The Biobased and Renewable Products Advocacy Group (BRAG) helps members develop and bring to market their innovative biobased and renewable chemical products through insightful policy and regulatory advocacy. BRAG is managed by B&C® Consortia Management, L.L.C., an affiliate of Bergeson & Campbell, P.C.

On February 13, 2017, seven democratic Senators sent a letter to White House Counsel Don McGahn requesting details on Carl Icahn’s role in the Trump Administration and the extent of his influence over the Renewable Fuel Standard (RFS) program.  On December 21, 2016, it was announced that Mr. Icahn would serve the Trump Administration as a special advisor for overhauling federal regulations.  The Senators’ letter highlights concerns over Icahn’s public statements regarding RFS obligations and his role as chairman of the board and majority shareholder of Icahn Enterprises.  The Senators noted that, as of September 30, 2016, Icahn Enterprises owned an 82 percent stake in CVR Energy, which is an oil refiner required to meet the RFS obligations.  The letter requests that McGahn provide answers to a number of questions regarding Icahn, including whether:
 

■  He is a federal employee;
 
■   He has access to confidential information;
 
■  He provided financial disclosures to the Administration;
 
■  He is barred from providing advice on any regulations;
 
■  He provided advice to President Trump on any Senate-confirmed or schedule C appointees;
 
■  The Administration believes he is subject to any laws or regulations governing conflicts of interest;
 
■  He has recused himself from any decisions or discussions that may present a conflict of interest; and
 
■  He is required to divest from any of his holdings.

 

On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology. The 2017 Update provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) with respect to regulating biotechnology products. Together with the National Strategy for Modernizing the Regulatory System for Biotechnology Products, published in September 2016, the 2017 Update offers a “complete picture of a robust and flexible regulatory structure that provides appropriate oversight for all products of modern biotechnology.” Within that regulatory structure, the federal agencies “maintain high standards that, based on the best available science, protect health and the environment, while also establishing transparent, coordinated, predictable and efficient regulatory practices.” More information is available in Bergeson & Campbell, P.C.’s (B&C®) memorandum White House Announces Release of Final Update to the Coordinated Framework for the Regulation of Biotechnology.


 

By Lynn L. Bergeson and Carla N. Hutton

On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology (2017 Update).  The Update to the Coordinated Framework provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) with respect to regulating biotechnology products.  Together with the National Strategy for Modernizing the Regulatory System for Biotechnology Products, published in September 2016, the Update to the Coordinated Framework offers a “complete picture of a robust and flexible regulatory structure that provides appropriate oversight for all products of modern biotechnology.”  Within that regulatory structure, the federal agencies “maintain high standards that, based on the best available science, protect health and the environment, while also establishing transparent, coordinated, predictable and efficient regulatory practices.”  To help product developers and the public understand what the regulatory pathway for products might look like, the 2017 Update presents information about agency roles and responsibilities in several forms, including:

  • Graphics that illustrate agency-specific overviews of regulatory roles;
  • Case studies that demonstrate how a product developer might navigate the regulatory framework; and
  • A comprehensive table that summarizes the current responsibilities and the relevant coordination across EPA, FDA, and USDA for the regulatory oversight of an array of biotechnology product areas.

In its blog item, “Increasing the Transparency, Coordination, and Predictability of the Biotechnology Regulatory System,” the Obama Administration acknowledges that while the 2017 Update represents “remarkable progress by the EPA, FDA, and USDA to modernize the regulatory system for biotechnology products, much work remains.”  EPA, FDA, and USDA will consider the comments submitted in response to the proposed 2017 Update and information gathered during the three public engagement sessions hosted by EPA, FDA, and USDA to inform ongoing and future agency activities.  In addition, the agencies commissioned an independent study by the National Academy of Sciences (NAS) on future biotechnology products.  When completed, the agencies will consider the study’s findings, as well as the comments.  More information on the Update to the Coordinated Framework will be available in our forthcoming memorandum, which will be available on our website under the key phrase biobased products, biotechnology.


 

On July 15, 2014, Inside EPA reported that "the White House is examining options for reversing EPA's proposed cuts to several renewable fuel standard (RFS) production targets in order to promote biofuels that create fewer greenhouse gases (GHGs) than conventional fuels, informed sources say, as part of the Obama administration's broader efforts to combat climate change."

The article also quotes sources stating:
"[F]igures under discussion between administration officials and industry representatives include raising the renewable fuel target -- largely met with corn ethanol production -- from 13 billion gallons in the proposed rule to a range of 13.5-13.6 billion gallons in the final rule; increasing the advanced biofuel target from 2.2 billion gallons in the proposed rule to a range of 2.3-2.5 billion gallons; and raising the biomass-based diesel target from 1.28 billion gallons under the proposed rule to 1.5-1.7 billion gallons in the final rule.

"The most dramatic increase under consideration is said to be for cellulosic biofuel, which would rise from 17 million gallons in the proposed rule to 23 million gallons in the final rule, the sources say. "