Fear and regulatory costs dogging genetically engineered crops

Genome editing, has taken crop plant breeding to “an entirely new level,” says Dr. Adrianne Massey. But “a totally dysfunctional regulatory system” and activist opposition continue as barriers to progress.

Although it has become the bogeyman of anti-agriculture activists, the reality is that genetic modification of crops and animals is not new, says Dr. Adrianne Massey. “Most people think we only started genetically changing crops when Monsanto introduced Roundup Ready soybeans,” she said at the Mississippi Farm Bureau Federation’s Summer Commodity Conference at Mississippi State University.

“But humans, over decades, even centuries, have genetically changed organisms we depend on, whether it be crops, animals, or microbes. We use microbes in food processing, all of our antibiotics come from microbes, vaccines, sewage treatment, some of you use microbials on your farms. All have been genetically modified, because we want things the way we want them — and we’re going to fiddle with them until we get them the way we want them.”

Massey, who is managing director of science and regulatory affairs for the Biotechnology Industry Organization (BIO), Washington, D.C., says the domestication of wild corn, cotton, wheat, and a host of food and fiber plants has been an ongoing process of genetic modification — each new, improved variety taking many years of work by plant breeders making crosses and back-crosses to select for desirable traits.

“The early corn plant was bushy, spreading, and produced only about five seeds that, when ripe, were hard as a rock. From that ancestor to today’s corn has been a long process of artificial selection. We saved the seed from plants we liked and planted them, selecting for traits we liked. We crossed the resulting plants with others to see if we could get something even better.

“A lot of that was guesswork and trial-and-error. Today, technology lets us compare the genetic makeup of corn’s ancestor with modern corn, allowing us to see that we’ve changed thousands of genes through the selective breeding process, moving more and more traits that we liked into the corn plant.”

With the advent of genetic engineering, and more recently genome editing, Massey says, scientists are now able to select a single gene that has a specific desirable trait, such as disease resistance, and insert it with great precision into an already elite variety to get an even better variety, in the process greatly reducing the time that would be required for conventional plant breeding.

Opponents of genetic manipulation of crops “say they’re OK with conventional plant breeding because it’s all natural and occurs within the same species,” she says. “But that’s not the case. When we figured out how plants reproduced, we started intentionally crossing them. Initially, we did it within the same species, but when we saw traits in relatives that we wanted in our crop plants, we started developing techniques to fool the plants into mating with each other. “Today’s major crop plants have genes that would never have got there naturally — they got there through unnatural methods of plant breeding that are basically laboratory techniques. As far back as the late 1700s, we started forcing crosses that could never have occurred in nature.”

From the wild forebear of today’s bread wheat, Massey says, there have been “forced crosses between 11 different species in 6 different genera. That wasn’t natural.” And when plant breeders reached a point where they couldn’t move genes through forced breeding, ”in the 1920s we figured how to mutate plants and seed through chemicals and X-rays, to create new genes within crop plants. We started slicing the DNA molecule, breaking a chromosome in two and sticking it to another chromosome. Some of the best barley we now use in making beer was developed through these mutation processes. The constant need to improve crops and give growers better varieties has involved thousands of mutation events.”

Genetic engineering, Massey says, is like selective breeding: “We’re moving genes that already exist in nature into a plant — we’re not creating new genes. Breeders are constantly working on crop plants that have specific traits that growers want.” But in conventional breeding, using pollen from a wild relative to try and introduce a desired trait into a modern variety, may result in the transfer of as many as 40,000 genes from the wild plant to the modern plant.

Plant breeders are then “constantly backcrossing to get rid of the thousands of unwanted ‘trash’ genes, while trying to retain the desirable gene. But with genetic engineering, they can select a single desirable gene from the wild relative and move into the modern variety without having to spend great amounts of time backcrossing to get rid of the trash genes.

“In the history of genetic modification,” Massey says, “we’ve had a continuum of new techniques that are informed by science — the more we learn, the better we’re able to do what we need to do, the more precise we can be.”

The latest technique, genome editing, has taken the process to “an entirely new level,” she says. “We’re able to bring in new genes from wherever we want; we can change the genetic makeup of a crop with a level of precision that’s breathtaking. We can find the specific molecule we want, cut it out, then insert it exactly where we want it in another plant. If a gene makes a protein we don’t want, or doesn’t work as it should, we can silence or remove it. We can change one nucleotide in three billion. That’s amazing! With genetic engineering, we know exactly which gene we’re moving and what it does.”

The concept of “trying to deal with thousands of genes that you don’t know what they do versus just one gene that you know exactly what it does,” is a concept easily understood by the public, Massey says. “But what they too often don’t understand is that without genetic engineering, the risk of an unintended change is much greater. All we’re doing in genetic engineering is getting better and better at developing plants with the characteristics we want that will give us the best yield and quality.”

Another big difference, she says: “When you move those 40,000 genes into a corn plant through conventional breeding, and then you go through years of crossbreeding and backcrossing, you’re going spend zero dollars for compliance with government regulations. But if you move just that single desirable gene through genetic engineering, it’s going to cost $15 million to $36 million because of regulatory compliance.”

In the early years of biotechnology, she says, a regulatory requirement that was used primarily for pharmaceuticals was added to products from genetic engineering, “which has added years and millions of dollars to the cost of developing a new product. These regulatory costs are extraordinary, and regulations, unfortunately, tend never to go away.

“The scientific community has shown there are no unique risks in genetically engineered organisms — if we add one gene to corn through genetic engineering, the risks for the modified variety are the same as for unmodified corn. Some 250 scientific societies around the world have proven that genetically modified crops are safe.”

In the early stages of genetically engineered crops, Massey says, field trials “were about equally divided between improving fruits and vegetables, extensive disease resistance work, and work to increase vitamin content and other desirable traits. But by 2002, companies were moving away from vegetable crops because they didn’t offer the volume needed to recoup their investment because of regulatory costs.

“We know so much more today about the genetic makeup of plants and how to make them better — and safe — yet we’re penalized for these achievements by regulators’ seemingly endless requirements for massive amounts of data. And that’s how a new product ends up costing $15 million to $36 million.”

There is also, Massey says, “an impact you don’t see, on schools like Mississippi State University or North Carolina State University, where I used to teach,” in that it’s economically not feasible for them to do genetic engineering work.

“There’s nothing about genetic engineering or gene editing that’s too hard for university scientists — they could’ve been using these tools all along. But I don’t know any university that’s got $15 million to give you a new sweet potato variety, or $36 million for a new cotton or soybean variety. University scientists have been pretty much shut out of crop improvement through genetic engineering — not because it’s risky, but because of the costly regulatory process. “

As tough as the regulatory system is for crops, Massey says, “it’s totally dysfunctional” for genetically engineered animals. “In 20 years, there has been only one approval: a genetically engineered salmon. In 2000, a cow developed by USDA was resistant to mastitis. In 2002, one of our members developed a cow that couldn’t get mad cow disease. We’ve developed chickens that are resistant to avian flu — the 48 million birds that had to be destroyed a while back, that didn’t have to happen. But the regulatory system is so nervous about approving a genetically engineered animal, it just won’t let them through.”