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

On May 12, 2020, a bill was introduced in the U.S. House of Representatives, which would make emergency supplemental appropriations for the fiscal year ending on September 30, 2020. Titled the Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act), this bill addresses various issues, many of which have been worsened by the COVID-19 pandemic. Some of these issues include provisions of revenue, health, retirement, government operations, and support for processed commodities, among others.

Of particular interest to the biofuels industry is the bill’s introduction of a Renewable Fuel Reimbursement Program, which would make payments to eligible entities that experienced market losses due to the pandemic between January 1, 2020, and May 1, 2020. Eligible entities will consist of any facility that produced renewable fuel or advanced biofuel in calendar year 2019. The amount of payment to an eligible entity will be the sum of $0.45 multiplied by the number of gallons of qualified fuel produced in that period. Should a determination be made that an entity was unable to produce qualified fuel for one or more months during the applicable period due to the pandemic, $0.45 multiplied by 50 percent of the number of gallons produced in the corresponding month in 2019 will be paid.


 
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By Lynn L. Bergeson

On May 12, 2020, the U.S. Food and Drug Administration (FDA) announced the release of an update to its Purple Book: Database of FDA-Licensed Biological Products (Purple Book). The update adds all FDA-licensed biological products, including products approved in the new drug applications (NDAs) that were deemed to be licenses (transition biological products). This update also includes a new feature allowing users to download reports. Historical reports now include highlighted sections reflecting changes made in the previous month. This is the second phase of FDA’s Purple Book planned improvements.

As reported in B&C’s biobased products blog on February 28, 2020, FDA is working to expand the Purple Book by transitioning from its current table list format to a searchable online database for all approved biosimilar products and their reference products. The first phase of the upgrade included information about a product’s proprietary and proper names, the full product label, dosage form, route of administration, strength, and marketing status, among other information. Subsequent phases will include the expansion of the number of FDA-licensed biological products included in the Purple Book online database until the final release, which will include information about all FDA-licensed biological products.


 
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By Lynn L. Bergeson

One of several changes to the Toxic Substance Control Act (TSCA) Chemical Data Reporting (CDR) rule, issued in final on April 9, 2020, is that in the 2020 cycle, EPA has changed the way that toll manufacturing must be reported. In this cycle, EPA will not accept reporting from only the contracting manufacturer in situations where a company contracts with another company (i.e., a toll manufacturer) for the production of chemicals. As in years’ past, EPA states in its final rule that if no report is filed, both the contracting and producing companies will be held liable if no reporting occurs. Under past CDR cycles, EPA would accept reporting from either the contracting manufacturer or the producing (formerly referred to as “toll”) manufacturer. In 2020, EPA has stated in multiple fora that for the 2020 reporting period, EPA will only accept manufacturing details from the actual producers, even if manufacturing was contracted by another company. This change may come as a surprise, especially to producing companies that heretofore may not have reported under the CDR rule and instead relied on the contracting company to do so.

EPA stated in the preamble to the final CDR rule that it chose to include two different reporting methodologies for a co-manufacturing situation, indicating that the methodologies are based on a desire to reduce reporting burden and maintain flexibility for both the contracting and producing company. EPA noted that the companies must work together to select between the methodologies for preparing their CDR methodologies. The two methodologies for reporting, codified at 40 C.F.R. Section 711.22(c), are:

(1) The contracting company initiates the required report for that site [defined by EPA at 40 C.F.R. §711.3 as the location where the chemical substance is physically manufactured for chemical substances co-manufactured] as the primary submitter. The contracting company must indicate on the report that this is a co-manufacturing situation, notify the producing company, and record the production volume domestically co-manufactured as set forth in §711.15(b)(3) and processing and use information set forth in §711.15(b)(4). Upon notification by the contracting company, the producing company must also record the production volume domestically co-manufactured and complete the rest of the report as prompted by e-CDRweb.

(2) Upon written agreement between the contracting company and the producing company, the producing company completes the full report for the co-manufactured chemical. The contracting company supplies the information not otherwise known to or reasonably ascertainable by the producing company.

In both cases, the producing company (toll manufacturer) must provide the manufacturing details. There is no mechanism for the contracting company to submit the entire Form U.

More information on the final CDR rule is available in our March 19, 2020, memorandum, “EPA Releases Final Amendments to CDR Rule, Extends Reporting Period.”

Tags: CDR, TSCA

 
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By Lynn L. Bergeson

On May 12, 2020, EPA released the signed final rule updating the definition of small manufacturers, including a new definition of what is considered a small government, used to determine reporting and recordkeeping requirements under TSCA. According to EPA, the updated definitions will reduce reporting burdens on chemical manufacturers and small governments while maintaining the Agency’s ability to receive the information it needs to understand exposure to chemical substances manufactured in the United States. The final rule makes a technical correction to the small manufacturer reference at 40 C.F.R. Section 704.104 for hexafluoropropylene oxide, which only includes a rule-specific small processor definition and not a small manufacturer definition. When reviewing the small manufacturer size standards, EPA found this to be an “inadvertent error.” The final rule also updates the current small manufacturer definition in the Preliminary Assessment Information Rule (PAIR) at 40 C.F.R. Section 712.25 to align it with the updated small manufacturer definition at 40 C.F.R. Section 704.3.

EPA notes that the updated definitions will apply to the CDR rule reporting period beginning June 1, 2020, and will impact certain reporting and recordkeeping requirements for TSCA Section 8(a) rules. EPA states that the final rule is based on 2018 dollars to ensure that the definition is as up to date as possible at the time of promulgation. The final rule will be effective 30 days after publication in the Federal Register. EPA has posted the pre-publication version of the final rule on its website.

More information on CDR reporting is available in our May 13, 2020, blog item, “New Reporting Procedure for Co-Manufacturers under TSCA CDR Rule May Catch Certain Manufacturers Off Guard,” and our March 19, 2020, memorandum, “EPA Releases Final Amendments to CDR Rule, Extends Reporting Period.”

Tags: CDR, TSCA

 
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By Lynn L. Bergeson

EPA will host a webinar on May 19, 2020, from 1:00 p.m. to 3:00 p.m. (EDT) to provide an overview of the 2020 CDR requirements. The webinar will include information about the revised reporting requirements, including:

  • New requirements for making confidential business information (CBI) claims;
  • Reporting refinements related to byproducts, including exemptions;
  • Phasing in certain processing and use data codes; and
  • Process improvements for reporting co-manufacturing.

The webinar will also introduce the updated e-CDRweb reporting tool. EPA notes that the presentation will be similar to the webinars EPA hosted on March 31, and April 9, 2020.

EPA states that although registration is not required, it is preferred. Details on how to access the webinar and slides will be sent to participants after registering. Participants should follow along with the webinar slides and use the following call-in number to access the audio: (866) 609-6049; Conference ID: 2499985. EPA will provide webinar materials, including transcripts and recordings, on its CDR website following the webinar.

Tags: CDR, CBI, TSCA

 
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By Lynn L. Bergeson

The Ministry of Industry and Trade of the Russian Federation formally announced that the May 1, 2020, deadline to submit substances and mixtures to its chemical inventory is extended to August 1, 2020.

Entities exporting products to the Russian Federation should nominate their substances and mixtures to the Russian chemical inventory to ensure continued access to the Russian market. New substance registration is required for substances or mixtures not on the inventory after the nomination process closes.

A company without a legal entity in Russia can appoint an Authorized Representative (AR) to submit information on its behalf and cover importation by its customers in the region. The appointment of an AR and timely submission allow a non-Russian company to maintain an uninterrupted supply chain into the region and support its Russian customers.

More information is available in The Acta Group’s (Acta®) April 2, 2020, memorandum, “Russian Federation Accepting Nominations to New Chemical Inventory,” as well as Acta’s website. Acta’s “Eurasia REACH: Achieving Timely Compliance with New Chemicals Requirements” webinar on May 27, 2020, will provide an overview of the Eurasian Economic Union (EAEU) Technical Regulation (TR) EAEU 041/2017 (Eurasia REACH) and its implementation status, including insights into the Eurasian regional political dynamics and impacts to implementation, and cover the requirements for submitting substances and mixtures to the Russian chemical inventory. Registration for the webinar is still open. Acta assists clients with AR appointment and provides broad-based, hands-on support in the Russian Federation to support its clients’ regulatory compliance and business success.


 
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By Lynn L. Bergeson

The 2020 GlobalChem webinar series addresses major developments in chemicals management and provides participants a chance to engage with policymakers and other key experts throughout the chemical industry value chain. On May 13, 2020, at 12:00 p.m. (EDT), Richard E. Engler, Ph.D., Director of Chemistry, Bergeson & Campbell, P.C. (B&C®), will present during the “TSCA New Chemicals” webinar. Other presenters include Lynn Dekleva, Ph.D., Associate Deputy Assistant Administrator for New Chemicals, U.S. Environmental Protection Agency (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP), Tala Henry, Ph.D., Deputy Director, EPA Office of Pollution Prevention and Toxics (OPPT); Mike Walls, Vice President, Regulatory and Technical Affairs, American Chemistry Council (ACC); and Ritesh Tiwari, Chemical Engineer, EPA. The webinar will address key changes in the Section 5 program and challenges faced by EPA and submitters, including information requirements, assessment of risks, and practical tips. Register for the 10-part webinar series online. B&C is a proud sponsor.


 
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