EPA is required under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, to make information publicly available and to publish information in the Federal Register pertaining to submissions under TSCA Section 5, including notice of receipt of a Premanufacture notice (PMN), Significant New Use Notice (SNUN) or Microbial Commercial Activity Notice (MCAN), including an amended notice or test information; an exemption application (Biotech exemption); an application for a test marketing exemption (TME), both pending and/or concluded; a notice of commencement (NOC) of manufacture (including import) for new chemical substances; and a periodic status report on new chemical substances that are currently under EPA review or have recently concluded review. This document covers the period from 02/01/ 2019 to 02/28/2019.
[Federal Register Volume 84, Number 89 (Wednesday, May 8, 2019)] [Notices] [Pages 20122-20128] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2019-09378] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPPT-2019-0075; FRL-9991-68] Certain New Chemicals; Receipt and Status Information for February 2019 AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: EPA is required under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, to make information publicly available and to publish information in the Federal Register pertaining to submissions under TSCA Section 5, including notice of receipt of a Premanufacture notice (PMN), Significant New Use Notice (SNUN) or Microbial Commercial Activity Notice (MCAN), including an amended notice or test information; an exemption application (Biotech exemption); an application for a test marketing exemption (TME), both pending and/or concluded; a notice of commencement (NOC) of manufacture (including import) for new chemical substances; and a periodic status report on new chemical substances that are currently under EPA review or have recently concluded review. This document covers the period from 02/01/ 2019 to 02/28/2019. DATES: Comments identified by the specific case number provided in this document must be received on or before June 7, 2019. ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2019-0075, and the specific case number for the chemical substance related to your comment, 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: Jim Rahai, Information Management Division (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-8593; 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. Executive Summary What action is the Agency taking? This document provides the receipt and status reports for the period from 02/01/2019 to 02/28/2019. The Agency is providing notice of receipt of PMNs, SNUNs and MCANs (including amended notices and test information); an exemption application under 40 CFR part 725 (Biotech exemption); TMEs, both pending and/or concluded; NOCs to manufacture a new chemical substance; and a periodic status report on new chemical substances that are currently under EPA review or have recently concluded review. EPA is also providing information on its website about cases reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN and exemption notices received, the date of receipt, the final EPA determination on the notice, and the effective date of EPA's determination for PMN/SNUN/MCAN notices on its website at: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices. This information is updated on a weekly basis. B. What is the Agency's authority for taking this action? Under the TSCA, 15 U.S.C. 2601 et seq., a chemical substance may be either an ``existing'' chemical substance or a ``new'' chemical substance. Any chemical substance that is not on EPA's TSCA Inventory of Chemical Substances (TSCA Inventory) is classified as a ``new chemical substance,'' while a chemical substance that is listed on the TSCA Inventory is classified as an ``existing chemical substance.'' (See TSCA section 3(11).) For more information about the TSCA Inventory go to: https://www.epa.gov/tsca-inventory. Any person who intends to manufacture (including import) a new chemical substance for a non-exempt commercial purpose, or to manufacture or process a chemical substance in a non-exempt manner for a use that EPA has determined is a significant new use, is required by TSCA section 5 to provide EPA with a PMN, MCAN or SNUN, as appropriate, before initiating the activity. EPA will review the notice, make a risk determination on the chemical substance or significant new use, and take appropriate action as described in TSCA section 5(a)(3). TSCA section 5(h)(1) authorizes EPA to allow persons, upon application and under appropriate restrictions, to manufacture or process a new chemical substance, or a chemical substance subject to a significant new use rule (SNUR) issued under TSCA section 5(a)(2), for ``test marketing'' purposes, upon a showing that the manufacture, processing, distribution in commerce, use, and disposal of the chemical will not present an unreasonable risk of injury to health or the environment. This is referred to as a test marketing [[Page 20123]] exemption, or TME. For more information about the requirements applicable to a new chemical go to: http://www.epa.gov/oppt/newchems. Under TSCA sections 5 and 8 and EPA regulations, EPA is required to publish in the Federal Register certain information, including notice of receipt of a PMN/SNUN/MCAN (including amended notices and test information); an exemption application under 40 CFR part 725 (biotech exemption); an application for a TME, both pending and concluded; NOCs to manufacture a new chemical substance; and a periodic status report on the new chemical substances that are currently under EPA review or have recently concluded review. C. Does this action apply to me? This action provides information that is directed to the public in general. D. Does this action have any incremental economic impacts or paperwork burdens? No. E. What should I consider as I prepare my comments for EPA? 1. Submitting confidential business information (CBI). Do not submit this information 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. Status Reports In the past, EPA has published individual notices reflecting the status of TSCA section 5 filings received, pending or concluded. In 1995, the Agency modified its approach and streamlined the information published in the Federal Register after providing notice of such changes to the public and an opportunity to comment (See the Federal Register of May 12, 1995 (60 FR 25798) (FRL-4942-7). Since the passage of the Lautenberg amendments to TSCA in 2016, public interest in information on the status of section 5 cases under EPA review and, in particular, the final determination of such cases, has increased. In an effort to be responsive to the regulated community, the users of this information, and the general public, to comply with the requirements of TSCA, to conserve EPA resources and to streamline the process and make it more timely, EPA is providing information on its website about cases reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN and exemption notices received, the date of receipt, the final EPA determination on the notice, and the effective date of EPA's determination for PMN/SNUN/MCAN notices on its website at: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices. This information is updated on a weekly basis. III. Receipt Reports For the PMN/SNUN/MCANs that have passed an initial screening by EPA during this period, Table I provides the following information (to the extent that such information is not subject to a CBI claim) on the notices screened by EPA during this period: The EPA case number assigned to the notice that indicates whether the submission is an initial submission, or an amendment, a notation of which version was received, the date the notice was received by EPA, the submitting manufacturer (i.e., domestic producer or importer), the potential uses identified by the manufacturer in the notice, and the chemical substance identity. As used in each of the tables in this unit, (S) indicates that the information in the table is the specific information provided by the submitter, and (G) indicates that this information in the table is generic information because the specific information provided by the submitter was claimed as CBI. Submissions which are initial submissions will not have a letter following the case number. Submissions which are amendments to previous submissions will have a case number followed by the letter ``A'' (e.g., P-18-1234A). The version column designates submissions in sequence as ``1'', ``2'', ``3'', etc. Note that in some cases, an initial submission is not numbered as version 1; this is because earlier version(s) were rejected as incomplete or invalid submissions. Note also that future versions of the following tables may adjust slightly as the Agency works to automate population of the data in the tables. Table I--PMN/SNUN/MCANs Approved * From 02/01/2019 to 02/28/2019 ---------------------------------------------------------------------------------------------------------------- Received Case No. Version date Manufacturer Use Chemical substance ---------------------------------------------------------------------------------------------------------------- J-19-0017.......... 1 2/1/2019 Danisco US, Inc.. (G) Production of a (G) Genetically chemical substance. modified microorganism for the production of a chemical substance. P-16-0541A......... 4 1/21/2019 Specialty (S) Adhesive for wood (S) Soybean meal, Organics, Inc. particle/chip/ reaction products fiberboard. with phosphoric trichloride. P-16-0584A......... 5 12/17/2018 CBI.............. (G) Additive used to (G) Multi-walled impart specific carbon nanotubes. physicochemical property(ies) to finished articles. P-16-0585A......... 5 12/17/2018 CBI.............. (G) Additive used to (G) Multi-walled impart specific carbon nanotubes. physicochemical property(ies) to finished articles. P-16-0586A......... 5 12/17/2018 CBI.............. (G) Additive used to (G) Multi-walled impart specific carbon nanotubes. physicochemical property(ies) to finished articles. [[Page 20124]] P-17-0322A......... 6 12/18/2018 CBI.............. (G) Auxiliary drier, (G) Zinc naphthenate has little drying complexes. action in itself but is very useful in combination with active driers. In vehicles that show poor tolerance for lead, calcium can replace part of the lead with a larger amount of calcium to prevent the precipitation of the lead & maintain drying efficiency. Calcium is also useful as pigment wetting & dispersing agents & help to improve hardness & gloss & reduce ``Silkins.'' When ground with drier adsorbing pigments, calcium minimizes loss of dry by being preferentially absorbed. P-18-0007A......... 2 12/17/2018 Nexoleum USA Corp (S) Used as a (S) Glycerides, soya plasticizer/ mono- and di-, stabilizer for epoxidized, acetates. flexible PVC. P-18-0008A......... 2 12/17/2018 Nexoleum USA Corp (S) Used as a (S) Glycerides, C16-18 plasticizer/ and C18-unsatd. mono- stabilizer for and di-, epoxidized, flexible PVC. acetates. P-18-0012A......... 3 12/17/2018 CBI.............. (G) Adhesives......... (G) Polyester polyol. P-18-0020A......... 4 2/1/2019 Myriant (G) Industrial coating (S) Butanediolic acid, Corporation. polyol with 2-ethyl-2- (hydroxymethyl)-1,3- propanediol, 2,5- Furandione and 1,3- propanediol, 3a,4,5,6,7,7a- hexahydro-4,7-methano- 1H-inden-5(or 6)-yl ester. P-18-0060A......... 4 1/8/2019 Eastman Chemical (S) Surfactant for (S) 1-Butanaminium, 4- Company, Inc. Liquid Dish; (S) amino-N-(2-hydroxy-3- Surfactant for Liquid sulfopropyl)-N, N- Laundry; (S) dimethyl-4-oxo-, N- Surfactant for coco alkyl derivs., Industrial Hand Wash; inner salts. (S) FDA related uses; (S) Export only volume of the TSCA manufactured NCS. P-18-0070A......... 9 12/18/2018 ArrowStar, LLC... (G) Chemical (G) Waste plastics, intermediate for polyester, depolymd. polyurethane industry. with glycols, polymers with dicarboxylic acids. P-18-0073A......... 5 12/19/2018 Earth Science (G) Non-Pesticide (S) Sulfuric acid, Laboratories. Agricultural Use ammonium salt (1:?). Chemical; (S) FIFRA Inert ingredient; (S) Anti-scalant; (S) Chlorine stabilizer. P-18-0107A......... 2 12/13/2018 Lanxess (S) Hydrolysis (G) Alcohol capped Corporation. stabilizer. polycarbodiimide from diethyldiisocyanatobe nzene. P-18-0162A......... 5 12/27/2018 CBI.............. (G) Adhesive component (G) Cashew nutshell liquid, polymer with diisocyanatoalkane, substituted- polyoxyalkyldiol and polyether polyol. P-18-0176A......... 3 2/6/2019 CBI.............. (G) Industrial coating (G) 5- Isobenzofurancarboxyl ic acid, 1,3-dihydro- 1,3-dioxo-, polymer with aminoalcohol, 2,2-dimethyl-1,3- propanediol, 2,5- furandione, polyalkylene glycol and unsaturated anhydride. P-18-0257A......... 2 1/29/2019 Everris NA, Inc.. (S) Inorganic (S) Phosphoric acid, Fertilizer. potassium salt (2:3). P-18-0303A......... 3 1/10/2019 CBI.............. (G) UV curable (G) 2-Propenoic acid, oligomer. polymer with aliphatic cyclic epoxide. P-18-0313A......... 3 1/25/2019 Ashland, Inc..... (G) Adhesive.......... (G) Alkoxylated glycol ether with 1,2- propanediol, reaction products with alkyl alcohol blocked 1,1'- methylenebis [4- isocyanatobenzene] homopolymer and 1,1'- methylenebis [4- isocyanatobenzene]. P-18-0321A......... 3 2/1/2019 CBI.............. (G) Intermediate for (G) Poly(oxy- use in chemical ethanediyl), (methyl manufacture. ethanediyl)bis[hydrox y-. P-18-0324A......... 4 12/19/2018 CBI.............. (S) Resin/binder in (G) Organic acid paint formulations dimethyl ester, for industrial and polymer with mixed architectural alkanediols and 5- applications. isocyanato-1- (isocyanatomethyl)- 1,3,3- trimethylcyclohexane, trimethoxysilylalkyla lkanamine-blocked. P-18-0326.......... 2 2/20/2019 CBI.............. (G) Chemical (G) Alkanoic acid, Intermediate. alkyl ester, manuf. of, byproducts from, distn. residues. P-18-0361A......... 3 12/13/2018 Lanxess, (S) Electrophoretic (S) Propanoic acid, 3- Solutions US Inc. paint. hydroxy-2- (hydroxymethyl)-2- methyl-, polymer with 1,3,5-tris(6- isocyanatohexyl)- 1,3,5-triazine- 2,4,6(1H,3H,5H)- trione, 3,5-dimethyl- 1H-pyrazole-blocked. P-18-0363A......... 2 12/12/2018 CBI.............. (G) Adhesive.......... (G) Phenol, polymer with formaldehyde, substituted phenol, sodium salts. P-18-0365A......... 4 1/9/2019 CBI.............. (G) Superabsorbent (G) Starch, polymer; (S) carboxymethyl ether, Manufacture for sodium salt, polymer export only. with polycarboxylic acid. P-18-0366A......... 4 1/9/2019 CBI.............. (G) Superabsorbent (G) Starch, polymer; (S) carboxymethyl ether, Manufacture for sodium salt, polymer export only. with mixed polycarboxylic acids. P-18-0384A......... 2 12/23/2018 Sigma-Aldrich (S) Starting material (S) Lithium 6. Co., LLC. for manufacture of 6 Lithium chloride scintillation crystals for use in radiation detection. P-18-0399A......... 4 1/14/2019 CBI.............. (G) Open, non- (G) Rosin adduct dispersive use ester, polymer with additive for polyols, compd. with industrial use only. ethanolamine. P-18-0400A......... 4 1/14/2019 CBI.............. (G) Open, non- (G) Rosin adduct dispersive use, ester, polymer with additive for textile polyols, potassium industry. salt. [[Page 20125]] P-18-0406A......... 2 12/13/2018 CBI.............. (G) Initiator......... (G) Formaldehyde, polymer with alkyl aryl ketones. P-19-0002A......... 4 12/19/2018 CBI.............. (S) Chemical (G) Polyaromatic Intermediate. symmetrical tetracarboxylic acid. P-19-0003A......... 3 12/19/2018 CBI.............. (S) Chemical (G) Polyaromatic ether Intermediate. symmetrical dicarboxylic anhydride. P-19-0004A......... 3 12/19/2018 CBI.............. (G) Molded parts and (G) Aromatic components. dianhydride, polymer with aromatic diamine and heteroatom bridged aromatic diamine, reaction products with aromatic anhydride. P-19-0006A......... 3 12/19/2018 CBI.............. (G) Rheology modifier. (G) Diisocyanate polymer blocked with alkoxyamine. P-19-0008A......... 3 12/12/2018 Allnex USA Inc... (S) The PMN substance (G) Substitued is an isolated polyalkylenepolycarbo intermediate monocycle ester, incorporated as a polymer with component in several dialkanolamine, allnex coating resin (hydroxyalkoxy)carbon products that are yl] derivs., only applied by (alkoxyalkoxy) Cathodic alkanolblocked. Electrodeposition (CED) and used as additives for corrosion protection. P-19-0020A......... 3 1/30/2019 CBI.............. (G) Lubricating (G) Alkylphenol, additive. reaction products with carbon dioxide, distn. residues from manuf. of alkylphenol derivs. and calcium alkylphenol derivs. P-19-0023A......... 2 12/14/2018 Allnex USA Inc... (S) Powder coating (G) Substituted resin for industrial carbomonocyle, application. polymer with substituted carbomonocycles, dialkyl-alkanediol, alkyl-hydroxyalkyl- alkanediol and alkanedioic acid. P-19-0038.......... 2 2/4/2019 Allan Chemical (S) Ink carrier for (S) Fatty acids, coco, Corporation. the ceramic iso-Bu esters. industries. P-19-0039.......... 4 2/11/2019 CBI.............. (S) Stabilizer for PVC (G) Phosphorous acid, P,P '[substituted bis(alkyl-polyalkyl glycol)] Poly carbomonocycle substituted ester. P-19-0040A......... 2 1/3/2019 CBI.............. (G) Intermediate...... (G) Alkyl bis(dialkylamino alkyl) amide. P-19-0048.......... 2 1/30/2019 CBI.............. (G) Coating additive.. (S) Poly(oxy-1,2- ethanediyl), .alpha.- hydro-.omega.-hydroxy- , mono-C12-14-alkyl ethers, phosphates, sodium salts. P-19-0049.......... 1 1/28/2019 Allnex USA Inc... (G) Isolated (G) Fatty acids, intermediate coating polymers with resin. substituted carbomonocycles, dialkanolamine, alkyl substituted alkanediamine and halo-substituted heteromonocycle, formates (salts). P-19-0050.......... 1 2/4/2019 Kimes (S) Rust preventative. (S) Petrolatum Technologies (petroleum), International, oxidized, Bu ester. Inc. P-19-0051.......... 1 2/5/2019 CBI.............. (G) UV curable inks... (G) 1,3- Propanediamine, N1,N1- dimethyl-, polymers with alkylene glycol ether with alkyltriol (3:1) mixed acrylates and adipates, and alkylene glycol monoacrylate ether with alkyltriol (3:1). P-19-0052.......... 2 2/8/2019 Evonik (S) Hard Surface (S) Poly(oxy-1,2- Corporation. Cleaner. ethanediyl), alpha- nonyl-omega-hydroxy-, branched and linear. P-19-0053.......... 1 2/10/2019 Wacker Chemical (S) Used as a surface (S) 1-Butanamine, N- Corporation. treatment, sealant, butyl-N- caulk, and coating [(triethoxysilyl)meth for mineral building yl]-. materials such as concrete, brick, limestone, and plaster, as well as on wood, metal and other substrates. Formulations containing the cross- linker provide release and anti- graffiti properties, water repellency, weather proofing, and improved bonding in adhesive/sealant applications. The new substance is a moisture curing cross- linking agent which binds/joins polymers together when cured. Ethanol is released during cure, and once the cure reaction is complete, the product will remain bound in the cured polymer matrix. P-19-0054.......... 1 2/11/2019 CBI.............. (G) automotive (G) Polyamines, lubricant additive. reaction products with succinic anhydride polyalkenyl derivs., metal salts. P-19-0055.......... 1 2/12/2019 Rahn USA Corp.... (S) The PMN is solely (S) 1,3-propanediol, 2- used as a photo ethyl-2- initiator within UV (hydroxymethyl)-, curable coating/ink polymer with oxirane, formulations. This 4- photo initiator is (dimethylamino)benzoa starting the te. polymerization process during the UV curing process of the formulation. The curing is achieved by UV light only, no heat is applied. After curing, the PMN substance is no longer available for exposure or release. P-19-0056.......... 1 2/15/2019 CBI.............. (G) The PMN substance (G) Aliphatic will be imported as a hydrocarbons, C8-20- raw material for branched and linear. manufacturing other aliphatic hydrocarbons. P-19-0057.......... 1 2/21/2019 CBI.............. (G) Treatment chemical (G) Alkanamine, [(Alkoxy)alkoxy]alkyl ] alkyl. [[Page 20126]] P-19-0060.......... 1 2/23/2019 Neste Oil US, Inc (G) The PMN substance (G) Aliphatic will be used as fuel. hydrocarbons, C8-18- branched and linear. P-19-0061.......... 1 2/23/2019 Neste Oil US, Inc (G) The PMN substance (G) Aliphatic will be used as fuel. hydrocarbons, C16-20- branched and linear. P-19-0062.......... 1 2/27/2019 CBI.............. (G) Industrial solvent (G) Hydrochlorofluoroolef in. SN-18-0002A........ 3 12/12/2018 CBI.............. (G) Flame retardant (G) Phosphoramidic for textile. acid, carbomonocyclic- , diphenylester (accession number 261553). SN-19-0003......... 1 1/10/2019 CBI.............. (G) Automotive engine (G) Silicophosphonate-- fluid additive. sodium silicate. SN-19-0004A........ 3 1/31/2019 CBI.............. (S) A lubricating (G) Pitch coke. agent used in the production of automotive disc brakes. ---------------------------------------------------------------------------------------------------------------- * The term `Approved' indicates that a submission has passed a quick initial screen ensuring all required information and documents have been provided with the submission prior to the start of the 90 day review period, and in no way reflects the final status of a complete submission review. In Table II. of this unit, EPA provides the following information (to the extent that such information is not claimed as CBI) on the NOCs that have passed an initial screening by EPA during this period: The EPA case number assigned to the NOC including whether the submission was an initial or amended submission, the date the NOC was received by EPA, the date of commencement provided by the submitter in the NOC, a notation of the type of amendment (e.g., amendment to generic name, specific name, technical contact information, etc.) and chemical substance identity. Table II--NOCs Approved * From 02/01/2019 to 02/28/2019 ---------------------------------------------------------------------------------------------------------------- Received Commencement If amendment, type of Case No. date date amendment Chemical substance ---------------------------------------------------------------------------------------------------------------- J-16-0021................. 12/18/2018 12/4/2018 N........................ (G) Modified trichoderma reesei. J-18-0026................. 12/21/2018 11/30/2018 N........................ (G) Biopolymer producing modified microorganism(s), with chromosomally-borne modifications. J-18-0027................. 12/21/2018 12/7/2018 N........................ (G) Biopolymer producing modified microorganism(s), with chromosomally-borne modifications. J-18-0044................. 12/21/2018 11/26/2018 N........................ (S) Saccharomyces cerevisae ne095. J-18-0046................. 2/14/2019 2/12/2019 N........................ (G) Genetically modified microorganism. J-19-0003................. 1/15/2019 1/5/2019 N........................ (G) Strain 2 genetically modified microorganism. P-08-0431................. 2/12/2019 1/26/2019 N........................ (S) Propane, 2,2- bis(methylthio)-. P-14-0443................. 1/23/2019 12/24/2018 N........................ (G) Alkane-alpha,omega-diyl bis{[(trimethoxysilyl)propyl] carbamate{time} . P-14-0519................. 2/15/2019 2/6/2019 N........................ (S) Siloxanes and silicones, di-me, hydrolysis products with dichloroethenylmethylsilane, 3-[2-(2- methoxyethoxy)ethoxy]propyl group terminated. P-15-0178................. 1/23/2019 1/21/2019 N........................ (G) Long chain aliphatic acid polymers, with adipic acid, di-meterephthalate, alkane acid, aromatic isocyanate and neopentyl glycol. P-16-0150................. 12/20/2018 11/29/2018 N........................ (G) Chlorofluorocarbon. P-16-0173A................ 12/20/2018 6/6/2016 Update CBI substantiation (G) Aminoalkyl alaninate for site. sodium salt (1:1), polymer with alkyldiol, dialkyl- alkanediol, alkyldioic acid, alkyldiol, polyol, cycloaliphatic diisocyanate, polyalkylene glycol mono- alkyl ether-blocked. P-16-0366A................ 2/27/2019 11/28/2017 Update CBI substantiation (G) Isocyanic acid, for manufacturing plant polymethylenepolyphenylene site, submitter and ester, polymer with technical contact. alkanolamine and alkylcarbonate, alkoxyethanol- blocked. P-16-0514................. 1/22/2019 1/16/2019 N........................ (G) Mixed metal oxide. P-16-0575................. 1/7/2019 1/3/2019 N........................ (S) Glucosyltransferase. P-16-0581................. 1/24/2019 1/22/2019 N........................ (G) Polysaccharide. P-16-0592................. 2/25/2019 2/25/2019 N........................ (S) Fatty acids, C8-C10, diesters with alpha-hydro- omega-hydroxypoly(oxy-1,4- butanediyl). P-17-0014................. 2/25/2019 2/25/2019 N........................ (S) Fatty acids, C8-C10, mixed esters with c18-unsatd. fatty acid dimers and alpha-hydro- omega-hydroxypoly(oxy-1,4- butanediyl). P-17-0261................. 1/22/2019 12/11/2018 N........................ (S) Benzoylbenzoate, esters with branched polyols. P-17-0261A................ 2/12/2019 12/11/2018 Specific chemical name (S) Poly(oxy-1,2- updated. ethanediyl),alpha-(2- benzoylbenzoyl)-omega-[(2- benzoylbenzoyl)oxy]-. P-17-0261A................ 2/27/2019 12/11/2018 Specific name CAS number (S) Poly(oxy-1,2- updated. ethanediyl),alpha-(2- benzoylbenzoyl)-omega-[(2- benzoylbenzoyl)oxy]-. P-17-0320................. 1/17/2019 1/15/2019 N........................ (G) Dodecanedioic acid and 1,6- hexane diol polymer with 3- hydroxy-2,2-dimethylpropyl 2,2-dimethylhydracrylate, neopentylglycol, 1,2 ethanediol, adipic acid, isophthalic acid, terephthalic acid, 2- oxooxopane, bayflex 2002h and 1,1'- methylenebis[isocyanatobenzen e]. P-18-0068................. 1/2/2019 12/21/2018 N........................ (G) Metal, alkylcarboxylate oxo complexes. P-18-0077................. 1/11/2019 12/18/2018 N........................ (S) Urea, reaction products with N-butylphophorothioic triamide and formaldehyde. P-18-0082................. 2/6/2019 1/9/2019 N........................ (G) Aspartic acid, tallow modified diester. P-18-0088................. 1/3/2019 1/2/2019 N........................ (G) Quaternary ammonium salt. P-18-0116................. 1/7/2019 12/18/2018 N........................ (S) Castor oil, reaction products with soybean oil. P-18-0224................. 1/9/2019 12/13/2018 N........................ (G) Alkenoic acid, polymer with alkenylcarbomonocycle, [alkanediylbis(substitutedalk ylene)] bis[heteromonocycle] and (alkylalkenyl) aromatic, salt. P-18-0225................. 1/9/2019 12/13/2018 N........................ (G) Alkenoic acid, polymer with substituted alkyloxirane, alkenylcarbomonocycle, alkyl substituted alkyl alkanediol and (alkylalkenyl) aromatic salt. P-18-0319................. 2/18/2019 1/29/2019 N........................ (G) Plant oil fatty acids, alkyl esters. [[Page 20127]] P-18-0324................. 1/16/2019 12/23/2018 N........................ (G) Organic acid dimethyl ester, polymer with mixed alkanediols and 5-isocyanato- 1-(isocyanatomethyl)-1,3,3- trimethylcyclohexane, trimethoxysilylaklanamine- blocked. ---------------------------------------------------------------------------------------------------------------- * The term `Approved' indicates that a submission has passed a quick initial screen ensuring all required information and documents have been provided with the submission. In Table III. of this unit, EPA provides the following information (to the extent such information is not subject to a CBI claim) on the test information that have passed an initial screening by EPA during this time period: The EPA case number assigned to the test information; the date the test information was received by EPA, the type of test information submitted, and chemical substance identity. Table III--Test Information Received From 02/01/2019 to 02/28/2019 ---------------------------------------------------------------------------------------------------------------- Case No. Received date Type of test information Chemical substance ---------------------------------------------------------------------------------------------------------------- P-19-0019..................... 2/4/2019 In Vitro Skin Corrosion: (G) haloalkane. Reconstructed Human Epidermis (RHE) Test Method (OECD Test Guideline 431). P-18-0306..................... 2/6/2019 Bacterial Reverse Mutation Test/ (S) 2-propenoic acid, 2-methyl- Ames Assay (OECD Test , 2-hydroxyethyl ester, Guideline 471) and Genetic polymer with butyl 2- Toxicology: Micronucleus Test propenoate, ethenylbenzene and (OECD Test Guideline 474). 2-oxiranylmethyl 2-methyl-2- propenoate. P-19-0033..................... 2/8/2019 Bacterial Reverse Mutation Test/ (G) sulfonium, triphenyl-, 5- Ames Assay (OECD Test (alkyl) fluoropentane Guideline 471), Acute Oral derivative. Toxicity (OECD Test Guideline 420). P-19-0054..................... 2/12/2019 Acute Oral Toxicity (OECD Test (G) polyamines, reaction Guidelines 423), Acute Dermal products with succinic Toxicity (OECD Test Guidelines anhydride polyalkenyl derivs., 402), Acute Eye Irritation metal salts, polyamines, (OECD Test Guidelines 405), reaction products with Bovine Corneal Opacity succinic anhydride polyalkenyl Permeability (OECD Test derivs., metal salts. Guidelines 437), Acute Dermal Irritation (OECD Test Guidelines 404), In Vitro Skin Irritation (OECD Test Guidelines 439), In Vitro Skin Corrosion (OECD Test Guidelines 431), Skin Sensitization (OECD Test Guidelines 406), Bacterial Reverse Mutation Test/Ames Assay (OECD Test Guideline 471), In Vitro Mammalian Chromosome Aberration (OECD Test Guideline 473), In Vitro Mammalian Cell Gene Mutation (OECD Test Guideline 490), Combined Repeated Dose Toxicity With The Reproduction/ Development Toxicity Screening Test (OECD Test Guideline 422), and Toxicokinetic Assessment. P-11-0264..................... 2/13/2019 Anaerobic Aquatic Metabolism (G) brominated polyphenyl (U.S. EPA Series 835--Fate, ether. Transport And Transformation Test Guidelines OPPTS 835.4400). P-16-0543..................... 2/13/2019 Exposure Monitoring Report..... (G) halogenophosphoric acid metal salt. P-16-0410..................... 2/14/2019 In Vitro Skin Irritation (OECD (G) phosphonic acid, Test Guidelines 439), In Vitro [(hydroxycyclosiloxanediyl) Skin Corrosion (OECD Test alkanediyl] dialkyl ester, Guidelines 431). alkali metal salt, reaction products with alkali metal silicate. P-18-0170..................... 2/14/2019 Bacterial Reverse Mutation Test/ (S) 1-propanaminium, N,N'- Ames Assay (OECD Test (oxydi-2,1-ethanediyl)bis[3- Guideline 471). chloro-2-hydroxy-N,N-dimethyl- , dichloride. P-18-0128..................... 2/15/2019 In Vitro Skin Irritation (OECD (S) inulin, 2-hydroxy-3- Test Guidelines 439), In-Vitro (trimethylammonio)propyl Eye Irritation (OECD Test ether, chloride. Guidelines 492). P-16-0581..................... 2/20/2019 Biosolubility In Simulated Lung (G) polysaccharide. Fluids. [[Page 20128]] P-18-0321..................... 2/20/2019 In Vitro Mutagenesis Studies: 3- (G) poly(oxy-ethanediyl), Test Battery, Guinea Pig (methyl ethanediyl)bis[hydroxy- Maximization Test, Acute . toxicity to the marine alga Skeleto11ema costatum, Acute Toxicity to Acarna tonsa, Acute toxicity to acartia tonsa, acute toxicity to juvenile turbot, marine algal inhibition test, Ready Biodegradability (OECD Test Guidelines 301F), Toxicological tests on polyglycol E-400, Evaluation of polyglycol E-400 in the aquatic environment, skin imitation and skin sensitization, Ready Biodegradability(OECD Test Guidelines 301), EFAST Report,EPIsuite (2) Reports, IRER Results, Oncologic Profiler in OECD QSAR Toolbox Results, Justification for Hazard Determination, Sustainable Futures Summary Assessment Using P2 Framework Models, Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials. Literature Articles: Fruijtier- Polloth, Hermansky et al., Herold 1989 ADH PEGs, JECFA WHO Summary, Biodegradation of Polyethers (PG, PPG, PTMG, and Others) by Dr. Kawai, Subacute Tox and Irritation of PEG by Smyth, Chronic Oral Tox of PEGs by Smyth. P-18-0124..................... 2/21/2019 Daphnid Chronic Toxicity Test (S) lithium nickel potassium (OECD Test Guidelines 202), oxide. Alga Growth Inhibition (OECD Test Guidelines 201), Fish Acute Toxicity Test, Freshwater And Marine (OECD Test Guidelines 203). P-05-0107..................... 2/26/2019 Aerobic Transformation In (G) perfluoroalkylethyl Aquatic Sediment Systems (OECD methacrylate copolymer organic Test Guidelines 308). acid salt. P-05-0075..................... 2/26/2019 Aerobic Transformation In (G) perfluoroalkylethyl Aquatic Sediment Systems (OECD methacrylate copolymer. Test Guidelines 308). P-06-0388..................... 2/26/2019 Aerobic Transformation In (G) perfluoroalkylethylmeth- Aquatic Sediment Systems (OECD acrylate copolymer. Test Guidelines 308). P-00-0281..................... 2/28/2019 Freshwater AAP Algal Medium, (G) alkylarylsulfonic acid, Daphnia Sp. Acute sodium salts. Immobilisation Test (OECD Test Guideline 202), A 96-Hour Static Acute Toxicity Test with The Fathead Minnow (OECD Test Guideline 203), A 96-Hour Toxicity Test with the Freshwater Alga (OECD Test Guideline 201), and Surface Tension of Aqueous Solutions (OECD Test Guideline 115). ---------------------------------------------------------------------------------------------------------------- If you are interested in information that is not included in these tables, you may contact EPA's technical information contact or general information contact as described under FOR FURTHER INFORMATION CONTACT to access additional non-CBI information that may be available. Authority: 15 U.S.C. 2601 et seq. Dated: April 19, 2019. Pamela Myrick, Director, Information Management Division, Office of Pollution Prevention and Toxics. [FR Doc. 2019-09378 Filed 5-7-19; 8:45 am] BILLING CODE 6560-50-P
| Publication Title | Federal Register Volume 84, Issue 89 (May 8, 2019) |
| Category | Regulatory Information |
| Collection | Federal Register |
| SuDoc Class Number | AE 2.7: GS 4.107: AE 2.106: |
| Publisher | Office of the Federal Register, National Archives and Records Administration |
| Section | Notices |
| Action | Notice. |
| Dates | Comments identified by the specific case number provided in this document must be received on or before June 7, 2019. |
| Contact | For technical information contact: Jim Rahai, Information Management Division (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, |
| Agency Name | ENVIRONMENTAL PROTECTION AGENCY |
| Page Number Range | 20122-20128 |
| Federal Register Citation | 84 FR 20122 |
| Docket Numbers | EPA-HQ-OPPT-2019-0075, FRL-9991-68 |
| FR Doc Number | 2019-09378 |
| fetchChildrenOnly | 1 |
| granuleId | 2019-09378 |
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| showPublinkTab | false |
| packageId | FR-2019-05-08 |
| agencies | Environmental Protection Agency |
| browsePath | 2019/05/05-08\/4 |