Seed World

Government Regs Limit Precision Plant Breeding

The global ag industry’s ability to feed a ballooning population may hinge on whether or not crop varieties created through genome editing and other new plant breeding innovations will fall under domestic and international regulations put in place for GMOs.

Farmers, plant breeders, agricultural technology innovators, and agri-companies form the front line in arguably the world’s most vital team effort: the race to more efficiently and more sustainably produce a whole lot more food. Their ability to successfully feed a ballooning global population will hinge on whether domestic and international policy and regulations support or hinder critical innovation and improvements in agriculture.

The numbers are stark. Currently, there are over 7.4 billion people vying for food on our planet, almost two-and-a-half times as many people as existed in 1960. Every single day, the world’s population increases by more than 100,000 people, which means that by 2050 our global population will likely hit 9.5 billion. According to a 2009 United Nations report, the world will have to produce a whopping 70 per cent more food to feed them all.

Because failure to meet this need would be so obviously catastrophic, we need to be doing everything we can to support our only potential avenue to success: science.

Currently, a number of innovative new plant breeding technologies are in the early stages of use in research programs. Among the most promising is genome editing: a process in which DNA is inserted, deleted or replaced at specific locations on chromosomes.

While nature has unlimited breeding opportunities over millennia to change and evolve plant genetics, humanity’s timelines — especially with a massive global food shortage looming — are necessarily shorter. Genome editing is simply a sped-up version of nature’s own crop improvement program, a high-tech way for scientists to precisely and efficiently select plant traits as they — and nature — have always done.

The real question, however, is how governments will interpret the products of genome editing and other new precision breeding technologies.

Back 25 years ago when GMOs first came on the market, the U.S. government set up a pre-market review and approval process for GMO crop varieties. This added layer of regulatory burden makes it difficult and costly to get GMO varieties to market.

“The regulatory burden for GMOs is extremely high,” says Bernice Slutsky, senior vice president for domestic and international policy with the American Seed Trade Association. “Basically, that means only the largest players can afford it and even for them, it is an economic burden. If you have a huge regulatory burden, the cost benefit analysis for crops that have very small markets means you can’t justify using the technology.”

The fact that regulation hampers progress means that it should be in place only if absolutely necessary, particularly given how vital increasing global food production is and will continue to be. Those who oppose biotechnology in GMOs cite the existence of the regulation as evidence supporting their perspective.

In fact, there have been big questions right from the beginning regarding the necessity of regulation.

“There was a recognition even back in 1986 when the Coordinated Framework for the Regulation of Biotechnology was put into place that genetic engineering in and of itself does not create special risks associated,” says Slutsky. “But, it’s difficult once you put regulations in place. Though they are supposed to be reviewed and refined as our experience and knowledge evolve, that’s not always easy to do.”

Now, as newer technologies like genome editing come to market, the U.S. government must decide whether a pre-market review and approval process will be placed upon plant varieties developed through those techniques.

Bernice Slutsky

The American Seed Trade Association argues it should not for certain applications of genome editing.

“If you can get to the same product end point through traditional breeding, we don’t think those products should fall under the existing biotech regulation,” says Slutsky.

“You have to ask: is there a reason, from a scientific and risk basis, for applying the special pre-market approval process to these newer categories of products? We would say no. What we are doing is essentially what plant breeders have always done, which is creating genetic diversity and variation within a plant’s gene pool.”

Part of the significant uncertainty surrounding how the regulatory environment might affect up-and-coming plant breeding technologies is due to the uncertainty surrounding the existing regulations themselves.

“We are in a situation across governments where the existing regulations for GMOs are currently not at all consistent with each other. There are different definitions, different legal frameworks around the world. What we hope will happen is, both domestically and internationally, that governments will have an active dialogue with each other in order to work towards consistent policies,” says Slutsky.

The U.S. government has a number of different initiatives underway to address the changing reality of agricultural research and innovation. The Coordinated Framework for Regulation of Biotechnology, the federal policy that outlines how products derived from biotechnology can be developed and introduced, has just gone through a review process.

“We think it’s a good thing that the Coordinated Framework has been reviewed, and that stemming from that review is a high-level report about what the government needs to think about as innovation moves forward in agriculture,” says Slutsky.

As well, the USDA is in the early stage of reviewing and revising their current regulations for genetically engineered plants.

Of course, clarifying our domestic regulatory environment is only the first component in today’s highly inter-connected international reality.

“The seed industry and agriculture in general are global industries. We can’t just consider the U.S. regulatory process. We have to consider the cost of compliance across all of our major markets,” says Slutsky. “I’m not saying it is going to be an easy path forward to get to that level of consistency, but I think there is some opportunity there and this is a priority for both the US seed sector and global seed sector.

For this reason, engaging trading partners on agricultural innovations, encouraging them to solidly define their own regulations, and working with them towards minimizing international restrictions on new technologies must also be a priority.

Back in 1900, U.S. corn fields averaged 26 bu/acre. Each American farmer produced enough total calories from farming to feed four people for a year. Today, enormous improvements in equipment, agronomics and plant genetics mean farmers typically produce more than six hundred per cent more corn per acre than farmers did 100 years ago. According to the USDA, an average American farmer today produces enough calories to feed 155 people for one year. While that number is impressive, farmers will need to successfully and sustainably grow/raise significantly more over the coming decades to meet global food demands. Scientists and ag innovators, working in concert with nature, are our best hope, so long as their efforts are not suffocated by unreasonable regulatory burden.