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

On May 29, 2020, the U.S. Environmental Protection Agency (EPA) issued a pre-publication version of a proposed anti-backsliding determination that no additional measures are necessary pursuant to the Clean Air Act (CAA) Section 211(v) to mitigate the adverse air quality impacts of renewable fuel volumes required under CAA Section 211(o). The proposed determination will be published in the Federal Register for a 30-day comment period. CAA Section 211 requires EPA to take two actions. The first action is for EPA to complete a study to determine whether renewable fuel volumes required under CAA Section 211(o) will adversely impact air quality given changes of vehicle and engine emissions of air pollutants. This study is often referred to as the anti-backsliding study and must include consideration of various blend levels, types of renewable fuels, and available vehicle technologies. The study must also include appropriate national, regional, and local air quality control measures. EPA has completed the study, which is available here.

The second action requires EPA to make a decision on whether it should proceed down one of the following paths:

  • Promulgation of fuel regulations to implement appropriate measures to mitigate any adverse impacts on air quality as a result of the renewable volumes required by Section 211; or
     
  • Determination that no such measures are required.

In this case, EPA is proposing a determination “that no additional appropriate fuel control measures are necessary to mitigate adverse air quality impacts of required renewable fuel volumes.”


 
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By Lynn L. Bergeson

EPA announced on June 1, 2020, the availability of the latest Toxic Substances Control Act (TSCA) Inventory. EPA notes that this biannual update to the public TSCA Inventory is part of its regular posting of non-confidential TSCA Inventory data. EPA plans the next regular update of the Inventory for early 2021. According to EPA, the Inventory contains 86,405 chemicals, of which 41,587 are active in the United States commerce. Other updates to the TSCA Inventory include updates to commercial activity data and regulatory flags, such as consent orders and significant new use rules (SNUR).


 
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By Lynn L. Bergeson

On June 3, 2020, the U.S. Department of Energy (DOE) Office of Energy Efficiency and Renewable Energy (EERE) announced that it will be hosting a public virtual workshop titled “Workshop on Predictive Models and High Performance Computing as Tools to Accelerate the Scaling-up of New Bio-Based Fuels.” The goal is to determine if predictive models and high performance computing can and should be used to reduce biotechnology uncertainty and accelerate scaling-up of biorefinery/chemical production equipment and optimize operations. The virtual workshop will be held from June 9 to June 11, 2020, from 10:30 a.m. to 4:30 p.m. (EDT) each day. Registration is required by 4:00 p.m. (EDT) June 5, 2020.


 
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By Lynn L. Bergeson

On June 30, 2020, from 9:00 a.m. to 5:30 p.m. (EDT),the U.S. Food and Drug Administration (FDA) will host a free regulatory training for industry on bioanalysis requirements and expectations. Focused on how FDA’s Center for Drug Evaluation and Research (CDER) approaches various issues in bioanalysis, the workshop aims to provide participants with a better understanding of how FDA performs bioanalysis. Topics to be covered, among others, include:

  • Bioanalytical method validation: history, process, and regulatory perspectives;
     
  • Biosimilars;
     
  • Regulated bioanalysis for large molecules;
     
  • Regulated bioanalysis for small molecules;
     
  • Drugs and biologics;
     
  • Bioanalysis of unstable analysis;
     
  • Repeat analysis; and
     
  • A case study on bioanalytical approaches to mitigate issues identified during bioequivalence clinical site inspection.

Registration is required.


 
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By Lynn L. Bergeson

On May 21, 2020, U.S. Senators Amy Klobuchar (D-MN) and Chuck Grassley (R-IA) introduced a bill directing the U.S. Department of Agriculture (USDA) Secretary to establish a renewable feedstock reimbursement program. Aiming to support biofuel producers that have been negatively affected by the COVID-19 pandemic, this bill can be cited as the Renewable Fuel Feedstock Reimbursement Act of 2020. Under the reimbursement program, biofuel producers will be reimbursed for their feedstock purchases from January 1, 2020, through March 31, 2020, through the Commodity Credit Corporation (CCC). Eligible parties will consist of those that produce renewable fuel used as transportation fuel and eligible feedstocks mean renewable biomass intended for production of the aforementioned renewable fuel. Furthermore, to be eligible to receive reimbursements, eligible entities must enter into an agreement with the USDA Secretary.

The two U.S. Senators initially introduced this idea in April 2020 as an amendment to the Coronavirus Aid, Relief, and Economic Stabilization (CARES) Act, which assists the biofuels industry sector. Assistance, however, was not included in the CARES Act package. Senators Klobuchar and Grassley, with industry support, now hope that this second attempt in support of the biofuels industry follows through.


 
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By Lynn L. Bergeson

On May 28, 2020, the U.S. Environmental Protection Agency (EPA) announced the issuance of the final rule amending the definition of small manufacturer, including a new definition for small government in accordance with the Toxic Substances Control Act (TSCA). Effective June 29, 2020, these amendments affect certain reporting and recordkeeping requirements in the Chemical Data Reporting (CDR) rule under TSCA.

Tags: TSCA, CDR

 
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By Lynn L. Bergeson

On May 22, 2020, EPA’s Office of Pesticide Programs (OPP) announced the opening of a 15-day comment period on its proposal to register a new active ingredient and biopesticide product. The biopesticide product, PHC-91398, would contain Ea peptide 91398, the new active ingredient that was derived from naturally occurring bacterium and induces natural plant defenses. The plant’s reaction to the peptide “activates a hypersensitive response in treated plants, which enables resistance to bacterial and fungal infection, as well as suppression of nematode egg production.” PHC-91398, the biopesticide product, is intended for use on a wide range of agricultural crops and home and garden uses. There will be three product applications:

  • Pre-plant foliar or root dip;
  • Foliar application in greenhouses and fields through a conventional spray, drip, or aerial equipment; and
  • Seed treatment.

Upon review of the data submitted in support of Ea peptide 91398, EPA states that toxicity, allergenicity to humans, and/or adverse effects on non-target organisms is not expected.

EPA is seeking comments, particularly from pesticide users, registrants, public interest organizations, and state, tribal, and local governments. Comments are due on or prior to June 5, 2020.


 
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By Lynn L. Bergeson

On May 21, 2020, the U.S. Department of Energy’s (DOE) Office of Energy Efficiency and Renewable Energy (EERE) announced the availability of approximately $21.3 million in funding for 106 Phase I small business innovation projects. The funds, announced by U.S. Secretary of Energy Dan Brouillette, are part of DOE’s $53 million available for Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) research and development projects. The selected small businesses represent 26 states. Most Phase I awards are $200,000 for a performance period of less than one year. Nine EERE technology offices will fund the awards under 12 topics.

Tags: DOE, EERE, Funding

 
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By Lynn L. Bergeson

On May 18, 2020, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) issued the much-anticipated final Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule. 85 Fed. Reg. 29790. The rule is intended to update and modernize USDA’s biotechnology regulations under the Plant Protection Act. The final rule amends the regulations regarding the movement (importation, interstate movement, and environmental release) of certain genetically engineered (GE) organisms in response to advances in genetic engineering and APHIS’s understanding of the plant pest risk posed by GE organisms, thereby reducing the regulatory burden for developers of organisms that are unlikely to pose plant pest risks. For more information, please read the full memorandum here.

Tags: USDA, APHIS, SECURE, GE

 
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By Lynn L. Bergeson

On May 18, 2020, USDA issued its final rule for the Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program (9003 Program), which incorporates the statutory definition changes as required in the Agricultural Act of 2018 (Farm Bill) and adopts the interim rule published on June 14, 2015. The 9003 Program replaces the Biorefinery Assistance Program (BAP), which guaranteed loans to fund the development, construction, and retrofitting of commercial-scale biorefineries using eligible technology. The final rule makes several specific changes to BAP, including:

  • Renames the program as the 9003 Program;
  • Revises the purpose statement for the program to include renewable chemicals and biobased product manufacturing;
  • Expands the program to include biobased product manufacturing facilities;
  • Adds definitions for “renewable chemicals” and “biobased product manufacturing”; and
  • Ensures diversity in the types of projects approved by the program.

The final rule became effective on May 18, 2020.


 
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By Lynn L. Bergeson

On May 15, 2020, U.S. Senators Cory Gardner (R-CO), Kirsten Gillibrand (D-NY), Ed Markey (D-MA), and Marco Rubio (R-FL) introduced the Bioeconomy Research and Development Act of 2020, creating a federal research initiative to ensure continued United States leadership in engineering biology. The National Engineering Biology Research and Development Initiative would focus on the advancement of societal well-being, national security, sustainability, and economic productivity and competitiveness. It would accomplish these goals through:

  • Advancement of areas of research at the intersection of biological, physical, chemical, data, and computational sciences;
  • Advancement of areas in biomanufacturing research;
  • Support of social and behavioral sciences and economics research that advances the field of engineering biology;
  • Improvement of the understanding of the engineering biology;
  • Support of risk research;
  • Development of novel tools and technologies to accelerate scientific understanding and technological innovation in engineering biology;
  • Expansion of the number of researchers, educators, and students with engineering biology training;
  • Acceleration of the translation and commercialization of engineering biology research and development by the private sector; and
  • Improvement of the interagency planning and coordination of federal government activities related to engineering biology.

According to Senator Rubio, the Bioeconomy Research and Development Act of 2020 has been endorsed by a number of leading research institutes, including the Biotechnology Innovation Organization (BIO), a Biobased and Renewable Products Advocacy Group (BRAG®) member.


 
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By Lynn L. Bergeson

The U.S. Air Force (USAF) Research Laboratory is sponsoring a $1 million challenge for synthetic biology solutions to reduce the cost and improve the quality for aerospace thermosets. This scientific challenge is focused on the use of biotechnology to create products or product precursors required by USAF. Interested parties must submit white papers on the viability of the approach to bio-synthesize two molecules A and B needed for aerospace thermosets. This is the first of three challenges and consists of three phases. Phase One is the white paper submission as previously described. Phase Two is when submitted white papers will be down-selected from the viable entrees. Potential awardees selected will then have two weeks to enter into a subsequent agreement with a company that can scale up their production concept and demonstrate capability to manufacture testable amounts with a United States company (if the awardees cannot manufacture the product themselves). In the third and final phase, semi-finalist teams will have one hour to pitch their concept and scale up strategy with their manufacturing partner (if needed) to the evaluation team.

The winner of the third phase will be awarded half of the prize ($500,000) based on their total cost estimate to complete the challenge. The team will then have to demonstrate that they can biosynthesize molecules A and B. Upon completion of this demonstration, the team will be given one-third of the prize award to demonstrate the viability of the concept to manufacture one gram each of A and B to test for purity. Interested parties must submit applications here on or prior to June 15, 2020.


 
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By Lynn L. Bergeson

On May 14, 2020, the American Cleaning Institute (ACI), a BRAG member, announced that the U.S. Environmental Protection Agency (EPA) approved eight cleaning product ingredients submitted by ACI for inclusion in EPA’s Safer Chemical Ingredients List (SCIL). EPA’s Safer Choice Program focuses on assisting consumers, businesses, and purchasers to find products that perform and contain ingredients that are safer for human health and the environment. SCIL is a list of chemical ingredients that have been evaluated and determined by the Safer Choice Program to be safer than traditional chemical ingredients. This is the first time that the Safer Choice Program has approved a SCIL submission by a non-manufacturer. Kathleen Stanton, ACI Associate Vice President of Technical and International Affairs and BRAG company representative, commented on ACI’s achievement stating that “[a]dding chemicals to the SCIL encourages innovation and growth in safer products, increases markets for manufacturers and helps protect people and the environment.” The following chemical surfactants were added to SCIL:

  • Octadecanoic acid, 2-ethylhexyl ester;
  • Alcohols, C12-15;
  • Octadecanoic acid, 12-hydroxy-;
  • Fatty acids, C8-18 and C18-unsaturated, sodium salts;
  • Fatty acids, C14-18 and C16-18-unsaturated, sodium salts;
  • Potassium oleate;
  • Fatty acids, palm-oil; and
  • Sulfuric acid, mono-C14-18-alkyl esters, sodium salts.

 
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From the current impacts of the Toxic Substances Control Act (TSCA) on science policies to challenges faced by industry, Lautenberg Implementation continues to evolve even four years after becoming law. B&C, The Environmental Law Institute (ELI), and the George Washington University (GWU) Milken Institute School of Public Health are pleased to present “TSCA Reform -- Four Years Later,” a complimentary virtual seminar bringing together government and industry officials to reflect on the accomplishments and challenges since the implementation of the 2016 Lautenberg Amendments and where TSCA stands today.

Panelists will dive into a host of topics, including the current impacts of TSCA on science policies, challenges faced by industry, and regulatory policies, especially those concerning ensuring compliance and enforcement. Confirmed speakers include:

  • Alexandra Dapolito Dunn, Assistant Administrator, Office of Chemical Safety and Pollution Prevention (OCSPP), EPA
  • Eve C. Gartner, Managing Attorney, Toxic Exposure & Health Program, Earthjustice
  • Lynn R. Goldman, Michael and Lori Milken Dean and Professor, Environmental and Occupational Health, Milken Institute School of Public Health, GWU
  • Jennifer Sass, Senior Scientist, Healthy People & Thriving Communities Program, Natural Resources Defense Council (NRDC)

Mark your calendar for Wednesday, June 24, 2020, 9:30 a.m. - 4:30 p.m. (EDT),to join ELI, B&C, the GWU Milken Institute School of Public Health, leading experts, and distinguished keynote speakers in a day-long exploration of the issues and regulations surrounding TSCA. Registration is free and open to the public, but an ELI account (no charge) is required.

Tags: TSCA, Seminar, B&C

 
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By Lynn L. Bergeson

On May 11, 2020, a total of 70 Mayors from various cities in the United States submitted a letter to Andrew Wheeler, U.S. Environmental Protection Agency (EPA) Administrator, criticizing the decision not to uphold the Renewable Fuel Standard (RFS) and not to reject proposed waivers under Section 211(o)(7) of the Clean Air Act. The Mayors state that this decision on waivers is already causing damage to the economy and will continue to devastate farmers, workers, and families who depend on the biofuels industry. The letter emphasizes:

The request for these waivers is unjustified under the law. Such waivers from RFS requirements may only be granted if there is a demonstration that the RFS causes severe economic harm to the economy as a whole. In reality, refiner market conditions are a result of plummeting demand for gasoline across the country, not compliance with the RFS. Further, the RFS already considers demand reduction by adjusting annual blending volumes to reflect actual motor fuel demand.

Furthermore, the signatory Mayors oppose the claim that higher Renewable Identification Numbers (RIN) prices damage biofuel refineries. Referencing an EPA market analysis, the Mayors argue that higher RIN prices are recovered in the sale of the product rather than disadvantaging merchant refiners. The letter concludes by requesting that EPA reject unjustifiable RFS waiver requests.

Tags: Biofuel, RFS

 
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