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.

By Lauren M. Graham, Ph.D.

On October 17, 2017, Congressman Jimmy Panetta (D-CA), Congressman Neal Dunn, M.D. (R-FL), and 77 additional House members sent a bipartisan letter to the U.S. Department of Agriculture (USDA), U.S. Food and Drug Administration (FDA), and U.S. Environmental Protection Agency (EPA) to urge the agencies to work together to promote innovative new technologies aimed at increasing crop yields and reducing the cost of production.  According to Congressman Panetta, the letter was prepared in response to duplicative or inconsistent regulatory proposals regarding biotechnology.  In the letter to Secretary Sonny Perdue, Commissioner Scott Gottlieb, and Administrator Scott Pruitt, the members highlighted several recent biotechnology regulatory efforts that warrant the Administration’s attention, as well as the importance of a consistent, science-based, risk-proportionate regulatory system.  Members concluded by urging the agencies to cooperate in creating consistent regulatory proposals that foster innovation; to increase engagement with trading partners to promote a harmonized, science-based international regulatory system for agricultural products; and to consider ways to engage with the public to discuss the continued advancement of biotechnology in agriculture.


 

By Lauren M. Graham, Ph.D.

On June 29, 2017, Representatives Bill Pascrell (D-NJ), Ryan Costello (R-PA), Brian Fitzpatrick (R-PA), and Linda Sánchez (D-CA) introduced the Renewable Chemicals Act of 2017 to the House.  If enacted, the legislation would create a targeted, short-term tax credit for the production of qualifying renewable chemicals from biomass and for investments in renewable chemical production facilities.  The tax credit would be provided based on job creation, innovation, environmental benefits, commercial viability, and contribution to U.S. energy independence.  Numerous industry stakeholders, including the Biotechnology Innovation Organization (BIO), Renmatix, and DSM, praised the proposed legislation. 


 

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 September 12, 2016, the  Biodiesel and Renewable Diesel Incentive Extension Act of 2016 (H.R. 5994) was introduced to the House of Representatives and referred to the House Committee on Ways and Means. The bill was introduced by Representative Diane Black (R-TN), and would extend the $1 per gallon biodiesel and renewable diesel blenders credit, originally set to expire December 31, 2016, through  December 31, 2018. The blenders tax credit of $1 was created in 2005 for biodiesel or renewable diesel used in qualified mixtures.  The Advanced Biofuels Association (ABFA) has spoken out in favor of extending the tax credit, with ABFA President Michael McAdams stating, "it is clear that the best chance for our industry to continue to have tax credit support at the federal level is for all of us to unite behind the existing blenders credit. Given the shortness of the year and the importance of certainty for the overall biodiesel industry, we simply owe it to all our members to give them the best opportunity to continue to have a tax credit in  2017  and  2018."

 

A post from the Environmental Law Institute's "Vibrant Environment" Blog

By Lynn L. Bergeson

The last thing the push for TSCA reform needs is another delay, and Senator Paul's unexpected interest in H.R. 2576 has caused just that. Under typical circumstances, a Member's focused interest in legislation is refreshing, and as today highlights, entirely too infrequent. In this instance, the circuitous road to TSCA reform is anything but typical—the complexity of the legislation has invited an unusual divisiveness that has frustrated passage—and delay is the enemy of the good.

When TSCA reform achieved bipartisan support in 2015, the Miracle on 34th Street quality of it all invited cautious optimism that reform of our ancient chemical management law just may be possible after all. Through 2015 and early 2016, the roller coaster ride the legislation took between the House and Senate was both nerve-wracking and energizing. Members and others "close to the legislation" metered out bits of information, sufficient to telegraph the patient was alive but requiring extreme measure to stay afloat. When the House voted on May 24, 2016, by an overwhelming majority to approve H.R. 2576, there was a palpable buzz in the chemical community and a real sense that this insanely stubborn law was finally going to relent and get its much- needed overhaul.

TSCA

Seemingly out of nowhere, Senator Paul put a hold on the bill's further consideration. Taking his explanation at face value, wishing to read the legislation is not an unreasonable request. In addition to wanting to read the legislation closely, Senator Paul reportedly is concerned about the enhanced criminalization provisions in the bill that raise fines for TSCA violations and enhance penalties for knowingly putting someone in imminent danger. Both of these changes are consistent with penalties stipulated in other federal environmental laws. Paul’s request to put a hold on TSCA, however, disturbs a fragile balance that is not well-suited to sustain disruption, and plainly breaks the momentum the legislation enjoyed before the Memorial Day recess.

It is imperative that days do not turn into weeks, or worse. We need this law, and we need it yesterday. TSCA has not kept pace with chemical innovation and EPA desperately needs enhanced authorities to manage potential risks from existing chemical substances. The Senate must make this vote a priority when it reconvenes so President Obama can sign it, as we expect he will, and we can start the important work of implementing the law.


 

On April 5, 2016, the biofuel trade associations Advanced Biofuels Business Council, Algae Biomass Organization, Biotechnology Innovation Organization (BIO), Growth Energy, National Biodiesel Board, and Renewable Fuels Association sent a letter to House and Senate Leaders asking for a multiyear extension of advanced biofuel tax credits. The six organizations are specifically asking that the Second Generation Biofuel Producer Tax Credit, the Special Depreciation Allowance for Second Generation Biofuel Plant Property, the Biodiesel and Renewable Diesel Fuels Credit, the Alternative Fuel and Alternative Fuel Mixture Excise Tax Credit, and the Alternative Fuel Vehicle Refueling Property through the Protecting Americans From Tax Hikes Act of 2015 are extended before they expire at the end of 2016. Other energy production tax credits have been extended, and the biofuel trade associations argue that extending certain energy tax provisions and not others creates investment uncertainty across the energy sector, and puts biofuel producers at a disadvantage.


 

On March 7, 2016, the U.S. Environmental Protection Agency (EPA) announced the update of three greenhouse gas (GHG) inventory guidance documents. The documents have new emission factors and guidance on data estimation methods, with specific sections on waste and biomass derived fuels. The updated guidance documents are needed by organizations that must report GHG emissions to EPA and cover direct emissions from stationary combustion sources, direct emissions from mobile combustion sources, and indirect emissions from purchased electricity.


 

EPA is inviting public comment on its analysis of greenhouse gas (GHG) emissions from the production and transport of cottonseed oil feedstock used in the production of biofuels. The Federal Register notice also provides an overview as to how EPA may apply its analysis in future determinations, as to whether biofuels from cottonseed oil will meet the criteria for renewable fuel under the Renewable Fuel Standard program. EPA notes that, based on its current analysis, it anticipates that biofuels produced from cottonseed oil could qualify as biomass-based diesel or advanced biofuel if typical fuel production process technologies are used. Comments on the draft analysis must be submitted by August 13, 2015.


 
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