Aqua-Bounty's New Immune Booster for Shrimp Shows Need for Regulatory Certainty in U.S. for Biotech
By Ross Kerber
Knight Ridder/Tribune Business News (via seafood.com news)
August 29, 2005
It can take genetically engineered products, such as Monsanto Co.'s altered corn, years to reach the market. Waltham-based Aqua Bounty's feed additive for shrimp is being used in Mexico, out of the FDA's jurisdiction.
Sports trainers use weights to bulk up their athletes. Shrimp farmers turn to Elliot Entis.
The chief executive of Aqua Bounty Technologies Inc. this year expects to sell $ 1 million worth of the company's first commercial product, a protein-based feed additive that boosts the immune systems of farm-raised shrimp, in Mexico.
Waltham-based Aqua Bounty is better known for its efforts to develop fast-growing, genetically modified salmon for human consumption, a $ 12 million effort that has been pending before the Food and Drug Administration for years.
The feed additive also is genetically engineered, produced by specially modified bacteria. But Entis said it did not need FDA approval. Because the substance is no longer in the shrimp by the time they are exported to the United States, the agency does not treat it as a food. Also, because the shrimp are raised in Mexico they are outside the FDA's jurisdiction, said Entis and government officials.
Aqua Bounty's experience shows the difficulties faced by agricultural biotechnology companies in bringing all but niche products to market under current regulations. But Entis, who is the leader of an industry group, also says that the situation his company faces illustrates the need for the FDA to spell out more clearly what data are needed to approve products developed with genetic techniques.
It can take such products years to reach the market. In addition to Aqua Bounty's salmon, examples include Monsanto Co.'s genetically engineered corn and soybeans, which now dominate US fields. Those products underwent extensive reviews in the 1990s by the FDA, the Department of Agriculture, and the Environmental Protection Agency. In Austin, Texas, ViaGen Inc. has agreed not to sell its cloned cattle to food companies while waiting for the FDA to evaluate the safety of the beef and milk the animals produce.
Currently, 'you make your best guess about what kind of research you need to do,' said Sara Davis, ViaGen vice president who, like Entis, is active in the Biotechnology Industry Organization, a Washington trade group.
William Muir, a genetics professor at Purdue University who follows the industry, said companies want limits on how long FDA reviews can last because lengthy delays can scare off investors.
To some extent, the industry's concerns mirror those of food-safety activists who charge that the FDA isn't keeping close track of biotechnology products. Their prime example is the GloFish, a genetically modified zebra fish meant for decorative fish tanks that is produced by Yorktown Technologies LP of Austin, Texas. The FDA allowed it to go on sale at the end of 2003 without a safety review, saying it posed no risk to public health.
An FDA spokeswoman said it is studying the biotech industry's proposals for clearer data submissions as part of an inter-agency task force with the White House and the Department of Agriculture. The Agriculture Department's biotechnology director, John Turner, said he expects rules by next year that will clarify which agencies have authority to oversee genetically engineered animals. Oversight of feed products likely will remain with the FDA, he said.
Advocacy groups still want more safety studies for modified foods and feeds. They cite a 2004 National Academy of Engineering report on genetically engineered foods that said 'altered foods should be assessed on a case-by-case basis before they are sold to the public' and monitored after they are placed on the market.
Technically, Aqua Bounty's shrimp feed additive is not sold to the public. Known as Shrimp IMS, for 'immune supplement,' it is a powder added to regular shrimp meal, which is composed of ground grain and fish. On an averaged-sized tropical shrimp farm of 2,500 acres, 3,000 tons of shrimp might consume 6,000 tons of ground plant feed during the three months they are grown. During that time the farm might mix 66 pounds of the additive into the plant feed.
The additive comes to market at a difficult time for many farmers. Shrimp imports to the United States grew to 1.1 billion pounds in 2004 from about 600 million pounds in 1996, according the trade website ShrimpNews.com. But prices per pound are declining and the new technique of raising shrimp in ponds has generated criticism from environmentalists.
Entis wouldn't discuss many details of how Shrimp IMS is made, calling the process proprietary, but he described the powder as a protein produced by e. coli bacteria whose makeup has been altered in a manner that has been acceptable to the FDA.
Mexican authorities cleared the additive after six months of study last year, said Antonio Pedroza, chief executive of MaltaCleyton, the Mexican firm that resells the Aqua Bounty product.
'At the beginning it was hard, because everybody is afraid of labels like GMOs [genetically modified organisms] and genetically modified foods,' Pedroza said. But now farmers report the additive keeps more shrimp larvae alive and increases shrimp yields up to 8 percent, he said.
Aqua Bounty has similar ambitions for its proposed Atlantic salmon. But the process for the additive is simpler than the one the firm uses for its salmon, which it is already breeding at a Prince Edward Island hatchery. The company refers to the fish as a 'transgenic' creature because one of its genes has been altered so that it produces growth hormone more steadily through the year.
They can grow to commercial size, 10 pounds, in about half the three years it takes to grow salmon in a farmed environment.
Entis first contacted the FDA about the salmon in 1995, started tests in 2000, and hopes it might be approved by next year.
Aqua Bounty also is working on an antiviral drug for shrimp.
'We're among a number of companies that have products in the pipeline that are more near-term than people know,' Entis said.
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