The title of this report poses what seems to be a simple question about the U.S. government’s postmarket oversight of biotech crops and foods: is the system prepared? This question cannot be answered, however, without first answering another question: prepared to do what? We give at least a partial answer to the second question in Objectives of Postmarket Oversight. We want the system of postmarket regulatory oversight to foster compliance with conditions of use or other restrictions imposed during the premarket review process; detect noncompliance and unforeseen health and environmental problems; take appropriate enforcement action to correct and penalize noncompliance; and manage follow-up investigations, market disruptions, and other conse- quences of noncompliance and unforeseen problems.
Our research casts doubt on the preparedness of the current postmarket oversight program to achieve these traditional objectives. For the products it has deregulated, APHIS lacks a regulatory handle to require systematic data collection by sponsors to detect unforeseen plant pests or envi- ronmental problems. EPA and its regulatory partners in the states have no program to provide direct oversight and enforcement of environmentally important PIP use restrictions, and EPA is still working out with the biotech industry how to ensure the effectiveness of the compliance pro- grams that PIP registrants are required to establish through their private contractual relationships with growers. FDA has no affirmative compliance and enforcement program for biotech crops or foods and lacks some of the basic analytical tools to test whether the biotech products already on the market are in compliance with applicable regulatory requirements.
We do not conclude that these gaps in postmarket oversight have resulted in widespread noncom- pliance with regulatory requirements or any specific food safety or environmental problems. The general experiences of StarLink and ProdiGene reveal some potential vulnerabilities in this regard but also show that the agencies have substantial resilience and capability to react to significant compliance problems when they do arise.
With respect to the traditional objectives of postmarket oversight, the real challenge for the sys- tem lies ahead. The biotechnology pipeline is likely to produce an increasing number and diversi- ty of GM crops and foods, including ones that involve novel proteins, claims of consumer benefits, and nontraditional uses of plants, such as the manufacture of pharmaceuticals and industrial chemicals. Many of these future applications of biotechnology will require tighter regu- latory control to protect human health and the environment, and they will call into serious ques- tion whether the current overall structure and approach to postmarket oversight is adequate to ensure compliance and to maintain public confidence in the regulatory system. There almost cer- tainly will be a need to enhance the resources devoted to postmarket oversight and to consider strategies that effectively harness public and private resources to ensure that consistent and cred- ible compliance with regulatory requirements is achieved.
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Beyond this need to achieve the traditional objectives of postmarket oversight, biotechnology raises a more fundamental issue that is centrally important in considering whether the system is prepared for the future: what degree of postmarket control does society want over GM crops and foods? The degree of control desired and what postmarket oversight should do in achieving it is fairly well established for conventional agricultural and food technologies such as pesticides, ani- mal drugs, and food additives. Health and environmental standards are widely recognized, pre- market approval systems are broadly accepted, and public expectations can be met by ensuring that products pass scientific muster at market entry and are used in accordance with the condi- tions established by the regulatory agencies. A general, if perhaps unspoken, consensus exists about the degree of control society wants over these conventional technologies, and postmarket oversight programs can be evaluated from the perspective of whether that degree of control is being provided.
Biotechnology is different, because societal consensus is still lacking about the degree of post- market control desired. This lack of consensus is based in part on some scientific and technical uncertainties, including:
• Is it possible to predict the future environmental effects of a GM plant that has been deregu- lated by APHIS on the basis of field trials?
" How great should concern be about compliance with buffers and refuges in light of the potential effects of Bt crops and other PIPs on insect resistance, nontargeted species, and biodiversity in general?
" Is it technologically feasible to measure the broad ecological effects of GM crops or to enforce strict standards for adventitious presence or identity preservation?
• Do biotech foods pose unpredictable risks of allergenicity that warrant greater postmarket oversight than other foods?
Questions like these can most likely be answered as science and technology improve and develop more certainty. The lack of consensus about the appropriate degree of postmarket control over biotech crops and foods also reflects, however, conflicting or uncertain social values, such as:
• What level of precaution is appropriate when faced with the potential risks of biotech crops and foods?
• How should the regulatory system address the fact that most of the benefits of the current technologies are enjoyed by one subset of society—the technology providers and farmers— whereas the potential risks are experienced by society at large?
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• How hard should the system work to satisfy the preferences of those who would rather avoid GM foods altogether?
• Who should bear the inconvenience and economic costs of whatever degree of protection and control is deemed appropriate?
These are value-laden questions for which there are no scientific answers. It is the combination of scientific and technical uncertainty and differences over values that fuels most of the current controversies surrounding biotechnology.
To answer our two broad questions—is the system prepared? and prepared to do what?—the scien- tific and technical uncertainties must be acknowledged and their implications understood; the value issues need to be put on the table and debated. Then, in light of the defined and probably still-conflicting values, society must determine the degree of postmarket control it desires for biotech crops and foods. The details of public policy will flow from there.
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The ProdiGene Incident
On November 13, 2002, the U.S. Department of Agriculture (USDA) announced it was investigating the possible contamination of soybeans by corn plants that had been genetically modified by ProdiGene Inc. (College Station, TX) to pro- duce an experimental vaccine for use against a viral disease in pigs (Fabi 2002a). Inspectors from the USDA, Animal and Plant Health Inspection Service (APHIS), detected the contamination during an inspection of a Nebraska soy- bean field where the pharmaceutical corn had been field-tested in 2001. In apparent violation of APHIS containment requirements mandated in an APHIS field trial permit, the farmer had not fully removed the corn plants from the field, and a few stalks had grown as “volunteers” during the 2002 growing sea- son. Because the soybeans harvested from the contaminated field had been com- mingled with other soybeans, APHIS ultimately quarantined 500,000 bushels of potentially contaminated soybeans to prevent any trace of pharmaceutical pro- tein from entering the food supply. U.S. Food and Drug Administration officials said that the small amount of unapproved corn material found in the soybeans posed minimal, if any, risk to consumers (Cassidy and Powell 2002).
Despite the lack of a real safety concern, reaction to the event was swift, intense, and broad. The Biotechnology Industry Organization (BIO), represent- ing technology providers, claimed the discovery proved that the regulatory sys- tem works, because the alleged permit violation was discovered by APHIS inspectors. The president of the National Food Processors Association, however, said the incident “very nearly placed the integrity of the food supply in jeop- ardy,” and another food industry spokesman called ProdiGene’s lack of compli- ance an “unacceptable risk to the U.S. food supply” (Fabi 2002; GMA 2002). Food industry officials questioned the sufficiency of current containment pro- cedures and, in a meeting with Secretary of Agriculture Ann Veneman, urged strengthening the regulations for pharmaceutical plants. The Center for Science in the Public Interest (CSPI), a prominent consumer advocacy group, said the alleged permit violations by ProdiGene demonstrated that the biotechnology
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industry “cannot be trusted to meet its obligations of safeguarding the food supply and environment” (CSPI 2002a). Declaring that it was unknown whether similar violations had gone undetected, CSPI called for “a robust inspection and enforcement program” (CSPI 2002b).
On December 6, USDA announced that ProdiGene, without admitting or denying any violations of the Plant Protection Act, had agreed to pay a fine of $250,000, reimburse USDA the approximately $3,000,000 required to destroy the 500,000 bushels of soybeans, and post a $1,000,000 bond (USDA 2002b). To guard against future incidents and allay the concerns of the food industry, BIO has urged its members not to plant pharmaceutical plants in major food crop pro- duction areas, a policy that has caused an uproar among farmer groups in the Corn Belt who want the option to plant high-value genetically modified crops.
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