Regulations Related to Genetic Engineering in Forestry

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The USDA's Animal and Plant Health Inspection Service is the primary regulating agency for research and commercialization of GE plants. The EPA is also responsible for regulating pesticide-producing GE plants. APHIS and EPA are responsible for regulating field testing and deregulating GE products for commercialization.

More Regulation and Risk Assessment Are Needed

Some GE plants may not be covered by APHIS's current regulations.

Technically, the public can comment on the permits and notifications, but APHIS may or may not use the public input in its decision making. APHIS's risk assessments for notifications and field trials are not subjected to external scientific review or any other public input.

Once a GE plant is deregulated, subsequent progeny of the plant are also deemed deregulated. The National Research Council (NRC) of the National Academy of Sciences has raised particular concerns that "stacked genes" developed through the cross-breeding of two or more GE plants with different GE traits may pose new risks and should not necessarily be considered deregulated by APHIS.

It is not clear that APHIS currently has the authority to deny permits on the basis of past permit violations.

To comply with the National Environmental Policy Act, federal agencies, in taking actions such as issuing permits, must first determine through an environmental assessment (EA) whether the proposed action would have a significant impact on the environment. If the agency cannot make such a finding, it is required by NEPA to issue an environmental impact statement (EIS). APHIS does not conduct EA's for field trials, only for commercialization, and has never conducted an EIS for any deregulation petition.

APHIS regulations do allow the commercialization of a GE crop without a prior affirmative approval by the agency and without public notice. Developers are not required to file a petition for nonregulated status before they produce a plant commercially. It is possible for developers to grow plants at a commercial scale under notification or field trial permits, even if the plants might pose some identifiable environmental or human health risk.

Since APHIS does not typically conduct an EA until the application for deregulation stage, in these situations APHIS would not have assessed the environmental impacts of planting at a larger scale and made an affirmative decision that larger-scale production would have no significant impact on the environment. Thus there is no opportunity for prior public notice or public comment.

When a crop is considered ready for commercialization, it is completely deregulated by APHIS. APHIS has no authority to monitor a deregulated GE crop after it has gone to market, and the manufacturer has no legal obligation to monitor or report unanticipated problems. A deregulation decision does not preclude APHIS from subsequently re-regulating a plant.

APHIS may not have the legal authority to inspect, or require monitoring or data reporting on crops that have been deregulated.

For more information see  Issues in the regulation of genetically engineered plants an animals, published by the Pew Initiative on Food and Biotechnology, and Raising Risk : Field Testing of Genetically Engineered Crops in the United States from the Texas Public Interest Research Group.