Inadequate legal tools, technical resources and funding listed as top concerns; North Carolina and Colorado develop noteworthy approaches

The ability of states to collaborate with federal regulators to oversee agricultural biotechnology and address the unique issues the technology raises at the local level varies state-to-state, according to a new report released today by the Pew Initiative on Food and Biotechnology. A consistent concern among many stakeholders, however, is whether state governments have the critical tools they need--including proper legal authority, financial resources and trained staff--to play their oversight role.

The report, titled Tending the Fields: State & Federal Roles In the Oversight of Genetically Modified Crops was prepared by Michael R. Taylor, Jody S. Tick and Diane M. Sherman of Resources for the Future to provide a national overview of the federal-state relationship in the oversight of genetically modified crops. The report is based on targeted data collected from 17 states and includes an analysis of 78 survey responses and interviews with biotech stakeholders across the country; along with vignettes intended to illuminate how some of these states are handling specific policy and process issues. No policy recommendations were included in the report.

"The states are on the front lines when it comes to managing agricultural biotechnology," said Michael Rodemeyer, executive director of the Pew Initiative on Food and Biotechnology. "Federal regulators rely on their state counterparts to be their 'eyes and ears' in the fields and communities where agricultural biotechnology products are being grown. Therefore, it is important to determine if state regulators have the tools they need to be effective partners in the oversight of agricultural biotechnology."

Key findings of the report include:

• Most officials and stakeholders at the state level believe state regulation of biotechnology should address local concerns whereas primary responsibility for human health and environmental protection should rest with federal regulators.
   
• The definition of "local concerns" with respect to biotech differs from state to state. For example, states with large agricultural sectors are intensely interested in the economic promise of agricultural biotechnology, but in some cases also need to take into account concerns that new GM crops could threaten valuable export markets for existing producers of conventional or organic crops. Local concerns in some states also include potential environmental and food safety risks of GM crops and other ag biotech products.
   
• There is broad sentiment among those interviewed for the report that many states do not have the legal tools, technical expertise and financial resources needed to effectively partner with federal regulators and carry out the necessary level of oversight.
   
• Legal frameworks that support federal regulators are problematic at the state level. For instance, companies that apply for permits to conduct field trials of GM crops can ask federal regulators to withhold key information--such as where trials will be conducted--from state regulators because such information is considered Confidential Business Information (CBI).
   
• While some states are responding to the issues raised by agricultural biotechnology in an innovative manner, others are struggling to find approaches to managing conflicts. In Colorado, state officials have used the possible introduction of "pharmaceutical" crops to develop a unique public participation process, and in North Carolina, concerned parties have developed voluntary protocols to prevent genetically modified and conventional strains of tobacco from mixing. In contrast, litigation has been filed in Hawaii to challenge aspects of Hawaii's biotech oversight, including its practice of classifying some data submitted for permits as CBI.

"The regulatory system for agricultural biotechnology is dependent on state and federal regulators playing a complementary and collaborative role," noted Michael R. Taylor, key author of the report and Senior Fellow at Resources for the Future. "The diverse levels of preparedness of states reflected in this report suggests that the federal-state partnership needs to be reviewed and strengthened to ensure that states have the resources they need to be full partners with federal regulators and to enable them to respond to unique local concerns."

Tending the Fields: State & Federal Roles In the Oversight of Genetically Modified Crops is the fourth product produced by the Pew Initiative that looks at the role of the states. In 2001 the Pew Initiative began tracking legislation pertaining to agricultural biotechnology that was being introduced at the state level. This data was compiled into a database and factsheet which have been updated annually since early 2002. Data and information related to the 2004 state legislative activity will be released in early 2005.

Resources for the Future previously prepared two other reports for the Pew Initiative. The first report, published in October 2001, examined the circumstances surrounding the accidental commingling of genetically modified corn, which was not approved for human consumption to the U.S. food supply. The second report, published in April 2003, examined the role of federal agencies in overseeing biotech crops after they entered the environment.

The Pew Initiative on Food and Biotechnology is a nonprofit, nonpartisan research project whose goal is to inform the public and policymakers on issues about genetically modified food and agricultural biotechnology, including its importance, as well as concerns about it and its regulation. It is supported by a grant from The Pew Charitable Trusts to the University of Richmond.

Tending the Fields
State & Federal Roles In the Oversight of Genetically Modified Crops

Source: http://pewagbiotech.org/research/fields/

Preface

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 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 Mike 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 the 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 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 substances that 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 from a grant to the University of Richmond.

Michael Rodemeyer
Executive Director
Pew Initiative on Food and Biotechnology
December 2004

Complete report (5.1MB): http://pewagbiotech.org/research/fields/report.pdf

Notes on Vignettes & Data for Select States

Source: http://pewagbiotech.org/research/fields/data.php

One section of the report draws on experiences around the country to illustrate how states are addressing some of the major issues concerning state oversight of biotech crops and foods. A common theme among the vignettes presented in this section is the effort of states, and biotech stakeholders at the state level, to act in furtherance or protection of a particular state or local interests that they see being affected by biotech crops and foods.

Each vignette speaks to one or more of the issues that states and stakeholders have suggested are challenges to effective oversight of biotech crops and their adoption. For example, pharma crops have presented a number of challenges to state agricultural interests. These include both a lack of clear legal authority for states to regulate field trials and the lack of a formalized role for public input within the federal field trial permitting process (as illustrated by Colorado’s attempt to instigate its own public process). In addition, it could be argued that state regulators and the public have insufficient access to confidential business information (CBI) data in field trial permit applications (as exemplified by the Hawaiian vignette). There is also the issue of balancing efforts to facilitate the market opportunities associated with pharma and other new biotech crops, while preserving the identity of conventional crops (currently at issue in North Carolina). In addition, pharma crops illustrate the challenge of finding adequate expertise to help evaluate the potential risks and benefits of such technologies and the potential for conventional crops in a state to suffer decreased market access as a consequence of planting biotech crops (as addressed in the vignette on the role of the California Rice Commission).

Similarly, the planting of any genetically modified crop—not just pharma crops—has the potential to affect negatively the market acceptance of other crops, conventional or organic, and some states have considered or taken steps to ensure their agricultural economies are not adversely impacted by the introduction of biotech crops. The vignette describing the reactions of North Dakota and other states to Roundup Ready wheat illustrates these challenges. A vignette on biotech-specific regulatory state statutes further illustrates the point made in Colorado’s pharma crop story regarding the ambiguity of the legal authority of the states to regulate agricultural biotechnology.

The history and issues underlying each story are complex and lend themselves to detailed analyses that are beyond the scope of this report. The intent of the vignettes is to capture enough background in each instance so that the potential implications of one state’s experience for other states can be seen.

A complete presentation of the vignettes appears in section IV of the report. However, vignettes and key agricultural data for select states (drawn from Appendix A) are presented here in order to provide a brief overview of biotech activity at the state level.