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.

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.


 

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.


 

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

 

By Lynn L. Bergeson

On March 3, 2020, EPA announced the availability of a supplemental notice of proposed rulemaking (SNPRM) to the Strengthening Transparency in Regulatory Science proposed rule. EPA notes that the SNPRM “is not a new rulemaking; rather, it provides clarifications on certain terms and aspects of the 2018 proposed rule.” The SNPRM:

  • Proposes that the scope of the rulemaking applies to influential scientific information, as well as significant regulatory decisions;
  • Defines and clarifies that the proposed rule applies to data and models underlying both pivotal science and pivotal regulatory science;
  • Proposes a modified approach to the availability provisions for data and models that would underlie influential scientific information and significant regulatory decisions, as well as an alternate approach; and
  • Clarifies the ability of the Administrator to grant exemptions.

EPA published the SNPRM in the Federal Register on March 18, 2020. 85 Fed. Reg. 15396. EPA states that it “is taking comment on whether to use its housekeeping authority independently or in conjunction with appropriate environmental statutory provisions as authority for taking this action.” On April 2, 2020, EPA announced that it would extend the comment period to May 18, 2020. EPA anticipates promulgating a final rule later in 2020. More information is available in our March 9, 2020, memorandum, “EPA Releases Supplemental Proposed Rule to the Proposed Rule on Strengthening Transparency in Regulatory Science.”


 

By Lynn L. Bergeson

The Product Stewardship Society is now accepting nominations for officials from member companies to serve on its Board of Directors. The Board establishes the organization’s strategic direction and goals, and monitors progress toward reaching those goals. Nominees must be members in good standing; self-nominations are allowed.

“Our Board members are leaders in a diverse range of business sectors. We are looking for leaders who have a passion for the Society and who wish to work with like-minded professionals to grow the profession and make a difference,” stated Lynn Bergeson, President of the Product Stewardship Society.

Deadline for the nominations is April 15, 2020. More information is available in the full press release.

Tags: PSS, Board

 

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

On February 25, 2020, DOE’s Oak Ridge National Laboratory (ORNL) announced that its scientists have developed a novel technique to closely observe the nanostructure of biomaterials without damaging the sample. Using a nonintrusive soft mechanical nanoablation (sMNA) technique can confirm structural features in starch, which is an important carbohydrate in the production of biofuels. ORNL’s chief scientist for systems biology and biotechnology, Brian Davison, highlighted the importance of plant cell wall structures in the next generation of biofuels, stating that the “study used starch as an example of how this technique can start to access some of these nanomechanical structure materials” that currently cannot be observed. ORNL’s study was published on February 6, 2020. ORNL scientists believe the novel technique can also be applied to nonliving materials and used on synthetic polymers or even three-dimensional-printed materials.


 

By Lynn L. Bergeson

On February 17, 2020, researchers from the University of Massachusetts Amherst (UMass Amherst) announced that one of its laboratories has developed a device using a natural protein to create electricity from moisture in the air. Electrical engineer Jun Yao and microbiologist Derek Lovley have created what they call “Air-Gen,” which consists of an air-powered generator with electrically conductive protein nanowires produced by the microbe Geobacter. The Air-gen connects electrodes to the protein nanowires in such a way that electrical current is generated from the water vapor naturally present in the atmosphere. According to Yao, the device generates clean energy 24/7. What Yao and Lovley describe as a low cost, non-polluting, and renewable device, can generate energy even in areas with extremely low humidity, such as the Sahara Desert. Although the current generation of Air-gen devices are only able to power small electronics, both scientists state that the ultimate goal is to develop large-scale systems that will highly contribute to sustainable energy production.


 

By Lynn L. Bergeson

Pennsylvania State University’s (Penn State) Huck Institutes of the Life Sciences’ Center of Excellence in Industrial Biotechnology (CoEIB) is now offering a new round of IMPACT Seed Grants to support interdisciplinary research, curricular development, or educational activities in the broad area of industrial biotechnology. These areas include but are not limited to: biopharmaceutical manufacturing, food biotechnology, and production of biobased chemicals. According to Penn State’s announcement, project proposals of up to $25,000 per project will be available. Favorable consideration will be given to grant proposals that: (1) leverage the capabilities in the CSL Behring Fermentation Facility; (2) provide matching funds to support new industry-funded collaborations; and (3) support graduate/undergraduate students in industrial biotechnology research or educational activities. The CSL Behring Fermentation Facility is a biotechnology pilot plant capable of research- and pilot-scale production of microbial cells, recombinant proteins, and other microbial products over a wide range of controlled conditions. Proposals should be submitted to CoEIB on or prior to 5:00 p.m. (EST) on February 7, 2020.


 

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.


 

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

First published last week, on November 25, 2019, the article titled “Consolidated Production of Coniferol and Other High-Value Aromatic Alcohols Directly from Lignocellulosic Biomass” has gained media attention across the globe. Given the finite geological oil reserves, the competition to identify alternative biobased and biorefinery processes continues to grow. According to the article, the aim in identifying such products is not only to find alternatives, but most importantly to “overcome significant costs and productivity barriers.” In the aforementioned article, published in the Green Chemistry Journal, scientists write about a novel technique using the biocatalytic production of coniferol (a versatile chemical block) directly from lignocellulosic biomass. The process to do so involves a biocatalytic treatment of lignocellulose, which releases and converts ferulic acid with feruloyl esterase (XynZ), carboxylic acid reductase (CAR), and aldo-keto reductase (AKR). This catalytic reaction achieves the equivalent release of ferulic acid from lignocellulose compared to alkaline hydrolysis, also displaying efficient conversion of ferulic acid to coniferol. Consolidating a biodegradation-biotransformation strategy for the production of high value fine chemicals from waste plant biomass, this novel process offers a potential to minimize environmental waste and add value to agro-industrial residues. A number of grants, including from the São Paulo Research Foundation and David Phillips Fellowship, supported the study outlined in the journal article. Grants of these types continue to arise as the need to address resource efficiency and, therefore, biobased chemical production has become the focus of various government agencies in many countries. The U.S. Department of Energy (DOE) for example, often provides scientist from all backgrounds similar opportunities.


 
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