More mad science! Feds approve GMO apple
Jenny Hopkinson
politico.com
Fri, 13 Feb 2015
A new genetically modified apple that doesn't brown when cut open or bruised finally has been cleared to be grown in the U.S.
An arm of the U.S. Department of Agriculture said Friday — after a three-year wait — that the Okanagan Specialty Fruit's Arctic Apple in Golden and Granny varieties doesn't pose any harm to other plants or pests. The apple won't be at grocery stores yet, though this was its last major regulatory hurdle. The company is still waiting on the conclusion of a voluntary review by the FDA before the apple can enter the market place.
Most apples start browning when the flesh is exposed to air or damaged. But the Canadian company behind the Arctic Apple says its browning-free variety will mean less food waste, more uses for cut apples and the preservation of nutrients.
Okanagan can now provide its trees to growers to ramp up production so the apple can make it to market and potentially get picked up for use by consumers, restaurant chains and grocery stores.
The apples could find their way into millions of Happy Meals and sit out on salad bars — without having been sprayed with citric acid, which is how other apples are kept from browning now.
Small companies and universities have been hesitant to go through the USDA process for taking genetically engineered foods to market because approvals take so long — and the products aren't making any money in the meantime. [size=14pt]But the apple's approval could be a test case that could spur the industry on.
The biotechnology space is the domain of large companies, like Monsanto, DuPont Pioneer and Syngenta. For a small company that lacks lobbyists and political clout "to actually break into this arena is challenging, and to be unnecessarily delayed is impediment enough that folks will say 'why would I go down that path.'" said Jennifer Armen, Okanagan's marketing director.
But the approval of a genetically modified apple for mass consumption also stokes the debate about GMOs, which have spawned legislation and regulation throughout the country.
Biotechnology has been used to enhance plants for more than 30 years, and millions of acres of government-approved GE corn, soybeans, cotton and canola are in production. However, genetically engineered produce like the Arctic Apple are uncommon, and the road it took to secure approval from USDA's Biotechnology Regulatory Service was even longer than usual.
It took nearly 36 months for BRS to grant Okanagan's petition for deregulation under the federal Plant Pest Act. That's nearly three times BRS' 13 to 15 month average.
Michael Firko, BRS' deputy administrator, in November declined to comment on why the Arctic Apple was taking so long to garner his agency's seal of approval.
But the Arctic Apple isn't like most of the products that go through Firko's office.
Nearly all of BRS' approvals have been for one of six major crops: corn, soybeans, cotton, canola, alfalfa and sugar beets. And the genetic enhancements approved have been for pest or herbicide resistance. What's more, most other GMO applications submitted to USDA are from the same big six biotech companies — Monsanto, Dow AgroSciences, Syngenta, DuPont Pioneer, Bayer Crop Sciences and BASF.
Okanagan is a new player, and its apple is a novelty: It contains traits meant to help consumers, not farmers.
For any item, gaining regulatory approval isn't easy. The average time from initial discovery to commercial launch is 13.1 years, according to a 2011 study by CropLife International, with regulatory proceedings accounting for more than one-third of that time.
The process is also pricey. CropLife found the average cost of commercializing a biotech plant trait from 2008 to 2012 was $136 million. Of that, about $35 million was for regulatory testing and registration, $31 million for discovery and $70 million for development.
As time-consuming and expensive as it is for every biotech product, the challenge is nearly insurmountable for small, innovative enterprises like Okanagan, which has six employees and survives on venture capital, said Karen Batra, a spokeswoman for the Biotechnology Industry Organization.
Firko is quick to dismiss such concerns. "I think this is kind of a myth that has been created" that commercializing a GE product is a rich man's game, he said, adding that BRS is "happy to accept a petition from anyone."
While BRS considered the Arctic Apple, the agency made a decision on eight of 11 other biotech products submitted after Okanagan — the other three are still pending. But it is not BRS' job to encourage companies to develop biotech crops, just to regulate them, Firko added.
One of the few products pending longer than the Arctic Apple is ArborGen's freeze-resistant eucalyptus tree, submitted in January 2011. The tree is undergoing a stricter environmental review because it's the first GE tree to seek approval.
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Jenny Hopkinson
politico.com
Fri, 13 Feb 2015
A new genetically modified apple that doesn't brown when cut open or bruised finally has been cleared to be grown in the U.S.
An arm of the U.S. Department of Agriculture said Friday — after a three-year wait — that the Okanagan Specialty Fruit's Arctic Apple in Golden and Granny varieties doesn't pose any harm to other plants or pests. The apple won't be at grocery stores yet, though this was its last major regulatory hurdle. The company is still waiting on the conclusion of a voluntary review by the FDA before the apple can enter the market place.
Most apples start browning when the flesh is exposed to air or damaged. But the Canadian company behind the Arctic Apple says its browning-free variety will mean less food waste, more uses for cut apples and the preservation of nutrients.
Okanagan can now provide its trees to growers to ramp up production so the apple can make it to market and potentially get picked up for use by consumers, restaurant chains and grocery stores.
The apples could find their way into millions of Happy Meals and sit out on salad bars — without having been sprayed with citric acid, which is how other apples are kept from browning now.
Small companies and universities have been hesitant to go through the USDA process for taking genetically engineered foods to market because approvals take so long — and the products aren't making any money in the meantime. [size=14pt]But the apple's approval could be a test case that could spur the industry on.
The biotechnology space is the domain of large companies, like Monsanto, DuPont Pioneer and Syngenta. For a small company that lacks lobbyists and political clout "to actually break into this arena is challenging, and to be unnecessarily delayed is impediment enough that folks will say 'why would I go down that path.'" said Jennifer Armen, Okanagan's marketing director.
But the approval of a genetically modified apple for mass consumption also stokes the debate about GMOs, which have spawned legislation and regulation throughout the country.
Biotechnology has been used to enhance plants for more than 30 years, and millions of acres of government-approved GE corn, soybeans, cotton and canola are in production. However, genetically engineered produce like the Arctic Apple are uncommon, and the road it took to secure approval from USDA's Biotechnology Regulatory Service was even longer than usual.
It took nearly 36 months for BRS to grant Okanagan's petition for deregulation under the federal Plant Pest Act. That's nearly three times BRS' 13 to 15 month average.
Michael Firko, BRS' deputy administrator, in November declined to comment on why the Arctic Apple was taking so long to garner his agency's seal of approval.
But the Arctic Apple isn't like most of the products that go through Firko's office.
Nearly all of BRS' approvals have been for one of six major crops: corn, soybeans, cotton, canola, alfalfa and sugar beets. And the genetic enhancements approved have been for pest or herbicide resistance. What's more, most other GMO applications submitted to USDA are from the same big six biotech companies — Monsanto, Dow AgroSciences, Syngenta, DuPont Pioneer, Bayer Crop Sciences and BASF.
Okanagan is a new player, and its apple is a novelty: It contains traits meant to help consumers, not farmers.
For any item, gaining regulatory approval isn't easy. The average time from initial discovery to commercial launch is 13.1 years, according to a 2011 study by CropLife International, with regulatory proceedings accounting for more than one-third of that time.
The process is also pricey. CropLife found the average cost of commercializing a biotech plant trait from 2008 to 2012 was $136 million. Of that, about $35 million was for regulatory testing and registration, $31 million for discovery and $70 million for development.
As time-consuming and expensive as it is for every biotech product, the challenge is nearly insurmountable for small, innovative enterprises like Okanagan, which has six employees and survives on venture capital, said Karen Batra, a spokeswoman for the Biotechnology Industry Organization.
Firko is quick to dismiss such concerns. "I think this is kind of a myth that has been created" that commercializing a GE product is a rich man's game, he said, adding that BRS is "happy to accept a petition from anyone."
While BRS considered the Arctic Apple, the agency made a decision on eight of 11 other biotech products submitted after Okanagan — the other three are still pending. But it is not BRS' job to encourage companies to develop biotech crops, just to regulate them, Firko added.
One of the few products pending longer than the Arctic Apple is ArborGen's freeze-resistant eucalyptus tree, submitted in January 2011. The tree is undergoing a stricter environmental review because it's the first GE tree to seek approval.
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