By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. National Science Foundation (NSF), on behalf of the federal agencies and departments participating on the National Science and Technology Council (NSTC) Subcommittee on Scientific Integrity (the Subcommittee), is organizing two virtual listening sessions to hear from members of the public about recommendations, issues, and concerns related to federal department and agency implementation of the NSTC Framework for Federal Scientific Integrity Policy and Practice (the Framework). 88 Fed. Reg. 60713. The Subcommittee is supporting the development of scientific integrity policies at federal departments and agencies and seeks public input on the development and implementation of these policies and associated procedures and practices. According to the notice, perspectives gathered during the virtual listening sessions will inform: (1) federal agencies’ finalization of Scientific Integrity Policies, in response to the Framework and its implementation memorandum from the White House Office of Science and Technology Policy (OSTP); (2) federal agency processes, procedures, and practices related to scientific integrity; and (3) other elements of federal implementation of the Framework. The listening sessions will be held September 15, 2023, 1 p.m. - 3 p.m. (EDT) and September 20, 2023, 5 p.m. - 7 p.m. (EDT). Registration is now open. More information on the Framework is available in our January 19, 2023, blog item.

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By Lynn L. Bergeson and Carla N. Hutton
 
On January 12, 2023, the White House Office of Science and Technology Policy (OSTP) announced the release of A Framework for Federal Scientific Integrity Policy and Practice, “a roadmap that will help strengthen scientific integrity policies and practices across the federal government.” The framework builds on the assessment of federal scientific integrity policies and practices described in the January 2022 report, Protecting the Integrity of Government Science, and draws from extensive input from federal agencies, as well as from across sectors, including academia, the scientific community, public interest groups, and industry. According to OSTP, the framework has several key components that federal departments and agencies will use to improve scientific integrity policies and practices, including:

• A consistent definition of scientific integrity for all federal agencies;
• A model scientific integrity policy to guide agencies as they build and update their policies; and
• A set of tools to help agencies regularly assess and improve their policies and practices.

The framework requires all agencies to designate a Scientific Integrity Official (SIO) and agencies that fund, conduct, or oversee research to designate a Chief Science Officer (CSO), and it establishes the National Science and Technology Council (NSTC) Subcommittee on Scientific Integrity to oversee implementation of the framework and evaluate agency progress. Agencies are directed to adopt the following timeline:

• Within 60 days from public posting of the framework: Agencies should submit new or updated agency and department draft scientific integrity policies for review by OSTP and the Subcommittee via the mailbox .(JavaScript must be enabled to view this email address);
• Within 120 days from public posting of the framework: OSTP and the Subcommittee will complete the reviews using the framework’s critical policy features for assessment;
• Within 180 days after public posting of the framework: Each agency should provide an opportunity for public input on its scientific integrity policies and practices, such as through a listening session or request for comment on its draft policy;
• Within 270 days from public posting of the framework: Final policies are due to OSTP. OSTP will compile and make public all agency policies, as well as all agencies’ designated CSOs and SIOs on a federal web page;
• Within 360 days from public posting of the framework and every two years thereafter: All agencies report to OSTP on their progress toward implementing the Framework; and
• For calendar year 2023 and annually thereafter: Each agency should publish, consistent with any requirements related to national security and privacy as well as any other applicable law, an annual report on the agency’s website.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 4, 2022, the release of a “new and improved” Framework for the Assessment of Environmental Performance Standards and Ecolabels for Federal Purchasing under its Environmentally Preferable Purchasing (EPP) program, as well as a webpage highlighting ecolabel criteria that address per- and polyfluoroalkyl substances (PFAS). EPA states that “[t]hese actions are a key step in implementing President Biden’s Executive Order on Catalyzing Clean Energy Industries and Jobs through Federal Sustainability and the accompanying Federal Sustainability Plan.
 
According to EPA, the EPP program helps federal government purchasers use private sector standards and ecolabels to identify and procure environmentally preferable products and services via the Recommendations of Specifications, Standards, and Ecolabels for Federal Purchasing. The updated Framework provides a streamlined, transparent, and consistent approach to assessing marketplace standards and ecolabels for environmental sustainability and for inclusion into the Recommendations.
 
EPA states that the updates to the Framework reflect lessons learned during the last five years of implementation and a desire to address a broader range of purchase categories with a more streamlined set of criteria. In addition, EPA updated the eligibility criteria for standards and ecolabels to support further their implementation across the federal government. EPA will use the Framework to update and expand the Recommendations to support the Biden Administration’s priorities and the Federal Sustainability Plan. The Recommendations currently include more than 40 private sector environmental performance standards and ecolabels in 25 purchase categories.
 
EPA will hold a webinar on March 2, 2022, at 2:00 p.m. (EST) to provide more information on the updated Framework and initial plans to expand the Recommendations. Stakeholders can register for the webinar and provide questions in advance.
 
EPA notes that the webpage highlighting how EPA’s Recommendations of Specifications, Standards, and Ecolabels address PFAS “is an important step toward providing federal purchasers with tools to avoid procurement of products containing PFAS.” The release of the webpage is concurrent with work to identify products and purchase categories that are known to be associated with key PFAS uses, as well as outreach to ecolabel and standard organizations regarding addressing PFAS.

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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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