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By   Lynn L. Bergeson 

EPA announced on January 8, 2021, that it released an updated and improved version of OncoLogic™, a system used to evaluate a chemical’s potential to cause cancer. EPA states that, in partnership with the Organization for Economic Cooperation and Development (OECD), it developed “a more user-friendly version of the most widely used piece of this system, greatly expanding its usability across the agency and the scientific community.” According to EPA, the updated module (version 9) is used to analyze organic chemicals, the largest group of chemicals contained in this tool. It features:

  • A streamlined interface that does not require expert knowledge to navigate;
     
  • A standardized reporting format that allows users to view and export results quickly; and
     
  • Increased transparency in the science behind the predictions provided by the model.

EPA notes that OncoLogic™ is one of many publicly available assessment methods, databases, and predictive tools it developed to estimate hazard to humans and the environment, particularly in the absence of test data. According to EPA, these tools and models support it in implementing programs and regulations, such as TSCA, and help external users assess and manage chemical risks. EPA states that version 8.0, which continues to include modules for fibers, metals, and polymers, will remain available to the public.


 

The Organization for Economic Cooperation and Development (OECD) recently released its document "OECD Guidance for Characterising Oleochemical Substances for Assessment Purposes," which is available online. The document seeks to present a "harmonised approach" for characterizing UVCB (substances of unknown or variable composition, complex reaction products or biological materials) oleochemical substances that are derivatives from animal and vegetable oils and fats.


In June 2012, the OECD Task Force on Hazard Assessment endorsed a pilot project to develop guidance on identifying UVCB using oleochemicals/oleoproducts as the pilot chemicals. The development of this guidance was, in part, in response to questions and concerns related to UVCB nomenclature that had been raised by the European Chemicals Agency (ECHA) in response to some UVCB chemical registrations under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.


Industry stakeholders, including U.S. chemical manufacturers, have expressed concern that if adopted under current regulatory regimes, the newly released OECD nomenclature guidance will require companies to obtain new chemical names for materials that they have used for many years. This, in turn, could trigger the need for new chemical review under EPA's Toxic Substances Control Act (TSCA).


All stakeholders within the biobased chemical space -- even those not directly engaged in oleo-based products -- should carefully review the existing guidance and monitor future OECD work in this arena as it will have widespread ramifications. OECD has already indicated that it will focus on biofuels in upcoming UVCB nomenclature guidance, a development that will have significant implications for the biochemical industry.