General Guidance when Applying for APHIS Permits
Regulated Microorganisms
Organisms that are or contain plant pests are included in the taxa or group of organisms contained in this list. These organisms are all regulated.
You can verify specific microbe requirements with the Agricultural Commodity Import Requirements (ACIR) database.
Reference For Genetically Engineered Microorganisms
APHIS-Biotechnology Regulatory Service (BRS) regulates and issues permits for genetically engineered microorganisms.
Genetic engineering is defined in 7 CFR § 340.3 as “techniques that use recombinant, synthesized, or amplified nucleic acids to modify or create a genome.”
To apply for a BRS permit, the applicant creates a permit application and an associated “Standard Operating Procedures” (SOP) using the APHIS eFile electronic permitting system.
Biotechnology Regulatory Services Permitting Assistant (BRSPA) Quick Reference
APHIS Permit Categories
| Application Form | Application Name |
|---|---|
| BRS/APHIS 2000 (Web) Application | Permit for importation, interstate movement, or environmental release of certain genetically engineered (GE) organisms |
| BRS/APHIS 2000 (XML Application) | Permit for importation, interstate movement, or environmental release of certain genetically engineered (GE) organisms |
| Dog Import Permits | Permit for importation of Live Dogs for resale, research, or veterinary treatment |
| PPQ-525A | Application for Permit to Receive Soil |
| PPQ-526 | Application for Permit to Move Live Plant Pests, Noxious Weeds, Soils, and Prohibited Plants |
| PPQ-546 | Agreement for Postentry Quarantine |
| PPQ-585 | Permit for Importation of timber and timber products |
| PPQ-586 | Application for movement of plants, plant products, plant pests, or soil in cargo through the United States |
| PPQ-587 | Permit for importation of plants or plant products |
| PPQ-588 | Application for permit to import prohibited plants or plant products for experimental purposes |
| PPQ-621 | Application for protected plant permit to engage in the business of importing, exporting or re-exporting terrestrial plants or plant products that are protected. |
| VS 16-3 and VS 16-7 (if applicable) |
Application for permit to import or transport Animal Products, Organisms or Vectors, and if applicable, application for Permit to Import Cell Cultures and Their Products. |
| VS 16-79 On-Hold | Only for shipments of animal products, organisms, and vectors. Request assistance for shipments placed on-hold by CBP because they do not meet APHIS VS requirements. |
| VS 17-129 | Application for permit to import/transit Live Animals |
PPQ-526 Permit
APHIS 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.
Guidance for submitting a PPQ-526 in the eFile Portal can be found here.
Timeline for permit application process:
| Step | Application Status | Time Range |
|---|---|---|
| Application review for completeness and assignment to Permit Scientist |
Submitted | 1- 2 Weeks |
| Application technical review – Risk analysis | Review Initiated | 1- 6 Weeks |
| Evaluation of Containment Facility, if necessary | Pending Containment Facility Review | 1- 20 Weeks |
| Determination of permit conditions to mitigate risk | In Review | 1- 2 Weeks |
| Consultation of draft permit with the State | Pending State Review | 1- 2 Weeks |
| Evaluation of State response | Pending APHIS Review | 1- 2 Weeks |
| Review of draft permit conditions by Applicant | Applicant Action Required | 1- 4 Weeks |
| Review of Applicant’s response and issuance of the Permit (Official Letter(s) may be issued if necessary). |
Pending APHIS Review | 1- 2 Weeks |
| Processed Application | 8 - 40 Weeks |
