Biotechnology Industry Says New FDA Rules Will Boost Food Safety

November 26, 2004

By Chris Clayton

Source: Omaha World-Herald


The biotechnology industry is lauding new proposed rules from the Food and Drug Administration, but critics argue they allow low-level contamination of the food supply from experimental plants.

The proposed rules, published Wednesday in the Federal Register, have set off a wave of complaints from biotech critics. The announcement coincided with release of a new poll showing consumers want tighter regulation of biotech foods.

Comments will be taken in a 60-day period, after which the rule could be adopted if the comments do not provide adequate reason to withdraw the proposal.

The new proposal acknowledges the possibility that material from a new plant variety could cross-pollinate other crops before the FDA approved it for commercial production. Under the proposal, a company, in an effort to "encourage early communication," would provide information to the FDA about the plant and potential proteins that might come from it.

About 60 percent of Nebraska's corn crop and more than 90 percent of the soybeans are considered genetically modified. That means a gene within the seeds has been altered to create a specific trait. Most common traits include genes that repel or kill certain pests or are resistant to herbicides.

Michael Phillips, vice president of the Biotechnology Industry Organization, said the proposal increases regulation on the industry.

"It's an extra safety precaution," Phillips said of the requirement that companies get preliminary clearance for experimental plants. "The critics of the industry should be applauding this effort instead of criticizing it."

Groups such as the Center for Food Safety and Friends of the Earth contend the rule essentially means the FDA says it is OK to contaminate food with untested genetic crops.

"They are calling it a food-safety measure," said Bill Freese, a research analyst for Friends of the Earth. "What they are really saying is the government is allowing the contamination of our food supply with experimental material they haven't tested. ... The biotech and food industry are really pushing this hard."

Mike Fromm, director of the University of Nebraska Center for Biotechnology, said critics are making something out of nothing because right now regulations for experimental plants now rest exclusively with the U.S. Department of Agriculture. This rule gives the FDA some involvement.

"While it's early in the testing stage, the FDA is saying 'Let's take a look at this and be a little cautious,'" Fromm said.

In its proposed rule, the FDA states that the volume of biotech field tests are expected to grow. That will lead to more cross-pollination of plants because of pollen drift and co-mingling of grain, which could result in low-level contamination in the food supply. FDA officials believe the risks that a new protein could have an allergen or toxin are low.

Phillips acknowledged that the rule also gives biotech companies a safe harbor against liability should a toxin or allergen from an experimental plant end up in the food supply.

Much of the biotech influence on food is through vegetable oils, starches and corn sweeteners extracted from the grains. Biotech corn is often used in milling food items.

A new poll shows American consumers have less understanding of biotech foods but want stronger regulations on those products.

The Pew Initiative for Food and Biotechnology -- a nonprofit group that studies genetically modified food and biotechnology in agriculture -- found that people are generally ambivalent about food made from genetically modified crops.

About 85 percent of consumers in the Pew poll strongly believe regulators should ensure biotech foods are safe before they come to market. About 40 percent also say there is too little regulation on genetically modified foods.

Most Americans support biotechnology that could improve their lives. More than half of Americans support using plants to make more affordable pharmaceuticals, as well as producing cheaper food to alleviate world hunger, the Pew poll found.

Farmers will increasingly rely on biotech crops, which will yield more complex seed varieties in the coming years, said Dan Berning, technical information manager for Pioneer Agriculture and Nutrition in Lincoln. Berning talked about the genetic future of corn at a farm meeting this week in Fremont.

"The use of these biotech traits is expected to continue to increase," Berning said.

Seed companies focus on "biotech stewardship," ensuring they don't disrupt overseas markets that are more sensitive to issues surrounding biotech crops, he said. U.S. consumers, in general, don't share the distrust of their food regulatory agencies that exists in other parts of the world.

"People still trust the government to be the watchdog and if the government says something is safe, then it must be OK," said Dan DiFonzo, a spokesman for the Pew Initiative.

Checks and balances have been established, especially after 2000 when a corn seed called StarLink was improperly allowed to be planted and harvested with other varieties of corn.

Though never proven to be dangerous, StarLink had not been approved for human consumption and a small amount of the grain wound up in food. Some countries shut off its ports to U.S. corn after that incident.

The problem with StarLink also is cited as an incident that got at least some consumers more engaged in biotech issues.

"Whenever there seems to be a scare people become more aware," DiFonzo said.

The StarLink incident led to more stringent standards on the production of biotech crops. It also forced the industry to develop better grain-segregation policies. Producers now are more aware of which grain elevators accept the hybrid they are growing and which elevators do not.

"From an industry standpoint, there's not a lot of benefit to having a negative reaction to some of those traits that we know are going to have a positive effect on the future," Berning said.