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USDA proposes rule to modernize biotech regulations

SECURE designed with regulatory flexibility for advances in genetic engineering and to shorten regulatory approval timeline.

The U.S. Department of Agriculture announced the availability of a proposed rule titled “Movement of Certain Genetically Engineered Organisms.” In preparing this proposal, USDA said it was guided by the following principles: sustainable, ecological, consistent, uniform, responsible and efficient (SECURE).

The SECURE rule will modernize the department’s biotechnology regulations with a balanced approach that continues to protect plant health while allowing agricultural innovation to thrive.

A lot has been learned in the last three decades, and the proposed rule should allow for a reduced timeline on new approvals for biotech events.

“As the name SECURE implies, this proposed rule incorporates the need for efficient and sustainable agricultural production to help feed and clothe the world, combined with responsible and predictable regulatory oversight to safeguard America’s ecology and plant health,” USDA undersecretary for marketing and regulatory programs Greg Ibach said.

“We think it strikes a great balance between efficiency as well as ensuring that consumers can feel that we have a secure and appropriate regulatory mechanism in place,” Ibach added.

SECURE would mark the first significant revision of USDA’s biotech regulations since they were established in 1987. For several years, USDA has worked to engage stakeholders about potential changes to these regulations, with the goal of fostering public confidence while providing the industry with an efficient and transparent review process that doesn’t restrict innovation.

USDA’s Animal & Plant Health Inspection Service (APHIS) oversees the importation, interstate movement and environmental release of genetically engineered (GE) organisms to ensure that they do not pose a plant pest risk. SECURE is designed to have sufficient regulatory flexibility for advances in genetic engineering and the understanding of the plant pest risk they pose. SECURE also incorporates certain provisions of the 2008 farm bill and 2015 recommendations from the USDA Office of General Counsel report on GE organisms.

“SECURE would enable APHIS to evaluate GE organisms for plant pest risk with greater precision than the current rule allows, ensuring oversight and risk are based on the best available science,” Ibach said. “This commonsense approach will ultimately give farmers more choices in the field and consumers more choices at the grocery store.”

In terms of a shorter approval timeline, Ibach explained that once USDA has made a decision on an innovation technique, it won’t have to require the same research over and over again. In turn, this will reduce the regulatory time frame on innovations replicated by different companies at the same time, Ibach explained.

USDA’s proposed rule will be available for public review, and comments will be accepted for 60 days beginning June 6 through Aug. 5, 2019. After the public comment period closes, USDA said it will decide next steps based on its evaluation of public comments. Additionally, USDA plans to publish a draft programmatic environmental impact statement soon, and the agency added that it looks forward to stakeholder input on that document. USDA also intends to have public meetings on the proposed rule during the comment period.

Dana O’Brien, executive vice president of the Biotechnology Innovation Organization’s (BIO) food and agriculture section, said, “BIO appreciates USDA’s diligent approach in undertaking this important biotechnology rule-making and the agency’s overall commitment to improving predictability and pre-market oversight based on actual risk. We are thoroughly reviewing the proposal with our members as well as with key stakeholders and look forward to engaging with USDA in the coming weeks.”

O’Brien added, “A functional, predictable, legally defensible and science-based regulatory infrastructure must be accompanied by credible, proactive transparency measures if we are to spur continued investment in and long-term success for the biology-driven innovations that are improving our planet, health and food. These advancements, driven by a deep understanding of biology and genetics, are at the very heart of BIO’s mission and membership.”

Members of the public will be able to submit comments at: www.regulations.gov/#!docketDetail;D=APHIS-2018-0034.

TAGS: Policy
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