Background on the Environmental Releases Database

There's much more here than meets the eye.

Field Tests (Release into the Environment)

The Process in a Nutshell:

• An institution wanting to bring a genetically modified plant to market first applies for a field test permit.

• If the plant falls under a set of well-characterized eligibility criteria and is one of a set of organisms, a streamlined permitting method known as the Notification Process may be used.

• If a permit is granted, institutions may perform the field tests on several sites in several states within a specified amount of time. Permits may be extended upon request. Institutions are not required to perform the field test, they simply have a permit to perform the test if they wish (much like obtaining a driver's license or fishing permit, one doesn't have to drive or fish).

• When an institution has gathered enough supporting field test data, it may apply to APHIS for deregulation of the tested organism in the form of a petition.

• If APHIS determines enough evidence exists, it will deregulate the organism, clearing the way for commercializing the crop.

• Depending on the characteristics of the organism and its phenotype, other agencies may also need to be consulted, notably the U.S. Food and Drug Administration and/or the U.S. Environmental Protection Agency.

The field test database and petitions for deregulation database may be searched separately and are linked together based on the association of field tests supporting petitions. Field tests that support a subsequent petition will have a link to the petition information listed under the Organism name in the field test search results display. Petitions will have a link to Field tests associated with the petition in the petition search results display.

For an example, go to the Field Tests Database, choose "Institution" and "APHIS Number/Range" to search, select "AgrEvo" for Institution and "94" for APHIS Number, then "Display to Screen". Three records will have links to Petition Data, as listed under the organism name.

The ISB Environmental Releases Database contains information on applications for field tests of genetically modified organisms maintained by the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture. USDA regulations state that a "release into the environment" (field test) of a "regulated article" (organism that may pose a plant pest risk) requires a permit from APHIS. A large majority of genetically modified organisms developed for agricultural purposes in the U.S. fall under these regulations. The agency reviews permit applications and prepares an Environmental Assessment (EA) in which the potential environmental impact of the release is evaluated. If the agency reaches a Finding Of No Significant Impact ("FONSI"), a permit is issued.

Notifications
Notifications are a type of release permit. Effective April 30, 1993, certain field tests may qualify for the notification process which expedites the permitting procedure. Field tests may be conducted under this process upon submission of a letter of notification and approval by APHIS. Originally, to be conducted under the streamlined Notification process, a field test must have involved tomato, corn, tobacco, soybean, cotton or potato, and must have met other specified eligibility criteria and performance standards. The agency does not prepare an EA for these field tests.

Effective June 3, 1997, additional organisms and gene constructs were included under the notification procedure. Eligible organisms and criteria are occasionally added.

Deregulatory Petitions
An institution may petition APHIS to have an article removed from the regulatory process, usually as a step toward commercialization. APHIS issues a Determination as well as an Environmental Assessment in making its decision.

The Environmental Releases Database contains records and EAs for all field tests conducted under permit, notification, or in the petition process for deregulation. This includes all of the Environmental Assessments obtainable from APHIS (over 430) for releases into the environment, and almost all EAs and accompanying Determinations for Petitions for Deregulation in plain text, Wordperfect, and Adobe PDF format (for petition documents). EAs range anywhere from 3 to 100+ pages.

Information in the database is updated regularly. All material is provided directly from APHIS and is unchanged from their original documents.

"APHIS will maintain an updated list of all notifications submitted. In the interest of providing the public access to information regarding the field trials that have been judged by APHIS to be eligible for notification, APHIS will periodically publish a notice in the Federal Register announcing the availability of such a list. Several commenters requested that a list of the notifications be published in the Federal Register. APHIS will instead, on request, directly provide the list to interested parties in a timely manner, either by mail or through the use of electronic equipment. APHIS has made arrangements with the National Biological Impact Assessment Program (a free biotechnology data base)* which is administered by USDA's Cooperative State Research Service, to make available current lists of notifications for release, that are pending and those which have been acknowledged by APHIS. The public may also review such lists in the Reading Room, Suite 7, 6505 Belcrest Rd., Hyattsville, Maryland."**

Federal Register, Docket No. 92-156-02,"Genetically Engineered Organisms and Products; Notification Procedures for the Introduction of Certain Regulated Articles; and Petition for Nonregulated Status", Final Rule, Animal and Plant Health Inspection Service, USDA.

** New Address (as of March 2002):
Biotechnology Permits Branch
USDA Animal and Plant Health Inspection Service
4700 River Road, Unit 133
Riverdale, MD 20737

* Information Systems for Biotechnology (ISB) is funded as the National Biological Impact Assessment Program.