View Rule

APHIS is revising its regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered organisms in order to update the regulations in response to advances in genetic engineering and APHIS' understanding of the plant health risk posed by genetically engineered organisms, thereby reducing the burden for regulated entities whose organisms pose no plant health risks.

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 (GE) organisms, to assess such organisms for plant pest risks in light of those advances and establish a process to determine whether APHIS has jurisdiction under the Plant Protection Act to regulate specific GE organisms under Part 340, and to respond to two Office of Inspector General audits regarding APHIS’ regulation of genetically engineered organisms, as well as the requirements of the 2008 Farm Bill.

Summary of the Legal Basis:

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

Alternatives:

Alternatives that we considered were (1) to leave the regulations unchanged and (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.

Anticipated Costs and Benefits:

At the proposed rule stage, APHIS estimated the cost savings for two regulatory oversight scenarios, based on a study of the costs encountered by private biotechnology developers as they pursue regulatory authorization of their innovations.  When only APHIS has regulatory oversight, compliance cost savings under the proposed rule were estimated to range from $1.5 million to $5.6 million ($3.6 million on average) for the development of a given GE plant.  If EPA and/or FDA also have an oversight role in the development of a given GE plant, compliance cost savings were estimated to range from $538,000 to $924,000 ($730,600 on average).  APHIS also identified that the proposed rule could spur innovation and provide impetus to the development of new horticultural varieties, where the costs of acquiring non-regulated status may have been high relative to the potential market. For example, if 10 new GE plants were developed annually without APHIS permits (all with no APHIS permit, but 8 still with EPA and/or FDA evaluation), the annual savings would be $13.0 million. Costs and benefits associated with the rule may be reassessed in response to comments and are subject to change at the final rule stage.

Risks:

Unless we issue this proposal, we will not be able to respond to the products of future technologies and not be able to provide appropriate oversight of GE organisms that pose a plant pest 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.