Document dYQKJpo84QZjY33onr4aQ5Yd5

EPA Background The products of agricultural biotechnology are particularly beneficial to the environment, which should be noteworthy to the U.S. Environmental Protection Agency (EPA). Widespread adoption of biotech crops since the early 1990s has resulted in higher yields per acre, significant advancement of integrated pest management at the intersection of biotech insect resistant traits and conventional insecticides, and significant labor savings for farmers. Their use reduces agriculture's energy consumption and C02 emissions and facilitates the use of no-till agriculture, which, in turn, lessens soil erosion and water pollution. According to peer reviewed publications measuring environmental impacts, the use of biotech seeds has reduced the environmental footprint of agriculture by 18 percent. The EPA is responsible for assessing the safety of pesticidal substances, including Plant Incorporated Protectants (PIPs) that are produced by certain biotech crops. The most common of these are the socalled "Bt" crops, which produce a protein, derived from soil bacteria, that controls certain insect pests that feed on the plant. In its own independent analysis, the EPA confirmed those pesticidal substances do not cause unreasonable adverse effects on humans or the environment. Biotechnology innovation in agriculture also includes an array of microbial products that range from those with pesticidal activity to those that simply promote soil health (biostimulants) and, therefore, improve plant productivity. Using microbial biopesticides and biostimulants further lessens the environmental impact of agriculture. Finally, The EPA also approves new uses of previously registered herbicides on biotech plants that are developed to resist those herbicides. Issues 1. The EPA's regulatory performance with respect to ag-biotech products has declined over the years, as regulatory requirements and costs have increased significantly. Even though Congress enacted the Pesticide Registration Improvement Act (PRIA) to impose very specific time limits for reviews of new uses and registration of new PIPs in GE plants, the EPA's Office of Pesticide Products (OPP) routinely extends the legally-mandated time limits for biotech products. 2. Additionally, the EPA has made several attempts in recent years to expand its authority over biotech crops into USDA's areas of oversight for biotech crops. As the U.S. government contemplates regulatory policy priorities for the EPA, it will be important to take into account the environmental benefits of biology-based agricultural solutions, the similarity of these products to those developed by conventional methods, and the impact of the agency's regulatory practices on modern agricultural innovation and farmer access to biology-based tools. 3. EPA should not further expand its premarket regulatory approval process to genome edited plants that could be produced using traditional plant breeding methods. 4. Oversight of the non-pesticidal biological products is unclear. Industry needs clarity of oversight and that oversight must be science-based, risk-based and not overly burdensome. Many small agricultural companies produce non-pesticidal microbial products, which makes it all the more important that EPA does not create regulations that are unnecessary, burdensome, expensive and time/resource consuming. Creating such a system for biotech products - both PIPs and microbial pesticides - led to the demise of many small companies in the 1990's. Request We urge EPA leadership to ensure OPP is following legally-mandated timelines and that the EPA is, more generally, not unnecessarily expanding regulatory authority or creating unnecessary regulations. 17cv1906 Sierra Club v. EPA - 6/22 Production ED 001523 00007827-00001