On September 18, the U.S. Food and Drug Administration (FDA) released guidance on a regulatory framework for approving the introduction of genetically modified animals into the nation’s food supply. The term “guidance” is agency-speak for “the law will look something like this.” With the announcement, the FDA opened a 60-day period for public comment.
Currently, the only genetically modified animal that’s licensed for sale in the U.S. is a glow-in-the-dark zebra fish, a pet. With the possible exception of a few inebriated frat boys, humans aren’t expected to consume this fish, and its need for warm water precludes any possibility of it escaping into the wild. But with the announcement of a roadmap for the approval of genetically modified animals, the glowing zebra fish will soon have some genetically modified company.
The FDA’s new guidance is primarily directed at animals genetically modified for pharmacological purposes, such as to grow a human liver in a pig, or to produce vaccines or antibiotics. But the guidance also includes provisions by which animals that are genetically modified for food purposes can enter the food supply.
All genetically modified animals, be they of the farm or pharm variety, will be classified as drugs. Technically, what’s considered to be the drug is the bit of foreign DNA that’s spliced into the animal’s cells, and the FDA is granting or denying its approval to just those bits of DNA, not to the whole organism. This creates a dangerous regulatory gray area, says Jaydee Hanson, a policy analyst at the Center for Food Safety.
“The FDA is trying to have it two ways,” he says. “The gene is in every cell of the animal, and regulating the animal is the only tool they have to control these genes, but they’re saying they’re only regulating the gene, not the animal…Drugs don’t go out and breed with each other. Drugs don’t get loose, animals do.”
For a case in point Hanson mentions the “AquAdvantage” line of genetically engineered salmon created by Aqua Bounty Technologies of Waltham, Mass. The “drug” to be regulated in this case is a gene that makes the salmon secrete extra growth hormone, causing the fish to reach maturity in 18 months instead of 30. The Los Angeles Times recently predicted these fish would be the first genetically modified animals approved by the FDA to enter the food supply.
Should any of these fish escape into the wild they could take their rapid-development genes with them, resulting in unknown ecological consequences. This could pose unacceptable risk, says Hanson, to wild, non-genetically modified salmon stocks.
Given the growing number of genetically modified animals being developed for market, Hanson says the FDA guidance, which considers the potential dangers posed by each genetically modified animal on a case-by-case basis, is an encouraging development. He’s hopeful the AquAdvantage salmon won’t be approved because of the ecological risk.
But while Hanson ranks the creation of a regulatory framework for these animals as a step in the right direction, he says the specific guidance language leaves much to be desired.
“They’re not offering good peer review, because the drug approval process is held in secret,” he says. This is ostensibly to protect trade secrets, but Hanson fears the lack of public access could compromise the integrity of the FDA’s review process.
“The genetically modified food industry is a small world,” he says. “You’re going to have someone who used to work for a company who now works for FDA in the position to approve something from their former company.”
In addition to concerns over the approval process, Hanson also takes issue with the FDA’s stance against labeling foods that contain genetically modified animal products. “If you want to sell a pig with a roundworm gene in it, fine,” he says, “but you have to let us know it has the gene.”
On this labeling issue, Hanson has plenty of company.
“They’re talking about pigs that are going to have mouse genes in them, and this is not going to be labeled?” Jean Halloran, director of food policy for Consumers Union, which publishes Consumer Reports magazine, told the Los Angeles Times. “We are close to speechless on this.”
Another concern is how the proprietary rights associated with the modified genes will be enforced. Because the genetic modifications are easily traceable, small livestock producers who introduce genetically modified animals into their herds, or who acquire animals with modified genes unintentionally, might someday receive an unexpected bill for the use of those genes. Hanson says that producers of genetically modified seeds have sued farmers on such grounds, including some cases in which the farmers hadn’t intentionally acquired the genetically modified plants, but were victims of contamination by pollen from neighboring genetically modified plants.
Given the importance of these regulations in protecting our food and environment from potentially dangerous genetically modified animals, Hanson hopes the public will play an active role in crafting the FDA’s draft guidance.
“If you ever wanted to make a public comment on a food and food safety issue,” he says, “this is the time.”
Ask Ari: Storing ratatouille
Q: Dear Flash,
You recently mentioned a method of storing surplus eggplant and tomatoes in ratatouille form. Can you elaborate?
—Curious About Ratatouille
A: Traditional ratatouille (from the French rata, or “chunky stew,” and touiller, which means “stirred”) is a tomato-based stew of eggplant, zucchini, onions and garlic. It can include other veggies too, which must have been the case in the rainbow-colored dish served as the grand finale in the Disney movie Ratatouille.
The ratatouille that I refer to as a storage product is a simpler animal—just tomato, eggplant, onions, garlic, olive oil and spices. I cut the tomatoes in half, the eggplant into rounds, chop the onions and leave the garlic cloves whole, and put the whole business in a baking pan, stir it up with olive oil, bay leaves and fresh rosemary, and bake slowly at 250–300 degrees, stirring occasionally. As it cooks, I taste it often and adjust the seasonings. Depending on the quantity, it can bake like this for more than two hours until it’s at a consistency you like.
In my oven-roasted storage ratatouille there are no hard-fast rules about the proportion of tomato to eggplant; any amount of either will do. A tomato-heavy mixture will taste more like red sauce, while an eggplant-heavy mixture will be more like eggplant parmesan.
You’ll be amazed at the extent to which the mixture cooks down in volume as the water cooks off, leaving a flavorful concentrate that can be used as a spread, sauce or even reheated with fresh vegetables into something like classic ratatouille.
To store it, transfer from the oven pan into sterile mason jars, screw on rings and lids, and process the jars in a water bath for 10 minutes. The jars that seal can be stored at room temperature until use. Jars that don’t seal should be frozen.
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