APHIS regulates the introduction (importation, interstate movement, or environmental release) of certain genetically engineered (GE) organisms. All regulated introductions of GE organisms must be authorized by APHIS under either its permitting or notification procedures.
When a developer has collected enough evidence that a GE organism poses no more of a plant pest risk than an equivalent non-GE organism, the developer may petition APHIS to determine non-regulated status for the GE organism. If the petition is approved by APHIS, the GE organism may then be introduced into the United States without any further APHIS regulatory oversight.
Each section below contains guidance, resources, application information, and status.
ePermits is a web-based system that allows users to submit import /interstate movement/transit/release permit applications, track applications, apply for renewals and amendments, and receive copies of their permits. Learn more about ePermits.
APHIS issues permits for the introduction of GE organisms that pose a plant pest risk, including plants, insects, or microbes. All regulated GE organisms are eligible for the permitting procedure. Applicants include scientific information for APHIS to review before APHIS issues the permit.
Notification is an administratively-streamlined alternative to a permit. The GE plant must meet specified eligibility criteria, and the introduction must meet certain pre-defined performance standards.
A person may petition the agency that a particular regulated article is unlikely to pose a plant pest risk, and, therefore, is no longer regulated under the plant pest provisions of the Plant Protection Act or the regulations at 7 CFR part 340. The petitioner is required to provide information under § 340.6(c)(4) related to plant pest risk that the agency may use to determine whether the regulated article is unlikely to present a greater plant pest risk than the unmodified organism. A GE organism is no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act when APHIS determines that it is unlikely to pose a plant pest risk.