FDA WANTS NOTIFICATION FROM BIOTECH SUPPLIERS

AMY I. STICKEL

WASHINGTON -- The Food and Drug Administration here has announced that it will implement a premarket notification requirement for bioengineered foods, according to Dr. Eric Flamm, an international policy analyst with FDA. Currently, companies that are developing bioengineered products do not need to notify FDA before those products hit the market, he said. However, most, if not all, bioengineering firms that are developing products have voluntarily consulted with FDA. Approval by the U.S. Department of Agriculture, and in some cases the Environmental Protection Agency, is required, Flamm said.

He said bioengineering firms voluntarily work with FDA to answer any concerns FDA may have about food safety and nutrition. Flamm said FDA can -- and has -- raised concerns about foods that were placed on the market without first consulting the administration.

"It's in everyone's interest to consult with us first," Flamm said.

The premarket notification procedure is still in the developmental stage, and Flamm said it is too early to know when a final decision will be released. Flamm said the entire review process for bioengineered foods has been streamlined since the first bioengineered whole food -- Davis, Calif.-based Calgene Inc.'s Flavr Savr tomato -- was approved last May. The review process for the Flavr Savr took five years. Now it is a matter of months, Flamm said.

As the current process stands, FDA does not grant "approval" to bioengineered products. Instead, FDA meets several times a year with advisory committees, and decides if a product needs further review. If a bioengineering company has successfully answered all the administration's concerns, no further review is required.

Besides FDA clearance, developers must also be granted USDA approval, which gives them what is called nonregulatory status. While FDA is concerned with food safety and nutrition issues, USDA focuses on environmental and agricultural issues. Every new plant introduced into the environment must have USDA approval, according to Jim Altemus, manager of plant science communications at Monsanto Co., St. Louis. After a company applies for nonregulated status, the department has 180 days to complete a review.

Plants that act as herbicides, or are resistant to herbicides, must undergo review by EPA as well, Flamm said.