82 FR 5523 - Updates to the Biotechnology Regulatory Services BQMS Program

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 82, Issue 11 (January 18, 2017)

We are advising the public that Biotechnology Regulatory Services of the Animal and Plant Health Inspection Service (APHIS) is updating its Biotechnology Quality Management System Program and renaming it the Biotechnology Quality Management Support Program to offer a more flexible, more customizable, and less costly program that is easily accessible to a wider universe of researchers and developers conducting biotechnology activities under APHIS' regulations. These updates represent the next step in the continual improvement to this voluntary quality management program.

[Federal Register Volume 82, Number 11 (Wednesday, January 18, 2017)]
[Notices]
[Pages 5523-5524]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-01017]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2016-0079]


Updates to the Biotechnology Regulatory Services BQMS Program

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public that Biotechnology Regulatory 
Services of the Animal and Plant Health Inspection Service (APHIS) is 
updating its Biotechnology Quality Management System Program and 
renaming it the Biotechnology Quality Management Support Program to 
offer a more flexible, more customizable, and less costly program that 
is easily accessible to a wider universe of researchers and developers 
conducting biotechnology activities under APHIS' regulations. These 
updates represent the next step in

[[Page 5524]]

the continual improvement to this voluntary quality management program.

FOR FURTHER INFORMATION CONTACT: Ms. Rochelle Langley, Quality 
Management Specialist, Biotechnology Regulatory Services, APHIS, 4700 
River Road Unit 146, Riverdale, MD 20737-1228; 301-851-3906, 
[email protected].

SUPPLEMENTARY INFORMATION: The U.S. Department of Agriculture's Animal 
and Plant Health Inspection Service (APHIS), regulates 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 (BRS) 
announced a voluntary, audit-based compliance assistance program known 
as the Biotechnology Quality Management System (BQMS) Program to assist 
the regulated community in achieving and maintaining compliance with 
requirements for field trials and movements of GE organisms under its 
regulations in 7 CFR part 340.
    Under the BQMS Program, APHIS-BRS has provided support for the 
voluntary adoption by participants of a quality management system to 
improve their management of domestic research and development of 
regulated GE organisms in order to fully comply with regulations. The 
BQMS Program included a mandatory audit standard that provided 
extensive criteria for the development, implementation, and an 
objective evaluation of the participant's quality management system.
    We are notifying the public that BRS is updating its BQMS Program 
and renaming it the Biotechnology Quality Management Support Program, 
which will use the same BQMS acronym, in order to reach a broader 
audience. After engaging with current and prospective BQMS 
participants, APHIS-BRS determined a modularized, more flexible, Web-
based approach reaches a wider universe of researchers and developers 
conducting biotechnology activities. Small organizations, academics, 
and first-time users now have access to a program that previously was 
only within the means of a select few with considerable resources. The 
new BQMS Program is no longer audit-based, and no longer requires an 
``all or nothing'' quality management system that relies on a BRS-
developed audit standard, a required 3-day BRS-led training session for 
all participants, and a third-party audit cycle to maintain Program 
recognition. The new BQMS Program remains a voluntary compliance 
assistance program but with fewer impediments to users--no required 
multi-day training, no cost-prohibitive third-party audits and 
associated travel expenses, and no exhaustive resource commitments.
    The new BQMS Program is a flexible, Web-based, modular approach 
designed to enhance compliance by enabling organizations large and 
small to develop sound quality management practices. Users can select 
any or all critical control points applicable to their organizations' 
compliance assistance needs such as: Site selection planning, 
procedures for storage, transportation (interstate movement and 
importation), environmental release planning and monitoring, post-
harvest handling and transfer, devitalization and final disposition, 
potential regulatory compliance incidents, and a reporting form for 
regulatory compliance incidents. User costs should decrease with the 
ability to easily choose only the modules they need to meet their 
unique compliance assistance needs.
    The new BQMS Program offers a comprehensive repository of user-
friendly, Web-based templates, guidelines, and checklists to assist 
users in the implementation of processes, procedures, and the 
foundation for a quality management system. No matter how big or small 
their organization, BQMS users will continue to have the option of 
requesting one-on-one tailored assistance from BRS staff, as in the 
past.
    Organizations participating in the voluntary program will be 
encouraged to use BQMS resources as a foundation to ensure all 
personnel are properly trained regarding the requirements for working 
with GE organisms; identify and develop control measures to minimize 
the risk or occurrence of unauthorized releases; and monitor quality 
management practices and procedures.
    These updates are the next step in the continual improvement of the 
voluntary BQMS Program.

    Done in Washington, DC, this 11th day of January 2017.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2017-01017 Filed 1-17-17; 8:45 am]
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