Information for Biopesticide Researchers
These CFR links are from the Code of Federal Regulations (CFR) Database offered by the Government Printing Office.
In some cases, Biopesticides may have different regulatory obligations for containment and experimental field releases than the more familiar requirements for conventional chemical pesticides.
These are generally regulated the same as for conventional chemical pesticides for field testing. See 40CFR172.3 for information on when you need a permit. Basically, any use/testing on a food or feed crop that will not be destroyed requires both an Experimental Use Permit and a tolerance decision (40CFR180). For non-food/feed uses you can test on no more than one surface acre of water per pest or 10 acres of land per pest. There are some further qualifications for this exemption from regulation that are described in 40CFR172.3. Certain kinds of pheromones may be tested on up to 250 acres without needing an EUP as described in two Federal Register notices: July 7, 1994 (all non-food uses of arthropod pheromones at a maximum use rate of 150 grams a.i./acre/year, food uses are allowed in a solid matrix dispenser - not available online), and August 30, 1995 (all food and non-food uses of certain straight chain Lepidopteran pheromones - Volume 60, Number 168, Pages 45156-45157).
A microbial pesticide is any microorganism (as defined in 40CFR152.20) that is being tested or used to control/mitigate any pest. This includes microorganisms intended to simply replace or out-compete detrimental microorganisms. These are subject to the same EUP regulatory obligations described above for Biochemical Pesticides and found in 40CFR172.3. For those microbial pesticides tested on less than one surface acre of water, special attention must be paid to assuring that the water is in a well contained system so as to prevent the microorganism from establishing itself over a larger area.
Genetically Modified and Non-Indigenous Microbal Pesticides:
Certain genetically modified and non-indigenous microbial pesticides may be subject to unique laboratory containment and small-scale field release provisions as described in 40CFR172.3 and Subpart C of 40CFR172. These pesticides are (1) those microbial pesticides whose pesticidal properties have been added or enhanced by the introduction of genetic material that has been deliberately modified and (2) non-indigenous microbial pesticides that have not been acted on by USDA, typically by issuing a permit. Note that you must have a permit from USDA for the actual field release, not just an import permit, to qualify for this exemption from the regulations. Those microbial pesticides falling under these descriptions must submit a Notification to EPA and obtain approval prior to any environmental release. Notification application guidance can be found in 40CFR172.46 and 40CFR172.48.
Plant-Incorporated Protectants, as more precisely defined in 40CFR174, consist of pesticidal substances that are genetically introduced into and used in a living plant. Note that pesticides include growth regulators as well as substances that mitigate pests. These are regulated as described above for Microbial Pesticides. A special case has arisen for these plant-associated pesticides. They sometimes need to have permission for seed production growth prior to approval of a full commercial-use registration by EPA. In these cases, a registration may be approved for the seed production. The terms of this registration may set specific limitations on the release of the plants prior to the full commercial-use registration.