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

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

On January 9, 2020, also in recognition of National Biotechnology Month, the U.S. Department of Agriculture (USDA), the U.S. Food and Drug Administration (FDA), and the U.S. Environmental Protection Agency (EPA) announced the launch of a unified website for biotechnology regulation. Streamlining information about the three agencies in charge of overseeing agriculture biotechnology products, this website comes, in part, to fulfill President Trump’s Executive Order (EO) on Modernizing the Regulatory Framework for Agricultural Biotechnology Products. The unified website also describes the federal review process for certain biotechnology products and allows users to submit questions to USDA, FDA, and/or EPA. Aiming to improve customer service to innovators and developers, the three agencies also wish to assure Americans about the safe use of biotechnology innovations. According to USDA Secretary of Agriculture, Sonny Purdue, all Americans deserve transparency and science-based regulations that foster innovation, conserve resources, and protect public health. BRAG will supplement this notice with more information next week.


 

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.

 
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