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 April 2, 2019, U.S. Food and Drug Administration (FDA) Commissioner, Scott Gottlieb, M.D., and Deputy Commissioner for Policy, Legislation and International Affairs, Anna Abram, released a statement on the status of FDA’s Plant and Animal Biotechnology Innovation Action Plan (Action Plan). Focused on FDA’s risk-based regulatory framework, the Action Plan aims at securing confidence in the safety and performance of plant and animal-based products for consumers, patients, and U.S. trading partners. In his published statement, Dr. Gottlieb emphasizes FDA’s ongoing implementation of the Action Plan, particularly on intentional genomic alterations in animals. Using genetic engineering and genome editing technologies, these innovations are providing additional clarity about how FDA’s regulatory framework works and should continue to work. A key part of the Action Plan’s implementation involves FDA’s Center for Veterinary Medicine’s Innovation Program, which provides sponsors with innovative products based on genomic alterations in animals to benefit from early feedback and guidance.
 
In the released statement, Abram further highlights the impacts of intentional genomic alterations in animals on human health. DNA editing not only benefits animals by halting animal-to-animal transmission of diseases, but also has the potential to benefit humans. According to Abram, FDA has already evaluated and approved several intentional genomic alterations in animals that produce drugs used to treat human diseases, advance the studies of new drugs, as well as human organ and tissue transplants.  The Commissioners state that by ensuring safety of intentional genomic alterations to animals and animal-derived foods, FDA will continue to evaluate the effectivity of these alterations based on the totality of evidence provided rather than from any one particular assessment or result.
 
On April 25, 2019, FDA’s Center for Veterinary Medicine and the Center for Biologics Evaluation and Research will host a live webinar to discuss policy changes that may improve the Action Plan framework.


 

By Lynn L. Bergeson

In a recent statement prepared by U.S. Food and Drug Administration’s (FDA) Susan Mayne, Ph.D., Director of FDA’s Center for Food Safety and Applied Nutrition, and by Dennis Keefe, Ph.D, Director of FDA’s Office of Food Additive Safety, FDA highlights its commitment to assisting plant biotechnology developers to foster innovation and ensure that consumers can confidently trust FDA’s high safety standards.  Plant biotechnology consists of methods used to introduce new traits or characteristics to a plant (e.g., plants resistant to insect pests, plants with reduced food waste, or plants with reduced levels of harmful elements, amongst others).  To assist developers in this field, FDA has a voluntary premarket Plant Biotechnology Consultation Program, which provides developers with the opportunity to engage with FDA to help navigate the appropriate regulatory pathways.  The program includes individualized advice from FDA’s biotechnology and food safety experts prior to a plant-based product being permitted to enter the market and allows for biotechnology developers to consult with these FDA experts throughout the entire development, data collection, and evaluation process.


 

By Lynn L. Bergeson

On October 30, 2018, the U.S. Food and Drug Administration (FDA) published a statement by FDA Commissioner Scott Gottlieb, M.D., and FDA Deputy Commissioner Anna Abram regarding FDA’s new action plan to advance plant and animal biotechnology innovation.  Aimed at ensuring the safety of plant and animal biotechnology products and avoiding unnecessary barriers to future innovation, the Action Plan focuses on three key priorities:

  1. Advancing public health by promoting innovation;
  2. Strengthening public outreach and communication; and
  3. Increasing engagement with domestic and international partners.

The statement includes an indication that FDA will be seeking public input in the coming year.  Once input is received, the first step in implementing the new action plan will be the adoption of “a comprehensive policy framework for the development and regulatory oversight of animal biotechnology products, including for intentionally genetically altered animals and the food and drug products derived from them.”  According to their statement, this policy framework will be modern and flexible, accompanied by two guidance documents in 2019.  The guidance documents are intended to provide greater clarity on how FDA will be applying regulatory oversight in evaluating risk profiles of various products.  In addition to these elements, the Action Plan also highlights FDA’s commitment to efforts with both national and international partners in fostering efficiency and cooperation.


 

By Lynn L. Bergeson

The 5th Biotechnology World Congress has been scheduled to take place in Bangkok, Thailand, from February 13-15, 2019.  The Welcome Letter states that the conference will “feature a variety of lectures in a number of key sessions in biotechnology, including a commercial exhibition and poster sessions” and the sessions given will include “strategic alliances in biotechnology, pharmaceutical biotechnology, medical biotechnology, plant and environmental biotechnology, bioprocess engineering, and industrial biotechnology.”  A list of the speakers and presentations that have already been scheduled is posted.  The event has put out a call for speakers and posters.  The deadline of abstract submissions for lecture and poster presentation is December 31, 2018; more information on how to apply is available online.


 

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.


 
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