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October 17, 2018

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EPA Issues Statements of Findings: Five New Chemical Substances Not Likely to Present an Unreasonable Risk

On May 17, 2018, the U.S. Environmental Protection Agency (EPA) issued a notice releasing statements of findings on new chemical substances made on Toxic Substances Control Act (TSCA) Section 5(a) notices during the period from February 1, 2018, to March 31, 2018.  83 Fed. Reg. 22978.  EPA is required to do so per TSCA Section 5(g) after its review of TSCA Section 5(a) notices when it makes a finding that a new chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment.  EPA posted these determinations on its website when they were made.  The statements of findings, all related to premanufacture notices (PMN), and their website links are:

  • EPA Case Number:  P-16-0415; chemical name:  generic:  polyurethane; polymer exemption flag (generic name); intended uses:  coating for oil and gas industry; known and reasonably foreseen use(s):  paint additive and coating additive. 

  • EPA Case Number:  P-18-0002; chemical name:  generic:  phosphinic acid, P,P-alkyl-, salt (generic name); intended use(s) (specific):  chemical intermediate for a non-halogenated flame retardant; known and reasonably foreseen use(s):  chemical intermediate; flame retardant. 

  • EPA Case Number:  P-18-0021; chemical name:  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 (generic name); intended use(s) (generic):  paint; known and reasonably foreseen use(s):  adhesive and sealant chemical.

  • EPA Case Numbers:  P-18-0044 - 0045:

    • P-18-0044:  chemical name:  generic:  fatty acids (generic name); intended use(s) (generic):  intermediate species known and reasonably foreseen use(s):  chemical intermediate; lubricant and lubricant additive; viscosity adjustor; coating.

    • P-18-0045:  chemical name:  generic:  fatty acids, alkyl esters; intended use(s) (generic):  application coating; known and reasonably foreseen use(s):  lubricant intermediate; mold release agent; plasticizer; processing aid.

  • EPA Case Number:  P-18-0083; chemical name:  specific:  2-propenoic acid, telomers with bualc.-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); intended use(s) (generic):  dispersant additive; known and reasonably foreseen use(s):  chelating agent.

Commentary

P-18-0044, P-18-0045, and P-18-0083 are notable in that EPA identified a hazard other than “low hazard” for heath or the environment and nevertheless concluded that exposures were low enough that the substances are not likely to present an unreasonable risk under the reasonably foreseeable conditions of use.  In the cases of P-18-0044 and P-18-0045, EPA identified health hazards, but EPA expects that exposures to the general population will be low and that there will not be consumer uses.  Furthermore, EPA expects that workers will “use adequate personal protective equipment.”  In the case of P-18-0083, EPA identified acute and chronic aquatic toxicity concentrations of concern of >20,000 and >1,000 parts-per-billion, respectively.  Even though these do not meet EPA’s thresholds for “low hazard,” EPA does not expect releases to exceed those thresholds.

©2018 Bergeson & Campbell, P.C.

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About this Author

Richard Engler PhD, Bergeson Campbell Law Firm, Senior Chemist
Senior Chemist

Richard E. Engler, Ph.D. is Senior Chemist with Bergeson & Campbell, P.C.  Dr. Engler is a 17-year veteran of the U.S. Environmental Protection Agency (EPA) and is one of the most widely recognized experts in the field of green chemistry, having served as senior staff scientist in EPA's Office of Pollution Prevention and Toxics (OPPT) and leader of EPA's Green Chemistry Program.  He has participated in thousands of Toxic Substances Control Act (TSCA) substance reviews at EPA, as well as pre-notice and post-review meetings with submitters to resolve complex or...

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Margaret Graham, Environmental Science and Policy Paralegal, Bergeson Campbell Law firm
Paralegal

Margaret R. Graham (Maggie), a paralegal with Bergeson & Campbell, P.C. (B&C®), holds a Masters degree in Environmental Science and Policy, and has over a decade of paralegal experience, including eight years focused in federal regulatory law.  Her understanding of environmental policy and the administrative and legislative process involved in regulatory compliance makes her an invaluable resource to B&C staff and clients, who rely on her research, project management, and writing and editing skills to complete efficiently briefs, pleadings, and other documents.

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