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 Richard E. Engler, Ph.D.
On June 12, 2017, the U.S. Environmental Protection Agency (EPA) awarded the 2017 Green Chemistry Challenge Award winners at a ceremony in Washington, D.C. in conjunction with the 21st Annual Green Chemistry and Engineering Conference. The award recognizes landmark green chemistry technologies developed by industrial pioneers and leading scientists that turn potential environmental issues into business opportunities, spurring innovation and economic development. The American Chemical Society (ACS) Green Chemistry Institute convened an independent panel of technical experts to judge the 2017 submissions and make recommendations to EPA regarding the winners.
This year's winners and technologies are:
Over the course of the Green Chemistry Challenge’s 22 year history, EPA estimates that winning technologies are responsible for annually reducing the use or generation of more than 826 million pounds of hazardous chemicals, saving 21 billion gallons of water, and eliminating 7.8 billion pounds of carbon dioxide equivalent releases to air. While we are saddened that this very successful voluntary program is slated to be defunded in the President's FY2018 budget, we applaud this year’s winners. Those who value the green chemistry program should consider contacting their Senators and Representatives to encourage continued support of this program. It has had outsized benefits for such a modestly funded program.
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 Lauren M. Graham, Ph.D.
On May 10, 2017, the U.S. Environmental Protection Agency (EPA) released Renewable Identification Numbers (RIN) generation data for April 2017, reporting that nearly 1.5 billion RINs were generated during the month.
Nearly 17.3 million D3 cellulosic biofuel RINs were generated in April, bringing the total for 2017 to 49.9 million, including 1.3 million D3 RINs generated for ethanol, 17.9 million generated for renewable liquefied natural gas, and 30.7 million generated for renewable compressed natural gas. Of the 49.9 million RINs, 44.7 million were generated by domestic producers, and 5.2 million were generated by importers.
More than 279.6 million D4 biomass-based diesel RINs were generated in April, resulting in a total of 973.3 million for 2017. The majority of RINs, 736.5 million, were generated for biodiesel, with 235.9 million for non-ester renewable diesel, and 937,219 for renewable jet fuel. Nearly 694.9 million RINs were generated by domestic producers, with 168.5 million generated by importers and nearly 109.9 million generated by foreign entities.
For D5 advanced biofuel, 7.0 million RINs were generated in April, which brought the total for 2017 to nearly 22.7 million. Naphtha accounted for the majority of RINs generated, 10.9 million, with 8.1 million generated for ethanol, 890,603 generated for heating oil, and 2.7 million generated for non-ester renewable diesel. In 2017, all D5 advanced biofuel RINs were generated by domestic producers.
Nearly 1.2 billion RINs were generated for D6 renewable fuel in April, resulting in a total of nearly 4.9 billion for 2017. The majority of RINs were generated for ethanol, nearly 4.8 billion, with nearly 84.8 million generated for non-ester renewable diesel. Nearly 4.8 billion RINs were generated by domestic producers, with 3.8 million generated by importers and nearly 84.8 million generated by foreign entities.
The data indicates that no D7 cellulosic RINs have been generated in 2017.
By Kathleen M. Roberts
On May 9, 2017, Senator Elizabeth Warren (D-MA), along with seven additional Democratic Senators, sent a letter to the Securities and Exchange Commission (SEC), the U.S. Environmental Protection Agency (EPA), and the Commodities Futures Trading Commission (CFTC) requesting an investigation into the activities of Carl Icahn for potential insider trading, market manipulation, and other securities and commodities law violations in the renewable fuel credit market. The letter states that the actions of and the massive profit earned by Icahn raise questions related to conflict-of-interest rules that apply to government officials, and questions regarding insider trading and market manipulation of renewable fuel credits, known as Renewable Identification Numbers (RIN) -- which SEC, EPA, and CFTC have jurisdiction over. EPA oversees the issuance and trading of RINs. CFTC works with EPA to ensure integrity in the RIN market since it has broad authority to prevent insider trading and other market manipulation in commodities markets and futures markets. SEC has jurisdiction to investigate whether Icahn’s actions as a senior adviser to President Trump affected CVR Energy's stock value or the accuracy of the company's annual and quarterly financial reporting and disclosure.
The Senators maintained that RIN insider trading and market manipulation hurts all parties, including biofuel producers and refineries, and requested an investigation by the three agencies based on the publically available information detailed in the letter. The Senators also requested information on whether EPA Administrator Scott Pruitt and SEC Chairman Jay Clayton would recuse themselves from the investigation.
By Kathleen M. Roberts
On May 1, 2017, DOE’s Office of Energy Efficiency and Renewable Energy (EERE) published a notice in the Federal Register regarding its intent to extend its use of the EERE Environmental Questionnaire, with changes, for three years. The questionnaire allows EERE to collect project-specific information from federal financial assistance awardees to evaluate the potential environmental impact of projects that it is considering for funding, pursuant to the National Environmental Policy Act (NEPA) of 1969.
EERE is also requesting comments on the questionnaire, specifically on:
- Whether the proposed collection of information is necessary for the proper performance of the functions of DOE, including whether the information shall have practical utility;
- The accuracy of DOE'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 respondents, including through the use of automated collection techniques or other forms of information technology.
Comments are due by June 30, 2017.
By Lauren M. Graham, Ph.D.
On April 24, 2017, U.S. Department of Justice (DOJ) attorneys representing the U.S. Environmental Protection Agency (EPA) and the renewable fuels and petroleum industries presented oral arguments before a three-judge panel of the U.S. Court of Appeals for the D.C. Circuit regarding the petition to review the renewable volume obligations (RVO) for 2014-2016. The petition, which was filed on January 8, 2016, by seven biofuel and agricultural groups, challenged EPA’s authority to set volume requirements for biofuel blending below standards put forth in the 2007 Renewable Fuel Standard (RFS) law. During the oral arguments, Samara Spence, a DOJ attorney, argued that insufficient infrastructure prevented EPA from setting a higher advanced biofuel standard in the 2014-2016 final rule. Seth Waxman, an attorney representing Americans for Clean Energy, argued that EPA misunderstood its authority under the statute. According to statements from the federal appeals court judges, scaling back the blending requirements may be viewed as an abuse of EPA’s authority.
In a joint statement in response to the oral arguments, the American Coalition for Ethanol, BIO, Growth Energy, the National Corn Growers Association, the National Sorghum Producers, and the Renewable Fuels Association stated that they are “optimistic that the Court will honor Congress’ intent and remove these and other obstacles EPA has impermissibly erected to cleaner and more sustainable renewable fuels from entering the marketplace.” More information on the petition to review the RFS for 2014, 2015, and 2016 is available in the Biobased and Renewable Products Advocacy Group (BRAG®) blog post “Biofuel, Corn, And Sorghum Farmers Challenge Lowered RFS Volumes.”
By Lauren M. Graham, Ph.D.
On April 24, 2017, Bob Dineen, President and CEO of the Renewable Fuels Association (RFA) sent a letter to EPA Administrator Scott Pruitt requesting that the 2018 Renewable Fuel Standard (RFS) Renewable Volume Obligations (RVO) rulemaking remain on schedule and maintain the conventional renewable fuel requirement at the statutory level of 15 billion gallons. According to the letter, regulatory certainty and sufficient lead time for planning are required to allow regulated parties to adapt and comply with the RFS.
The letter states that ethanol producers are set to produce a record supply of 16 billion gallons of conventional renewable fuel in 2017, which is well above the 15-billion-gallon conventional renewable fuel RVO, and refiners and blenders have increased the inclusion of ethanol in U.S. gasoline. Additionally, data from the Energy Information Administration (EIA) demonstrates that, on average, the ethanol content of gasoline consumed in the U.S. in 2016 was above the purported “blend wall.” Dinneen urged Pruitt to ensure a timely RVO rulemaking process to allow the evolution of the marketplace to continue.
By Richard E. Engler, Ph.D.
On April 5, 2017, the U.S. Environmental Protection Agency (EPA) announced that Industrial Microbes, Inc. (Industrial Microbes) has been awarded $300,000 in funding through the Small Business Innovation Research (SBIR) Program to develop a green fermentation platform to replace carbon-emitting petrochemical production with newer methods that use methane and carbon dioxide to produce chemicals. The project aims to improve the efficiency of chemical manufacturing while limiting pollution using a fermentation process based on engineered enzyme pathways within living cells, similar to the chemical conversion process used to brew beer. Well-to-gate life cycle analysis of the process demonstrated that carbon dioxide emissions were reduced by six-fold compared to the current production process, due to carbon dioxide fixation and more efficient unit operations. Industrial Microbes is one of nine small businesses that received a total of nearly $2.7 million in funding through the SBIR Program to develop and commercialize new environmental technologies.