By Lynn L. Bergeson and Margaret R. Graham
On June 30, 3017, the National Academies of Sciences, Engineering, and Medicine (NAS) released its final version of its report Preparing for Future Products of Biotechnology, which it states “analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making [and] … identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.” This report is a collaboration among a committee of experts including the Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System (Committee), the Board on Life Sciences, the Board on Agriculture and Natural Resources, the Board on Chemical Sciences and Technology, and the Division on Earth and Life Studies and sponsored by the U.S. Environmental Protection Agency (EPA), the U.S. Department of Agriculture (USDA), and the U.S. Food and Drug Administration (FDA). Lynn L. Bergeson was an external contributor to the Committee’s deliberations and presented before the Committee on the subject of the biotechnology regulatory system.
The report includes sections on emerging trends and products of biotechnology; the current biotechnology regulatory system; understanding risks related to future biotechnology products; opportunities to enhance the capabilities of the biotechnology regulatory system; and an index on congressionally defined product categories that FDA regulates; as well as conclusions and recommendations that were included in our blog item on the prepublication version.
More information on the regulatory issues of biotechnology products is available on our biobased products blog under key word biotechnology, as well as the Bergeson & Campbell, P.C. (B&C®) regulatory developments website under key phrase biobased products, biotechnology.
By Kathleen M. Roberts
On June 5, 2017, the U.S. Department of Energy (DOE), in collaboration with the U.S. Department of Agriculture’s (USDA) National Institute of Food and Agriculture (NIFA), announced that up to $9 million in funding will be available through the Biomass Research and Development Initiative (BRDI) in fiscal year (FY) 2017. Projects funded by BRDI will focus on developing economically and environmentally sustainable sources of renewable biomass, increasing the availability of renewable fuels and biobased products, and diversifying the nation’s energy portfolio. DOE and NIFA are soliciting applications from all interested parties, including for-profit entities, universities, nonprofits, and national laboratories, to address any or all of the following legislatively mandated technical areas:
- Feedstocks development;
- Biofuels and biobased products development; and
- Biofuels development analysis.
DOE anticipates funding one to six awards and NIFA anticipates funding three to 14 awards, with awards ranging from $500,000 to $2 million. Concept papers are due by July 7, 2017
, and full applications are due by September 22, 2017
. More information on BRDI is available on DOE's Office of Energy Efficiency and Renewable Energy (EERE) Exchange website
By Lauren M. Graham, Ph.D.
On May 23, 2017, President Trump released the Administration’s proposed budget for fiscal year (FY) 2018, which includes significant cuts to the U.S. Department of Energy (DOE), U.S. Environmental Protection Agency (EPA), and U.S. Department of Agriculture (USDA) budgets. According to the proposed budget, funding for DOE would be cut by 5.6 percent to $28 billion, with $636 million allotted for the Office of Energy Efficiency and Renewable Energy (EERE) and $56.6 million for the Bioenergy Technologies Office (BETO). The proposed DOE budget aims to eliminate the Advanced Research Projects Agency – Energy (ARPA-E), which advances high-potential, high-impact energy technologies that are too early for private-sector investment.
The proposed EPA budget of $5.7 billion would cut funding by 31 percent when compared to estimated 2017 appropriations. Funding for the Clean Power Plan and climate change research and partnership programs, such as the Energy Star program, would be eliminated. Also included in the cuts would be a $17 million reduction in funding for the Federal Vehicle and Fuels Standards and Certifications program, which oversees the Renewable Fuel Standard (RFS) program. According to EPA, it will continue to implement, maintain oversight of, and evaluate compliance with the RFS program in 2018.
Under the proposed budget, funding for mandatory USDA programs would decrease from $123 billion in FY 2017 to $116 billion in FY 2018 and funding for discretionary programs would decrease from $26 billion to $21 billion. The Biomass Crop Assistance Program and the Rural Energy for America Program are among the programs targeted for elimination.
More information on the proposed agency budgets is available at the DOE, EPA, and USDA websites.
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-2015-0057-0001. Registration 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.
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.