Homestead mailing list

[Gene GeRue <genegerue AT ruralize.com>]

(Page 2 of 2)

Larisa Rudenko, a senior biotechnology adviser in the F.D.A.’s  
veterinary drug division, said in a May presentation at the  
biotechnology industry’s annual convention that each new type of  
genetically engineered animal would require approval for use in the  
food supply. That will be done, she said, under the umbrella of  
existing rules for drugs used in treating animal diseases.
Skip to next paragraph
Multimedia
Farming With Borrowed GenesGraphic
Farming With Borrowed Genes

While the implanted gene is somewhat like a drug, the existing rules  
would have to be stretched to fit.

But industry executives and some former agency officials said it was  
unlikely that Congress would enact totally new laws for transgenic  
animals. And using the drug laws, they say, would provide tighter  
control than an alternative approach of using the rules governing  
food additives. Agency officials have said that the veterinary drug  
rules would be used, and they have already been overseeing some  
experimental work on that basis. But they continued to debate the  
issue, and the policy has never been made official.

The regulatory guidelines would indicate how the drug rules would be  
interpreted for transgenic animals, and what types of data would be  
needed to prove safety and efficacy. But there are open questions  
about how the drug rules would actually translate. While a chemical  
drug must be shown to be consistent and stable, for instance, it is  
unclear how that standard would apply to a gene passed from  
generation to generation. Some critics say that while the drug rules  
do provide fairly strict regulation of food safety, there are  
drawbacks to adapting that approach. Because applications for  
approval of drugs are confidential, for instance, there would be no  
opportunity for public comment before the agency acted.

“In order to create confidence in a new technology, you really don’t  
want behind-closed-door proceedings,” said Margaret Mellon, director  
of the food and environment program at the Union of Concerned  
Scientists.

Another worry is that the F.D.A. might not have enough expertise or  
authority to conduct a vigorous review of the environmental impact of  
transgenic animals. The F.D.A. has dismissed this concern, however,  
saying it has sufficient expertise and can consult with other agencies.

The biotechnology regulatory branch of the Department of Agriculture  
created an animal division last December to figure out what its role  
should be.

Genetically engineered animals are often created by injecting the  
gene of interest into a single-cell embryo. A more recent technique  
that is more efficient is to put the gene into a skin cell and create  
an embryo from that cell by cloning.

In both cases, the embryo with the foreign gene is then implanted  
into the womb of a surrogate mother. After some transgenic animals  
are born, additional ones can be made by conventional breeding,  
because the foreign gene generally will be passed on to some of the  
offspring, as would any other gene.

The fast-growing salmon is the transgenic animal that has been  
swimming upstream the longest at the F.D.A. Its developer, Aqua  
Bounty Technologies of Waltham, Mass., has been working to win agency  
approval for about 10 years. Aqua Bounty’s fish are Atlantic salmon  
that have been given a growth-hormone gene from the Chinook salmon.  
They have also been equipped with a genetic on-switch from a fish  
called the ocean pout, a distant cousin of the salmon.

Normally, salmon produce growth hormone only in warmer months, but  
the pout gene’s on-switch keeps the hormone flowing year round. That  
enables the Aqua Bounty fish to grow faster, reaching their market  
weight in about 18 months instead of 30.

Elliot Entis, Aqua Bounty’s chief executive, said the company had  
already given the F.D.A. studies showing that the fish were healthy  
and that the implanted gene remained stable over generations.

He said the company also had tests done to show that its fish  
contained the same level of fats, proteins and other nutrients as  
other farmed salmon and would not set off unexpected allergic  
reactions in people who eat them. The fish also taste the same as  
other farmed Atlantic salmon, Mr. Entis said.

“Nobody has ever analyzed salmon as closely as we have had done,” he  
said. But the F.D.A. is asking for more data on safety and potential  
environmental effects on wild salmon.

Industry executives say the Enviropigs would be the next candidate  
for F.D.A. approval. The pigs contain a bacterial gene that allows  
them to produce an enzyme that helps them more fully digest a vital  
nutrient, phosphorus, in their feed. That means less phosphorus in  
the manure, which in turn could mean less phosphorus running off into  
lakes and oceans, where it can cause algal blooms and fish kills.

MaRS Landing, a technology promoting organization in Ontario, is  
trying to find a corporate partner for the pig, said John Kelly, the  
agency’s executive director.

Less far along in the approval pipeline are pigs that contain a gene  
from the roundworm allowing them to produce omega-3 fatty acids, a  
nutrient normally found in fish that is good for the heart. That, in  
theory, could make eating pork or bacon healthier, although that has  
yet to be tested.

Jing X. Kang, an associate professor at Harvard Medical School who  
helped direct the project, said the researchers were looking for  
corporate backers while also trying to raise the level of omega-3 in  
the meat.

Carol Tucker Foreman, director of the Food Policy Institute at the  
Consumer Federation of America, a consumer advocacy group in  
Washington, said regulations might not assuage consumers, many of  
whom object to the genetic engineering of animals on humane or  
ethical grounds, more than on safety concerns.

“The fact that the F.D.A. has a powerful regulatory process for  
reviewing genetically engineered animals, far greater than they apply  
to genetically engineered crops, may not make any difference at all,”  
Ms. Foreman said. “Because that’s not what it’s all about.”

Article in full at:
http://www.nytimes.com/2007/07/30/washington/30animal.html? 
pagewanted=1&hp