2010-17526. Solicitation of Letters of Interest to Participate in Biotechnology Quality Management System Program

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Notice.

SUMMARY:

We are advising the public that the Animal and Plant Health Inspection Service (APHIS) is soliciting letters of interest to participate in the APHIS Biotechnology Quality Management System Program. The Biotechnology Quality Management System Program is a voluntary compliance assistance program designed to help regulated entities develop and implement sound management practices, thus enhancing compliance with the regulatory requirements for field trials and movement of genetically engineered organisms in 7 CFR part 340.

DATES:

Letters of interest may be submitted at any time.

FOR FURTHER INFORMATION CONTACT:

Dr. Edward Jhee, Chief, Compliance Assistance Branch, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 91, Riverdale, MD 20737-1236; [phone], ([e-mail]).

SUPPLEMENTARY INFORMATION:

Background

APHIS regulates the introduction—the importation, interstate movement, and environmental release—of genetically engineered (GE) organisms that are, or may be, plant pests. It is essential that applicants approved to introduce regulated GE organisms comply with all APHIS regulations and permit conditions. To assist regulated entities in achieving and maintaining compliance with the regulatory requirements for field trials and movements of GE organisms in 7 CFR part 340, APHIS has developed a voluntary, audit-based compliance assistance program known as the Biotechnology Quality Management System Program (BQMS Program). The BQMS Program is designed to assist all regulated entities—to include universities, small businesses, and large companies—develop sound management practices through the creation and implementation of a customized biotechnology quality management system (BQMS).

APHIS conducted a BQMS Program pilot development project in 2009, during which five entities participated and assisted APHIS in evaluating a BQMS draft audit standard, program training sessions, and audit procedures. APHIS selected the volunteer participants for the pilot program after soliciting letters of interest through a notice^[1] published in the Federal Register on September 2, 2008 (73 FR 51266-51267, Docket No. APHIS-2008-0098). In addition, APHIS published a notice in the Federal Register (74 FR 26831-26832, Docket No. APHIS-2008-0098) on June 4, 2009, soliciting comments from the public on the BQMS draft audit standard. Comments on the BQMS draft audit standard were to have been received on or before August 3, 2009. APHIS subsequently published a notice in the Federal Register on August 24, 2009 (74 FR 42644, Docket No. APHIS-2008-0098), reopening the comment period on the draft audit standard until October 23, 2009.

Following the pilot development project and after evaluating the comments submitted on the BQMS draft audit standard, APHIS made adjustments to the BQMS Program and to the BQMS audit standard. APHIS will soon publish a notice in the Federal Register announcing the availability of our evaluation of the comments received and the availability of a revised BQMS audit standard.

APHIS is now soliciting letters of interest from regulated entities interested in participating in the BQMS Program and the requisite training sessions. APHIS anticipates scheduling two training sessions during the remainder of calendar year 2010, most likely during summer and fall, and two training sessions in 2011, most likely in spring and fall. Regulated entities interested in participating should indicate their preference for the scheduling of a training session. Exact training session dates will be determined following discussions with interested entities. Each training session will be limited to five or six entities with approximately two or three representatives from each entity.

Participants in the BQMS Program will be expected to commit to the following:

• Attend required APHIS training sessions on the BQMS Program;
• Develop and implement a BQMS within their organization;
• Establish methods and procedures for monitoring critical processes and procedures for the movement and field testing of regulated GE organisms;
• Participate in evaluations after completing training modules; and
• Submit to a third-party verification audit in order to receive full Program recognition.

Participating in the BQMS Program will provide regulated entities with concrete, practical compliance assistance and will afford participants an opportunity to demonstrate their commitment to regulatory accountability, increased transparency, and the identification and implementation of measures to minimize the occurrence of compliance infractions.

APHIS is interested in advancing the BQMS Program in the next few months and encourages interested entities to submit letters of interest as soon as possible. APHIS will, however, accept letters of interest at any time. Interested entities may submit letters of interest by mail or e-mail to the person listed under FOR FURTHER INFORMATION CONTACT. APHIS will promptly contact all regulated entities that submit letters of interest to discuss their participation in the BQMS Program and requisite training sessions. A list of future training dates will be posted on the APHIS Web site at (http://www.aphis.usda.gov/​biotechnology/​news_​bqms.shtml).

Done in Washington, DC, this 13^th day of July 2010.

Kevin Shea

Acting Administrator, Animal and Plant Health Inspection Service.

Footnotes

1.  All notices mentioned in this docket, as well as comments received and supporting and related materials, can be viewed at (http://www.regulations.gov/​fdmspublic/​component/​main?​main=​DocketDetail&​d=​APHIS-2008-0098).