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 Lynn L. Bergeson, Richard E. Engler, Ph.D., and Margaret R. Graham

On April 25, 2017, the U.S. Environmental Protection Agency (EPA) issued two notices in the Federal Register expressing its determination that 28 new chemical notifications are “not likely to present an unreasonable risk of injury to health or the environment.”  82 Fed Reg. 19044 (Statement of Findings for December 2016); 82 Fed. Reg. 19046 (Statements of Findings for February 2017).  The statements of findings list premanufacture notices (PMN) and microbial commercial activity notices (MCAN) regarding new polymer and biodegradable chemicals submitted to EPA under Section 5 of the Toxic Substances Control Act (TSCA).  The notices listed in the December 2016 statement of findings are:

The notices listed in the February 2017 statement of findings are:

Commentary

The publication of these two notices fulfills EPA’s obligation under TSCA Section 5(g) to publish its findings; all of these determinations had previously been posted to the EPA website.  It is to EPA’s credit that EPA has made its determinations public as soon as practicable by posting those determinations on its website.  We recognize that publication in the Federal Register often lags behind EPA’s decisions because of resource constraints and competition with other Federal Register notices.  We are pleased to see new chemicals cleared for production.

Nevertheless, EPA’s pace of approving new chemicals for the marketplace has slowed tremendously since enactment of TSCA reform.  Furthermore, these notices do not provide any line of sight on the reasons contributing to the delays, or EPA’s resolution of these issues.  To date, EPA has only published its final determinations for substances with low concerns for heath and ecological hazards.  With only 28 new chemicals approved from the time period of December 1, 2016, to February 28, 2017, EPA will need to work much faster to even come close to its annual average number of 700-800 PMN reviews and keep the backlog of cases under review from continuing to grow.


 

The attorneys, scientists, policy experts, and regulatory advisors of Bergeson & Campbell, P.C. (B&C®), The Acta Group (Acta®), and B&C® Consortia Management, L.L.C. (BCCM) endeavor year-round to keep you informed on key developments as they happen, and prepared for looming changes and deadlines, to help you maintain compliance and competitive advantage as you market your products throughout the world. As the new year begins, we offer you this look back at the top stories of 2016 (as measured by clicks, reads, and shares by readers of our blogs and e-mails), a year that was full of surprises and dramatic shifts -- many of which will play out well into the new year.

 

June 22, 2016

TSCA Reform:  An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA

 

September 22, 2016

Proposition 65:  OEHHA Adopts Revisions to Its Proposition 65 Warning Regulations

 

August 8, 2016

TSCA Reform: Proposed Changes to SNUR Procedures Would, Perhaps Inadvertently, Result in Disclosure of CBI to Third Parties/Possible Competitors

 

June 29, 2016

TSCA Reform:  EPA Publishes First Year Implementation Plan

 

April 8, 2015

K-REACH:  List of Priority Existing Substances Submitted for Consultation

 

December 20, 2016

TSCA:  EPA Amends Procedures for TSCA Section 6 Rulemaking

 

January 6, 2016

EPA Releases Preliminary Risk Assessment for Neonicotinoid Insecticide Imidacloprid

 

January 8, 2016

EPA Sued Over Guidance Classifying Seeds Coated with Neonicotinoid Insecticides as Treated Articles Exempt from Registration under FIFRA

 

February 10, 2016

Bayer Announces That It Will Not Submit Voluntary Cancellation Requests for Flubendiamide

 

October 19, 2016

Brazil Delays Promulgation of Final Industrial Chemicals Regulation

 

October 6, 2015

EPA Announces Revisions to Its Worker Protection Standard

 

September 28, 2016

EPA Announces Regulatory Determinations on MCANs and PMNs

 

January 13, 2016

EPA Denies SDA Nomenclature Petition, But Options for Adding Biobased Sources Remain Open

 

December 1, 2016

Brexit -- An Overview of Transformative Developments and Their Potential Impact on European Chemical Laws

 

 

Top Articles Authored by B&C:

 

Kathleen M. Roberts, Richard E. Engler, Ph.D., Charles M. Auer, Lynn L. Bergeson, "An Analysis of Section 8 of the New Toxic Substances Control Act," BNA Daily Environment Report, August 9, 2016.

 

Lynn L. Bergeson, Charles M. Auer, "An Analysis of TSCA Reform Provisions Pertinent to Industrial Biotechnology Stakeholders," Industrial Biotechnology, Volume 12, Issue 4, August 2016.

 

Charles M. Auer, "Old TSCA, New TSCA, and Chemical Testing," BNA Daily Environment Report, August 16, 2016.

 

L. Bergeson, B. Auerbach, L. Campbell, T. Backstrom, S. Dolan, J. Vergnes, R. Engler, J. Bultena, K. Baron, C. Auer, "The DNA of the U.S. Regulatory System: Are We Getting It Right for Synthetic Biology?," Woodrow Wilson International Center for Scholars Synthetic Biology Project Report, October 15, 2015.

 

 

Coming first quarter 2017 from ABA Books:

 

Lynn L. Bergeson, Charles M. Auer, New TSCA: A Guide to the Lautenberg Chemical Safety Act and Its Implementation, American Bar Association (2017).


 

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.