Navigating the rigorous regulatory system

In both the U.S. and Canada, the regulatory process required to bring a biotech crop to market is extremely rigorous and challenging. As industry members involved in the process for the past several years, we’re amazed at how opponents to ag-biotech claim biotech enhanced crops aren’t thoroughly evaluated. Nothing could be further from the truth!

Our timeline below demonstrates how long it’s taken just to get to the point where we could even apply for deregulation (never mind gain approval!):OSF Timeline 1996-2011

Assuming Arctic® apples complete both the U.S. and Canadian regulatory processes by early 2014; this means it will have taken 18 years to bring our very first products to market! This includes over a decade of real-world field trial experience, meticulous data collection, analysis, numerous internal and third-party experiments and the production of a 163-page petition – plus various appendices and responses to regulatory questions. This is all for an apple that’s the same in every way (including no new proteins) to its conventional counterparts; except it doesn’t brown, of course!

We want consumers to know how intensive the process truly is. We’re working hard to create greater public awareness of what the review process truly entails, so claims that ag-biotech products are unduly “fast-tracked” or “rubber-stamped” can be put to rest.

Keep in mind that for a grower-led company with only seven employees, bringing Arctic® apples to market is a monumental task. We are dedicated to our goal because we believe Arctic® apples offer the industry and consumers meaningful benefits. We are so excited that nearly two decades of hard work is about to pay off, and not just for us, but for everyone throughout the supply chain!

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About Joel Brooks

Growing up in the Okanagan, Joel had the opportunity to experience apple growing first hand, a background that lead him to his role as Product & Special Projects Manager. Joel feels privileged to work with such great people towards a goal that’s so easy to get behind – helping people to eat more apples.

Comments

  1. PythagoreanCrank

    Would traditional breeding methiods be subject to the same deregulation? If not, wouldn’t it have just have been easier to breed this trait in conventionally? Would the deregulation process be even more rigorous for transgenic?

    • Joel

      Thanks for the comment PythagoreanCrank!

      If apples were conventionally bred to have the same level as polyphenol oxidase (the enzyme that controls the browning process) as Arctic apples do, the regulatory requirements needed for biotech crops wouldn’t apply. In fact, last year Dr. Kevin Folta wrote on variety of Sultana grape that underwent a spontaneous, but “natural”, mutation which caused them to resist browning. Even though in this instance a new protein was created (Arctic apples have no new proteins – though they are technically transgenic) these grapes did not have to undergo any review at all and can even marketed as organic. Check out the full article here.

      If we could have bred this trait into apples conventionally, we would have. Unfortunately, it would likely take decades and even then have no guarantee of success. Additionally, we couldn’t apply this enhancement to ALL varieties as we can now (Arctic Granny, Arctic Golden, etc). With biotech, we can apply the nonbrowning enhancement precisely and safely – not to mention it opens up the door for further traits down the road (fire blight resistance being one of them).

  2. Framermo

    I have read that all GMO patents are owned by one or two mega agribusineses like  Monsanto. Are you not just a subsidiary of Monsanto?

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