Washington, DC
April 24, 2003

While much of the debate over biotech crops has been focused on their approval before they enter the environment or reach the market, there are significant issues concerning post-market oversight of these crops that need to be addressed as this technology continues to grow, according to a new report released today by the Pew Initiative on Food and Biotechnology.

In "Post-Market Oversight of Biotech Foods: Is the System Prepared?" authors Michael Taylor and Jody Tick of Resources for the Future find that the current regulatory oversight system for agricultural biotechnology is focused mainly on pre-market approval and that there are potential vulnerabilities in the system due to the relatively low priority and limited resources for post-market oversight. Post-market oversight is intended to ensure compliance with restrictions that agencies might impose as a condition of approval (such as requiring buffer zones between genetically modified and conventional crops) and to detect and address any unanticipated health or environmental problems that could occur after a biotech product is planted in fields or enters the marketplace.

Although these gaps in post-market oversight have not resulted in widespread noncompliance with regulatory requirements nor any known food safety or environmental problems, the real challenge for the post-market oversight system lies ahead as future biotech products that cross traditional boundaries, such as plants that produce pharmaceuticals, may call for tighter regulatory control.

Two recent experiences have tested and demonstrate the importance of post-market oversight: StarLink, a variety of biotech corn approved only for use in animal feed but that accidentally ended up in the human food supply, triggering massive recalls; and the ProdiGene incident, where corn that was engineered to produce a pig vaccine became commingled with soybeans destined for the human food supply -- but were stopped in the nick of time.

"Although the agencies with oversight for biotech crops have shown substantial resilience and capacity to react to significant problems, as was evidenced by the StarLink and ProdiGene incidents, there are some serious questions about whether the current regulatory regime is prepared for what lies ahead," said Michael Rodemeyer, executive director of the Pew Initiative. "Plant biotechnology holds promises for products with strong consumer benefits, such as allergen-free crops or plant-made drugs that help solve unmet medical needs, but these new applications also call into question whether the government's post-market oversight can ensure compliance as well as maintain consumer confidence, which is essential to the well-being of this industry."

Crops produced through biotechnology are currently regulated through a patchwork of laws: the Coordinated Framework for Regulation of Biotechnology was established in 1986, after it was decided that no new laws were needed to regulate the products of agricultural biotechnology. As a result, three federal agencies (the Food and Drug Administration, the Department of Agriculture and the Environmental Protection Agency) use at least ten different laws and numerous agency regulations and guidelines to address biotechnology products. Each of the laws currently used was developed before the advent of biotechnology products and reflects widely different regulatory approaches and procedures.

The report identifies some gaps and potential vulnerabilities in the post-market oversight programs established under this regulatory framework. For example:

• USDA's Animal and Plant Health Inspection Service (APHIS), which oversees biotech plantings, does not have the authority under current regulations to impose conditions on the use of biotech crops once they have been "deregulated" (approved for large-scale planting) and cannot require biotech developers to monitor those crops' impact on the environment post-approval.
• Although the EPA is responsible for setting standards to manage the environmental impact of pesticides, including so-called plant-incorporated protectants (or PIPs, like Bt, a bacterium that is engineered into the plant so that it produces its own pesticide), farmers are not legally accountable to EPA for meeting those standards. EPA now only imposes conditions on the biotech companies; the companies, in turn, are supposed to monitor how farmers use their products based on what farmers tell them. There are no official EPA standards for what constitutes an adequate degree of compliance or government audits of how well farmers are complying.
• Currently, the FDA has no affirmative post-market inspection or compliance program for biotech foods, such as it has for other categories of food and drug products it regulates. Should there ever be a question about whether food has been contaminated with some non-food GM crop (such as a biopharmed plant), there are questions as to whether the agency has the detection methods it needs, the capacity to conduct large-volume sampling and testing, and adequate legal tools, such as the authority, to examine food industry records.

These gaps in current post-market oversight programs raise some significant questions about the degree of control society wants over the presence of GM traits in the food supply and the roles of the government and the private sector in achieving that degree of control. To further explore what degree of control might be appropriate and challenges to achieving it, the report analyzes the issues surrounding how the regulatory system should address adventitious presence (the low-level, unintended presence of something other than the specific crop being sold), and the government's role, if any, in establishing identity preservation and traceability systems.

"Our report raises questions about the future preparedness of the post-market oversight program to achieve its traditional objectives, including the enforcement of regulatory restrictions and the detection and correction of unanticipated health or environmental problems," said Michael R. Taylor, the report's key author and Senior Fellow at Resources for the Future. "There almost certainly will be a need to
enhance the resources devoted to post-market oversight and to consider strategies that effectively harness public and private resources to ensure that consistent and credible compliance with regulatory requirements is achieved. The time is ripe to address these issues - before a crisis occurs."

The peer-reviewed report is based on an extensive literature review and interviews with experts representing regulatory agencies, various segments of the food and technology sectors and consumer advocacy groups (from food companies, technology providers, agricultural producers, grain traders and processors, consumer and environmental groups, government regulators and policy officials). A full copy of the paper, as well as the names of the interviewees and reviewers, can be found at www.pewagbiotech.org/research/postmarket/

Resources for the Future (RFF) has operated since 1952 as an independent, nonprofit research institute dedicated to objective analysis of natural resource and environmental issues.

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 funded by a grant from The Pew Charitable Trusts to the University of Richmond.