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Proposed Rule

Introduction of Organisms and Products Altered or Produced Through Genetic Engineering

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Animal and Plant Health Inspection Service, USDA.


Proposed rule; notice of public scoping session and extension of public comment period.


We are advising the public that the Animal and Plant Health Inspection Service (APHIS) is holding a public scoping session for issue-focused public meeting(s) to be held in April 2009 on the APHIS proposed rule, “Importation, Interstate Movement, and Release Into the Environment of Certain Genetically Engineered Organisms.” The purpose of the scoping session is to discuss with all interested parties the agenda and format for the April 2009 issue meeting(s).


The scoping session will be on March 13, 2009, from 9 a.m. to 4 p.m.


The scoping session will be held at USDA Center at Riverside, 4700 River Road, Riverdale, MD, in Conference Room A. For directions or facilities information, call (301) 734-8010.

Other Information: Additional details regarding the format of the meeting are available at​biotechnology/​340/​340_​index.shtml.

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If you plan to attend the scoping session, please contact Mr. Richard Coker, BRS, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1238; (301) 734-5720.

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On October 9, 2008, APHIS published in the Federal Register (73 FR 60007-60048, Docket No. APHIS-2008-0023) a proposal [1] to revise our regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered (GE) organisms. The proposed revisions would bring the regulations into alignment with provisions of the Plant Protection Act (7 U.S.C. 7701 et seq.) and update the regulations in response to advances in genetic science and technology and our accumulated experience in implementing the current regulations. APHIS sought public comment on the proposal from October 9, 2008, to November 24, 2008.

On January 16, 2009, APHIS published in the Federal Register (74 FR 2907-2909, Docket No. APHIS-2008-0023) a notice announcing the reopening of the public comment period for the proposed rule for an additional 60 days, particularly seeking additional comments on the following four issues:

Issue 1: Scope of the regulation and which GE organisms should be regulated.

Issue 2: Incorporation into APHIS regulations of the Plant Protection Act's noxious weed authority.

Issue 3: Elimination of notification procedure and revision of the permit procedure.

Issue 4: Environmental release permit categories and regulation of GE crops that produce pharmaceutical and industrial compounds.

All four issues were among those that have been raised in the comments we have received so far on the proposed rule. In some cases commenters identified concerns about these issues, but did not provide specific suggestions as to how the proposed rule could be modified to address these concerns. By extending the comment period, APHIS is seeking to increase the transparency of the rulemaking process and elicit more specific information and detailed suggestions regarding these issues. We noted in the January 2009 notice reopening the comment period that APHIS intends to hold an additional public meeting on the proposed rule during the extended public comment period. We intend to hold additional public meeting(s) in the greater Washington, DC area in April 2009; to ensure that we identify the full range of topics for the April meeting's agenda, we will be holding a scoping session on March 13, 2009.

The March 13, 2009 scoping session will begin with a discussion of the topics to be included on the agenda for the April 2009 meeting(s). In a previous notice published in the Federal Register (74 FR 2907-2909, Docket No. APHIS-2008-0023) APHIS outlined four issues on which the Agency is seeking comment. Those four issues will be included in the agenda for the April 2009 meeting(s), along with other significant issues deemed appropriate by APHIS based on recommendations made by interested parties at the scoping session. The meeting participants at the March 13 meeting will also be asked to offer recommendations regarding collaborative meeting formats that would best ensure agenda issues will be frankly and fully explored in the April 2009 meeting(s).

Those wishing to attend the March 13 scoping meeting should contact Mr. Richard Coker at (301) 734-5720. Also contact Mr. Coker if you require a sign language interpreter or other special accommodations. Those unable to attend the scoping session may submit comments or suggestions for the April issue meeting(s) to APHIS at the address listed under FOR FURTHER INFORMATION CONTACT no later than March 20, 2009.

Parking and Security Procedures

Please note that a fee of $3.00 in exact change is required to enter the parking lot at the USDA Center at Riverside. The machine accepts $1 bills or quarters.

Upon entering the building, visitors should inform security personnel that they are attending the 340 Proposed Rule public meeting. State-issued photo identification is required and all bags will be screened. Security personnel will direct visitors to the registration tables located outside of Conference Room A on the first floor. Registration upon arrival is required for all participants.

Purpose and Nature of the April 2009 Issue Meeting(s)

The April 2009 issue meeting(s) will provide an opportunity for interested persons to discuss in a collaborative forum the key concerns that were raised during the comment period on the Start Printed Page 10518proposed rule with USDA officials and with one another. The issue-focused meeting(s) will be open to the public and announced in advance in the Federal Register. The proceedings will be transcribed, and the transcripts will be made part of the rulemaking record. The meeting(s) is intended to provide a forum for all interested parties to attend and participate in all the discussions to foster focused, substantive dialogue on the key issues.

Tentatively identified agenda items for consideration at the April issue meeting(s) include the four issues outlined above from the January 16, 2009 Federal Register notice.

Extension of Comment Period

APHIS is extending the comment period for the proposed rule, which currently closes on March 17, 2009, until 60 days following the April meeting(s) in order to include in the administrative record the transcripts of the scoping session and public meeting(s), written comments submitted by persons unable to attend the meeting(s), and other written comments submitted by interested parties on the matters addressed at the public meeting(s). Persons wishing to submit written comments on the proposed rule may continue to do so until 60 days after the April public meeting(s) through the Web site (see footnote 1). The new date for the close of the comment period will be provided in our notice announcing the date and other details of the April 2009 issue meeting(s). We will accept all comments we receive between March 18, 2009 (the day after the close of the current comment period) and the date of the notice that we will publish to announce the date(s) of April 2009 issue meeting(s) and formally reopen the comment period.

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Done in Washington, DC, this 9th day of March 2009.

Kevin Shea,

Acting Administrator, Animal and Plant Health Inspection Service.

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1.  To view the proposed rule, supporting documents, and any comments we have received, and to submit written comments on the proposed rule, go to​fdmspublic/​component/​main?​main=​DocketDetail&​d=​APHIS-2008-0023.

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[FR Doc. E9-5372 Filed 3-9-09; 4:15 pm]