[Federal Register Volume 75, Number 192 (Tuesday, October 5, 2010)]
[Notices]
[Pages 61413-61414]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-24995]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2008-0098]
Notice of Availability of Biotechnology Quality Management System
Audit Standard and Evaluation of Comments
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service has developed an audit standard for its
biotechnology compliance assistance program. The audit standard, which
was made available in draft form for comment in an earlier notice, will
be used by participating regulated entities to 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. We are also making available a
document containing our evaluation of the comments we received on the
draft audit standard.
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, e-mail:
edward.m.jhee@aphis.usda.gov. To obtain copies of the audit standard or
our evaluation of comments submitted on the draft audit standard,
contact Ms. Cindy Eck at (301) 734-0667, e-mail:
cynthia.a.eck@aphis.usda.gov. Those documents may also be viewed on the
APHIS Web site at the address provided at the end of this document.
SUPPLEMENTARY INFORMATION:
Background
The Animal and Plant Health Inspection Service (APHIS) regulates
the introduction--the importation, interstate movement, and
environmental release--of genetically engineered (GE) organisms that
are, or may be, plant pests. In September 2007, APHIS' Biotechnology
Regulatory Services announced it was developing a voluntary, audit-
based compliance assistance program known as the Biotechnology Quality
Management System Program (BQMS Program) 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.
Under the BQMS Program, APHIS provides support for an entity's
voluntary adoption of a customized biotechnology quality management
system (BQMS) to improve their management of domestic research and
development of regulated GE organisms. The BQMS audit standard provides
criteria for the development, implementation, and objective evaluation
of the entity's BQMS.
On June 4, 2009, APHIS published a notice \1\ in the Federal
Register (74 FR 26831-26832, Docket No. APHIS-2008-0098) announcing the
availability of 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 for an additional 60
days ending October 23, 2009. APHIS solicited comments on the draft
audit standard in general and sought specific input on the following
four questions:
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
1. Do the critical control points in Requirement 7 of the draft
audit standard identify all areas and elements that organizations
should focus on in order to maintain compliance with the regulatory
requirements under 7 CFR part 340?
2. Is the draft audit standard consistent with current best
practices used by the regulated community?
3. Can the public identify incentives USDA might employ to
encourage participation in the voluntary program by commercial industry
as well as academic institutions?
4. The BQMS is designed to be flexible according to the size of the
participating organization. Is this flexibility apparent in the draft
audit standard?
APHIS also received input on the draft audit standard from
organizations
[[Page 61414]]
that participated in a BQMS pilot development project conducted during
2009. Five organizations participated in the pilot development project
and assisted APHIS in evaluating the draft audit standard, program
training sessions, and audit procedures established for the BQMS
Program.
Following the pilot development project and after evaluating the
comments submitted on the BQMS draft audit standard, APHIS made
adjustments to the BQMS audit standard. You may view the public
comments submitted on the draft audit standard, APHIS' evaluation of
the comments received, and the revised BQMS audit standard on the
Regulations.gov Web site (see footnote 1 for a link).
The revised audit standard and the comment evaluation document, as
well as additional information about the BQMS Program, may be found on
the APHIS Web site at http://www.aphis.usda.gov/biotechnology/news_bqms.shtml. Copies of those documents may also be obtained from the
person listed under FOR FURTHER INFORMATION CONTACT.
Done in Washington, DC, this 29th day of September 2010.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2010-24995 Filed 10-4-10; 8:45 am]
BILLING CODE 3410-34-P