (2) The significant new uses are:
721.11130 ............................. 2070–0012 and § 721.63(c). (i) Industrial, commercial, and
721.11131 ............................. 2070–0012 (ii) Hazard communication. consumer activities. Requirements as
721.11132 ............................. 2070–0012 Requirements as specified in § 721.72(a) specified in § 721.80(f). It is a significant
721.11133 ............................. 2070–0012 through (d), (e) (concentration set at new use to import the PMN substance
721.11134 ............................. 2070–0012 1.0%), (f), (g)(1)(ii), (g)(2)(ii), (g)(4)(iii),
721.11135 ............................. 2070–0012
to contain more than 0.1% residual
and (g)(5). Alternative hazard and isocyanate by weight. It is a significant
721.11136 ............................. 2070–0012
721.11137 ............................. 2070–0012 warning statements that meet the new use to import the PMN substance
721.11138 ............................. 2070–0012 criteria of the Globally Harmonized to contain more than 1% of a
721.11139 ............................. 2070–0012 System and OSHA Hazard confidential component by weight.
721.11140 ............................. 2070–0012 Communication Standard may be used. (ii) [Reserved]
721.11141 ............................. 2070–0012 (iii) Industrial, commercial, and (b) Specific requirements. The
721.11142 ............................. 2070–0012 consumer activities. Requirements as provisions of subpart A of this part
721.11143 ............................. 2070–0012 specified in § 721.80(f) and (k). A apply to this section except as modified
721.11144 ............................. 2070–0012 significant new use is any spray by this paragraph (b).
721.11145 ............................. 2070–0012 (1) Recordkeeping. Recordkeeping
application method that results in
721.11146 ............................. 2070–0012
greater worker inhalation exposures to requirements as specified in
721.11147 ............................. 2070–0012
721.11148 ............................. 2070–0012 vapor, mist, or aerosol than the roller § 721.125(a) through (c) and (i) are
coating application. applicable to manufacturers and
* * * * * (iv) Release to water. Requirements as processors of this substance.
specified in § 721.90(b)(1), and (c)(1). (2) Limitations or revocation of
* * * * * (b) Specific requirements. The certain notification requirements. The
provisions of subpart A of this part provisions of § 721.185 apply to this
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PART 721—[AMENDED] apply to this section except as modified section.
by this paragraph (b). (3) Determining whether a specific use
■ 3. The authority citation for part 721 (1) Recordkeeping. Recordkeeping is subject to this section. The provisions
continues to read as follows: requirements as specified in of § 721.1725(b)(1) apply to paragraph
Authority: 15 U.S.C. 2604, 2607, and § 721.125(a) through (i), and (k) are (a)(2)(i) of this section.
2625(c). applicable to manufacturers and ■ 6. Add § 721.11126 to subpart E to
processors of this substance. read as follows:
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![47018 Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Rules and Regulations
§ 721.11126 Mixed metal oxide (generic). substance other than by recycling as (1) Recordkeeping. Recordkeeping
(a) Chemical substance and described in the Order. requirements as specified in
significant new uses subject to reporting. (b) Specific requirements. The § 721.125(a) through (i), are applicable
(1) The chemical substance generically provisions of subpart A of this part to manufacturers and processors of this
identified as a mixed metal oxide apply to this section except as modified substance.
(P–16–514) is subject to reporting under by this paragraph (b). (2) Limitations or revocation of
this section for the significant new uses (1) Recordkeeping. Recordkeeping certain notification requirements. The
described in paragraph (a)(2) of this requirements as specified in provisions of § 721.185 apply to this
section. § 721.125(a) through (j) are applicable to section.
(2) The significant new uses are: manufacturers, importers, and (3) Determining whether a specific use
(i) Protection in the workplace. processors of this substance. is subject to this section. The provisions
Requirements as specified in (2) Limitations or revocation of of § 721.1725(b)(1) apply to paragraph
§ 721.63(a)(1), (a)(3) through (5) certain notification requirements. The (a)(2)(iii) of this section.
(respirators must provide a National provisions of § 721.185 apply to this
■ 8. Add § 721.11128 to subpart E to
Institute for Occupational Safety and section.
read as follows:
Health assigned protection factor of at (3) Determining whether a specific use
least 1,000), and (a)(6) (particulate), is subject to this section. The provisions § 721.11128 Alkyl polyamine (generic).
(when determining which persons are of § 721.1725(b)(1) apply to paragraphs (a) Chemical substance and
reasonably likely to be exposed as (a)(2)(iii) and (iv) of this section. significant new uses subject to reporting.
required for § 721.63(a)(1) and (4), ■ 7. Add § 721.11127 to subpart E to (1) The chemical substance generically
engineering control measures (e.g., read as follows: identified as alkyl polyamine (PMN
enclosure or confinement of operation, § 721.11127 Modified alkyl polyamine P–16–577) is subject to reporting under
general and local ventilation) or (generic). this section for the significant new uses
administrative control measures (e.g., (a) Chemical substance and described in paragraph (a)(2) of this
workplace policies and procedures) significant new uses subject to reporting. section.
shall be considered and implemented to (1) The chemical substance generically (2) The significant new uses are:
prevent exposure, where feasible), identified as modified alkyl polyamine (i) Protection in the workplace.
§ 721.63(b) (concentration set at 1.0%), (PMN P–16–576) is subject to reporting Requirements as specified in
and § 721.63(c). under this section for the significant § 721.63(a)(1), (a)(2)(i)(iii), (a)(3),
(A) As an alternative to the respirator new uses described in paragraph (a)(2) (a)(6)(v), (a)(6) (particulate), (when
requirements in paragraph (a)(2)(i) of of this section. determining which persons are
this section, a manufacturer or processor (2) The significant new uses are: reasonably likely to be exposed as
may choose to follow the new chemical (i) Protection in the workplace. required for § 721.63(a)(1), engineering
exposure limit (NCEL) provision listed Requirements as specified in control measures (e.g., enclosure or
in the TSCA section 5(e) Order for this § 721.63(a)(1), (a)(2)(i) and (iii), (a)(3), confinement of the operation, general
substance. The NCEL is 0.04 mg/m3 as and (a)(6) (particulate), (vapor), (when and local ventilation) or administrative
an 8-hour time weighted average. determining which persons are control measures (e.g., workplace
Persons who wish to pursue NCELs as reasonably likely to be exposed as policies and procedures) shall be
an alternative to § 721.63 respirator required for § 721.63(a)(1), engineering considered and implemented to prevent
requirements may request to do so control measures (e.g., enclosure or exposure, where feasible), § 721.63(b)
under § 721.30. Persons whose § 721.30 confinement of the operation, general (concentration set at 1.0%), and
requests to use the NCELs approach are and local ventilation) or administrative § 721.63(c).
approved by EPA will be required to control measures (e.g., workplace (ii) Hazard communication.
follow NCELs provisions comparable to policies and procedures) shall be Requirements as specified in § 721.72(a)
those contained in the corresponding considered and implemented to prevent through (e) (concentration set at 1.0%),
TSCA section 5(e) Order. exposure, where feasible), § 721.63(b) (f), (g)(1)(i), (ii), (vi), (viii), (g)(2)(i)
(B) [Reserved] (concentration set at 1.0%), and through (iii) and (v), (g)(3)(i) and (ii),
(ii) Hazard communication. § 721.63(c). and (g)(5). Alternative hazard and
Requirements as specified in § 721.72(a) (ii) Hazard communication. warning statements that meet the
through (e) (concentration set at 1.0%), Requirements as specified in § 721.72(a) criteria of the Globally Harmonized
(f), (g)(1)(iv), (lung toxicity if inhaled), through (e) (concentration set at 1.0%), System and OSHA Hazard
(eye irritation), (allergic skin reaction), (f), (g)(1)(i), (ii), (vi), (viii), (g)(2)(i) Communication Standard may be used.
(g)(2)(i) through (iii) and (v) (use through (iii) and (v), (g)(3)(i) and (ii), (iii) Industrial, commercial, and
respiratory protection or maintain and (g)(5). Alternative hazard and consumer activities. Requirements as
workplace airborne concentrations at or warning statements that meet the specified in § 721.80(k). It is a
below an 8-hour time-weighted average criteria of the Globally Harmonized significant new use to manufacture the
of 0.04 mg/m3), (g)(4)(i), and (g)(5). System and OSHA Hazard chemical substance more than 9
Alternative hazard and warning Communication Standard may be used. months.
statements that meet the criteria of the (iii) Industrial, commercial, and (iv) Release to water. Requirements as
Globally Harmonized System and OSHA consumer activities. Requirements as specified in § 721.90(a)(4), (b)(4), and
Hazard Communication Standard may specified in § 721.80(k). It is a (c)(4) where N = 2.
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be used. significant new use to manufacture the (b) Specific requirements. The
(iii) Industrial, Commercial, and chemical substance more than 9 provisions of subpart A of this part
consumer activities. Requirements as months. apply to this section except as modified
specified in § 721.80(e), (f), (k), and (q). (b) Specific requirements. The by this paragraph (b).
(iv) Disposal. Requirements as provisions of subpart A of this part (1) Recordkeeping. Recordkeeping
specified in § 721.85. It is a significant apply to this section except as modified requirements as specified in
new use to dispose of the PMN by this paragraph (b). § 721.125(a) through (i) and (k) are
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![47020 Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Rules and Regulations
to reporting under this section for the reporting under this section for the ■ 15. Add § 14;721.11135 to subpart E to
significant new uses described in significant new uses described in read as follows:
paragraph (a)(2) of this section. paragraph (a)(2) of this section. The
(2) The significant new uses are: requirements of this section do not § 721.11135 Imino alkane amine phosphate
(i) Protection in the workplace. (generic).
apply to quantities of the substance after
Requirements as specified in they have been reacted (cured). (a) Chemical substance and
§ 721.63(a)(1), (a)(2)(i), (iii), and (iv), (2) The significant new uses are: significant new uses subject to reporting.
(a)(3), and (a)(6)(v), (particulate), (when (i) Industrial, Commercial, and (1) The chemical substance generically
determining which persons are consumer activities. Requirements as identified as imino alkane amine
reasonably likely to be exposed as specified in § 721.80(f) and (t)(60 phosphate (P–17–206) is subject to
required for § 721.63(a)(1), engineering kilograms). It is a significant new use to reporting under this section for the
control measures (e.g. enclosure or use the substance other than as a significant new uses described in
confinement of operation, general and leveling agent for coatings applied to paragraph (a)(2) of this section. The
local ventilation) or administrative aluminum printing plates. requirements of this section do not
control measures (e.g. workplace (ii) [Reserved] apply to quantities of the substance after
policies and procedures) shall be (b) Specific requirements. The they have been reacted (cured).
considered and implemented to prevent provisions of subpart A of this part (2) The significant new uses are:
exposure, where feasible), § 721.63(b) apply to this section except as modified (i) Protection in the workplace.
(concentration set at 1.0%) and by this paragraph (b). Requirements as specified in
§ 721.63(c). (1) Recordkeeping. Recordkeeping § 721.63(a)(1), (a)(2)(i) and (iii), (a)(3),
(ii) Hazard communication. requirements as specified in and (a)(6)(v), (particulate), (when
Requirements as specified in § 721.72(a) § 721.125(a) through (c) and (i) are determining which persons are
through (e)(concentration set at 1.0%), applicable to manufacturers, importers, reasonably likely to be exposed as
(f), (g)(1)(i) through (iii), (iv), (vi), and and processors of this substance. required for § 721.63(a)(1), engineering
(ix), (g)(2)(i), (ii), (iii), and (v), (g)(3)(i) (2) Limitations or revocation of control measures (e.g. enclosure or
and (ii), and (g)(5). Alternative hazard certain notification requirements. The confinement of operation, general and
and warning statements that meet the provisions of § 721.185 apply to this local ventilation) or administrative
criteria of the Globally Harmonized significant new use rule. control measures (e.g. workplace
System and OSHA Hazard ■ 14. Add § 14;721.11134 to subpart E to policies and procedures) shall be
Communication Standard may be used. read as follows: considered and implemented to prevent
(iii) Industrial, Commercial, and exposure, where feasible), § 721.63(b)
consumer activities. Requirements as § 721.11134 Oxyalkylene urethane (concentration set at 1.0%) and
specified in § 721.80(k) and (q). It is a polyolefin (generic).
§ 721.63(c).
significant new use to manufacture, (a) Chemical substance and (ii) Hazard communication.
process, or use the PMN substance to significant new uses subject to reporting. Requirements as specified in § 721.72(a)
result in inhalation exposures to vapor, (1) The chemical substance generically through (e)(concentration set at 1.0%),
dust, mist, or aerosols to the substance. identified as oxyalkylene urethane (f), (g)(1)(i), (g)(2)(i) and (v), (g)(3)(i) and
(iv) Release to water. Requirements as polyolefin (PMN P–17–199) is subject to (ii), (g)(4)(iii), and (g)(5), Alternative
specified in § 721.90(a)(4), (b)(4), and reporting under this section for the hazard and warning statements that
(c)(4) where N = 2 for P–17–165 and N significant new uses described in meet the criteria of the Globally
= 4 for P–17–149, P–17–150, and P–17– paragraph (a)(2) of this section. Harmonized System and OSHA Hazard
151. (2) The significant new uses are: Communication Standard may be used.
(b) Specific requirements. The (i) Industrial, commercial, and
(iii) Industrial, Commercial, and
provisions of subpart A of this part consumer activities. Requirements as
consumer activities. Requirements as
apply to this section except as modified specified in § 721.80. It is a new use the
specified in § 721.80(f) and (k). It is a
by this paragraph (b). manufacture (including import) the
significant new use to modify
(1) Recordkeeping. Recordkeeping PMN substance with an average
processing or use if it results in
requirements as specified in molecular weight greater than specified
inhalation exposure to vapor, dust, mist,
§ 721.125(a) through (i) and (k) are in the Order or with more than 1% of
or aerosols to the substance.
applicable to manufacturers, importers, the molecular weight content below
1,000 Daltons. (iv) Disposal. Requirements as
and processors of these substances.
(ii) [Reserved] specified in § 721.85(a)(1), (b)(1), and
(2) Limitations or revocation of
(b) Specific requirements. The (c)(1).
certain notification requirements. The
provisions of § 721.185 apply to this provisions of subpart A of this part (v) Release to water. Requirements as
section. apply to this section except as modified specified in § 721.90(a)(1), (b)(1), and
(3) Determining whether a specific use by this paragraph. (c)(1).
is subject to this section. The provisions (1) Recordkeeping. Recordkeeping (b) Specific requirements. The
of § 721.1725(b)(1) apply to paragraph requirements as specified in provisions of subpart A of this part
(a)(2)(iii) of this section. § 721.125(a) through (c) and (i) are apply to this section except as modified
applicable to manufacturers and by this paragraph (b).
■ 13. Add § 14;721.11133 to subpart E to
read as follows: processors of this substance. (1) Recordkeeping. Recordkeeping
(2) Limitations or revocation of requirements as specified in
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§ 721.11133 Fluorinated propenoic poly certain notification requirements. The § 721.125(a) through (k) are applicable
alkyl ether ester (generic). provisions of § 721.185 apply to this to manufacturers, importers, and
(a) Chemical substance and section. processors of this substance.
significant new uses subject to reporting. (3) Determining whether a specific use (2) Limitations or revocation of
(1) The chemical substance generically is subject to this section. The provisions certain notification requirements. The
identified as fluorinated propenoic poly of § 721.1725(b)(1) apply to paragraph provisions of § 721.185 apply to this
alkyl ether ester (P–17–175) is subject to (a)(2)(i) of this section. section.
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(3) Determining whether a specific use substance for consumer use or for criteria of the Globally Harmonized
is subject to this section. The provisions commercial uses that could introduce System and OSHA Hazard
of § 721.1725(b)(1) apply to paragraph the substance into a consumer setting. Communication Standard may be used.
(a)(2)(iii) of this section. (iv) Release to water. Requirements as (iii) Industrial, Commercial, and
■ 16. Add § 14;721.11136 to subpart E to specified in § 721.90(a)(4), (b)(4), and consumer activities. Requirements as
read as follows: (c)(4) where N = 15. specified in § 721.80(f), (k), and (q). It is
(b) Specific requirements. The a significant new use to modify
§ 721.11136 Fatty acids, tall-oil, reaction provisions of subpart A of this part processing methods if such modification
products with 2-[(2- apply to this section except as modified would result in inhalation exposures to
aminoalkyl)amino]alkanol, compds. with by this paragraph (b). the PMN substance by vapor, dust, mist,
alkylene oxide-glycidyl o-tolyl ether (1) Recordkeeping. Recordkeeping
polymer dihydrogen phosphate alkyl ether
or aerosol, at a concentration of greater
(generic).
requirements as specified in than 1 percent by weight or volume. It
§ 721.125(a) through (i) and (k) are is a significant new use to use the PMN
(a) Chemical substance and applicable to manufacturers, importers, substance in the confidential
significant new uses subject to reporting. and processors of this substance. formulation at a concentration greater
(1) The chemical substance generically (2) Limitations or revocation of than 1 percent by weight or volume. It
identified as fatty acids, tall-oil, reaction certain notification requirements. The is a significant new use to manufacture,
products with 2-[(2- provisions of § 721.185 apply to this process, or use the substance for
aminoalkyl)amino]alkanol, compds. section. consumer use or for commercial uses
with alkylene oxide-glycidyl o-tolyl (3) Determining whether a specific use that could introduce the substance into
ether polymer dihydrogen phosphate is subject to this section. The provisions a consumer setting.
alkyl ether (P–17–223) is subject to of § 721.1725(b)(1) apply to paragraph (iv) Release to water. Requirements as
reporting under this section for the (a)(2)(iii) of this section. specified in § 721.90(a)(4), (b)(4), and
significant new uses described in
■ 17. Add § 14;721.11137 to subpart E to (c)(4) where N = 65.
paragraph (a)(2) of this section. The (b) Specific requirements. The
read as follows:
requirements of this section do not provisions of subpart A of this part
apply to quantities of the substance after § 721.11137 Oxirane, 2-alkyl-, polymer with apply to this section except as modified
they have been reacted (cured). oxirane, mono[N-[3-(carboxyamino)-4(or 6)-
by this paragraph (b).
(2) The significant new uses are: alkylphenyl]carbamate], alkyl ether, ester
(1) Recordkeeping. Recordkeeping
(i) Protection in the workplace. with 2,2′,2″-nitrilotris-[alkanol] (generic).
requirements as specified in
Requirements as specified in (a) Chemical substance and § 721.125(a) through (i) and (k) are
§ 721.63(a)(1), (a)(2)(i), (a)(3), and significant new uses subject to reporting. applicable to manufacturers, importers,
(a)(6)(v), (particulate), (when (1) The chemical substance generically and processors of this substance.
determining which persons are identified as oxirane, 2-alkyl-, polymer (2) Limitations or revocation of
reasonably likely to be exposed as with oxirane, mono[N-[3- certain notification requirements. The
required for § 721.63(a)(1) and, (carboxyamino)-4(or 6)- provisions of § 721.185 apply to this
engineering control measures (e.g. alkylphenyl]carbamate], alkyl ether, section.
enclosure or confinement of operation, ester with 2,2′,2″-nitrilotris-[alkanol] (P– (3) Determining whether a specific use
general and local ventilation) or 17–230) is subject to reporting under is subject to this section. The provisions
administrative control measures (e.g. this section for the significant new uses of § 721.1725(b)(1) apply to paragraph
workplace policies and procedures) described in paragraph (a)(2) of this (a)(2)(iii) of this section.
shall be considered and implemented to section. The requirements of this section ■ 18. Add § 14;721.11138 to subpart E to
prevent exposure, where feasible), do not apply to quantities of the read as follows:
§ 721.63(b) (concentration set at 1.0%) substance after they have been reacted
and § 721.63(c). (cured). § 721.11138 Formaldehyde, polymer with
(ii) Hazard communication. (2) The significant new uses are: (chloromethyl) oxirane and substituted
Requirements as specified in § 721.72(a) (i) Protection in the workplace. aromatic compounds (generic).
through (e)(concentration set at 1.0%), Requirements as specified in (a) Chemical substance and
(f), (g)(1)(i) and (ii), (g)(2)(i), (ii), and (v), § 721.63(a)(1), (a)(2)(i) and (iii), (a)(3), significant new uses subject to reporting.
(g)(3)(i) and (ii), and (g)(5), Alternative and (a)(6)(v), (particulate), (when (1) The chemical substance generically
hazard and warning statements that determining which persons are identified as formaldehyde, polymer
meet the criteria of the Globally reasonably likely to be exposed as with (chloromethyl) oxirane and
Harmonized System and OSHA Hazard required for § 721.63(a)(1), engineering substituted aromatic compounds (P–17–
Communication Standard may be used. control measures (e.g. enclosure or 236) is subject to reporting under this
(iii) Industrial, Commercial, and confinement of operation, general and section for the significant new uses
consumer activities. Requirements as local ventilation) or administrative described in paragraph (a)(2) of this
specified in § 721.80(f), (k), and (q). It is control measures (e.g. workplace section. The requirements of this section
a significant new use to modify any policies and procedures) shall be do not apply to the PMN substance after
processing if such modification would considered and implemented to prevent it has been incorporated into the
result in inhalation exposures to the exposure, where feasible), § 721.63(b) confidential forms identified in the
PMN substance by vapor, dust, mist, or (concentration set at 1.0%) and Order.
aerosol, at a concentration of greater § 721.63(c). (2) The significant new uses are:
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than 1 percent by weight or volume. It (ii) Hazard communication. (i) Protection in the workplace.
is a significant new use to use the PMN Requirements as specified in § 721.72(a) Requirements as specified in
substance in the confidential through (e)(concentration set at 1.0%), § 721.63(a)(1), (a)(2)(i), (iii), and (iv),
formulation identified in the Order at (f), (g)(1)(i) and (ii), (eye irritation), (a)(3), and (a)(6) (particulate), (when
concentration greater than 1 percent by (g)(2)(i), (ii), and (v), (g)(3)(i) and (ii), determining which persons are
weight or volume. It is a significant new and (g)(5). Alternative hazard and reasonably likely to be exposed as
use to manufacture, process, or use the warning statements that meet the required for § 721.63(a)(1), engineering
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![Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Rules and Regulations 47023
apply to this section except as modified (2) Limitations or revocation of section. The requirements of this Order
by this paragraph (b). certain notification requirements. The do not apply to quantities of the PMN
(1) Recordkeeping. Recordkeeping provisions of § 721.185 apply to this substance after they have been entrained
requirements as specified in section. in cured coating or ink.
§ 721.125(a) through (e), (i), and (j) are (3) Determining whether a specific use (2) The significant new uses are:
applicable to manufacturers and us subject to this section. The provisions (i) Protection in the workplace.
processors of this substance. of § 721.1725(b)(1) apply to paragraph Requirements as specified in
(2) Limitations or revocation of (a)(2)(ii) of this section. § 721.63(a)(1), (a)(3) through (5)
certain notification requirements. The ■ 23. Add § 721.11143 to subpart E to (respirators must provide a National
provisions of § 721.185 apply to this read as follows: Institute for Occupational Safety and
section. Health (NIOSH) assigned protection
■ 22. Add § 721.11142 to subpart E to § 721.11143 Alkanoic acid, 2-alkyl-, factor (APF) of at least 10), and (a)(6)
read as follows: substituted alkyl ester, polymer with alkyl (particulate), (when determining which
alkenoate, substituted carbomonocycle, persons are reasonably likely to be
§ 721.11142 Metal oxide reaction products substituted alkyl alkenoate and alkyl exposed as required for § 721.63(a)(1)
with cadmium metal selenide sulfide, and substituted alkenoate, substituted
alkanenitrile-initiated (generic).
and (4), engineering control measures
amine (generic).
(e.g. enclosure or confinement of
(a) Chemical substance and (a) Chemical substance and operation, general and local ventilation)
significant new uses subject to reporting. significant new uses subject to reporting. or administrative control measures (e.g.
(1) The chemical substance generically (1) The chemical substance generically workplace policies and procedures)
identified as metal oxide reaction identified as alkanoic acid, 2-alkyl-, shall be considered and implemented to
products with cadmium metal selenide substituted alkyl ester, polymer with prevent exposure, where feasible),
sulfide, and amine (PMN P–17–244) is alkyl alkenoate, substituted § 721.63(b) (concentration set at 1.0%),
subject to reporting under this section carbomonocycle, substituted alkyl and § 721.63(c).
for the significant new uses described in alkenoate and alkyl substituted (ii) Hazard communication.
paragraph (a)(2) of this section. alkenoate, substituted alkanenitrile- Requirements as specified in § 721.72(a)
(2) The significant new uses are: initiated (PMN P–17–265) is subject to through (e)(concentration set at 1.0%),
(i) Protection in the workplace. reporting under this section for the (f), (g)(1)(i) through (iii) and (ix), (eye
Requirements as specified in significant new uses described in irritation), (g)(2)(ii) through (iv), (avoid
§ 721.63(a)(1), (a)(2)(i), (a)(3) through (5) paragraph (a)(2) of this section. The skin and eye contact), (use skin and eye
(respirators must provide a National requirements of this section do not protection), and (g)(5). Alternative
Institute for Occupational Safety and apply to quantities of the substance after hazard and warning statements that
Health assigned protection factor (APF) they have been completely reacted or meet the criteria of the Globally
of at least 50), and (a)(6)(particulate), cured. Harmonized System and OSHA Hazard
(when determining which persons are (2) The significant new uses are: Communication Standard may be used.
reasonably likely to be exposed as (i) Industrial, commercial, and (iii) Industrial, commercial, and
required for § 721.63(a)(1) and (4), consumer activities. Requirements as consumer activities. Requirements as
engineering control measures (e.g., specified in § 721.80. It is a significant specified in § 721.80(k) (surface drier in
enclosure or confinement of the new use to manufacture the PMN clear and pigmented coatings systems)
operation, general and local ventilation) substance with an acid concentration and (p) (430,000 kilograms).
or administrative control measures (e.g., greater than 20%. It is a significant new (b) Specific requirements. The
workplace policies and procedures) use to manufacture the PMN substance provisions of subpart A of this part
shall be considered and implemented to with an amine concentration greater apply to this section except as modified
prevent exposure, where feasible), and than 5%. by this paragraph (b).
§ 721.63(c). It is a significant new use to (ii) [Reserved] (1) Recordkeeping. Recordkeeping
handle the solid form of the substance (b) Specific requirements. The requirements as specified in
without use of a fume hood or glove provisions of subpart A of this part § 721.125(a) through (i).
box. apply to this section except as modified (2) Limitations or revocation of
(ii) Industrial, commercial, and by this paragraph (b). certain notification requirements. The
consumer activities. Requirements as (1) Recordkeeping. Recordkeeping provisions of § 721.185 apply to this
specified in § 721.80(q), (k) (down requirements as specified in section.
converting phosphor particle for use in § 721.125(a), (b), (c), and (i). ■ 25. Add § 721.11145 to subpart E to
conjunction with optoelectronic (2) Limitations or revocation of read as follows:
components), and (y)(1) and (2). certain notification requirements. The
(iii) Disposal. Requirements as provisions of § 721.185 apply to this § 721.11145 Sulfuric acid mixed salt
specified in § 721.85. It is a significant section. (generic).
new use to dispose of the substance and ■ 24. Add § 721.11144 to subpart E to (a) Chemical substance and
any waste stream containing the read as follows: significant new uses subject to reporting.
substance other than in a permitted (1) The chemical substance identified
hazardous waste incinerator. § 721.11144 Manganese heterocyclic- generically as sulfuric acid mixed salt
(b) Specific requirements. The amine carboxylate complexes (generic). (PMN P–17–318) is subject to reporting
provisions of subpart A of this part (a) Chemical substance and under this section for the significant
daltland on DSKBBV9HB2PROD with RULES2
apply to this section except as modified significant new uses subject to reporting. new uses described in paragraph (a)(2)
by this paragraph (b). (1) The chemical substance identified of this section.
(1) Recordkeeping. Recordkeeping generically as manganese heterocyclic- (2) The significant new uses are:
requirements as specified in amine carboxylate complexes (PMN P– (i) Protection in the workplace.
§ 721.125(a) through (e), (i), and (j) are 17–301) is subject to reporting under Requirements as specified in
applicable to manufacturers and this section for the significant new uses § 721.63(a)(1), (a)(2)(i), (a)(3), and
processors of this substance. described in paragraph (a)(2) of this (a)(6)(v), (particulate), (when
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![Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Rules and Regulations 47025
control measures (e.g., enclosure or Globally Harmonized System and OSHA (1) Recordkeeping. Recordkeeping
confinement of the operation, general Hazard Communication Standard may requirements as specified in
and local ventilation) or administrative be used. § 721.125(a) through (i) are applicable to
control measure (e.g., workplace (iii) Industrial, commercial, and manufacturers and processors of this
policies and procedures) shall be consumer activities. Requirements as substance.
considered and implemented to prevent specified in § 721.80(k). It is a
significant new use to manufacture the (2) Limitations or revocation of
exposure, where feasible), § 721.63(b)
(concentration set at 1.0%), and chemical substance more than 6 certain notification requirements. The
§ 721.63(c). months. It is a significant new use to provisions of § 721.185 apply to this
(ii) Hazard communication. modify manufacture, processing, or use section.
Requirements as specified in § 721.72(a) if it results in inhalation exposure to (3) Determining whether a specific use
through (e)(concentration set at 1.0%), vapor, dust, mist, or aerosols to the is subject to this section. The provisions
(f), (g)(1)(irritation to skin, eyes, lungs, substance. of § 721.1725(b)(1) apply to paragraph
and mucous membranes), (g)(2)(i) (b) Specific requirements. The (a)(2)(iii) of this section.
through (iii) and (v), and (g)(5). provisions of subpart A of this part [FR Doc. 2018–19950 Filed 9–14–18; 8:45 am]
Alternative hazard and warning apply to this section except ss modified
BILLING CODE 6560–50–P
statements that meet the criteria of the by this paragraph (b).
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Document Created: 2018-09-15 01:37:35
Document Modified: 2018-09-15 01:37:35
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Direct final rule. | |
| 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. | |
| 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: | |
| FR Citation | 83 FR 47004 | |
| RIN Number | 2070-AB27 | |
| CFR Citation | 40
CFR
721 40 CFR 9 | |
| CFR Associated | Chemicals; Hazardous Substances; Environmental Protection and Reporting and Recordkeeping Requirements |
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