[Federal Register Volume 74, Number 106 (Thursday, June 4, 2009)]
[Notices]
[Pages 26831-26832]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-13053]


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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 
Pilot Project Draft Audit Standard

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 seeking comments on the draft audit standard 
developed for its Biotechnology Quality Management System pilot 
project. The Biotechnology Quality Management System is a voluntary 
compliance assistance program designed to help regulated entities 
develop sound management practices, thus enhancing compliance with the 
regulatory requirements for environmental releases and movements of 
regulated articles in accordance with 7 CFR part 340.

DATES: We will consider all comments we receive on or before August 3, 
2009.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2008-0098 to submit or view comments and 
to view supporting and related materials available electronically.
     Postal Mail/Commercial Delivery: Please send two copies of 
your comment to Docket No. APHIS-2008-0098,

[[Page 26832]]

Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 
River Road Unit 118, Riverdale, MD 20737-1238. Please state that your 
comment refers to Docket No. APHIS-2008-0098.
    Reading Room: You may read any comments that we receive on this 
docket in our reading room. The reading room is located in room 1141 of 
the USDA South Building, 14th Street and Independence Avenue SW., 
Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., 
Monday through Friday, except holidays. To be sure someone is there to 
help you, please call (202) 690-2817 before coming.
    Other Information: Additional information about APHIS and its 
programs is available on the Internet at http://www.aphis.usda.gov.

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]. To obtain copies of the draft audit 
standard, contact Ms. Cindy Eck at (301) 734-0667, e-mail: 
[email protected]. The draft audit standard is also 
available on the Internet at http://www.aphis.usda.gov/biotechnology/news_bqms.shtml.

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. 
Such GE organisms and products are considered ``regulated articles.'' 
Applicants that are issued permits or received acknowledgment of 
notifications to introduce GE organisms are required to comply with all 
APHIS regulations.
    To enhance improvements in compliance, APHIS initiated development 
of a voluntary, audit-based compliance assistance program known as the 
Biotechnology Quality Management System (BQMS). On September 20, 2007, 
APHIS issued a press release announcing plans to establish a BQMS Pilot 
Development Project.
    APHIS selected five volunteer participants for the pilot program 
after soliciting letters of interest through a notice published in the 
Federal Register on September 2, 2008 (73 FR 51266-51267, Docket No. 
APHIS-2008-0098). The main component of the BQMS pilot project is the 
draft audit standard, which provides criteria used for the objective 
evaluation of quality management systems to determine if a system will 
be certified as an APHIS Biotechnology Quality Management System during 
the audit portion of the pilot program. The regulatory requirements of 
7 CFR part 340 for performance standards and permit conditions are the 
foundation for the draft audit standard.
    The draft audit standard is used by pilot participants to develop 
sound management practices to enhance compliance with the regulatory 
requirements of 7 CFR part 340 for environmental releases, 
importations, and interstate movements of regulated articles. 
Participants have applied the draft audit standard to their 
organization's regulated biotechnology program to plan, implement, 
document, and examine the efficacy of quality assurance and quality 
control measures related to introductions of regulated articles.
    APHIS is soliciting comments for a period of 60 days on the draft 
audit standard currently used in the BQMS pilot project. Within the 
draft audit standard, Requirement 7 specifies that participants address 
critical control points for the introduction of regulated articles by 
developing containment procedures for regulated articles; developing 
measures for the identification of regulated articles in storage, being 
moved, imported, or transferred, and in field locations; developing 
procedures for planning and monitoring environmental releases of 
regulated articles; developing methods for post-harvest handling 
activities and methods to maintain the identity of regulated material; 
developing procedures for the devitalization and disposition of 
regulated articles; as well as developing procedures for the submission 
of regulatory compliance incidents to the appropriate regulatory 
authorities. APHIS is soliciting comments on the draft audit standard 
as a whole, and Requirement 7 in particular.
    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?
    Upon conclusion of the BQMS pilot project, APHIS will consider all 
comments received during the comment period to revise the draft audit 
standard to improve the efficacy of this project. This feedback, as 
well as comments from the participants on the pilot BQMS project, will 
be used to inform the development of a BQMS audit standard and any 
future BQMS initiative. The BQMS draft audit standard is available for 
public review as indicated under the ADDRESSES and FOR FURTHER 
INFORMATION CONTACT sections of this notice.

    Done in Washington, DC, this 29th day of May 2009.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E9-13053 Filed 6-3-09; 8:45 am]
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