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 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. 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 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.