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 August 2, 2018, the Trump Administration’s Principal Deputy Director of the U.S. Fish and Wildlife Service, Gregory J. Sheehan, reversed an Obama era 2014 policy on the use of biotechnology on wildlife refuges. On July 17, 2014, the Obama Administration issued a memorandum prohibiting the use of genetically modified biotechnology crops to feed wildlife and the use of neonicotinoid pesticides in agricultural practices. This ban was issued in response to lawsuits that claimed the use of toxic pesticides and genetically engineered crops violated environmental laws. The 2014 memorandum declared that the use of these products should be phased out by 2016. In his 2018 memorandum, Sheehan argued that genetically modified crops and bee-killing pesticides are necessary to promulgate maximum production of farming practices in refuges.


 

By Lynn L. Bergeson

On March 28, 2018, Secretary of the U.S. Department of Agriculture (USDA) Sonny Perdue issued a statement providing clarification on USDA’s oversight of plants produced through innovative new breeding techniques that include techniques called genome editing.  The announcement states that under its biotechnology regulations, USDA “does not regulate or have any plans to regulate plants that could otherwise have been developed through traditional breeding techniques as long as they are not plant pests or developed using plant pests,” which “includes a set of new techniques that are increasingly being used by plant breeders to produce new plant varieties that are indistinguishable from those developed through traditional breeding methods” and “[t]he newest of these methods, such as genome editing, expand traditional plant breeding tools because they can introduce new plant traits more quickly and precisely, potentially saving years or even decades in bringing needed new varieties to farmers.”   Secretary Perdue stated that using this science, “farmers can continue to meet consumer expectations for healthful, affordable food produced in a manner that consumes fewer natural resources.”


 

By Lauren M. Graham, Ph.D.

On January 8, 2018, U.S. Secretary of Agriculture Sonny Perdue presented to President Donald Trump the findings of the Interagency Task Force on Agriculture and Rural Prosperity.  The Task Force was established in 2017 following an Executive Order by President Trump to ensure the informed exercise of regulatory authority that impacts agriculture and rural communities.  According to the report, over 100 actions organized around five key topic areas, specifically e-connectivity, quality of life, rural workforce, innovation and technology, and economic development, were identified.
 
Of the recommendations related to economic development, the Task Force identified regaining American energy dominance as a key objective.  The report states that “[‌b]oosting production of all sources of energy from natural gas, oil, coal, nuclear, and renewables is essential to America’s national security interest and rural America’s economy.  The federal government must ensure a regulatory environment which can unleash this potential while keeping Americans safe and healthy.”

Regarding innovation and technology, the report recognizes biotechnology as “another area of U.S. leadership, being a sector that has driven innovation in fuels, chemicals, manufacturing, and agriculture.”  The Task Force recommended that:

  • The U.S. Department of State, the U.S. Department of Agriculture (USDA), and other relevant agencies develop a communications strategy to increase acceptance of biotech products; and
  • The federal government continue efforts to modernize the federal regulatory system for biotechnology products, particularly by:
    • Coordinating the federal regulation of biotechnology products;
    • Coordinating interagency action through the Office of Science and Technology Policy; and
    • Expediting the commercialization of biotechnology products.
​​The full report is available on the USDA website.

 

By Kathleen M. Roberts

On November 8, 2017, the U.S. Department of Agriculture’s (USDA) National Institute of Food and Agriculture (NIFA) issued a statement soliciting applications for its Biotechnology Risk Assessment Research Grants Program.  The program aims to support the generation of new information that will assist federal regulatory agencies in making science-based decisions about the effects of introducing genetically engineered (GE) organisms, including microorganisms, into the environment.  Exploratory research that relates specifically to federal regulatory needs is preferred. USDA anticipates approximately $3.5 million in funding will be available for 2018 grants.  Applicants must submit a letter of intent by 5:00 p.m. (EST) on December 21, 2017.  Applications are due by 5:00 p.m. (EST) on February 22, 2018.


 

By Lauren M. Graham, Ph.D.

Industrial Biotechnology recently published a special issue to highlight the advances and challenges in algae-based products and applications.  The article, written by B&C® Consortia Management, L.L.C. (BCCM) affiliate Bergeson & Campbell, P.C. (B&C®) Managing Partner, Lynn L. Bergeson; B&C Senior Chemist, Richard E. Engler, Ph.D.; and BCCM Manager, Lauren M. Graham, Ph.D., examines the complex regulatory domain and discusses the significance and implications of the Toxic Substances Control Act (TSCA) for industrialized microorganisms, such as algae.  The article titled “TSCA Affects on Algae, Other Novel Biosources, and Bioprocesses” provides an overview of the fundamentals of TSCA, the U.S. Environmental Protection Agency’s (EPA) review of new substances, the impact that chemical identity has on EPA’s regulation of new substances, and available reporting exemptions.  In the article, the authors highlight the need for chemical product innovators “to understand how TSCA, significantly amended in 2016, applies to biomass starting material, including industrial microorganisms (such as algae); intermediates; and commercial products, and build TSCA compliance into business timelines and budgets.”  While the products of industrial microbes have the potential to reduce toxicity, greenhouse gas (GHG) emissions, and dependence on non-renewable resources, companies must comply with TSCA and the Federal Food, Drug, and Cosmetic Act (FFDCA) to ensure that such products successfully enter the market.


 

By Lauren M. Graham, Ph.D.

On October 17, 2017, Congressman Jimmy Panetta (D-CA), Congressman Neal Dunn, M.D. (R-FL), and 77 additional House members sent a bipartisan letter to the U.S. Department of Agriculture (USDA), U.S. Food and Drug Administration (FDA), and U.S. Environmental Protection Agency (EPA) to urge the agencies to work together to promote innovative new technologies aimed at increasing crop yields and reducing the cost of production.  According to Congressman Panetta, the letter was prepared in response to duplicative or inconsistent regulatory proposals regarding biotechnology.  In the letter to Secretary Sonny Perdue, Commissioner Scott Gottlieb, and Administrator Scott Pruitt, the members highlighted several recent biotechnology regulatory efforts that warrant the Administration’s attention, as well as the importance of a consistent, science-based, risk-proportionate regulatory system.  Members concluded by urging the agencies to cooperate in creating consistent regulatory proposals that foster innovation; to increase engagement with trading partners to promote a harmonized, science-based international regulatory system for agricultural products; and to consider ways to engage with the public to discuss the continued advancement of biotechnology in agriculture.


 

By Lauren M. Graham, Ph.D.

On October 12, 2017, the U.S. Food and Drug Administration (FDA) announced two public meetings regarding its Agricultural Biotechnology Education and Outreach Initiative.  The meetings will be held in Charlotte, North Carolina, on November 7, 2017, from 8:00 a.m. to 1:00 p.m. (EST) and in San Francisco, California, on November 14, 2017, from 8:00 a.m. to 1:00 p.m. (PST).  FDA states the purpose of the public meetings is “to provide the public with an opportunity to share information, experiences, and suggestions to help inform the development of this education and outreach initiative.”  This initiative, which Congress appropriated $3 million to fund, calls upon FDA to work with USDA to provide education and outreach to the public on agricultural biotechnology and food and animal feed ingredients derived from biotechnology.  More information on the initiative and information on how to register for the meetings is available on FDA’s website.  Comments on questions listed in the Federal Register notice, scheduled to be published tomorrow, are also being requested and can be filed in Docket FDA-2017-N-5991 on www.regulations.gov.  Comments are due by November 17, 2017.


 

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.


 

By Lauren M. Graham, Ph.D.

On May 31, 2017, Deinove, a biotech company focused on producing high-value compounds from rare bacteria, announced the beginning of the second phase of a project with Flint Hills Resources to develop a nutritional supplement for animal feed.  Flint Hills Resources is a member of BRAG and a leading refining, petrochemicals, and biofuels company in the United States. 

During the first phase of the project, which began in November 2015, several bacterial strains were selected from Deinove’s library to produce target compounds.  The second phase will involve:​

  • Producing the additives in sufficient quantities to test their beneficial effects on the target animal species and analyze the results obtained;
  • Optimizing the fermentation parameters; and
  • Defining the technical and economic conditions for the development of the production process.

Depending on the results of efficacy tests, one or two strains may be selected for the industrialization step. 


 
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