Public Meeting on Proposed Rule for Biotechnology Regulations

Public Meeting on Proposed Rule for Biotechnology Regulations

Proposed Revisions to APHIS Regulation of Genetically Engineered Organisms

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

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 Previously Under Consideration

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.

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.
Meeting Issue Papers

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