[Federal Register Volume 75, Number 137 (Monday, July 19, 2010)]
[Pages 41798-41799]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-17526]



Animal and Plant Health Inspection Service

[Docket No. APHIS-2008-0098]

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 

[[Page 41799]]

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; (301) 734-6356, 



    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.

    \1\ All notices mentioned in this docket, as well as comments 
received and supporting and related materials, can be viewed at 

    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 
    Participants in the BQMS Program will be expected to commit to the 
     Attend required APHIS training sessions on the BQMS 
     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.
[FR Doc. 2010-17526 Filed 7-16-10: 12:33 pm]