Updates to the Biotechnology Regulatory Services BQMS Program, 5523-5524 [2017-01017]
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Federal Register / Vol. 82, No. 11 / Wednesday, January 18, 2017 / Notices
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/#!docket
Detail;D=APHIS-2016-0070.
• Postal Mail/Commercial Delivery:
Send your comment to Docket No.
APHIS–2016–0070, Regulatory Analysis
and Development, PPD, APHIS, Station
3A–03.8, 4700 River Road, Unit 118,
Riverdale, MD 20737–1238.
Supporting documents and any
comments we receive on this docket
may be viewed at https://www.
regulations.gov/#!docketDetail;D=
APHIS-2016-0070 or in our reading
room, which is located in room 1141 of
the USDA South Building, 14th Street
and Independence Avenue SW.,
Washington, DC. Normal reading room
hours are 8 a.m. to 4:30 p.m., Monday
through Friday, except holidays. To be
sure someone is there to help you,
please call (202) 7997039 before coming.
FOR FURTHER INFORMATION CONTACT: Dr.
Donna Malloy, Operational Support
Section, Center for Veterinary Biologics,
Policy, Evaluation, and Licensing, VS,
APHIS, 4700 River Road, Unit 148,
Riverdale, MD 20737–1231; phone (301)
851–3426, fax (301) 734–4314.
For information regarding the
environmental assessment or the risk
analysis, or to request a copy of the
environmental assessment (as well as
the risk analysis with confidential
business information redacted), contact
Dr. Patricia L. Foley, Risk Manager,
Center for Veterinary Biologics, Policy,
Evaluation, and Licensing, VS, APHIS,
1920 Dayton Avenue, P.O. Box 844,
Ames, IA 50010; phone (515) 337–6100,
fax (515) 337–6120.
SUPPLEMENTARY INFORMATION: Under the
Virus-Serum-Toxin Act (21 U.S.C. 151
et seq.), the Animal and Plant Health
Inspection Service (APHIS) is
authorized to promulgate regulations
designed to ensure that veterinary
biological products are pure, safe,
potent, and efficacious before a
veterinary biological product license
may be issued. Veterinary biological
products include viruses, serums,
toxins, and analogous products of
natural or synthetic origin, such as
vaccines, antitoxins, or the immunizing
components of microorganisms
intended for the diagnosis, treatment, or
prevention of diseases in domestic
animals.
APHIS issues licenses to qualified
establishments that produce veterinary
biological products and issues permits
to importers of such products. APHIS
also enforces requirements concerning
production, packaging, labeling, and
shipping of these products and sets
standards for the testing of these
products. Regulations concerning
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veterinary biological products are
contained in 9 CFR parts 101 to 124.
A field test is generally necessary to
satisfy prelicensing requirements for
veterinary biological products. Prior to
conducting a field test on an unlicensed
product, an applicant must obtain
approval from APHIS, as well as obtain
APHIS’ authorization to ship the
product for field testing.
To determine whether to authorize
shipment and grant approval for the
field testing of the unlicensed product
referenced in this notice, APHIS
considers the potential effects of this
product on the safety of animals, public
health, and the environment. Based
upon a risk analysis and other relevant
data, APHIS has prepared an
environmental assessment (EA)
concerning the field testing of the
following unlicensed veterinary
biological product:
Requester: Biomune Company.
Product: Bursal Disease-Marek’s
Disease-Newcastle Disease Vaccine,
Serotype 3, Live Marek’s Disease Vector.
Possible Field Test Locations:
Alabama, Delaware, Georgia, Maryland,
North Carolina, Pennsylvania, and
Virginia.
The above-mentioned product is a
live Marek’s Disease serotype 3 vaccine
virus containing a gene from the
Newcastle disease virus and a gene from
the infectious bursal disease virus. This
vaccine would be the recombinant
fraction used in combination with a
conventional live Marek’s disease
vaccine virus, either a serotype 1 or
serotype 2 strain, during the field safety
tests. The attenuated vaccine is
intended for use in healthy 18-day-old
or older embryonated eggs or day-old
chickens, as an aid in the prevention of
infectious bursal disease, Marek’s
disease, and Newcastle disease.
The EA has been prepared in
accordance with: (1) The National
Environmental Policy Act of 1969
(NEPA), as amended (42 U.S.C. 4321 et
seq.), (2) regulations of the Council on
Environmental Quality for
implementing the procedural provisions
of NEPA (40 CFR parts 1500–1508), (3)
USDA regulations implementing NEPA
(7 CFR part 1b), and (4) APHIS’ NEPA
Implementing Procedures (7 CFR part
372).
We are publishing this notice to
inform the public that we will accept
written comments regarding the EA
from interested or affected persons for a
period of 30 days from the date of this
notice. Unless substantial issues with
adverse environmental impacts are
raised in response to this notice, APHIS
intends to issue a finding of no
significant impact (FONSI) based on the
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Sfmt 4703
5523
EA and authorize shipment of the above
product and the two products with a
conventional live Marek’s disease
vaccine virus, either a serotype 1 or
serotype 2 strain, that incorporate it as
a recombinant fraction, for the initiation
of field tests following the close of the
comment period for this notice.
Because the issues raised by field
testing and by issuance of a license are
identical, APHIS has concluded that the
EA that is generated for field testing
would also be applicable to the
proposed licensing action. Provided that
the field test data support the
conclusions of the original EA and the
issuance of a FONSI, APHIS does not
intend to issue a separate EA and FONSI
to support the issuance of the associated
product licenses, and would determine
that an environmental impact statement
need not be prepared. APHIS intends to
issue a veterinary biological product
license for this vaccine and the two
associated products containing it
following satisfactory completion of the
field test, provided no adverse impacts
on the human environment are
identified and provided the product
meets all other requirements for
licensing.
Authority: 21 U.S.C. 151–159.
Done in Washington, DC, this 11th day of
January 2017.
Kevin Shea,
Administrator, Animal and Plant Health
Inspection Service.
[FR Doc. 2017–01010 Filed 1–17–17; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2016–0079]
Updates to the Biotechnology
Regulatory Services BQMS Program
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
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
SUMMARY:
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18JAN1
mstockstill on DSK3G9T082PROD with NOTICES
5524
Federal Register / Vol. 82, No. 11 / Wednesday, January 18, 2017 / Notices
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, Rochelle.A.Langley@
aphis.usda.gov.
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, auditbased 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 auditbased, 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
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17:41 Jan 17, 2017
Jkt 241001
required multi-day training, no costprohibitive 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 userfriendly, 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
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2016–0113]
Notice of Request for Extension of
Approval of an Information Collection;
Interstate Movement of Fruit From
Hawaii
Animal and Plant Health
Inspection Service, USDA.
ACTION: Extension of approval of an
information collection; comment
request.
AGENCY:
In accordance with the
Paperwork Reduction Act of 1995, this
notice announces the Animal and Plant
Health Inspection Service’s intention to
request an extension of approval of an
information collection associated with
the regulations for the interstate
movement of fruit from Hawaii.
DATES: We will consider all comments
that we receive on or before March 20,
2017.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/#!docket
Detail;D=APHIS-2016-0113.
• Postal Mail/Commercial Delivery:
Send your comment to Docket No.
APHIS–2016–0113, Regulatory Analysis
and Development, PPD, APHIS, Station
3A–03.8, 4700 River Road, Unit 118,
Riverdale, MD 20737–1238.
Supporting documents and any
comments we receive on this docket
may be viewed at https://www.
regulations.gov/#!docketDetail;D=
APHIS-2016-0113 or in our reading
room, which is located in room 1141 of
the USDA South Building, 14th Street
and Independence Avenue SW.,
Washington, DC. Normal reading room
hours are 8 a.m. to 4:30 p.m., Monday
through Friday, except holidays. To be
sure someone is there to help you,
please call (202) 799–7039 before
coming.
SUMMARY:
For
information on the regulations for the
interstate movement of fruit from
Hawaii, contact Dr. Robert Baca,
Assistant Director, Permitting and
Compliance Coordination, Compliance
and Environmental Coordination
Branch, PPQ, APHIS, 4700 River Road,
Unit 150, Riverdale, MD 20737; (301)
851–2292. For copies of more detailed
information on the information
collection, contact Ms. Kimberly Hardy,
APHIS’ Information Collection
Coordinator, at (301) 851–2483.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\18JAN1.SGM
18JAN1
]]>Agencies
[Federal Register Volume 82, Number 11 (Wednesday, January 18, 2017)]
[Notices]
[Pages 5523-5524]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-01017]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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,
Rochelle.A.Langley@aphis.usda.gov.
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
