[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]


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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.

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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:
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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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    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]
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