In May 2010, OSF initiated the regulatory review process to allow our nonbrowning Arctic® Apples to be grown and sold in the U.S. market. In this post, we’ll present an overview of what’s entailed in that process, and how you can get involved.
In our case, two U.S. agencies are involved in reviewing Arctic® Apple trees and fruit:
- The U.S. Department of Agriculture (USDA) is responsible for ensuring that genetically modified (GM) plants don’t pose a pest or disease threat. Its review and approval is mandatory before a GM plant can be grown in the United States. To initiate USDA’s review, we are requesting “deregulated status,” i.e. a determination that Arctic® Apples are not a plant risk. Agency regulations and guidance define the required information to provide to USDA.
- The Food and Drug Administration (FDA) is responsible for the safety of food and animal feed. Although FDA’s approval is not required for Arctic® Apples, we are voluntarily consulting with that agency to demonstrate that our apples are just like other apples, other than their nonbrowning feature. FDA guidance defines the information to be provided for that agency’s review.
We actually began collecting information for these reviews early in the last decade. USDA requires significant documentation proving a plant’s safety, so we planted test orchards beginning in 2003. Third-party crop consultants have been managing and tracking the orchards’ progress. Today’s apple trees reach commercial bearing age within 2-3 years and are typically replaced at any time after 20 years, so we have plenty of experience with our now middle-aged trees. This long-term data demonstrates that our Arctic® Apple trees grow, react to insects and disease pressures, flower and fruit, and otherwise behave no differently than the conventional trees that are serving as our controls in the same orchards. The difference is evident only when an Arctic® Apple is bitten, sliced, or otherwise bruised. And, then it does not brown!
Over the course of this year, our science team has worked diligently to respond to any and all questions that USDA’s and FDA’s very thorough review staffs have posed of us. This is a positive and gratifying experience for us and validates the quality of our work. We will continue to work with both agencies to address requests for more information or clarification, as we near the opportunity to commercialize Arctic® Apples.
Once USDA completes its review, the agency will request the public’s comment. To initiate this public comment period, USDA will post a notice in the Federal Register, viewable via the Government Printing Office’s website. Once we learn the details we will also post that information, including our petition and all its data, to our Arctic® Apple website and report on it here in our blog.
The public typically has 60 days to comment on USDA deregulation petitions. Based on past experience with other GM plant petitions, comments are typically requested in writing, either by mail or sometimes online. USDA will consider those public comments and issue a final decision at a later date. Meanwhile, FDA will notify OSF and the public of its voluntary finding via a letter posted to that agency’s website.
We invite your comments to USDA when the time comes. We want you to be as reassured of the similarity and safety of Arctic® Apples as we are. And keep in mind that we are also planning to label Arctic® Apples at point of sale so you can find Arctic® Apples when you’re looking for them! (Just as Gala, Fuji or Golden Delicious apples are currently identified at point of sale, you will know when you are buying Arctic® Apples.) You can read more about that in our website FAQs.