Seed World

Maneuvering Through the Regulatory Maze


The U.S. regulatory system remains the gold standard, but the recent drive to introduce new, genetically enhanced crops to feed a growing population is putting unrelenting pressure on both the regulatory system and the seed industry.

In order for the exciting new generation crops we’ve all been hearing about to reach the farm, they must first pass through the regulatory process, which, especially for the approval of new biotech traits, has become even more complicated in the United States over the past few years.

“Not much has changed since 2009; we are in a pretty similar place in terms of the amount of time it takes to bring a product through the regulatory process,” says Andy LaVigne, president and CEO of the American Seed Trade Association, which has provided the voice for the seed industry in the regulatory process debate over the last few years.

On average it takes about two to three years to get a product through the approvals process, says LaVigne, but recent legal challenges to certain biotech products cause the regulatory process to get bogged down. “[United States Agriculture Secretary] Tom Vilsack mentioned changing Part 340 regulations, which essentially governs the deregulation of biotech products,” explains LaVigne. “Our hope is that the administration recognizes the constraints on the system and makes it a priority to modify the system to avoid the legal matters, as well as improve efficiencies.”

Public Perception
It’s not the job of regulatory agencies in the United States to “sell” the products they approve to the general public, but it is their responsibility to tell a compelling story about why they have approved them. If they fail to do that, as recent litigations in the United States around Roundup Ready alfalfa and sugar beets has shown, there will be a backlash of public opinion, particularly around new biotech traits.“I believe that public perception would be better informed by knowing how regulators use a science-based approach to understand and look at products,” says Philip Miller, global regulatory lead for Monsanto.

However, as weather extremes such as floods and droughts take a toll on global crop yields, they also inflate the weekly grocery bill. That, in turn, starts to influence public opinion about things like biotechnology, which is focusing on a new generation of traits to make tomorrow’s crops more drought-tolerant or water efficient.

These and other products are likely to be in demand, not just for growers contending with  water shortages and other challenges, but also consumers, whose perceptions are beginning to change as the economic impacts of these problems are felt. There is also a creeping recognition that these new technologies are quite different from the first generation of genetically modified products, which focused on resistance to herbicides or insects.

“In terms of something like drought tolerance, I think there is real public awareness, and I think we will see this in our wallets when we go to the grocery store,” says Andrew Reed, head of regulatory affairs at BASF. “Crops that have better tolerance to medium-level stress, and can still yield well, will resonate with the general public. Traits like that are a bit closer to the consumer than herbicide tolerance.”

Increasingly Complex
Although the courts have upheld the United States Department of Agriculture’s decision to deregulate certain biotech crops, the legal battles have taken a toll on its resources. “There has been a series of litigations by critics of biotech questioning the decisions to approve biotech crops which have consumed the USDA’s regulatory agencies’ resources,” says Miller. “That has been one of the factors that has led to the slowing down of the approval process in the United States.”

Another factor lengthening approval timelines is a significant increase in new products being submitted by more companies. “One of the things that has been critical has been making sure that the USDA has the resourcing it needs to handle that growth in innovation that will benefit the U.S. grower,” he says.

LaVigne says some additional resources have been allocated to the biotechnology regulatory system over the past couple of years, but given the current economic situation, he believes resources will continue to be tight for all programs for a while yet.

As products and technologies become more complex, requirements are becoming more rigorous.  “There are more linkages between traits, there’s more stacking of traits,” says Thomas Klevorn of Context Network. “When a company stacks two pesticidally-active genes in a plant, there’s the potential for a new approval process. It’s like a new product mix in a formulation, so the EPA gets involved. That could make the approval process more complicated as well.”

One of the big questions facing the industry, says Klevorn, is whether regulatory agencies may begin, as part of insect resistance strategies, to move towards having companies demonstrate whether one gene is as good, or better, than another gene for control of an insect. “Currently we don’t have to do that specifically in the United States—the customer ultimately decides if it works or not,” says Klevorn.

He believes that in some instances, such as traits for insect control, there may be a move towards requiring proof that whatever genes are put into the market will dramatically reduce the opportunity for insect resistance to occur. “It will never be 100 percent guaranteed to prevent insect resistance,” says Klevorn. “Companies may have to get a lot closer to 100 percent efficacy in insect resistance management than they may have had to in the past to get their insect resistance products commercialized.”

Expanding the Toolbox
The toolbox available to researchers and scientists also has a huge effect on the regulatory system. “The current technological environment influences the regulatory system,” says LaVigne. “To ensure that only safe products hit the marketplace, the regulatory environment has to change and evolve along with the industry’s ever-advancing technologies used to improve breeding and crop production techniques.”

However, technology is constantly providing new techniques that are bringing genetic modification of plants closer to more conventional plant breeding techniques. “Over the past few years there has been a slow transition from working with foreign genes—genes that come from widely different organisms like bacteria—to identifying plant genes that are involved in key traits like drought tolerance and making smaller, subtler changes to these genes that are already in the plant, or bringing in a gene from a closely related species,” says Malcolm Devine of Crookedholm Partners Inc. “These fine-tuning techniques, although they involve going in and making a very small and precise genetic modification, will be regarded more as forms of mutation breeding and not GM.”

Devine believes that U.S. regulatory authorities will eventually move towards treating plants developed using these techniques in the same way as mutation breeding, which is essentially free of regulation. “What I am saying is that over time a new toolbox has been developed which may open the door to smaller and more precise genetic modifications that could result in enhancing certain traits, but without the very high regulatory burden that comes with transgenic GM as we know it,” he says.

Communication is Key
The industry and regulatory bodies have recognized that everyone has to work together to make products available faster to growers. ASTA spends a substantial amount of time meeting with the USDA, FDA and Congress, says LaVigne.

“We have a great deal of dialogue with the regulatory community,” he explains. “We continue to see progress in this area because the various agencies and people in these positions have a better u
nderstanding of the technologies at work, and a lot more information is easily accessible, making it easier for them to research the industry and different issues.”

It’s a continual work in progress. “Our member companies have done a great job acting as ambassadors to help introduce regulators to all aspects of seed research, production and distribution and the intricacies involved by opening up their facilities for tours, field days and demonstrations,” says LaVigne.

The U.S. regulatory system will remain the gold standard for other regulatory organizations, as it is based strongly on science and product safety, contends LaVigne. “The certainty provided by the U.S. regulatory process is conducive for researchers to develop new tools that benefit America’s farmers,” he says. “If anything, the U.S. regulatory process encourages research and development of new products, whereas other regulatory processes around the world discourage this type of innovation.”

The drive to introduce new, genetically enhanced crops to feed a growing global population puts unrelenting pressure on both the regulatory system and the seed industry, both of which have to rise to the challenge of feeding people safely and efficiently.

“As we deal with the constraints placed on the food system, such as limited land and water, coupled with the increasing global population, these new traits will only provide additional opportunities to showcase the benefits that can be seen from modern plant breeding,” says LaVigne. Angela Lovell

Playing the Game
What can companies do to ensure regulatory submissions are met in a timely manner?

Make sure you understand the regulations and what the regulatory agency wants. “We listen to what the regulators need and what they believe they will need to understand in order to successfully get through their review process and their scientific assessment,” says Philip Miller, global regulatory lead with Monsanto.

“I would say the conversations we have had with the regulators have been very helpful,” says Andrew Reed, director of regulatory affairs with BASF. “The United States is one country where a company can go in and have a consultation. They help us determine where we need to focus.”

Many companies begin the dialogue with regulatory agencies long before they are ready to submit their products for approval. “We share with them proactively both what we are working on and how we are working on it, and include them in that dialogue many years before we come in with a product,” says Miller.

Make sure they understand you and your technology and products. “We continue to work with agencies to help them understand the seed industry and how it fits into the rollout process of new products,” says Andy LaVigne, president and CEO of the American Seed Trade Association. “It’s always valuable to bring regulators to a facility to see the process and to help them understand the intricacies.”