APHIS Factsheet

Biotechnology Regulatory Services June 2008 

The Biotechnology Quality 

Management System

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. It is essential that applicants 

approved to introduce regulated GE organisms comply 

with all APHIS regulations and permit conditions. To 

improve quality compliance, APHIS is developing a 

voluntary, audit-based compliance assistance program 

known as the Biotechnology Quality Management 

System (BQMS). 

 BQMS will complement, not replace, APHIS’ existing regulatory compliance and inspection process. 

The current permit and notification process will still be 

used to place specific requirements on applicants that 

wish to field test or move regulated GE organisms. 

Permit and notification holders will still be required to 

identify and self-report any potential noncompliance 

incidents. APHIS will also continue to conduct inspections for permits and notifications to ensure 

compliance with regulations. 

 BQMS will help the universities, producers, and 

companies, who introduce regulated GE organisms, to 

analyze their operations, identify control points where 

problems could occur, and apply mitigation measures 

to address those vulnerabilities. BQMS will take a 

proactive approach to compliance and will provide the 

opportunity to head off potential compliance problems 

before they happen.

 APHIS will implement the voluntary BQMS 

through an agency directive, and participation in the 

program will not be a regulatory requirement. Voluntary participation in the BQMS program will enable 

a participant to demonstrate to APHIS and the public 

that it has carefully considered how planning, training, 

managing, and monitoring all activities associated with 

developing regulated GE organisms will be achieved. 

Participants will be able to demonstrate their commitment to meeting the requirements for introducing 

these organisms.

Principles of the BQMS Standard

Recognizing that they must meet the needs of 

differing infrastructures among participants, APHIS 

officials have designed the BQMS to be guided by 

eight principles of quality management. The principles 

of the BQMS standard will ensure that there is a system of accountability as well as a tool for open communication between APHIS and its stakeholders at all 

levels. APHIS is committed to a quality management 

system that will work as an evolving system of management and accountability, as well as a communication tool for all stakeholders to achieve their planned 

results. 

The eight principles of the BQMS standard are: 

Meeting regulatory requirements: Organizations must 

understand APHIS’— as well as other agencies’—

regulatory expectations for transporting and field 

testing regulated GE organisms.

Leadership: Senior management in organizations 

must establish direction, unity of purpose, and a 

supportive work environment to achieve regulatory 

compliance.

Involvement of people: Organizations should 

empower employees at all levels and use their 

employees’ abilities for the organization’s benefit.

Process approach: Organizations must recognize that 

all work is accomplished through processes and 

manage them accordingly.

System approach to management: Expanding on the 

process principle—organizations should understand 

that achieving objectives requires a system of 

interrelated processes.

Continual improvement: Organizations should recognize and act on the understanding that all processes 

can be continually improved.

Factual approach to decisionmaking: Organizations 

should acknowledge that sound decisions must be 

based on the analysis of factual data and information.

Cooperative supplier relationships: Organizations and 

their suppliers (i.e., cooperators and subcontractors) 

should each enhance their ability to meet regulatory 

requirements by developing and maintaining actively 

cooperative relationships with one another.
United States Department of Agriculture • Animal and Plant Health Inspection Service • Safeguarding American Agriculture

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. 

Development and Implementation

BQMS is designed to be compatible with quality 

management guidelines used by the agricultural, biotechnology, and seed industries. The program’s best 

management practices will be prepared in accordance 

with existing examples and guidance developed by 

industry and other Federal agencies, such as the U.S. 

Food and Drug Administration, National Oceanic and 

Atmospheric Administration, and the Environmental 

Protection Agency. 

 As part of the program development process, 

APHIS has created a pilot program to introduce BQMS 

to a range of stakeholders at varying levels. The 

BQMS pilot development project is designed to:

• Evaluate the BQMS standard and guidelines by 

 testing specific elements of the program

• Provide feedback on program strengths and areas 

 in need of improvement

• Provide training on the standard and guidelines to 

 pilot participants

• Track a small number of project participants 

 who will participate in the development and imple- 

 mentation of a BQMS within their organizations

• Provide guidelines for audits to be conducted after 

 organizations have implemented a BQMS