The following comment was submitted electronically to the Office of Science and Technology Policy (OSTP) on February 3, 2023 in response to a Request for Information on the subject of Identifying Ambiguities, Gaps, Inefficiencies, and Uncertainties in the Coordinated Framework for the Regulation of Biotechnology (CF)1. Download a PDF of the comment here.
The Institute for Agriculture and Trade Policy (IATP) appreciates this opportunity to respond to the RFI and to propose modifications to the CF to implement the Executive Order (EO) 14081 to “support the safe use of biotechnology by clarifying and streamlining regulations in service of a science- and risk-based, predictable, efficient, and transparent regulatory system to support the safe use of products of biotechnology.” (Federal Register, Vol. 87, No. 243, p. 77901) This revision of the CF, if finalized, would be the second since 2015 dedicated to reducing the regulatory requirements (e.g., procedures to determine that a product is not a “regulated article”) and costs to biotechnology product developers towards expediting the commercialization of current and future anticipated products. IATP responded to the 2015 RFI to revise the CF.2
Before responding to the RFI questions, it is important to note that despite OSTP’s support of biotechnology, OSTP has never published a strategic review of federal agency research and financial support for biotechnology. Such a review is far overdue. The following comments are limited to the application of biotechnology to agricultural and food inputs and ingredients. The National Science and Technology Council has not published a report on agricultural biotechnology since the 2009 “National Plant Genome Five Year Initiative.”3 The link to this report is broken, so we cannot comment on it as an input to help evaluate agency performance under the then applicable CF. Indeed, despite the government’s considerable investment in agricultural biotechnology,4 there are almost no performance audits, even of the regulatory performance to risk assess and risk manage agricultural and food products derived from techniques of genetic engineering (GE). A 2016 General Accountability Office report on U.S. Department of Agriculture’s inadequate oversight of GE crops is the exception to the dearth of performance audits.5
IATP trusts that the OSTP’s recently released “Framework for Federal Scientific Integrity Policy and Practice”6 will be effectively implemented in the agencies subject to the CF. We agree with the Union of Concerned Scientists that the text of the Framework is a “landmark achievement”7 while recognizing that the Framework did not include measures proposed to protect whistleblowers who identified senior management as the source of integrity violations.8 The implementation of that Framework in the CF relevant agriculture and food agencies (USDA, the Food and Drug Administration and the Environmental Protection Agency) needs a benchmark of comparison to show that the agencies are implementing a strategy of federal science and not merely responding to industry demands. In the absence of a strategic plan for biotechnology and performance reviews of agency science, research and development and regulatory activities, U.S. agricultural biotechnology policy does not have rudder.
Violations of scientific integrity in the narrowest sense, e.g., falsifying data in federal science, are relatively rare. However, “sins of omission” in the use of science for risk assessment can occur under regulatory and budgetary constraints. Agencies are under huge pressure to provide new legal and scientific rationales for exempting biotechnology product developer applications for commercialization from pre-market safety reviews. According to one analysis of this system in the USDA, as codified in the so-call SECURE rule,"99% of GM plants will be exempt from premarket field testing and data-based risk assessment requirements.”9 This system for exempting new GE plant varieties from risk assessment, as advocated for by GE product developers, is “reconstituting the same conditions that led to the public rejection and mistrust of the first generation of GM foods.”10
Simply revising the CF to clarify agency roles and responsibilities will not of itself improve public confidence in the regulatory system or trust that federal regulatory science serves the public interest. U.S. agencies may learn from the European Commission’s attempt to gain public trust in its biotechnology regulatory system. European researchers into the European Commission’s proposed regulatory framework for exempting most New Genetic Techniques (NGTs) from risk assessment characterize the framework as one aimed to show the NGTs are “safe enough.” However, in that case, the regulatory “dialogue” between regulators and industry marginalizes such a wide array of social, economic and environmental concerns and alternative agricultural policies and practices that the researchers involved characterize the exclusionary regulatory strategy as not “trustworthy enough.”11 It is not unfair to suggest that the objective of the CF is only to coordinate agency activities to produce agricultural biotechnology products that are “safe enough” to be commercialized.
Even prior to the traumatization of federal science during the Trump administration,12 the “war on science” has led agencies to develop survival strategies that include reducing the regulatory burdens of proof. The CF should explicitly reference and integrate the “Framework for Federal Scientific Integrity Policy and Practice” in the CF and not relegate the CF to a description of bureaucratic responsibilities and new measures to accommodate industry demands and expedite commercialization of agricultural and food products derived from GE techniques.
To continue reading, download a PDF of the comment.
4. There is no unified budget across agencies for biotechnology comparable to, e.g., the annual fiscal year budget for the National Nanotechnology Initiative.
5. “Genetically Engineered Crops: USDA Needs to Enhance Oversight and Better Understand Unintended Effects of Mixing with Other Crops,” General Accountability Office, GAO 16-241. April 14, 2016. https://www.gao.gov/products/gao-16-241
7. Jacob Carter, “New White House Guidance Protects Federal Scientists and Their Work,” Union of Concerned Scientists, January 12, 2023. https://blog.ucsusa.org/jacob-carter/new-white-house-guidance-protects-federal-scientists-and-their-work/
8. “Biden New Science Integrity Plan: Buzzwords and Evasions,” Public Employees for Environmental Responsibility,” January 23, 2023. https://peer.org/biden-new-science-integrity-plan-buzzwords-and-evasions/
9. Jennifer Kuzma and Khara Grieger, “Community-led governance for gene-edited crops,” Science, November 20, 2020. https://www.science.org/doi/10.1126/science.abd1512
11. Kjeldaas, S., Dassler, T., Antonsen, T. et al. With great power comes great responsibility: why ‘safe enough’ is not good enough in debates on new gene technologies. Agric Hum Values (2022). https://doi.org/10.1007/s10460-022-10367-6
12. Lisa Friedman, “Depleted under Trump, a “Traumatized” EPA Struggles With Its Mission,” The New York Times, January 25, 2023.