Web Content Viewer (JSR 286)

Actions
Loading...

Microbial Organisms Used to Control Invertebrate Plant Pests and Plant Pathogens

Under the authority of the Plant Protection Act of 2000, APHIS Plant Protection and Quarantine (PPQ) 526 permits are required for the importation, interstate movement, and environmental release of biological control organisms and biopesticides for plant pests, diseases, and weeds. Often the organisms are not plant pathogens, but their potential effects on beneficial organisms could indirectly affect plant health.  This policy refers to biopesticide microbial organisms that control invertebrate plant pests and microbial plant diseases (pathogens).  Permits may be required for foreign isolates of microorganisms even if the species and genus is present in the environment of the United States.

APHIS-Biotechnology Regulatory Service (BRS) regulates and issues permits for genetically engineered microorganisms.  For more information or to contact BRS for guidance go to the BRS Website.  

Permits are required for the following:

Importation of microorganisms for research

Research includes lab work, plant inoculations in growth chambers and greenhouses, and field releases of less than ten acres.  APHIS regulates the movement of these imported organisms into and through the United States, and containment may be required to safeguard against unauthorized movement into the environment.  National Environmental Policy Act and the Endangered Species Act risk analyses are required before APHIS issues permits for environmental releases of microorganisms.
 
Importation of microorganisms registered by the U.S. Environmental Protection Agency (EPA) for commercial use or research authorized by Experimental Use Permits.

APHIS issues permits for the importation of EPA-registered biopesticides.  APHIS permits are NOT required for subsequent interstate movement of EPA-registered biopesticides.  For field releases of microbial organisms not authorized by an APHIS permit, or for commercial use of any microbial biopesticide, not yet registered by the EPA, the applicant should contact EPA for guidance.  
 


Permit Requirements

Foreign microbial strains

A PPQ 526 permit is required for the importation, and interstate movement of microbial biological control organisms of foreign origin.
 
Soil to isolate microorganisms

A PPQ 526 permit is required for the importation and interstate movement of foreign soil for isolating organisms used in biocontrol/biopesticide research. After the researcher isolates and retains microorganisms, a new PPQ 526 permit is required for movement that specifically identifies the foreign organisms.
 
Domestically isolated microbial strains

A PPQ 526 permit is typically NOT required for the interstate movement or release into the environment of domestically isolated microorganisms that are not plant pests, and are widely prevalent in the continental United States. For the purposes of permitting policy, widely prevalent organisms are established throughout their ecological range, must be collected within the continental United States, and not originate from Hawaii or U.S. territories.
 
Export and import of microorganisms

PPQ 526 permits are required for the importation of all microorganisms that are plant pathogens or potential biological control organisms. This requirement is for organisms/strains of domestic or foreign origin, and includes foreign isolates that have previously entered the United States under the authorization of a permit. An export certification or permit from PPQ is not required by APHIS; however, the country to which the microorganism is exported may have entry requirements that can be obtained from their regulatory officials. If domestic microorganisms are exported to a foreign country for research or processing purposes, they are now designated as foreign-origin microorganisms and will require permits for importation back into the United States. Permits will be required for the re-importation and any subsequent interstate movement or release of foreign-origin organisms that were previously imported into the U.S. and then exported to a foreign country. Certification of the identity and purity of the shipment contents by lot number must be included with the shipment documentation. The certification must be dated within 60 days of arrival at the port of entry, and the certifying laboratory must be located in the country from which the product was exported. The certification must indicate that the only living organisms (i.e., active ingredient) in the shipment are those authorized by the PPQ 526 permit with the exception of those organism that are not under the jurisdiction of the Plant Protection Act or another Federal Agency. If it is confirmed that the imported organism is taxonomically identical to the original domestically isolated exported organism, permits authorizing subsequent interstate movement including releases of less than ten acres may NOT be required, depending on the documentation provided. For field releases of ten acres or more, and for commercial use of any microbial biopesticide, the applicant must contact EPA for guidance.
 
EPA-registered biopesticides

Importation of EPA-registered biopesticides, including those authorized by EPA-issued Experimental Use Permits, requires a PPQ 526 permit as well as an EPA Notice of Arrival. EPA regulates the domestic use of registered biopesticides, and does not have the authority to regulate these organisms in foreign commerce. The shipment documents must include laboratory certification of the identity and purity of the shipment contents by lot number, dated within 60 days of arrival at the port of entry, and the certifying laboratory must be located in the exporting country. The certification must indicate that the only living organisms (i.e., active ingredient) in the shipment are those authorized by the PPQ 526 permit and are consistent with the EPA Notice of Arrival.
 
Importation of organisms that may not be plant pathogens, biopesticides, or biocontrol organisms

PPQ 526 permits may be required for the importation of some microorganisms even if it is determined that they are not plant pathogens, and there are no current claims that they are potential microbial biological control organisms. Upon receipt of a PPQ526 permit application for the importation of microorganisms for the intended use of research or environmental release, APHIS will conduct an evaluation to determine whether the organisms have plant pest biocontrol or biopesticide properties that are regulated under the authority of APHIS. However, if these foreign microorganisms have properties that might enhance plant growth and health by facilitating uptake of nutrients from the soil or another mechanism of action, they may still require a PPQ526 permit for their importation and subsequent movement. For example, other Federal Agencies, including EPA or FDA, may regulate microorganisms that enhance plant growth and health. APHIS coordinates with EPA and FDA during the evaluation and decision making process. If EPA registers the product or authorizes it for research, a PPQ 526 permit may be needed for the importation of microorganisms, because EPA doesn’t regulate movement of microorganisms in foreign commerce. EPA provides exceptions to Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) for some plant health/growth enhancing properties, and APHIS may not require a PPQ526 permit for microorganisms that would have an exception to FIFRA. For more information, the applicant should contact EPA for guidance. If the microorganism’s mechanism of action as a biopesticide/biological control organism is the production of an antibiotic, in addition to the guidance provide in this document, the applicant should contact the Food and Drug Administration for guidance.
 
Importation of products such as foreign soil amendments, biofertilizers, growth enhancers, plant health promoters, biostimulants, composts or similar materials that contain unidentified microorganisms and unauthorized substrates for environmental release


View the following link for information:

Questions for field releases (<10 acres) of microbial biological control organisms of foreign origin


Responses to these questions and other information will support the determination that further detailed analysis and consultation is not needed, or to identify the situations and conditions when such analysis or consultation may need to be conducted. These determinations must be made prior to approving your proposed field research. View the following link for details: 

 



Additional Information