83 FR 52179 - Significant New Use Rules on Certain Chemical Substances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 83, Issue 200 (October 16, 2018)
Federal Register Volume 83, Issue 200 (October 16, 2018)
| Page Range | 52179-52187 | |
| FR Document | 2018-22397 |
[Federal Register Volume 83, Number 200 (Tuesday, October 16, 2018)] [Proposed Rules] [Pages 52179-52187] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-22397] ======================================================================= ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 721 [EPA-HQ-OPPT-2017-0575; FRL-9984-93] RIN 2070-AB27 Significant New Use Rules on Certain Chemical Substances AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. ----------------------------------------------------------------------- SUMMARY: EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 13 chemical substances which are the subject of premanufacture notices (PMNs). This action would require persons to notify EPA at least 90 days before commencing manufacture (defined by statute to include import) or processing of any of these 13 chemical substances for an activity that is designated as a significant new use by this proposed rule. If this proposed rule [[Page 52180]] is made final, persons may not commence manufacture or processing for the significant new use until they have submitted a Significant New Use Notice, and EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken any actions as are required as a result of that determination. DATES: Comments must be received on or before November 15, 2018. ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2017-0575], 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 proposed 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 proposed SNURs would need to certify their compliance with the SNUR requirements should these proposed rules be finalized. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, pursuant to 40 CFR 721.20, any persons who export or intend to export a chemical substance that is the subject of this proposed rule on or after November 15, 2018 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) 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 CBI to EPA through regulations.gov or email. Clearly mark the 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? EPA is proposing these SNURs under TSCA section 5(a)(2) for 13 chemical substances which were the subjects of PMNs P-16-192, P-16-354 and P-16-355, P-16-380 through P-16-385, P-16-483 and P-16-484, P-16- 575, and P-16-581. These proposed SNURs would require persons who intend to manufacture or process any of these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. The record for the proposed SNURs on these chemicals was established as docket EPA-HQ-OPPT-2017-0575. That record includes information considered by the Agency in developing these proposed SNURs. 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)(i) (15 U.S.C. 2604(a)(1)(B)(i)) 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. TSCA prohibits such manufacturing or processing from commencing until EPA has conducted a review of the SNUN, made an appropriate determination on the SNUN, 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. Pursuant to Sec. 721.1(c), persons subject to these SNURs must comply with the same SNUN requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A) (15 U.S.C. 2604(a)(1)(A)). In particular, these requirements include the information submission requirements of TSCA sections 5(b) and 5(d)(1) (15 U.S.C. 2604(b) and 2604(d)(1)), the exemptions authorized by TSCA sections 5(h)(1), 5(h)(2), 5(h)(3), and 5(h)(5) and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA must either [[Page 52181]] 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 significant new uses for the chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances, and potential human exposures and environmental releases that may be associated with the conditions of use of the substances, in the context of the four bulleted TSCA section 5(a)(2) factors listed in this unit. IV. Substances Subject to This Proposed Rule EPA is proposing significant new use and recordkeeping requirements for 13 chemical substances in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each chemical substance: PMN number. Chemical name (generic name, if the specific name is claimed as CBI). Chemical Abstracts Service (CAS) Registry number (if assigned for non-confidential chemical identities). Basis for the SNUR. Information identified by EPA that would help characterize the potential health and/or environmental effects of the chemical substances if a manufacturer or processor is considering submitting a SNUN for a significant new use designated by the SNUR. This information may include testing not required to be conducted but which would help characterize the potential health and/or environmental effects of the PMN substance. Any recommendation for information 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 VII. for more information. CFR citation assigned in the regulatory text section of these proposed rules. The regulatory text section of these proposed rules specifies the activities designated as significant new uses. Certain new uses, including production volume limits and other uses designated in the proposed rules, may be claimed as CBI. The chemical substances that are the subject of these proposed SNURs are undergoing premanufacture review. EPA has initially determined under TSCA section 5(a)(2), 15 U.S.C. 2604(a)(2), that certain changes from the conditions of use described in the PMNs could result in changes in the type or form of exposure to the chemical substances and/or increased exposures to the chemical substances and/or changes in the reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of the chemical substances. Consequently, EPA is proposing to designate these changes as significant new uses. PMN Number: P-16-192 Chemical Name: Silanized amorphous silica (generic). CAS Number: Not available. Basis for action: The PMN states that the use of the substance will be as a reinforcing filler for the production of rubber goods. Based on test data for crystalline silica, EPA identified concerns for lung effects if the chemical substance is not used following the limitations noted below. The conditions of use of the PMN substance as described in the PMN include the following protective measures: 1. Manufacture of the PMN substance in an amorphous form. The proposed SNUR would designate as a ``significant new use'' the absence of this protective measure. Potentially useful information: EPA has determined that certain information about the physical-chemical properties of the PMN substance may be potentially useful if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that information about the physical form, particle size, and water solubility would help characterize the potential health effects of the PMN substance. CFR citation: 40 CFR 721.11182. PMN Numbers: P-16-354 and P-16-355 Chemical name: Esteramine (generic). CAS number: Not available. Basis for action: The PMNs state that the generic (non- confidential) use of the substances will be as a chemical intermediate. Based on the physical/chemical properties of the PMN substances and Structure Analysis Relationships (SAR) analysis of test data on analogous substances, EPA has identified concerns for irritation and developmental/reproductive toxicity, and aquatic toxicity at surface water concentrations exceeding 1 part per billion (ppb), if the chemical substances are not used following the limitations noted below. The conditions of use of the PMN substances as described in the PMNs include the following protective measures: 1. No release of a manufacturing, processing, or use stream associated with any use of the substances, other than the confidential chemical intermediate use described in the PMNs, into the waters of the United States exceeding a surface water concentration of 1 ppb; and 2. No manufacturing, processing or use of the PMN substances resulting in inhalation exposures to the substances. The proposed SNUR would designate as a ``significant new use'' the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the aquatic and human health toxicity of the PMN substances may be potentially useful to characterize the health and environmental effects of the PMN substances if a manufacturer or [[Page 52182]] processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of specific organ toxicity and aquatic toxicity testing would help characterize the potential health and environmental effects of the PMN substances. CFR citation: 40 CFR 721.11183. PMN Numbers: P-16-380, P-16-381, P-16-382, P-16-383, P-16-384, and P- 16-385 Chemical Names: Formic acid, compds. with hydrolyzed bisphenol A- epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3- dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2- (methylamino)ethanol reaction products acetates (salts), (generic) (P- 16-380), propanoic acid, 2-hydroxy-, compds. with hydrolyzed bisphenol A-epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3- dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2- (methylamino)ethanol reaction products formates (salts), (generic) (P- 16-381), formic acid, compds. with hydrolyzed bisphenol A- epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3- dimethylbutylidene)amino] ethyl]-1,2-ethanediamine-dialdehyde-2- (methylamino)ethanol reaction products sulfamates (salts), (generic) (P-16-382), formic acid, compds. with hydrolyzed bisphenol A- epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3- dimethylbutylidene)amino] ethyl]-1,2-ethanediamine-dialdehyde-2- (methylamino)ethanol reaction products acetates (salts), (generic) (P- 16-383), propanoic acid, 2-hydroxy-, compds. with hydrolyzed bisphenol A-epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3- dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2- (methylamino)ethanol reaction products formates (salts), (generic) (P- 16-384), formic acid, compds. with hydrolyzed bisphenol A- epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3- dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2- (methylamino)ethanol reaction products sulfamates (salts), (generic) (P-16-385). CAS Numbers: Not available. Basis for action: The PMNs state that the generic (non- confidential) use of the substances will be as a component of an electrocoat resin. Based on the physical/chemical properties of the PMN substances and test data on analogous substances, EPA has identified concerns for lung effects and toxicity to aquatic organisms at concentrations that exceed 16 ppb if the chemical substances are not used following the limitations noted below. The conditions of use of the PMN substances as described in the PMNs include the following protective measures: 1. No manufacturing, processing or use of the PMN substances resulting in inhalation exposures to the substances; and 2. No release of a manufacturing, processing, or use stream associated with any use of the substances exceeding a surface water concentration of 16 ppb. The proposed SNUR would designate as a ``significant new use'' the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the health and environmental effects of the PMN substances may be potentially useful if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of specific target organ, pulmonary, and acute aquatic toxicity testing would help characterize the potential health and environmental effects of the PMN substances. CFR citation: 40 CFR 721.11184 (P-16-380); 40 CFR 721.11185 (P-16- 381); 40 CFR 721.11186 (P-16-382); 40 CFR 721.11187 (P-16-383); 40 CFR 721.11188 (P-16-384); and 40 CFR 721.11189 (P-16-385). PMN Numbers: P-16-483 and P-16-484 Chemical names: Inorganic acids, metal salts, compds. with modified heteroaromatics, (generic) (P-16-483) and Inorganic acids, metal salts, compds. with substituted aromatic heterocycle, (generic) (P-16-484). CAS numbers: Not available. Basis for action: The PMNs state that the generic (non- confidential) use of P-16-483 will be as a plastic additive and the generic (non-confidential) use of P-16-484 will be as a chemical intermediate. Based on test data submitted on P-16-483 and data for analogous compounds, EPA has identified concerns for irritation, specific organ effects, and aquatic toxicity if the chemical is not used following the limitations noted below. The conditions of use of the PMN substances as described in the PMNs include the following protective measures: 1. No use of the substances other than the confidential use described in the PMNs; 2. No release of a manufacturing, processing, or use stream associated with any use of the substances exceeding a surface water concentration of 34 ppb; and 3. No manufacturing, processing or use of the PMN substances without the engineering controls described in the PMNs to limit exposure to dust. The proposed SNUR would designate as a ``significant new use'' the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the human health and environmental toxicity of the PMN substances may be potentially useful to characterize the effects of the PMN substances if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of aquatic toxicity and specific organ toxicity and aquatic toxicity testing would help characterize the potential health and environmental effects of the PMN substances. CFR citations: 40 CFR 721.11190 (P-16-683) and 40 CFR 721.11191 (P- 16-684). PMN Number: P-16-575 Chemical name: Glucosyltransferase. International Union of Biochemistry and Molecular Biology Number: 2.4.1.5 CAS number: 9032-14-8. Basis for action: The PMN states that the use of the substance will be for polymerization of glucose. Based on the allergenic properties of proteins and review of surrogate enzymatic protein data submitted, EPA has identified concerns for respiratory sensitization if the chemical is not used following the limitations noted below. The conditions of use of the PMN substance as described in the PMN include the following protective measure: 1. No manufacture, processing, or use of the PMN substance that results in inhalation exposures to the substance. The proposed SNUR would designate as a ``significant new use'' the absence of this protective measure. Potentially useful information: EPA has determined that certain information about the workplace exposure to the PMN substance may be potentially useful to characterize the health effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that [[Page 52183]] would be designated by this proposed SNUR. EPA has determined that the results of workplace air monitoring would help characterize the potential health effects of the PMN substance. CFR citation: 40 CFR 721.11192. PMN Number: P-16-581 Chemical name: Alpha 1,3-polysaccharide (generic). CAS number: Not available. Basis for action: The PMN states that the uses of the substance will be as a polymer additive, paper coating component, composite component, and fiber additive. Based on analogy to high molecular weight polymers, EPA has identified concerns for lung effects if the chemical is not used following the limitations noted below. The conditions of use of the PMN substance as described in the PMN include the following protective measures: 1. No use of the substance other than the uses described in the PMN; and 2. No manufacture, processing, or use with particle size less than 10 micrometers. The proposed SNUR would designate as a ``significant new use'' the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the toxicity of the PMN substance may be potentially useful to characterize the health effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of pulmonary effects toxicity testing of the PMN substance may be potentially useful in characterizing the health effects of the PMN substance. CFR citation: 40 CFR 721.11193. V. Rationale and Objectives of the Proposed Rule A. Rationale During review of the PMNs submitted for the chemical substances that are the subject of these proposed SNURs and as further discussed in Unit IV, EPA identified certain reasonably foreseen changes from the conditions of use identified in the PMNs and determined that those changes could result in changes in the type or form of exposure to the chemical substances and/or increased exposures to the chemical substances and/or changes in the reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of the chemical substances. B. Objectives EPA is proposing SNURs for 13 specific chemical substances which are undergoing premanufacture review because the Agency wants to achieve the following objectives with regard to the significant new uses that would be designated in this proposed rule: EPA would 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 would be obligated to make a determination under TSCA section 5(a)(3) regarding the use described in the SNUN, under the conditions of use. The Agency will either determine under section 5(a)(3)(C) that the significant new use is not likely to present an unreasonable risk, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, or make a determination under section 5(a)(3)(A) or (B) and take the required regulatory action associated with the determination, before manufacture or processing for the significant new use of the chemical substance can occur. Issuance of a proposed SNUR for a chemical substance does not signify that the chemical substance is listed on the 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. Applicability of the Proposed Rules to Uses Occurring Before the Effective Date of the Final Rule To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substances subject to this proposed rule were undergoing premanufacture review at the time of signature of this proposed rule and were not on the TSCA Inventory. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the TSCA Inventory, no person may commence such activities without first submitting a PMN. Therefore, for the chemical substances subject to this proposed SNUR, EPA concludes that the proposed significant new uses are not ongoing. EPA designates October 10, 2018, as the cutoff date for determining whether the new use is ongoing. The objective of EPA's approach is to ensure that a person cannot defeat a SNUR by initiating a significant new use before the effective date of the final rule. Persons who begin commercial manufacture or processing of the chemical substances for a significant new use identified on or after that date would have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons would have to first comply with all applicable SNUR notification requirements and EPA would have to take action under section 5 allowing manufacture or processing to proceed. VII. Development and Submission of Information EPA recognizes that TSCA section 5 does not require development of any particular new information (e.g., generating test data) before submission of a SNUN. There is an exception: If a person is required to submit information for a chemical substance pursuant to a rule, order or consent agreement under TSCA section 4 (15 U.S.C. 2603), then TSCA section 5(b)(1)(A) (15 U.S.C. 2604(b)(1)(A)) requires such information to be submitted to EPA at the time of submission of the SNUN. In the absence of a rule, order, or consent agreement under TSCA section 4 covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information known to or reasonably ascertainable by them (see Sec. 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. Unit IV. lists potentially useful information for all SNURs listed here. Descriptions are provided for informational purposes. The potentially useful information identified in Unit IV. will be useful to EPA's evaluation in the event that someone submits a SNUN for the significant new use. Companies who are considering submitting a SNUN are encouraged, but not required, to develop the information on the substance, which may assist with EPA's analysis of the SNUN. EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. Furthermore, pursuant to TSCA section 4(h), which pertains to reduction of testing in vertebrate animals, EPA encourages consultation with the Agency on the use of alternative test methods and strategies (also called New Approach Methodologies, or NAMs), if available, to generate the recommended test data. EPA encourages dialog with Agency representatives to help determine how best the submitter can meet both the [[Page 52184]] data needs and the objective of TSCA section 4(h). The potentially useful information described in Unit IV. may not be the only means of providing information to evaluate the chemical substance associated with the significant new uses. However, submitting a SNUN without any test data may increase the likelihood that EPA will take action under TSCA section 5(e) or 5(f). EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests. SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following: Human exposure and environmental release that may result from the significant new use of the chemical substances. Information on risks posed by the chemical substances compared to risks posed by potential substitutes. VIII. SNUN Submissions According to Sec. 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in Sec. 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 Sec. 720.40 and Sec. 721.25. E-PMN software is available electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca. IX. Economic Analysis EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors of the chemical substances subject to this proposed rule. EPA's complete economic analysis is available in the docket under docket ID number EPA-HQ-OPPT- 2017-0575. X. Statutory and Executive Order Reviews A. Executive Order 12866 This proposed rule would establish SNURs for 13 new chemical substances that were the subject of PMNs. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993). B. Paperwork Reduction Act (PRA) According to PRA, 44 U.S.C. 3501 et seq., an Agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable. 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. 605(b)), 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 SNUN submitted by any small entity would not cost significantly more than $9,816. A copy of that certification is available in the docket for this action. This proposed rule 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 $9.816. 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 proposed rule. As such, EPA has determined that this proposed rule 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. 1502, 1503, 1504, or 1505 et seq.). E. Executive Order 13132 This action would 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 proposed rule would not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This proposed rule would 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 proposed rule. 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. [[Page 52185]] H. Executive Order 13211 This proposed rule 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 Sec. 12(d) (Pub. L. 104-113, 12(d)), 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). List of Subjects in 40 CFR Part 721 Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements. Dated: October 5, 2018. Tala R. Henry, Acting Director, Office of Pollution Prevention and Toxics. Therefore, it is proposed that 40 CFR part 721 is amended as follows: PART 721--[AMENDED] 0 1. The authority citation for part 721 continues to read as follows: Authority: 15 U.S.C. 2604, 2607, and 2625(c). 0 2. Add Sec. 721.11182 to subpart E to read as follows: Sec. 721.11182 Silanized amorphous silica (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as silanized amorphous silica (P-16-192) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80. It is a significant new use to manufacture the substance other than in an amorphous form. (ii) [Reserved] (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (c), and (i) are applicable to manufacturers, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 3. Add Sec. 721.11183 to subpart E to read as follows: Sec. 721.11183 Esteramine (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as esteramine (PMN P-16-354 and P-16-355) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80. It is a significant new use to manufacture, process, or use the substances in any manner that results in inhalation exposure. It is a significant new use to release a manufacturing, processing, or use stream associated with any use of the substances, other than the confidential chemical intermediate use described in the premanufacture notices, into the waters of the United States exceeding a surface water concentration of 1 part per billion (ppb) using the methods described in Sec. 721.91. (ii) [Reserved] (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) though (e), and (i) are applicable to manufacturers and processors of these substances. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 4. Add Sec. 721.11184 to subpart E to read as follows: Sec. 721.11184 Formic acid, compds. with hydrolyzed bisphenol A- epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3- dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2- (methylamino)ethanol reaction products acetates (salts), (generic) (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as formic acid, compds. with hydrolyzed bisphenol A-epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) polymer-N1-(1,3-dimethylbutylidene)-N2-[2- [(1, 3-dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2- (methylamino)ethanol reaction products acetates (salts), (P-16-380) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, Commercial, and consumer activities. Requirements as specified in Sec. 721.80. It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure. (ii) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) where N = 16. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (c), (i), and (k) are applicable to manufacturers, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 5. Add Sec. 721.11185 to subpart E to read as follows: Sec. 721.11185 Propanoic acid, 2-hydroxy-, compds. with hydrolyzed bisphenol A-epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3- dimethylbutylidene) amino]ethyl]-1,2-ethanediamine-dialdehyde-2- (methylamino)ethanol reaction products formates (salts), (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically as propanoic acid, 2- hydroxy-, compds. with hydrolyzed bisphenol A-epichlorohydrin- polyethylene glycol ether with bisphenol A (2:1) polymer-N1-(1,3- dimethylbutylidene)-N2-[2-[(1, 3-dimethylbutylidene)amino]ethyl]-1,2- ethanediamine-dialdehyde-2-(methylamino)ethanol reaction products formates (salts), (P-16-381) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, Commercial, and consumer activities. Requirements as specified in Sec. 721.80. It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure. [[Page 52186]] (ii) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) where N = 16. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (c), (i), and (k) are applicable to manufacturers, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 6. Add Sec. 721.11186 to subpart E to read as follows: Sec. 721.11186 Formic acid, compds. with hydrolyzed bisphenol A- epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-dimethylbutylidene) amino]ethyl]-1,2-ethanediamine-dialdehyde-2-(methylamino)ethanol reaction products sulfamates (salts), (generic), (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as formic acid, compds. with hydrolyzed bisphenol A-epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) polymer-N1-(1,3-dimethylbutylidene)-N2-[2- [(1, 3-dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2- (methylamino)ethanol reaction products sulfamates (salts), (P-16-382) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, Commercial, and consumer activities. Requirements as specified in Sec. 721.80. It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure. (ii) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) where N = 16. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (c), (i), and (k) are applicable to manufacturers, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 7. Add Sec. 721.11187 to subpart E to read as follows: Sec. 721.11187 Formic acid, compds. with hydrolyzed bisphenol A- epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-dimethylbutylidene) amino]ethyl]-1,2-ethanediamine-dialdehyde-2-(methylamino)ethanol reaction products acetates (salts), (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as formic acid, compds. with hydrolyzed bisphenol A-epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) polymer-N1-(1,3-dimethylbutylidene)-N2-[2- [(1, 3-dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2- (methylamino)ethanol reaction products acetates (salts), (P-16-383) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, Commercial, and consumer activities. Requirements as specified in Sec. 721.80. It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure. (ii) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) where N = 16. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (c), (i), and (k) are applicable to manufacturers, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 8. Add Sec. 721.11188 to subpart E to read as follows: Sec. 721.11188 Propanoic acid, 2-hydroxy-, compds. with hydrolyzed bisphenol A-epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3- dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2- (methylamino)ethanol reaction products formates (salts), (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as propanoic acid, 2-hydroxy-, compds. with hydrolyzed bisphenol A-epichlorohydrin- polyethylene glycol ether with bisphenol A (2:1) polymer-N1-(1,3- dimethylbutylidene)-N2-[2-[(1, 3-dimethylbutylidene)amino] ethyl]-1,2- ethanediamine-dialdehyde-2-(methylamino)ethanol reaction products formates (salts), (P-16-384) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, Commercial, and consumer activities. Requirements as specified in Sec. 721.80. It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure. (ii) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) where N = 16. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (c), (i), and (k) are applicable to manufacturers, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 9. Add Sec. 721.11189 to subpart E to read as follows: Sec. 721.11189 Formic acid, compds. with hydrolyzed bisphenol A- epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-dimethylbutylidene) amino]ethyl]-1,2-ethanediamine-dialdehyde-2-(methylamino)ethanol reaction products sulfamates (salts), (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as formic acid, compds. with hydrolyzed bisphenol A-epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1) polymer-N1-(1,3-dimethylbutylidene)-N2-[2- [(1, 3-dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2- (methylamino)ethanol reaction products sulfamates (salts), (P-16-385) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, Commercial, and consumer activities. Requirements as specified in Sec. 721.80. It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure. (ii) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) where N = 16. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (c), (i), and (k) are [[Page 52187]] 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. 721.11190 to subpart E to read as follows: Sec. 721.11190 Inorganic acids, metal salts, compds. with modified heteroaromatics, (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as inorganic acids, metal salts, compds. with modified heteroaromatics, (PMN P-16-483) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(j). It is a significant new use to manufacture, process, or use the substance without the engineering controls described in the premanufacture notice to limit exposure to dust. (ii) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) where N = 34 ppb. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (c), (i), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725 (b)(1) apply to paragraph (a)(2)(i) of this section. 0 11. Add Sec. 721.11191 to subpart E to read as follows: Sec. 721.11191 Inorganic acids, metal salts, compds. with substituted aromatic heterocycle, (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as inorganic acids, metal salts, compds. with substituted aromatic heterocycle, (PMN P-16-484) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(j). It is a significant new use to manufacture, process, or use the substance without the engineering controls described in the premanufacture to limit exposure to dust. (ii) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) where N = 34. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (c), (i), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of this section. 0 12. Add Sec. 721.11192 to subpart E to read as follows: Sec. 721.11192 Glucosyltransferase, International Union of Biochemistry and Molecular Biology Number: 2.4.1.5. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as glucosyltransferase, International Union of Biochemistry and Molecular Biology Number: 2.4.1.5 (PMN P-16-575, CAS No. 9032-14-8) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(y)(1) and (y)(2). (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. 0 13. Add Sec. 721.11193 to subpart E to read as follows: Sec. 721.11193 Alpha 1,3-polysaccharide (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as alpha 1,3-polysaccharide (generic) (PMN P-16-581) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80. It is a significant new use to use the substance other than as a polymer additive, paper coating component, composite component, or fiber additive. It is a significant new use to manufacture, process or use the PMN substance with particle size less than 10 micrometers. (ii) [Reserved] (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (c) and (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. [FR Doc. 2018-22397 Filed 10-15-18; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 83, No. 200 / Tuesday, October 16, 2018 / Proposed Rules 52179
III. Notice and Comment System (ISS); and (3) removal of the information on the Petition may be
IV. Ordering Paragraphs conflation of differential flows between accessed via the Commission’s website
I. Introduction Output Sub System (OSS) operations at http://www.prc.gov. Interested
and automation barcode sortation (BCS) persons may submit comments on the
On October 5, 2018, the Postal Service operations in the Marketing Mail Letters Petition and Proposal Eight no later than
filed a petition pursuant to 39 CFR cost model. Id. at 3. November 9, 2018. Pursuant to 39
3050.11 requesting that the Commission The Postal Service states that U.S.C. 505, the Commission designates
initiate a rulemaking proceeding to modification 1 aligns the current Katalin K. Clendenin as an officer of the
consider changes to analytical operational flows of automation pre- Commission (Public Representative) to
principles relating to periodic reports.1 barcoded Mixed AADC (MAADC) mail represent the interests of the general
The Petition identifies the proposed with modeled automation mail. Id. at 4. public in this proceeding.
analytical changes filed in this docket as The modification changes the inflow of
Proposal Eight. 10,000 pieces of modeled mail from the IV. Ordering Paragraphs
II. Proposal Eight outgoing secondary entry point. Id. The It is ordered:
Postal Service states that the 1. The Commission establishes Docket
Background. The Postal Service seeks ‘‘modification directly impacts only the No. RM2019–1 for consideration of the
to modify the modeling methodology in Automation MAADC Presort Letters and matters raised by the Petition of the
First-Class Mail and Marketing Mail Cards categories.’’ Id. United States Postal Service for the
Letter cost models to reflect current The Postal Service states that the Initiation of a Proceeding to Consider
operational flows. Petition, Proposal current letter models do not account for Proposed Changes in Analytical
Eight at 1. The Postal Service states that mechanical rejects that flow to manual Principles (Proposal Eight), filed
Proposal Eight relates to the operations. Id. The Postal Service states October 5, 2018.
Commission’s directive in the FY 2017 that the delivery BCS (DBCS) Input 2. Comments by interested persons in
Annual Compliance Determination Output Sub System (DIOSS) reject rate this proceeding are due no later than
Report for the Postal Service to ‘‘provide is composed of the OSS rate of rejects November 9, 2018.
a plan to move the passthrough toward flowing to manual operations. Id. 3. Pursuant to 39 U.S.C. 505, the
100 percent’’ for USPS Marketing Mail Modification 2 ‘‘corrects the DIOSS Commission appoints Katalin K.
Automation Letters Barcoding.2 The operations’ treatment of rejects to that of Clendenin to serve as an officer of the
Postal Service states Proposal Eight traditional OSS/ISS operations for Commission (Public Representative) to
‘‘aligns the barcode cost avoidance and treatment of pieces flowing to manual represent the interests of the general
the associated passthrough with the operations and to OSS operations.’’ Id. public in this docket.
Commission’s directive.’’ Id. The Postal Service suggests that the 4. The Secretary shall arrange for
The Postal Service states that it current Marketing Mail Letters cost publication of this Order in the Federal
developed its current mail processing model, calculating the barcode cost Register.
letter cost models when cancellation avoidance as the difference between By the Commission.
equipment had limited functionality. Id. modeled (Non-Automation) Machinable
at 2. The outgoing primary scheme Stacy L. Ruble,
MAADC letters and Automation
could not isolate mail for all automated MAADC letters, ‘‘conflates the value of Secretary.
area distribution centers (AADCs), and the barcode with intrinsic differences [FR Doc. 2018–22457 Filed 10–15–18; 8:45 am]
mail for low volume AADCs flowed to between non-barcoded and automation BILLING CODE 7710–FW–P
the outgoing secondary scheme. Id. mail.’’ Id. at 5. Modification 3 corrects
The Postal Service states that due to the model for machinable MAADC mail
advances in Optical Character by using the same down flow densities ENVIRONMENTAL PROTECTION
Recognition (OCR) technology, its as automation MAADC mail, ‘‘thereby AGENCY
Advanced Facer Canceller System accurately estimating the value of a
(AFCS) is now able to read addresses barcode when used as a benchmark.’’ Id. 40 CFR Part 721
and isolate locally-processed mail from The Postal Service states that this [EPA–HQ–OPPT–2017–0575; FRL–9984–93]
mail destinating in the service territory modification applies only to Marketing
of other processing facilities. Id. This RIN 2070–AB27
Mail Letters. Id. at 6.
capability eliminated the need for local Rationale and impact. The Postal
separations on outgoing primary Significant New Use Rules on Certain
Service states that it intends for the
schemes, or the processing of pre- Chemical Substances
proposal to modify the letter processing
barcoded mail on the outgoing models to reflect ‘‘current operational AGENCY: Environmental Protection
secondary scheme. Id. The Postal reality.’’ Id. at 1. The Postal Service Agency (EPA).
Service states the result is an increased states that the proposal would increase ACTION: Proposed rule.
quantity of mail processed on the the barcode cost avoidance of Marketing
outgoing primary scheme. Id. at 2–3. Mail Automation MAADC letters from SUMMARY: EPA is proposing significant
Proposal. The Postal Service proposes $0.001 to $0.006, while reducing the new use rules (SNURs) under the Toxic
three operational and methodological passthrough from 1300 percent to 217 Substances Control Act (TSCA) for 13
changes: (1) Modification of models to percent. Id. at 6. The Postal Service chemical substances which are the
reflect current operational flows; (2) provides the change in mail processing subject of premanufacture notices
amozie on DSK3GDR082PROD with PROPOSALS1
correction of the exclusion of unit costs for Marketing Mail Letters (PMNs). This action would require
mechanical rejects from the Input Sub and First-Class Mail Letters and Cards. persons to notify EPA at least 90 days
Id. at 7–8. before commencing manufacture
1 Petition of the United States Postal Service for
(defined by statute to include import) or
the Initiation of a Proceeding to Consider Proposed III. Notice and Comment processing of any of these 13 chemical
Changes in Analytical Principles (Proposal Eight),
October 5, 2018 (Petition). The Commission establishes Docket substances for an activity that is
2 Id. Docket No. ACR2017, Annual Compliance No. RM2019–1 for consideration of designated as a significant new use by
Determination Report, March 29, 2018, at 26. matters raised by the Petition. More this proposed rule. If this proposed rule
VerDate Sep<11>2014 17:27 Oct 15, 2018 Jkt 247001 PO 00000 Frm 00009 Fmt 4702 Sfmt 4702 E:\FR\FM\16OCP1.SGM 16OCP1](https://thefederalregister.org/doc/83_FR_52379/page/1.svg)
![52180 Federal Register / Vol. 83, No. 200 / Tuesday, October 16, 2018 / Proposed Rules
is made final, persons may not • Manufacturers or processors of one 355, P–16–380 through P–16–385, P–
commence manufacture or processing or more subject chemical substances 16–483 and P–16–484, P–16–575, and
for the significant new use until they (NAICS codes 325 and 324110), e.g., P–16–581. These proposed SNURs
have submitted a Significant New Use chemical manufacturing and petroleum would require persons who intend to
Notice, and EPA has conducted a review refineries. manufacture or process any of these
of the notice, made an appropriate This action may also affect certain chemical substances for an activity that
determination on the notice, and has entities through pre-existing import is designated as a significant new use to
taken any actions as are required as a certification and export notification notify EPA at least 90 days before
result of that determination. rules under TSCA. Chemical importers commencing that activity.
DATES: Comments must be received on are subject to the TSCA section 13 (15 The record for the proposed SNURs
or before November 15, 2018. U.S.C. 2612) import certification on these chemicals was established as
ADDRESSES: Submit your comments, requirements promulgated at 19 CFR docket EPA–HQ–OPPT–2017–0575.
identified by docket identification (ID) 12.118 through 12.127 and 19 CFR That record includes information
number EPA–HQ–OPPT–2017–0575], 127.28. Chemical importers must certify considered by the Agency in developing
by one of the following methods: that the shipment of the chemical these proposed SNURs.
• Federal eRulemaking Portal: http:// substance complies with all applicable B. What is the Agency’s authority for
www.regulations.gov. Follow the online rules and orders under TSCA. Importers taking this action?
instructions for submitting comments. of chemicals subject to these proposed
Do not submit electronically any SNURs would need to certify their Section 5(a)(2) of TSCA (15 U.S.C.
information you consider to be compliance with the SNUR 2604(a)(2)) authorizes EPA to determine
Confidential Business Information (CBI) requirements should these proposed that a use of a chemical substance is a
or other information whose disclosure is rules be finalized. The EPA policy in ‘‘significant new use.’’ EPA must make
restricted by statute. support of import certification appears this determination by rule after
• Mail: Document Control Office at 40 CFR part 707, subpart B. In considering all relevant factors,
(7407M), Office of Pollution Prevention including the four bulleted TSCA
addition, pursuant to 40 CFR 721.20,
and Toxics (OPPT), Environmental section 5(a)(2) factors listed in Unit III.
any persons who export or intend to
Protection Agency, 1200 Pennsylvania Once EPA determines that a use of a
export a chemical substance that is the
Ave. NW, Washington, DC 20460–0001. chemical substance is a significant new
subject of this proposed rule on or after
• Hand Delivery: To make special use, TSCA section 5(a)(1)(B)(i) (15
November 15, 2018 are subject to the
arrangements for hand delivery or U.S.C. 2604(a)(1)(B)(i)) requires persons
export notification provisions of TSCA
delivery of boxed information, please to submit a significant new use notice
section 12(b) (15 U.S.C. 2611(b)) and
follow the instructions at http:// (SNUN) to EPA at least 90 days before
must comply with the export
www.epa.gov/dockets/contacts.html. they manufacture or process the
notification requirements in 40 CFR part
Additional instructions on chemical substance for that use. TSCA
707, subpart D. prohibits such manufacturing or
commenting or visiting the docket,
along with more information about B. What should I consider as I prepare processing from commencing until EPA
dockets generally, is available at http:// my comments for EPA? has conducted a review of the SNUN,
www.epa.gov/dockets. 1. Submitting CBI. Do not submit CBI made an appropriate determination on
FOR FURTHER INFORMATION CONTACT: to EPA through regulations.gov or email. the SNUN, and taken such actions as are
For technical information contact: Clearly mark the part or all of the required in association with that
Kenneth Moss, Chemical Control information that you claim to be CBI. determination (15 U.S.C.
Division (7405M), Office of Pollution For CBI information in a disk or CD– 2604(a)(1)(B)(ii)). As described in Unit
Prevention and Toxics, Environmental ROM that you mail to EPA, mark the V., the general SNUR provisions are
Protection Agency, 1200 Pennsylvania outside of the disk or CD–ROM as CBI found at 40 CFR part 721, subpart A.
Ave. NW, Washington, DC 20460–0001; and then identify electronically within C. Applicability of General Provisions
telephone number: (202) 564–9232; the disk or CD–ROM the specific General provisions for SNURs appear
email address: moss.kenneth@epa.gov. information that is claimed as CBI. In
For general information contact: The in 40 CFR part 721, subpart A. These
addition to one complete version of the provisions describe persons subject to
TSCA-Hotline, ABVI-Goodwill, 422 comment that includes information
South Clinton Ave., Rochester, NY the rule, recordkeeping requirements,
claimed as CBI, a copy of the comment exemptions to reporting requirements,
14620; telephone number: (202) 554– that does not contain the information
1404; email address: TSCA-Hotline@ and applicability of the rule to uses
claimed as CBI must be submitted for occurring before the effective date of the
epa.gov. inclusion in the public docket. rule. Provisions relating to user fees
SUPPLEMENTARY INFORMATION: Information so marked will not be appear at 40 CFR part 700. Pursuant to
disclosed except in accordance with § 721.1(c), persons subject to these
I. General Information procedures set forth in 40 CFR part 2. SNURs must comply with the same
A. Does this action apply to me? 2. Tips for preparing your comments. SNUN requirements and EPA regulatory
You may be potentially affected by When preparing and submitting your procedures as submitters of PMNs under
this action if you manufacture, process, comments, see the commenting tips at TSCA section 5(a)(1)(A) (15 U.S.C.
or use the chemical substances http://www.epa.gov/dockets/ 2604(a)(1)(A)). In particular, these
amozie on DSK3GDR082PROD with PROPOSALS1
contained in this proposed rule. The comments.html. requirements include the information
following list of North American II. Background submission requirements of TSCA
Industrial Classification System sections 5(b) and 5(d)(1) (15 U.S.C.
(NAICS) codes is not intended to be A. What action is the Agency taking? 2604(b) and 2604(d)(1)), the exemptions
exhaustive, but rather provides a guide EPA is proposing these SNURs under authorized by TSCA sections 5(h)(1),
to help readers determine whether this TSCA section 5(a)(2) for 13 chemical 5(h)(2), 5(h)(3), and 5(h)(5) and the
document applies to them. Potentially substances which were the subjects of regulations at 40 CFR part 720. Once
affected entities may include: PMNs P–16–192, P–16–354 and P–16– EPA receives a SNUN, EPA must either
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processor is considering submitting a Basis for action: The PMNs state that substances as described in the PMNs
SNUN for a significant new use that the generic (non-confidential) use of the include the following protective
would be designated by this proposed substances will be as a component of an measures:
SNUR. EPA has determined that the electrocoat resin. Based on the physical/ 1. No use of the substances other than
results of specific organ toxicity and chemical properties of the PMN the confidential use described in the
aquatic toxicity testing would help substances and test data on analogous PMNs;
characterize the potential health and substances, EPA has identified concerns 2. No release of a manufacturing,
environmental effects of the PMN for lung effects and toxicity to aquatic processing, or use stream associated
substances. organisms at concentrations that exceed with any use of the substances
CFR citation: 40 CFR 721.11183. 16 ppb if the chemical substances are exceeding a surface water concentration
not used following the limitations noted of 34 ppb; and
PMN Numbers: P–16–380, P–16–381, P–
below. The conditions of use of the 3. No manufacturing, processing or
16–382, P–16–383, P–16–384, and P–16–
PMN substances as described in the use of the PMN substances without the
385
PMNs include the following protective engineering controls described in the
Chemical Names: Formic acid, measures: PMNs to limit exposure to dust.
compds. with hydrolyzed bisphenol A- 1. No manufacturing, processing or The proposed SNUR would designate
epichlorohydrin-polyethylene glycol use of the PMN substances resulting in as a ‘‘significant new use’’ the absence
ether with bisphenol A (2:1) polymer- inhalation exposures to the substances; of these protective measures.
N1-(1,3-dimethylbutylidene)-N2-[2-[(1, and Potentially useful information: EPA
3-dimethylbutylidene)amino]ethyl]-1,2- 2. No release of a manufacturing, has determined that certain information
ethanediamine-dialdehyde-2- processing, or use stream associated about the human health and
(methylamino)ethanol reaction products with any use of the substances environmental toxicity of the PMN
acetates (salts), (generic) (P–16–380), exceeding a surface water concentration substances may be potentially useful to
propanoic acid, 2-hydroxy-, compds. of 16 ppb. characterize the effects of the PMN
with hydrolyzed bisphenol A- The proposed SNUR would designate substances if a manufacturer or
epichlorohydrin-polyethylene glycol as a ‘‘significant new use’’ the absence processor is considering submitting a
ether with bisphenol A (2:1) polymer- of these protective measures. SNUN for a significant new use that
N1-(1,3-dimethylbutylidene)-N2-[2-[(1, Potentially useful information: EPA would be designated by this proposed
3-dimethylbutylidene)amino]ethyl]-1,2- has determined that certain information SNUR. EPA has determined that the
ethanediamine-dialdehyde-2- about the health and environmental results of aquatic toxicity and specific
(methylamino)ethanol reaction products effects of the PMN substances may be organ toxicity and aquatic toxicity
formates (salts), (generic) (P–16–381), potentially useful if a manufacturer or testing would help characterize the
formic acid, compds. with hydrolyzed processor is considering submitting a potential health and environmental
bisphenol A-epichlorohydrin- SNUN for a significant new use that effects of the PMN substances.
polyethylene glycol ether with would be designated by this proposed CFR citations: 40 CFR 721.11190 (P–
bisphenol A (2:1) polymer-N1-(1,3- SNUR. EPA has determined that the 16–683) and 40 CFR 721.11191 (P–16–
dimethylbutylidene)-N2-[2-[(1, 3- results of specific target organ, 684).
dimethylbutylidene)amino] ethyl]-1,2- pulmonary, and acute aquatic toxicity
ethanediamine-dialdehyde-2- PMN Number: P–16–575
testing would help characterize the
(methylamino)ethanol reaction products potential health and environmental Chemical name: Glucosyltransferase.
sulfamates (salts), (generic) (P–16–382), effects of the PMN substances. International Union of Biochemistry and
formic acid, compds. with hydrolyzed CFR citation: 40 CFR 721.11184 (P– Molecular Biology Number: 2.4.1.5
bisphenol A-epichlorohydrin- 16–380); 40 CFR 721.11185 (P–16–381); CAS number: 9032–14–8.
polyethylene glycol ether with 40 CFR 721.11186 (P–16–382); 40 CFR Basis for action: The PMN states that
bisphenol A (2:1) polymer-N1-(1,3- 721.11187 (P–16–383); 40 CFR the use of the substance will be for
dimethylbutylidene)-N2-[2-[(1, 3- 721.11188 (P–16–384); and 40 CFR polymerization of glucose. Based on the
dimethylbutylidene)amino] ethyl]-1,2- 721.11189 (P–16–385). allergenic properties of proteins and
ethanediamine-dialdehyde-2- review of surrogate enzymatic protein
(methylamino)ethanol reaction products PMN Numbers: P–16–483 and P–16–484 data submitted, EPA has identified
acetates (salts), (generic) (P–16–383), Chemical names: Inorganic acids, concerns for respiratory sensitization if
propanoic acid, 2-hydroxy-, compds. metal salts, compds. with modified the chemical is not used following the
with hydrolyzed bisphenol A- heteroaromatics, (generic) (P–16–483) limitations noted below. The conditions
epichlorohydrin-polyethylene glycol and Inorganic acids, metal salts, of use of the PMN substance as
ether with bisphenol A (2:1) polymer- compds. with substituted aromatic described in the PMN include the
N1-(1,3-dimethylbutylidene)-N2-[2-[(1, heterocycle, (generic) (P–16–484). following protective measure:
3-dimethylbutylidene)amino]ethyl]-1,2- CAS numbers: Not available. 1. No manufacture, processing, or use
ethanediamine-dialdehyde-2- Basis for action: The PMNs state that of the PMN substance that results in
(methylamino)ethanol reaction products the generic (non-confidential) use of P– inhalation exposures to the substance.
formates (salts), (generic) (P–16–384), 16–483 will be as a plastic additive and The proposed SNUR would designate
formic acid, compds. with hydrolyzed the generic (non-confidential) use of P– as a ‘‘significant new use’’ the absence
bisphenol A-epichlorohydrin- 16–484 will be as a chemical of this protective measure.
amozie on DSK3GDR082PROD with PROPOSALS1
polyethylene glycol ether with intermediate. Based on test data Potentially useful information: EPA
bisphenol A (2:1) polymer-N1-(1,3- submitted on P–16–483 and data for has determined that certain information
dimethylbutylidene)-N2-[2-[(1, 3- analogous compounds, EPA has about the workplace exposure to the
dimethylbutylidene)amino]ethyl]-1,2- identified concerns for irritation, PMN substance may be potentially
ethanediamine-dialdehyde-2- specific organ effects, and aquatic useful to characterize the health effects
(methylamino)ethanol reaction products toxicity if the chemical is not used of the PMN substance if a manufacturer
sulfamates (salts), (generic) (P–16–385). following the limitations noted below. or processor is considering submitting a
CAS Numbers: Not available. The conditions of use of the PMN SNUN for a significant new use that
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H. Executive Order 13211 apply to this section except as modified compds. with hydrolyzed bisphenol A-
This proposed rule is not subject to by this paragraph (b). epichlorohydrin-polyethylene glycol
Executive Order 13211, entitled (1) Recordkeeping. Recordkeeping ether with bisphenol A (2:1) polymer-
‘‘Actions Concerning Regulations That requirements as specified in N1-(1,3-dimethylbutylidene)-N2-[2-[(1,
Significantly Affect Energy Supply, § 721.125(a) through (c), and (i) are 3-dimethylbutylidene)amino]ethyl]-1,2-
Distribution, or Use’’ (66 FR 28355, May applicable to manufacturers, importers, ethanediamine-dialdehyde-2-
22, 2001), because this action is not and processors of this substance. (methylamino)ethanol reaction products
expected to affect energy supply, (2) Limitations or revocation of acetates (salts), (P–16–380) is subject to
distribution, or use and because this certain notification requirements. The reporting under this section for the
action is not a significant regulatory provisions of § 721.185 apply to this significant new uses described in
action under Executive Order 12866. section. paragraph (a)(2) of this section.
■ 3. Add § 721.11183 to subpart E to (2) The significant new uses are:
I. National Technology Transfer and read as follows: (i) Industrial, Commercial, and
Advancement Act (NTTAA) consumer activities. Requirements as
§ 721.11183 Esteramine (generic).
In addition, since this action does not specified in § 721.80. It is a significant
involve any technical standards, (a) Chemical substance and new use to manufacture, process, or use
NTTAA § 12(d) (Pub. L. 104–113, 12(d)), significant new uses subject to reporting. the substance in any manner that results
does not apply to this action. (1) The chemical substances
in inhalation exposure.
identified generically as esteramine
J. Executive Order 12898 (ii) Release to water. Requirements as
(PMN P–16–354 and P–16–355) are
specified in § 721.90(a)(4), (b)(4), and
This action does not entail special subject to reporting under this section
(c)(4) where N = 16.
considerations of environmental justice for the significant new uses described in
(b) Specific requirements. The
related issues as delineated by paragraph (a)(2) of this section.
(2) The significant new uses are: provisions of subpart A of this part
Executive Order 12898, entitled apply to this section except as modified
‘‘Federal Actions to Address (i) Industrial, commercial, and
consumer activities. Requirements as by this paragraph (b).
Environmental Justice in Minority (1) Recordkeeping. Recordkeeping
Populations and Low-Income specified in § 721.80. It is a significant
new use to manufacture, process, or use requirements as specified in
Populations’’ (59 FR 7629, February 16, § 721.125(a) through (c), (i), and (k) are
1994). the substances in any manner that
results in inhalation exposure. It is a applicable to manufacturers, importers,
List of Subjects in 40 CFR Part 721 significant new use to release a and processors of this substance.
Environmental protection, Chemicals, manufacturing, processing, or use (2) Limitations or revocation of
Hazardous substances, Reporting and stream associated with any use of the certain notification requirements. The
recordkeeping requirements. substances, other than the confidential provisions of § 721.185 apply to this
chemical intermediate use described in section.
Dated: October 5, 2018. ■ 5. Add § 721.11185 to subpart E to
Tala R. Henry, the premanufacture notices, into the
waters of the United States exceeding a read as follows:
Acting Director, Office of Pollution Prevention
and Toxics. surface water concentration of 1 part per § 721.11185 Propanoic acid, 2-hydroxy-,
billion (ppb) using the methods compds. with hydrolyzed bisphenol A-
Therefore, it is proposed that 40 CFR described in § 721.91. epichlorohydrin-polyethylene glycol ether
part 721 is amended as follows: (ii) [Reserved] with bisphenol A (2:1) polymer-N1-(1,3-
PART 721—[AMENDED] (b) Specific requirements. The dimethylbutylidene)-N2-[2-[(1, 3-
provisions of subpart A of this part dimethylbutylidene)amino]ethyl]-1,2-
■ 1. The authority citation for part 721 apply to this section except as modified ethanediamine-dialdehyde-2-
by this paragraph (b). (methylamino)ethanol reaction products
continues to read as follows: formates (salts), (generic).
Authority: 15 U.S.C. 2604, 2607, and
(1) Recordkeeping. Recordkeeping
requirements as specified in (a) Chemical substance and
2625(c).
§ 721.125(a) though (e), and (i) are significant new uses subject to reporting.
■ 2. Add § 721.11182 to subpart E to applicable to manufacturers and (1) The chemical substance
read as follows: processors of these substances. generically as propanoic acid, 2-
§ 721.11182 Silanized amorphous silica (2) Limitations or revocation of hydroxy-, compds. with hydrolyzed
(generic). certain notification requirements. The bisphenol A-epichlorohydrin-
(a) Chemical substance and provisions of § 721.185 apply to this polyethylene glycol ether with
significant new uses subject to reporting. section. bisphenol A (2:1) polymer-N1-(1,3-
(1) The chemical substance ■ 4. Add § 721.11184 to subpart E to dimethylbutylidene)-N2-[2-[(1, 3-
generically identified as silanized read as follows: dimethylbutylidene)amino]ethyl]-1,2-
amorphous silica (P–16–192) is subject ethanediamine-dialdehyde-2-
§ 721.11184 Formic acid, compds. with (methylamino)ethanol reaction products
to reporting under this section for the hydrolyzed bisphenol A-epichlorohydrin-
significant new uses described in formates (salts), (P–16–381) is subject to
polyethylene glycol ether with bisphenol A
paragraph (a)(2) of this section. (2:1) polymer-N1-(1,3-dimethylbutylidene)-
reporting under this section for the
(2) The significant new uses are: N2-[2-[(1, 3- significant new uses described in
amozie on DSK3GDR082PROD with PROPOSALS1
(i) Industrial, commercial, and dimethylbutylidene)amino]ethyl]-1,2- paragraph (a)(2) of this section.
consumer activities. Requirements as ethanediamine-dialdehyde-2- (2) The significant new uses are:
specified in § 721.80. It is a significant (methylamino)ethanol reaction products (i) Industrial, Commercial, and
new use to manufacture the substance acetates (salts), (generic) consumer activities. Requirements as
other than in an amorphous form. (a) Chemical substance and specified in § 721.80. It is a significant
(ii) [Reserved] significant new uses subject to reporting. new use to manufacture, process, or use
(b) Specific requirements. The (1) The chemical substance the substance in any manner that results
provisions of subpart A of this part generically identified as formic acid, in inhalation exposure.
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(ii) Release to water. Requirements as § 721.11187 Formic acid, compds. with formates (salts), (P–16–384) is subject to
specified in § 721.90(a)(4), (b)(4), and hydrolyzed bisphenol A-epichlorohydrin- reporting under this section for the
(c)(4) where N = 16. polyethylene glycol ether with bisphenol A significant new uses described in
(2:1) polymer-N1-(1,3-dimethylbutylidene)- paragraph (a)(2) of this section.
(b) Specific requirements. The N2-[2-[(1, 3-dimethylbutylidene)
provisions of subpart A of this part (2) The significant new uses are:
amino]ethyl]-1,2-ethanediamine-dialdehyde-
apply to this section except as modified 2-(methylamino)ethanol reaction products
(i) Industrial, Commercial, and
by this paragraph (b). acetates (salts), (generic). consumer activities. Requirements as
specified in § 721.80. It is a significant
(1) Recordkeeping. Recordkeeping (a) Chemical substance and
new use to manufacture, process, or use
requirements as specified in significant new uses subject to reporting.
the substance in any manner that results
§ 721.125(a) through (c), (i), and (k) are (1) The chemical substance
in inhalation exposure.
applicable to manufacturers, importers, generically identified as formic acid, (ii) Release to water. Requirements as
and processors of this substance. compds. with hydrolyzed bisphenol A- specified in § 721.90(a)(4), (b)(4), and
(2) Limitations or revocation of epichlorohydrin-polyethylene glycol (c)(4) where N = 16.
certain notification requirements. The ether with bisphenol A (2:1) polymer- (b) Specific requirements. The
provisions of § 721.185 apply to this N1-(1,3-dimethylbutylidene)-N2-[2-[(1, provisions of subpart A of this part
section. 3-dimethylbutylidene)amino]ethyl]-1,2- apply to this section except as modified
■ 6. Add § 721.11186 to subpart E to ethanediamine-dialdehyde-2- by this paragraph (b).
read as follows: (methylamino)ethanol reaction products (1) Recordkeeping. Recordkeeping
acetates (salts), (P–16–383) is subject to requirements as specified in
§ 721.11186 Formic acid, compds. with reporting under this section for the § 721.125(a) through (c), (i), and (k) are
hydrolyzed bisphenol A-epichlorohydrin- significant new uses described in
polyethylene glycol ether with bisphenol A
applicable to manufacturers, importers,
paragraph (a)(2) of this section. and processors of this substance.
(2:1) polymer-N1-(1,3-dimethylbutylidene)- (2) The significant new uses are:
N2-[2-[(1, 3-dimethylbutylidene) (2) Limitations or revocation of
amino]ethyl]-1,2-ethanediamine-dialdehyde-
(i) Industrial, Commercial, and certain notification requirements. The
2-(methylamino)ethanol reaction products consumer activities. Requirements as provisions of § 721.185 apply to this
sulfamates (salts), (generic), specified in § 721.80. It is a significant section.
new use to manufacture, process, or use ■ 9. Add § 721.11189 to subpart E to
(a) Chemical substance and the substance in any manner that results
significant new uses subject to reporting. read as follows:
in inhalation exposure.
(1) The chemical substance (ii) Release to water. Requirements as § 721.11189 Formic acid, compds. with
generically identified as formic acid, specified in § 721.90(a)(4), (b)(4), and hydrolyzed bisphenol A-epichlorohydrin-
compds. with hydrolyzed bisphenol A- (c)(4) where N = 16. polyethylene glycol ether with bisphenol A
epichlorohydrin-polyethylene glycol (2:1) polymer-N1-(1,3-dimethylbutylidene)-
(b) Specific requirements. The N2-[2-[(1, 3-dimethylbutylidene)
ether with bisphenol A (2:1) polymer- provisions of subpart A of this part amino]ethyl]-1,2-ethanediamine-dialdehyde-
N1-(1,3-dimethylbutylidene)-N2-[2-[(1, apply to this section except as modified 2-(methylamino)ethanol reaction products
3-dimethylbutylidene)amino]ethyl]-1,2- by this paragraph (b). sulfamates (salts), (generic).
ethanediamine-dialdehyde-2- (1) Recordkeeping. Recordkeeping (a) Chemical substance and
(methylamino)ethanol reaction products requirements as specified in significant new uses subject to reporting.
sulfamates (salts), (P–16–382) is subject § 721.125(a) through (c), (i), and (k) are (1) The chemical substance
to reporting under this section for the applicable to manufacturers, importers, generically identified as formic acid,
significant new uses described in and processors of this substance. compds. with hydrolyzed bisphenol A-
paragraph (a)(2) of this section. (2) Limitations or revocation of epichlorohydrin-polyethylene glycol
(2) The significant new uses are: certain notification requirements. The ether with bisphenol A (2:1) polymer-
(i) Industrial, Commercial, and provisions of § 721.185 apply to this N1-(1,3-dimethylbutylidene)-N2-[2-[(1,
consumer activities. Requirements as section. 3-dimethylbutylidene)amino]ethyl]-1,2-
specified in § 721.80. It is a significant ■ 8. Add § 721.11188 to subpart E to ethanediamine-dialdehyde-2-
new use to manufacture, process, or use read as follows: (methylamino)ethanol reaction products
the substance in any manner that results § 721.11188 Propanoic acid, 2-hydroxy-, sulfamates (salts), (P–16–385) is subject
in inhalation exposure. compds. with hydrolyzed bisphenol A- to reporting under this section for the
(ii) Release to water. Requirements as epichlorohydrin-polyethylene glycol ether significant new uses described in
specified in § 721.90(a)(4), (b)(4), and with bisphenol A (2:1) polymer-N1-(1,3- paragraph (a)(2) of this section.
(c)(4) where N = 16. dimethylbutylidene)-N2-[2-[(1, 3- (2) The significant new uses are:
(b) Specific requirements. The dimethylbutylidene)amino]ethyl]-1,2- (i) Industrial, Commercial, and
ethanediamine-dialdehyde-2- consumer activities. Requirements as
provisions of subpart A of this part (methylamino)ethanol reaction products
apply to this section except as modified specified in § 721.80. It is a significant
formates (salts), (generic). new use to manufacture, process, or use
by this paragraph (b).
(a) Chemical substance and the substance in any manner that results
(1) Recordkeeping. Recordkeeping significant new uses subject to reporting. in inhalation exposure.
requirements as specified in (1) The chemical substance (ii) Release to water. Requirements as
§ 721.125(a) through (c), (i), and (k) are generically identified as propanoic acid, specified in § 721.90(a)(4), (b)(4), and
amozie on DSK3GDR082PROD with PROPOSALS1
applicable to manufacturers, importers, 2-hydroxy-, compds. with hydrolyzed (c)(4) where N = 16.
and processors of this substance. bisphenol A-epichlorohydrin- (b) Specific requirements. The
(2) Limitations or revocation of polyethylene glycol ether with provisions of subpart A of this part
certain notification requirements. The bisphenol A (2:1) polymer-N1-(1,3- apply to this section except as modified
provisions of § 721.185 apply to this dimethylbutylidene)-N2-[2-[(1, 3- by this paragraph (b).
section. dimethylbutylidene)amino] ethyl]-1,2- (1) Recordkeeping. Recordkeeping
■ 7. Add § 721.11187 to subpart E to ethanediamine-dialdehyde-2- requirements as specified in
read as follows: (methylamino)ethanol reaction products § 721.125(a) through (c), (i), and (k) are
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applicable to manufacturers, importers, (1) The chemical substance identified (b) Specific requirements. The
and processors of this substance. generically as inorganic acids, metal provisions of subpart A of this part
(2) Limitations or revocation of salts, compds. with substituted aromatic apply to this section except as modified
certain notification requirements. The heterocycle, (PMN P–16–484) is subject by this paragraph (b).
provisions of § 721.185 apply to this to reporting under this section for the (1) Recordkeeping. Recordkeeping
section. significant new uses described in requirements as specified in
■ 10. Add § 721.11190 to subpart E to paragraph (a)(2) of this section. § 721.125(a) through (c), and (i) are
read as follows: (2) The significant new uses are: applicable to manufacturers and
(i) Industrial, commercial, and processors of this substance.
§ 721.11190 Inorganic acids, metal salts,
compds. with modified heteroaromatics,
consumer activities. Requirements as
specified in § 721.80(j). It is a significant (2) Limitations or revocation of
(generic).
new use to manufacture, process, or use certain notification requirements. The
(a) Chemical substance and provisions of § 721.185 apply to this
significant new uses subject to reporting. the substance without the engineering
controls described in the section.
(1) The chemical substance identified
premanufacture to limit exposure to ■ 13. Add § 721.11193 to subpart E to
generically as inorganic acids, metal
salts, compds. with modified dust. read as follows:
heteroaromatics, (PMN P–16–483) is (ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and § 721.11193 Alpha 1,3-polysaccharide
subject to reporting under this section (generic).
for the significant new uses described in (c)(4) where N = 34.
(b) Specific requirements. The (a) Chemical substance and
paragraph (a)(2) of this section.
(2) The significant new uses are: provisions of subpart A of this part significant new uses subject to reporting.
(i) Industrial, commercial, and apply to this section except as modified (1) The chemical substance generically
consumer activities. Requirements as by this paragraph (b). identified as alpha 1,3-polysaccharide
specified in § 721.80(j). It is a significant (1) Recordkeeping. Recordkeeping (generic) (PMN P–16–581) is subject to
new use to manufacture, process, or use requirements as specified in reporting under this section for the
the substance without the engineering § 721.125(a) through (c), (i), and (k) are significant new uses described in
controls described in the applicable to manufacturers and paragraph (a)(2) of this section.
premanufacture notice to limit exposure processors of this substance. (2) The significant new uses are:
to dust. (2) Limitations or revocation of
certain notification requirements. The (i) Industrial, commercial, and
(ii) Release to water. Requirements as
provisions of § 721.185 apply to this consumer activities. Requirements as
specified in § 721.90(a)(4), (b)(4), and
section. specified in § 721.80. It is a significant
(c)(4) where N = 34 ppb.
(b) Specific requirements. The (3) Determining whether a specific use new use to use the substance other than
provisions of subpart A of this part is subject to this section. The provisions as a polymer additive, paper coating
apply to this section except as modified of § 721.1725(b)(1) apply to paragraph component, composite component, or
by this paragraph (b). (a)(2)(i) of this section. fiber additive. It is a significant new use
(1) Recordkeeping. Recordkeeping ■ 12. Add § 721.11192 to subpart E to to manufacture, process or use the PMN
requirements as specified in read as follows: substance with particle size less than 10
§ 721.125(a) through (c), (i), and (k) are micrometers.
§ 721.11192 Glucosyltransferase,
applicable to manufacturers and International Union of Biochemistry and (ii) [Reserved]
processors of this substance. Molecular Biology Number: 2.4.1.5. (b) Specific requirements. The
(2) Limitations or revocation of provisions of subpart A of this part
(a) Chemical substance and
certain notification requirements. The apply to this section except as modified
significant new uses subject to reporting.
provisions of § 721.185 apply to this by this paragraph (b).
(1) The chemical substance identified
section.
as glucosyltransferase, International (1) Recordkeeping. Recordkeeping
(3) Determining whether a specific use
is subject to this section. The provisions Union of Biochemistry and Molecular requirements as specified in
of § 721.1725 (b)(1) apply to paragraph Biology Number: 2.4.1.5 (PMN P–16– § 721.125(a) through (c) and (i) are
(a)(2)(i) of this section. 575, CAS No. 9032–14–8) is subject to applicable to manufacturers and
■ 11. Add § 721.11191 to subpart E to
reporting under this section for the processors of this substance.
read as follows: significant new uses described in
(2) Limitations or revocation of
paragraph (a)(2) of this section.
§ 721.11191 Inorganic acids, metal salts, (2) The significant new uses are: certain notification requirements. The
compds. with substituted aromatic (i) Industrial, commercial, and provisions of § 721.185 apply to this
heterocycle, (generic). consumer activities. Requirements as section.
(a) Chemical substance and specified in § 721.80(y)(1) and (y)(2). [FR Doc. 2018–22397 Filed 10–15–18; 8:45 am]
significant new uses subject to reporting. (ii) [Reserved] BILLING CODE 6560–50–P
amozie on DSK3GDR082PROD with PROPOSALS1
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Document Created: 2018-10-15 23:42:36
Document Modified: 2018-10-15 23:42:36
| 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 | Proposed Rules | |
| Action | Proposed rule. | |
| Dates | Comments must be received on or before November 15, 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, | |
| FR Citation | 83 FR 52179 | |
| RIN Number | 2070-AB27 | |
| CFR Associated | Environmental Protection; Chemicals; Hazardous Substances and Reporting and Recordkeeping Requirements |
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