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

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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By Lynn L. Bergeson

B&C, the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health are pleased to present "TSCA Reform -- Four Years Later," on June 24, 2020. This complimentary virtual conference marks the fourth Toxic Substances Control Act (TSCA) Annual Conference, reflecting on the accomplishments and challenges since the implementation of the 2016 Lautenberg Amendments and where TSCA stands today.

Speakers include:

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. Mark your calendar to join ELI, B&C, the George Washington University Milken Institute School of Public Health, leading experts, and distinguished keynote speakers in a day-long exploration of the issues and regulations surrounding TSCA.


 
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By Lynn L. Bergeson

On April 24, 2020, the U.S. Department of Energy’s (DOE) Office of Energy Efficiency and Renewable Energy (EERE) announced that it intends to issue a funding opportunity to:

  • Stimulate technology innovation;
     
  • Enable manufacturing of cutting-edge products in the United States; and
     
  • Improve energy productivity of manufacturing.

On behalf of the Advance Manufacturing Office (AMO), this potential funding opportunity aims to advance the Trump Administration’s goal of enhancing manufacturing competitiveness through technological innovation. The Funding Opportunity Announcement (FOA), titled “FY20 Advanced Manufacturing Multi-Topic FOA,” will fund high-impact, applied research and development (R&D) projects that align with research opportunities across AMO. The FOA will focus on three areas:

  • Modular, hybrid, and/or catalytic processes to improve energy efficiency in chemical manufacturing;
     
  • Next-generation manufacturing processes that improve energy efficiency in energy-intensive and energy-dependent industries, including steel manufacturing; and
     
  • Connected, flexible, and efficient manufacturing facilities, products, and energy systems, including the integration of direct air capture at industrial facilities.

The FOA is expected to be released during this Spring.

Tags: DOE

 
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By Lynn L. Bergeson

On April 28, 2020, U.S. Representative Abby Finkenauer (D-IA) introduced the Clean Fuels Deployment Act of 2020, which would fund installation and conversion of fuel pump infrastructure to deliver higher blends of biofuel. Co-sponsored by Representatives Angie Craig (D-MN), Don Bacon (R-NE), and Roger Marshall (R-KS), this bipartisan bill creates a clean fuels grant program with $600 million over a six-year period to help biofuel retailers. The plan is to assist retailers to offer higher ethanol blends; expand the geographic area selling ethanol blends; accelerate the deployment of fueling infrastructure; and support biodiesel, bioheat, and sustainable aviation fuel markets. A number of biofuels and energy associations and companies are in support of the bill. Thanking Representative Finkenauer for introducing the bill, Kelly Nieuwenhuis, representing the Iowa Corn Growers Association (ICGA), stated that the Clean Fuels Deployment Act will “expand long-term economic opportunities for farmers and biofuels producers.”


 
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By Lynn L. Bergeson

On April 29, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Research and Development (ORD) announced a virtual meeting of the Board of Scientific Counselors (BOSC) Chemical Safety for Sustainability and Health and Environmental Risk Assessment (CSS-HERA) Subcommittee. The purpose of the meeting will be to review the draft 2019-2022 Strategic Research Action Plan (StRAP) of the HERA research program. The videoconference meeting will be held over a period of two days on May 12, 2020, from 12:30 p.m. to 5:00 p.m. (EDT), and May 13, 2020, from 12:30 p.m. to 5:00 p.m. (EDT). The meeting is open to the public. Those interested in participating must register by May 8, 2020.


 
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By Lynn L. Bergeson

From June 15 to 19, 2020, the American Chemical Society (ACS) will be hosting their annual Green Chemistry and Engineering (GC&E) Conference virtually. Richard E. Engler, Ph.D., Director of Chemistry at Bergeson & Campbell, P.C. (B&C®) will be proudly presenting a poster titled: “TSCA Tutor -- The Importance of Regulatory Awareness and Applications.” The poster presentation will highlight B&C’s complete suite of TSCA TutorTM regulatory training courses online and on-demand. This year’s conference registration is free, so check out B&C’s poster and contact us if you are interested in learning more about TSCA TutorTM.

Professionals seeking expert, efficient, essential training can preview and enroll in on-demand classes to complete at their own pace and timing. In addition to the newly released online e-learning courses, B&C’s TSCA TutorTM training platform offers live in-person training at a company’s site and customized live webinar training, so that companies can mix and match training modules and training approaches to provide the most suitable combination for their work needs.

TSCA awareness is a critically important element in the 21st century work environment for any business that involves industrial chemicals. The new normal requires awareness of TSCA’s application to a company’s operations to ensure consistent compliance with TSCA regulations and, importantly, to understand and anticipate how EPA’s ongoing implementation of new TSCA will affect a company’s industrial chemical selection and use processes.

TSCA TutorTM online training courses include:

  • Video lessons.
     
  • Detailed handout materials, including copies of all presentations and relevant course materials from EPA and other sources.
     
  • Customizable, yet detailed and ready-to-use Standard Operating Procedures (SOP) for the regulatory topic covered in the session.

The courses were developed and are presented by members of B&C’s renowned TSCA practice group, which includes six former senior EPA officials; an extensive scientific staff, including seven Ph.D.s; and a robust and highly experienced team of lawyers and non-lawyer professionals extremely well versed in all aspects of TSCA law, regulation, policy, compliance, and litigation.

Online courses are offered at $100 for one-hour modules and $200 for two-hour modules, or $1,400 for the full 12-module training. Courses can be completed at the learner’s own pace, and enrollment is valid for one full year. Interested professionals should visit www.TSCAtutor.com to view sample course segments and purchase modules. Volume discounts are available for companies wishing to purchase courses for multiple employees. Companies interested in live in-person or customized live webinar training should contact .(JavaScript must be enabled to view this email address) to schedule.

For more information about TSCA Tutor™, contact Heidi Lewis at .(JavaScript must be enabled to view this email address).

Tags: TSCA

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

On April 17, 2020, U.S. Department of Agriculture (USDA) Secretary, Sonny Perdue, announced $19 billion to farmers and ranchers as part of its COVID-19 relief program. Aimed at providing critical support in maintaining the integrity of the U.S. food supply chain and ensuring that every American has access to the food needed, the funds will be used not only to directly support farmers and ranchers, but also for USDA purchase and distribution. The latter goal means that USDA will partner with regional and local distributors affected by the closure of businesses to purchase $3 billion in fresh produce, dairy, and meat. The distributors will then provide boxes of fresh food supplied to food banks and other non-profits serving Americans in need. The one element not mentioned in the use of the relief funds, however, was assistance for biofuel producers who are bearing the impact of decrease in consumption.

In early April, 15 U.S. Senators had submitted a bipartisan letter to Secretary Perdue, requesting the use of its authority to assist the biofuels industry’s economic circumstances brought by the COVID-19 pandemic. Highlighting the negative impacts of the pandemic on farmers and producers who are suffering from the impact of the decrease in consumption, the letter asked that USDA consider the allocation of additional funds to assist the biofuels industry sector. Assistance would be helpful in the format of reimbursements for feedstocks and additional relief funds to the Higher-Blends Infrastructure Incentive Program to drive future biofuel demand. At the time, the 15 signatories of the letter seemed hopeful of receiving the aid requested and much needed. It seems as though USDA’s focus, however, is not geared toward addressing the biofuel industry’s request. According to an article, Secretary Perdue addressed this issue by stating that it is not within his authority to extend the aid to energy production and that USDA does not have a fundamental way to help the biofuels sector.


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

In March 2020, a paper by master’s degree student Anastasia Prosina titled “Algae-Based Printer Ink as the Way to Foster In-Situ Resource Utilization in Habitation Structures” was published in ResearchGate. Prosina’s paper, submitted to Sasakawa International Center for Space Architecture (SICSA), proposes that the most feasible long-term habitat off-Earth will consist of a 3D printed mixture of algae and regolith, the layer of unconsolidated rocky material covering bedrock. Proposed as an alternative to building structures in space that require intensive mining and sifting, the 3D printed mixture can be cultivated in a lab controlled by biological media. In addition, “[t]he utilization of algae off-Earth is not limited to a singular application and its cultivation would allow for a substantial yield of products, and local micro and macro environmental benefits.” According to Prosina, because of the high protein in and natural thermostatic qualities of algae biomass, this new printing mixture would allow for easier and safer production of everyday consumables, including clothes. Prosina’s paper outlines the benefits and complications of algae production and utilization processes, concluding that algae has the best potential for establishing long-term habitation on the Moon and Mars.


 
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By Lynn L. Bergeson

On April 22, 2020, the U.S. Department of Energy’s (DOE) Rapid Advancement in Process Intensification Deployment (RAPID) Manufacturing Institute announced the availability of $4 million for five selected projects. The projects align with RAPID’s research focus areas in chemical and commodity processing, renewable bioproducts, natural gas upgrading, modeling and simulation, module manufacturing, and intensified process fundamentals.

Tags: DOE, RAPID

 
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By Lynn L. Bergeson

EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) is hosting the following webinars to educate scientists on the more than 30 federal opportunities available in Research Triangle Park, North Carolina:

Webinar participants will learn about OCSPP’s role in protecting human health and the environment, OCSPP’s newly formed worksite located in Research Triangle Park, and the more than 30 scientific positions for which OCSPP is recruiting. The webinar will also cover finding and applying to EPA jobs, creating profiles and saving searches on USAJobs, education and transcript requirements for scientific positions, and the federal general schedule (GS) pay scale, benefits, and retirement.

Tags: OCSPP, webinar

 
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Bergeson & Campbell, P.C. (B&C®) is pleased to release a timely episode of the All Things Chemical™ podcast, “Chemical Distribution in the Time of COVID-19 — A Conversation with Eric R. Byer, NACD.” In this episode, Lynn L. Bergeson, Managing Partner, B&C, and Eric Byer, President and CEO of the National Association of Chemical Distributors (NACD), sat down to discuss current challenges facing small and large chemical distributors, and how NACD member companies are able to continue to distribute much needed chemical products, including sanitizers and other cleaning products, in response to the pandemic.

Lynn and Eric’s conversation focuses on unique “in the moment” issues and a broad range of federal, state, and international issues on which NACD is focused, including extending the Chemical Facility Anti-Terrorism Standards (CFATS) program, Toxic Substances Control Act (TSCA) implementation initiatives, and the impact of tariffs on imports from China on NACD member companies.  Eric is an amazing leader of an essential trade association, and this conversation provides insights into his success as President and CEO of NACD.

The full podcast episode is available to stream online, where listeners can also find the recent podcast “COVID-19, FIFRA, and EPA — A Conversation with Lisa Campbell”  Additional updates on chemical regulatory activity related to COVID-19 can be found on B&C’s Pesticide Law and Policy Blog® and on the Regulatory Developments page of B&C's website, including these recent updates:

All Things Chemical™ engages listeners in intelligent, insightful conversation about everything related to industrial, pesticidal, and specialty chemicals and the law and business issues surrounding chemicals. B&C’s talented team of lawyers, scientists, and consultants will keep listeners abreast of the changing world of both domestic and international chemical regulation and provide analysis of the many intriguing and complicated issues surrounding this space.  All Things Chemical™ is available now on iTunes, Spotify, Stitcher, and Google Play Music.  Subscribe so you never miss an episode. 


 
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Register now for the American Bar Association (ABA) webinar “Navigating the Jurisdictional Tightrope Between Biopesticides, Biostimulants, and Related Emerging Technologies” with Bergeson & Campbell P.C. (B&C®) professionals deconstructing the jurisdictional boundaries distinguishing pesticides, biopesticides, plant regulators, biostimulants, and related technologies. The webinar will focus on draft EPA guidance intended to clarify the lines between and among those products that are subject to FIFRA registration as plant regulators and those biostimulant products not subject to FIFRA registration. The webinar also will focus on new and evolving chemistry and technology issues that may blur some jurisdictional lines or potentially move products from one category to another.  Lynn L. Bergeson, Managing Partner, B&C; Lisa R. Burchi, Of Counsel, B&C; and Sheryl Dolan, Senior Regulatory Consultant, B&C, will present.


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

On April 6, 2020, the U.S. Food and Drug Administration (FDA) published a report that provides options and recommendations for a new methodology to evaluate changes in resource capacity needs of human drug and biosimilar biologic review programs. Titled “Independent Evaluation of the PDUFA and BsUFA Resource Capacity Planning Adjustment Methodology: Evaluation and Recommendations,” the analysis of the methodology was reviewed by an outside consultant, contracted by FDA. The report summarizes the evaluation of FDA’s proposed capacity planning adjustment methodology to calculate the annual fees for human drugs and biosimilar biologics under the FDA Reauthorization Act of 2017. According to the report’s executive summary, “[t]he report examines the options and recommendations for the proposed capacity adjustment methodology to accurately assess changes in the resource and capacity needs for prescription drug and biologic biosimilar fee direct review work.” Relevant to those interested in developing, and streamlining such products, as part of the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) and Biosimilar User Fee Amendments of 2017 (BsUFA II) commitments, FDA is developing this methodology to improve its user fee resources. Comments will be accepted until May 6, 2020.

Tags: FDA, Biologic

 
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