The FDA has issued draft guidelines for approval of genetically modified (GM) animals in relation to any risk to humans, the environment, or the animals. Consumers, so far, are less than thrilled about the FDA’s guidelines. It's all tough to swallow.
(The FDA calls it GE food, but why shouldn’t General Electric live a little?)
The
FDA’s press release is somewhat cryptic, although it does contain a few nice, unambiguous statements:
Under the draft guidance, in those cases in which the GE animal is intended for food use, producers will have to demonstrate that food from the GE animal is safe to eat. The FDA will review this information as part of its food safety assessment, consistent with that recommended in the recently adopted Codex Alimentarius Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Animals. Codex is a worldwide food safety organization sponsored by the United Nations.
So they're basing it on the UN code, probably a good idea, because food imports can have a single standard, too. The press release explains the statutory framework, then gets a bit convoluted:
The draft guidance describes how the FDA may exercise enforcement discretion, that is, not require premarket approval, for some GE animals depending on potential risk, as we did after reviewing information about Zebra danio, aquarium fish genetically engineered to glow in the dark. For example, the draft guidance states the FDA's intent to exercise enforcement discretion for laboratory animals used for research and kept in confined conditions. The agency does not expect to exercise enforcement discretion for animal species traditionally consumed as food and expects to require approval of all GE animals intended to go into the human food supply.
Meaning they won’t waive their regulatory role in terms of food animals. Press releases in government circles do affect the mind.
Consumers, meanwhile, aren’t waiving any of their doubts. This debate has been around for a while, and the menu doesn’t yet include enthusiasm.
Reuters:
Consumer groups called the FDA's action a good first step, but said the guidelines fail to answer several important questions.
One concern is the approval process, which would be secretive to protect companies' proprietary interests.
"It's unclear whether FDA has the authority and expertise to address the full range of risks," said Gregory Jaffe of the Center for Science in the Public Interest.
Foods produced from some bioengineered animals will not have to be labeled, the FDA said, also drawing some ire.
"It is incomprehensible to us that FDA does not view these animals as different from their conventional counterparts," said Jean Halloran, director of food policy initiatives at Consumers Union.
Point by point:
The approval process could create real problems if it leaks proprietary secrets, as in legal liabilities. A competitor could go and buy the product and pull it apart, and probably will. But the FDA can’t be a source of industrial espionage, real or imagined.
The FDA has access to external expertise, but it’s unlikely they have the budget or structure for a built-in genetics analysis division, which is what they’d need. This isn’t the sort of science where you can just have a few geneticists fluttering around the office.
Unless you clone them.
Labeling of existing supermarket goods isn’t an exact science, either. How useful are the labels? People will want to know whether their food is GM, and aren’t going to be pleased if they can’t find out.
They are considered different from their conventional counterparts, hence the guidelines. Whether the law has anything on the books to enforce the differences in the supermarkets is another thing. If there’s no law, the FDA is working as a food regulator, not a court.
I’m an organic food fan. I’m not opposed on principle to GM, but on the basis of new science where the data is lacking. There needs to be intensive study of the facts of GM food and GM animals, and frankly there just hasn’t been enough time.
The FDA has a practical problem in this regard. Getting the data on these subjects where the applicant is the primary source of information falls way short of ideal. If that information is incorrect, getting good information looks difficult at best.
Administratively, that information gap could be a nightmare, and it could drag on for years.
Unfortunately, unlike normal food, Consumer Law By Innuendo isn’t really the best result, in this case.
If this doesn’t work, you can assume that law suit from the six ton mouse about “unauthorized use of genetic materials” is serious.
