WASHINGTON, March 9, 2017 – Federal agencies that regulate biotechnology may not have the staffing and expertise to handle the plethora of new products expected over the next five to 10 years, according to a new report from the National Academies of Sciences, Engineering, and Medicine.
“EPA, FDA, USDA, and other relevant agencies will need to be prepared for this potential increase (in products), including finding effective means of evaluation that maintains public safety, protects the environment, and satisfies the statutory requirements appropriate for each agency,” the report says.
Among its recommendations, the report says it would be helpful “to have a single point of entry into the regulatory system” to direct products to the appropriate agency “and to increase transparency for developers and society.”
New biotech agricultural products are among those in development. The report says that currently, biotech plants consist of genetically engineered (GE) varieties of “a few widely grown crops, such as corn, soybean, and cotton” – 10 crop species in total.
But the number of GE crops is likely to “increase substantially over the next five to 10 years,” the report says, mentioning research to develop a gene resistant to citrus greening disease, which is now in confined trials.
“We just see this exploding,” said Richard Murray, an engineering professor at the California Institute of Technology who chaired the scientific committee that wrote the report.
The Obama administration requested the study in order to help agencies carry out an overhaul of the way they regulate biotechnology. The agencies wanted an assessment of the types of products and regulatory challenges they could face.
The advent of technologies such as CRISPR-Cas9, a targeted genome-editing technique, will “enable certain genetic manipulations to be more readily accomplished,” the report says, noting that USDA’s Animal and Plant Health Inspection Service already has given the go-ahead to several such products. (Examples include a DuPont Pioneer variety of waxy corn and a non-browning mushroom developed at Penn State University.)
Transgenic research also is underway to fight Pierce disease in grapes and bacterial spot disease in tomatoes, while outside the U.S., “examples of future biotechnology products include GE banana and cassava, for which trials were being conducted in varieties with improved insect and disease resistance and increased nutrient content.”
Although the committee that wrote the report does not expect that the “risk-assessment endpoints associated with these new crops would be different from those associated with crops that had already gone through the regulatory process,” there might be other factors to consider.
“The synergistic effects of multiple genetic changes could lead to unintended effects in the biochemistry of crops (affecting nutrients, immunogens, phytohormones, or toxicants) or in the phenotypic characteristics of crops due to more complicated epigenetic effects,” the report said. “Off-target effects in genes from base-pair insertions and deletions via genome editing should also be considered.”
In addition, the committee said it expected the use of biotechnology plants “to spread beyond agricultural fields,” citing as an example “a novelty product like the glowing plant,” which can provide natural lighting that doesn’t need electricity.
“However, a more important type of plant that the committee thought would be likely to become increasingly common is endangered or locally extinct plants that have been engineered to be able to thrive in natural ecosystems in which they once were widespread,” the report said, mentioning the American chestnut, a hardwood tree that was “decimated by a fungal blight introduced in the early 1900s. Genetically engineered resistance to the blight could allow this tree species to grow to maturity and reclaim some of its native range.”
The report said that federal agencies will have to perform ecological risk assessments “for likely inadvertent release of novelty plants into natural ecosystems as well as for the intentional release of plants such as blight-resistant American chestnut. “
Such products could fall into a “regulatory gap,” the report said. “For example, if USDA determines that a product is not regulated by virtue of the mechanism used to insert the genetic modification or the source of the genetic material, then the agency may have no authority to do a National Environmental Policy Act assessment.”
Among other things, the National Academies report recommends that EPA, FDA and USDA use pilot projects to test new ways to assess the ecological risk and benefits of future products. The report also suggests that the National Science Foundation, Defense Department and other agencies that fund biotech research should consider investing in regulatory science as well.
Two scientists were allowed to serve on the study committee even though they had declared conflicts of interest, said Bruce Darling, the National Academies’ executive officer. He said their expertise was needed to properly assess the new biotech products that regulators could be facing. The committee needed scientists with the “vision to imagine and to understand how the field would develop.”
The Trump administration faces a long list of decisions to make about biotech regulation. In January, the outgoing Obama administration released its plan for updating the government-wide Coordinated Framework for Regulation of Biotechnology; APHIS proposed a rule to streamline the process for approving new biotech-produced traits; and FDA asked for comments about its regulation of gene-edited animals and mosquito-related biotech products.
(Phil Brasher contributed to this report.)