[Federal Register: July 19, 2010 (Volume 75, Number 137)]
[Notices]
[Page 41798-41799]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19jy10-27]
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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 Program
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 (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
[[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,
(edward.m.jhee@aphis.usda.gov).
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.
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\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).
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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.
[FR Doc. 2010-17526 Filed 7-16-10: 12:33 pm]
BILLING CODE: 3410-34-S