By Lynn L. Bergeson

On April 29, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Research and Development (ORD) announced a virtual meeting of the Board of Scientific Counselors (BOSC) Chemical Safety for Sustainability and Health and Environmental Risk Assessment (CSS-HERA) Subcommittee. The purpose of the meeting will be to review the draft 2019-2022 Strategic Research Action Plan (StRAP) of the HERA research program. The videoconference meeting will be held over a period of two days on May 12, 2020, from 12:30 p.m. to 5:00 p.m. (EDT), and May 13, 2020, from 12:30 p.m. to 5:00 p.m. (EDT). The meeting is open to the public. Those interested in participating must register by May 8, 2020.

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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.

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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.

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As previously reported in the Biobased and Renewable Products Advocacy Group’s (BRAG^®) Biobased and Renewable Products Update of 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 .  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 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).

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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).

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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:

• Modernizing the Regulatory System for Biotechnology Products:  An Update to the Coordinated Framework for the Regulation of Biotechnology (Update); and
• National Strategy for Modernizing the Regulatory System for Biotechnology Products (Strategy).

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.”

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On August 3, 2016, 24 farmer and public interest organizations wrote to the Obama Administration expressing their disappointment with the direction that the White House Office of Science and Technology Policy (OSTP) has taken with the proposed modernization of the Coordinated Framework for Regulation of Biotechnology (Coordinated Framework). The letter argues that an overly permissive regulatory framework for genetically engineered (GE) products has resulted in negative consequences, and that GE products need broader and more cautious regulatory oversight. The letter also states that public engagement with the project has not been proactively pursued by the Coordinated Framework's Working Group, and demands "more transparency, more public meetings and more public input."

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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.

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On March 2, 2016, the renewable diesel producer and Biobased and Renewable Products Advocacy Group (BRAG®) member Neste announced that Prince Ea is joining the Pre-order the Future Project. Prince Ea, a well known spoken word artist and environmentalist, will work with Neste's Pre-order the Future team as a futurologist, researching how renewable materials can be used to build innovative new products. The project is launching in Spring 2016 and will focus on sustainable living issues and future public spaces.

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According to a Federal Register notice published on February 5, 2016, 81 Fed. Reg. 6225, the U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) announced its intent to "prepare a programmatic environmental impact statement (EIS) in connection with potential changes to the regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered [(GE)] organisms." The notice identifies "reasonable alternatives and potential issues" to be evaluated in the EIS and requests public comments to define further the scope of the alternatives and environmental impacts and issues for APHIS to consider. Comments will be due March 7, 2016.

Background

Under the Plant Protection Act (PPA), APHIS currently regulates the introduction (movement into the U.S. or interstate, or release into the environment) of GE organisms that may present a plant pest risk through its regulations in 7 C.F.R. Part 340, "Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests." The notice notes that APHIS' regulation of certain GE organisms to protect plant health is aligned with the Coordinated Framework for the Regulation of Biotechnology (CF). While APHIS, the U.S. Environmental Protection Agency (EPA), and the U.S. Food and Drug Administration (FDA) are in the process of working to modernize a number of CF issues and activities, the Federal Register notice states "that effort is distinct from and entirely compatible with APHIS' effort to revise its biotechnology regulations" at 7 C.F.R. Part 340. The notice addresses only proposed changes to the APHIS regulations. More information on the efforts to modernize the CF, including two public engagement sessions that will be held in March 2016, is available on our website.

APHIS states that during the past 28 years of its regulation of certain GE organisms, advances in biotechnology and new issues raised by a range of stakeholders have emerged, and APHIS is considering amending the 7 C.F.R. Part 340 regulations pertaining to introductions of certain GE organisms to address the advances in biotechnology and the new issues raised by stakeholders. According to APHIS, this update would increase the "efficiency and precision" of its regulations. The proposed revisions would align the range of potential risks that APHIS may consider under Part 340 with both the plant pest and noxious weed authorities of the PPA, "to ensure a high level of environmental protection pursuant to APHIS' PPA authorities to regulate plant pest and noxious weeds, improve regulatory processes so that they are more transparent to stakeholders and the public, and provide regulatory relief to the extent possible so that unnecessary regulatory burdens are eliminated." APHIS states that the changes would ensure that it "can continue to effectively regulate the products of biotechnology that may pose plant pest or noxious weed risks to U.S. agriculture and the environment."

Programmatic EIS

APHIS states that it is planning to prepare a programmatic EIS in connection with the proposed revisions and amendments that it is considering. The notice states that aspects of the human environment that may be potentially affected by such proposed regulatory revisions and amendments that APHIS has preliminarily identified for evaluation in the EIS will include:

• Potential impacts on U.S. agriculture and forestry production (e.g., conventional, biotechnology-based, and organic);
   
• Potential impacts on current and potential future uses of products of biotechnology in agriculture and forestry;
   
• Agronomic practices employed in biotechnology crop production that may have environmental consequences or impacts (i.e., tillage, crop rotation, and agronomic inputs);
   
• Potential impacts on aspects of the physical environment that include soil quality, water resources, air quality, and climate change;
   
• Potential impacts on aspects of the biological environment such as animal and plant communities, weed and insect resistance to herbicides and insecticides (respectively), the potential gene flow and weediness of regulated GE crop plants, and biodiversity;
   
• Potential impacts on consumer health and agricultural worker safety;
   
• Animal feed and health; and
   
• Socioeconomic considerations, to include potential impacts of regulated GE crop plants on the domestic economic environment, international trade, and coexistence among all forms of U.S. agriculture, conventional, biotechnology-based, and organic, in providing market demand for food, feed, fiber, and fuel.

Importantly, APHIS has preliminarily identified possible new definitions to be used in its proposed Part 340 biotechnology regulations for consideration and analysis in the EIS:

• Biotechnology -- Laboratory-based techniques to create or modify a genome that result in a viable organism with intended altered phenotypes. Such techniques include, but are not limited to, deleting specific segments of the genome, adding segments to the genome, directed altering of the genome, creating additional genomes, or direct injection and cell fusion beyond the taxonomic family that overcomes natural physiological reproductive or recombination barriers. This definition does not include and is intended not to include traditional breeding, marker assisted breeding, or chemical or radiation-based mutagenesis.
   
• Product of biotechnology -- An organism developed using biotechnology.
   
• Regulated organism -- An organism developed using biotechnology that poses plant pest or noxious weed risks as documented in an APHIS risk analysis that APHIS has determined to regulate.

APHIS states that it is considering, and invites public input on, these proposed definitions. Such input should address APHIS' regulatory objectives to safeguard agricultural plants and agriculturally important natural resources from plant pest or noxious weed damage (biological, chemical, or physical) caused by a "product of biotechnology," including its potential, or lack of potential to pose plant pest or noxious weed risks. APHIS will use these proposed definitions in the four proposed alternatives that it proposes to examine in the EIS. These proposed alternatives are:

• First Alternative: Take no action. Under this "no action" alternative, APHIS would make no changes to the existing 7 C.F.R. Part 340 regulations for certain GE organisms that pose a potential plant pest risk, and APHIS would continue to regulate certain GE organisms as it does today. APHIS would not revise its current regulations to add the definitions listed above. The No Action alternative represents the baseline against which the proposed revisions to the regulations will be compared.
   
• Second Alternative: Revise the current APHIS regulations concerning the introduction of certain GE organisms to provide for a process to review and regulate certain products of biotechnology to protect plant health; analyze potential plant pest and/or noxious weed risks first; and thereafter regulate only when appropriate and necessary. Under this alternative, APHIS would revise its current regulations to implement a two-step process that would ensure a thorough review of a product of biotechnology's potential to pose plant health risks (plant pest and/or noxious weed). According to APHIS, such a two-step process would enable it to consider and place risk-appropriate regulatory controls on the importation, movement, or "outdoor" use of those products that are determined to pose actual plant pest or noxious weed risks (regulate only when APHIS has determined that certain plant health risks are appropriate and necessary to require some regulatory action to be taken and implemented).
   
• Third Alternative: Revise the current APHIS regulations concerning the introduction of certain GE organisms to provide for the regulation of "products of biotechnology" as either plant pests or noxious weeds using the existing plant pest "analysis trigger" or a noxious weed "analysis trigger" that might classify plants produced through biotechnology as potential plant pests or noxious weeds. The notice states that under this third alternative, APHIS' proposed regulations would substantially increase oversight and resources over those currently used to regulate GE organisms. APHIS would not exempt certain "products of biotechnology" from APHIS regulatory oversight if a "product of biotechnology" was developed using a plant pest; or, if it posed a risk as a noxious weed pursuant to the PPA definition of a noxious weed. Introductions of products of biotechnology that posed a plant pest risk or noxious weed risk would require a permit and conditions would be applied for import, interstate movement, or "outdoor" use. APHIS states that its proposed regulatory scheme would include the range of actions and processes that would enable it to become, to the extent permitted by its PPA authorities, an "all-encompassing, wide-scale regulatory permitting authority," but still fully comply with the CF and support the continued development of products of biotechnology.
   
• Fourth Alternative: Withdraw the current 7 C.F.R. Part 340 regulations completely and implement a voluntary, non-regulatory consultative process for certain products of biotechnology whereby APHIS would document plant pest or noxious weed risks, if any, of certain products of biotechnology as defined above. Under this fourth alternative, developers would be responsible for ensuring that their respective products of biotechnology do not pose risks as a plant pest or noxious weed pursuant to their respective PPA definitions, and that their activities related to the importation, interstate movement, or release into the environment of their respective products of biotechnology are not in violation of any existing statutes or federal regulations that relate to plant pests or noxious weeds. Under this alternative, APHIS would not have a dedicated regulatory scheme to regulate specifically any products of biotechnology that may pose plant pest or noxious weed risks and therefore would not require consultation nor prescribe methods or practices related to any products of biotechnology. APHIS would manage any products of biotechnology that pose plant pests or noxious weed risks using its other existing regulations pursuant to the PPA; e.g., 7 C.F.R. Parts 330 and 360.

APHIS requests comments and information related to the topics and issues presented in the Federal Register notice so that the scope of the analysis in the draft EIS, including the types and range of reasonable alternatives, is "reasonable and appropriate," and proposed revisions to 7 C.F.R. Part 340 are well-evaluated. APHIS states that public input will be helpful in further defining the scope of the issues and reasonable alternatives under consideration. APHIS will publish a notice in the Federal Register to announce the availability of a draft EIS when it is issued and to invites the public to provide comments on it.

Commentary

APHIS' efforts to solicit comment and consider potentially radical changes to its regulation of products of biotechnology are commendable. The notice reflects an awareness of the changing nature of the regulatory, commercial, and societal implications of the federal regulation of genetically modified organisms (GMO). The range of options under consideration cover the gamut -- from doing nothing, to regulating nothing and relying on voluntary efforts. As the public's attention has been focused in recent days on the Zika virus and the role genetically modified mosquitoes may play in fighting the explosive spread of the virus, the notice is likely to generate significant comment.

The invitation for comment on a wholesale set of options for how USDA should regulate GMO's is separate from the Administration-wide review of the CF. Whether EPA might invite similar public consideration of regulatory options on the merits of more, less, or the same level of review and regulation is unclear, and certainly has not been discussed publicly when EPA staff have described its actions under the Administration-wide review. Under the guise of reviewing the effectiveness of the current CF, some options for change to the EPA roles as they relate to USDA efforts might be part of what some stakeholders will want to comment on. As some of the USDA decisions to de-regulate traits then go to EPA for review under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), some observers may leverage the USDA review process as a means to prompt changes to the EPA process. Whether EPA would incorporate or even consider changes under the guise of its relationship to the USDA role would itself be a separate question.

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