Report

Tending The Fields

State and Federal Roles in the Oversight of Genetically Modified Crops

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Tending the Fields examines the role of state governments in the regulatory oversight of crops and foods produced using the tools of modern biotechnology. Not surprisingly, most states with large agricultural sectors are intensely interested in the economic promise of agricultural biotechnology. Many are eager to capture the economic development and growth potential of a new technology that could provide added value to low-priced commodity crops States recognize, however, that such economic benefits could be jeopardized if public anxiety or market access for conventional crops is threatened. As a result, states have an important stake in the regulation of agricultural biotechnology not only to protect health and safety, but also to advance and protect important economic interests Although they tend to defer to the scientific and technical expertise at the federal regulatory agencies on safety issues, states generally want to be a full partner with federal regulators to ensure that state interests are adequately addressed. The report documents diverse and innovative state approaches to developing policies that take into account local interests and issues. It contains a number of examples of state responses, including efforts by Colorado to develop a public participation process for the consideration of “pharmaceutical” crops, a North Carolina initiative to develop identity preservation criteria for both biotech and conventional tobacco crops, and the efforts in a number of states to develop their own regulatory approaches.

For the last several years, the Pew Initiative on Food and Biotechnology has published an annual round-up of state legislative activities dealing with genetically modified (GM) food and agricultural biotechnology. From those studies, it has become apparent that states are on the “front line” of agricultural biotechnology, where they serve as the initial responders to the promises and conflicts that can accompany the introduction of any novel technology into the marketplace.

In the present study, we asked Michael Taylor, Jody Tick, and Diane Sherman of Resources for the Future, who had previously studied post-market issues for us, to take a look at how state regulators were responding to agricultural biotechnology, and how the federal-state partnership to ensure food safety and protect the environment was faring.

As did PIFB's state legislative surveys, Taylor, Tick, and Sherman found a diverse range of state regulatory responses to agricultural biotechnology. Not surprisingly, most states with large agricultural sectors are intensely interested in the economic promise of agricultural biotechnology. Many are eager to capture the economic development and growth potential of a new technology that could provide added value to low-priced commodity crops. States recognize, however, that such economic benefits could be jeopardized if public anxiety or market access for conventional crops is threatened. As a result, states have an important stake in the regulation of agricultural biotechnology not only to protect health and safety, but also to advance and protect important economic interests. Although they tend to defer to the scientific and technical expertise at the federal regulatory agencies on safety issues, states generally want to be a full partner with federal regulators to ensure that state interests are adequately addressed.

States have long shared responsibility with the federal government for inspection and enforcement of laws regulating pesticides and plant pests - the laws under which genetically modified crops are typically regulated. In addition to participating in the review of permits for genetically modified crops, states have a particular interest in, and responsibility for, oversight of field trials to ensure that experimental GM crops do not accidentally
commingle with crops headed for the food supply. This is especially true in the case of crops that have been modified to produce non-food substances, such as compounds used for industrial or pharmaceutical production. In such cases, states are not only concerned about potential food safety or environmental issues, but also the economic damage that could result to existing agricultural production.

A key question is whether the states have adequate legal tools, technical expertise, and financial resources to play a complementary, collaborative role in the regulation of agricultural biotechnology. Based on the research conducted for this report, the answer varies from state to state, but there appears to be a fairly broad sentiment among those interviewed for this report that many states are not as well prepared as they might be, and that in particular the financial resources available for state level biotech oversight are inadequate.

The legal frameworks under which the states and federal agencies are working to regulate biotechnology also raise a number of issues that state and federal regulators are actively working to address. One issue, which has been the subject of litigation in Hawaii, deals with Confidential Business Information, or CBI. Applicants for permits to conduct field trials of GM crops are required to submit information to the federal agencies so that the agencies can assess risks; the companies usually claim that much of the information is CBI which, under federal law, may not be disclosed. That often prevents the federal agencies from sharing the information because some state “sunshine” laws would require states to disclose such information. Without the information, states may not have an adequate basis on which to make an independent determination about the safety of the field trials, and they thus rely on informal means to obtain information, such as the voluntary cooperation of the biotechnology companies.

A second issue arising from the legal framework concerns pesticidal substancesthat are produced within plants that have been genetically modified (so-called “plant-incorporated protectants,” or PIPs). Field tests of traditional (or conventional) experimental pesticides are regulated both by EPA (under an Experimental Use Permit, or EUPs) and by the states. While EPA approves EUPs for field trials of PIPs, for a number of reasons, EPA does not consider either the seed or the GM plant to be “pesticides” under the law. As a result, states are unsure whether they have the same independent authority to oversee the field trials of PIPs as they do for traditional pesticides.

The report documents diverse and innovative state approaches to developing policies that take into account local interests and issues. The report contains a number of examples of state responses, including efforts by Colorado to develop a public participation process for the consideration of “pharmaceutical” crops, a North Carolina initiative to develop identity preservation criteria for both biotech and conventional tobacco crops, and the efforts in a number of states to develop their own regulatory approaches. The report does not contain policy recommendations. Instead, the purpose of this report is simply to bring the wealth of work occurring at the state level to the attention of a broader audience and to assist states in learning from each other. A better understanding of the critical role that states play in the oversight of agricultural biotechnology also helps provide a clearer picture of the overall regulatory framework that applies to this technology.

The Initiative gratefully acknowledges the work of Michael R. Taylor, Jody S. Tick, and Diane M. Sherman of Resources for the Future, for their usual thoughtful work and careful research. We share their hope that this report will contribute to informed debate and sound public policy development.

The opinions expressed in this report are those of the authors and do not necessarily reflect the views of the Pew Charitable Trusts, which supports the Pew Initiative on Food and Biotechnology through a grant to the University of Richmond.