November 26, 2002
The United States Food and Drug Administration (FDA) isn't likely to waver from its policy of zero tolerance for contamination of crops by plants biologically engineered for pharmaceutical use, a spokesman for the agency said last week at a biologics forum hosted by Iowa State University.
The FDA issued a draft guidance statement in September recommending that pharmaceutical crops not be grown in areas where they might cross contaminate other plants used for food and feed purposes. In response, the Biotechnology Industry Organization (BIO) recently adopted a similar statement on geographic planting restrictions for genetically engineered crop varieties. Under this policy, BIO member companies will no longer grow corn that produces pharmaceuticals in Iowa and other corn belt states.
The FDA's guidance statement is directed at industries manufacturing the pharmaceutical crops, not at research universities such as Iowa State University, said Dr. Keith Webber of the FDA Center for Biologics Evaluation and Research. He said the Animal and Plant Health Inspection Service (APHIS) Biotechnology Regulatory Services division, which oversees the importation and interstate movement of pharmaceutical plants as well as their release into the environment, has final control over approving such university trials.
The U.S. Department of Agriculture and APHIS have a risk-based approach to preventing cross contamination between crops, setting minimum distance requirements and other confinement policies.
The FDA's primary concern in writing its guidance statement is with the continued safety, purity, potency and strength of pharmaceuticals, Webber said.
"We didn't want to completely ignore the problem of where you can grow these crops, but it was not the primary focus," he said.
However, distance requirements serve a dual purpose of maintaining the potency of the drugs and preventing their spread in food and feed supplies, Webber noted.
The geographic restrictions recommended are based on the agency's position of minimizing risk, rather than any specific scientific studies, he added.
"The basis is primarily that one should take measures to minimize risk, regardless of whether it is a documented risk or a perceived risk," Webber said. "The FDA likes to see risk minimized."
The guidance document doesn't specifically address tolerance levels for risk management, but Webber said the FDA will likely maintain a zero tolerance policy.
"I don't know that we will move away from the zero tolerance standpoint with regard to food contaminant issues," he said. "We expect companies to keep (the pharmaceutical traits) out of food and feed products."
According to the FDA, companies applying for a license to grow pharmaceutical crops would be held responsible for any contamination that occurs. Iowa farmers in the audience, however, suggested that farmers who grow the crops are the ones who could do the best job of preventing contamination by following acceptable separation distances and other policies set by APHIS. Restricting pharmaceutical crops from entire geographic regions would mean the loss of a potentially profitable niche market for Iowans, they said.