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Trump streamlines regulatory maze for ag biotechnology

Executive order will help eliminate delays, reduce developer costs and provide greater certainty about review process for farmers.

In another move to help modernize regulations, while in Iowa on Tuesday, President Donald Trump signed an executive order directing federal agencies to streamline agricultural biotechnology regulatory processes. The Modernizing the Regulatory Framework for Agricultural Biotechnology Products Executive Order calls for, among other things, regulatory streamlining in order to facilitate the innovation of agricultural biotechnology to the market efficiently, consistently and safely under a predictable, consistent, transparent and science-based regulatory framework.

Based on recommendations by the Administration's Rural Development Taskforce, the executive order (EO 13874) directs the Food & Drug Administration, U.S. Department of Agriculture and Environmental Protection Agency to review their respective agricultural biotechnology regulatory systems in an effort to streamline processes and remove overly burdensome regulations. The order also encourages the agencies to collaborate on commonsense regulations and to develop awareness and educational programs to gain acceptance of new technologies by consumers and global trading partners.

The current regulatory process is a maze that can take more than a decade to navigate, delaying innovations that can bring safe, resilient crops to the market. USDA processed an average of five petitions each year from 1993 through 2017. This executive order will help eliminate delays, reduce developer costs and provide greater certainty about the review process for farmers.

Biotechnology has been used in farming for decades to produce safer, more sustainable crops. Streamlining the biotechnology regulatory process will help create an environment that fosters greater investment in these innovative crops, the White House said.

Secretary of Agriculture Sonny Perdue welcomed the action, stating that the current regulatory framework has impeded biotech innovation instead of facilitating it. “We need all the tools in the toolbox to meet the challenge of feeding everyone now and into the future. If we do not put these safe biotechnology advances to work here at home, our competitors in other nations will,” Perdue said.

Biotechnology Innovation Organization (BIO) president and chief executive officer Jim Greenwood added, “America is on the threshold of entering a new era of sustainable agriculture and food production, and it’s important we get this right for farmers, consumers, U.S. companies and the world as a whole. With prudent regulations, we can foster American innovation and bring to market biology-driven solutions that are improving nutrition, reducing food waste, increasing crop yield, combating debilitating crop diseases and advancing environmentally friendly farming practices.”

Greenwood applauded the Administration for taking action to ensure government policy does not hinder 21st-century biotechnology from addressing the many global challenges — from a looming food crisis to climate change — facing society today.

“We will continue to engage with the agencies throughout this process to ensure our regulatory infrastructure is science based and transparent, and just as we are committed to working with the government, we also pledge to be a driver of forthright conversations and dialogues with consumers in an effort to identify shared values and energize public understanding,” Greenwood said.

Regarding the livestock industry, the executive order provides a framework to support leadership in emerging technologies such as gene editing for livestock -- an innovation that promises to eliminate costly diseases that cause animal suffering, lower the need to use antibiotics and further reduce agriculture's environmental impact, the National Pork Producers Council (NPPC) said in a statement.

"The United States is falling behind countries such as Canada, Brazil and China that have established regulatory frameworks conducive to investment in the development of gene editing," NPPC president David Herring said. "We are hopeful that this executive order breaks the FDA's current grip on gene editing so a regulatory framework can be established at the USDA to ensure that American farmers – not our competitors in foreign markets – realize its vast potential."

FDA continues to advance a regulatory framework for gene-edited livestock that runs counter to the executive order, NPPC stated. Despite there being no statutory requirement, FDA currently holds regulatory authority over gene editing in food-producing animals. FDA oversight will treat any gene-edited animal as a living animal drug – and every farm raising them as a drug manufacturing facility – thus undermining U.S. agricultural competitiveness relative to other countries with more progressive regulatory policies on gene editing.

TAGS: Policy
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