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.
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By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

On January 13, 2020, U.S. Representative Cindy Axne announced that the Government Accountability Office (GAO) has responded to a bipartisan letter submitted by members of the House Biofuels Caucus (HBC) requesting an investigation into misuse of small refinery exemptions (SREs) by the U.S. Environmental Protection Agency (EPA). Submitted in August 2019, the bipartisan letter requested that GAO examine EPA’s review and approval of SRE waivers under the Renewable Fuel Standard (RFS). HBC’s letter also included a request for inspection of the U.S. Department of Energy’s (DOE) viability scores for SREs reviewed in 2018. HBC’s concerns were mostly related to the economic consequences to rural communities due to the exemption of approximately four billion gallons of fuel from the RFS in 2018. In addition to the aforementioned requests, HBC members asked that GAO also consider the following questions:

  • Has DOE changed the criteria, the interpretation of the criteria, the methodology, or any other significant aspect of how it makes its recommendations to EPA for SREs?
     
  • Other than the viability score provided by DOE, what other factors are being considered by EPA in awarding SRE waivers? How has this changed since the previous Administration?
     
  • Since the development of DOE’s 2011 methodology, what percentage of applications that received a disqualifying viability score from the DOE were granted?
     
  • How many times has DOE recommended a partial waiver for a refinery?
     
  • Has EPA granted a partial waiver?
     
  • Does EPA or DOE consider the economic viability of the parent refiner company when considering an application from an individual refinery?
     
  • Does DOE take Renewable Identification Numbers (RIN) into account when assessing relief petitions?

On January 10, 2020, GAO responded to the bipartisan request, agreeing to review matters related to the approval of SRE waivers and stating that it will begin its work shortly. Mark E. Gaffigan, Managing Director of GAO’s Natural Resources and Environment, and his staff will be in charge of the investigation.

In August 2019, Axne had also submitted a letter to EPA’s Acting Inspector General (IG), Charles Sheehan, requesting an investigation of this matter. In its response letter to HBC, GAO stated that it will be in contact with the cognizant IG’s office to ensure that efforts are not duplicated.


 
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By Lynn L. Bergeson

On January 10, 2020, DOE announced that it will provide up to $75 million for research and development (R&D) of sustainable bioenergy crops within a period of five years. The bioenergy crops to be developed should be tolerant of environmental stress and resilient to changing environment conditions. Funded projects will focus on better comprehending the genetic and physiological mechanisms influencing plant productivity, resource use, and resilience, among other factors. DOE is encouraging researchers to draw on resources of its Office of Science user facilities and to take advantage of “omics” tools and techniques, including genomics, proteomics, and metabolomics. Funding applications will be open for industry, non-profit research institutions, and universities with possible collaborators at DOE national laboratories and other federal agencies. Beginning this fiscal year, funding will be awarded in the form of five-year grants ranging from $1 to $3 million per year. DOE’s funding opportunity announcement (FOA) and a companion laboratory call can be accessed here.

Tags: DOE, Biofuel

 
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By Lynn L. Bergeson

On January 10, 2020, the National Farmers’ Union of Scotland (NFUS) announced its pursuit for high level solutions to machinery problems linked to biofuel content. According to NFUS, many Scottish and UK farmers are experiencing issues because of the percentage of biofuel content in fuel for farming machinery. In December 2019, NFUS submitted a letter to Grant Shapps, Member of Parliament (MP) and Secretary of State for Transport, requesting long-term solutions for this problem. NFSU’s key requests include:

  • Broker a fuel replacement scheme to enable farmers with problematic fuel to receive a fuel uplift and refill of alternative fuel suitable for their needs;
     
  • Conduct a review of the specification and testing protocols ensuring that fuel produced in the UK is fit for farmers’ purposes and is reliable;
     
  • Ensure that the review of specifications and testing protocols occur in a timely manner to prevent a future crisis; and
     
  • Lead further research into the behavior of recycled oil and animal fats within diesel to determine if specific components need to be excluded from it.

Also in December 2019, NFUS representatives attended a meeting with industry experts, which resulted in the creation of a task force to begin working on this issue immediately. NFUS Policy Adviser Zoe Meldrum stated, “Fuel problems remain a top priority for our members and time and resource continues to be dedicated towards finding practical solutions and apply lessons from this event to ensure fuel issues such as this cannot impact agriculture again.”


 
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By Lynn L. Bergeson

On January 1, 2020, U.S. President Donald Trump released a statement recognizing the beginning of National Biotechnology Month and the country’s “enormous potential” of biotechnology to improve lives in the United States and around the globe. Highlighting the benefits of biotechnology in different sectors, President Trump states that for every one job in biotechnology, nearly two other jobs are created in various sectors in the rural United States. In his statement, the President assures Americans that his policies to encourage innovation and drive job growth will continue:

As we mark the start of National Biotechnology Month and a new decade of American ingenuity, we recognize the importance of American leadership in maintaining science- and risk-based review and regulation of biotechnology products, promoting and safeguarding critical biotechnology infrastructure and data, and preparing the next generation of biotechnology scientists, engineers, and innovators. Together, we can ensure this booming, innovative industry continues to foster economic growth and American innovation.


 
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By Lynn L. Bergeson

On January 9, 2020, also in recognition of National Biotechnology Month, the U.S. Department of Agriculture (USDA), the U.S. Food and Drug Administration (FDA), and the U.S. Environmental Protection Agency (EPA) announced the launch of a unified website for biotechnology regulation. Streamlining information about the three agencies in charge of overseeing agriculture biotechnology products, this website comes, in part, to fulfill President Trump’s Executive Order (EO) on Modernizing the Regulatory Framework for Agricultural Biotechnology Products. The unified website also describes the federal review process for certain biotechnology products and allows users to submit questions to USDA, FDA, and/or EPA. Aiming to improve customer service to innovators and developers, the three agencies also wish to assure Americans about the safe use of biotechnology innovations. According to USDA Secretary of Agriculture, Sonny Purdue, all Americans deserve transparency and science-based regulations that foster innovation, conserve resources, and protect public health. BRAG will supplement this notice with more information next week.


 
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By Lynn L. Bergeson

On January 8, 2020, the U.S. Department of Energy (DOE) announced the launch of its Energy Storage Grand Challenge (the Grand Challenge). A comprehensive program to accelerate the development, commercialization, and utilization of next-generation energy storage technologies, the Grand Challenge builds on the $158 million Advanced Energy Storage Initiative announced in President Trump’s Fiscal Year (FY) 2020 budget request. U.S. Secretary of Energy Dan Brouillette states that the Grand Challenge will address the creation and sustainability of U.S. global leadership in energy storage utilization and exports, with a secure and independent manufacturing supply chain. Through a series of research and development (R&D) funding opportunities, prizes, partnerships, and other programs, the Grand Challenge aims to achieve the following goals by 2030:

  • Technology Development -- through the establishment of a comprehensive R&D portfolio;
     
  • Technology Transfer -- through the acceleration of the technology pipeline from research to private-sector adoption;
     
  • Policy and Valuation -- through the development of best models, data, and analysis to inform effective value propositions and use cases for storage technologies;
     
  • Manufacturing and Supply Chain -- through design of new technologies that will strengthen U.S. manufacturing, recyclability, and independence from foreign sources; and
     
  • Workforce -- through training the next generation of American workers to meet 21st century electric grid and energy storage value chain needs.

As its first step in the Grand Challenge, DOE plans on releasing requests for information (RFI) on the key questions and issues the challenge seeks to address in the near future. Also in the coming weeks, DOE intends to host a series of workshops with key stakeholders to share information about various storage technologies, barriers to their deployment, and overcoming these barriers to bring technologies to market.

Tags: DOE, Challenge

 
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By Lynn L. Bergeson

On January 2, 2020, EPA published a Federal Register notice announcing the availability of the updated “Working Approach” document for a 45-day comment period. As reported in the Bergeson & Campbell, P.C. (B&C®) December 20, 2019, blog item, EPA released an updated version of the “Working Approach” document that builds upon EPA’s November 2017 “New Chemicals Decision-Making Framework: Working Approach to Making Determinations under Section 5 of TSCA.” Comments are due on or prior to February 18, 2020. The updated document explains its approach for making one of the five affirmative determinations on new chemical notices under the Toxic Substances Control Act (TSCA):

  • The chemical or significant new use presents an unreasonable risk of injury to health or the environment;
     
  • Available information is insufficient to allow EPA to make a reasoned evaluation of the health and environmental effects associated with the chemical or significant new use;
     
  • In the absence of sufficient information, the chemical or significant new use may present an unreasonable risk of injury to health or the environment;
     
  • The chemical is or will be produced in substantial quantities and either enters or may enter the environment in substantial quantities or there is or may be significant or substantial exposure to the chemical; or
     
  • The chemical or significant new use is not likely to present an unreasonable risk of injury to health or the environment.

EPA notes that the updated document reflects feedback from a 2017 public meeting and comment period and EPA’s additional experience implementing the 2016 amendments to TSCA Section 5, and includes:

  • Additional clarification and detail throughout;
     
  • General guiding principles and concepts for making determinations;
     
  • Decision-making logic and key questions that EPA must address; and
     
  • Example applications of the Working Approach to reach each of the affirmative determinations under TSCA Section 5(a)(3).

EPA has posted a document summarizing public comments received on the 2017 document and its responses. More information is available in B&C’s December 20, 2019, memorandum, “EPA Releases Updated Version of ‘Working Approach’ Document for New Chemicals Review.”


 
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By Lynn L. Bergeson

On January 6, 2020, the American Chemical Society’s (ACS) Green Chemistry Institute opened its call for abstracts for the 24th Annual Green Chemistry & Engineering Conference (GC&E). This year, the conference will be held in Seattle, WA, from June 16 to June 18, 2020. Conference sessions will include a wide variety of topics, including biobased and renewable chemicals innovation, innovation in analytical chemistry applications, and making organic chemistry more sustainable. The full list of sessions can be accessed here. Parties interested in submitting an abstract can do so here prior to February 17, 2018.


 
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By Lynn L. Bergeson

In late December 2019, CRDF Global, an independent non-profit focused on the global scientific community and alternatives to weapons research, announced a partnership with the Ministry of Education and Science of Ukraine (MES) in launching the 2020 U.S.-Ukraine Alternative Energy Research Competition. Currently accepting proposals from joint teams of U.S. and Ukrainian researchers, the competition will focus on the advancement of alternative energy sources. Intended to work toward a future of affordable solutions to address the rapid increase of the global population and, consequently, energy consumption increase, the competition is accepting proposals that directly apply to photovoltaic or biofuel technology. These include proposals on engineering, nanotechnology, biochemistry, microbiology, and plant study research. Awards of up to $72,000 will be provided for 12 months. Proposals are due no later than February 28, 2020.


 
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By Lynn L. Bergeson

On December 19, 2019, the U.S. Environmental Protection Agency (EPA) Administrator, Andrew Wheeler, signed the final rule on the Renewable Fuel Standard (RFS) program, setting the renewable fuel percentages for 2020. Titled Renewable Fuel Standard Program: Standards for 2020 and Biomass-Based Diesel Volume for 2021 and Other Changes, the final rule establishes the annual percentage standards for cellulosic biofuel, biomass-based diesel, advanced biofuel, and total renewable fuel that apply to gasoline and diesel transportation fuel produced or imported in 2020. The rule also establishes the applicable volume of biomass-based diesel for 2021. The final volume requirements can be accessed here. Thus far, industry stakeholders seem displeased with the standard calculations to account for volumes of fuels projected to be exempted from the renewable volume obligations (RVOs). The waiver limits biofuel producers were hoping for are not reflected in the final rule. While the final rule has not yet been published in the Federal Register (FR), it will become effective 60 days after the FR publication. Bergeson & Campbell, P.C. will continue to monitor and provide further details once the final rule is published.

Tags: RFS, Biofuel

 
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By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

The implementation date of the United States (U.S.) National Bioengineered Food Disclosure Standard (NBFDS) is January 1, 2020. Adopted in February 2019 by the U.S. Department of Agriculture’s (USDA) Agricultural Marketing Services (AMS), the NBFDS regulations (7 C.F.R. Part 66) directed USDA to establish a national mandatory standard for disclosing foods that are or may be bioengineered (BE). NBFDS requires food manufacturers, importers, and certain retailers to disclose information about whether food offered for sale is BE or uses BE food ingredients. Designed to inform consumers about the food they are purchasing, AMS developed a list of BE foods to identify crops or foods that are available in BE form. In this case, USDA defines BE foods “as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in nature.” The list includes any BE crops or foods that are in legal production somewhere in the world and is to be updated by AMS annually. Because new BE crops and foods continue to be developed, even if a food is not listed, regulated entities whose records show that a food they are selling is BE must make the appropriate food disclosure. The NBFDS timeline is as follows:

  • Implementation Date: January 1, 2020, for large food manufacturers; January 1, 2021, for small food manufacturers;
  • Voluntary Compliance Date: ends on December 31, 2021; and
     
  • Mandatory Compliance Date: January 1, 2022.

A decision tool has been made available by USDA to guide regulated entities subject to NBFDS in determining whether compliance with the law is necessary. The tool is to be used for each individual ingredient that may be used in a food. Frequently asked questions (FAQ) are also available.

Tags: USDA

 
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By Lynn L. Bergeson

On December 13, 2019, EPA announced that it has contracted the National Academies of Science (NAS) to conduct a peer review of its Application of Systematic Review in TSCA Risk Evaluations. According to EPA, this review will help provide it with important feedback on its approach to selecting and reviewing the scientific studies that are used to inform Toxic Substances Control Act (TSCA) risk evaluations. EPA states that “integrating systematic review principles into the TSCA risk evaluation process is critical to developing transparent, reproducible and scientifically credible risk evaluations.” EPA will provide NAS with the document published in June 2018, “as well as additional publicly available information” that can inform its review, including previously received public comments on this method. NAS will use their study process to conduct an objective and independent peer review, including convening a public meeting and issuing a final report, by June 2020. EPA notes that it will continue its work on the risk evaluations currently underway using the established systematic review process. EPA will incorporate NAS’s recommendations “as appropriate into our systematic review methods and use the updated process in future risk evaluations as timing allows.”


 
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By Lynn L. Bergeson

On December 9, 2019, the Sustainable Chemistry Research and Development Act of 2019 (H.R. 2051) was passed by the House of Representatives. H.R. 2051 establishes an interagency working group (IWG) led by the Office of Science and Technology Policy to coordinate Federal programs and activities in support of sustainable chemistry. The IWG will develop a roadmap for sustainable chemistry with a framework of attributes characterizing sustainable chemistry, assess the state of sustainable chemistry in the United States, and identify methods by which federal agencies can incentivize sustainable chemistry activities, challenges to sustainable chemistry progress, and opportunities for expanding federal sustainable chemistry efforts. On December 10, 2019, the bill was received in the Senate, read twice, and referred to the Committee on Commerce, Science, and Transportation.


 
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By Lynn L. Bergeson

On December 9, 2019, 22 Senate Democrats released a letter supporting the expansion of green energy tax credits. This letter was drafted in response to the Growing Renewable Energy and Efficiency Now (GREEN) Act discussion draft that was circulated in the U.S. House of Representatives on November 19, 2019. The Senators agree with the priorities of the GREEN Act and pledge to similarly prioritize and include:

  • Offshore Wind Investment Tax Credit,
     
  • Storage Investment Tax Credit,
     
  • Solar and Clean Energy Investment Tax Credit Extension,
     
  • Energy Efficiency Tax Credit,
     
  • Clean Vehicles, and
     
  • Onshore Wind.
     

 
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By Lynn L. Bergeson

The U.S. Environmental Protection Agency (EPA) announced on December 9, 2019, that in advance of its December 10, 2019, public meeting on new chemicals, it is providing the meeting materials and announcing the availability of a new web page detailing cases with completed confidential business information (CBI) determinations under the Toxic Substances Control Act (TSCA). Materials for the December 10, 2019, meeting include:

The new CBI web page includes a table of all the final CBI determinations under TSCA Section 14(g). The table contains information from CBI reviews including:

  • Case Number;
     
  • Submission Type;
     
  • CBI Review Category (specific chemical identity, other information, or both);
     
  • Final Determination;
     
  • Determination Rationale Summary;
     
  • For CBI Claims for Specific Chemical Identity:
     
    • EPA Unique Identifier (UID);
       
    • Accession Number;
       
    • Generic Name; and
  • Expiration Date for Chemical Identity and Non-Chemical Identity CBI Claims.

EPA states that it plans to update this information on a quarterly basis.

Tags: TSCA, CBI

 
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