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Reviewing New Chemicals under the Toxic Substances Control Act (TSCA)

Chemicals Determined Not Likely to Present an Unreasonable Risk Following Pre-Manufacture Notification Review

This page describes the chemical substances EPA has determined are “not likely to present an unreasonable risk” following review of pre-manufacture notifications under section 5 of TSCA, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, P.L. 114-182.

Note:  For these “not likely to present an unreasonable risk” cases,” PMN submitters may commence manufacture upon notification by EPA, notwithstanding any remaining portion of the applicable review period, in accordance with section 5(g) of TSCA, as amended.

View the interim and final status of Section 5 pre-manufacture notices reviewed under TSCA.

Case
Number
Chemical
Identity
EPA Determination
Following PMN Review
Summary Review
Start Date
Decision
Date
P-18-0147 Generic: Phenol, 4-ethenyl-, 1-substituted, polymer with 1-(1,1-substituted)-4-ethenylbenzene and ethenylbenzene, 2, 2'-(1,2-diazenediyl)bis[2-substituted]-initiated, hydrolyzed The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, based on the risk assessment presented below. Although EPA estimated that the new chemical substance could be very persistent, the chemical substance has low potential for bioaccumulation, such that repeated exposures are not expected to be cumulative. Based on analogous chemical substances, EPA estimates that the chemical substance has low environmental hazard and the potential for the following human health hazard: irritation. EPA concludes that the new chemical substance is not likely to present an unreasonable risk to human health or the environment under the conditions of use. View the determination document.  4/4/18 11/29/18
P-18-0279 Generic: Substituted heteromonocycle, polymer with substituted alkanediol and diisocyanate substituted carbomonocyle, alkylene glycol acrylate-blocked The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, based on the risk assessment presented below. Although EPA estimated that the new chemical substance could be very persistent, the new chemical substance has low potential for bioaccumulation, such that repeated exposures are not expected to be cumulative. Based on EPA’s TSCA New Chemicals Program Chemical Category for Acrylates and test data on analogous chemical substances, EPA estimates that the chemical substance has low environmental hazard and potential for the following human health hazards: irritation and sensitization. EPA concludes that the new chemical substance is not likely to present an unreasonable risk under the conditions of use.View the determination document.  8/16/18 11/21/18
P-18-0136 Specific: Generic: 1-Butanaminium, N,N,N-tributyl-, 2(or5)- [[benzoyldihydrodioxo[(sulfophenyl)amino]heteropolycycle]oxy]-5(or 2)-(1,1- dimethylpropyl)benzenesulfonate (2:1) The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, based on the risk assessment presented below. Although EPA estimated that the new chemical substance could be very persistent, the new chemical substance has low potential for bioaccumulation, such that repeated exposures are not expected to be cumulative. Based on EPA’s TSCA New Chemicals Program Chemical Category for Acid Dyes and Amphoteric Dyes2 and test data on the chemical substance and analogous chemical substances, EPA estimates that the chemical substance has moderate environmental hazard and potential for the following human health hazards: systemic toxicity from repeated exposures. EPA concludes that the new chemical substance is not likely to present an unreasonable risk under the conditions of use. View the determination document.  4/9/18 11/20/18
P-17-0382 Specific: Amides, tallow, N,N-bis(2-hydroxypropyl), CASRN 1454803-04-3 The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, based on the risk assessment. View the determination document.  8/24/17 11/21/18
P-18-0054 Generic: 2-Alkenoic acid, 2-alkyl-, 2-alkyl ester, polymer with alkyl 2-alkenoate, 2-substitutedalkyl 2-alkenoate and 2-substitutedalkyl 2-alkyl-2-alkenoate, esters with carboxylic acids, tert alkylperoxoate initiated; polymer exemption flag. The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, based on the risk assessment. View the determination document.  11/20/17 11/21/18
P-18-0078 Generic: 2-Alkenoic acid, 2-alkyl-, 2-alkyl ester, polymer with alkyl 2-alkenoate, 2-substitutedalkyl 2-alkenoate and 2-substitutedalkyl 2-alkyl-2-alkenoate, tert alkylperoxoate initiated; polymer exemption flag. The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, based on the risk assessment. View the determination document.  12/27/17 11/21/18
P-18-0261 Generic: Metal, alkylcarboxylate oxo complexes The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, based on the risk assessment. View the determination document.  7/26/18 11/20/18
J-18-0044 Specific: Saccharomyces cerevisiae NE095 The microorganism is not likely to present an unreasonable risk (5(a)(3)(C)) The microorganism is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material. View the determination document.  8/30/18 11/20/18
J-18-0041 Generic: E. coli K-12 C003: Arsenic detecting strain of E. coli with extra-chromosomal elements, including an intergeneric screening marker The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) The new microorganism is not likely to present an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, based on the risk assessment. View the determination document.  8/9/18 11/7/18
P-18-0233 Generic: Alkyl Alkenoic acid, alkyl ester, telomer with alkylthiol, substituted carbomonocycle, substituted alkyl alkyl alkenoate and hydroxyalkyl alkenoate, tert-butyl alkyl peroxoate-initiated The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, based on the risk assessment. View the determination document.  7/6/18 11/2/18
P-18-0224 and P-18-0225 Generic (P-18-0224): Alkenoic acid, polymer with alkenylcarbomonocycle, [alkanediylbis(substitutedalkylene)] bis[heteromonocycle] and (alkylalkenyl) aromatic, salt
Generic (P-18-0225): Alkenoic acid, polymer with substituted alkyloxirane, alkenylcarbomonocycle, alkyl substituted alkyl alkanediol and (alkylalkenyl) aromatic salt
The chemical substances are not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substances are not likely to present an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, based on the risk assessment. View the determination document.  6/27/18 10/30/18
P-18-0030 Generic: Poly[oxy(methyl-alkylendiyl)], a,a',a''-1,2,3-alkanetriyltris[w-hydroxy-, polymer with 1,1'-alkylenebis[4-isocyanatocarbomonocycle], 2-substituted ethyl acrylate- and 2-substituted ethyl methacrylate-blocked The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, based on the risk assessment. View the determination document.  10/23/17 10/30/18
J-18-0019 to 0021 Generic: Genetically modified microorganism The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) The microorganisms are not likely to present an unreasonable risk based on low human health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material. View the determination document.  8/2/18 10/30/18
J-18-0026-0027 Generic: Biopolymer producing modified microorganism(s) with chromosomally-borne modifications The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) The microorganisms are not likely to present an unreasonable risk based on low human health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material.  View the determination document.  7/23/18 10/19/18
P-18-0041 Specific: 2,5-Furandione, polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-5(or 6)-yl ester, ester with 2,3-dihydroxypropyl neodecanoate; CASRN: none The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, based on the risk assessment presented.  View the determination document.  11/6/17 10/2/18
P-16-0581 Generic (P-16-0581): alpha 1,3-polysaccharide The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C))* *In EPA’s original screening analysis for this PMN in 2016, EPA identified potential for risk for inhalation of respirable particles, which resulted in the interim finding. Based on an amendment to the PMN indicating that respirable particles are not expected under the intended conditions of use, EPA revised its assessment for the intended conditions of use.  EPA's final determination that the chemical substance is not likely to present unreasonable risk is based on EPA's risk assessment for the chemical substance under intended conditions of use in the PMN and EPA's issuance of a proposed SNUR to address certain reasonably foreseen uses. Conditions of use that fall under the restrictions of the proposed SNUR are not likely to present unreasonable risk of injury to health or the environment because (1) those conditions of use are not likely to be commenced during the pendency of proposed SNUR and (2) upon finalization of the SNUR those conditions of use would be prohibited unless and until EPA makes an affirmative determination that the significant new use is not likely to present an unreasonable risk or takes appropriate action under section 5(e) or 5(f). View the determination document and the terms of the SNUR 9/19/16 10/9/18
P-16-0575 Specific (P-16-0575, non-CBI): Glucosyltransferase (International Union of Biochemistry and Molecular Biology (IUBMB) enzyme nomenclature recommendations: IUBMB Number 2.4.1.5) The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C))* *In EPA's original screening analysis for this PMN in 2016, EPA identified potential for risk if the substance is inhaled under reasonably foreseen conditions of use, which resulted in the interim finding. EPA's final determination that the chemical substance is not like to present unreasonable risk is based on EPA's risk assessment for the chemical substance under the intended conditions of use in the PMN where inhalation exposure is not expected, and EPA's issuance of a proposed SNUR to address certain reasonably foreseen uses. Conditions of use that fall under the restrictions of the proposed SNUR are not likely to present unreasonable risk of injury to health or the environment because (1) those conditions of use are not likely to be commenced during the pendency of proposed SNUR and (2) upon finalization of the SNUR those conditions of use would be prohibited unless and until EPA makes an affirmative determination that the significant new use is not likely to present an unreasonable risk or takes appropriate action under section 5(e) or 5(f). View the determination document and the terms of the SNUR 9/15/16 10/9/18
P-16-0483-0484 Generic (P-16-0483): Inorganic acids, metal salts, compds. with modified heteroaromatics
Generic (P-16-0484): Inorganic acid, metal salt, compd. with substituted aromatic heterocycle
The chemical substances are not likely to present an unreasonable risk (5(a)(3)(C)) *EPA's final determination that the chemical substances are not likely to present unreasonable risk is based on EPA's risk assessment for the chemical substances under intended conditions of use described in the PMN and EPA's  issuance of a proposed SNUR to address certain reasonably foreseen uses. Conditions of use that fall under the restrictions of the proposed SNUR are not likely to present unreasonable risk of injury to health or the environment because (1) those conditions of use are not likely to be commenced during the pendency of proposed SNUR and (2) upon finalization of the SNUR those conditions of use would be prohibited unless and until EPA makes an affirmative determination that the significant new use is not likely to present an unreasonable risk or takes appropriate action under section 5(e) or 5(f). View the determination document and the terms of the SNUR 7/18/16 10/9/18
P-16-0380-0385 Generic (P-16-0380): 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-16-0381): 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-16-0382): 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-16-0383): 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-16-0384): 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-16-0385): 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).
The chemical substances are not likely to present an unreasonable risk (5(a)(3)(C))* *In EPA’s original screening analysis for these PMNs in 2016, EPA identified potential for health effects if inhaled and risk to the environment, which resulted in the interim finding. After additional evaluation, EPA determined that inhalation exposure is not a condition of use for these PMNs. Based on an amendment to the PMNs addressing water releases, EPA revised its assessment for the intended conditions of use. EPA's final determination that the chemical substance is not likely to present unreasonable risk is based on EPA's risk assessment for the chemical substances under intended conditions of use described in the amended PMNs, and EPA's issuance of a proposed SNUR that addresses a certain reasonably foreseen use. The condition of use that falls under the restrictions of the proposed SNUR is not likely to present unreasonable risk of injury to health or the environment because (1) the condition of use is not likely to be commenced during the pendency of proposed SNUR and (2) upon finalization of the SNUR the condition of use would be prohibited unless and until EPA makes an affirmative determination that the significant new use is not likely to present an unreasonable risk or takes appropriate action under section 5(e) or 5(f). View the determination document and the terms of the SNUR 6/22/16 10/9/18
P-16-0354-0355 Generic (P-16-0354 and P-16-0355): Esteramine The chemical substances are not likely to present an unreasonable risk (5(a)(3)(C))* *In EPA’s original screening analysis for these PMNs in 2016, EPA identified potential for risk to the environment, which resulted in the interim finding. Based on an amendment to the PMNs addressing water releases under the intended conditions of use, EPA revised its assessment for the intended conditions of use. EPA's final determination that the chemical substance is not likely to present unreasonable risk is based on EPA's risk assessment for the chemical substances under intended conditions of use described in the PMN and EPA's issuance of a proposed SNUR that addresses certain reasonably foreseen uses. Conditions of use that fall under the restrictions of the proposed SNUR are not likely to present unreasonable risk of injury to health or the environment because (1) those conditions of use are not likely to be commenced during the pendency of proposed SNUR and (2) upon finalization of the SNUR those conditions of use would be prohibited unless and until EPA makes an affirmative determination that the significant new use is not likely to present an unreasonable risk or takes appropriate action under section 5(e) or 5(f). View the determination document and the terms of the SNURR.  6/22/16 10/9/18
P-16-0192 Generic (P-16-0192): Silanized amorphous silica The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C))* *In EPA’s original screening analysis for this PMN in 2016, EPA identified potential for risk for lung effects for reasonably foreseen conditions of use, which resulted in the interim finding. EPA's final determination that the chemical substance is not likely to present unreasonable risk is based on EPA's risk assessment for the chemical substance under the intended conditions of use described in the PMN where the substance is manufactured in an amorphous form and EPA's issuance of a proposed SNUR to address certain reasonably foreseen uses. Conditions of use that fall under the restrictions of the proposed SNUR are not likely to present unreasonable risk of injury to health or the environment because (1) those conditions of use are not likely to be commenced during the pendency of proposed SNUR and (2) upon finalization of the SNUR those conditions of use would be prohibited unless and until EPA makes an affirmative determination that the significant new use is not likely to present an unreasonable risk or takes appropriate action under section 5(e) or 5(f).  View the determination document and the terms of the SNUR 6/22/168 10/9/18
P-18-0070 Generic: Waste plastics, polyester, depolymd. with glycols, polymers with dicarboxylic acids The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, based on the risk assessment presented.  View the determination document.  1/4/18 10/5/18
P-18-0100 Generic: Substituted alkanoic acid polymer with alkylcarbonate, alkanediols and isocyanate substituted carbomonocycles, sodium salt, alkenoic acid substituted polyol reaction products-blocked.  The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, based on the risk assessment presented. View the determination document.  1/26/18 10/5/18
P-18-0102 Generic: Alkenoic acid, ester with [oxybis(alkylene)]bis[alkyl-substituted alkanediol], polymer with alkylcarbonate, alkanediols, substituted alkanoic acid and isocyanate and alkyl substituted carbomonocycle, sodium salt. The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, based on the risk assessment presented. View the determination document.  1/26/18 10/5/18
P-18-0116 Generic: Fatty acid oil reaction product with fatty acid oil The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, based on the risk assessment presented.  View the determination document.  2/26/18 10/5/18
P-18-0137 Generic: Alkylsilsesquioxane, ethoxy-terminated The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, based on the risk assessment presented. View the determination document.  3/23/18 10/5/18
P-18-0227 Specific: D-Glucaric acid (CASRN: 87-73-0) The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, based on the risk assessment presented.  View the determination document.  6/29/18 10/5/18
P-18-0231 Generic: Alkanoic acid, substituted alkyl-, polymer with isocyanatoalkane, alkyl carbonate, alkanediol and polyalkylene glycol ether with alkyl(substituted alkyl) alkanediol alkenoate, glycerol monoacrylate alkanoate-blocked The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, based on the risk assessment presented. View the determination document.  6/29/18 9/26/18
J-18-0022 to 0025 Generic: Modified Saccharomyces cerevisiae The microorganisms are not likely to present an unreasonable risk (5(a)(3)(C)) The microorganisms are not likely to present an unreasonable risk based on low human health hazard and low environmental hazard associated with the recipient microorganisms and introduced genetic material. S. cerevisiae is not pathogenic to humans or animals and has an extensive history of safe use in food processing. The introduced genetic modifications pose low concern for health and environmental hazard and do not include antibiotic resistance markers. View the determination document.  7/13/18 9/27/18
P-18-0230 Specific: Waxes and Waxy substances, rice bran, oxidized, calcium salts (CASRN 1850357-57-1) The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, based on the risk assessment presented. View the determination document.  6/29/18 9/18/18
P-17-0332 Generic: Benzenesulfonic acid, (alkenediyl)bis[[[(hydroxyalkyl)amino]-(phenylamino)-triazin-2- yl]amino]-, N-(hydroxyalkyl) derivs., salts The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, based on the risk assessment presented below. Although EPA estimated that the new chemical substance could be very persistent, the chemical substance has low potential for bioaccumulation, such that repeated exposures are not expected to be cumulative. Based on test data on the new chemical substance and analogous chemical substances, EPA estimates that the chemical substance has moderate environmental hazard and low human health hazard. EPA determines that the new chemical substance is not likely to present an unreasonable risk under the conditions of use. View the determination document.  6/19/17 9/18/18
J-18-0028 to 0030 Generic: Saccharomyces cerevisiae modified The microorganisms are not likely to present an unreasonable risk (5(a)(3)(C)) The microorganisms are not likely to present an unreasonable risk based on low human health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material. S. cerevisiae is not pathogenic to humans or animals and has an extensive history of safe use in food processing. View the determination document.  7/3/18 9/14/18
P-16-0532 Generic: Substituted heteromonocycle Chemical substance not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental concerns. View the determination document.  8/25/18 9/6/18
J-18-0004 to 0009 Generic: Biofuel-producing modified microorganisms, with chromosomally-borne modifications The microorganisms are not likely to present an unreasonable risk (5(a)(3)(C)) The microorganisms are not likely to present an unreasonable risk based on low human health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material. View the determination document.  6/14/18 9/6/18
J-18-0012 Generic: Genetically modified yeast Microorganism not likely to present an unreasonable risk (5(a)(3)(C)) The microorganism is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material. View the determination document.  6/6/18 8/27/18
J-18-0001 Generic: Modified Corynebacterium glutamicum Microorganism not likely to present an unreasonable risk (5(a)(3)(C)) The microorganism is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material. View the determination document.  12/8/17 8/2/18
P-16-0510 Specific: Oxirane, 2-methyl-, polymer with oxirane, bis[2-[(1-oxo-2-propen-1-yl)amino]propyl] ether (CASRN: 1792208-65-1) Chemical substance not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, based on the risk assessment. Although EPA estimated that the new chemical substance could be very persistent, the chemical substance has low potential for bioaccumulation, such that repeated exposures are not expected to be cumulative. Based on EPA’s TSCA New Chemicals Program Chemical Categories for Acrylates and Acrylamides and test data on analogous chemical substances, EPA estimates that the chemical substance has low to moderate environmental hazard and the potential for the following human health hazards: irritation, mutagenicity, developmental/reproductive toxicity, neurotoxicity, and carcinogenicity. Based on test data on structural analogues to the low molecular weight components of the PMN substance, systemic effects were used as the endpoint for evaluation. EPA determines that the conditions of use would not produce these potential unreasonable risks because the PMN submitter would import the chemical substance in solution at a concentration of 50% or less for processing which would result in a deodorizer for use at a concentration of 2% by weight in the formulation of the final product. View the determination document. 8/5/16 7/30/18
P-18-0142 Generic: Alkanoic acid, alkyl-, alkyl ester, polymer with substituted alkenoates, alkenoic acid, alkyl peroxoate-initiated; polymer exemption flag. Polymer exemption flag: The chemical must be manufactured such that it meets the polymer exemption criteria as described under 40 CFR §723.250(e)(1), in addition to meeting the definition of polymer at 40 CFR §723.250(b). Chemical substance not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental concerns. View the determination document.  3/27/18 7/27/18
J-18-0002/3 Generic: Saccharomyces cerevisiae modified Microorganisms not likely to present an unreasonable risk (5(a)(3)(C)) The microorganisms are not likely to present an unreasonable risk based on low human
health hazard and low environmental hazard associated with the recipient microorganisms and introduced genetic material. View the determination document. 
2/12/18 6/12/18
P-18-0083 Specific: 2-Propenoic acid, telomers with Bu alc.-2-[(2-propen-1-yloxy)methyl]oxirane reaction products, sodium bisulfite and sodium 2-hydroxy-3-(2-propen-1-yloxy)-1-propanesulfonate(1:1), sodium salts, peroxydisulfuric acid ([(HO)S(O)2]2O2) sodium salt (1:2)-initiated. (CASRN: 2118944-42-4) Chemical substance not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental concerns. View the determination document.  1/3/18 3/23/18
P-18-0044-0045 Generic (P-18-0044): Fatty acids
Generic (P-18-0045): Fatty acids, alkyl esters
Chemical substances not likely to present an unreasonable risk (5(a)(3)(C)) These chemical substances are not likely to present an unreasonable risk based on low/moderate human health hazard and low environmental hazard. View the determination document.  11/7/17 3/23/18
P-18-0021 Generic: Dicarboxylic acids, polymers with substituted poly( substituted alkendiyl) ,3-hydroxy-2-(hydroxyalkyl)-2-alkylalkenoic acid, 5-substituted-1-(substituted alkyl)-1,3,3-trialkyl carbomonocyle, alkanediol, alkane-triol, alcohol blocked compounds with aminoalcohol; polymer exemption flag. Chemical substance not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document.  10/16/17 3/23/18
P-18-0002 Generic: Phosphinic acid, P,P-alkyl-, salt Chemical substance not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk of injury to health or the environment. View the determination document.  10/2/17 3/19/18
P-16-0415 Generic: Polyurethane; polymer exemption flag. Chemical substance not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk based on low human health concern and low environmental hazard when made in accordance with the polymer exemption. View the determination document.  6/22/16 3/19/18
J-17-0028 Generic: Biofuel producing Saccharomyces cerevisiae modified, genetically stable Microorganism not likely to present an unreasonable risk (5(a)(3)(C)) The microorganism is not likely to present an unreasonable risk based on low human
health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material. View the determination document. 
9/28/17 1/4/18
J-17-0022 Generic: Modified Trichoderma reesei Microorganism not likely to present an unreasonable risk (5(a)(3)(C)) The microorganism is not likely to present an unreasonable risk based on low human
health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material. View the determination document. 
10/9/17 1/4/18
J-17-0021 Generic: Modified Saccharomyces cerevisiae Microorganism not likely to present an unreasonable risk (5(a)(3)(C)) The microorganism is not likely to present an unreasonable risk based on low human
health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material. View the determination document. 
10/6/17 1/4/18
J-17-0015, 0016, 0017, 0018, and 0019 Generic: Saccharomyces cerevisiae modified Microorganisms not likely to present an unreasonable risk (5(a)(3)(C)) The microorganism is not likely to present an unreasonable risk based on low human
health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material. View the determination document. 
8/7/17 1/4/18
P-18-0026 Specific: Silsesquioxanes, 2,4,4-trimethylpentyl, hydroxy-terminated. (CASRN: 217654-68-7) Chemical substance not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 10/17/17 12/12/17
P-18-0032 Generic: Alkyl alkenoic acid, alkyl ester, polymer with alkyl alkenoate, dialkyl alkanediol, substituted carbomonocycle, disubstituted heteromonocycle,disubstituted heteropolycyclic, alkanediol, substituted alkyl alkyl alkenoate and substituted heteromonocycle, dialkyl peroxide initiated. Chemical substance not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 10/27/17 12/12/17
P-17-0153 Specific: D-Glucitol, 1-deoxy-1-(dimethylamino)-. (CASRN: 76326-99-3) Chemical substance not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 11/23/16 12/12/17
P-17-0390 Generic: Carbomonocyclic dicarboxylic acid, polymer with alkenedioic acid, substituted heteropolycycle, substituted heteromonocycle, alkanediol, alkanedioic acid, alkoxylated substituted dicarbomonocycle, alkoxylated substituted dicarbomonocycle and alkanetriol, carbomonocyclic carboxylate alkanoate Chemical substance not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 09/06/17 11/02/17
P-17-0190 Generic: Butanoic acid, 3-oxo-, 2-[(2-methyl-1-oxo-2-propen-1-yl)oxy]ethyl ester, polymer with cycloalkyl 2-methyl-2-propenoate, ethenylbenzene, 2-ethylhexyl 2- propenoate, methyl 2-methyl-2-propenoate and 2-methylpropyl 2-methyl-2- propenoate Chemical substance not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 12/26/16 09/06/17
J-17-0014 Generic: organic acid producing yeast, modified, genetically stable Microorganism not likely to present an unreasonable
risk (5(a)(3)(C))
The microorganism is not likely to present an unreasonable risk based on low human
health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material. View the determination document. 
7/10/17 10/5/17
P-16-0508 Generic: Terephthalic acid and alcohol ester polymer hydroxy glycol and 2-Ethylhexyl alcohol; polymer exemption flag. Chemical substance not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 10/04/16 09/26/17
P-14-0314 Generic: Poly aliphatic phosphate Chemical substance not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 6/22/2016 7/31/2017
J-17-0008, 0009, 0010, 0011, 0012, and 0013 Generic: Modified microorganism Microorganism not likely to present
an unreasonable risk (§5(a)(3)(C))
The microorganisms are not likely to present an unreasonable risk based on low human health hazard and low environmental hazard associated with the recipient microorganisms and introduced genetic material. The introduced genetic modifications pose low concern for health and environmental hazard and do not include antibiotic resistance markers. View the determination document. 5/8/2017 7/27/2017
P-17-0117 & P-17-0118 Specific (P-17-0117): 1,6,10-Dodecatriene, 7,11-dimethyl-3-methylene-, (6E)-, homopolymer, 2-hydroxypropyl-terminated (CASRN: 1898242-86-8); polymer exemption flag.
Specific (P-17-0118): 1,6,10-Dodecatriene, 7,11-dimethyl-3-methylene-, (6E)-, homopolymer, 2-hydroxyethyl-terminated (CASRN: 2007163-32-6); polymer exemption flag
Polymer exemption flag: The chemical must be manufactured such that it meets the polymer exemption criteria as described under 40 CFR §723.250(e)(1), in addition to meeting the definition of polymer at 40 CFR §723.250(b).
Chemical substance not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 11/17/2016 7/24/2017
P-17-0293 Generic: Substituted carbomonocycle, polymer with substituted carbonomoncycles, alkyl substituted- alkanediols, alkanediol, alkanedioic acid, and dialkylene glycol; polymer exemption flag. Polymer exemption flag: The chemical must be manufactured such that it meets the polymer exemption criteria as described under 40 CFR §723.250(e)(1), in addition to meeting the definition of polymer at 40 CFR §723.250(b). Chemical substance not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 4/24/2017 7/21/2017
P-17-0266 Specific: Alcohols, C12-13-branched and linear, dimerized (CASRN: 2041102-78-5). Chemical substance not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 3/22/2017 7/27/2017
P-17-0219 Generic: Polyester of aliphatic glycols and aromatic diacids; polymer exemption flag. Polymer exemption flag: The chemical must be manufactured such that it meets the polymer exemption criteria as described under 40 CFR §723.250(e)(1), in addition to meeting the definition of polymer at 40 CFR §723.250(b). Chemical substance not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 1/25/2017 7/14/2017
P-17-0112 Specific: 1,4-Benzenedicarboxylic acid, polymer with hexanedioic acid and 1,6-hexanediol
(CASRN: 84191-80-0); polymer exemption flag.
Polymer exemption flag: The chemical must be manufactured such that it meets the polymer
exemption criteria as described under 40 CFR §723.250(e)(1), in addition to meeting the
definition of polymer at 40 CFR §723.250(b).
Chemical substance not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 11/16/2016 7/6/2017
P-17-0264 Generic: Alkanoic acid, 2-alkyl-, substituted alkyl ester, polymer with alkyl alkenoate, substituted carbomonocycle, substituted alkyl alkenoate and alkyl substituted alkenoate, substituted alkanenitrile-initiated; polymer exemption flag. Polymer exemption flag: The chemical must be manufactured such that it meets the polymer exemption criteria as described under 40 CFR §723.250(e)(1), in addition to meeting the definition of polymer at 40 CFR §723.250(b). Chemical substance not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 3/22/2017 6/29/2017
P-16-0426 Generic: Alkenyl bis-succinimide Chemical substance not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 6/30/2016 6/28/2017
P-17-0255 Generic: Carbomonocyclic dicarboxylic acid, polymer with carbomonocyclic dicarboxylic acid, alkanedioic acid, alkenedioic acid, substituted dioxoheteropolycyclic, substituted dioxoheteropolycyclic, alkanedioic acid, alkoxylated alkylidene dicarbomonocycle and alkoxylated alkylidene dicarbomonocycle, ester. Chemical substance not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 3/14/2017 6/7/2017
P-16-0587 Specific: Galactoarabinoxylan (CASRN: 37324-70-2). Chemical substance not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 9/22/2016 6/15/2017
P-16-0401 Generic: Alkyl acrylate polymer; polymer exemption flag. Polymer exemption flag: The chemical must be manufactured such that it meets the polymer exemption criteria as described under 40 CFR §723.250(e)(1), in addition to meeting the definition of polymer at 40 CFR §723.250(b). Chemical substance not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 6/22/2016 6/15/2017
P-16-0588 Generic: Alkyl methacrylate, polymer with alkyl acrylate and polyesters; polymer exemption flag. Polymer exemption flag: The chemical must be manufactured such that it meets the polymer exemption criteria as described under 40 CFR §723.250(e)(1), in addition to meeting the definition of polymer at 40 CFR §723.250(b). Chemical substance not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 9/22/2016 5/30/2017
P-16-0303 Generic: Alkyl methyacrylate polymer with styrene, amino acrylate and acrylic acid, ammonium salt; polymer exemption flag. Polymer exemption flag: The chemical must be manufactured such that it meets the polymer exemption criteria as described under 40 CFR §723.250(e)(1), in addition to meeting the definition of polymer at 40 CFR §723.250(b). Chemical substance not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 6/22/2016 5/30/2017
P-17-0237-0238 Specific (P-17-0237): 1,6,10-Dodecatriene, 7,11-dimethyl-3-methylene-, (6E)-, homopolymer, hydrogenated, 2-hydroxyethyl-terminated (CASRN: 2007163-33-7).
Specific (P-17-0238): 1,6,10-Dodecatriene, 7,11-dimethyl-3-methylene-, (6E)-, homopolymer, 2-hydroxypropyl-terminated, hydrogenated (CASRN: 1912453-88-3).
Chemical substance not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 2/23/2017 5/19/2017
P-17-0256 Generic: Carbopolycyclic dicarboxylic acid, dialkyl ester, polymer with dialkyl carbomonocyclic diester, dialkyl substituted carbomonocyclic diester alkali metal salt and alkanediol; polymer exemption flag. Polymer exemption flag: The chemical must be manufactured such that it meets the polymer exemption criteria as described under 40 CFR §723.250(e)(1), in addition to meeting the definition of polymer at 40 CFR §723.250(b). Chemical substance not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 3/14/2017 5/18/2017
P-17-0207 Generic: 2-alkenoic acid, 2 alkyl, 2 alkyl ester, polymer with alkyl alkenoate, carbomonocyle, alkyl alkenoate and alkyl alkenoate, alkyl peroxide initiated; polymer exemption flag. Polymer exemption flag: The chemical must be manufactured such that it meets the polymer exemption criteria as described under 40 CFR §723.250(e)(1), in addition to meeting the definition of polymer at 40 CFR §723.250(b). Chemical substance not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 1/23/2017 5/18/2017
P-17-0246 Generic: Polycarbonate polyol. Chemical substance not likely to present an unreasonable risk (5(a)(3)(C)) The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 2/28/2017 5/11/2017
P-16-0578 Generic: Alkenoic acid, alkyester, polymer with N-(dialkyl-oxoalkyl)-alkenamide, alkenylbenzene, alkyl alkenoate and alkenoic acid; polymer exemption flag.

Chemical substance not likely to present
an unreasonable risk (§5(a)(3)(C)).

Polymer exemption flag: The chemical must be manufactured such that it meets the polymer
exemption criteria as described under 40 CFR §723.250(e)(1), in addition to meeting the
definition of polymer at 40 CFR §723.250(b).

The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 9/18/2016 5/15/2017
J-17-0007 Generic: Biofuel producing Saccharomyces cerevisiae modified, genetically stable Microorganism not likely to present
an unreasonable risk (§5(a)(3)(C))
The microorganism is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material. View the determination document. 2/1/2017 4/27/2017
P-17-0227 Generic: 2-Alkenoic acid, 2-alkyl-, alkyl ester, polymer with 2-alkyl 2-propenoate and -(2-alkyl-1-oxo-2-alken-1-yl--alkoxypoly(oxy-1,2-alkanediyl), ester with -2-alken-1-yl--hydroxypoly(oxy-1,2-alkanediyl); polymer exemption flag.

Chemical substance not likely to present
an unreasonable risk (§5(a)(3)(C)).

Polymer exemption flag: The chemical must be manufactured such that it meets the polymer
exemption criteria as described under 40 CFR §723.250(e)(1), in addition to meeting the
definition of polymer at 40 CFR §723.250(b).

The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 2/1/2017 4/27/2017
P-17-0194 Generic: Hydrogenated dihalo dialkyl diindolotriphenodioxazine, dihydrodisubstituted isoindolyl alkyl derivs. Chemical substance not likely to present
an unreasonable risk (§5(a)(3)(C))
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 1/4/2017 3/13/2017
P-17-0215 Generic: Copolymer of alpha-olefin and dibutyl maleate. Chemical substance not likely to present
an unreasonable risk (§5(a)(3)(C))
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 1/16/2017 3/13/2017
P-17-0214 Generic: 2-Propenoic acid, polymer with alkene and alkenyl acetate, alkyl 2-alkyl isoalkyl esters. Chemical substance not likely to present
an unreasonable risk (§5(a)(3)(C))
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 1/16/2017 3/13/2017
P-17-0014 Specific: Fatty acids, C8-10, mixed esters with C18-unsatd. fatty acid dimers and .alpha.-hydro-.omega.-hydroxypoly(oxy-1,4-butanediyl) (CASRN: None). Chemical substance not likely to present
an unreasonable risk (§5(a)(3)(C))
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 2/6/2017 3/13/2017
P-17-0008 Generic: Modified 1,3-isobenzofurandione, polymer with 1,2-ethanediol, 2-ethyl-2-(alkoxyalkyl)-1,3-propanediol and 1,3-Isobenzofurandione, alkanoate Chemical substance not likely to present
an unreasonable risk (§5(a)(3)(C))
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 11/2/2016 3/30/2017
P-16-0592 Specific: Fatty acids, C8-10, diesters with .alpha.-hydro-.omega.-hydroxypoly(oxy-1,4-butanediyl) (CASRN: None) Chemical substance not likely to present
an unreasonable risk (§5(a)(3)(C))
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 1/23/2017 3/13/2017
P-17-0185 Generic: Fatty acids, C18-unsatd., dimers, hydrogenated, polymers with C18-unsatd. fatty acid trimers, alkylenediamine and hydroxyalkanoic acid. Chemical substance not likely to present
an unreasonable risk (§5(a)(3)(C))
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 12/30/2016 2/13/2017
P-17-0182 Generic: Alkyldioic acid, polymer with 2,2-dimethyl-1,3-propanediol, heteropolycyclic carboxy acid anhydride and 1,3-propanediol. Chemical substance not likely to present
an unreasonable risk (§5(a)(3)(C))
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 12/30/2016 2/13/2017
P-17-0160-0161 Generic: 2-Propenoic acid, alkyl-, alkyl ester, polymer with alkyl 2-propenoate, dialkyloxoalkyl-2-propenamide and alkyl 2-propenoate. Generic: 2-Propenoic acid, alkyl-, alkyl ester, polymer with alkyl 2-propenoate, dialkyloxoalkyl-2-propenamide, ethenylbenzene and alkyl 2-propenoate. Chemical substances not likely to present
an unreasonable risk (§5(a)(3)(C))
The chemical substances are not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 11/30/2016 2/13/2017
P-17-0158 Generic: Perylene bisimide Chemical substance not likely to present
an unreasonable risk (§5(a)(3)(C))
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 11/30/2016 2/13/2017
J-17-0006 Generic: Saccharomyces cerevisiae modified Microorganism not likely to present
an unreasonable risk (§5(a)(3)(C))
The microorganism is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material. View the determination document. 11/23/2016 2/13/2017
P-17-0144 Specific: Amines, C36-alkylenedi-, polymers with octahydro-4,7-methano-1H-indenedimethanamine and pyromellitic dianhydride, maleated (CASRN: 2020378-57-6). Chemical substance not likely to present
an unreasonable risk (§5(a)(3)(C))
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 11/18/2016 1/18/2017
J-17-0001-0005 Generic: Saccharomyces cerevisiae modified Microorganisms not likely to present
an unreasonable risk (§5(a)(3)(C))
The microorganisms are not likely to present an unreasonable risk based on low human
health hazard and low environmental hazard associated with the recipient microorganism and
introduced genetic material. View the determination document.
10/24/2016 1/18/2017
P-17-0016-0021
  • Generic: (P-17-0016): Hydroxyl alkyl acrylate ester, polymer with acrylates, aromatic vinyl
    monomer, cycloaliphatic lactone, and alkyl carboxylic acid, peroxide initiated
  • Generic (P-17-0017): Hydroxyl alkyl acrylate ester, polymer with acrylates, aromatic vinyl
    monomer, cycloaliphatic lactone, and alkyl carboxylic acid, peroxide initiated.
  • Generic (P-17-0018): Hydroxyl alkyl acrylate ester, polymer with acrylates, aromatic vinyl
    monomer, cycloaliphatic lactone, and alkyl carboxylic acid, Azobis[aliphatic nitrile] initiated
  • Generic (P-17-0019): Hydroxyl alkyl acrylate ester, polymer with acrylates, aromatic vinyl
    monomer, cycloaliphatic lactone, and alkyl carboxylic acid, peroxide initiated
  • Generic (P-17-0020): Hydroxyl alkyl acrylate ester, polymer with acrylates, aromatic vinyl
    monomer, cycloaliphatic lactone, and alkyl carboxylic acid, peroxide initiated
  • Generic (P-17-0021): Hydroxyl alkyl acrylate ester, polymer with acrylates, aromatic vinyl
    monomer, cycloaliphatic lactone, and alkyl carboxylic acid, Azobis[aliphatic nitrile] initiated
Chemical substances not likely to present
an unreasonable risk (§5(a)(3)(C))
The chemical substances are not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 10/25/2016 12/19/2016
P-17-0009 Generic: Depolymerized waste plastics Chemical substance not likely to present
an unreasonable risk (§5(a)(3)(C))
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 10/13/2016 12/1/2016
J-16-0033 Generic: Saccharomyces cerevisiae modified to express glucoamylase activity Microorganism not likely to present
an unreasonable risk (§5(a)(3)(C))
The microorganism is not likely to present an unreasonable risk based on low human
health hazard and low environmental hazard associated with the recipient microorganism and
introduced genetic material. View the determination document.
8/22/2016 12/1/2016
J-16-0034 Generic: Saccharomyces cerevisiae modified Microorganism not likely to present
an unreasonable risk (§5(a)(3)(C))
The microorganism is not likely to present an unreasonable risk based on low human
health hazard and low environmental hazard associated with the recipient microorganism and
introduced genetic material. View the determination document.
8/23/2016 12/1/2016
J-16-0036 --0041 Generic: Biofuel producing modified microorganism(s), with chromosomally-borne modifications Microorganism not likely to present
an unreasonable risk (§5(a)(3)(C))
The microorganisms are not likely to present an unreasonable risk based on low human
health hazard and low environmental hazard associated with the recipient microorganism and
introduced genetic material. View the determination document.
9/7/2016 12/1/2016
J-16-0035 Generic: Saccharomyces cerevisiae modified Microorganism not likely to present
an unreasonable risk (§5(a)(3)(C))
The microorganism is not likely to present an unreasonable risk based on low human
health hazard and low environmental hazard associated with the recipient microorganism and
introduced genetic material. View the determination document.
8/23/2016 12/1/2016
P-16-0580 Generic: Trimethylolpropane ester of mixed linear and branched carboxylic acids Chemical substance not likely to present
an unreasonable risk (§5(a)(3)(C))
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 9/19/2016 11/10/2016
J-16-0025 Generic: Trichoderma reesei modified Microorganism not likely to present
an unreasonable risk (§5(a)(3)(C))
The microorganism is not likely to present an unreasonable risk based on low human
health hazard and low environmental hazard associated with the recipient microorganism and
introduced genetic material. View the determination document.
7/29/2016 11/14/2016
J-16-0024 Generic: Trichoderma reesei modified Microorganism not likely to present
an unreasonable risk (§5(a)(3)(C))
The microorganism is not likely to present an unreasonable risk based on low human
health hazard and low environmental hazard associated with the recipient microorganism and
introduced genetic material. View the determination document.
7/28/2016 11/14/2016
P-16-0519 Generic: Polyalkylether polyester Chemical substances not likely to present
an unreasonable risk (§5(a)(3)(C))
The chemical substance is not likely to present an unreasonable risk based on low
human health hazard and low environmental hazard. View the determination document.
8/12/2016 11/17/2016
P-16-0518 Generic: Polyalkylether polyester Chemical substances not likely to present
an unreasonable risk (§5(a)(3)(C))
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 8/12/2016 11/17/2016
P-16-0403 Generic: Heteropolycyclic carboxylic acid, polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol and 4-substitutedbenzene, substituted carbomonocycle- and alkyl-substituted carbomonocycle-blocked Chemical substances not likely to present
an unreasonable risk (§5(a)(3)(C))
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 6/22/2016 11/17/2016
P-16-0545 Generic: substituted siloxane polymer Chemical substances not likely to present
an unreasonable risk (§5(a)(3)(C))
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard.View the determination document. 9/2/2016 11/10/2016
P-16-0515 Generic: Diamine substituted arylimidazole Chemical substances not likely to present
an unreasonable risk (§5(a)(3)(C))
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 8/9/2016 11/10/2016
P-16-0492 Generic: Polyester-amide polymer of 'isophthalic acid' with diamino-alkane, cyclohexanedialcohol, alkanetriol, di-isocyanate and acrylic acid-ethylene copolymer Chemical substances not likely to present
an unreasonable risk (§5(a)(3)(C))
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 7/25/2016 11/10/2016
J-16-0023 Generic: Trichoderma reesei modified Microorganism not likely to present
an unreasonable risk (§5(a)(3)(C))
The microorganism is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material. View the determination document. 7/16/2016 10/19/2016
J-16-0022 Generic: Trichoderma reesei modified Microorganism not likely to present
an unreasonable risk (§5(a)(3)(C))
The microorganism is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material. View the determination document. 7/15/2016 10/19/2016
J-16-0021 Generic: Trichoderma reesei modified Microorganism not likely to present
an unreasonable risk (§5(a)(3)(C))
The microorganism is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material. View the determination document. 7/15/2016 10/19/2016
J-16-0020 Generic: Trichoderma reesei modified Microorganism not likely to present
an unreasonable risk (§5(a)(3)(C))
The microorganism is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material. View the determination document. 6/29/2016 10/4/2016
J-16-0019 Generic: Trichoderma reesei modified Microorganism not likely to present
an unreasonable risk (§5(a)(3)(C))
The microorganism is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material. View the determination document. 6/29/2016 10/4/2016
P-16-0459 Generic: Carbomonocyclic dicarboxylic acid, polymer with alkanedioic acid, substituted heteropolycycle, substituted carbomonocycle, alkyl alkenoate, alkanedioic acid, alkoxylated substituted dicarbomonocycle, alkoxylated substituted dicarbomonocycle, alkenoic acid, oxo alkyl initiated. Chemical substances not likely to present
an unreasonable risk (§5(a)(3)(C))
The chemical substances are not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. Although EPA estimated that the new chemical substances would be very persistent, this did not indicate a likelihood that the chemical substances would present an unreasonable risk, given that the chemical substances have low potential for bioaccumulation, low human health hazard, and low environmental hazard. View the determination document. 7/8/2016 10/4/2016
P-16-0343 and P-16-0344 Generic: Modified urethane polymer. Chemical substances not likely to present
an unreasonable risk (§5(a)(3)(C))
The chemical substances are not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. Although EPA estimated that the new chemical substances would be very persistent, this did not indicate a likelihood that the chemical substances would present an unreasonable risk, given that the chemical substances have low potential for bioaccumulation, low human health hazard, and low environmental hazard. View the determination document. 6/22/2016 9/16/2016
P-16-0391 Generic: Polyester polyol polymer with aliphatic isocyanate and phenol derivates Chemical substance not likely to present
an unreasonable risk (§5(a)(3)(C))
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. Although EPA estimated that the new chemical substance would be very persistent, this did not indicate a likelihood that the chemical substance would present an unreasonable risk, given that the chemical substance has low potential for bioaccumulation, low human health hazard, and low environmental hazard. View the determination document. 6/22/2016 9/14/2016
J-16-0010 Generic: Saccharomyces cerevisiae modified Microorganism not likely to present
an unreasonable risk (§5(a)(3)(C))
The microorganism is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material. S. cerevisiae is not pathogenic to humans or animals and has an extensive history of safe use in food processing. The introduced genetic modifications pose low concern for health and environmental hazard and do not include antibiotic resistance markers. View the determination document. 6/22/2016 9/14/2016
J-16-0011, J-16-0012, J-16-0013, J-16-0014, J-16-0015, and J-16-0016 Generic: Biofuel Producing Organism Microorganism not likely to present
an unreasonable risk (§5(a)(3)(C))
The microorganisms are not likely to present an unreasonable risk based on low human health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material. The recipient microorganism is not pathogenic to humans or animals and has an extensive history of safe use. The introduced genetic modifications pose low concern for health and environmental hazard and do not include antibiotic resistance markers. View the determination document. 6/22/2016 9/14/2016
J-16-0017 Generic: Saccharomyces cerevisiae modified Microorganism not likely to present
an unreasonable risk (§5(a)(3)(C))
The microorganism is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material. S. cerevisiae is not pathogenic to humans or animals and has an extensive history of safe use in food processing. The introduced genetic modifications pose low concern for health and environmental hazard and do not include antibiotic resistance markers. View the determination document. 6/22/2016 9/14/2016
J-16-0018 Generic: Saccharomyces cerevisiae modified Microorganism not likely to present
an unreasonable risk (§5(a)(3)(C))
The microorganism is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material. S. cerevisiae is not pathogenic to humans or animals and has an extensive history of safe use in food processing. The introduced genetic modifications pose low concern for health and environmental hazard and do not include antibiotic resistance markers. View the determination document. 6/22/2016 9/14/2016
P-16-0366 Generic: Blocked polyisocyanate Chemical substance not likely to present
an unreasonable risk (§5(a)(3)(C))
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. Although EPA estimated that the new chemical substance would be very persistent, this did not indicate a likelihood that the chemical substance would present an unreasonable risk, given that the chemical substance has low potential for bioaccumulation, low human health hazard, and low environmental hazard. View the determination document. 6/22/2016 9/12/2016
P-16-0373 Generic: Tris(alkyloxyphenyl)triazine compounds Chemical substance not likely to present
an unreasonable risk (§5(a)(3)(C))
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. Although EPA estimated that the new chemical substance would be very persistent, this did not indicate a likelihood that the chemical substance would present an unreasonable risk, given that the chemical substance has low potential for bioaccumulation, low human health hazard, and low environmental hazard. View the determination document. 6/22/2016 9/12/2016
P-16-0466 Generic: 2,5-Furandione, telomer with ethenylbenzene and (alkylethyl)benzene, amides with polyethylene-polypropylene glycol aminoalkyl Me ether, alkali salts Chemical substance not likely to present
an unreasonable risk (§5(a)(3)(C))
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental toxicity. Although EPA estimated that the new chemical substance would be very persistent, this did not indicate a likelihood that the chemical substance would present an unreasonable risk, given that the chemical substance has low potential for bioaccumulation, low human health hazard, and low environmental hazard. View the determination document. 7/11/2016 9/2/2016
J-16-0006 Generic: Trichoderma reesei modified Microorganism not likely to present
an unreasonable risk (§5(a)(3)(C))
The microorganism is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material. T. reesei is not pathogenic to humans or animals and has a long history of safe use for production of enzymes. The introduced genetic modifications pose low concern for health and environmental hazard, do not include antibiotic resistance markers, and do not provide a growth advantage over the parental strain. View the determination document. 6/22/2016 9/2/2016
P-16-0348 Generic: Polypentaerythritol, mixed esters with linear and branched monoacids Chemical substance not likely to present
an unreasonable risk (§5(a)(3)(C))
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. Although EPA estimated that the new chemical substance would be very persistent, this did not indicate a likelihood that the chemical substance would present an unreasonable risk, given that the chemical substance has low potential for bioaccumulation, low human health hazard, and low environmental hazard. View the determination document. 6/22/2016 9/2/2016
P-16-0392 Generic: Modified vegetable oil Not likely to present
an unreasonable risk (§5(a)(3)(C))
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental toxicity. Although EPA estimated that the new chemical substance would be very persistent, this did not indicate a likelihood that the chemical substance would present an unreasonable risk, given that the chemical substance has low potential for bioaccumulation, low human health hazard, and low environmental hazard. View the determination document. 6/22/2016 7/29/2016
P-16-0351 Generic: Glycerides, C14-18 and C16-C18 unsaturated, from fermentation Not likely to present
an unreasonable risk (§5(a)(3)(C))
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental toxicity. Although EPA estimated that the new chemical substance would be persistent, this did not indicate a likelihood that the chemical substance would present an unreasonable risk, given that the chemical substance has low potential for bioaccumulation, low human health hazard, and low environmental hazard. View the determination document. 6/22/2016 7/29/2016
P-16-0340 Generic: Glycerides, C8-18 and C18 unsaturated, from fermentation Not likely to present
an unreasonable risk (§5(a)(3)(C))
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental toxicity. Although EPA estimated that the new chemical substance would be persistent, this did not indicate a likelihood that the chemical substance would present an unreasonable risk, given that the chemical substance has low potential for bioaccumulation, low human health hazard, and low environmental hazard. View the determination document. 6/22/2016 7/29/2016
P-16-0302 Generic: Organic modified propyl silsesquioxane Not likely to present
an unreasonable risk (§5(a)(3)(C))
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental toxicity. Although EPA estimated that the new chemical substance would be very persistent, this did not indicate likelihood that the chemical substance would present an unreasonable risk, given that the chemical substance has low potential for bioaccumulation, low human health hazard, and low environmental hazard. View the determination document. 6/22/2016 7/20/2016
P-16-0301 Generic: Propyl silsesquioxanes, hydrogen-terminated Not likely to present
an unreasonable risk (§5(a)(3)(C))
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. 6/22/2016 7/20/2016
P-16-0292 Generic: Depolymerized waste plastics. Not likely to present
an unreasonable risk (§5(a)(3)(C))
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. Although EPA estimated that the new chemical substance would be very persistent, this did not indicate a likelihood that the chemical substance would present an unreasonable risk, given that the chemical substance has low potential for bioaccumulation, low human health hazard, and low environmental hazard. View the determination document. 6/22/2016 7/20/2016
P-16-0281 Generic: Fatty alcohols-dimers, trimers, polymers Not likely to present
an unreasonable risk (§5(a)(3)(C))
The chemical substance is not likely to present an unreasonable risk based on low health hazard concern and low environmental toxicity. View the determination document. 6/22/2016 7/15/2016