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Biotech Regulatory Process .jpg USDA APHIS

USDA finalizes biotech rule revisions

SECURE rule paves way for agricultural innovation and will require regulation based on risk, not process.

The U.S. Department of Agriculture issued its final rule to modernize agricultural biotechnology regulations, marking the first comprehensive revision of the regulations since they were established in 1987. The Sustainable, Ecological, Consistent, Uniform, Responsible & Efficient (SECURE) rule modernizes the agency's oversight of traditional and new plant breeding methods such as gene editing and acknowledges that regulations should be commensurate with risk.

“USDA’s SECURE rule will streamline and modernize our regulatory system, facilitate science-based innovations and provide our farmers with the tools they need to produce the world’s safest, most abundant and most affordable food supply, which will help us continue to 'do right and feed everyone' – safely,” Agriculture Secretary Sonny Perdue said.

After 30 years of experience, regulatory scientists with USDA’s Animal & Plant Health Inspection Service (APHIS) know that simply using a plant pest in the development of a plant does not necessarily cause the plant to pose a risk to plant health. USDA said the final rule puts in place a more efficient process to identify plants that would be subject to regulation, focusing on the properties of the plant rather than on its method of production. APHIS will evaluate plants developed using genetic engineering for plant pest risk under a new process called a regulatory status review, regulating only those that plausibly pose an increased plant pest risk.

Under the previous regulations, APHIS assessed the plant pest risk of each plant transformation event (also sometimes referred to as the individual transformed line, transgenic line or genetically engineered [GE] line) separately, even though the inserted genetic material may have been identical or very similar to transformation events already assessed. This has sometimes been referred to as an “event-by-event” approach.

Under the revised regulations, developers have the option of requesting a permit or a regulatory status review of a plant developed using genetic engineering that has not been previously evaluated and determined to be non-regulated. This process replaces the petition process in the previous regulations. The revised regulations evaluate whether a plant requires oversight based on the characteristics of the plant itself and not on the method by which the plant was genetically engineered. Once APHIS determines that the plant is not regulated, subsequent transformation events using the same plant-trait-mechanism of action combination would not be regulated. 

The SECURE rule codifies Perdue’s statement on plant breeding innovation (issued in March 2018) and exempts from regulation plants that could otherwise have been developed through conventional breeding techniques. Examples of genetic changes exempted include gene deletions and simple genetic transfers from one compatible plant relative to another. The rule also exempts new varieties of plants that are the same as plants developed through genetic engineering that APHIS already reviewed and found unlikely to pose a plant pest risk. In addition, the new rule provides mechanisms to adapt to future innovations that cannot yet be anticipated.

Although plants developed using genome editing techniques are exempt from regulation if they could have otherwise been produced through conventional breeding techniques, the regulations focus on the plant pest risk presented by the product. Thus, some plants developed using genome editing techniques will be regulated if they pose a plausible plant pest risk. The processes established in the final rule enable APHIS to efficiently remove many products from regulation and regulate a subset that present a risk to plant health.

Many comments on the biotech rule had wanted to make sure the final rule was not out of step with world trading partners, as this could disrupt trade.

The National Grain & Feed Assn. (NGFA) said in an email statement to Feedstuffs that it supports the use of agricultural biotechnology and plant breeding innovation to provide farmers with improved technology that can contribute to a sustainable, abundant and affordable food and feed supply. However, for grain elevators and exporters as well as farmers and downstream customers they serve, there is a pressing need to provide transparency in the types and uses of gene editing and other technology being deployed and commercialized in U.S. grain and oilseed production.

"On that score, NGFA is disappointed that USDA’s final rule allows crop technology developers to make a 'self-determination' that their plant is exempt from APHIS regulatory oversight without a concurrent obligation to notify the agency so that such information is available to the marketplace and consumers," NGFA said.

NGFA said it does appreciate that APHIS states in its final rule that it is “committed to continuing to work with international trading partners and exporters to resolve trade concerns,” but we believe transparency in the types of crop technology being deployed is essential to avoiding future trade disruptions.

Other initial comments following the rule announcement said USDA struck the right balance of protecting plant health while positioning U.S. agriculture at the forefront of innovation.

The American Seed Trade Assn. (ASTA) said while it is still analyzing the full details of the SECURE rule, the rule acknowledges that some applications of gene editing result in the development of plant varieties that are essentially equivalent to varieties developed through more traditional breeding methods and would, thus, treat these varieties in the same way from a policy standpoint. ASTA said USDA also rightly recognized the continuing evolution of the science of plant breeding and, thus, has included a mechanism for additional exemptions. A clear and transparent, science-based process for these future exemptions will be important to support continuing innovation that's so vital to agriculture.

It is important that seed companies have a clear pathway to request and obtain confirmation that a product meets one of the exemptions in the final rule before the exempted plant or category of plants is placed on the market, ASTA pointed out. A well-defined and efficient confirmation process will bring value in marketing products both in the domestic and export markets while making information about these products available to stakeholders and the public.

“In order to foster an environment that supports continued innovation, it is critical that USDA works closely with [the Environmental Protection Agency and the Food & Drug Administration] to ensure consistent, science-and risk-based policies across the U.S. government while continuing to take a leadership role in working towards alignment at the international level,” ASTA president and chief executive officer Andy LaVigne said.

“At a time when agriculture is facing many economic headwinds, the science-based rule provides the opportunity to solve current and future challenges for agricultural production and food security,” American Farm Bureau Federation president Zippy Duvall said. “This final rule will ensure the U.S. remains a leader in biotechnology while providing the safe, healthy and wholesome food supply America’s families deserve.”

House Agriculture Committee ranking member Michael Conaway (R., Texas) said he looks forward to “updates on the regulatory framework for gene-edited animals that ends the misguided regulation that inaccurately defines animals as drugs. USDA’s expertise and vision will lend credibility to what is currently an anti-innovation status quo.”

The rule is scheduled to be published in the Federal Register on May 18. It will be fully implemented by Oct. 1, 2021, with key changes implemented starting April 5, 2021. For more information about the rule, visit USDA's SECURE rule webpage.

TAGS: Policy
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