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Proposed Revisions to APHIS Regulation of Genetically Engineered Organisms |
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On October 8, 2008, APHIS published a proposed rule to revise its regulations of genetically engineered organisms. This rule has not been made final, pending the review and consideration of the extensive comments the Agency received.
On April 29-30, 2009, APHIS held an issue-focused public meeting on a proposed rule to revise existing regulations regarding the importation, interstate movement and environmental release of certain genetically engineered organisms in Riverdale, Md. Transcripts of the public meeting will be made part of the rulemaking record.
In order to ensure all transcriptions are available for public consideration, APHIS extended the comment period for the proposed rule until June 29, 2009. The public comment period was reopened on January 16, 2009, after receiving comments from more than 15,000 people on the 45-day comment period that opened on October 9, 2008.
While BRS’ current regulations have been effective in ensuring the safe introduction of GE organisms, the program is considering potential revisions to update its existing regulations in light of advances in science and technology and to reflect APHIS’ experience by incorporating lessons learned. Revising our biotechnology regulations will better position us to address new challenges, as well as meet current needs in evaluating and addressing the plant pest or noxious weed risks associated with the importation, interstate movement, and field release of certain GE organisms. The proposed changes will also improve regulatory processes so they are more transparent to stakeholders and the public, make more efficient use of agency resources, and eliminate unnecessary regulatory burdens.
Federal Register Notices Associated with the Proposed Rule
April 13, 2009 Federal Register Notice on Public Meeting
March 11, 2009 Federal Register Notice on Scoping Meeting and Extension of Public Comment Period
January 16, 2009 Federal Register Notice on the Proposed Biotechnology Regulatory Revisions
November 10, 2008 Correction Notice to the Proposed Biotechnology Regulatory Revisions
October 9, 2008 Federal Register Notice on the Proposed Biotechnology Regulatory Revisions
Press Releases Associated with the Proposed Rule
April 8, 2009 Press Release on Public Meeting
March 6, 2009 Press Release on Scoping Meeting
January 15, 2009 Press Release on the Proposed Biotechnology Regulatory Revisions
October 6, 2008 Press Release on the Proposed Biotechnology Regulatory Revisions
Documents Associated with the Proposed Rule
Transcript and Related Documents from April 29-30, 2009 Public Meeting
Transcript of March 13, 2009 Public Scoping Meeting
Transcript of October 6, 2008 Media Call on the Proposed Regulatory Revisions
Proposed Biotechnology Regulatory Revisions Questions and Answers
Proposed Biotechnology Regulatory Revisions Factsheet
Changes Under Consideration |
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In the proposed rule, some of the changes that APHIS is considering include:
- Aligning the regulations with the plant pest and noxious weed provisions of the Plant Protection Act,
- Discontinuing the notification procedure,
- Adapting the permitting system to address a wide variety of different species and genetic modifications,
- Improving and clarify the petition procedure to approve nonregulated status, and
- Establishing a new petition procedure for APHIS to approve new conditional exemptions from the requirement to obtain a permit.
Public Participation |
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Learn about how the public has participated in the rulemaking process.
The Environmental Analysis Process |
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As part of the regulatory revision process, APHIS is conducting a detailed analysis of the biotechnology regulatory alternatives that APHIS is considering. APHIS is preparing an environmental impact statement (EIS) that evaluates the environmental impacts of the proposed regulatory changes.
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