April 25, 2016
As a growing list of genetically engineered plant and animal crops enter the marketplace with minimal, if any, regulation from the United States Department of Agriculture (USDA), the Government Accountability Office (GAO) is urging USDA to set a clear timeline for updating its biotechnology regulations. In a report released on April 14, 2016, GAO cautioned:
Until a rule is finalized USDA will continue to lack regulatory authority to assess the potential risks, if any, posed by GE [genetically engineered] crops created with alternative technologies. Completing a new rule to update USDA’s regulations is particularly important given that the number of GE crops developed with alternative technologies is expected to grow.
The report also highlights the need for further data collection from farmers who cultivate non-genetically modified crops, recommending that the agency “include farmers growing identity-preserved crops in its survey efforts to better understand the impacts of unintended mixing.” According to the report, USDA has generally agreed with these GAO recommendations.
Why was this Report Needed?
In 2013, Senator Jon Tester (D-MT) requested that GAO collect information from three federal agencies tasked with oversight on biotechnology: USDA, the Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA). This request resulted in the recently published report, “USDA Needs to Enhance Oversight and Better Understand Impacts of Unintended Mixing with Other Crops.”
Current USDA biotechnology regulations date back to 1986 (with minor changes), and have long since become obsolete in face of a rapidly evolving biotechnology landscape. The existing, outdated regulations limit the regulatory purview of USDA to genetic modification that involves genetic material from a plant pest, effectively deregulating over thirty “gene silencing” crop varieties (a form of genetic modification to edit or delete genes).
A biotechnology memorandum issued by the Obama Administration in July 2015 tasked USDA, FDA, and EPA with providing regular updates to their inter-agency Coordinated Framework for the Regulation of Biotechnology, as well as with creating an outline for a long-term strategy for regulation. USDA’s response thus far has been to continue collecting public comments on key issues for farmers, particularly co-existence and the contamination of crops due to genetic drift. Overall, the call for “coordinated framework” remains quite uncoordinated.
In February 2016, the Animal and Plant Health Inspection Service (APHIS) published a notice of intent to prepare a programmatic environmental impact statement on biotechnology, with the public comment period extending until April 21, 2016. These comments will be used to inform a proposed rule, which could be introduced as early as this summer, though the timeline remains quite uncertain.
According to the GAO report, USDA officials intend to publish a proposed rule for updated biotechnology regulations no later than September 2016; however, they do not yet have a timeline for finalizing the new rule. GAO has recommended a timeline with milestones and interim steps be established so that USDA can show progress toward implementation. They correctly note that without defined tasks and milestones it will be difficult for any of the agencies to set clear priorities and move efficiently toward the achievement of goals.
GAO Report Findings on Biotechnology and Co-existence
The GAO report provides a comprehensive overview of current biotechnology regulations, addressing the steps that each of the three agencies charged with biotechnology regulation –USDA, EPA, and FDA – have taken to regulate new and evolving genetically engineered crops. It also reports on the data USDA has collected on the co-mingling of genetically modified and non-genetically modified crops, including steps to reduce commingling. Lastly, the report addresses how each of the agencies share information on their biotechnology regulation activities with the public.
The report found that EPA and FDA are both fully engaged in regulating genetically engineered crops; their legal authority is the same regardless of whether the genetically engineered organism they regulate includes gene insertion, edition, or deletion, and regardless of the method used to genetically modify a crop. The report identified USDA as the only agency in need of updating its regulations.
USDA had previously taken steps to address the issue of economic losses due to the commingling of unregulated genetically modified and identity-preserved seed, particularly in post-harvest stages and during shipment. The report notes that the 2014 National Organic Survey indicated a small level of economic loss – estimated to be $6.1 million from 2011-2014 – incurred by organic farmers due to contamination by the unintended presence of genetically engineered crops. However, according to USDA, this estimate does not include ancillary losses such as for reshipping and re-storing shipment, or costs associated with finding new buyers. Additionally, the question on economic losses in the 2014 Organic Survey was asked in context of crop insurance; restructuring the question may increase response rates.
Additional data collection on the extent and impact of co-mingling is necessary because while USDA now has some data on economic losses among organic farmers, it still needs to collect data from non-organic farmers using non-GMO seeds. According to USDA, identity-preserved crop acreage is significantly greater than organic acreage.
To remedy this data gap, USDA will collect information on economic loss due to crop contamination through ongoing discussions with the USDA Advisory Committee on Biotechnology and 21st Century Agriculture (AC21) and through continued public comment solicitations.
The GAO report recommends that the agency also determine what additional questions should be included in future organic surveys to ensure that loss estimates are accurate. They also suggest surveying identity-preserved producers in order to fully assess the economic loss due to crop contamination.
Categories: Competition & Anti-trust, Conservation, Energy & Environment, Research, Education & Extension