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Trump administration looks to improve biotech regulatory system

By Norwalk Reflector staff • Jun 18, 2019 at 9:00 AM

The federal government is taking steps to improve the agricultural biotechnology regulatory system — a move met with approval from farmers.

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, according to U.S. Department of Agriculture officials.

“Our current regulatory framework has impeded innovation instead of facilitating it,” U.S. Secretary of Agriculture Sonny Perdue said in a press release. “With this executive order, President Trump is once again putting America first and setting us on a course to modernize our regulatory framework so that it works for our farmers, ranchers, and consumers. 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.

“Science-based advances in biotechnology have great promise to enhance rural prosperity and improve the quality of life across America’s heartland and around the globe,” Perdue added. “I applaud President Trump for signing this important executive order that will help America’s farmers do what we aspire to do at USDA: ‘Do right and feed everyone.’”

In addition, the United States-Mexico-Canada (USMCA) Trade Agreement sets unprecedented standards for agricultural biotechnology. For the first time, the agreement specifically addresses agricultural biotechnology to support 21st century innovations in agriculture. The text covers all biotechnologies, including new technologies such as genome editing, whereas the Trans-Pacific Partnership text covered only traditional rDNA technology.

Specifically, the United States, Mexico, and Canada have agreed to provisions to enhance information exchange and cooperation on agricultural biotechnology trade-related matters.

USDA is one of three federal agencies which regulate products of food and agricultural technology. Together, USDA, the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) have a coordinated framework for the regulation of biotechnology and regulates these products for human, animal, plant and environmental health. For products derived from plant biotechnology, USDA’s regulations focus on protecting plant health; FDA oversees food and feed safety; and EPA regulates the sale, distribution, and testing of pesticides in order to protect human health and the environment.

USDA continues to coordinate closely with the EPA and FDA to fulfill oversight responsibilities and provide the appropriate regulatory environment. This ensures the safety of products derived from new technologies, while fostering innovation at the same time, agency officials said.

“Soybean farmers appreciate the steps toward a more consistent, coordinated approach to the biotech regulatory system domestically and abroad,” said Davie Stephens, a Kentucky soy grower who serves as president of the American Soybean Association (ASA).

In a press release, the group said it “applauds” Trump, the USDA, EPA and FDA for “their work to improve the regulatory process for biotechnology by ensuring decisions are transparent, timely and based firmly on sound science, and evaluation of risk.”

By promoting agricultural innovation and confidence in new technologies, farmers, small agribusinesses, researchers, and others have the opportunity to pursue advanced ways to grow our food, fight plant pests and disease, reduce reliance on fertilizers and other resources, and respond to consumer demands to reduce the impact of agriculture on the environment, in keeping with farming’s ongoing good stewardship efforts. “ASA looks forward to working with the responsible agencies to help move these improvements forward,” the release stated.

As per Perdue’s announcement on plant breeding technology issued on March 28, 2018, the USDA does not regulate or have any plans to regulate plants that could otherwise have been developed through traditional breeding techniques. This includes a set of new techniques that are increasingly being used by plant breeders to produce new plant varieties that are indistinguishable from those developed through traditional breeding methods.

In April 2017, Trump issued an executive order establishing the Interagency Task Force on Agriculture and Rural Prosperity “to ensure the informed exercise of regulatory authority that impacts agriculture and rural communities.” As Secretary of Agriculture, Sonny Perdue was selected to serve as the chairman of the Task Force, which includes 22 federal agencies as well as local leaders. Specifically, the Executive Order was established to identify changes that, among other things, “advance the adoption of innovations and technology for agricultural production and long-term, sustainable rural development… improve food safety… [and] encourage the production, export, and use of domestically produced agricultural products.”

The Task Force report to the President was released in January 2018, and it recognized that “on the biotechnology front, better coordination of the Department of Agriculture, Environmental Protection Agency, and Food and Drug Administration regulations on genetic modification of crops and livestock is needed to reduce barriers to commercialization of safe, beneficial and improved genetically engineered entities. Our regulatory system must protect public health, welfare, safety, and our environment while promoting economic growth, innovation, competitiveness, and job creation.”

The Task Force recommended that the Federal Government “continue efforts to modernize the federal regulatory system for biotechnology products,” including specific recommendations to:

1. Speed the safe commercialization of novel biotechnology products

2. Improve navigability of the regulatory system for small and mid-sized innovators,

3. Promote understanding of how a risk- and science-based regulatory approach effectively protects consumers, and

4. Remove unjustified trade barriers and expand markets for American products.

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