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USDA Animal and Plant Health Inspection Service
Regulated genetically engineered organisms
"Deregulation" of genetically engineered organisms

The traditional mandate of the Animal and Plant Health Inspection Service (APHIS) within the US Department of Agriculture has been to monitor and prevent the spread of plant and animal diseases, particularly those of importance to agriculture. Also within the purview of APHIS is the control of weedy "invasive" species (like the Kudzu vines of the southeastern US). APHIS inspects new plants and animals brought into the country, quarantines products that could spread diseases into the US, and helps to control the spread of new diseases, invasive plants, animals, and insects. Similarly, APHIS has regulatory jurisdiction over the release of new GE plants and microorganisms into the environment, and evaluates their potential to become plant pests, weedy "escapes," or otherwise cause damage to US agriculture.
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Regulated genetically engineered organisms

Notification

The applicant must notify APHIS in writing, and must demonstrate that the GE organism meets certain eligibility criteria and that mechanisms for containment of the GE organisms are adequate. In practice, this may be little more than a formal statement that the organism meets the standards of 7 CFR 340. The GE organisms cannot be grown until APHIS receives and "acknowledges" this application. Most new GE plants go through the notification process. Since 1987, there have been 5663 notifications to APHIS of GE field trials-- but 254 of those were denied by APHIS, and 76 were withdrawn by the applicant.

Release Permits

Organisms that do not meet the safety criteria of the notification process (mainly GE microorganisms and pharmaceutical-producing plants) must first be granted a release permit before field testing. Organisms requiring a permit generally undergo more careful scrutiny and the approval process is more time-consuming. Since 1987, there have been 1057 requests for release permits-- all were approved but 124, which were withdrawn by the applicant.

Notifications and release permits are only valid for one year-- the application process must be repeated every year, even if the GE variety is the same. APHIS officials may also conduct inspections of field test sites. Additionally, the developers of regulated GE varieties are required to notify APHIS immediately of any accidents or unintended releases of regulated organisms.

The easiest way to determine what kinds of experimental genetically engineered plants have been field tested is to look through the data listed on the APHIS website. APHIS maintains a database of applications (for notification or permits) currently being considered, as well as many of the recent accepted applications. Virginia Tech maintains a searchable database of all field releases of GE plants. NOTE: many of the GE crops listed in these databases are experimental in nature only, and may never actually be marketed-- but this is a great way to keep track of "what's in the pipeline." To determine which of these have actually been approved for marketing, see the next section.
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After the developer of a GE variety has accumulated several years of data from regulated field trials, the developer may petition APHIS to allow the new GE variety to be deregulated. This means that, as far as APHIS is concerned, the deregulated GE variety will be treated no differently than organisms developed by conventional means. Future outdoor plantings, import, and interstate movement no longer require notification or release permits. Deregulation is the first important step in the eventual marketing of a new GE variety in the US--the new variety must also acquire approval from the FDA and EPA (if necessary) before commercial release. To date, there have been 76 petitions for deregulated status, and 52 have been approved (12 different plant species). The difference largely represents petitions which were withdrawn by the developer before APHIS issued a final decision.

To petition for deregulated status, the developer of a new GE plant submits all of its available data to address the potential environmental impact and plant pest risk. In general, this is a back-and-forth consultation process between the developer and APHIS, with APHIS providing guidelines for the kinds of data that should be submitted. APHIS requires data to answer the following questions:

• Does the plant exhibit any plant pathogenic properties? That is, is the plant likely to cause diseases in other plants?
• Is the plant more likely to become a weed than a non-GE variety?
• Is the plant likely to increase the weediness of other cultivated or wild species it could interbreed with?
• Could the plant cause any damage to processed agricultural commodities?
• Could the plant cause harm to any other organisms (such as bees) that are important to agriculture?