Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.

By Richard E. Engler, Ph.D. and Margaret R. Graham

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 health 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.

More information on TSCA’s implementation is available on our TSCA Reform News & Information web page. 


 

By Charles M. Auer and Oscar Hernandez, Ph.D.

On September 21, 2016, the U.S. Environmental Protection Agency (EPA) Office of Pollution Prevention and Toxics (OPPT) announced its regulatory determinations for a batch of Microbial Commercial Activity Notices (MCAN) and premanufacture notices (PMN).

The announcement by EPA consisted of ten new microorganisms submitted as MCANs and seven new chemicals submitted as PMNs.  All microorganisms and chemical substances were determined “not likely to present an unreasonable risk” (per Toxic Substances Control Act (TSCA) Section 5(a)(3)(C)).  This determination was based in all cases on the low hazard of the microorganism or the chemical substance.  The microorganisms and chemical substances are:

MCANs:

  • J-16-0010:  Generic: Saccharomyces cerevisiae modified;
  • J-16-0011, J-16-0012, J-16-0013, J-16-0014, J-16-0015, and J-16-0016:  Generic:  Biofuel Producing Organism;
  • J-16-0017:  Generic: Saccharomyces cerevisiae modified;
  • J-16-0018:  Generic: Saccharomyces cerevisiae modified; and
  • J-16-0006:  Generic: Trichoderma reesei modified.

PMNs:

  • P-16-0343 and P-16-0344:  Generic:  Modified urethane polymer;
  • P-16-0391:  Generic:  Polyester polyol polymer with aliphatic isocyanate and phenol derivates;
  • P-16-0366: Generic:  Blocked polyisocyanate;
  • P-16-0373:  Generic:  Tris(alkyloxyphenyl)triazine compounds;
  • P-16-0466:  Generic:  2,5-Furandione, telomer with ethenylbenzene and (alkylethyl)benzene, amides with polyethylene-polypropylene glycol aminoalkyl Me ether, alkali salts; and
  • P-16-0348:  Generic: Polypentaerythritol, mixed esters with linear and branched monoacids.

In both types of submissions, the EPA reports are facilitated by the use of templates.  The footnotes in the template describe the approach and methodology followed to identify uses and to determine persistence, bioaccumulation, human health hazard, and environmental hazard. 

The MCAN template includes three footnotes that describe:  (1) identification of “known” and “reasonably foreseen” uses; (2) criteria for human health hazard; and (3) criteria for ecological hazard.

The PMN template includes seven footnotes that describe:  (1) identification of “known” and “reasonably foreseen” uses; (2) criteria for persistence; (3) criteria for bioaccumulation; (4) criteria for human health hazard ranking; (5) criteria for ecological hazard ranking; (6) link to the TSCA New Chemicals Program Chemical Categories; and (7) link to the Organization for Economic Cooperation and Development’s (OECD) 2014 Guidance on Grouping of Chemicals.   The OECD link and a link to the Sustainable Futures Manual within footnote 5 are obsolete.

The ecological hazard ranking criteria are consistent with OPPT’s past practice.  The human health ranking criteria departs from practice by using a single descriptor for all endpoints.  Other approaches that EPA has used for several years utilize criteria that address specific end points.  Examples include the ChAMP (Chemical Assessment and Management Program) Methodology and the section 8(e) program.

Risk Determinations

For the MCANs, the “unlikely to present” determination is based on the human health hazard criteria identified in the template for human health hazard:  “a microorganism is considered to have low human health hazard if it is not known to be a frank human pathogen that causes disease in healthy adults, and/or animal studies have demonstrated a lack of pathogenicity or toxicity”; and “a microorganism is considered to be of low ecological hazard if it is not known to be an animal or plant pathogen, and the genetic modifications do not impart pathogenic or toxigenic traits, and the introduced genetic material does not provide a selective growth advantage in outcompeting indigenous microbial communities in the environment.”

For the chemical substances, estimates indicated that the majority of these chemicals were persistent or very persistent and bioaccumulation potential was low for all chemicals.  Human health hazard was determined by using a combination of physicochemical properties and structural analogs.  Ecological hazard determinations utilized analog information and, as appropriate, estimates made by the Ecological Structure Activity Relationships (ECOSAR) Class Program.  Exposure estimates were not conducted based of the low hazard concern from which followed the “not likely to present an unreasonable risk” determination.


 

By Lynn L. Bergeson

On Friday, July 22, 2016, the U.S. Environmental Protection Agency (EPA) posted the first four Toxic Substances Control Act (TSCA) Section 5(a) determinations made following review of pre-manufacture notifications (PMN) according to TSCA as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century law, Pub. L. No. 114-182 (Lautenberg).  EPA’s determination on all four chemical substances was “not likely to present and unreasonable risk,” under new TSCA Section 5(a)(C)(3).  The PMN Case Numbers, Chemical Identities, a summary of the determination, the decision dates, as well as the links to the determinations themselves are below.  The review start date for all of these determinations was the date of Lautenberg’s enactment, June 22, 2016.  Bergeson & Campbell, P.C. (B&C®) is reviewing these determinations and will provide an analysis.

  • P-16-0281:  Generic: Fatty Alcohols-Dimers, Trimers, Polymers.  EPA determined that “[t]he chemical substance is not likely to present an unreasonable risk based on low health hazard concern and low environmental toxicity.”  The decision was issued on July 15, 2016.
  • P-16-0292:  Generic: Depolymerized Waste Plastics.  EPA determined that “[t] he 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.”  The decision was issued on July 20, 2016.
  • P-16-0301: Generic:  Propyl Silsesquioxanes, Hydrogen-Terminated.  EPA determined that “[t]he chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard.”  The decision was issued on July 20, 2016.
  • P-16-0302:  Generic:  Organic Modified Propyl Silsesquioxane.  EPA determined that “[t]he 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.”  The decision was issued on July 20, 2016.