Joint Regulation of Microbial Pesticide Products
The environmental release of certain micro-organisms is jointly regulated by APHIS and the U.S. Environmental Protection Agency (EPA).
Authorities
EPA has authority under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to regulate biologically and chemically derived pesticides, including microbial pesticides. Microbial pesticides have micro-organisms (such as a bacterium, fungus, virus, or protozoan) as the pesticide active ingredient. EPA has authority over the commercial use and field testing of microbial pesticides.
APHIS has authority under the Plant Protection Act of 2000 to regulate the importation, interstate movement, and field release of biological control organisms. A biological control organism is defined in the statue as “any enemy, antagonist, or competitor used to control a plant pest or noxious weed.”
APHIS' authority includes genetically engineered organisms whose oversight is administered by Biotechnology Regulatory Services (BRS). Nonengineered organisms are administered by Plant Protection and Quarantine (PPQ).
Frequently Asked Questions
No. Provided the application meets all of PPQ’s requirements, the permit would not be withheld based on any suspected regulation under FIFRA by EPA. PPQ may inform you that the product may be subject to regulation under FIFRA and recommend you contact EPA's Office of Pesticide Programs (OPP), Biopesticides and Pollution Prevention Division (BPPD).
No. A PPQ 526 permit would no longer be required for importation, interstate movement, or environmental release, and any existing PPQ 526 permit would be cancelled, if EPA regulates a microbial product under one of the following:
- An EPA experimental use permit or a FIFRA section 18 emergency exemption
- The product is currently registered with EPA as a microbial pesticide product
- The product is being transferred, sold, or distributed in accordance with EPA's regulations in 40 CFR 152.30
Yes. You need a PPQ 526 permit for any microbial product lacking an EPA registration unless the product is labeled in accordance with 40 CFR 156. The PPQ 526 permit is required until you obtain an EPA product registration.
Yes. You need a PPQ 526 permit for any organism(s) that is in an EPA-registered product if:
- The organism(s) will be used to develop a product, or
- The final product is intended for non-EPA registered product use.
This may necessitate EPA verification by PPQ. The PPQ 526 permit will be required until an EPA product registration is obtained.
Contact Us
APHIS-PPQ
For questions or more information about APHIS requirements for nonengineered organisms, visit Regulated Organism and Soil Permits or contact our Pest Permits Team.
For questions about permits for regulated organisms and soil:
Pest Permits Team
APHIS-BRS
For questions or more information about APHIS requirements for modified micro-organisms, visit Biotechnology Permits or contact our BRS staff.
Biotech Microbes
Email: biotechmicrobes@usda.gov
EPA
For questions or more information about EPA requirements, contact EPA's Office of Pesticide Programs, Biopesticides and Pollution Prevention Division. View EPA Contacts