Signs of the future
By Jennifer M. Latzke
We all see the signs at the edges of fields denoting the varieties in field trials. Farmers go to university and corporate field days where the latest plant hybrids and varieties are on display in real-world growing conditions. They pore over lists of new seed releases and discuss the merits of one plant number over another.
And yet, farmers take for granted that field trials are logical extensions of releasing new and improved crops to boost yields and quality and ultimately our bottom lines.
Adrianne Massey, Ph.D., is the managing director of Science and Regulatory Affairs for the Biotechnology Industry Organization. Massey said the Animal and Plant Health Inspection Service reported that in 2012, about 12,000 field trials were conducted in the United States—and of those only five were found to be in noncompliance with APHIS regulations.
“Field trials are longstanding tools for managing agricultural research and product development,” Massey said. “They allow universities and companies to test new seed varieties before they are placed on the market in order to verify they are of the highest quality. Field trials also help industry, government and university scientists understand how plants function in real-life growing conditions in different environments and at variable locations.”
When biotechnology first came on the research scene more than 30 years ago, many of today’s advancements were just dreams of scientists. In 1986, the U.S. government published the Coordinated Framework for the Regulation of Biotechnology. This framework laid out the federal government’s responsibilities in overseeing the development and commercialization of biotechnology products. Then, a year later, U.S. Department of Agriculture implemented regulations for biotechnology, commonly called APHIS Part 340 regulations under the Federal Plant Pest Act and the Plant Quarantine Act.
APHIS classified “biotechnology” as the use of recombinant DNA technology or genetic engineering to modify living organisms. All biotech products—whether crops, animal biologics or other uses—are regulated under the USDA, the U.S. Environmental Protection Agency, and the U.S. Food and Drug Administration. Each agency has control over approvals for certain uses. And products derived from biotech aren’t approved for planting or to enter the food supply until all three agencies have determined that they are as safe as conventional crops.
Pre-commercial testing starts with laboratory screening to first figure out if the seed in question has commercial applications and if it’s safe and effective. Once researchers select the promising pre-commercial materials that they want to put forth for field trials, they contact APHIS and start the permitting and notification process.
According to BIO, the process defines the conditions for field tests and looks for parameters like confinement of the pre-commercial experimental materials, redundancy measures in place to reduce risk of the trait or crop’s release into the environment, how the tests will be conducted, how materials will be imported or transported across state lines and more.
APHIS reviews all of this information and can either issue a permit or accept a notification for environmental release, depending on whether the requirements for confinement and safety are met. The notification classification came about in 1994 as more field tests were coming online from biotech breakthroughs. Most of the products that get a notification include biotech traits that have already been field tested and approved for commercial release. However, there are still guidelines in place for the testing, storage, shipping and maintenance of the materials.
A permit is more detailed and stringent than a notification. Permits are usually issued when the product includes a plant incorporated protectant—traits for herbicide or insect resistance—and the test is larger than 10 acres. EPA will also require an Experimental Use Permit and if the product is meant for food or feed, the FDA also has to review the test.
At its meeting of agricultural stakeholders in 2012, APHIS reported that in 2011 and 2012 it had authorized 9,453 and 11,602 field trials, respectively, Massey said. “The 2012 field trials were conducted by 74 entities, 30 of which were academic institutions,” Massey said. “State inspectors from local USDA Plant Protection and Quarantine offices inspected 22 percent of the planted field trials, at least one in every state.” When APHIS reviewed 74 percent of the PPQ inspection reports, it found a total of 4 instances of non-compliance. And of those only one received a letter or warning, according to APHIS.
It’s in researchers’ interests to comply with regulations that are in place. And some companies even go above and beyond the standards in place.
Rick Turner is the global market head of Wheat and Oilseeds for Bayer CropScience. Like other technology providers, Bayer’s research begins in the lab and in the greenhouse and continues on into field trials. Once a seed is ready for field trials, it’s already undergone years of testing as well as the permitting or notification process.
“We do all of the initial work in the greenhouses, and then we reach the point of proof of concept and we have to move to the field,” Turner said. “The things that go into the field already have achieved a basic level of proof of concept. They’ve pretty well demonstrated their worth before they go into the field, but the field just gives us a lot more variables.”
Companies like Bayer follow the guidelines set forth by USDA and add their own standards above and beyond the USDA standards.
“In no cases are there less than USDA standards, but in some cases we may add incremental stewardship initiatives,” Turner said. “We might add more isolation than is required, maybe more monitoring.”
Finding a site suitable for a field test is critical, Turner said. Researchers look at the agronomic characteristics of the field—is there irrigation, adequate fertility, etc.—and then evaluate the security and accessibility or isolation of the field. Working with preferred vendors and cooperators helps because they are familiar with the regulatory processes involved. From documenting chain of custody of materials to following field protocols, there are a lot of people involved in the field trial process.
Dialogue among trait providers, researchers, and regulatory agencies is key to ensuring that field trials are conducted safely and efficiently Turner said. And, when incidents may occur, there will be reviews of the measures in place to see if there can be improvements. Working with industry organizations like BIO helps all trait providers follow good stewardship practices too.
Education is another key factor in the field trial process, Turner said. When researchers can get involved in communities and schools and show scientific principles have a place in agriculture that helps create a holistic view of stewardship of traits and research.
“We have a need for research and science and it’s an important topic in the ag community and outside of it as well,” Turner said. “Science is an important part of any technology moving forward, whether that’s air emissions or crop production. It takes science to drive those forward. And that’s really important for the public in general to understand.” Innovations come through scientific experimentation and finding the things that work and don’t work, he added.
Agriculture is the one bright spot in the U.S. economy and science has put forth innovations that help farmers keep it there. “As a critical step in ag innovation, field trials are essential for ensuring American farmers have access to the best agronomic tools—such as crops that resist pests and survive better in a drought,” Massey said.
Jennifer M. Latzke can be reached by phone at 620-227-1807 or by email at firstname.lastname@example.org.
According to the Biotech Industry Organization:
In the United States, 86 percent of all corn planted is biotech varieties; 93 percent of all soybeans are biotech; and 93 percent of all cotton is biotech.
In 2010, biotech crop area globally reached 366 million acres. In the U.S. that year, more than 165 million acres of biotech crops were planted.
Today 15.4 million farmers in 29 countries use agricultural biotechnology and 90 percent, or 14.4 million of these are resource-poor farmers in developing countries.
From 1996 to 2008, biotech crops helped reduce pesticide spraying by 352 million kilograms, a decrease of 8.4 percent.
Since 1996, the introduction of biotechnology traits has added 74 million tonnes of soybeans and 79.7 million tonnes of corn to the world supply. U.S. corn yields increased 36 percent; soybean yields increased 12 percent; and cotton yields increased 31 percent since 1995, due in part to biotechnology.