Federal Register, Volume 74, Number 41, March 4, 2009, Pages 9343-9564 Page: 9,419
vii, 9564, ii p. ; 28 cm.View a full description of this periodical.
Extracted Text
The following text was automatically extracted from the image on this page using optical character recognition software:
Federal Register/Vol. 74, No. 41/Wednesday, March 4, 2009 / Notices
safeguards that should be implemented.
The NIH Guidelines will never be
complete or final since all conceivable
experiments involving recombinant
DNA cannot be foreseen. Therefore, it is
the responsibility of the institution and
those associated with it to adhere to the
intent of the NIH Guidelines as well as
to their specifics. Each institution (and
the Institutional Biosafety Committee
acting on its behalf) is responsible for
ensuring that all recombinant DNA
research conducted at or sponsored by
that institution is conducted in
compliance with the NIH Guidelines.
General recognition of institutional
authority and responsibility properly
establishes accountability for safe
conduct of the research at the local
level. The following roles and
responsibilities constitute an
administrative framework in which
safety is an essential and integral part of
research involving recombinant DNA
molecules. Further clarifications and
interpretations of roles and
responsibilities will be issued by NIH as
necessary."
Section IV-A is proposed to be
amended to read: "The safe conduct of
experiments involving recombinant
DNA depends on the individual
conducting such activities. The NIH
Guidelines cannot anticipate every
possible situation. Motivation and good
judgment are the key essentials to
protection of health and the
environment. The NIH Guidelines are
intended to assist the institution,
Institutional Biosafety Committee,
Biological Safety Officer, and the
Principal Investigator in determining
safeguards that should be implemented.
The NIH Guidelines will never be
complete or final since all experiments
involving recombinant and/or synthetic
nucleic acids cannot be foreseen. The
utilization of new genetic manipulation
techniques may enable work previously
done by recombinant means to be
accomplished faster, more efficiently or
at larger scale. These techniques have
not yet yielded organisms that present
safety concerns that fall outside the
current risk assessment framework used
for recombinant DNA research.
Nonetheless, an appropriate risk
assessment of experiments involving
these techniques must be conducted
taking into account the way these
approaches may alter the risk
assessment. In addition, as the field
develops, new techniques and
applications need to be monitored and
assessed to determine whether revisions
to the NIH Guidelines are needed. As
new techniques develop, the NIHGuidelines should be periodically
reviewed to determine whether and how
such research should be explicitly
addressed. It is the responsibility of the
institution and those associated with it
to adhere to the intent of the NIH
Guidelines as well as to their specifics.
Therefore, each institution (and the
Institutional Biosafety Committee acting
on its behalf) is responsible for ensuring
that all recombinant and/or synthetic
nucleic acids research conducted at or
sponsored by that institution is
conducted in compliance with the NIH
Guidelines. General recognition of
institutional authority and
responsibility properly establishes
accountability for safe conduct of the
research at the local level. The following
roles and responsibilities constitute an
administrative framework in which
safety is an essential and integral part of
research involving recombinant and/or
synthetic nucleic acid molecules.
Further clarifications and
interpretations of roles and
responsibilities will be issued by NIH as
necessary."
Section II. Safety Considerations
Currently, the risk assessment
framework of the NIH Guidelines uses
the risk group of the parent organism as
a starting point for determining the
necessary containment level. For
example, genetic modifications using a
Risk Group 3 organism (defined as
agents that are associated with serious
or lethal human disease for which
preventive or therapeutic interventions
may be available) would generally be
carried out at BL3 but the containment
level might be raised or lowered
depending on the specific construct and
the experimental manipulations. The
RAC concluded that the current risk
assessment framework under the NIH
Guidelines is applicable to experiments
with synthetic nucleic acids. However,
additional language is proposed to
provide further guidance for evaluating
research utilizing the capabilities of
synthetic biology, as use of these
techniques may lead to the creation of
complex organisms for which
identification of a parent organism, the
starting point of the existing
recombinant DNA risk assessment, is
more difficult. Risk assessment may also
be complicated by the limitations in
predicting function from sequence(s) or
the synergistic effects from combining
sequences from different sources in a
novel context.
Section II-A-3 (Comprehensive Risk
Assessment) currently states:
"In deciding on the appropriate
containment for an experiment, the
initial risk assessment from AppendixB, Classification of Human Etiologic
Agents on the Basis of Hazard, should
be followed by a thorough consideration
of the agent itself and how it is to be
manipulated. Factors to be considered
in determining the level of containment
include agent factors such as: Virulence,
pathogenicity, infectious dose,
environmental stability, route of spread,
communicability, operations, quantity,
availability of vaccine or treatment, and
gene product effects such as toxicity,
physiological activity, and allergenicity.
Any strain that is known to be more
hazardous than the parent (wild-type)
strain should be considered for handling
at a higher containment level. Certain
attenuated strains or strains that have
been demonstrated to have irreversibly
lost known virulence factors may
qualify for a reduction of the
containment level compared to the Risk
Group assigned to the parent strain (see
Section V-B, Footnotes and References
of Sections I-IV).
A final assessment of risk based on
these considerations is then used to set
the appropriate containment conditions
for the experiment (see Section II-B,
Containment). The containment level
required may be equivalent to the Risk
Group classification of the agent or it
may be raised or lowered as a result of
the above considerations. The
Institutional Biosafety Committee must
approve the risk assessment and the
biosafety containment level for
recombinant DNA experiments
described in Sections III-A,
Experiments that Require Institutional
Biosafety Committee Approval, RAC
Review, and NIH Director Approval
Before Initiation; III-B, Experiments that
Require NIH/OBA and Institutional
Biosafety Committee Approval Before
Initiation; III-C, Experiments that
Require Institutional Biosafety
Committee and Institutional Review
Board Approvals and NIH/OBA
Registration Before Initiation; III-D,
Experiments that Require Institutional
Biosafety Committee Approval Before
Initiation.
Careful consideration should be given
to the types of manipulation planned for
some higher Risk Group agents. For
example, the RG2 dengue viruses may
be cultured under the Biosafety Level 2
(BL2) containment (see Section II-B);
however, when such agents are used for
animal inoculation or transmission
studies, a higher containment level is
recommended. Similarly, RG3 agents
such as Venezuelan equine
encephalomyelitis and yellow fever
viruses should be handled at a higher
containment level for animal
inoculation and transmissionexperiments.
9419
Upcoming Pages
Here’s what’s next.
Search Inside
This issue can be searched. Note: Results may vary based on the legibility of text within the document.
Tools / Downloads
Get a copy of this page or view the extracted text.
Citing and Sharing
Basic information for referencing this web page. We also provide extended guidance on usage rights, references, copying or embedding.
Reference the current page of this Periodical.
United States. Office of the Federal Register. Federal Register, Volume 74, Number 41, March 4, 2009, Pages 9343-9564, periodical, March 4, 2009; Washington D.C.. (https://digital.library.unt.edu/ark:/67531/metadc132903/m1/84/: accessed April 26, 2024), University of North Texas Libraries, UNT Digital Library, https://digital.library.unt.edu; crediting UNT Libraries Government Documents Department.