United States Department of Agriculture

Animal and Plant Health Inspection Service

Program Aid No. 2056

Biotechnology 

Quality Management 

System Program

Improving the Management 

of Regulated Genetically 

Engineered Organisms
“I cannot imagine the agricultural biotechnology regulatory compliance industry 

without this type of assistance/guidance 

program (BQMS Program); it is the last piece 

of the puzzle.”

- BQMS Pilot Program Participant
ABOUT THE PROGRAM

The U.S. Department of Agriculture’s (USDA) 

Animal and Plant Health Inspection Service (APHIS), 

Biotechnology Quality Management System Program 

(BQMS Program) provides compliance assistance 

to the regulated community for the voluntary adoption of a biotechnology quality management system 

(BQMS). A BQMS serves as an important tool to help 

organizations involved in biotechnology research and 

development analyze the critical control points within 

their management system to better maintain compliance with USDA APHIS regulations for the import, 

interstate movement, and environmental release of 

regulated genetically engineered (GE) organisms. 

As part of the BQMS Program initiative, APHIS 

launched a pilot project to test the applicability of 

the BQMS draft audit standard and guidelines. 

APHIS gathered public feedback to refine the draft 

audit standard and guidelines in preparation for the 

Program’s full implementation.
A Dynamic, Science-Based Approach

A BQMS integrates a science-based approach 

of risk assessment and mitigation, allowing for 

sound decisionmaking and effective management 

of the research and development of regulated GE 

organisms. A BQMS also integrates principles 

from other quality management systems, such as 

the Codex Alimentarius Hazard Analysis Critical 

Control Point System and International Organization for Standardization (ISO) 9001:2008. 

The BQMS Program staff will 

provide one-on-one targeted 

assistance when needed.

“...We are better organized and equipped to 

ensure that internal and external associates 

can perpetuate good practices.”

- BQMS Pilot Program Participant

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Providing Assistance Every Step of the Way

The BQMS Program provides participants with 

the tools and guidance needed to develop a 

BQMS that is tailored to their organization’s 

needs. Specifically, the Program provides: 

• interactive training workshops with 

other BQMS Program participants and 

USDA officials, 

• documented guidelines and templates to aid 

in the development of a BQMS,

• a baseline assessment of current management 

practices in relationship to the BQMS audit 

standard, 

• one-on-one targeted assistance as needed,

• internal audit training, 

• facilitated third-party audits of the 

organization’s BQMS, and 

• acknowledgement of BQMS Program completion.

The BQMS Program staff will work with you to identify 

critical control points during field trials of your GE plants.

BQMS Program Mission

Within USDA, APHIS Biotechnology 

Regulatory Services (BRS) provides 

support for the voluntary adoption of a 

BQMS to improve the management of an 

organization’s domestic research and 

development of regulated GE organisms. 

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Raising the Bar

Although the Program provides support, it places

ownership and responsibility on the participating 

organization to control identified risks to the confinement, containment, and identity of regulated 

GE organisms. This ownership enables researchers to document the effectiveness of their management systems for regulated GE imports, interstate 

movements, and environmental releases. It also 

requires continuous self-monitoring and verification to demonstrate that the system is working 

and to reveal when potential regulatory noncompliance incidents have occurred.

Expect a Difference 

Participants will develop, implement, and maintain a BQMS within their organization to manage 

the movement and field release of regulated GE 

organisms. Specifically, organizations will:

• work to identify critical control points in 

the organization’s processes for working 

with regulated GE organisms, 

• develop or revise standard operating 

procedures that address critical control points,

• properly train personnel on the standard 

operating procedures, 

• undergo a third-party audit to determine 

effectiveness of the organization’s quality 

management system, and

• become an organization recognized as 

completing the BQMS Program.

The BQMS Program will help 

you develop a program to train 

your staff in standard operating procedures for handling 

regulated GE organisms.

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Get Started Today

The BQMS Program is available to interested 

parties in the regulated community who wish 

to validate their approach to APHIS regulatory 

compliance. Participation is limited based on 

available resources. Please visit www.aphis.usda.

gov/biotechnology/news_bqms.shtml for a list of 

tentative training dates. 

To learn more about the BQMS Program and 

how you can participate, go to: www.aphis.usda.

gov/biotechnology/news_bqms.shtml

To contact a BQMS Program representative, 

e-mail us at BRS.BQMS@aphis.usda.gov or 

call us at (301) 734-7324.

The BQMS Program will help you to better understand the 

value of quality management systems in biotechnology by 

bringing good management practices to your organization.

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The U.S. Department of Agriculture (USDA) prohibits discrimination in all its programs and activities on the basis of race, color, 

national origin, age, disability, and where applicable, sex, marital 

status, familial status, parental status, religion, sexual orientation, 

genetic information, political beliefs, reprisal, or because all or 

part of an individual’s income is derived from any public assistance 

program. (Not all prohibited bases apply to all programs.) Persons 

with disabilities who require alternative means for communication 

of program information (Braille, large print, audiotape, etc.) should 

contact USDA’s TARGET Center at (202) 720-2600 (voice and TDD). 

To file a complaint of discrimination, write to USDA, Director, Office 

of Civil Rights, 1400 Independence Avenue, S.W., Washington, D.C. 

20250-9410, or call (800) 795-3272 (voice) or (202) 720-6382 (TDD). 

USDA is an equal opportunity provider and employer.

Issued September 2010