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USDA REOPENS COMMENT PERIOD ON BIOTECHNOLOGY QUALITY MANAGEMENT SYSTEM DRAFT AUDIT STANDARD

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Jim Barrett (301) 734-6405
Suzanne Bond (301) 734-5175

WASHINGTON, Aug. 24, 2009--The U.S. Department of Agriculture's Animal and Plant Health Inspection Service (APHIS) is seeking additional public comment on the draft audit standard developed for the biotechnology quality management system (BQMS) pilot project. Reopening the comment period will allow interested persons additional time to prepare and submit comments.

The BQMS is a voluntary compliance assistance program that aims to help stakeholders manage the regulatory requirements for field trials and interstate movement of certain genetically engineered (GE) organisms. Additional information about the program can be found at http://www.aphis.usda.gov/biotechnology/news_bqms.shtml.

Participants in the BQMS pilot program would use the audit standard to develop and review sound management practices that help enhance compliance with APHIS' biotechnology regulations for environmental releases, importations and interstate movements of regulated articles. The standard is designed to provide a management framework upon which users can base their current regulatory practices.

APHIS is reopening the comment period for an additional 60 days on the draft audit standard used in the BQMS pilot project. Upon conclusion of the BQMS pilot project, APHIS will consider all comments received during the comment period to revise the draft standard to improve the efficacy of this project. This feedback, as well as comments from the participants on the BQMS pilot project, will be used to inform the development of a BQMS audit standard and any future BQMS initiative.

Notice of this action is published in today's Aug. 24 Federal Register.

Consideration will be given to comments received on or before Oct. 23. Send two copies of postal mail or commercial delivery comments to Docket No. APHIS-2008-0098, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. APHIS-2008-0098. If you wish to submit a comment using the Internet go to the Federal eRulemaking portal at http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2008-0098.

Comments are posted on the Regulations.gov Web site and also can be reviewed at USDA, Room 1141, South Building, 14th St. and Independence Ave., S.W., Washington, D.C., between 8 a.m. and 4:30 p.m., Monday through Friday, excluding holidays. To facilitate entry into the comment reading room, please call (202) 690-2817.

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