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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.

Certain of EPA’s determinations that a chemical is not likely to present unreasonable risk are based upon both the Agency’s risk assessment for the chemical substance under intended conditions of use described in the PMN and the 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). The links to the terms of these proposed SNURs are provided below along with the determination documents.

View the interim 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
SN-19-0005 Generic: Functionalized multi-walled carbon nanotubes 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. 05/20/2019 08/09/2019
P-19-0085 Generic: Aliphatic hydrocarbons, C16-18-branched and linear 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. 05/10/2019 08/07/2019
P-18-0190,
P-18-0191
Generic (P-18-0190): 2,5-Furandione, polymer with ethenylbenzene, 4-hydroxy-substituted butyl amide, polymers with epichlorohydrin and trimethylolpropane, sodium salts

Generic: (P-18-0191): 2,5-Furandione, polymer with ethenylbenzene, 4-hydroxy-substituted butyl [3-[2-[1-[[(substituted phenyl)amino]carbonyl]-2-oxopropyl]diazenyl]phenyl]methyl amide, polymers with epichlorohydrin and trimthylolpropane, sodium 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. View the determination document. 05/25/2018 08/06/2019
P-18-0035 Generic: Methacrylic acid heterocyclic alkyl ester 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. 10/30/2017 07/31/2019
P-18-0009 Generic: Phosphonic acid, dimethyl ester, polymer with alkyl diols 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. 10/04/2017 07/31/2019
P-17-0395 Generic: Alkyl tri dithiocarbmate tri 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. View the determination document. 09/26/2017 07/31/2019
P-17-0346 Specific: Phosphonium, triphenylpropyl-, bromide; CASRN: 6228-47-3 The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) “Not likely to present an unreasonable risk” section 5(a)(3)(C) determination.

“*In EPA’s original screening analysis for this PMN in 2017, EPA identified potential risks to the environment, workers, and the general population, which resulted in the interim finding. Based on amendments provided by the submitter that include measures to reduce worker inhalation exposure to the new chemical substance and clarifying releases to water, EPA revised its assessment for the intended conditions of use. EPA’s final determination that the new chemical substance is not likely to present unreasonable risk is based on EPA’s revised risk assessment for the chemical substance under the intended conditions of use, where EPA expects that employers will require and workers will use appropriate personal protective equipment in a manner adequate to protect them, 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 the 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.
07/10/2017 07/31/2019
P-17-0312,
P-17- 0313,
P-17-0314,
P-17-0315,
P-17-0316,
P-17-0317
Generic (P-17-0312): Organic acid, compds. with bisphenol A-epichlorohydrin-polypropylene glycol diglycidyl ether polymer-disubstituted amine-disubstituted polypropylene glycol reaction products,

Generic (P-17-0313): Phenol, 4,4'-(1-methylethylidene)bis-, polymer with 2-(chloromethyl)oxirane and alpha-(2-oxiranylmethyl)-omega-(2-oxiranylmethoxy)poly[oxy(methyl-1,2-ethanediyl)], reaction products with disubstituted amine and disubstituted polypropylene glycol, organic acid salts,

Generic (P-17-0314): Organic acid, 2-substituted-, compds. with bisphenol A-epichlorohydrin-polypropylene glycol diglycidyl ether polymer-disubstituted aminedisubstituted polypropylene glycol reaction products,

Generic (P-17-0315): Phenol, 4,4'-(1-methylethylidene)bis-, polymer with alpha-(2-substituted-methylethyl)-omega-(2-substituted-methylethoxy)poly[oxy(methyl-1,2-ethanediyl)], 2-(chloromethyl)oxirane and alpha-(2-oxiranylmethyl)-omega-(2-oxiranylmethoxy)poly[oxy(methyl-1,2-ethanediyl)], alkylphenyl ethers, reaction products with disubstituted amine, organic acid salts,

Generic (P-17-0316): Organic acid, compds. with bisphenol A-epichlorohydrin-disubstituted polypropylene glycol-polypropylene glycol diglycidyl ether polymer alkylphenyl ethers-disubstituted amine reaction products,

Generic (P-17-0317): Organic acid, compds. with bisphenol A-epichlorohydrin-polypropylene glycol diglycidyl ether polymer-disubstituted polypropylene glycol reaction products
The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) “Not likely to present an unreasonable risk” section 5(a)(3)(C) determination.

“*In EPA’s original screening analysis for this PMN in 2017, EPA identified potential for risk to workers and the environment under foreseeable conditions of use, which resulted in the interim finding. EPA subsequently determined that there are no reasonably foreseen conditions of use for the new chemical substances and the PMN submitter provided additional information that changed the environmental hazard profile of the new chemical substance. EPA’s final determination that the new chemical substances are not likely to present unreasonable risk is based on EPA’s revised hazard and risk assessment for the chemical substances under the intended conditions of use, where EPA expects that employers will require and workers will use appropriate personal protective equipment in a manner adequate to protect them, and no unreasonable risk to the environment was identified.” View the determination document and the terms of the SNUR.
05/24/2019 07/31/2019
P-19-0096 Generic: Benzofuranone, bis(branched alkyl)-[dialkyl[tetrakis(branched alkyl)-alkyl-dibenzo-substitutedphosphite-yl] phenyl]- 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. 05/29/2019 07/31/2019
P-19-0062 Generic: Hydrochlorofluoroolefin 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. 02/27/2019 07/31/2019
P-19-0029 Specific: Phosphonium, tributylethyl-, diethyl phosphate (1:1); CASRN 20445-94-7 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. 11/29/2018 07/31/2019
P-18-0394 Generic: substituted benzylic ether polyethylene glycol alkyl ether derivative 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. 09/28/2018 07/29/2019
P-18-0300 Generic: Heteromonocycle, alkenoic 1:1 salt, polymer with alpha-(2-methyl-1-oxo-2-propen-1-y)l-omegamethoxypoly(oxy-1,2-ethanediyl) and methylalkenoic acid 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. 09/10/2018 07/29/2019
P-18-0286 Specific: Propane, 1,1,1,3,3,3-hexafluoro-2-methoxy- CASRN: 13171-18-1 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. View the determination document. 8/27/2018 07/31/2019
P-18-0257 Specific: Phosphoric acid, potassium salt (2:3); CASRN: 66923-00-0 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. View the determination document. 07/23/2018 07/26/2019
P-18-0103 Generic: Alkylnitrile imidazole 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. 02/05/2018 07/31/2019
P-16-0442
P-16-0443
P-16-0444
P-16-0445
Generic:
P-16-0442 - Carboxylic acids, unsaturated, polymers with disubstituted amine, alkanediol, substituted alkylpropanoic acid, alkanedioic acid and substituted isocyanatocycloalkane, compds with alkylamine

P-16-0443 – Carboxylic acids, unsaturated, hydrogenated polymers with disubstituted amine, alkanediol, substituted alkylpropanoic acid, alkanedioic acid and substituted isocyanatocycloalkane, compds with alkylamine

P-16-0444 - Carboxylic acids, unsaturated, polymers with substituted alkanediamine, alkanediol, substituted alkylpropanoic acid, alkanedioic acid and substituted isocyanatocycloalkane, compds with alkylamineAmine salted polyurethane

P-16-0445 - Carboxylic acids, unsaturated, hydrogenated polymers with substituted alkanediamine, alkanediol, substituted alkylpropanoic acid, alkanedioic acid and substituted isocyanatocycloalkane, compds with alkylamine
The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) “Not likely to present an unreasonable risk” section 5(a)(3)(C) determination.

“*In EPA’s original screening analysis for this PMN in 2016, EPA identified a potential for risk to workers, which resulted in the interim finding. The PMN submitter provided additional information that changed the human health hazard profile and potential risk to workers. EPA’s final determination that the new chemical substance is not likely to present unreasonable risk is based on EPA’s revised hazard and risk assessment for the chemical substance under the intended conditions of use, where EPA expects that employers will require and workers will use appropriate personal protective equipment in a manner adequate to protect them, and no unreasonable risk to the environment was identified.” View the determination document and the terms of the SNUR.
06/23/2016 07/31/2019
P-16-0092 Generic: Polymeric polyamine The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) “Not likely to present an unreasonable risk” section 5(a)(3)(C) determination.

“*In EPA’s original screening analysis for this PMN in 2015, EPA determined that certain exposure criteria were met and identified concerns for ecotoxicity, which resulted in an interim decision to require testing by order. The submitter provided the proposed test data during the review period, removing the basis for the order. 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 for the intended conditions of use and EPA’s issuance of a proposed SNUR to address certain reasonable foreseen uses.” View the determination document and the terms of the SNUR.
06/22/2016 07/31/2019
P-18-0401 Specific: Glycerides, C16-18 and CI8-unsatd. mono- and di-, citrates; CASRN: 91052-16-3 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. 09/29/2018 07/24/2019
P-18-0177 Specific: Waxes and Waxy substances, rice bran, oxidized; CASRN: 1883583-80-9 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. 05/15/2018 07/26/2019
P-17-0362 Generic: Aliphatic phosphoric amide ester The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) “Not likely to present an unreasonable risk” section 5(a)(3)(C) determination.

“In EPA’s original screening analysis for this PMN in 2017, EPA identified environmental risk under reasonably foreseen conditions of use and potential for risk to workers, which resulted in the interim finding. EPA subsequently determined that although there are reasonably foreseen conditions of use for the new chemical substance, the chemical substance has low human health hazard and low environmental hazard based on data submitted on the new chemical substance that changed the human health hazard and environmental hazard profiles and potential risk to workers and the environment. EPA’s final determination that the new chemical substance is not likely to present unreasonable risk is based on EPA’s revised hazard and risk assessment for the chemical substance under the conditions of use, where EPA believes that this chemical substance is not likely to present an unreasonable risk even if potential exposures were high.” View the determination document.
07/26/2017 07/24/2019
P-19-0081 Generic: 2-Propenoic acid, alkyl ester, reaction products with mixed substituted alkyl esters of phosphorodithioic acid and propylene oxide 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. 05/01/2019 07/23/2019
P-18-0185 Generic: Fatty acid, polymer with alkanedioic acid dialkyl ester, hydroxyl alkyl substituted alkanediol, substituted carbomonocycle and alkylol substituted alkane; 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).
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. 05/21/2018 07/14/2019
P-18-0285 Specific: Butanedioic acid, 2-methylene-, polymer with 2-methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonic acid, sodium zinc salt; CASRN: 2220235-78-7 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. 08/27/2018 07/23/2019
P-18-0223 Generic: Alkane, bis(alkoxymethyl)-dimethyl- 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. 06/26/2018 07/17/2019
P-19-0068 Generic: 1,4-benzenedicarboxylic acid, polymer with diol, 5-amino-1,3,3-trimethylcyclohexanemethanamine, 1,2-ethanediol and urea 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. 04/16/2019 07/12/2019
P-16-0417 Generic: Isocyanate terminated polyurethane resin The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) “Not likely to present an unreasonable risk” section 5(a)(3)(C) determination.

*In EPA’s original screening analysis for this PMN in 2016, EPA identified concern for risks to human health and the environment under the reasonably foreseen conditions of use, which resulted in the interim finding. EPA’s final determination that the new 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, where EPA expects that employers will require and workers will use appropriate personal protective equipment in a manner adequate to protect them, 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 the 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.
06/22/2016 06/30/2019
J-19-0021,
J-19-0022
Generic: Saccharomyces cerevisiae strain CBI The microorganism 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.  04/04/2019 06/25/2019
P-18-0241,
P-18-0244,
P-18-0245
Generic: 2-Propenoic acid, 2-methyl-, methyl ester, polymer with ethenylbenzene, ethyl 2-propenoate, 2-oxiranylmethyl 2-methyl-2-propenoate and 1,2-propanediol mono(2-methyl-2-propenoate), reaction products with diethanolamine, polymers with substituted-alkyl acrylate, formates (salts), (P-18-0241)

2-Propenoic acid, 2-methyl, methyl ester, polymer with ethenylbenzene, ethyl 2-propenoate, 2-oxiranylmethyl 2-methyl-2-propenoate and 1,2-propanediol mono(2-methyl-2-propenoate), reaction products with diethanolamine, polymers with substituted-alkyl methacrylate, formates (salts), (P-18-0244)

2-Propenoic acid, 2-methyl-, methyl ester, polymer with ethenylbenzene, ethyl 2-propenoate, 2-oxiranylmethyl 2-methyl-2-propenoate, and 1,2-propanediol mono(2-methyl-2-propenoate), reaction products with diethanolamine, polymers with alkylene glycol monoacrylate, formates (salts), (P-18-0245).
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. 07/16/2018 06/30/2019
P-19-0071 Generic: Trimethylolpropane, alkenoic acid, triester. 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. 03/22/2019 06/19/2019
P-19-0031 Generic: Phenol, 4,4'-(1-methylethylidene)bis-, polymer with formaldehyde, 2-(chloromethyl)oxirane, alpha-hydro-omega-hydroxypoly(oxy-1,2-ethanediyl), and polyamines 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. 12/28/2018 06/21/2019
P-18-0402 Generic: Phenol, alkanepolyolbis(heteroalkylene)bis-, polyalkylene derivs. 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. 03/11/2019 06/30/2019
P-18-0397 Generic: Substituted alkanedioic acid, polymer with substituted alkanoic acid 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. 09/29/2018 06/21/2019
P-19-0072 Specific: 1-Butanol, reaction products with 2-[(2-propen-1-yloxy)methyl]oxirane; 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. View the determination document. 03/26/2019 06/21/2019
P-18-0170 Specific: 1-Propanaminium, N,N'-(oxydi-2,1-ethanediyl)bis[3-chloro-2-hydroxy-N,N-dimethyl-, chloride (1:2); CASRN: 96320-92-2 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. 05/10/2018 06/27/2019
P-18-0011 Specific: 1H-Imidazole, 1,2,4,5-tetramethyl-; CASRN: 1739‐83‐9 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. 10/05/2017 06/30/2019
P-18-0239,
P-18-0240
Generic (P-18-0239): N-alkyl propanamide
Generic (P-18-0240): N-alkyl acetamide
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 for the intended conditions of use and EPA’s issuance of a proposed SNUR to address certain reasonably foreseen uses. View the determination document and the terms of the SNUR. 07/16/2018 06/30/2019
J-19-0019,
J-19-0020
Generic: Genetically modified microorganism
for the production of an enzyme substance
The microorganism 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.  03/20/2019 06/13/2019
P-19-0065 Specific: 2lambda5, 4lambda5, 6lambda5
- 1,3,5,2,4,6 Triazatriphosphorine, 2,2,4,4,6,6 – hexaphenoxy-; CASRN: 1184-10-7
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. 03/22/2019 06/14/2019
P-19-0012 Generic: Benzenedicarboxylic acid, reaction
products with isobenzofurandione and diethylene glycol
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. 12/20/2018 06/14/2019
P-18-0404 Generic: alkylmultiheteroatom,2-functionalisedalkyl-2-hydroxyalkyl-,
polymer with alkylheteroatom-multialkylfunctionalised carbomonocyleheteroatom
and multiglycidylether difunctionalised polyalkylene glycol
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. 10/19/2018 06/14/2019
P-18-0260 Generic: Fatty acids, polymers with alkanoic acid and substituted carbomonocycle,
peroxide-initiated, polymers with alkanoic
acid esters and substituted carbomonocycle,
ammonium salts; 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. 07/26/2018 06/14/2019
P-18-0125 Generic: Oxoalkylcarboxylic acid, 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 for the intended conditions of use and EPA’s issuance of a proposed SNUR to address certain reasonably foreseen uses. View the determination document and the terms of the SNUR. 03/07/2018 06/14/2019
P-18-0282 Generic: Fatty acid ester, polyether,
diisocyanate polymer
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. 08/24/2018 05/30/2019
P-17-0108 Specific: Carbonodithioic acid, O-[2-
[(dithiocarboxy)amino]-2-methylpropyl]
ester, sodium salt (1:2); CASRN: 1947332-67-3
The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) 'Not likely to present an unreasonable risk' section 5(a)(3)(C) determination*

*In EPA’s original screening analysis for this PMN in 2016, EPA identified potential risk to workers, substantial releases and significant exposure, and risk to the environment, which resulted in the interim finding. The PMN submitter clarified that the new chemical substance would not be released to surface water and provided an updated Safety Data Sheet. EPA’s final determination that the new 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, where worker exposure is expected be controlled through the use of appropriate PPE and release to water is not expected. View the determination document.
11/09/2016 05/01/2019
P-16-0429 Generic: Endcapped polysiloxane The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) 'Not likely to present an unreasonable risk' section 5(a)(3)(C) determination*

*In EPA’s original screening analysis for this PMN in 2016, EPA identified potential for risk to workers, which resulted in the interim finding. EPA's final determination that the new 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 EPA expects that employers will require and workers will use appropriate personal protective equipment in a manner adequate to protect them. View the determination document.
06/22/2016 05/17/2019
P-16-0225 Specific: Isomer mixture of Cyclohexanol,
4-ethylidene-2-propoxy- (CASRN: 1631145-48-6) (35-45%) and Cyclohexanol, 5-
ethylidene-2-propoxy-
(CASRN: 1631145-49-7) (45-55%)
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. 06/22/2016 05/07/2019
P-16-0470 Specific: 2,7-Nonadien-4-ol, 4,8-dimethyl-;
CASRN: 103983-77-3
The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) 'Not likely to present an unreasonable risk' section 5(a)(3)(C) determination*

*In EPA’s original screening analysis for this PMN in 2016, EPA identified environmental risk under reasonably foreseen conditions of use and potential for risk to workers, which resulted in the interim finding. EPA subsequently determined that there are no reasonably foreseen conditions of use for the new chemical substance and the PMN submitter provided additional information that changed the human health hazard profile and potential risk to workers. EPA’s final determination that the new chemical substance is not likely to present unreasonable risk is based on EPA’s revised hazard and risk assessment for the chemical substance under the intended conditions of use, where EPA expects that employers will require and workers will use appropriate personal protective equipment in a manner adequate to protect them, and no unreasonable risk to the environment was identified. View the determination document.
07/14/2016 05/17/2019
P-19-0034 Generic: Metal, bis(2,4-pentanedionato-
kO2,kO4)-, (T-4)-,
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 for the intended conditions of use and EPA’s issuance of a proposed SNUR to address certain reasonably foreseen uses. View the determination document and the terms of the SNUR. 12/06/2018 05/31/2019
P-19-0028 Generic: Alkyl salicylate, metal 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. View the determination document. 02/22/2019 05/21/2019
P-19-0020 Generic: Alkylphenol, reaction products
with carbon dioxide, distn. residues from
manuf. of alkylphenol derivs. and calcium
alkylphenol derivs.
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. 01/31/2019 04/30/2019
P-19-0004 Generic: Aromatic dianhydride, polymer
with aromatic diamine and heteroatom
bridged aromatic diamine, reaction products
with aromatic anhydride
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 for the intended conditions of use and EPA’s issuance of a proposed SNUR to address certain reasonably foreseen uses. View the determination document and the terms of the SNUR. 12/21/2018 05/31/2019
P-18-0322 Generic: Heteromonocycle, 4,6-dimethyl-2-(1
-phenylethyl)-
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 for the intended conditions of use and EPA’s issuance of a proposed SNUR to address certain reasonably foreseen uses. View the determination document and the terms of the SNUR. 09/21/2018 05/31/2019
P-18-0321 Generic: Poly(oxy-ethanediyl), (methyl ethanediyl) bis[hydroxy-, 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. 09/21/2018 05/31/2019
P-18-0270 Generic: Ethanol, 2-butoxy-, 1,1'-ester 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 for the intended conditions of use and EPA’s issuance of a proposed SNUR to address certain reasonably foreseen uses. View the determination document and the terms of the SNUR. 08/06/2018 05/31/2019
P-18-0247,
P-18-0248,
P-18-0249,
P-18-0250,
P-18-0251,
P-18-0252,
Generic (P-18-0247): Isocyanic acid,
polymethylenepolyphenylene ester, polymer
with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, polyetherpolyol, .alpha.,alpha.'
-[(1- methylethylidene)di-4,1-phenylene]bis[.omega.
-hydroxypoly(oxy-1,2-ethanediyl)] and 1,2-
propanediol, iso-Bu alc.- and 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and Et alc.- and methanol-and 1-methoxy-2-propanol-blocked,

Generic (P-18-248): Isocyanic acid,
polymethylenepolyphenylene ester, polymer with polyetherpolyol, 2-butoxyethanol- and 2-(2-butoxyethoxy) ethanol- and methanol blocked,

Generic (P-18-249): Isocyanic acid,
polymethylenepolyphenylene ester, polymer with polyetherpolyol, 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and methanol and 1-methoxy-2-propanol-blocked

Generic (P-18-0250): is Isocyanic acid,
polymethylenepolyphenylene ester, polymer
with polyetherpolyol, 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and 1(or2)-(2-methoxymethylethoxy)propanol-blocked

Specific (P-18-0251): Isocyanic acid,
polymethylenepolyphenylene ester, 2-butoxyethanol-and 2-(2-butoxyethoxy)ethanol- and methanol-
and 1(or2)-(2-methoxymethylethoxy)propanol-blocked

Specific (P-18-0252): Isocyanic acid,
polymethylenepolyphenylene ester, 2-butoxyethanol-and 2-(2-butoxyethoxy)ethanol- and methanol-
and 1-methoxy-2-propanol-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. 07/18/2018 04/29/2019
P-18-0234 Generic: Alkenoic acid, reaction products with bis substituted alkane and ether polyol 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 for the intended conditions of use and EPA’s issuance of a proposed SNUR to address certain reasonably foreseen uses. View the determination document and the terms of the SNUR. 07/06/2018 05/31/2019
P-18-0228 Generic: Branched alkenyl acid, alkyl ester,homopolymer 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 for the intended conditions of use and EPA’s issuance of a proposed SNUR to address certain reasonably foreseen uses. View the determination document and the terms of the SNUR. 08/30/2018 05/31/2019
P-18-0091 Generic: Vegetable oil, polymers with diethylene glycol- and polyol- and polyethylene glycol-depolymd poly(ethylene terephthalate) waste plastics and
arylcarboxylic acid anhydride
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. 01/17/2018 05/31/2019
P-17-0253 Generic: Oxirane, 2-methyl-, polymer with oxirane, methyl 2-(substituted carbomonocycle isoquinolin-
2(3H)-yl) propyl ether
The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) “Not likely to present an unreasonable risk” section 5(a)(3)(C) determination*

*In EPA’s original screening analysis for this PMN in 2017, EPA identified potential for risk to workers for lung effects, which resulted in the interim finding. The PMN submitter provided acute and 5-day inhalation toxicity studies and also provided an updated Safety Data Sheet. EPA's final determination that the new 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, based on the submitted data, a lower level of respiratory protection is expected to mitigate lung effects than the level estimated in the original screening analysis, and employers will require and workers will use appropriate personal protective equipment in a manner adequate to protect them. View the determination document.
03/14/2017 04/24/2019
P-16-0425 Generic: Amino-silane The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) “Not likely to present an unreasonable risk” section 5(a)(3)(C) determination*

*In EPA’s original screening analysis for this PMN in 2016, EPA identified potential risks to workers, which resulted in the interim finding. Based on additional information provided by the submitter, EPA revised its assessment for the intended conditions of use. EPA’s final determination that the new chemical substance is not likely to present unreasonable risk is based on EPA’s revised risk assessment for the chemical substance under the intended conditions of use, where EPA expects that employers will require and workers will use appropriate personal protective equipment in a manner adequate to protect them, 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 the 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.
06/22/2016 05/31/2019
P-16-0314 Specific: Ethanone, 1-(5-propyl-1,3-benzodioxol-2-yl)- 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. 06/22/2016 05/28/2019
J-19-0018 Generic: Protein-producing modified microorganism, with chromosomally-borne modifications The microorganism 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.  03/05/19 05/29/19
P-18-0339 Generic: Alkyl heteromonocycle with heteroatom substituted alkyl cycloalkane and 2-hydroxyethyl heteromonocycle methacrylate-blocked homopolymer 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. 09/26/2018 05/20/2019
P-18-0220 Generic: Heteromonocycle [(alkylalkylidene)bis (substituted carbomoncycle)]bis-, polymer with
alkyl isocyanate, alkenoate (ester)
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. 06/21/2018 05/21/2019
P-18-0120 Specific: 1H-Pyrrole-2,5-dione, 1,1'-C36-
alkylenebis-; CASRN: 1911605-95-2
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. 02/28/2018 05/20/2019
P-19-0057 Generic: Alkanamine, [(Alkoxy)alkoxy]alkyl] alkyl 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. 02/21/2019 05/14/2019
P-19-0060,
0061
Generic: P-19-0056: Aliphatic hydrocarbons, C8-C20-branched and linear
P-19-0060: Aliphatic hydrocarbons, C8-C18-
branched and linear
P-19-0061: Aliphatic hydrocarbons, C16-20-
branched and linear
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. 02/23/2019 05/15/2019
  Generic: P-19-0056: Aliphatic hydrocarbons, C8-C20-branched and linear
P-19-0060: Aliphatic hydrocarbons, C8-C18-
branched and linear
P-19-0061: Aliphatic hydrocarbons, C16-20-
branched and linear
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. 02/15/2019 05/15/2019
P-19-0054 Generic: Polyamines, reaction products with
succinic anhydride polyalkenyl derivs, metal
salts, Polyamines, reaction products with
succinic anhydride polyalkenyl derivs, metal
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. View the determination document. 02/11/2019 05/10/2019
P-17-0245 Generic: Unsaturated polyfluoro ester The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) “Not likely to present an unreasonable risk” section 5(a)(3)(C) determination

*In EPA’s original screening analysis for this PMN in 2017, EPA identified potential risk to workers and the general population and that the substance may degrade to a persistent, bioaccumulative, and toxic chemical, which resulted in the interim finding. The submitter provided additional information indicating there will be no releases to water and that disposal of wastes will be by RCRA-certified hazardous waste incineration. EPA’s final determination that the new 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 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 the 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.
02/28/2017 04/15/2019
P-17-0152 Generic: Poly-(2-methyl-1-oxo-2-propen-1-yl)
ester with Ethanaminium, N,N,N-trialkyl,
chloride and methoxypoly(oxy-1,2-ethanediyl)
The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) “Not likely to present an unreasonable risk” section 5(a)(3)(C) determination

*In EPA’s original screening analysis for this PMN in 2017, EPA identified potential for lung effects from cationic binding and risk to the environment, which resulted in the interim finding. Based on amendments to the PMN, EPA revised its assessment for the intended conditions of use. EPA’s final determination that the new chemical 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 amended PMN where estimated releases to water are lower than in the initial assessment and inhalation exposures are 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 the 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.
11/23/2016 04/15/2019
P-16-0422 Specific: 1,2-Cyclohexanedicarboxylic acid, 1-
(phenylmethyl) ester, ester with 2,2,4-trimethyl-1,3-pentanediol mono(2-methylpropanoate)
(CASRN: 1661012-65-2)
The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) “Not likely to present an unreasonable risk” section 5(a)(3)(C) determination

*In EPA’s original screening analysis for this PMN in 2016, EPA identified potential human health risk to workers and chronic risk to the environment, which resulted in the interim finding. The submitter provided new information including a proposed new analogue to be used in the human health and environmental assessment, new process information including waste water treatment efficiency, and new information on releases. EPA’s final determination that the new chemical 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 amended PMN, where worker exposure is expected to be controlled through the use of appropriate PPE, where submitter controls will keep water releases below the concentration of concern, 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 the 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.
06/22/2016 04/15/2019
P-14-0482 Generic: Organic salt The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) “Not likely to present an unreasonable risk” section 5(a)(3)(C) determination

*In EPA’s original screening analysis for this PMN in 2014, EPA identified potential human health risk to workers, substantial releases, and risk to the environment, which resulted in the interim finding. The submitter amended the PMN, revising the production volume and intended conditions of use. EPA’s final determination that the new chemical 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 amended PMN where worker exposure is expected to be controlled through the use of appropriate PPE, expected releases to the environment are lower than originally estimated, 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 the 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.
06/22/2016 04/15/2019
P-19-0046 Specific: 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters; CASRN 90218-76-1 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. View the determination document.  01/31/2018 04/26/2019
P-18-0266 Specific: Alkanes, C20-45 branched and linear; CASRN: 2133415-24-2 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.  07/30/2018 04/25/2019
P-18-0188 Generic: Alkyl substituted alkenoic acid, alkyl
ester, polymer with alkanediol alkyl-alkenoate, reaction products with alkenoic acid, isocyanato -(isocyanatoalkyl)-alkyl substituted carbomonocycle and substituted alkanediol
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.  05/23/2018 05/02/2019
P-18-0406 Generic: Formaldehyde, polymer with alkyl
aryl ketones
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.  09/30/2018 05/02/2019
P-18-0305 Generic: Alkenoic acid, alkyl-,alkyl ester, polymer with alkyl alkenoate, substituted heteromonocycycle, substituted carbomonocycle, substituted alkanediol
and alkenoic acid, alkali metal 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. View the determination document.  09/12/2018 02/23/2019
P-18-0186 Generic: Polyolefin ester 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.  5/22/2018 04/24/2019
J-19-0012,
J-19-0013,
J-19-0014,
J-19-0015
Generic: Biofuel producing Saccharomyces cerevisiae modified, genetically stable The microorganism 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.  01/31/19 04/26/19
J-19-0017 Generic: Genetically modified microorganism for the production of a chemical substance The microorganism 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.  02/01/19 04/18/19
J-19-0011 Generic: Genetically modified microorganism for the production of a chemical substance The microorganism 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.  01/31/19 04/18/19
P-19-0045 Generic: Non-metal tetrakis (hydroxyalkyl)-, halide, polymer with amide oxidized 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.  12/21/2018 04/18/2019
P-19-0032 Generic: Carbonic dichloride, polymer with 4,4'-(1-methylethylidene)bis[phenol] ester, polymer with tetrol and polyether tetrol 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.  12/19/2018 04/17/2019
P-19-0030 Generic: Triethanolamine modified
Phosphinicocarboxylates, sodium 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. View the determination document.  12/18/2018 04/24/2019
P-18-0375 Specific: Fats and Glyceridic oils, vegetable, sulfonated,sodium salts (CASRN: 97489-04-8) 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.  10/10/2018 04/18/2019
P-18-0312 Generic: Formaldehyde, polymer with 2-
phenoxyalkanol and .alpha.-phenyl-.omega.
hydroxypoly(oxy-1,2-alkylnediyl), dihydrogen
phosphate 2-phenoxyalkyl hydrogen phosphate, alkaline 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. View the determination document.  09/20/2018 04/18/2019
P-18-0122 Generic: Alkylamide, polymer with alkylamine, formaldehyde, and polycyanamide, alkyl acid 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 for the intended conditions of use and EPA’s issuance of a proposed SNUR to address certain reasonably foreseen uses. View the determination document. and the terms of the SNUR. 03/01/2018 04/15/2019
P-19-0040 Generic: Alkyl bis(dialkylamino alkyl) amide, 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.  12/20/2018 04/18/2019
P-19-0010 Generic: Hydrogenated fatty acid dimers,
polymers with 1,1'-methylenebis[4-
isocyanatobenzene], polypropylene glycol,
polypropylene glycol ether with
trimethylolpropane (3:1), and 1,3-propanediol,
propylene glycol monomethacrylate-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 for the intended conditions of use and EPA’s issuance of a proposed SNUR to address certain reasonably foreseen uses. View the determination document. and the terms of the SNUR. 10/29/2018 04/15/2019
P-18-0222 Generic: Silane, alkenylalkoxy-, polymer with alkene
and alkene
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 for the intended conditions of use and EPA’s issuance of a proposed SNUR to address certain reasonably foreseen uses. View the determination document. and the terms of the SNUR. 06/22/2018 04/15/2019
P-18-0162 Generic: Cashew nutshell liquid, polymer with
diisocyanatoalkane, substituted-polyoxyalkyldiol
and polyether polyol
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 for the intended conditions of use and EPA’s issuance of a proposed SNUR to address certain reasonably foreseen uses. View the determination document. and the terms of the SNUR. 05/08/2018 04/15/2019
P-17-0239 Generic: Substituted carboxylic acid, polymer with
2,4-diisocyanato-1-methylbenzene, hexanedioic acid,
alpha-hydro-omega-hydroxypoly[oxy(methyl-1,2-
ethanediyl)], 1,1'-methylenebis[4-
isocyanatobenzene], 2,2'-oxybis[ethanol], 1,1'-oxybis
[2-propanol] and 1,2-propanediol.
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 for the intended conditions of use and EPA’s issuance of a proposed SNUR to address certain reasonably foreseen uses. View the determination document. and the terms of the SNUR. 06/05/2017 04/15/2019
P-18-0073 Specific: Sulfuric acid, ammonium salt (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 for the intended conditions of use and EPA’s issuance of a proposed SNUR to address certain reasonably foreseen uses. View the determination document. and the terms of the SNUR. 12/21/2017 04/15/2019
P-18-0048 Specific: Acetic acid, 2-(2-butoxyethoxy) -;
(CASRN: 82941-26-2)
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 for the intended conditions of use and EPA’s issuance of a proposed SNUR to address certain reasonably foreseen uses. View the determination document. and the terms of the SNUR. 11/13/2017 04/15/2019
P-17-0284 Specific: 2-Heptanone, 4-hydroxy-, CASRN: 25290-14-6 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.  04/13/17 04/10/19
P-17-0285 Specific: 4-Hepten-2-one, CASRN: 24332-22-7 The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) 'Not likely to present an unreasonable risk' section 5(a)(3)(C) determination*

*In EPA’s original screening analysis for this PMN in 2017, EPA identified potential for risk to workers from inhalation and dermal exposure and risk to the general population from exposure from drinking water, which resulted in the interim finding. The PMN submitter provided additional information on potential releases to water and also provided an updated Safety Data Sheet. EPA's final determination that the new 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 expected releases to water are lower than those estimated in the original screening analysis, and workers will use appropriate personal protective equipment in a manner adequate to protect them. View the determination document. 
04/13/2017 04/10/2019
P-19-0035 Specific: Acetamide, 2-(4-methylphenoxy)-N-1H-pyrazol-3-yl-N-(2-thienylmethyl)-;CASRN: 1374760-95-8 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.  12/11/18 03/28/19
P-19-0037 Generic: D-Glucaric acid, mixed alkali metal 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. View the determination document.  12/11/18 04/12/19
P-16-0602 Generic: Carbonic acid, dialkyl ester, polymers
with 5-amino-1,3,3-
trimethylcycloalkanemethanamine, 2-ethyl-1-
alcohol-blocked 1,6-diisocyanatoalkane
homopolymer and 1,6-alkanediol and
trimethylolakane
The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) 'Not likely to present an unreasonable risk' section 5(a)(3)(C) determination*

*In EPA’s original screening analysis for this PMN in 2016, EPA identified potential for risk for lung effects, which resulted in the interim finding. The PMN submitter provided additional information on the intended use, which indicated inhalation exposure to workers is not expected. EPA's final determination that the new 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 inhalation exposure is not expected.  View the determination document. 
09/30/16 04/10/19
P-16-0446 Generic: Fatty acids, reaction products with alkylamine,
polymers with substituted carbomonocycle, substituted
alkylamines, heteromonocycle and substituted alkanoate,
lactates (salts)
The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) 'Not likely to present an unreasonable risk' section 5(a)(3)(C) determination*

*In EPA’s original screening analysis for this PMN in 2016, EPA identified potential for risk for lung effects from cationic binding and potential for high releases and risk to the environment, which resulted in the interim finding. The PMN submitter provided an acute inhalation toxicity study and clarified release and exposure parameters. EPA's final determination that the new 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 expected releases to water are lower than those estimated in the original screening analysis, and lung effects are no longer expected based on the submitted data as well as particle size and the proportion of cationic amine moieties present in the polymer.  View the determination document. 
06/24/16 04/16/19
P-19-0003 Generic: Polyaromatic ether symmetrical dicarboxylic
anhydride
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.  12/20/18 04/19/19
P-18-0174 Generic: Enzyme 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.  05/09/18 04/16/19
P-18-0229 Generic: Modified branched alkenyl acid, alkyl ester,
homopolymer,
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.  08/30/18 03/28/19
P-18-0179,
P-18-0180,
P-18-0181
Generic (P-18-0179): Phenol, polymer with
formaldehyde and phenolic resin, sodium salt

Generic (P-18-0180): Phenol, polymer with
formaldehyde and phenolic resin, potassium salt

Generic (P-18-0181): Phenol, polymer with
formaldehyde and phenolic resin, potassium
sodium 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.  05/16/18 03/28/19
P-19-0027 Generic: Substituted Carbomoncycle, polymer
with haloalkyl substituted heteromonocycle,
dialkyl-alkanediamine and hydro-hydroxypoly
[oxy(alkylalkanediyl)], reaction products with
metal oxide and dialkanolamine, acetates (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. View the determination document.  11/28/18 04/03/19
P-18-0085 Generic: Fatty acids reaction products with
ethyleneamines and dialkyl ester
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.  01/08/18 03/15/19
P-18-0101 Generic: Pentaerythritol, mixed esters with
linear and branched fatty 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. View the determination document.  01/26/18 03/29/19
P-17-0191 Generic: Alkyldiamine, aminoalkyl
dimethylaminoalkyl dimethyl-, reaction products
with propylene oxide
The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) 'Not likely to present an unreasonable risk' section 5(a)(3)(C) determination*

*In EPA’s original screening analysis for this PMN in 2017, EPA identified neurotoxicity and corrosion as hazards and the potential for risk to workers from dermal exposure and risk to the general population from exposure from drinking water and fish ingestion, which resulted in the interim finding. The PMN submitter clarified that the new chemical substance would not be released to water, and wastes would be incinerated. EPA's final determination that the new 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 there will be no releases to water, and workers will use appropriate personal protective equipment in a manner adequate to protect them. View the determination document.
01/25/17 03/28/19
P-17-0220 Generic: 2-Oxepanone, reaction products with
alkylenediamine-alkyleneimine polymer, 2-[[(2-alkyl)oxy]alkyl]oxirane and tetrahydro-2H-
pyran-2-one
The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) 'Not likely to present an unreasonable risk' section 5(a)(3)(C) determination*

*In EPA’s original screening analysis for this PMN in 2017, EPA identified potential for risk for lung effects from cationic binding and potential for risk to the environment, which resulted in the interim finding. The PMN submitter clarified the processes used for equipment cleaning and handling of wastes and provided processing information indicating that although there may be potential for worker inhalation exposure, cationic binding will not occur because of interaction of the new chemical substance with another substance in the formulation. EPA's final determination that the new 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 estimated surface water concentrations indicate unreasonable risk to the environment is not likely and lung effects are not likely. View the determination document. 
01/25/17 03/28/19
P-19-0026 Generic: Alkanoic acid, compounds with
substituted carbomonocycle-dialkyl-
alkanediaminehalosubstitued heteromonocycle-
polyalkylene glycol polymerdialkanolamine reaction
products
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.  11/27/18 03/26/19
P-18-0307 Generic: Alkyl Alkenoic acid, alkyl ester, telomer
with alkyl alkenoate, substituted alkyl alkyl alkenoate,
alkylthiol, substituted carbomonocycle, hydroxyalkyl
alkyl alkenoate and alkyl alkyl alkenoate
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.  09/14/18 03/21/19
P-19-0009 Generic: Carbonmonocycles, polymer with haloalkyl
substituted heteromonocycle and hydro-hydroxypoly
[oxy(alkyl-alkanediyl)], dialkyl-
alkanediamineterminated, hydroxyalkylated,
acetates (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. View the determination document.  10/23/18 03/15/19
P-18-0284 Generic: Inorganic acid, reaction products
with alkyl alcohol
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.  08/27/18 03/15/19
P-18-0278 Generic: Isophthalic acid, polymer with terephthalic
acid and C4 and C6 dialkyl amines
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.  08/16/18 03/13/19
J-19-0006,
J-19-0007,
J-19-0008
Generic: Genetically modified microorganism for
the production of a chemical substance
The microorganism 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.  11/16/18 03/08/19
P-19-0025 Specific: 11-Docosene, CASRN 62978-77-2 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.  11/19/18 03/08/19
P-19-0021,
P-19-0022
P-19-0021: Generic: Hydroxyalkyl carboxylic acid,
polymer with alkylamine, alkylene carbonate,
alkanediol, isocyanate, compd. with alkylamine

P-19-0022: Generic: Hydroxyalkyl carboxylic acid,
polymer with alkylamine, alkyl carbonate,
alkanediol, isocyanate, compd. with alkylamine
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.  11/12/18 03/08/19
P-19-0002 Generic: Polyaromatic symmetrical tetracarboxylic
acid
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.  12/28/18 03/08/19
P-18-0272 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.  08/07/18 03/08/19
P-18-0169 Generic: Propanoic acid, 3-hydroxy-2-
(hydroxymethyl)-2-methyl-, polymer with dimethyl
carbonate, 1,6-hexanediol, diamine and 1,1'-
methylenebis[4-isocyanatocyclohexane], acrylate-
blocked, compds. with triethylamine
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.  05/07/18 02/28/19
P-17-0119 Generic: Alkyl alkenoic acid, alkoxyalkyl ester,
polymer with alkyl alkenoate, alkyl alkyl alkenoate
and tris alkyl silyl alkyl alkenaote
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.  06/26/17 02/28/19
P-18-0077 Specific: Urea, reaction products with N-
butylphosphorothioic triamide and formaldehyde
(CASRN: 2093385-47-6)
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 12/03/18
P-18-0132 Generic: Substituted benzene, 4-methoxy-2-nitro-
5-[2-[(1E)-1-[[(2-methoxyphenyl)amino]carbonyl]-2-oxopropylidene]hydrazinyl]-, sodium salt (1:1)
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. View the determination document.  03/20/18 02/26/19
P-18-0107 Generic: Alcohol capped polycarbodiimide from diethyldiisocyanatobenzene. 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.  02/06/18 02/28/19
P-18-0118,
P-18-0119
Generic (P-18-0118): Oxirane, 2-methyl-, polymer
with methoxirane homopolymer, 1,1'-methylenebis[4-isocyanatobenzene], and glycerol-propylene oxide
polymer.

Generic (P-18-0119): Oxirane, 2-methyl-, polymer with
methoxirane homopolymer, 1,1'- methylenebis
[isocyanatobenzene], and glycerol-propylene oxide
polymer.
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.  02/26/18 02/28/19
P-18-0379 Generic: Cashew nutshell liquid polymer with
Epichlorohydrin, formaldehyde, phenol, amines
and glycol.
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.  09/28/18 02/28/19
P-18-0277 Generic: Poly[2-(Dimethylamino)ethyl acrylate
chloride salt, vinyl acetate, methacrylic acid and
alkyl acrylates]
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.  08/28/18 02/28/19
P-19-0007 Generic: Alkenoic acid, alkyl-, hydroxyalkyl ester,
polymer with alkyl-alkenoate, alkenylcarbomonocycle,
hydroxyalkyl-alkenoate, alkyl substituted alkenoate and heteromonocycle, alkyl substituted peroxoate-initiated,
polymers with [substituted alkanenitrile]-initiated acrylic
acid-alkane acrylates-alkyl substituted carbomoncycle
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).
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.  10/16/18 02/28/19
P-17-0387,
P-17-0388
Generic: Dicarboxylic acids, polymers with alkanoic
acid, alkanediol, susbtituted-alkylalkanoic acid,
substituted alkyl carbomonocyle, alkanedioic acid
and alkanediol, alkanolamine blocked compds with
alkanolamine.
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.  08/30/17 02/28/19
P-19-0008 Generic: Substitued polyalkylenepolycarbomonocycle
ester, polymer with dialkanolamine, (hydroxyalkoxy)
carbonyl] derivs., (alkoxyalkoxy) alkanol 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.  10/22/18 02/08/19
P-18-0238 Generic: Saccharide reaction products with acid
anhydride, etherified
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.  7/16/16 02/13/19
P-16-0400 Specific: Alkanes, C11-16-branched and linear;
CASRN: 1809170-78-2
The chemical substance is not likely to present an unreasonable risk (5(a)(3)(C)) 'Not likely to present an unreasonable risk' section 5(a)(3)(C) determination*

*In EPA’s original screening analysis for this PMN in 2016, EPA identified potential for health effects and risk to the environment, which resulted in the interim finding. Upon further review of submitted data on analogous chemical substances, EPA revised its hazard and risk assessment for the new chemical substance. EPA's final determination that the chemical substance is not likely to present unreasonable risk is based on EPA's revised risk assessment for the chemical substance under the conditions of use. View the determination document. 
06/22/16 12/21/18
P-18-0020 Specific: Butanedioic acid, polymer 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
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.  10/16/17 02/05/19
J-18-0045 Generic: Biofuel producing Saccharomyces cerevisiae
modified, genetically stable
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. S. cerevisiae is not pathogenic to humans or animals and has an extensive history of safe use in food processing. View the determination document.  09/27/18 12/19/18
J-18-0046,
J-18-0047
Generic: Genetically modified microorganism 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.  09/30/18 12/19/18
J-19-0002,
J-19-0002,
J-19-0004
Generic: Genetically modified microorganism 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.  10/05/18 12/19/18
P-18-0221 Generic: Polyglycerol reaction product with acid
anhydride, etherified
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.  06/21/18 12/21/18
P-18-0324 Generic: Organic acid dimethyl ester, polymer
with mixed alkanediols and 5-isocyanato-1-
(isocyanatomethyl)-1,3,3-trimethylcyclohexane, trimethoxysilylalkylalkanamine-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.  9/24/18 12/20/18
P-19-0006 Generic: Diisocyanate polymer blocked with alkoxyamine 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.  10/09/18 12/20/18
P-17-0281 Generic: Polysiloxane-polyester polyol carboxylate 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 2017, EPA identified potential for risk to workers. 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 and reasonably foreseen conditions of use where EPA expects that workers will use appropriate personal protective equipment, consistent with the Safety Data Sheet (SDS) prepared by the PMN submitter, in a manner adequate to protect them. View the determination document.  04/21/17 12/04/18
P-18-0007,
P-18-0008
Specific (P-18-0007): Glycerides, soya mono-
and di-, epoxidized, acetates (CASRN: 2097734-14-8)

Specific (P-18-0008): Glycerides, C16-18 and C18-
unsatd. mono- and di-, epoxidized, acetates
(CASRN: 2097734-15-9)
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.  10/04/17 12/11/18
P-18-0212 Generic: Substituted carbomonocycle, polymer
with alkyl alkenoate, alkenyl substituted
carbomonocycle, substituted alkanediol,
heteropolycycle, alkylene glycol and alkenoic
acid, compd. with alkylamino alkanol; 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)
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.  06/14/18 11/30/18
SN-15-0009 Generic: Fatty acid amide The significant new use is not likely to present an unreasonable risk (5(a)(3)(C)) The significant new use is not likely to present an unreasonable risk of injury to health or the environment under the conditions of use, 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, based on the risk assessment. View the determination document.  06/22/16 12/12/18
P-18-0219 Generic: Polythioether, short chain diol polymer
terminated with aliphatic diisocyanate
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.  06/20/18 12/12/18
P-18-0068 Generic: Metal, oxo alkylcarboxylate 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.  12/13/17 12/12/18
J-18-0042,
J-18-0043
Generic: Biofuel producing Saccharomyces cerevisiae
modified, genetically stable
The microorganism 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. S. cerevisiae is not pathogenic to humans or animals and has an extensive history of safe use in food processing. View the determination document.  08/15/18 11/29/18
P-18-0319 Generic: Plant oil fatty acids, alkyl esters 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.  09/20/18 12/04/18
P-18-0152 eneric: Hydrolyzed functionalized di-amino silanol
polymer
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.  04/20/18 11/29/18
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.  04/04/18 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.  08/16/18 11/21/18
P-18-0136 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.  04/09/18 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.  08/24/17 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.  07/26/18 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.  08/30/18 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.  08/09/18 11/07/18
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.  07/06/18 11/02/18
P-18-0224,
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.  06/27/18 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,
J-18-0020,
J-18-0021
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.  08/02/18 10/30/18
J-18-0026,
J-18-0027
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.  07/23/18 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.  11/06/17 10/02/18
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 09/19/16 10/09/18
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 09/15/16 10/09/18
P-16-0483,
P-16-0484

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 07/18/16 10/09/18
P-16-0380,
P-16-0381,
P-16-0382,
P-16-0383,
P-16-0384,
P-16-0385

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 06/22/16 10/09/18
P-16-0354,
P-16-0355

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 SNUR 06/22/16 10/09/18
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 06/22/16 10/09/18
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.  01/04/18 10/05/18
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.  01/26/18 10/05/18
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.  01/26/18 10/05/18
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.  02/26/18 10/05/18
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.  03/23/18 10/05/18
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.  06/29/18 10/05/18
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.  06/29/18 09/26/18
J-18-0022
J-18-0023,
J-18-0024,
J-18-0025

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.  07/13/18 09/27/18
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.  06/29/18 09/18/18
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.  06/19/17 09/18/18
J-18-0028,
J-18-0029,
J-18-0030

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.  07/03/18 09/14/18
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.  08/25/18 09/06/18
J-18-0004,
J-18-0005,
J-18-0006,
J-18-0007,
J-18-0008,
J-18-0009

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.  06/14/18 09/06/18
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.  06/06/18 08/27/18
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.  12/08/17 08/02/18
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. 08/05/16 07/30/18
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.  03/27/18 07/27/18
J-18-0002,
J-18-0003

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. 
02/12/18 06/12/18
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.  01/03/18 03/23/18
P-18-0044,
P-18-0045

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 03/23/18
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 03/23/18
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.  10/02/17 03/19/18
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.  06/22/16 03/19/18
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. 
09/28/17 01/04/18
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. 
10/09/17 01/04/18
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. 
10/06/17 01/04/18
J-17-0015,
J-17-0016,
J-17-0017,
J-17-0018,
J-17-0019

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. 
08/7/17 01/04/18
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. 
07/10/17 10/05/17
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. 06/22/2016 07/31/2017
J-17-0008,
J-17-0009,
J-17-0010,
J-17-0011,
J-17-0012,
J-17-0013
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. 05/08/2017 07/27/2017
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 07/24/2017
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. 04/24/2017 07/21/2017
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. 03/22/2017 07/27/2017
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. 01/25/2017 07/14/2017
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 07/06/2017
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. 03/22/2017 06/29/2017
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. 06/30/2016 06/28/2017
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. 03/14/2017 06/07/2017
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. 09/22/2016 06/15/2017
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. 06/22/2016 06/15/2017
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. 09/22/2016 05/30/2017
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. 06/22/2016 05/30/2017
P-17-0237,
P-17-0238

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. 02/23/2017 05/19/2017
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. 03/14/2017 05/18/2017
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. 01/23/2017 05/18/2017
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. 02/28/2017 05/11/2017
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. 09/18/2016 05/15/2017
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. 02/01/2017 04/27/2017
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. 02/01/2017 04/27/2017
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. 01/04/2017 03/13/2017
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. 01/16/2017 03/13/2017
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. 01/16/2017 03/13/2017
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. 02/06/2017 03/13/2017
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. 11/02/2016 03/30/2017
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. 01/23/2017 03/13/2017
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 02/13/2017
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 02/13/2017
P-17-0160,
P-17-0161

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 02/13/2017
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 02/13/2017
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 02/13/2017
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 01/18/2017
J-17-0001,
J-17-0002,
J-17-0003,
J-17-0004,
J-17-0005

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 01/18/2017
P-17-0016,
P-17-0017,
P-17-0018,
P-17-0019,
P-17-0020,
P-17-0021

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 12/01/2016
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.
08/22/2016 12/01/2016
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.
08/23/2016 12/01/2016
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.
09/07/2016 12/01/2016
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.
08/23/2016 12/01/2016
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. 09/19/2016 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.
07/29/2016 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.
07/28/2016 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.
08/12/2016 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. 08/12/2016 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. 06/22/2016 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. 09/02/2016 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. 08/09/2016 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. 07/25/2016 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. 07/16/2016 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. 07/15/2016 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. 07/15/2016 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. 06/29/2016 10/04/2016
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. 06/29/2016 10/04/2016
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. 07/8/2016 10/04/2016
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. 06/22/2016 09/16/2016
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. 06/22/2016 09/14/2016
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. 06/22/2016 09/14/2016
J-16-0011, J-16-0012, J-16-0013, J-16-0014, J-16-0015,  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. 06/22/2016 09/14/2016
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. 06/22/2016 09/14/2016
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. 06/22/2016 09/14/2016
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. 06/22/2016 09/12/2016
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. 06/22/2016 09/12/2016
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. 07/11/2016 09/02/2016
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. 06/22/2016 09/2/2016
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. 06/22/2016 09/2/2016
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. 06/22/2016 07/29/2016
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. 06/22/2016 07/29/2016
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. 06/22/2016 07/29/2016
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. 06/22/2016 07/20/2016
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. 06/22/2016 07/20/2016
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. 06/22/2016 07/20/2016
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. 06/22/2016 07/15/2016