The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service is proposing to revise regulations (7 CFR Part 340) regarding the importation, interstate movement and environmental release of certain genetically engineered organisms. The update to the regulations is in response to advances in genetic engineering and the accumulated experience in implementing the current regulations, as well as to reduce the burden on regulated entities. This is the first comprehensive revision of the regulations since they were established in 1987. The proposed rule is open for a 120-day comment period from January 19, 2017 until May 19, 2017 on Regulations.gov.
In an exclusive Q&A interview with Andy LaVigne, president and CEO of the American Seed Trade Association, he explained what the proposal means for the American agricultural industry.
Q: So this is the first major revision of the regulations since they were established in 1987. What are your thoughts on the changes that were proposed?
A: Well, we are still working through the proposal itself. There are a number of things that we want to make sure are addressed dealing with Part 340 in the whole review and deregulation process that the USDA goes through with respect to the biotech traits in the marketplace. There are also provisions in there that deal with plant breeding innovation and plant breeding techniques. That is an area we have the most interest in this time. We think that the proposal that they came up with is very beneficial to the seed industry and the breeding community, and that’s an area we are very pleased with the results that we saw.
Q: Out of the 122 pages of the revision, what major revisions effect the American agriculture industry?
A: The main area is that they look at gene editing techniques for plant breeding. In the document, they talk about how you can use gene editing techniques for both creating new biotech traits and placing them in crop varieties, or you can use gene editing techniques to develop new varieties. In their proposal, they are proposing to exclude those kinds of gene editing techniques used to create new plant varieties. And so for us, that’s very important because it’s very similar to the processes that we use today with our current breeding techniques to develop new varieties and bring them to the marketplace.
Q: What key factors prompted this revision, and when did it all begin?
A: There’s a number of things. They’ve been working on this actually for well over 10 years. Under the Bush administration, they proposed changes to Part 340 right at the end of that administration. And they were sitting in the department for the last eight years, and the department finally told them and started the process of review again. During that time is when breeding techniques evolved, and this opportunity to use gene editing came into play. So that’s why this is addressed in the proposal that came out of the USDA this time versus back under the Bush administration. It really is just an evolution of what’s happening in the industry that’s trying to get their regulations up to date and potentially looking into the future.
Another key area that we’re working with the administration on is to ensure that they’re talking with our trading partners, and that policy development in other countries, as well as in the U.S., is consistent across the board so that there’s not a negative impact on the movement of agricultural products globally that may be produced from gene editing techniques. So our main goal is to make sure that consistency across the board is there for all products in the marketplace and that there is not any negative impact on the movement because of a certain technique being used.
Q: What is the approval process for the revision?
A: These processes are always somewhat fluid, especially when done right at the transition from one administration to another. Our anticipation is that they’ll review all regulations that have been proposed. So this will also get a review from the administration. There’s a possibility it can get pulled back, revised and put back out. There’s a possibility they can go through the 120-day comment period and extend the comment period to provide people additional time. So there’s a number of various factors that can come into play. This is obviously the first step of several that will come in the future, and we’ll have to see really what the next two to three months hold with the new administration coming in.
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