[Federal Register Volume 73, Number 170 (Tuesday, September 2, 2008)]
[Notices]
[Pages 51266-51267]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-20285]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2008-0098]


Solicitation of Letters of Interest To Participate in 
Biotechnology Quality Management System Pilot Project

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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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; (301) 734-
6356, [email protected].

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

[[Page 51267]]

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.
[FR Doc. E8-20285 Filed 8-29-08; 8:45 am]
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