E8-20285. Solicitation of Letters of Interest To Participate in Biotechnology Quality Management System Pilot Project

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Notice.

SUMMARY:

We are advising the public that the Animal and Plant Health Inspection Service is soliciting letters of interest to participate in a voluntary pilot project for its Biotechnology Quality Management System (BQMS). The BQMS is a voluntary compliance assistance program designed to help stakeholders develop sound management practices, thus enhancing compliance with the regulatory requirements for field trials and movement of genetically engineered organisms in 7 CFR part 340. The Pilot Development Project will test the applicability of a biotechnology quality management audit standard and accompanying guidelines and assist APHIS in further development of BQMS. APHIS' goal for the pilot project is to obtain feedback from participants on the strengths and areas for improvement to the audit standard and guidelines prior to full implementation of the system.

DATES:

Letters of interest will be accepted from September 2, 2008, to October 1, 2008.

FOR FURTHER INFORMATION CONTACT:

Dr. Edward Jhee, Biotechnology Quality Management System Program Manager, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 91, Riverdale, MD 20737-1236; [phone], [e-mail].

SUPPLEMENTARY INFORMATION:

Background

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. It is essential that applicants approved to introduce regulated GE organisms comply with all APHIS regulations and permit conditions. To improve compliance, APHIS is developing a voluntary, audit-based compliance assistance program known as the Biotechnology Quality Management System (BQMS). BQMS will help universities, small businesses, and large companies develop sound management practices to enhance compliance with the regulatory requirements for field trials and movements of GE organisms in 7 CFR part 340.

APHIS is seeking voluntary participants for a BQMS pilot project who will serve as a broad representation of the regulated community. APHIS will select participants who are:

(1) Currently conducting regulated environmental field release and movements under notification or permit, and who

(2) Intend to apply for a renewal or new notification or permit, annually, for the next 3 years.

APHIS will select one applicant from each of the following three categories to participate in the pilot project: One applicant from a large corporate business (greater than 50 employees), 1 applicant from a small business (less than 15 employees), and 1 applicant from an academic institution.

Participants in the BQMS Pilot Development Project will review the BQMS process and provide feedback. Specifically, participants will test the feasibility of the BQMS standards and guidelines by developing and implementing a quality management system for their organization that proactively manages regulated movement and field releases. Participating in the quality management system will demonstrate an organization's commitment to regulatory accountability, increased transparency, and identification and implementation of measures to minimize the occurrence of compliance infractions.

A draft audit standard for the BQMS program and a series of guidelines to assist participants in using this compliance assistance program to proactively comply with APHIS regulations are presently undergoing a technical review with audit industry experts. This review will be completed before the pilot project begins.

Organizations that wish to participate in the BQMS Pilot Development Project should submit a letter of interest (1-2 pages) that includes the following:

(1) A short description of current active notifications and permits; and

(2) A statement of the organization's commitment to:

• Develop and implement a BQMS program within their organization;
• Attend all required training sessions on the development and implementation of a BQMS to be held by APHIS-BRS-Regulatory Operations Programs (ROP);
• Establish methods and procedures for monitoring critical processes and procedures for the movement and field testing of regulated GE agriculture;
• Provide required data and provide feedback to APHIS-BRS-ROP on how to improve the BQMS program standard and guidelines;
• Participate in surveys after completing training modules; and
• Submit to a third-party external verification audit.

APHIS will accept letters of interest through October 1, 2008. APHIS will evaluate letters and notify all applicants of its final selections. You may submit participation letters of interest by mail or e-mail to the person listed under FOR FURTHER INFORMATION CONTACT at the beginning of this notice.

Done in Washington, DC, this 26th day of August 2008.

Kevin Shea,

Acting Administrator, Animal and Plant Health Inspection Service.