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Notice of Availability of Biotechnology Quality Management System Pilot Project Draft Audit Standard

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Information about this document as published in the Federal Register.

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Animal and Plant Health Inspection Service, USDA.




We are advising the public that the Animal and Plant Health Inspection Service is seeking comments on the draft audit standard developed for its Biotechnology Quality Management System pilot project. The Biotechnology Quality Management System is a voluntary compliance assistance program designed to help regulated entities develop sound management practices, thus enhancing compliance with the regulatory requirements for environmental releases and movements of regulated articles in accordance with 7 CFR part 340.


We will consider all comments we receive on or before August 3, 2009.


You may submit comments by either of the following methods:

  • Federal eRulemaking Portal: Go to​fdmspublic/​component/​main?​main=​DocketDetail&​d=​APHIS-2008-0098 to submit or view comments and to view supporting and related materials available electronically.
  • Postal Mail/Commercial Delivery: Please send two copies of your comment to Docket No. APHIS-2008-0098, Start Printed Page 26832Regulatory 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.

Reading Room: You may read any comments that we receive on this docket in our reading room. The reading room is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 690-2817 before coming.

Other Information: Additional information about APHIS and its programs is available on the Internet at

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Dr. Edward Jhee, Biotechnology Quality Management System Program Manager, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 91, Riverdale, MD 20737-1236; (301) 734-6356, To obtain copies of the draft audit standard, contact Ms. Cindy Eck at (301) 734-0667, e-mail: The draft audit standard is also available on the Internet at​biotechnology/​news_​bqms.shtml.

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The U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) regulates the introduction—meaning the importation, interstate movement, and environmental release—of genetically engineered (GE) organisms that are, or may be, plant pests. Such GE organisms and products are considered “regulated articles.” Applicants that are issued permits or received acknowledgment of notifications to introduce GE organisms are required to comply with all APHIS regulations.

To enhance improvements in compliance, APHIS initiated development of a voluntary, audit-based compliance assistance program known as the Biotechnology Quality Management System (BQMS). On September 20, 2007, APHIS issued a press release announcing plans to establish a BQMS Pilot Development Project.

APHIS selected five volunteer participants for the pilot program after soliciting letters of interest through a notice published in the Federal Register on September 2, 2008 (73 FR 51266-51267, Docket No. APHIS-2008-0098). The main component of the BQMS pilot project is the draft audit standard, which provides criteria used for the objective evaluation of quality management systems to determine if a system will be certified as an APHIS Biotechnology Quality Management System during the audit portion of the pilot program. The regulatory requirements of 7 CFR part 340 for performance standards and permit conditions are the foundation for the draft audit standard.

The draft audit standard is used by pilot participants to develop sound management practices to enhance compliance with the regulatory requirements of 7 CFR part 340 for environmental releases, importations, and interstate movements of regulated articles. Participants have applied the draft audit standard to their organization's regulated biotechnology program to plan, implement, document, and examine the efficacy of quality assurance and quality control measures related to introductions of regulated articles.

APHIS is soliciting comments for a period of 60 days on the draft audit standard currently used in the BQMS pilot project. Within the draft audit standard, Requirement 7 specifies that participants address critical control points for the introduction of regulated articles by developing containment procedures for regulated articles; developing measures for the identification of regulated articles in storage, being moved, imported, or transferred, and in field locations; developing procedures for planning and monitoring environmental releases of regulated articles; developing methods for post-harvest handling activities and methods to maintain the identity of regulated material; developing procedures for the devitalization and disposition of regulated articles; as well as developing procedures for the submission of regulatory compliance incidents to the appropriate regulatory authorities. APHIS is soliciting comments on the draft audit standard as a whole, and Requirement 7 in particular.

1. Do the critical control points in Requirement 7 of the draft audit standard identify all areas and elements that organizations should focus on in order to maintain compliance with the regulatory requirements under 7 CFR part 340?

2. Is the draft audit standard consistent with current best practices used by the regulated community?

3. Can the public identify incentives USDA might employ to encourage participation in the voluntary program by commercial industry as well as academic institutions?

4. The BQMS is designed to be flexible according to the size of the participating organization. Is this flexibility apparent in the draft audit standard?

Upon conclusion of the BQMS pilot project, APHIS will consider all comments received during the comment period to revise the draft audit standard to improve the efficacy of this project. This feedback, as well as comments from the participants on the pilot BQMS project, will be used to inform the development of a BQMS audit standard and any future BQMS initiative. The BQMS draft audit standard is available for public review as indicated under the ADDRESSES and FOR FURTHER INFORMATION CONTACT sections of this notice.

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Done in Washington, DC, this 29th day of May 2009.

Kevin Shea,

Acting Administrator, Animal and Plant Health Inspection Service.

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[FR Doc. E9-13053 Filed 6-3-09; 8:45 am]