Regulatory situation in the USA

Authorization for plant protection products is governed in general by the EPA (Environmental Protection Agency) and more precisely by the OPP (Office of Pesticide Programs). The market approval procedure is initially at the federal level and then at the level of each state. Thus, the company requesting approval first submits a request file at the federal level, and once federal approval has been granted, the company files in each state in which it intends to commercialize the product. Certain states may request additional tests, not previously requested by the federal authority. 

The reference text which regulates approval in the United States is the FIFRA (Federal Insecticide, Fungicide and Rodenticide Act), which is equivalent to European Directive No. 91/414. This text, which presents the outlines for the market approval of plant protection products, was considerably amended in 1986 by the Food Quality Protection Act. To compile their approval registration file, companies must carry out ecotoxicity tests to assess effects on the environment and in particular on nontargeted organisms such as bees. 

Tests on bees are requested for all products, whether they are insecticides, fungicides, herbicides, rodenticides, or disinfectants, etc., once they are to be used outdoors and bees may come into contact with them. Three official test methods, harmonized with those of the OECD [21, 22] and certified by the OPP, are available (OPPTS Nos 850.3020 [23], 850.3030 [24] and 850.3040 [25]). 

If bees can come into contact with the plant protection products, the contact LD50 must be measured. Similarly, in the case of possible ingestion of the product by bees, the oral LD50 must be estabhshed. The method used is defined by OPPTS Guideline No. 850.3020. 

If the product has a growth regulating action, brood food tests are required. 

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