By Jenny Hopkinson – Politico, 13 February 2015

Photo by Andrew Wong/Getty Images

Source: http://www.politico.com/story/2015/02/genetically-modified-apple-federal-approval-115181.html

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. 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.

When the South Carolina-based tree breeder first considered seeking regulatory approval in the late 2000s, the company expected an 18-month to two-year wait, said Les Pearson, director of regulatory affairs for the company.

“We assumed that over time the process would become more efficient,” Pearson said. “The 30-plus years of experience [of USDA] with the technology should be a factor in making the [regulatory] decision and somehow that has been missing.”

A tougher sell

Once approved, new GMO products face sales hurdles.

The big biotech players know that herbicide- and pest-resistant plants have proven profitable, and farmers, the primary customers for biotech crop companies, are quick to adopt the technology with its promise of lower chemical inputs and low or no tillage.

A consumer-facing trait is a tougher sell, said Susan Knowlton, a DuPont Pioneer senior research manager. Biotech companies need to convince food makers that consumers will accept the products.

In the 1990s, customer pressure led McDonald’s to stop using a potato modified to resist certain diseases in its french fries, and the fast food giant has been noncommittal on whether it will use a non-browning potato developed by spud-giant J.R. Simplot that gained USDA signoff late last year.

Friends of the Earth urged McDonald’s and baby food maker Gerber to reject the Arctic Apple, arguing that it is not being sufficiently tested for safety. Another advocacy group, Food & Water Watch, responded Friday to USDA’s approval of the Arctic Apple with similar disdain.

“This GMO apple is simply unnecessary,” the group said. “… The USDA has let down U.S. apple growers and the public by wasting resources on this useless and risky food.”

DuPont’s Plenish soybean is one of the few examples of a major biotech company commercializing a nutrition-based trait, but even that has been slow going. The soybean, approved by USDA in June 2010 after more than three years of review, is modified to produce oil that does not need to be hydrogenated to stay shelf stable, making it trans fat free. The oil is being tested by food companies whose interest was bolstered after FDA’s announcement in 2013 that wants to phase out trans fats.

Knowlton said at least one retail product has already started using its GMO soybean oil, though she could not disclose it due to a confidentiality agreement.

Lawmakers are also putting increased attention on GMO foods. On Thursday, bills that would require the labeling of genetically engineered ingredients in food were reintroduced in both chambers of Congress.

The expense, risk and regulatory delays are pushing small GMO technology companies to look more at overseas markets.

With no predictable regulatory approval process in the United States, ArborGen has developed a “very strong interest in Brazil,” Pearson said.

Brazil’s law governing GE plants was passed in 2005, and officials there are still working toward fully implementing the measure. But Brazilian authorities seem to be more open to biotechnology, Pearson said, issuing approvals for some products that have yet to be deregulated in the United States and expressing interest in working with biotech companies.

It’s not just GE crop producers looking to Brazil. The country also has been more open to GE animals, approving the release of mosquitoes modified to prevent the spread of dengue fever and funding a project to develop goats whose milk can prevent childhood diarrhea.

In the United States, however, the FDA, which regulates genetically modified animals, has yet to allow any into the market. AquaBounty Technologies, a Maynard, Mass.-based company that has created a GE salmon that grows at twice the rate of conventional varieties, first started the process for regulatory approval in 1995.

James Murray, a researcher at the University of California, Davis, working on the goat, said the project moved to Brazil because “the regulatory environment here has made it very difficult to even fund the work.”

“If Brazil wants to fund the work and we have colleges there that want to do the work,” then that’s where biotech projects will go, Murray said.

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GE Free BC and CBAN press release on the GE apple: https://gefreebc.wordpress.com/2015/02/13/ge-free-bc-and-cban-press-release-on-the-ge-apple/

Center for Food Safety – USDA Approves Genetically Engineered Apple Despite Health Concerns: http://www.centerforfoodsafety.org/press-releases/3753/usda-approves-genetically-engineered-apple-despite-health-concerns#