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

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.”


 

By Lynn L. Bergeson

On June 19, 2018, the National Academies of Sciences, Engineering, and Medicine (National Academies) published a press release announcing the availability of a final report entitled Biodefense in the Age of Synthetic Biology.  According to the National Academies, the final report concludes that “[s]ynthetic biology expands the possibilities for creating new weapons -- including making existing bacteria and viruses more harmful -- while decreasing the time required to engineer such organisms.”  Some malicious applications of synthetic biology that may not seem plausible right now could become achievable with future advances.

The final report, which builds on and supersedes an interim report released in August 2017, explores and envisions potential misuses of synthetic biology, including concepts that are regularly discussed in open meetings.  In the interim report, the Committee on Strategies for Identifying and Addressing Potential Biodefense Vulnerabilities Posed by Synthetic Biology proposed a strategic framework intended to identify and prioritize potential areas of concern associated with the field and to help biodefense analysts as they consider the current and future synthetic biology capabilities.  The Committee designed the framework for analyzing existing biotechnology tools to evaluate the dangers at present, understand how various technologies compare with and complement each other, and assess the implications of new experimental outcomes.  More information is available in Bergeson & Campbell, P.C.’s (B&C®) memorandum.


 

By Kathleen M. Roberts

On January 10, 2018, the U.S. National Aeronautics and Space Administration (NASA) announced the next phase of its international collaboration to study the impact of biofuels on jet engine performance, emissions, and contrail formation.  In February, NASA’s DC-8 Airborne Science Laboratory will sample and analyze gases and particles present in the wake of the German Aerospace Center’s (DLR) Advanced Technology Research Aircraft (ATRA) A320 aircraft as it burns alternative biofuels.  Eight joint DC-8/A320 flights are planned to sample three different fuels at a variety of altitudes and airspeeds under contrail forming and non-contrail forming conditions.  The objective of the project is to assess the effects of alternative fuels on aircraft engine performance and emissions, particularly regarding the impact of soot from those emissions on the size, concentration, and lifetime of contrail ice particles. 
 
The research is a continuation of NASA’s investigation on the impact of biofuels on jet engine pollution, as previously reported in the Biobased and Renewable Products Advocacy Group (BRAG®) blog post NASA Confirms Biofuels Reduce Jet Engine Pollution.  Compared to previous experiments, NASA will be flying where contrails form and persist, which will provide more opportunities for gathering data, and will be analyzing data using a much more extensive instrument.

Tags: NASA, Biofuel

 

By Lynn L. Bergeson and Margaret R. Graham

On January 10-11, 2018, the National Academies of Sciences, Engineering, and Medicine’s (NAS) Standing Committee on Use of Emerging Science for Environmental Health Decisions (ESEHD) convened a workshop entitled “The Promise of Genome Editing Tools to Advance Environmental Health Research.”  The meeting is intended to bring together experts in molecular biology, toxicology, and public health to explore opportunities for using genome (and epigenome) editing technologies in environmental health research.  Participants are scheduled  to discuss genome editing tools such as CRISPR/Cas9 and their applications to help reveal the mechanisms through which environmental stressors influence  human health, including developing models of health and disease, testing chemicals for toxicity, and determining mechanisms of toxicity; and speakers explored how research that leverages genome editing tools might inform different types of decisions, including for risk assessment and environmental policy.  The sessions included:

  • Genome and Epigenome Editing: Trends, Techniques, and Capabilities;
  • Exploring Toxicology-Relevant Uses of Genome Editing Tools; and
  • Incorporating Genome Editing Tools into Environmental Health Research:  Pathways Forward.

More information on ESEHD regarding this workshop and other events is available on NAS’ website.

Tags: NAS, ESEHD

 

By Kathleen M. Roberts

On December 4, 2017, the U.S. Department of Defense (DOD), the General Services Administration (GSA), and the National Aeronautics and Space Administration (NASA) issued in the Federal Register a notice of request for public comment regarding an extension of a previously approved ICR regarding biobased procurements.  Pursuant to Federal Acquisition Regulation (FAR) clause 52.223-2, prime contractors are required to report annually the product types and dollar values of U.S. Department of Agriculture (USDA)-designated biobased products purchased to the System for Award Management (SAM) website, which supports annual reporting to the Office of Federal Procurement Policy (OFPP) concerning actions taken to implement and measure progress in carrying out the preference for biobased products required under Section 9002 of the Farm Security and Rural Investment Act of 2002. 
 
Public comments are invited specifically on:

  • Whether the collection of information is necessary for the proper performance of functions of the FAR, and whether it will have practical utility;
  • Whether the estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology;
  • Ways to enhance the quality, utility, and clarity of the information to be collected; and
  • Ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.
  • ​​Comments are due by January 3, 2018.

 

By Lauren M. Graham, Ph.D.

On August 21, 2017, the National Academies of Sciences, Engineering, and Medicine (NAS) released their interim report titled A Proposed Framework for Identifying Potential Biodefense Vulnerabilities Posed by Synthetic Biology.  The U.S. Department of Defense (DOD) asked NAS to develop the framework to:

  • Guide an assessment of the security concerns related to advances in synthetic biology;
  • Assess the level of concern warranted for various advances and identify areas of vulnerability; and
  • Prioritize options to address these vulnerabilities.
The report provides an overview of the categories of synthetic biology and a set of initial questions aimed at guiding the assessment of concern related to the technologies and applications of the field.  The framework outlines factors for assessing the levels of concern that each technology and application presents in terms of malicious use, as well as factors for assessing the capability for mitigation.  The final report will use the framework to provide DOD with an assessment of concerns and mitigation options by developing informed answers to the questions posed in the interim report.

 

By Kathleen M. Roberts

On August 28, 2017, the U.S. Department of Defense (DOD), the General Services Administration (GSA), and the National Aeronautics and Space Administration (NASA) issued in the Federal Register a notice of request for public comment on an extension of a previously approved information collection requirement regarding Biobased Procurements.  Pursuant to the Federal Acquisition Regulation (FAR) Clause 52.223-2, Affirmative Procurement of Biobased Products Under Service and Construction Contracts, prime contractors are required to report annually the product types and dollar values of U.S. Department of Agriculture (USDA)-designated biobased products purchased to the System for Award Management (SAM) website.  Federal agencies use the submitted information to report annually to the Office of Federal Procurement Policy (OFPP) concerning actions taken to implement and measure progress in carrying out the preference for biobased products required under Section 9002 of the Farm Security and Rural Investment Act of 2002, codified at 7 U.S.C. § 8102.  
 
Comments are due by October 27, 2017.  Public comments are invited specifically on:

  • Whether the collection of information is necessary for the proper performance of functions of the FAR, and whether it will have practical utility;
  • Whether the estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology;
  • Ways to enhance the quality, utility, and clarity of the information to be collected; and
  • Ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.
Tags: DOD, GSA, NASA, Biobased

 

By Lauren M. Graham, Ph.D.

On June 30, 2017, the National Academies of Sciences, Engineering, and Medicine (NAS) released the final version of its report Preparing for Future Products of Biotechnology, which is the result of a collaboration by a committee of experts convened by NAS.  The report provides an overview of the committee’s discussion on “the future products of biotechnology that are likely to appear on the horizon, the challenges that the regulatory agencies might face, and the opportunities for enhancing the regulatory system to be prepared for what might be coming.”  The committee reached consensus on its conclusions and recommendations regarding actions that can be taken to enhance the capabilities of the biotechnology regulatory system to prepare for the anticipated future of biotechnology products, which are also presented in the report.
 
More information on the NAS report is available in the Biobased and Renewable Product Advocacy Group (BRAG®) blog post “NAS Releases Final Report on Preparing for Future Products of Biotechnology.”


 

By Lynn L. Bergeson and Margaret R. Graham

On June 30, 3017, the National Academies of Sciences, Engineering, and Medicine (NAS) released its final version of its report Preparing for Future Products of Biotechnology, which it states “analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making [and] … identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.”  This report is a collaboration among a committee of experts including the Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System (Committee), the Board on Life Sciences, the Board on Agriculture and Natural Resources, the Board on Chemical Sciences and Technology, and the Division on Earth and Life Studies and sponsored by the U.S. Environmental Protection Agency (EPA), the U.S. Department of Agriculture (USDA), and the U.S. Food and Drug Administration (FDA).  Lynn L. Bergeson was an external contributor to the Committee’s deliberations and presented before the Committee on the subject of the biotechnology regulatory system.  

The report includes sections on emerging trends and products of biotechnology; the current biotechnology regulatory system; understanding risks related to future biotechnology products; opportunities to enhance the capabilities of the biotechnology regulatory system; and an index on congressionally defined product categories that FDA regulates; as well as conclusions and recommendations that were included in our blog item on the prepublication version.

More information on the regulatory issues of biotechnology products is available on our biobased products blog under key word biotechnology, as well as the Bergeson & Campbell, P.C. (B&C®) regulatory developments website under key phrase biobased products, biotechnology.


 
On March 15, 2017, the National Aeronautics and Space Administration (NASA) published the results of a joint study with German and Canadian agencies on the impact of biofuels on jet engine pollution, including emissions and contrail formation.  The results demonstrate that the use of a 50-50 blend of aviation fuel and fuel of hydro processed esters and fatty acids from camelina plant oil reduced particle emissions by 50-70 percent.  Since soot emissions are a major driver of contrail formation, the particle reductions observed with the use of biofuel are expected to result in a reduced concentration of ice crystals in the contrails, thus, minimizing the impact of the contrails on the environment.  NASA plans to continue to study and demonstrate the potential benefits of biofuels, particularly on their proposed supersonic X-plane.

 
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