Biobased Products News and Policy Report – Update from Bergeson & Campbell, P.C.

Biobased and Renewable Products Update


Bicameral Bills Seek To Reform RFS

On November 14, 2019, Senator Tom Udall (D-NM) and Representative Peter Welch (D-VT) introduced legislation seeking to reform the Renewable Fuel Standard (RFS) under the Clean Air Act (CAA). The Growing Renewable Energy through Existing and New Environmentally Responsible (GREENER) Fuels Act is intended to mitigate the “harmful environmental impacts of the corn ethanol mandate,” according to a press release issued by the lawmakers. The bill would phase out the corn ethanol mandate and immediately reduce the amount of ethanol in fuel by as much as 1 billion gallons by capping the amount of ethanol that can be blended into conventional gasoline at 9.7 percent. The legislation also seeks to help farmers return cornfields to pasture and wildlife habitat through a 10 cents per renewable identification number (RIN) fee to fund a new Private Land Protection and Restoration Fund in the U.S. Treasury. The fund will help pay for Department of Interior (DOI) programs that pay for easements on private lands to keep them out of agricultural production; keep the lands in conservation uses like grass, forest, stream buffers, or pollinator habitat; and help farmers transition land currently in crop production into other uses. The GREENER Fuels Act also would extend the cellulosic and advanced next-generation biofuel mandate until 2 billion gallons of annual production is achieved or 2037, whichever is sooner, and alters the way the mandate is implemented to produce liquid transportation fuels that dramatically reduce greenhouse gas emissions.

EPA Announces OCSPP Meeting To Discuss TSCA New Chemicals Program

On November 20, 2019, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) announced a public meeting to engage with stakeholders interested on the implementation of the Toxic Substances Control Act (TSCA) New Chemicals Program. The meeting will be held on December 10, 2019, from 10:00 a.m. to 3:00 p.m. (EST), and will include:

  • An overview of EPA’s updated “Working Approach” document that builds on EPA’s “New Chemicals Decision Making Framework: Working Approach to Making Determinations under Section 5 of TSCA”;
  • A demonstration of how EPA uses key concepts in the Working Approach to reach certain conclusions and/or make determinations under TSCA Section 5(a)(3) using case examples;
  • An update on confidential business information (CBI) process improvements and clarifications; and
  • A discussion of EPA’s ongoing efforts and progress to increase transparency.

During the meeting, EPA will provide an opportunity for stakeholders to provide input on the topics mentioned above. Feedback can also be submitted via the docket on or prior to January 24, 2020.

By the end of 2019, EPA expects to make the “Working Approach” document available for written public comments.

FDA Acting Director Of Therapeutic Biologics And Biosimilars Provides Statement On Continued Efforts To Facilitate Competition In The Biologic Marketplace

On November 15, 2019, Sarah Yim, M.D., acting director of the Food and Drug Administration (FDA) Office of Therapeutic Biologics and Biosimilars in FDA’s Center for Drug Evaluation and Research, released a statement on FDA’s continued progress facilitating competition in the biologic marketplace with approval of its 25th biosimilar project. In her statement, Dr. Yim highlights FDA’s approval of one of nine new biosimilar products approved in 2019. Bringing the overall total of biosimilar approvals to 25, Dr. Yim states: “I’m pleased to see this progress and am confident that the market for these therapies will continue to grow.” Approved under FDA’s Biosimilar Product Development Program, the 25th biosimilar announced is one of 38 products that have been enrolled in the program. The program’s goal is to discuss development of proposed biosimilar products or interchangeable products, laying the foundation for ongoing competition in the marketplace.

Typically more complex than other drugs and developed through advanced science, biological products, commonly referred to as biologics, are generally made from natural or living sources, such as animal and plant cells, and microorganisms such as bacteria or yeast. Biologics and biosimilar products are highly similar to, and have no clinically meaningful differences from, existing FDA-approved biologic products called reference products. As part of FDA’s efforts to support these products, Dr. Yim also highlighted FDA’s work under the Biosimilars Action Plan. The work under this plan includes efforts to develop and implement new biosimilar-specific review templates and progress toward the development and validation of pharmacodynamic biomarkers tailored to biosimilar development. Part of these efforts involves FDA’s provision of scientific and regulatory clarity for the biosimilar development community, combined with communication and outreach education. Dr. Yim concludes: “The promise of biosimilar and interchangeable biological products in providing increased access to important therapies is great, and the FDA will continue to do all that we can to facilitate competition in this area.”

Other News

Futurism, “This Startup Says It Can Create “Meat” Out of Thin Air
ScienceDaily, “Researchers Design an Improved Pathway to Carbon-Neutral Plastics

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