EPA Pre-Manufacture Notice Review Determinations under Amended TSCA
This page describes the regulatory determinations EPA has made following review of pre-manufacture notifications under section 5 of TSCA, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century law, P.L. 114-182.
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 |
|---|---|---|---|---|---|
| P-17-0016-0021 |
|
Chemical substances not likely to present an unreasonable risk (§5(a)(3)(C)) |
The chemical substances are not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. | 10/25/2016 | 12/19/2016 |
| P-17-0009 | Generic: Depolymerized waste plastics | Chemical substance not likely to present an unreasonable risk (§5(a)(3)(C)) |
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. | 10/13/2016 | 12/1/2016 |
| J-16-0033 | Generic: Saccharomyces cerevisiae modified to express glucoamylase activity | Microorganism not likely to present an unreasonable risk (§5(a)(3)(C)) |
The microorganism is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material. View the determination document. |
8/22/2016 | 12/1/2016 |
| J-16-0034 | Generic: Saccharomyces cerevisiae modified | Microorganism not likely to present an unreasonable risk (§5(a)(3)(C)) |
The microorganism is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material. View the determination document. |
8/23/2016 | 12/1/2016 |
| J-16-0036 --0041 | Generic: Biofuel producing modified microorganism(s), with chromosomally-borne modifications | Microorganism not likely to present an unreasonable risk (§5(a)(3)(C)) |
The microorganisms are not likely to present an unreasonable risk based on low human health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material. View the determination document. |
9/7/2016 | 12/1/2016 |
| J-16-0035 | Generic: Saccharomyces cerevisiae modified | Microorganism not likely to present an unreasonable risk (§5(a)(3)(C)) |
The microorganism is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material. View the determination document. |
8/23/2016 | 12/1/2016 |
| P-16-0580 | Generic: Trimethylolpropane ester of mixed linear and branched carboxylic acids | Chemical substance not likely to present an unreasonable risk (§5(a)(3)(C)) |
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. | 9/19/2016 | 11/10/2016 |
| J-16-0025 | Generic: Trichoderma reesei modified | Microorganism not likely to present an unreasonable risk (§5(a)(3)(C)) |
The microorganism is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material. View the determination document. |
7/29/2016 | 11/14/2016 |
| J-16-0024 | Generic: Trichoderma reesei modified | Microorganism not likely to present an unreasonable risk (§5(a)(3)(C)) |
The microorganism is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material. View the determination document. |
7/28/2016 | 11/14/2016 |
| P-16-0519 | Generic: Polyalkylether polyester | Chemical substances not likely to present an unreasonable risk (§5(a)(3)(C)) |
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. |
8/12/2016 | 11/17/2016 |
| P-16-0518 | Generic: Polyalkylether polyester | Chemical substances not likely to present an unreasonable risk (§5(a)(3)(C)) |
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. | 8/12/2016 | 11/17/2016 |
| P-16-0403 | Generic: Heteropolycyclic carboxylic acid, polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol and 4-substitutedbenzene, substituted carbomonocycle- and alkyl-substituted carbomonocycle-blocked | Chemical substances not likely to present an unreasonable risk (§5(a)(3)(C)) |
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. | 6/22/2016 | 11/17/2016 |
| P-16-0545 | Generic: substituted siloxane polymer | Chemical substances not likely to present an unreasonable risk (§5(a)(3)(C)) |
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard.View the determination document. | 9/2/2016 | 11/10/2016 |
| P-16-0515 | Generic: Diamine substituted arylimidazole | Chemical substances not likely to present an unreasonable risk (§5(a)(3)(C)) |
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. | 8/9/2016 | 11/10/2016 |
| P-16-0492 | Generic: Polyester-amide polymer of 'isophthalic acid' with diamino-alkane, cyclohexanedialcohol, alkanetriol, di-isocyanate and acrylic acid-ethylene copolymer | Chemical substances not likely to present an unreasonable risk (§5(a)(3)(C)) |
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. | 7/25/2016 | 11/10/2016 |
| J-16-0023 | Generic: Trichoderma reesei modified | Microorganism not likely to present an unreasonable risk (§5(a)(3)(C)) |
The microorganism is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material. View the determination document. | 7/16/2016 | 10/19/2016 |
| J-16-0022 | Generic: Trichoderma reesei modified | Microorganism not likely to present an unreasonable risk (§5(a)(3)(C)) |
The microorganism is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material. View the determination document. | 7/15/2016 | 10/19/2016 |
| J-16-0021 | Generic: Trichoderma reesei modified | Microorganism not likely to present an unreasonable risk (§5(a)(3)(C)) |
The microorganism is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material. View the determination document. | 7/15/2016 | 10/19/2016 |
| J-16-0020 | Generic: Trichoderma reesei modified | Microorganism not likely to present an unreasonable risk (§5(a)(3)(C)) |
The microorganism is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material. View the determination document. | 6/29/2016 | 10/4/2016 |
| J-16-0019 | Generic: Trichoderma reesei modified | Microorganism not likely to present an unreasonable risk (§5(a)(3)(C)) |
The microorganism is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material. View the determination document. | 6/29/2016 | 10/4/2016 |
| P-16-0459 | Generic: Carbomonocyclic dicarboxylic acid, polymer with alkanedioic acid, substituted heteropolycycle, substituted carbomonocycle, alkyl alkenoate, alkanedioic acid, alkoxylated substituted dicarbomonocycle, alkoxylated substituted dicarbomonocycle, alkenoic acid, oxo alkyl initiated. | Chemical substances not likely to present an unreasonable risk (§5(a)(3)(C)) |
The chemical substances are not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. Although EPA estimated that the new chemical substances would be very persistent, this did not indicate a likelihood that the chemical substances would present an unreasonable risk, given that the chemical substances have low potential for bioaccumulation, low human health hazard, and low environmental hazard. View the determination document. | 7/8/2016 | 10/4/2016 |
| P-16-0343 and P-16-0344 | Generic: Modified urethane polymer. | Chemical substances not likely to present an unreasonable risk (§5(a)(3)(C)) |
The chemical substances are not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. Although EPA estimated that the new chemical substances would be very persistent, this did not indicate a likelihood that the chemical substances would present an unreasonable risk, given that the chemical substances have low potential for bioaccumulation, low human health hazard, and low environmental hazard. View the determination document. | 6/22/2016 | 9/16/2016 |
| P-16-0391 | Generic: Polyester polyol polymer with aliphatic isocyanate and phenol derivates | Chemical substance not likely to present an unreasonable risk (§5(a)(3)(C)) |
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. Although EPA estimated that the new chemical substance would be very persistent, this did not indicate a likelihood that the chemical substance would present an unreasonable risk, given that the chemical substance has low potential for bioaccumulation, low human health hazard, and low environmental hazard. View the determination document. | 6/22/2016 | 9/14/2016 |
| J-16-0010 | Generic: Saccharomyces cerevisiae modified | Microorganism not likely to present an unreasonable risk (§5(a)(3)(C)) |
The microorganism is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material. S. cerevisiae is not pathogenic to humans or animals and has an extensive history of safe use in food processing. The introduced genetic modifications pose low concern for health and environmental hazard and do not include antibiotic resistance markers. View the determination document. | 6/22/2016 | 9/14/2016 |
| J-16-0011, J-16-0012, J-16-0013, J-16-0014, J-16-0015, and J-16-0016 | Generic: Biofuel Producing Organism | Microorganism not likely to present an unreasonable risk (§5(a)(3)(C)) |
The microorganisms are not likely to present an unreasonable risk based on low human health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material. The recipient microorganism is not pathogenic to humans or animals and has an extensive history of safe use. The introduced genetic modifications pose low concern for health and environmental hazard and do not include antibiotic resistance markers. View the determination document. | 6/22/2016 | 9/14/2016 |
| J-16-0017 | Generic: Saccharomyces cerevisiae modified | Microorganism not likely to present an unreasonable risk (§5(a)(3)(C)) |
The microorganism is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material. S. cerevisiae is not pathogenic to humans or animals and has an extensive history of safe use in food processing. The introduced genetic modifications pose low concern for health and environmental hazard and do not include antibiotic resistance markers. View the determination document. | 6/22/2016 | 9/14/2016 |
| J-16-0018 | Generic: Saccharomyces cerevisiae modified | Microorganism not likely to present an unreasonable risk (§5(a)(3)(C)) |
The microorganism is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material. S. cerevisiae is not pathogenic to humans or animals and has an extensive history of safe use in food processing. The introduced genetic modifications pose low concern for health and environmental hazard and do not include antibiotic resistance markers. View the determination document. | 6/22/2016 | 9/14/2016 |
| P-16-0366 | Generic: Blocked polyisocyanate | Chemical substance not likely to present an unreasonable risk (§5(a)(3)(C)) |
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. Although EPA estimated that the new chemical substance would be very persistent, this did not indicate a likelihood that the chemical substance would present an unreasonable risk, given that the chemical substance has low potential for bioaccumulation, low human health hazard, and low environmental hazard. View the determination document. | 6/22/2016 | 9/12/2016 |
| P-16-0373 | Generic: Tris(alkyloxyphenyl)triazine compounds | Chemical substance not likely to present an unreasonable risk (§5(a)(3)(C)) |
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. Although EPA estimated that the new chemical substance would be very persistent, this did not indicate a likelihood that the chemical substance would present an unreasonable risk, given that the chemical substance has low potential for bioaccumulation, low human health hazard, and low environmental hazard. View the determination document. | 6/22/2016 | 9/12/2016 |
| P-16-0466 | Generic: 2,5-Furandione, telomer with ethenylbenzene and (alkylethyl)benzene, amides with polyethylene-polypropylene glycol aminoalkyl Me ether, alkali salts | Chemical substance not likely to present an unreasonable risk (§5(a)(3)(C)) |
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental toxicity. Although EPA estimated that the new chemical substance would be very persistent, this did not indicate a likelihood that the chemical substance would present an unreasonable risk, given that the chemical substance has low potential for bioaccumulation, low human health hazard, and low environmental hazard. View the determination document. | 7/11/2016 | 9/2/2016 |
| J-16-0006 | Generic: Trichoderma reesei modified | Microorganism not likely to present an unreasonable risk (§5(a)(3)(C)) |
The microorganism is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard associated with the recipient microorganism and introduced genetic material. T. reesei is not pathogenic to humans or animals and has a long history of safe use for production of enzymes. The introduced genetic modifications pose low concern for health and environmental hazard, do not include antibiotic resistance markers, and do not provide a growth advantage over the parental strain. View the determination document. | 6/22/2016 | 9/2/2016 |
| P-16-0348 | Generic: Polypentaerythritol, mixed esters with linear and branched monoacids | Chemical substance not likely to present an unreasonable risk (§5(a)(3)(C)) |
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. Although EPA estimated that the new chemical substance would be very persistent, this did not indicate a likelihood that the chemical substance would present an unreasonable risk, given that the chemical substance has low potential for bioaccumulation, low human health hazard, and low environmental hazard. View the determination document. | 6/22/2016 | 9/2/2016 |
| P-16-0392 | Generic: Modified vegetable oil | Not likely to present an unreasonable risk (§5(a)(3)(C)) |
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental toxicity. Although EPA estimated that the new chemical substance would be very persistent, this did not indicate a likelihood that the chemical substance would present an unreasonable risk, given that the chemical substance has low potential for bioaccumulation, low human health hazard, and low environmental hazard. View the determination document. | 6/22/2016 | 7/29/2016 |
| P-16-0351 | Generic: Glycerides, C14-18 and C16-C18 unsaturated, from fermentation | Not likely to present an unreasonable risk (§5(a)(3)(C)) |
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental toxicity. Although EPA estimated that the new chemical substance would be persistent, this did not indicate a likelihood that the chemical substance would present an unreasonable risk, given that the chemical substance has low potential for bioaccumulation, low human health hazard, and low environmental hazard. View the determination document. | 6/22/2016 | 7/29/2016 |
| P-16-0340 | Generic: Glycerides, C8-18 and C18 unsaturated, from fermentation | Not likely to present an unreasonable risk (§5(a)(3)(C)) |
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental toxicity. Although EPA estimated that the new chemical substance would be persistent, this did not indicate a likelihood that the chemical substance would present an unreasonable risk, given that the chemical substance has low potential for bioaccumulation, low human health hazard, and low environmental hazard. View the determination document. | 6/22/2016 | 7/29/2016 |
| P-16-0302 | Generic: Organic modified propyl silsesquioxane | Not likely to present an unreasonable risk (§5(a)(3)(C)) |
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental toxicity. Although EPA estimated that the new chemical substance would be very persistent, this did not indicate likelihood that the chemical substance would present an unreasonable risk, given that the chemical substance has low potential for bioaccumulation, low human health hazard, and low environmental hazard. View the determination document. | 6/22/2016 | 7/20/2016 |
| P-16-0301 | Generic: Propyl silsesquioxanes, hydrogen-terminated | Not likely to present an unreasonable risk (§5(a)(3)(C)) |
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. View the determination document. | 6/22/2016 | 7/20/2016 |
| P-16-0292 | Generic: Depolymerized waste plastics. | Not likely to present an unreasonable risk (§5(a)(3)(C)) |
The chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. Although EPA estimated that the new chemical substance would be very persistent, this did not indicate a likelihood that the chemical substance would present an unreasonable risk, given that the chemical substance has low potential for bioaccumulation, low human health hazard, and low environmental hazard. View the determination document. | 6/22/2016 | 7/20/2016 |
| P-16-0281 | Generic: Fatty alcohols-dimers, trimers, polymers | Not likely to present an unreasonable risk (§5(a)(3)(C)) |
The chemical substance is not likely to present an unreasonable risk based on low health hazard concern and low environmental toxicity. View the determination document. | 6/22/2016 | 7/15/2016 |