Release to the environment, movement, transfer and granting non-regulated status of GE plants are governed by the United States Department of Agriculture through the Biotechnology Regulatory Services (BRS) of the Animal and Plant Health Inspection Services (APHIS) under the authority of Federal Plant Pest Act (FPPA) and Plant Quarantine Act (PQA)
The activity of USDA relates mainly to whether a GE plant might be a pest of noxious - that is, iff it may harm agricultural practices, the public health and the environment.
USDA- Regulatory Procedures for release to environment, interstate transport and commercialization.
USDA-APHIS regulates release to environment and interstate transport through two processes: permitting and notification.
Based on the nature of a new GE plant event in regard to its potential to be a plant pest, GE plants considered to be low risk (for example plants with delayed fruit ripening properties) go through an expedited permitting procedure called notification.
GE plants which may pose higher risks (for example plants transformed to produce pharmaceuticals or industrial proteins) are evaluated through a rigorous permitting process.
Regulatory Procedures for release to environment,
interstate transport and commercialization.
After generating sufficient data indicating (ppt) normal growth, morphology, reproductive properties and safety of the newly generated plant to be used as food or feed, the developer submits a petition to USDA for obtaining deregulated statues to initiate commercialization.
APHIS - BRS conducts an in-depth Environmental Assessment (ppt) to determine whether the new plant variety can be safely releases to the environment.
The review is published in Federal Register and open for public comments for 60 days. Public input and all comments are considered and included in the final decision which should be made by BRS no later than 180 days upon receipt of the petition.
Pharmaceuticals & Industrials (USDA)
Plants can also be genetically engineered to produce pharmaceuticals (plant-made pharmaceuticals; PMPs) and industrial proteins (plant made industrial proteins PMIPs). Release to environment, movement and transfer of GE crops producing pharmaceuticals and industrials are also regulated bu USDA-APHIS.
Field testing for PMPs and PMIPs can only be performed after obtaining a release permit from USDA following a rigorous review process which is conducted on a case by case basis. The developers submit all plans for the release. Scientists at APHIS evaluate impacts of introduction of the new GE line to agriculture and environment. Possible toxicity of GE plants to non target organisms and endangered species are also evaluated and permit conditions address the degree way the crop is to be confined.
At the end of the review process, APHIS-BRS grants the applicant an experimental release permit if all the planting plans including isolation and confinement measures are considered sufficient.
USDA inspectors monitor the activities during the trials via visits to the trial site during planting, throughout the growth season and also after the harvest.
Veterinary Biologics (USDA)
Veterinary biologics are regulated by USDA through Center for Veterinary Biologics (CVB) as for any other veterinary biologics produced by non-GE methods.
CVB is responsible for ensuring safety and quality of the veterinary biological products by promoting the use of quality assurance processes and application of standard production methods.