The EPA issued an order to the company ordering the company to immediately stop the sale, use, or removal of seed treatment fungicides Rancona V RTU FS (EPA Reg. No. 400-595) and Rancona V 100 Pro FS (EPA Reg. No. 400-596) (collectively, ?the Rancona Products?) that were misbranded in violation of FIFRA Section 12(a)(1)(E).
FIFRA requires the EPA to review registered pesticides at least every 15 years to determine whether they continue to meet FIFRA?s standard for registration. In September 2019, the EPA reviewed pesticide products with the pesticide chemical carboxin (CAS No. 5234-68-4) and noted that tolerances (i.e., the maximum residue level of a pesticide that legally can be present in food or feed) for carboxin on certain commodities, including rye, had not been established as required by the Federal Food, Drug, and Cosmetic Act (FFDCA). Subsequently, the EPA inspected product labels and accompanying documentation for the Rancona Product, which contain carboxin as an active ingredient and determined that, as labeled, the products provided directions for use on rye and did not contain any restrictions against using the products on rye seed destined for consumption or other use, which would be necessary in light of the lack of adequate tolerances. Absent such a restriction, use of the products on rye could result in the production, sale, and consumption of food that would be considered adulterated under Section 402 of the FFDCA, because the pesticide residues are cons