Biotechnology

By Sarah Gonzalez, Director of Communications and Digital Media President Donald Trump directed the U.S. Department of Agriculture (USDA), the U.S. Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA) to streamline their regulation of agricultural biotechnology in an executive order issued June 11. “The United States must employ a science-based regulatory system that evaluates products based on human health and safety and potential benefits and risks to the environment,” the executive order stated. “Such a system must both foster public confidence in ... Read More

The U.S. Department of Agriculture (USDA) today (June 6) published a new proposed rule for the regulation of plant-based agricultural biotechnology products.   Under the proposed rule, USDA’s Animal and Plant Health Inspection Service (APHIS) – which has authority to determine whether agricultural biotech traits pose a plant pest or noxious weed risk to the environment – would exempt most crops developed with gene-editing techniques from regulation. APHIS said these plants can be produced through traditional breeding techniques, making them unlikely to pose a greater plant pest risk ... Read More

By Randy Gordon, President and CEO A diverse collection of 21 European agricultural, food, chemical, health care and machinery organizations on April 23 distributed an “open letter” to European Union (EU) member states urging that they initiate targeted changes to Europe’s biotech law to allow for the adoption of more “practical and science-based rules” to govern new plant breeding methods, such as gene-editing. The letter was spurred by the European Court of Justice’s decision in July 2018 that interpreted the provisions of EU GMO Directive 2001/18 as requiring that products derived ... Read More

By Bobby Frederick, Director of Legislative Affairs and Public Policy For the first time since mid-2017, China this week announced import approvals for genetically modified crops. The Chinese government announced the approvals on Jan. 8 during a round of trade talks in Beijing between Chinese officials and a U.S. delegation that included USDA Undersecretary for Trade and Foreign Agricultural Affairs Ted McKinney.   The Ministry of Agriculture and Rural Affairs (MARA) of the People’s Republic of China approved the following genetically modified crops for import: Corn (1): ... Read More

By Sarah Gonzalez, Director of Communications and Digital Media; and Randy Gordon, President The U.S. Department Agriculture (USDA) on Dec. 20 issued its final rule for the National Bioengineered Disclosure Standard, adopting several of NGFA’s recommendations submitted in response to the agency’s proposed rule for implementing the congressionally required mandatory labeling of bioengineered food. The National Bioengineered Food Disclosure Law, passed by Congress in July 2016, directed USDA to establish a national mandatory standard for food manufacturers, importers and certain retailers ... Read More

By Randy Gordon, President The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) also is planning next spring to propose a major overhaul of its approach to regulating plant biotechnology. The proposal, which is expected to be issued for public comment as early as March 2019, is intended to revamp the agency’s so-called “Part 340” regulations under which it determines whether plant biotechnology methods – including genome editing – pose a plant pest risk.  APHIS has jurisdiction over plant pest risks under the Plant Protection Act. USDA, the Food ... Read More

By Randy Gordon, President The U.S. Food and Drug Administration (FDA) on Oct. 29 announced its intent to update its policies and issue several new guidance documents over the next year outlining the agency’s approach to providing regulatory oversight of plant and animal biotechnology, including the application of such plant breeding innovation techniques as gene (genome) editing. The agency outlined its approach in a five-page “Plant and Animal Biotechnology Innovation Action Plan” available here. The unveiling of FDA’s plan follows the agency’s 2017 request for public comments on its ... Read More

The European Commission (EC) has announced authorization allowing the import of five genetically modified strains of corn and sugar beets for use as food or feed.  The approvals include two new ones for stacked biotech corn traits developed by Monsanto and DuPont Pioneer – MON 87427 X MON 89034 x NK 603; and 1507 X 59122 X MON 810 X NK 603. Both are herbicide and insect-resistant traits. The EC also renewed the market authorization for two strains of biotech-enhanced corn (DAS-59122-7 and GA 21), as well as one sugar beet trait (H7-1). The authorizations came after approval by ... Read More

By Randy Gordon, President; and Sarah Gonzalez, Director of Communications and Digital Media The European Union (EU) Court of Justice, in a highly anticipated decision issued July 25, ruled that genetic mutation (mutagenesis) of organisms – better known as “gene editing” – is subject to the EU’s extensive regulations governing genetically modified organisms (GMOs). The case [Case C-528/16] was brought by nine French agricultural associations – led by a group called Confédération paysanne, a French agricultural union – that asked the court to limit the current EU exemption for plant ... Read More