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 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 January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology. The 2017 Update provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) with respect to regulating biotechnology products. Together with the National Strategy for Modernizing the Regulatory System for Biotechnology Products, published in September 2016, the 2017 Update offers a “complete picture of a robust and flexible regulatory structure that provides appropriate oversight for all products of modern biotechnology.” Within that regulatory structure, the federal agencies “maintain high standards that, based on the best available science, protect health and the environment, while also establishing transparent, coordinated, predictable and efficient regulatory practices.” More information is available in Bergeson & Campbell, P.C.’s (B&C®) memorandum White House Announces Release of Final Update to the Coordinated Framework for the Regulation of Biotechnology.


 

By Lynn L. Bergeson and Carla N. Hutton

On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology (2017 Update).  The Update to the Coordinated Framework provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) with respect to regulating biotechnology products.  Together with the National Strategy for Modernizing the Regulatory System for Biotechnology Products, published in September 2016, the Update to the Coordinated Framework offers a “complete picture of a robust and flexible regulatory structure that provides appropriate oversight for all products of modern biotechnology.”  Within that regulatory structure, the federal agencies “maintain high standards that, based on the best available science, protect health and the environment, while also establishing transparent, coordinated, predictable and efficient regulatory practices.”  To help product developers and the public understand what the regulatory pathway for products might look like, the 2017 Update presents information about agency roles and responsibilities in several forms, including:

  • Graphics that illustrate agency-specific overviews of regulatory roles;
  • Case studies that demonstrate how a product developer might navigate the regulatory framework; and
  • A comprehensive table that summarizes the current responsibilities and the relevant coordination across EPA, FDA, and USDA for the regulatory oversight of an array of biotechnology product areas.

In its blog item, “Increasing the Transparency, Coordination, and Predictability of the Biotechnology Regulatory System,” the Obama Administration acknowledges that while the 2017 Update represents “remarkable progress by the EPA, FDA, and USDA to modernize the regulatory system for biotechnology products, much work remains.”  EPA, FDA, and USDA will consider the comments submitted in response to the proposed 2017 Update and information gathered during the three public engagement sessions hosted by EPA, FDA, and USDA to inform ongoing and future agency activities.  In addition, the agencies commissioned an independent study by the National Academy of Sciences (NAS) on future biotechnology products.  When completed, the agencies will consider the study’s findings, as well as the comments.  More information on the Update to the Coordinated Framework will be available in our forthcoming memorandum, which will be available on our website under the key phrase biobased products, biotechnology.


 

On October 25, 2016, Richard E. Engler, Ph.D., Senior Chemist with Bergeson & Campbell, P.C. (B&C®), presented “Under-appreciated Regulatory Barriers to Commercialization of Algae and Algal Products” at the Algae Biomass Summit in Phoenix, Arizona. Dr. Engler’s presentation was part of the Legal, IP and Regulatory Issues -- Challenges and Opportunities track of the summit, and explored how algae processing and use is regulated by the Federal Food, Drug, and Cosmetic Act (FFDCA) and the Toxic Substances Control Act (TSCA). The TSCA Inventory lists all chemical substances that may be manufactured or imported into the U.S. for TSCA purposes, and all chemicals in commerce must be on the TSCA Inventory or eligible for exemption. Intergeneric algae are reportable under TSCA, as well as spent biomass byproduct, depending on use. Algae and algal products have similar requirements to demonstrate safety under FFDCA, but this is done mainly through scientific studies as there is no list (or inventory) published by the U.S. Food and Drug Administration (FDA) of approved ingredients. Dr. Engler ended the presentation by emphasizing the need to understand regulatory burdens and seek assistance in preparation, review, and communication with regulators to bring a product to market. For a copy of this presentation, contact Dr. Engler at .(JavaScript must be enabled to view this email address).


 

On September 22, 2016,  Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology (Update to the Coordinated Framework) was published in the  Federal Register . This proposed update provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and U.S. Department of Agriculture (USDA) with respect to the regulation of biotechnology products. More information about what this means for the future of biotechnology and the biotechnology industry is available in the Bergeson & Campbell, P.C. (B&C®) memorandum "Biotechnology: White House Releases Proposed Update to the Coordinated Framework and National Strategy for Modernizing the Regulatory System for Biotechnology Products." Comments are due by  November 1, 2016 , at  5:00 p.m. (EDT).


 

On September 16, 2016, the White House posted a blog item, "Building on 30 Years of Experience to Prepare for the Future of Biotechnology" and released two documents intended to modernize federal regulation of biotechnology products. In July 2015, the White House directed the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) to develop a long-term strategy to ensure that the system is prepared for the future products of biotechnology, and commission an expert analysis of the future landscape of biotechnology products to support this effort. The proposed Update to the Coordinated Framework updates the 1986 Coordinated Framework for the Regulation of Biotechnology and provides a comprehensive summary of the roles and responsibilities of EPA, FDA, and USDA with respect to the regulation of biotechnology products. The National Strategy for Modernizing the Regulatory System for Biotechnology Products (National Strategy) sets forth a long-term strategy intended to ensure that the federal regulatory system is equipped to assess efficiently the risks, if any, of the future products of biotechnology. The Update to the Coordinated Framework is now available for comments per the Federal Register notice. Comments will be due by November 1, 2016, at 5:00 p.m. (EDT). Read the full memorandum on the Bergeson & Campbell P.C. (B&C®) website.


 

By Lynn L. Bergeson and Margaret R. Graham

On September 16, 2016, the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA), in collaboration with the White House, released two documents that will update the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework) that was first rolled out by the White House Office of Science and Technology Policy (OSTP) in 1986 and updated in 1992.  The White House states that this is “an important step to ensure public confidence in the regulatory system for biotechnology products and to improve the transparency, predictability, coordination, and, ultimately, efficiency of that system.”  The documents released are:

The Update document is intended to help product developers and the public understand what the regulatory pathway for products might look like.  The White House states that the Update document presents information about agency roles and responsibilities in several forms, including:

  • Graphics that illustrate agency-specific overviews of regulatory roles;
  • Case studies that demonstrate how a product developer might navigate the regulatory framework, and;
  • A comprehensive table that summarizes the current responsibilities and the relevant coordination across EPA, FDA, and USDA for the regulatory oversight of an array of biotechnology product areas.

The White House is seeking public comment on this proposed Update.  The comment deadline will be 40 days from the date of publication in the Federal Register.

The Strategy document, which the White House states “sets forth a vision for ensuring that the Federal regulatory system is equipped to assess efficiently the risks, if any, associated with future products of biotechnology while supporting innovation, protecting health and the environment, maintaining public confidence in the regulatory process, increasing transparency and predictability, and reducing unnecessary costs and burdens,” also details many existing activities at EPA, FDA, and USDA; new activities that have been instigated by the memorandum on “Modernizing the Regulatory System for Biotechnology Products,” which directed EPA, FDA, and USDA to update the Coordinated Framework; and key commitments that these three agencies will keep going forward to continue the modernization process.  These commitments are:

  • EPA, FDA, and USDA will review existing communication tools and, as appropriate, may revise existing or develop new user-friendly sources of regulatory information for product developers and the general public.
  • EPA, FDA, and USDA are emphasizing their commitments to interagency communication and collaboration in order to make timely decisions on regulatory jurisdiction for biotechnology products and to optimize the review and use of scientific data for regulatory assessments.
  • EPA and FDA intend to clarify their respective approaches for oversight of products developed using genome editing techniques, including, for example, pesticidal products at EPA and genetically engineered animals at FDA.
  • EPA, FDA, and USDA will continue to examine their regulatory structures with the goal of clarifying how the U.S. Federal Government will regulate genetically engineered insects in an integrated and coordinated fashion to cover the full range of potential products.
  • EPA, FDA, and USDA commit to reporting annually, for at least the next five years, on specific steps that they are taking to implement the Strategy, as well as any additional actions being taken to improve the transparency, predictability, and efficiency of biotechnology regulation and the coordination among the regulatory agencies.
  • EPA, FDA, and USDA will continue to provide leadership in international fora to promote scientific competency, understanding of the U.S. regulatory approach, and regulatory compatibility worldwide for biotechnology products.
  • EPA, FDA, and USDA commissioned a study by the National Academy of Sciences, entitled “Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System.”  This report is still forthcoming.

On Tuesday, September 20, 2016, at 2:00 p.m. (EDT), OSTP, EPA, FDA, and USDA will be participating in a conference call on the White House’s efforts in regards to the above.  More information regarding registration for the call and submitting questions is available online.

More information concerning the Coordinated Framework, the memorandum on “Modernizing the Regulatory System for Biotechnology Products,” and other current biotechnology issues are available in our memoranda on our website under the key phrase “Biobased Products, Biotechnology.”


 

On March 9, 2016, the second public meeting on the July 2, 2015, memorandum entitled “Modernizing the Regulatory System for Biotechnology Products,” was convened in the U.S. Environmental Protection Agency’s (EPA) Region 6 Office in Dallas, Texas.  Representatives from EPA, the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the White House Office of Science and Technology Policy (OSTP) discussed their current roles and responsibilities regarding biotechnology products under the Coordinated Framework for Regulation of Biotechnology (CF) by reviewing case studies of hypothetical products.

 

Two documents were released prior to the public meeting:  (1) Table of the oversight of biotechnology products and relevant coordination across EPA, FDA, and USDA; and (2) Regulation of Biotechnology Products -- Clarifying Roles and Responsibilities through Hypothetical Case Studies.  A copy of the agenda is available here.

 

According to OSTP’s blog item on the meeting, the table document summarizes current responsibilities and the relevant coordination across USDA, EPA, and FDA for the regulatory oversight of biotechnology products.  OSTP cautions that it should not be interpreted as a guarantee that specific products in any of the product areas described in the table have been in the past, or will be in the future, determined to be safe by the relative regulatory agencies.

 

The case studies document states that its intention is to provide general information to developers who believe they have, or are uncertain as to whether they may have, a biotechnology product that is subject to regulation under one or more of the federal laws described in the CF.  It also demonstrates how an innovator might navigate the regulatory framework, starting from research activities in the laboratory to full commercialization of the product.  OSTP states that all of the case studies are of hypothetical products, selected because they cover multiple biotechnology product areas with different characteristics and intended uses, and because they illustrate how agencies coordinate their oversight under the CF.  The case studies discussed included the following hypothetical, genetically engineered organisms:

 

1.                  Corn, a field crop used for food.  In the first case study, corn with pesticidal properties is engineered with a plant pest component to have pesticidal activity against certain insects.

 

2.                  Plum, a fruit tree/crop used as food.  In the second case study, plum with pesticidal properties is genetically engineered without a plant pest component to resist a fungus.

 

3.                  Canola, a field crop, used as food.  In the third case study, herbicide-tolerant Canola is genetically engineered with a plant pest component to tolerate an already registered herbicide.

 

4.         Rose, an ornamental plant.  In the fourth case study, a rose is genetically engineered with a plant pest component to increase the production of a pigment in its petals.

 

5.         Microbial Pesticide, a bacterium that is not considered a plant pest.  In the fifth case study, a microbial pesticide is genetically engineered to enhance its pesticidal properties.

 

6.         Microbial Pesticide, a phytopathogenic bacterium.  In the sixth case study, a microbial pesticide that is genetically engineered to express a pesticidal substance that protects against insects.

 

7.         Algae for Biofuels.  In the seventh case study, a unicellular alga is genetically engineered with a plant pest component to produce industrial oils for conversion into biofuels.

 

8.                  Rabbit, an animal.  In the eighth case study, a rabbit is genetically engineered to make a therapeutic protein (recombinant insulin) for treatment of humans lacking this protein activity.

 

The first public engagement session took place on October 30, 2015, at FDA’s White Oak Campus in Silver Spring, Maryland.  A transcript from the meeting is available online.  The third public meeting will be held on March 30, 2016, at the University of California, Davis Conference Center in Davis, California.

 

More information regarding the CF is available in Bergeson & Campbell, P.C.’s (B&C®) memoranda OSTP Seeks Comment on Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology, White House Directs EPA, FDA, and USDA to Update the Coordinated Framework for the Regulation of Biotechnology, and Second Meeting on Modernizing the Regulatory System for Biotechnology Products Will Be Held March 9.


 

On February 1, 2016, the dates and locations for the last two public engagement sessions discussing the "Modernizing the Regulatory System for Biotechnology Products" memorandum were announced. The first meeting occurred on October 30, 2015, and a record of the meeting is available on the U.S. Food and Drug Administration (FDA) website. The second of the three meetings will be held on March 9, 2016, at the U.S. Environmental Protection Agency's (EPA) Region 6 office in Dallas, Texas. The third meeting will be held on March 30, 2016, at the University of California's David Conference Center in Davis, California. A Federal Register notice will be published with additional details on meeting times, agendas, and how to participate.


 

On October 16, 2015, the U.S. Food and Drug Administration (FDA), along with the Office of Science and Technology Policy (OSTP), the U.S. Environmental Protection Agency (EPA), and the U.S. Department of Agriculture (USDA) announced in the Federal Register a public meeting Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the Regulation of the Products of Biotechnology. The meeting is intended to discuss FDA's role in responding to the July 2015 Executive Office of the President (EOP) memorandum "Modernizing the Regulatory System for Biotechnology Products" and will invite oral comments from interested parties. The meeting will be held on October 30, 2015, at FDA's White Oak Campus in Silver Spring, Maryland. Registering early is recommended due to limited space. The deadline for written comments is November 13, 2015. For more information or to register for this meeting, visit FDA's website.


 
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