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White House order calling on agencies to streamline biotech

By MICHELE F. MIHALJEVICH

WASHINGTON, D.C. — An executive order signed June 11 by President Trump calling for a simplification of the review process for genetically modified farm products was met with praise by seed and commodity groups, while a hunger organization expressed concern.

The order will help eliminate delays, reduce developer costs, and provide greater certainty about the review process for farmers, the White House said. Under it, heads of the USDA, U.S. EPA, and the U.S. Food and Drug Administration (FDA) have 180 days to identify relevant regulations and guidance documents that can be streamlined, and take steps to accomplish such streamlining.

The agencies may use their existing statutory authority to exempt low-risk products of agricultural biotechnology from undue regulation.

USDA, EPA, and FDA will work to establish a website that provides links to relevant U.S. government regulatory information. The site will allow biotechnology developers to submit questions and receive responses about the review process.

The agencies will also conduct reviews of their “regulations and guidance that may apply to genome-edited-specialty-crop-plant products designed to have significant health, agricultural, or environmental benefits, in particular those likely to benefit rural communities significantly,” the order states.

“Based on the findings of its review, each of the agencies shall take steps to update its regulations and guidance, as necessary and appropriate, to remove undue barriers that impede small, private U.S. developers, the U.S. government, and academic institutions from bringing innovative and safe genome-edited-specialty-crop-plant products to the marketplace.”

Regulations for products of agricultural biotechnology should ensure public confidence in the oversight of such products and promote future innovation and competitiveness, the order said.

The current regulatory framework has impeded innovation rather than facilitating it, said USDA Secretary Sonny Perdue. “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,” he added.

Trump’s order “promotes a science- and risk-based program that will lay out a clear, predictable, and efficient regulatory framework,” the National Corn Growers Assoc. stated. “This will offer cost savings to technology developers, open the pipeline for product approval to a larger sphere, and allow farmers more rapid access to the tools that they need in the field.”

The order will allow USDA and other agencies to work with the country’s trade partners abroad to remove barriers to trade created by non-transparent and non-science-based regulatory approval processes, the organization said.

Alison Cohen, senior director of programs for WhyHunger, called the executive order a “gross misstep toward ending hunger, combating climate change, and building a just food and farm system. Essentially the executive order is giving a blank check to Monsanto, ADM, and the like to continue with their practice of industry consolidation.

“It effectively negates the science indicating that one-third of our greenhouse gas emissions come from industrialized agriculture and ultimately portends further biotech-related public health concerns for all of us. There is no solution to climate change and hunger while industrial agriculture and international agri-food businesses dominate and pollute our fields, oceans, food stocks, and markets.”

WhyHunger works to end hunger and advance the human right to nutritious food in the United States and around the world, according to its website.

Andy LaVigne, president and CEO of the American Seed Trade Assoc., said breeding methods such as gene editing hold potential for public- and private-sector plant breeding programs of every size and sector, from specialty to row crops.

“To fully realize the potential of these innovations, plant breeders need clarity and consistency around plant breeding policy, both domestically and internationally,” he said. “This includes ensuring that USDA, FDA, and EPA are coordinated in their approaches, with clearly defined, science- and risk-based roles and responsibilities that focus on the end-product, not the breeding method.

“Through evolving plant breeding methods, like gene editing, scientists are able to create new varieties in years, instead of decades.”

The National Pork Producers Council (NPPC) welcomed the executive order’s goal of streamlining regulations, said David Herring, its president. The order “paves the way for common-sense regulation to keep America first in agriculture so that we remain the global leader in an economic sector that has offset the U.S. trade imbalance for decades, and that is so critical for the prosperity of our rural communities.”

The 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, NPPC said.

6/19/2019