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)

Page Range		5523-5524
FR Document		2017-01017

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 Issue 11 (Wednesday, January 18, 2017)

[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]
BILLING CODE 3410-34-P

5524 Federal Register / Vol. 82, No. 11 / Wednesday, January 18, 2017 / Notices

the continual improvement to this required multi-day training, no cost- DEPARTMENT OF AGRICULTURE
voluntary quality management program. prohibitive third-party audits and
FOR FURTHER INFORMATION CONTACT: Ms. associated travel expenses, and no Animal and Plant Health Inspection
Rochelle Langley, Quality Management exhaustive resource commitments. Service
Specialist, Biotechnology Regulatory The new BQMS Program is a flexible, [Docket No. APHIS–2016–0113]
Services, APHIS, 4700 River Road Unit Web-based, modular approach designed
146, Riverdale, MD 20737–1228; 301– to enhance compliance by enabling Notice of Request for Extension of
851–3906, Rochelle.A.Langley@ Approval of an Information Collection;
organizations large and small to develop
aphis.usda.gov. Interstate Movement of Fruit From
sound quality management practices.
SUPPLEMENTARY INFORMATION: The U.S. Hawaii
Users can select any or all critical
Department of Agriculture’s Animal and control points applicable to their AGENCY: Animal and Plant Health
Plant Health Inspection Service organizations’ compliance assistance Inspection Service, USDA.
(APHIS), regulates the importation, needs such as: Site selection planning, ACTION: Extension of approval of an
interstate movement, and environmental procedures for storage, transportation information collection; comment
release of genetically engineered (GE)
(interstate movement and importation), request.
organisms that are, or may be, plant
environmental release planning and
pests. In September 2007, APHIS’ SUMMARY: In accordance with the
monitoring, post-harvest handling and
Biotechnology Regulatory Services Paperwork Reduction Act of 1995, this
(BRS) announced a voluntary, audit- transfer, devitalization and final
notice announces the Animal and Plant
based compliance assistance program disposition, potential regulatory
Health Inspection Service’s intention to
known as the Biotechnology Quality compliance incidents, and a reporting
request an extension of approval of an
Management System (BQMS) Program form for regulatory compliance
information collection associated with
to assist the regulated community in incidents. User costs should decrease the regulations for the interstate
achieving and maintaining compliance with the ability to easily choose only the movement of fruit from Hawaii.
with requirements for field trials and modules they need to meet their unique
DATES: We will consider all comments
movements of GE organisms under its compliance assistance needs. that we receive on or before March 20,
regulations in 7 CFR part 340. The new BQMS Program offers a 2017.
Under the BQMS Program, APHIS– comprehensive repository of user- ADDRESSES: You may submit comments
BRS has provided support for the friendly, Web-based templates, by either of the following methods:
voluntary adoption by participants of a guidelines, and checklists to assist users • Federal eRulemaking Portal: Go to
quality management system to improve in the implementation of processes, http://www.regulations.gov/#!docket
their management of domestic research
procedures, and the foundation for a Detail;D=APHIS-2016-0113.
and development of regulated GE • Postal Mail/Commercial Delivery:
quality management system. No matter
organisms in order to fully comply with Send your comment to Docket No.
regulations. The BQMS Program how big or small their organization,
BQMS users will continue to have the APHIS–2016–0113, Regulatory Analysis
included a mandatory audit standard and Development, PPD, APHIS, Station
that provided extensive criteria for the option of requesting one-on-one tailored
assistance from BRS staff, as in the past. 3A–03.8, 4700 River Road, Unit 118,
development, implementation, and an Riverdale, MD 20737–1238.
objective evaluation of the participant’s Organizations participating in the Supporting documents and any
quality management system. voluntary program will be encouraged comments we receive on this docket
We are notifying the public that BRS to use BQMS resources as a foundation may be viewed at http://www.
is updating its BQMS Program and to ensure all personnel are properly regulations.gov/#!docketDetail;D=
renaming it the Biotechnology Quality trained regarding the requirements for APHIS-2016-0113 or in our reading
Management Support Program, which working with GE organisms; identify room, which is located in room 1141 of
will use the same BQMS acronym, in and develop control measures to the USDA South Building, 14th Street
order to reach a broader audience. After minimize the risk or occurrence of and Independence Avenue SW.,
engaging with current and prospective unauthorized releases; and monitor Washington, DC. Normal reading room
BQMS participants, APHIS–BRS quality management practices and hours are 8 a.m. to 4:30 p.m., Monday
determined a modularized, more
procedures. through Friday, except holidays. To be
flexible, Web-based approach reaches a
These updates are the next step in the sure someone is there to help you,
wider universe of researchers and
continual improvement of the voluntary please call (202) 799–7039 before
developers conducting biotechnology
BQMS Program. coming.
activities. Small organizations,
academics, and first-time users now Done in Washington, DC, this 11th day of
FOR FURTHER INFORMATION CONTACT: For
have access to a program that previously January 2017.
information on the regulations for the
was only within the means of a select interstate movement of fruit from
Kevin Shea,
few with considerable resources. The Hawaii, contact Dr. Robert Baca,
new BQMS Program is no longer audit- Administrator, Animal and Plant Health Assistant Director, Permitting and
Inspection Service. Compliance Coordination, Compliance
based, and no longer requires an ‘‘all or
[FR Doc. 2017–01017 Filed 1–17–17; 8:45 am] and Environmental Coordination
nothing’’ quality management system
that relies on a BRS-developed audit BILLING CODE 3410–34–P Branch, PPQ, APHIS, 4700 River Road,
mstockstill on DSK3G9T082PROD with NOTICES

standard, a required 3-day BRS-led Unit 150, Riverdale, MD 20737; (301)
training session for all participants, and 851–2292. For copies of more detailed
a third-party audit cycle to maintain information on the information
Program recognition. The new BQMS collection, contact Ms. Kimberly Hardy,
Program remains a voluntary APHIS’ Information Collection
compliance assistance program but with Coordinator, at (301) 851–2483.
fewer impediments to users—no SUPPLEMENTARY INFORMATION:

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Document Created: 2018-02-01 15:19:02
Document Modified: 2018-02-01 15:19:02

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
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]
FR Citation		82 FR 5523

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

DEPARTMENT OF AGRICULTUREAnimal and Plant Health Inspection Service

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

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service