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USDA uses science-based regulatory systems to allow for the safe development, use, and trade of products derived from new agricultural technologies. USDA continues to regulate the importation, interstate movement, and field-testing of newly developed genetically engineered (GE) organisms that qualify as "regulated articles” to ensure they do not pose a threat to plant health before they can be commercialized. These science-based evaluations facilitate the safe introduction of new agricultural production options and enhance public and international confidence in these products. As a part of this effort, the Animal and Plant Health Inspection Service (APHIS) will publish a proposed rule to revise its regulations regarding the regulation of GE organisms. 

Statement of Need:

This rule is necessary in order to respond to advances in genetic engineering and APHIS’ understanding of the pest risks posed by genetically engineered organisms, to evaluate genetically engineered plants for noxious weed risk (an evaluation that is not part of the current regulations), to respond to two Office of Inspector General audits regarding APHIS’ regulation of genetically engineered organisms, and to respond to the requirements of the 2008 Farm Bill.

Summary of the Legal Basis:

The Plant Protection Act of 200, as amended (7 U.S.C. 7701 et seq.).

Alternatives:

Alternatives that we considered were (1) to leave the regulations unchanged; (2) to regulate all GE organisms as presenting a possible plant pest or noxious weed risk, without exception, and with no means of granting nonregulated status; or (3) to withdraw APHIS regulations governing biotechnology and instead implement a voluntary program under which developers would present genetically engineered organisms to APHIS for an evaluation of their plant pest and noxious weed risk, and organisms determined to be plant pests and/or noxious weeds would be regulated under other APHIS regulations.

Anticipated Costs and Benefits:

Not yet determined.

Risks:

Unless we issue this proposal, we may not be able to regulate a genetically engineered plant that does not pose a plant pest risk, but does pose a noxious weed risk. Additionally, as noted above, the current regulations do not incorporate recommendations of two OIG audits, and do not respond to the requirements of the 2008 Farm Bill, particularly regarding APHIS oversight of field trials and environmental releases of genetically engineered organisms.