Policy ForumBiotech Regulation

A missed opportunity for U.S. biotechnology regulation

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Science  16 Sep 2016:
Vol. 353, Issue 6305, pp. 1211-1213
DOI: 10.1126/science.aai7854

A rare policy window (1)—an opportunity for change that happens when problem, political, and policy streams come together—recently opened for biotechnology regulation in the United States: an explosion of genetic engineering (GE) techniques and products challenging federal oversight; intensifying public, media, and political attention; and a growing number of policy ideas for change. When the White House in summer 2015 called for a process to revisit the 1986 Coordinated Framework for the Regulation of Biotechnology (CFRB) (24), it was seen as an opportune moment to match biotechnology innovation with innovation in the design of a U.S. regulatory system. However, the White House's Office of Science and Technology Policy (OSTP) interagency process for reviewing the framework fell short in multiple ways. The process has prevented clarification and restructuring of the regulatory system, as well as opportunities to increase the legitimacy of that system in the eyes of the public and stakeholders.

The CFRB was predicated on the view that it is the final product of GE that bears the risk, not the process by which it is produced, and that there are no new categories of risk associated with GE compared with conventional genetic-exchange methods like breeding (2). No new biotechnology laws were enacted by Congress; instead, older laws covering product categories like pesticides, plant pests, toxic substances, and drugs were used to divide authorities among agencies to regulate products of biotechnology and GE organisms (GEOs).

New GE technologies, like synthetic biology, gene-editing, and gene-drive systems, as well as novel GE products, are challenging regulatory definitions, highlighting inadequacies in health and environmental assessments, and revealing gaps in agency jurisdiction (57). Confidence in the CFRB has been decreasing, as concerned parties question why ground-breaking technological products go through outdated and tangential regulatory processes (4).

For example, release of the first GE mosquito in the United States was approved by the Food and Drug Administration (FDA) as an Investigational New Animal Drug (INAD). This GE line of Aedes aegypti contains sterility genes, designed to allow mating with wild members of the species but from which most of their offspring die in early development. By reducing the population of disease-carrying mosquitos, human illnesses from Dengue or Zika virus may decrease (8). However, typically, INADs submitted to FDA are for chemical substances injected, topically applied, or fed to animals to treat or prevent disease. INADs are primarily reviewed based on safety and efficacy to the target animal. The ultimate goal of the sterile transgenic mosquito is the population's own demise; therefore, FDA's regulatory focus does not appear to fit the situation or address risks of greatest concern. FDA's statutory authority does not focus on environmental impacts, and although those impacts might be examined through the National Environmental Policy Act (NEPA), the agency is not known for its expertise in ecological risk analysis, a key area of concern about the release of transgenic mosquitos.

Uncertainty associated with review of existing and new GE products under the CFRB demanded attention and catalyzed the interagency review. As such, the White House called for a year-long process for “development of an updated CFRB to clarify the roles and responsibilities of the agencies that regulate the products of biotechnology” (3). During the past year, representatives from the three federal agencies of the CFRB (FDA, Environmental Protection Agency, and Department of Agriculture) and the White House (Interagency Working Group) have been meeting in closed session, while in parallel, three public meetings were held. The memo also called for an external study, and for this, the National Academies of Sciences, Engineering, and Medicine (the Academies) was commissioned to identify the kinds of products that may be produced with biotechnology in the next 10 years and to provide advice on the scientific capabilities, tools, and expertise that may be needed for assessing risk in a report due December 2016 (9).

Parties to agreements on biodiversity

The countries that have ratified or accessioned the Convention on Biological Diversity (CBD) and its Cartagena Protocol on Biosafety (BSP) are shown, as well as nonparties.


Regulatory Options Are Off the Table

During the first public meeting in October 2015, OSTP staff stated that the interagency process would likely not result in revision of authorities or creation of new ones. Rather it would clarify existing authorities (4). This was disappointing to many scholars and practitioners given that the CFRB had not been revisited in more than 30 years (10).

On 8 March 2016, just a day before the second public meeting, the OSTP published draft case studies of regulating GE products under the CFRB to illustrate these clarifications (4). However, the GE products chosen for the cases fell neatly into existing authorities under the CFRB, and their regulatory paths could have been predicted by attentive scholars and practitioners before the start of the OSTP process (e.g., plants engineered with plant-pest sequences or containing pesticidal proteins).

At the third and final public meeting, several participants questioned why the cases failed to represent a challenging set that could truly serve to clarify authorities for emerging GE products (4). Products that are already stretching regulatory definitions and agency boundaries, like gene-edited crops (7), or that are poised to be problematic in the near future, like GE insects with gene drives or GE animals for environmental release or as livestock, were absent from the OSTP case studies. The OSTP responded to this criticism in the third meeting, stating that “these case studies were derived in order to give an overview of the current roles and responsibilities for current products of biotechnology” (4). When pressed that there are current products for which agency jurisdictions are not clear or are absent (e.g., 57, 11), no further explanation was provided (4). Thus, the portion of the OSTP process that was in the public eye shifted from “development of an updated CFRB” in the White House memo to clarification of authorities for current products that clearly fall into existing authorities.

Perhaps the limitations in the case studies and scope of the OSTP process were due to challenges in the political stream, such as behind-the-scene influences of certain stakeholders or political appointees within agencies, or interagency differences of opinion. However, people outside these circles do not know the reasons for the shortcomings, as the interagency discussions have not been open to the public.

The interagency working group has also been tasked with developing a long-term plan for horizon scanning of new biotech products and mechanisms to ensure that the regulatory system is well prepared (4). A draft of this plan and the final cases are to be published by the summer of 2016 for public comment through the Federal Register. If this deadline is met, the timing will occur before release of the Academies' study, and it is difficult to see how this external expert process will inform the interagency long-term planning process slated for this political administration.

Limited Forms of Engagement

Although the OSTP is to be commended for hosting three public meetings, the format did not meaningfully engage external scholars and practitioners, stakeholders, and interested and affected parties with local and specialized knowledge (12). Public meetings, with lengthy agency presentations and brief comments from various groups, are best for expressing views on controversial topics and are one of the least rigorous forms of public participation. Participants self-select, are generally wealthier, and have special interests (13). The OSTP public meetings took this form with some exception: The second meeting in Dallas, Texas, allowed for written questions, and the third at the University of California, Davis, involved a 1-hour breakout, discussion session (although results of the breakouts were not reported back to the full group for discussion). The least participatory meeting, the first one, for which the case studies were not available, took place in Washington, DC, yet this is where most interest groups with concerns about over- or underregulation reside (e.g., consumer and environmental groups or trade organizations).

Practitioners and scholars have been studying and implementing forms of public engagement that are more deliberative (i.e., that include back-and-forth exchange among diverse groups with bi-directional learning) and representatives (1114). Meaningful public and stakeholder engagement is not easy. It takes planning and careful design, as well as time and resources. However, it is not expensive in comparison with biological research—it requires no high-tech equipment, materials, or facilities. There is a vast scholarly literature to guide when, how, and why to do it (e.g., 1114). Scholars have stressed the need for wider engagement in order to make decision-making for GEOs development and deployment more equitable, fair, and “strongly objective” (15).

The “public” political stream has magnified for biotechnology products, especially GEOs in the environment, with citizens demanding labeling of GE foods, and nongovernmental organizations promulgating lawsuits against federal agencies because of insufficient environmental assessments. In failing to conduct a rigorous mode of engagement, the OSTP process ignored the public part of the politics stream, constraining policy agenda setting to an inner circle of policy elites through the closed-door interagency process.

External experts do not seem to have been meaningfully engaged. Outside product developers and natural scientists are often a part of scientific or stakeholder advisory panels for federal decisions about biotechnology products and regulations. The current Academies' panel includes them, but its report is due after the OSTP draft long-term plan, and the scope does not include recommendations on revisions of authorities or regulations under the CFRB (9). Also, Academies' panels deliberate in private, and their composition is limited in expertise and experiences. Between the OSTP “clarification” scope and the Academies' study, this rare opportunity for changing biotech regulation is getting lost.

Another important expert group includes those who study policy evaluation, design, and implementation from the behavioral, economic, management, policy, political, and social sciences and fields of applied ethics, communication, democratic engagement, and risk perception. OSTP did not appear to make it a priority to engage them, even though arguably their expertise would be most important given that many have studied biotechnology regulation and governance. As a result, the OSTP process may be less responsive to the multitude of ideas for biotechnology regulation from the scholarly and think-tank literature [e.g., (1619)].

The lack of transparency and few opportunities for meaningful, deliberative engagement stifled policy innovation during the OSTP process, which is almost sure to lead to further distrust, skepticism, and decreased public legitimacy in the CFRB.

Missed Opportunity for Global Alignment

The possibility of harmonizing the CFRB with a major international approach was not explicitly considered in the OSTP public process (3). The issue arose in public comments, but responses were not given by the agencies because the public comment periods were designed only to listen (i.e., no back-and-forth dialogue) (3). The United States is not a party to the Cartagena Protocol on Biosafety (BSP) or the overarching United Nations (UN) Convention on Biological Diversity (CBD), which has been a key international mechanism for outlining countries' obligations to each other for safe transfer and use of living modified organisms (LMOs, also known as GEOs). With 196 parties to the CBD and 170 parties to the BSP (19), the protocol, although imperfect, is the closest mechanism possible for GEOs' oversight and international harmonization. It allows flexibility in design of national biosafety regulations but establishes rules and procedures for the safe transfer and use of LMOs and guidance for risk assessment.

Elements of the CBD-BSP are thought by many to run counter to U.S. federal policy, trade, and business interests [e.g., (20)]: In it, there are a form of the precautionary principle that troubles U.S. agencies and biotech developers and a call to consider socioeconomic impacts from LMOs, including impacts on indigenous and local communities (19). However, many parties to the CBD-BSP balance provisions in the protocol with producing and releasing LMOs. Several grow sizable acreages of GE crops (e.g., Brazil, second; India, fourth; and China, sixth in the world) (21). Other parties allowed release of transgenic insects before the United States (Panama, Malaysia, and Brazil) (7).

Although this article does not argue for U.S. participation in the CBD and BSP, it does lament the lack of discussion and analysis of pros and cons under the OSTP interagency process. For example, logical benefits of U.S. participation could be to have a voice in (i) drafting subprotocols under the BSP, (ii) interpreting the CBD-BSP statement on precaution less stringently in the formulation of risk assessment standards, and (iii) promoting the possibility (however remote) of harmonizing data packages to fit what U.S. companies do for risk assessment. U.S. participation could potentially increase global good will, perhaps inciting less controversy in trade disputes through the World Trade Organization.

Another option that was not considered in the OSTP process, at least publicly, but was raised in the public comments (4) is the passing of a U.S. national law to consolidate biotechnology regulatory authorities under the CFRB. Authorities under the CFRB are diffuse, outdated, and confusing, especially for newer biotechnology products. This situation is bound to get worse. A new biotechnology regulatory law would require significant political will in Congress. If the OSTP process had considered this option and engaged scholars, practitioners, and stakeholders to do so, there could have been a higher probability of placing biotechnology regulation on the agenda for the upcoming presidential administration. If societal benefits were found to be greater than societal costs, Congress might have even mustered political will to pass new legislation.

A consolidated biotechnology regulatory law is not so preposterous. Many developing countries have passed specific biosafety laws for GEOs as a result of participation in the CBD-BSP, and some developed countries have specific laws for GEOs regardless of participation in the CBD-BSP (23). Some countries with specific biotechnology laws, such as Australia, are growing substantial acreages of GE crops (22). In the United States, a consolidated biotechnology law could create more certainty for GE product developers, especially important to small companies that have fewer resources to navigate complicated regulatory paths in the CFRB. A new biotechnology-focused law could provide an opportunity to harmonize with the CBD-BSP, if analyses showed benefits of doing so.

Open policy windows to improve biotechnology governance are rare, as they depend on the confluence of policy, political, and problem streams. Perhaps there is still time to alter the OSTP process before the next presidential administration takes over (a time when activities from the previous administration are often abandoned). Other policy windows may open in the future. But opportunities to effect meaningful and impactful change for safe, responsible, legitimate, and appropriate use of GEOs were missed at this key juncture in the biotech revolution, although it is poised to change nearly every sector and even our conceptions of nature.

References and Notes

  1. Links to all the documents, transcripts, public comments, and case studies from this process can be found in the Public Docket folder at https://www.regulations.gov/docket?D=FDA-2015-N-3403.
  2. For more information about the Academies' study scope, visit http://nas-sites.org/biotech/. Although I am a member of the Academies study committee, the views expressed in this article are my own, drawing on two decades of scholarship and practice in biotechnology regulation. I do not speak for the study committee or for the National Academies of Sciences, Engineering, and Medicine.

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