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 Lynn L. Bergeson and Margaret R. Graham

On May 18, 2017, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) published a notice in the Federal Register announcing the dates it would be hosting three public meetings to provide the public with an opportunity to offer comments on the proposed revisions to its regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered (GE) organisms.  82 Fed. Reg. 22802.  USDA has stated that it is updating its regulations “in response to advances in genetic engineering and [its] accumulated experience in implementing the current regulations, as well as [to] reduce the burden on regulated entities.”  The dates and locations for the public meetings are:

  • June 6, 2017, at the APHIS Center for Animal Welfare in Kansas City, Missouri;
  • June 13, 2017, at the University of California, Davis Conference Center, Davis, California; and
  • June 16, 2017, at the USDA Center at Riverside, Riverdale, Maryland. 

APHIS will be accepting comments on the proposed revisions until June 19, 2017, in Docket ID No. APHIS-2015-0057-0001Registration is available online.  The meetings will be webcast for those unable to attend in person.


 

By Kathleen M. Roberts

On April 25, 2017, the U.S. Department of Agriculture’s (USDA) Rural Business-Cooperative Service published in the Federal Register a notice that it is requesting approval from the Office of Management and Budget (OMB) of a revision to a currently approved information collection for the Advanced Biofuel Payment Program, which provides funding to eligible advanced biofuel producers to support the production of biofuel products.  The Rural Business-Cooperative Service is specifically seeking comments on the following topics:

  • Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
  • The accuracy of the agency's estimate of the burden of the proposed collection of information including the validity of the methodology and assumptions used;
  • Ways to enhance the quality, utility, and clarity of the information to be collected; and
  • Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.                          
Comments on this notice, which are due by June 26, 2017, will be summarized and included in the request for OMB approval. 

 

On February 17, 2017, the U.S. Department of Agriculture (USDA) announced it is accepting applications for the Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program.  The Program provides guaranteed loans for projects developing, constructing, or retrofitting commercial scale biorefineries and biobased product manufacturing facilities.  The developments must use eligible technology, including new commercial scale processing and manufacturing equipment.  Applicants must submit a Letter of Intent by March 6, 2017, that identifies the Borrower, Lender, and Project sponsors, and describes the project, project location, proposed feedstock, primary technologies of the facility, primary products, loan amount, and total project cost estimate.  Applications are due on April 3, 2017, at 4:30 pm (EDT)


 

On February 21, 2017, USDA announced in the Federal Register that the comment period for the Designation of Product Categories for Federal Procurement proposed rule had been extended.  The proposed rule aims to amend the Guidelines for Designating Biobased Products for Federal Procurement to add 12 product categories composed of intermediate ingredient and feedstock materials and to propose a minimum biobased content for each category.  In addition to the product categories and biobased content, USDA is seeking comments on appropriate performance standards for each product category, the positive environmental and human health attributes of biobased products within the proposed categories, and how small businesses may be affected by the proposed rule.  Comments are now due by April 13, 2017.


 

On January 13, 2017, the DOE Bioenergy Technologies Office (BETO), together with the U.S. Department of Agriculture (USDA) National Institute of Food and Agriculture (NIFA), announced the intent to issue a request for applications (RFA) titled “Fiscal Year 17 Biomass Research and Development Initiative (BRDI).”  Projects funded through BRDI must address one of the foll owing topic areas:
 



 
Feedstocks development :  Research, development, and demonstration (RD&D) focused on feedstocks and feedstock logistics as it relates to the production of raw materials for conversion to biofuels and biobased products;
 



 
Biofuels and biobased products development :  RD&D focused on the development of cost-effective, innovative technologies for the use of cellulosic biomass in the production of biofuels, bioenergy, and biobased products, and product diversification to increase the feasibility of fuel production in a biorefinery; and
 

 
Biofuels development analysis :  Optimization of performance and quantification of the project’s impact on sustainability using systems evaluation methods.
 
The full RFA is expected to be posted on the Office of Energy Efficiency and Renewable Energy’s (EERE) Exchange in February 2017, with the full notice of intent currently available.

 

On January 12, 2017, USDA released a report on the lifecycle greenhouse gas (GHG) balance of corn ethanol, titled “A Life-Cycle Analysis of the Greenhouse Gas Emissions of Corn-Based Ethanol.”  The study reviewed industry and farm sector performance over the past decade and found that in the United States corn-based ethanol generates 43 percent less GHG emissions than gasoline.  Compared to previous studies, the lifecycle GHG benefits were greater due to improvements in corn production efficiency, conservation practices, and ethanol production technologies.  The report also presented two projected GHG emissions profiles for corn ethanol in 2022, with one assuming a continuation of observable trends and the other analyzing additional improvements that could further reduce the GHG emissions.


 

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.


 

On January 6, 2017, the U.S. Department of Energy (DOE) and USDA announced a $22.7 million funding opportunity to support integrated biorefinery (IBR) optimization, with DOE providing up to $19.8 million and USDA’s National Institute of Food and Agriculture (NIFA) providing up to $2.9 million .  To date, there are only a limited number of pioneer-scale commercial IBRs in the early stages of start-up and production, due to the technical and non-technical challenges associated with the reliable and continuous operation of IBRs.  The funding opportunity will be jointly managed by the DOE’s Bioenergy Technologies Office (BETO) and USDA-NIFA to address the barriers impeding the wider deployment of highly efficient IBR facilities, including increased capital, operational expenses, and scale-up complications.  Projects will be selected from the following topic areas:
 



 
Robust, continuous handling of solid materials (dry and wet feedstocks, biosolids, and/or residual solids remaining in the process) and feeding systems to reactors under various operating conditions;
 

 
High value products from waste and/or other under-valued streams in an IBR; 
 

 
Industrial separations within an IBR; and  
 
Analytical modeling of solid materials (dry and wet feedstocks, and/or residual solids remaining in the process) and reactor feeding systems. 
 
The submission deadline for concept papers is February 6, 2017, and the submission deadline for full applications is April 3, 2017.

 

On December 29, 2016, the U.S. Department of Agriculture (USDA) Commodity Credit Corporation (CCC) published in the Federal Register a notice of available funds regarding the Biofuel Production Incentive (BPI) for companies refining biofuel from certain domestically grown feedstocks. The notice aims to improve transparency and simplify the process of administering CCC funds to support the Farm-to-Fleet program by identifying a specific BPI payment rate. The Farm Service Agency (FSA), which administers CCC funds, will determine the per gallon incentive amount by multiplying the number of gallons of qualifying biofuel blend delivered to the U.S. Department of Navy by the appropriate payment rate based on the table below. The type of feedstock used does not affect the payment rate, as it is solely based on the blend rate of the biofuel. There is currently $50 million in funding available through 2018 to support the BPI payments. Biofuel vendors with a Defense Logistics Agency (DLA) Energy contract that deliver eligible blended F–76 or JP–5 biofuel and meet the eligibility requirements can submit a claim to receive a BPI payment. 
 

Blend rate BPI payment rate per gallon
10% 8.3350 cents
11% 9.1685 cents
15% 12.5025 cents
20% 16.6700 cents
25% 20.8375 cents
30% and up to a maximum as permitted by the MILSPEC 25.0000 cents

 

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.


 
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