The Biotechnology Evaluation (BE) unit of APHIS has received numerous inquiries concerning the internal process employed by BE after permit applications for introduction of a transgenic arthropod (or other invertebrate) are received. During the period January to June 1996, BE developed a set of procedures as the first two applications for release of transgenic arthropods (mites) and other invertebrates (nematodes) were processed. These internal procedures will be utilized for subsequent applications and will be modified as deemed appropriate. This information is made available as part of the expanding efforts of APHIS to communicate with interested entities and to make the permitting process as transparent and understandable as possible.
- Applicant submits materials—Form 2000 and supporting documents—to BSS–BE for review (electronic version encouraged).NOTE: The submission of an application may be preceded by an informal voluntary consultation (301-734-7612), in which the applicant can obtain: (1) information concerning protocols, data requirements, and APHIS procedures, (2) a preliminary determination of regulatory status for the proposed introduction, and (3) application materials, some of which are also available on the APHIS web page. This preliminary communication is strongly recommended.
- Initial processing of application.2a. Application is reviewed for completeness; i.e., all requested information is present; missing material is requested or application returned.
2b. The 120-day interval for completion of the review process is initiated upon determination that the application satisfies all requirements.
2c. Application is made available to the public (without CBI) by placement on the APHIS web page.
- Preliminary review initiated.3a. Regulatory status is determined; i.e., is the organism a “regulated article” under the Federal Plant Pest Act (FPPA)?
3a1. If the organism is determined to be an unregulated article, a Regulatory Assessment (RA) is prepared documenting such, and is placed on the APHIS web page. If requested by the applicant, and if the affected State concurs, a courtesy permit is issued.3b. Relevant APHIS documents are reviewed; e.g., has a related organism been previously permitted?
3a2. If the organism is determined to be a regulated article, the review process continues.
3b1. If a related or similar organism has been previously permitted, and a review indicates that there will be no significant differences between the organisms relative to the likelihood of becoming a plant pest or having a significant impact on the environment, then an expedited review and permit issuance can be achieved, with the adoption of prior assessment documents and placement of same on the APHIS web page.
3b2. If a related or similar organism has not been previously permitted, the review process continues.
- The preliminary review is completed within 7 days and the affected State(s) are notified electronically (email) that an application to release a transgenic organism in their state has been received, that APHIS has determined that the proposed release involves a regulated article under APHIS jurisdiction, and that APHIS within 30 days will complete a full assessment of the proposed release and will submit electronically to the State(s) that draft assessment for concurrence.
- The APHIS assessment will consider: (a) Risks associated with introduction of nontransgenic form of organism, and (b) Potential additional risks associated with introduction of transgenic organism.5a. Assessment may conclude that the proposed release of the transgenic arthropod poses a significant threat to plants or the environment and thus cannot be permitted. The applicant and State(s) are informed of the basis of the decision and the availability of an appeal process.
5b. Assessment may conclude that, although the proposed release of the transgenic arthropod may pose a threat to crops or the environment, mitigations may be available to reduce that threat. The applicant is so advised, the 120-day clock is stopped, and a dialogue between the applicant, APHIS, and possibly the affected State(s) continues until agreement on mitigations is reached or the application is withdrawn.
5c. Assessment may conclude that there is no significant risk that the proposed release of the transgenic organism poses a threat to plants or the environment.
- The draft assessment is submitted to the affected State(s) for review and concurrence (to be achieved by State within 30 days).6a. The State(s) may concur, with no conditions.
6b. The State(s) may concur, with conditions. Subsequent consultations between APHIS, State(s), and applicant to obtain agreement on those conditions for release.
6c. The State(s) may not concur. Subsequent consultations between APHIS, State(s), and applicant to resolve differences, possibly leading to withdrawal of application.
- Upon State(s) concurrence, APHIS prepares a final assessment in the form of an Environmental Assessment (EA), in compliance with the National Environmental Policy Act (NEPA).
7a. Initial determination of categorical exclusion under APHIS Implementing Procedures for NEPA. If the action can be categorically excluded, an EA is not prepared. A decision document for the Director, BSS, is prepared that includes the results of the assessment.
7b. If the proposed action is not excluded from NEPA, an EA and Finding Of No Significant Impact (FONSI) is prepared for the Director, BSS. Included in this process is consideration of Endangered Species Act requirements, consultation with USDI–FWS is initiated if appropriate, and applicant is informed of possible delay in permitting.
7c. Director of BSS reviews application and EA, and if approves, signs FONSI.
7d. Availability of EA/FONSI is announced in Federal Register and placed on APHIS Home Page.
7e. After appropriate interval, Director of BSS may issue permit.
source: http://www.aphis.usda.gov/biotech/arthropod/tgenproc.html 25feb01
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