U.S. Not Prepared To Monitor Biotech Crops

The post market oversight of biotech crops, also known as genetically modified, is intended to ensure compliance with restrictions that agencies might impose to protect public health and the environment.

The current regulatory oversight system, write the authors of "Post-Market Oversight of Biotech Foods: Is the System Prepared?" is poorly equipped to carry out this mandate.

"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 Taylor, the report's key author and senior fellow at Resources for the Future.

Post market oversight Taylor explained, includes requiring buffer zones between genetically modified and conventional crops 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.

The report finds that biotech crops are regulated through a patchwork of laws -- three federal agencies use at least 10 different laws and a range of 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, explained Taylor and coauthor Jody Tick, also with Resources for the Future.

The reports finds, for example, that the U.S. Department of Agriculture'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 approved for for large scale planting.

In addition, APHIS cannot require biotech developers to monitor those crops' impact on the environment post-approval.

The U.S. Environmental Protection Agency (EPA) is responsible for regulations that manage the environmental impact of pesticides, including those incorporated into biotech crops, but agricultural interests are not legally bound to meeting the EPA's standards, according to the report.

The agency can only impose conditions on biotech companies, which are supposed to monitor how farmers use their products.

"There are no official EPA standards for what constitutes an adequate degree of compliance or government audits of how well farmers are complying," the authors wrote.

And they say the U.S. Food and Drug Administration (FDA) has no affirmative post market inspection or compliance program for biotech foods, even though it has for other categories of food and drug products it regulates.

This calls into question whether the FDA 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.

The importance of post market oversight has been heightened by two high profile events with biotech corn.

In 2000, StarLink, a variety of biotech corn approved only for use in animal feed, accidentally ended up in the human food supply. It resulted in the recall of more than 300 food products and costing farmers, food processors and the grain industry millions of dollars in lost profit.

The second event occurred in November 2002, when it was discovered that corn genetically modified and grown by ProdiGene to produce a protein that serves as a pig vaccine, contaminated some 500,000 bushels of soybeans grown in Nebraska.

The soybeans were grown in a field that had previously been used by ProdiGene to grow the biopharm corn. When the corn crop failed, ProdiGene plowed it under and planted food grade soybeans.

The soybeans were intercepted before they could reach the human or animal food supply, and USDA officials said this demonstrated that adequate safeguards are in place. But others are less than convinced and the believe the concern over biopharm crops warrants greater regulatory oversight.

"Although the agencies with oversight for biotech crops have shown substantial resilience and capacity to react to significant problems, 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."

The debate over genetically modified, or biotech, crops has grown in recent months, as the United States and the European Union (EU) are engaged in a very public dispute over the safety of biotech foods. The U.S. government, in particular Bush administration officials, are keen to allow more biotech crops, but many others are wary of the potential health, environmental and economic impacts of biotechnology.

The EU has refused to grant import licenses for biotech food for the past four years because many Europeans are worried about possible health and environmental risks.

EU officials are not slated to decide on any new policies affecting biotech foods until October.

The United States produces some two-thirds of the world's GM crops and U.S. officials estimate the EU ban has cost its agricultural industry hundreds of millions, including some $300 million a year in corn sales alone.

They contend the ban is negatively affecting global trade, slowing development of new GM crops and contributing to famine in developing countries. Some 34 percent of U.S. corn is genetically modified, as is some 71 percent of U.S. cotton and 75 percent of U.S. soybeans.

With biotech crops now common in the United States and the Bush administration's eagerness to promote biotechnology, including biopharm crops, oversight of approved biotechnology producsts is emerging as a very real issue, said Taylor.

"The time is ripe to address these issues," he said, "before a crisis occurs."