GE NEWS ARCHIVE
Mothers for Natural Law
International News on Genetic Engineering in Agriculture
Biweekly News 98/11/01
Thanks to Cliff Kinzel and Richard Wolfson for these items.
Articles have been aggressively shortened.
The New York Times Sunday Magazine
"Playing God in the Garden"
(An excerpt from a 16-page printout)
...I checked with the F.D.A. to find out exactly what had been done to insure the safety of this [genetically-engineered New Leaf] potato. I was mystified by the fact that the Bt toxin was not being treated as a "food additive" subject to labeling, even though the new protein is expressed in the potato itself. The label on a bag of biotech potatoes in the supermarket will tell a consumer all about the nutrients they contain, even the trace amounts of copper. Yet it is silent not only about the fact that those potatoes are the product of genetic engineering but also about their containing an insecticide.
At the F.D.A., I was referred to James Maryanski, who oversees biotech food at the agency. I began by asking him why the F.D.A. didn't consider Bt a food additive. Under F.D.A. law, any novel substance added to a food must -- unless it is "generally regarded as safe" ("GRAS," in F.D.A. parlance) -- be thoroughly tested and if it changes the product in any way, must be labeled.
"That's easy," Maryanski said. "Bt is a pesticide, so it's exempt" from F.D.A. regulation. That is, even though a Bt potato is plainly a food, for the purposes of Federal regulation it is not a food but a pesticide and therefore falls under the jurisdiction of the E.P.A...
Since my Bt potatoes were being regulated as a pesticide by the E.P.A. rather than as a food by the F.D.A., I wondered if the safety standards are the same. "Not exactly," Maryanski explained. The F.D.A. requires "a reasonable certainty of no harm" in a food additive, a standard most pesticides could not meet. After all, "pesticides are toxic to something," Maryanski pointed out, so the E.P.A. instead establishes human "tolerances" for each chemical and then subjects it to a risk-benefit analysis.
When I called the E.P.A. and asked if the agency had tested my Bt potatoes for safety as a human food, the answer was ... not exactly. It seems the E.P.A. works from the assumption that if the original potato is safe and the Bt protein added to it is safe, then the whole New Leaf package is presumed to be safe. Some geneticists believe this reasoning is flawed, contending that the process of genetic engineering itself may cause subtle, as yet unrecognized changes in a food.
The original Superior potato is safe, obviously enough, so that left the Bt toxin, which was fed to mice, and they "did fine, had no side effects," I was told. I always feel better knowing that my food has been poison-tested by mice, though in this case there was a small catch: the mice weren't actually eating the potatoes, not even an extract from the potatoes, but rather straight Bt produced in a bacterial culture.
So are my New Leafs safe to eat? Probably, assuming that a New Leaf is nothing more than the sum of a safe potato and a safe pesticide, and further assuming that the E.P.A.'s idea of a safe pesticide is tantamount to a safe food. Yet I still had a question. Let us assume that my potatoes are a pesticide -- a very safe pesticide. Every pesticide in my garden shed -- including the Bt sprays -- carries a lengthy warning label. The label on my bottle of Bt says, among other things, that I should avoid inhaling the spray or getting it in an open wound. So if my New Leaf potatoes contain an E.P.A.-registered pesticide, why don't they carry some such label?
Maryanski had the answer. At least for the purposes of labeling, my New Leafs have morphed yet again, back into a food: the Food, Drug and Cosmetic Act gives the F.D.A. sole jurisdiction over the labeling of plant foods, and the F.D.A. has ruled that biotech foods need be labeled only if they contain known allergens or have otherwise been "materially" changed.
But isn't turning a potato into a pesticide a material change?
It doesn't matter. The Food, Drug and Cosmetic Act specifically bars the F.D.A. from including any information about pesticides on its food labels.
I thought about Maryanski's candid and wondrous explanations the next time I met Phil Angell, who again cited the critical role of the F.D.A. in assuring Americans that biotech food is safe. But this time he went even further. "Monsanto should not have to vouchsafe the safety of biotech food," he said. "Our interest is in selling as much of it as possible. Assuring its safety is the F.D.A.'s job."...
The Ottawa Citizen Fri 23 Oct 1998 Page A1
By James Baxter
SCIENTISTS `PRESSURED' TO APPROVE CATTLE DRUG: HEALTH CANADA RESEARCHERS ACCUSE FIRM OF BRIBERY IN BID TO OK `QUESTIONABLE' PRODUCT
...The senators [of the Senate Standing Committee on Agriculture and Forestry] sat dumbfounded as Dr. Margaret Haydon told of being in a meeting when officials from Monsanto Inc., the drug's manufacturer, made an offer of between $1 million and $2 million to the scientists from Health Canada -- an offer that she told the senators could only have been interpreted as a bribe.
Ray Mowling, vice-president of Monsanto Canada Inc., who attended the hearings yesterday, said Monsanto does give money to Health Canada to oversee studies, but denied that company officials ever tried to bribe the scientists...
Dr. Chopra also raised questions about the ethics of making cows sick to produce more milk. In its packaging, Dr. Chopra says Monsanto list 20 side effects, including swollen and ulcerated udders, skin rashes, hoof disorders, and reduced hemoglobin. Most veterinarians said that cows suffering these conditions would be in some discomfort if not considerable pain.
These conditions are usually treated with antibiotics, which, in turn, can make their way into the milk. Over time, scientists fear humans will build up tolerances to many of the strongest antibiotics, rendering them useless against infection. Another concern is that most dairy cattle eventually are slaughtered for meat, and no studies have been done on the effects of eating beef from rBST-injected cows.
Follow up on the last newsletter, item 4, "rBGH - FDA misreported data":
In the October 6 Rutland Herald newspaper in Vermont spokespersons for the US Food and Drug Administration and Monsanto flatly contradicted one another - with Monsanto claiming they gave the controversial rat studies to the FDA prior to rBGH approval in 1993, while the FDA stated "We do not have the data from that study."
WORLD AG RESEARCHERS SPURN CROPS WITH 'TERMINATOR GENES'
WASHINGTON, Oct 30 (Reuters) - Scientists at the world's largest agricultural research network, who focus on feeding the poor, will not develop crops with "terminator genes" that produce sterile seeds, the network's leaders decided on Friday.
Crops with such "suicidal tendencies" would be a nightmare in the developing world, where farmers, as a matter of course, retain part of each harvest as seed for next year, said Ismail Serageldin, chairman of the Consultative Group on International Agricultural Research.
"If you didn't know (about the seeds), you would be wiped out," Serageldin said at a news conference.
The Consultative Group on International Agricultural Research, with its network of 16 research centers around the world, specializes in crops and livestock useful to small-scale farmers in developing nations. It is funded by the World Bank, the United Nations, foundations and dozens of nations.
Copyright 1998 Reuters Limited.
MONSANTO MAY BE CHARGED WITH VIOLATING ENVIRONMENTAL POLLUTION LAWS
According to the Daily Mail (Oct 25, 1998) in the U.K., the British government is considering charging Monsanto and British based sub-contractor Perryfields Holdings Ltd with violating environmental pollution laws for a Roundup-resistant rapeseed (canola) farm test site in Lincolnshire, where GE rapeseed plants contaminated an adjoining non-GE rapeseed plot.
The companies were ordered by the Agriculture Ministry to dig up and destroy a field of oilseed rape, which is used in the production of margerine and vegetable oils, on a 1,000 square metre Government licensed site. All seeds harvested over the next two years within a 50-metre radius of the site, at Rothwell in Lincolnshire, will also be ditched.
Minutes of a recent meeting of the Advisory Committee on Releases to the Environment reveal that Monsanto and Perryfields failed to prevent genetically modified winter oilseed rape cross-pollinating with another field of their normal oilseed rape. A pollen barrier, or buffer zone, of only two metres instead of the required six surrounded the test site.
The minutes say that "a breach of consent occurred" and show that Monsanto officials had not visited the trail site even though it was the company's duty to do so.
Tony Strickland, trials manager for Perryfields Holdings, of Inkberrow, Hereford and Worcester, said, " We expect to be prosecuted. A path was put around the test area and those on site overlooked the fact that the pollen barrier was then too small. This increased the risk of cross-pollination."
NETHERLANDS FILES SUIT TO CANCEL EU PATENTING OF PLANTS AND ANIMALS
THE HAGUE, Oct 19 (AFP) - The Dutch government filed a suit with the European Court of Justice on Monday in a bid to cancel a directive over the patenting of biotechnological discoveries, the economics ministry said.
The EU Life Patents Directive, which came into being in July, permits the patenting of biotechnological discoveries, such as the genetic manipulation of plants and animals as well as the technical methods used to change the organisms.
The Dutch government, which voted against extending biotechnological patents to plants and animals, filed an appeal seeking to nullify the directive on legal grounds, claiming that it violated international treaties and basic human rights, the economics ministry spokesman said.
"We voted against the directive because we felt it went too far and should not have included patents on living beings," the spokesman added.
In accordance with Title 17 U.S.C. Section 107, this material is compiled for educational use only.
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