When is a fish not a fish but a drug? When government regulators take old laws and twist themselves into knots trying to apply them to new technology.
In the emotionally charged battle over the safety and appropriateness of genetically modified foods, people on both sides agree that the way the government oversees genetically modified plants and animals is patchy, inconsistent and at times just plain bizarre.
Soon, analysts say, the system may be stretched to the breaking point. That could leave many genetically modified crops unregulated ? a worry for those who fear environmental and safety risks or who believe that government vetting is key for broad public acceptance.
"It's a bit of a mess," said Jennifer Kuzma, a science policy expert at the Humphrey School of Public Affairs at the University of Minnesota.
The web of regulations used to govern genetically engineered species draws on more than 10 laws, all written for other purposes. Some were crafted to address issues such as tainted drugs, wheat spiked with sawdust and pollution by industrial chemicals.
The results can be odd.
Atlantic salmon that grow quickly thanks to a growth hormone gene from another salmon species are deemed "new animal drugs" because the Food and Drug Administration decided to regulate genetically engineered animals under the Food, Drug and Cosmetic Act of 1938.
A cotton plant that makes insect-killing proteins with the help of a gene from a soil bacterium is a pesticide in the eyes of the Environmental Protection Agency, which regulates the crop under the Federal Insecticide, Fungicide and Rodenticide Act of 1972.
In what some critics deem the biggest contortion, many genetically modified crops are classified as "potential plant pests" so that the U.S. Department of Agriculture may preside over them through the Federal Plant Pest Act of 1957 ? even though the key traits added to the plants have nothing to do with pests.
Some crops are regulated by more than one agency: A corn plant engineered to kill insects, for example, is reviewed by the EPA and USDA and also gets a voluntary assessment from the FDA.
Industry executives, consumer advocates and biotechnology analysts all find fault with the system, though they often disagree about what is wrong and how it should be fixed. Some feel this talk of a fish that's a drug and corn that's a pest does little to instill confidence in consumers, many of whom are deeply suspicious of genetic engineering to begin with.
"This convolution makes people lose faith in the system," Kuzma said. "They just go, 'Well, that's silly.'"
Faith is further eroded, Kuzma and others said, because most genetically modified crops are not required to go through an FDA safety review. Companies have voluntarily shared safety data with the FDA for all genetically modified crops now grown in the U.S., but Andrew Kimbrell, executive director of the Washington, D.C.-based Center for Food Safety, says, "There should be mandatory testing." His organization has sued the government over its handling of the crops.
People have tinkered with the DNA in plants and animals since agriculture's early days by breeding varieties and selecting desired traits like heftier grain yields, more succulent meat or resistance to a disease-causing fungus. But these traditional methods, which are not regulated in the U.S., are imprecise. And they have limits: By and large, breeders can work only with genes that already exist in the species they're trying to improve.
The rise of genetic engineering ? in which specific genes are inserted into the DNA of a plant, animal or microbe ? changed all that. Genes can come from any species, adding traits that never existed in a pig, say, or a corn plant.
The new gene must be active, so scientists attach it to a piece of DNA that serves as an "on" switch. In plants, this often comes from a virus that infects cauliflower.
The gene must then be moved into cells. For this job, scientists often use bits of DNA obtained from a bacterium that infects plants and creates a disease called crown gall.
These DNA pieces don't harm plants. But because they come from a virus and a bacterium that do, the USDA decided it could use plant-pest laws to oversee genetically modified crops created this way. The decision amounted to "a scientific and legal fiction to get most of the crops regulated," said Gregory Jaffe, director of the biotechnology project for the Washington, D.C.-based Center for Science in the Public Interest.
The patchwork system emerged after 1986, when the Reagan administration decided no new regulations were needed because genetic engineering didn't pose any unique risks compared with traditional plant breeding. The thinking was that what mattered was what you ended up with, not how you got there.
The FDA later decided that genetically modified plants would be considered safe as long as they were essentially the same as conventional plants, with the same basic nutrient content and no signs of new allergens or toxins. (Genetically modified animals, by contrast, go through a full approval process.) If the plant was substantially changed, more stringent safety tests would be required. Only one plant ? the Flavr Savr tomato, which ripened on the vine without softening because of a piece of engineered DNA that blocked a key enzyme ? has received this level of vetting.
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