Two decades into the era of agricultural biotechnology, the United States is updating its regulatory system, in which USDA, EPA and FDA are the gatekeepers for commercialization of genetically modified crops and livestock. A key question is how to treat new techniques that, unlike traditional biotechnology, do not involve gene transfers from different species of plants or animals. In a growing number of cases, USDA has decided that gene-edited plants are outside of its jurisdiction, which is based on plant protection laws. Farm groups and state agriculture officials argued at a House hearing that gene editing and similar methods should be exempted permanently from biotechnology regulation.
The largest U.S. farm group, the American Farm Bureau Federation, said U.S. officials conducting the update “must approach this process mindful of international implications.” The new framework will affect U.S. standing as a scientific innovator and, given the U.S. role as the world’s largest ag exporter, could ignite change in biotech rules in other nations.
When it announced the overhaul of biotechnology rules last July, the White House said advances in science “have been altering the product landscape” so it was appropriate to “develop a long-term strategy to ensure that the system is prepared for the future products of biotechnology.” The government’s Coordinated Framework for the Regulation of Biotechnology was issued in 1986 and has not been revised since 1992.
Earlier this month DuPont Pioneer said it expects by 2021 to be selling a gene-edited strain of high-starch “waxy” corn seed to farmers. It would be the first commercial crop variety developed with CRISPR gene-editing technology by the second-largest seed company in the world.
“Plant breeding techniques that do not introduce genes from other species – techniques such as gene editing and cisgenics – should not be regulated under APHIS’s regulatory framework,” said New Mexico state agriculture secretary Jeff Witte, referring to the USDA agency that decides if biotech crops are safe, the Animal and Plant Health Inspection Service. “Any future proposed rule should ensure a risk-based, transparent and predictable regulatory system and APHIS’s regulatory oversight must be limited to transgenic products that pose a plant risk.”
Witte testified on behalf of the National Association of State Departments of Agriculture. The 5.9 million-member American Farm Bureau Federation and the National Council of Farmer Cooperatives, whose members handle, process and market ag products, joined NASDA in telling the House Agriculture subcommittee on research that new-generation technology is more precise than the transgenic methods of first-generation GMOs and in many cases produces results that could have been obtained over time by conventional breeding.
They warned against unwarranted expansion of the definition of biotechology as part of the overhaul of the Coordinated Framework for the Regulation of Biotechnology. One proposal by USDA would mean regulation of all but the most traditional breeding techniques, said Witte.
“The level of agency oversight for products of biotechnology ought to be proportionate to the actual risk posed by the organism,” said Illinois Farm Bureau president Richard Guebert. Companies spend an average $138 million to develop an agricultural biotechnology product, a cost that deters work on crops that are not widely grown or on crops with traits benefiting consumers or the environment, he said. “Minimizing unnecessary regulation will allow small and medium-sized companies and universities to move forward in developing innovative products for specific regions of the country.”
NCFC president Chuck Conner said GMO plants grown around the world have an impeccable safety record so “the expansion of regulatory scope cannot be justified by APHIS from either a scientific or risk persepective.” Regulation should be confined to DNA modifications that cannot be achieved through conventional breeding, he said.
“Under this definition, new plant varieties should be subject to little or no pre-market regulatory review if there is no insertion and stable transmission to subsequent generations of genetic material that encodes an expressed protein,” said Conner. “Additionally, based on over 30 years of regulatory experience, if there is insertion and stable transmission of genetic material, new plant varieties would also not be subject to a pre-market regulatory review if the inserted genetic material is from a sexually compatible plant.”
Environmental group Greenpeace says the United States has pressured the European Union not to regulate “new plant breeding techniques,” reported news site EurActiv earlier this month. The European Commission, the administrative arm of the EU, has delayed a decision on the regulatory format that should apply to gene editing and other new techniques.
To read written testimony or watch a video of the hearing, click here.