Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List; Amendments to the Select Agent and Toxin Regulations, 2762-2774 [2016-00681]
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Proposed Rules
Federal Register
Vol. 81, No. 11
Tuesday, January 19, 2016
This section of the FEDERAL REGISTER
contains notices to the public of the proposed
issuance of rules and regulations. The
purpose of these notices is to give interested
persons an opportunity to participate in the
rule making prior to the adoption of the final
rules.
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
7 CFR Part 331
9 CFR Part 121
[Docket No. APHIS–2014–0095]
RIN 0579–AE08
Agricultural Bioterrorism Protection
Act of 2002; Biennial Review and
Republication of the Select Agent and
Toxin List; Amendments to the Select
Agent and Toxin Regulations
Animal and Plant Health
Inspection Service, USDA.
ACTION: Proposed rule.
AGENCY:
In accordance with the
Agricultural Bioterrorism Protection Act
of 2002, we are proposing to amend and
republish the list of select agents and
toxins that have the potential to pose a
severe threat to animal or plant health,
or to animal or plant products. The Act
requires the biennial review and
republication of the list of select agents
and toxins and the revision of the list as
necessary. This action would implement
the findings of the fourth biennial
review of the list. In addition, we are
proposing several amendments to the
regulations, including the addition of
provisions to address the inactivation of
select agents, provisions addressing
biocontainment and biosafety, and
clarification of regulatory language
concerning security, training, incident
response, and records. These changes
would increase the usability of the
select agent regulations as well as
provide for enhanced program
oversight.
DATES: We will consider all comments
that we receive on or before March 21,
2016.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/#!docket
Detail;D=APHIS-2014-0095.
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SUMMARY:
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• Postal Mail/Commercial Delivery:
Send your comment to Docket No.
APHIS–2014–0095, 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-2014-0095 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.
FOR FURTHER INFORMATION CONTACT: Dr.
Freeda Isaac, National Director,
Agriculture Select Agent Services,
APHIS, 4700 River Road Unit 2,
Riverdale, MD 20737–1231; (301) 851–
3300, Option 3.
SUPPLEMENTARY INFORMATION: The
Public Health Security and Bioterrorism
Preparedness and Response Act of 2002
(referred to below as the Bioterrorism
Response Act) provides for the
regulation of certain biological agents
that have the potential to pose a severe
threat to both human and animal health,
to animal health, to plant health, or to
animal and plant products. The Animal
and Plant Health Inspection Service
(APHIS) has the primary responsibility
for implementing the provisions of the
Act within the United States
Department of Agriculture (USDA).
Veterinary Services (VS) select agents
and toxins are those that have been
determined to have the potential to pose
a severe threat to animal health or
animal products. Plant Protection and
Quarantine (PPQ) select agents and
toxins are those that have the potential
to pose a severe threat to plant health
or plant products. Overlap select agents
and toxins are those that have been
determined to pose a severe threat to
both human and animal health or to
human health and animal products.
Overlap select agents are subject to
regulation by both APHIS and the
Centers for Disease Control and
Prevention (CDC), which has the
primary responsibility for implementing
the provisions of the Bioterrorism
Response Act for the Department of
Health and Human Services (HHS).
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Subtitle B (which is cited as the
‘‘Agricultural Bioterrorism Protection
Act of 2002’’ and referred to below as
the Act), section 212(a), provides, in
part, that the Secretary of Agriculture
(the Secretary) must establish by
regulation a list of each biological agent
and each toxin that the Secretary
determines has the potential to pose a
severe threat to animal or plant health,
or to animal or plant products.
Paragraph (a)(2) of section 212 requires
the Secretary to review and republish
the list every 2 years and to revise the
list as necessary. In this document, we
are proposing to amend and republish
the list of select agents and toxins based
on the findings of our fourth biennial
review of the list.
In determining whether to include an
agent or toxin on the list, the Act
requires that the following criteria be
considered:
• The effect of exposure to the agent
or the toxin on animal and plant health,
and on the production and marketability
of animal or plant products;
• The pathogenicity of the agent or
the toxin and the methods by which the
agent or toxin is transferred to animals
or plants;
• The availability and effectiveness of
pharmacotherapies and prophylaxis to
treat and prevent any illness caused by
the agent or toxin; and
• Any other criteria that the Secretary
considers appropriate to protect animal
or plant health, or animal or plant
products.
We use the term ‘‘select agents and
toxins’’ throughout the preamble of this
proposed rule. Unless otherwise
specified, the term ‘‘select agents and
toxins’’ will refer to all agents or toxins
listed by APHIS. When it is necessary to
specify the type of select agent or toxin,
we will use the following terms: ‘‘PPQ
select agents and toxins’’ (for the plant
agents and toxins listed in 7 CFR 331.3),
‘‘VS select agents and toxins’’ (for the
animal agents and toxins listed in 9 CFR
121.3), or ‘‘overlap select agents and
toxins’’ (for the overlap agents and
toxins listed in both 9 CFR 121.4 and 42
CFR 73.4).
On February 27, 2015, we published
in the Federal Register (80 FR 10627,
Docket No. APHIS–2014–0095) an
advance notice of proposed rulemaking
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and request for comments (ANPR) 1 in
order to announce our intention to
review the select agent list. We solicited
comments regarding potential additions
and deletions from the list of select
agents and toxins for 60 days ending
April 28, 2015. We received 20
comments by that date. They were from
scientists, scientific organizations, a
State government, private individuals,
and industry groups. Suggestions in
these comments were used in order to
inform our discussions on the content of
the select agent list.
PPQ Select Agents and Toxins
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APHIS’s PPQ program convened an
interagency working group to review the
list of PPQ select agents and toxins and
develop recommendations regarding
possible changes to that list. Using the
four criteria for listing found in the Act,
economic crop data, current Federal
quarantine notices, and new scientific
information, the working group
revisited the currently listed PPQ select
agents and toxins and evaluated a
number of new plant pathogens for
inclusion on the list. Based on this
review, APHIS is proposing to amend
the list of PPQ select agents and toxins
listed in 7 CFR 331.3 by removing three
PPQ select agents and toxins from the
list. Specifically, we are proposing to
remove the following:
• Peronosclerospora philippinensis
(Peronosclerospora sacchari) and
Sclerophthora rayssiae: There are no
viable cultures of these corn pathogens
currently held in U.S. laboratories, they
are difficult to grow or maintain,
difficult to keep viable during transport,
and would require a large amount of
inoculum to infect fields by artificial
means due to the fact that they must
spread via infected plant material; and
• Phoma glycinicola (formerly
Pyrenochaeta glycines): This soybean
pathogen’s natural distribution is
limited to two countries in Africa, it
does not spread rapidly in the field,
soybean importation pathways into the
United States by which the pathogen
might enter are limited, and while no
U.S. soybean variety is immune to this
pathogen, Environmental Protection
Agency-approved fungicides are
available to treat any infestation.
VS Select Agents and Toxins
APHIS’ VS program also convened an
interagency working group to review the
list of VS select agents and toxins and
the list of overlap select agents and
toxins in 9 CFR part 121 in order to
1 To view the ANPR and the comments we
received, go to https://www.regulations.gov/
#!docketDetail;D=APHIS-2014-0095.
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consider changes to the lists. Based on
the review, APHIS is proposing to
remove three overlap select agents and
toxins from the list set out in § 121.4(b):
• Bacillus anthracis (Pasteur strain):
Historically, the B. anthracis Pasteur
strain has been retained as a select agent
to allow for continued oversight of
laboratories in which the accidental (or
intentional) combination of this strain
with the excluded Sterne strain could
occur to produce the wild type
phenotype B. anthracis de novo.
However, a recent study 2 indicates that
bacterial transformation of B. subtilis
with plasmid DNA is inefficient;
indicating that transformation with
bacteria such as B. anthracis (e.g., pXO1
into B. anthracis Pasteur strain) would
also be inefficient. Given that B.
anthracis Pasteur strain does not encode
the plasmid which carries the
pathogenic toxin genes, analogous to the
Sterne strain which was excluded from
Select Agent oversight in 2003, we
believe there is no potential for high
animal mortality rates or for misuse that
might result in social or economic
disruption. Therefore, we are proposing
that the Pasteur strain be removed from
the overlap select agent list.
• Brucella abortus and Brucella suis:
While both of these organisms have
been eradicated from the domestic
livestock industry, they are currently
endemic in wildlife and feral swine
populations in the United States.
However, there is an extensive
regulatory control program in place for
B. abortus in the remaining affected
Designated Surveillance Area. APHIS
has also recently enacted a national
program to control feral swine that will
include surveillance and disease
monitoring for swine brucellosis.
Therefore, we believe the effect of
exposure to these agents on animal
health and on the production and
marketability of animal products is
minimized. We are proposing that these
two Brucella species be removed from
the overlap select agent list. However,
Brucella melitensis, as a foreign animal
disease agent not currently found in the
United States, would be kept as a VS
select agent.
Accordingly, CDC will also be
proposing a parallel change to its
overlap select agent regulations.
Additional Changes
We are proposing to make several
changes to the regulations, including the
addition of provisions to address the
2 C. Johnston, B. Martin, G. Fichant, P. Polard,
and J.P. Claverys. ‘‘Bacterial transformation:
distribution, shared mechanisms and divergent
control.’’ Nature Reviews Microbiology. 2014. 12:
181–196.
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inactivation of select agents, provisions
addressing biocontainment and
biosafety, and clarification of regulatory
language concerning security, training,
incident response, and records. These
changes, which are described in detail
below, would increase the usability of
the select agent regulations as well as
provide for enhanced program
oversight.
Definitions
In 7 CFR 331.1 and 9 CFR 121.1, we
are proposing to add definitions for
inactivation and kill curve. We believe
these definitions are necessary as they
are included in the additional
biocontainment and biosafety language
we are proposing to add to the
regulations.
The definition of inactivation would
be established as ‘‘a method to render a
select agent non-viable but retain
characteristic of interest for future use,
or to render any nucleic acids that can
produce infectious forms of any select
agent virus non-infectious for future
use.’’ This definition draws a distinction
between inactivation for waste
treatment and inactivation of regulated
material for future purposes such as
research. The definition of kill curve
would be established as ‘‘the results of
a dose-response experiment where a
select agent is subjected to increasing
amounts of the inactivating treatment to
determine the minimum conditions
required to render it non-viable or to
render any nucleic acids that can
produce infectious forms of any select
agent virus as non-infectious.’’
Exclusions and Inactivation
We are proposing to amend 7 CFR
331.3(d)(2), 9 CFR 121.3(d)(2), and 9
CFR 121.4(d)(2), which currently
exclude nonviable select agents or
nonfunctional toxins from the
requirements of the regulations, in order
to clarify our policy that an entity must
use a validated method to render a
select agent nonviable or regulated
nucleic acids non-infectious for future
use. This means that the method must
be scientifically sound and that it will
produce consistent results each time it
is used.
We are proposing that inactivation
include the use of one of the following:
The exact conditions of a commonly
accepted method that has been
validated as applied (e.g., autoclaving),
a published method with adherence to
the exact published conditions (i.e.,
extrapolations or deductions are to be
avoided), or in-house methods, only if
validation testing includes the specific
conditions used and appropriate
controls.
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We are also proposing that the entity
develop a site-specific kill curve in
order to define conditions of
inactivation for each select agent or
regulated nucleic acid. If there are
strain-to-strain variations in the
resistance of a select agent to the
inactivation procedure, then a specific
kill curve would have to be developed
for each strain that undergoes the
inactivation procedure. A new kill curve
would have to be created upon any
change in procedure or inactivation
equipment. In addition, a validated
sterility testing protocol would have to
be conducted in order to ensure that the
inactivation method has rendered a
select agent nonviable or regulated
nucleic acids non-infectious.
In addition, we are proposing that an
entity be required to report any viability
of a select agent or infectivity of
regulated nucleic acids that can produce
infectious forms of any select agent
virus that was subjected to a validated
inactivation protocol to APHIS or CDC.
We are also proposing to require that
an entity review annually, and revise as
necessary, the following: (1) The kill
curve procedure and results; (2) sitespecific standard operating procedures
to ensure that select agents or regulated
nucleic acids that can produce
infectious forms of any select agent
virus are inactivated by a safety margin;
and (3) the validated sterility testing
protocol used to ensure that the
inactivation method has rendered a
select agent non-viable or regulated
nucleic acids that can produce
infectious forms of any select agent
viruses non-infectious.
Finally, we are proposing that written
records be kept for any select agent that
has been rendered nonviable or
regulated nucleic acids that have been
rendered non-infectious. We are
particularly requesting comments
regarding whether there are more
specific measures available to
demonstrate that a select agent has been
rendered nonviable, or a regulated
infectious nucleic acid has been
rendered non-infectious.
We are also proposing to add to 7 CFR
331.3(e), 9 CFR 121.3(e), and 9 CFR
121.4(e) a paragraph stating that an
individual or entity may make a written
request to the Administrator for
reconsideration of a decision denying an
exclusion application. The written
request for reconsideration would have
to state the facts and reasoning upon
which the individual or entity relies to
show the decision was incorrect. The
Administrator would grant or deny the
request for reconsideration as promptly
as circumstances allow and will state, in
writing, the reasons for the decision.
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This language was included in previous
versions of the regulations and was
erroneously removed by an earlier
rulemaking.
Exemptions for Select Agents and
Toxins
Sections 7 CFR 331.5, 9 CFR 121.5,
and 9 CFR 121.6 concern conditions
under which entities may be exempted
from the requirements of the
regulations. Paragraph (a) requires that
the identification of the agent or toxin
be reported to APHIS or CDC. Since
select agents and toxins have the
potential to pose a severe threat to both
human and animal health, to animal
health, to plant health, or to animal and
plant products, clinical and diagnostic
laboratories typically have their initial
results confirmed by a registered or
certified reference laboratory. We are
proposing to require that in addition to
notifying APHIS or CDC, the reference
laboratory inform the specimen provider
upon confirmation of the identification
of a select agent or toxin. This change
would clarify our expectations regarding
communication and notification
between the reference laboratory and
the specimen provider.
We are also proposing to add language
to paragraph (a) in sections 7 CFR 331.5,
9 CFR 121.5, and 9 CFR 121.6 that
specifies that entities may be required to
report identification of agents or toxins
to other appropriate authorities when
required by Federal, State, or local law.
This language was added to the CDC
select agent regulations in a previous
rulemaking, but not to the APHIS
regulations and this change is necessary
in order to achieve uniformity across all
regulations associated with the
diagnosis and care for individuals
infected with a select agent or toxin.
Specifically, we are proposing to add
provisions that state that we do not
regulate material containing select
agents or toxins when it is in a patient
care setting and is not being collected or
otherwise tested or retained, nor do we
regulate waste generated during delivery
of patient care. However, once delivery
of patient care for the select agent or
toxin infection has concluded, these
specimens would become subject to the
requirements of the regulations. If an
entity cannot meet these requirements,
then the material may be transferred to
another entity according to the select
agent regulations or destroyed using an
approved method. The decision to
retain, transfer, or destroy any
specimens must be made within 7
calendar days of the conclusion of
patient care. These requirements would
be set out in new paragraphs 9 CFR
121.3(d)(4) and 9 CFR 121.4(d)(4).
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Registration and Related Security Risk
Assessments
The regulations in 7 CFR 331.7 and 9
CFR 121.7 set out registration
requirements for those entities that wish
to work with select agents and toxins
and stipulates the individuals within
those entities that must undergo a
security risk assessment by the Attorney
General.
We are proposing to state that an
entity registered to possess, use, or
transfer a select agent or toxin would
have to meet the requirements of the
regulations for those select agents and
toxins listed on the entity’s official
registration regardless of whether the
entity is in possession of those select
agents or toxins and without regard to
the amount of select agents or toxins in
the entity’s possession. This change
would serve to codify existing policy
and would be added as a new paragraph
(b).
Responsible Official
The regulations in 7 CFR 331.9 and 9
CFR 121.9 set out requirements for
entities requesting to work with select
agents and toxins to designate a
responsible official, who ensures that
the entity continues to meet the
requirements of the regulations.
Paragraph (a)(6) requires the
responsible official to ensure that
annual inspections are conducted for
each location where select agents or
toxins are stored or used in order to
determine compliance with the
regulations. The responsible official also
must document the results of each
inspection and identify and address any
deficiencies.
We are proposing to require that any
corrections of deficiencies found must
also be documented. This change is
necessary to improve recordkeeping
practices and to provide a more
complete account of facility
containment and security procedures.
We are also proposing to replace the
word ‘‘laboratory’’ with the phrase
‘‘registered space.’’ This terminology is
more accurate, as registered spaces are
not always laboratories.
We are also proposing to add a new
paragraph (a)(7), which would require
the entity’s responsible official to
provide contact information for the
USDA or HHS Office of Inspector
General Hotline, so that employees and
other individuals may anonymously
report any containment or security
concerns they may have. Although the
select agent program has established a
whistleblower portal on its Web site,
there is currently no requirement for
employees at registered entities to be
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made aware of its existence or how to
use it. Adding this requirement would
allow for increased worker involvement
in biosafety/biocontainment and
security programs at registered entities
and may also enhance the quality of
Federal oversight in this area.
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Security Risk Assessments
We are proposing to amend the
regulations in 7 CFR 331.10 and 9 CFR
121.10. These regulations establish
parameters for restricting access to
select agents and toxins and the process
by which individuals may be approved
for access to select agents and toxins
after the completion of a security risk
assessment by the Attorney General.
Paragraph (e) states that a person with
valid approval from the HHS Secretary
or Administrator to have access to select
agents or toxins may request, through
his or her responsible official, that the
HHS Secretary or APHIS Administrator
provide their approved access status to
another registered individual or entity
for a specified period of time. We are
proposing to also require that the
responsible official at the visiting
person’s home entity notify the host
entity if that person’s approved access
to select agents or toxins has been
terminated. This would ensure that an
individual whose permissions have
been terminated would not be allowed
further access to select agents and
toxins.
Security, Biocontainment/Biosafety,
and Incident Response Plans
The regulations require registered
entities to develop and implement a
number of plans in order to ensure the
safety and security of the select agents
they handle. These are:
• A security plan, as described by the
regulations in 7 CFR 331.11 and 9 CFR
121.11, that provides for measures
sufficient to safeguard the select agent
or toxin against unauthorized access,
theft, loss, or release;
• A biocontainment plan, in the case
of PPQ select agents, or a biosafety plan,
in the case of VS and overlap select
agents, as described in the regulations in
7 CFR 331.12 and 9 CFR 121.12, that
provides for measures sufficient to
contain the select agent or toxin (e.g.,
physical structure and features of the
entity, and operational and procedural
safeguards); and
• An incident response plan, as
described in the regulations in 7 CFR
331.14 and 9 CFR 121.14, that provides
for measures that the registered entity
will implement in the event of theft,
loss, or release of a select agent or toxin;
inventory discrepancies; security
breaches (including information
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systems); severe weather and other
natural disasters; workplace violence;
bomb threats and suspicious packages;
and emergencies such as fire, gas leak,
explosion, power outage, etc. The
response procedures must account for
hazards associated with the select agent
or toxin and appropriate actions to
contain such agent or toxin.
All of these plans require annual
review and revision as necessary. Drills
or exercises must also be conducted at
least annually to test and evaluate the
effectiveness of the plans. The plans
must be reviewed and revised, as
necessary, after any drill or exercise and
after any incident. We are proposing to
require that these drills or exercises be
documented to include how the drill or
exercise tested and evaluated the plan,
any problems identified, any corrective
action taken, and the names of the
individuals who participated in the drill
or exercise. This will provide a more
thorough accounting of required
activities as well as increasing the
efficacy of the plans via testing and
entity-directed improvements. We are
proposing to add these requirements to
7 CFR 331.11(h), 331.12(e), 331.14(f), 9
CFR 121.11(h), 121.12(e), and 121.14(f).
We are also proposing to add a
requirement that the biocontainment,
biosafety, and incident response plans
be submitted for initial registration,
renewal of registration, or when
requested. These additions would be
located in 7 CFR 331.12(a), 331.14(a), 9
CFR 121.12(a), and 121.14(a). This
change is necessary in order to bring the
requirements for these plans in line
with existing requirements for the
security plan.
Details of the changes we are
proposing to the security, biosecurity,
and biosafety plans individually may be
found below.
Security Plan
Paragraph (c)(5) of 7 CFR 331.11 and
9 CFR 121.11 requires that the security
plan describe procedures for addressing
loss or compromise of keys, passwords,
combinations, etc. and protocols for
changing access numbers or locks
following staff changes. We are
proposing to add keycards to that list as
they are commonly used. We are also
proposing to use the term ‘‘access
permissions’’ instead of the term
‘‘access numbers,’’ as it covers a broader
range of topics.
We are also proposing to add a new
paragraph (c)(11) to the regulations in 7
CFR 331.11 and 9 CFR 121.11. This
would require that the security plan
contain a description of how the entity
authorizes the means of entry into areas
where select agents or toxins are stored
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or used, which would include a
description of all centralized access
control management systems (e.g.,
keycards) and/or mechanical key
management. This requirement would
allow us to directly ascertain the way in
which entities allow individuals entry
to areas containing select agents and
toxins and potentially identify any
weaknesses in that process.
In the same sections, paragraphs
(d)(7)(i) through (d)(7)(v) encompass a
list of activities that individuals with
access approval from the Administrator
or the HHS Secretary must immediately
report to the responsible official. We are
proposing to add a new paragraph
(d)(7)(vi) to require that the responsible
official must be notified of any loss of
computer, hard drive, or other data
storage device containing information
that can be used to gain access to select
agents or toxins. Such notification will
facilitate notification of the Federal
Bureau of Investigation if deemed
necessary by the responsible official as
the loss of such equipment may be
criminal in nature.
Biocontainment/Biosafety Plan
Paragraph (a) of 7 CFR 331.12 and 9
CFR 121.12 requires that the
biocontainment or biosafety plan
contain sufficient information and
documentation to describe the biosafety
and containment procedures for each
select agent or toxin that the registered
entity will possess. The plan must also
include a description of the biosafety
and containment procedures for any
animals (including arthropods) or plants
intentionally or accidentally exposed to
or infected with a select agent. We are
proposing to additionally require that
laboratory-specific biocontainment and/
or biosafety manuals must be accessible
to individuals working in those
laboratories. This change would help to
foster an enhanced culture of
responsibility by ensuring that
appropriate biocontainment and/or
biosafety resources are available to all
staff with access to select agents and
toxins within a select agent laboratory.
In the aftermath of recent biosafety
incidents involving an unintentional
release of potentially viable anthrax
within the CDC’s Roybal Campus, in
Atlanta, GA, and the inadvertent crosscontamination and shipment of a
laboratory specimen of low-pathogenic
avian influenza virus with the VS select
agent highly pathogenic avian influenza
virus, we believe that the
biocontainment and biosafety plans
should be designed according to a sitespecific risk assessment in accordance
with the risk posed by a select agent or
toxin. Therefore, we are proposing to
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add specific provisions to the
biocontainment and biosafety plans that
would require completion of a written
risk assessment for each procedure. This
risk assessment would have to include
the following elements: A description of
the safeguards in place to protect entity
personnel, the public, and the
environment from exposure to the select
agent or toxin; decontamination
procedures; waste management
procedures; and procedures for
handling select agents and toxins in the
same spaces as non-select agents and
toxins in order to prevent unintentional
cross-contamination.
We are specifically requesting
comments regarding any specific
biocontainment or biosafety measures to
prevent laboratory acquired infections
or accidental or intentional release of
the select agents and toxins from an
entity into the community.
Finally, paragraph (c)(2) of 9 CFR
121.12 requires that entities should
consider the guidance found in the
Occupational Safety and Health
Administration regulations in 29 CFR
1910.1200 and 1910.1450. We are
proposing to remove this reference as
the information in those regulations is
also contained in the CDC/National
Institutes of Health publication,
‘‘Biosafety in Microbiological and
Biomedical Laboratories,’’ which is
referenced in paragraph (c)(1) and a
second reference is therefore
duplicative.
Training
We are proposing to amend the
regulations in 7 CFR 331.15 and 9 CFR
121.15, which concern provision of
mandatory training for staff and visitors
who work in or visit areas where select
agents or toxins are handled or stored.
We are proposing to require that all
individuals who have received approval
to have access to select agents and
toxins must undergo training regardless
of whether they have access to those
select agents or toxins. The training
would have to be completed within a
year of that individual’s approval or
prior to entry into an area where select
agents and toxins are used or stored,
whichever occurs first. This change is
necessary in order to codify our position
regarding which individuals at
registered entities are required to
receive training.
Transfers
We are proposing to amend the
regulations in 7 CFR 331.16 and 9 CFR
121.16, which concern the transfer of
select agents and toxins to a registered
entity. Specifically, paragraph (b) states
that select agents and toxins may need
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a permit issued in accordance with 7
CFR part 330 or 9 CFR part 122. We
have determined that a permit for the
importation or interstate movement of a
select agent or toxin listed in 7 CFR
331.3, 9 CFR 121.3, or 121.4 is not
required for such importation and/or
interstate movement provided that the
select agent or toxin is authorized for
transfer in accordance with 7 CFR
331.16(b) or 9 CFR 121.16(b).
Records
The regulations in 7 CFR 331.17 and
9 CFR 121.17 concern required
recordkeeping procedures for regulated
entities as those records relate to select
agents and toxins. Paragraph (a)(3)(x)
requires that registered entities record
the destruction of any toxins by
specifically noting the quantity of toxin
destroyed, the date of such action, and
by whom. However, there is not an
equivalent requirement regarding the
destruction of select agents. We are
proposing to add this requirement in
order to ensure consistency with the
toxin provisions and ensure proper
tracking of select agents from
acquisition to destruction. These
requirements would be added in a new
paragraph (a)(1)(ix).
We are also proposing to require that
regulated entities maintain records
concerning those select agents that have
been rendered nonviable or regulated
nucleic acids that have been rendered
non-infectious. These records would
specifically capture the activities
detailed under the heading ‘‘Exclusions
and Inactivation’’ above. Such
recordkeeping is necessary in order to
confirm that an entity has performed the
procedures necessary. The select agent
program would then have the ability to
review those records in order to ensure
that the entity is performing all
procedures necessary for nonviability or
inactivation. The requirements would
be added in a new paragraph (a)(8) in 7
CFR 331.17 and 9 CFR 121.17.
We are also proposing to state that
any records created that contain
information related to an entity’s
registration or its select agents and
toxins must be provided promptly upon
request. This requirement would be
added to revised paragraph (c). Given
the wide variety of entities regulated
under the Federal Select Agent Program,
the scope of records readily available for
program review will enhance the ability
of the program to evaluate entity
biosafety, biocontainment, security, and
incident response programs. Paragraph
(c) in both 7 CFR 331.17 and 9 CFR
121.17 would also be revised to specify
that such records may include, but are
not limited to, biocontainment
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certifications, laboratory notebooks,
institutional biosafety and/or animal use
committee minutes and approved
protocols, and records associated with
occupational health and suitability
programs.
Finally, paragraph (b) in both 7 CFR
331.17 and 9 CFR 121.17 requires that
regulated entities implement a system to
ensure that all records and databases
created under this part are accurate,
have controlled access, and that their
authenticity may be verified. To ensure
the accuracy of handwritten records, we
are proposing to specify that such
records must be legible.
Records for Select Agents in Long-Term
Storage
Paragraph (a)(1) in both 7 CFR 331.17
and 9 CFR 121.17 requires entities to
maintain an accurate, current inventory
for each select agent (including viral
genetic elements, recombinant and/or
synthetic nucleic acids, and organisms
containing recombinant and/or
synthetic nucleic acids) held in longterm storage. We continue to receive
comments critical of that portion of the
regulations. Criticism is typically
focused on the belief that a containerbased inventory requirement is not a
useful mechanism to track inventory of
biological agents, since small amounts
could be stolen without detection and
used to grow larger quantities.
However, the Public Health Security
and Bioterrorism Preparedness and
Response Act of 2002 obliges APHIS
and CDC to include a requirement for
‘‘the prompt notification of the
Secretary, and appropriate Federal,
State, and local law enforcement
agencies, of the theft or loss of listed
agents and toxins’’ in the regulations.
We are therefore soliciting comment
regarding what regulatory requirement
or requirements should be implemented
such that a registered entity could
quickly determine whether a select
agent had been lost or stolen from longterm storage without that registered
entity first having an accurate, current
inventory for each select agent held in
long-term storage. Additionally, we are
soliciting ideas concerning ways in
which the current regulations could be
amended to address the possibility of
theft of a select agent from a container
held in long-term storage.
Executive Order 12866 and Regulatory
Flexibility Act
This proposed rule has been
determined to be not significant for the
purposes of Executive Order 12866 and,
therefore, has not been reviewed by the
Office of Management and Budget.
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In accordance with the Regulatory
Flexibility Act, we have analyzed the
potential economic effects of this action
on small entities. The analysis is
summarized below. Copies of the full
analysis are available by contacting the
person listed under FOR FURTHER
INFORMATION CONTACT or on the
Regulations.gov Web site (see
ADDRESSES above for instructions for
accessing Regulations.gov).
The Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002 (Pub. L. 107–188)
provides for the regulation of certain
biological agents and toxins that have
the potential to pose a severe threat to
human, animal, or plant health, or to
animal or plant products. APHIS has
completed its fourth biennial review of
select agent regulations and is proposing
changes that would increase their
usability as well as provide for
enhanced program oversight. The
proposed amendments include
provisions to address the inactivation of
select agents, provisions addressing
biosafety, and clarification of regulatory
language concerning security, training,
incident response, and records.
The proposed rule would require that
entities develop an agent-specific kill
curve in order to define conditions of
inactivation for each select agent or
regulated infectious nucleic acid and
maintain written records of having done
so.3 Costs of complying with this
amendment are therefore expected to be
modest.
Currently, there are 291 entities
registered with APHIS and CDC. Of
these entities, there are 240 registered to
possess Tier 1 select agents and toxins,
including 78 academic, 29 commercial,
80 State government, 37 Federal
government, and 16 private (non-profit)
institutions, most of which are
considered to be small entities. Based
on proposed record keeping and
reporting requirements, an additional 10
to 20 hours per year may be required.
At an imputed cost of $33.40 per hour
(GS–12, step 2), this additional time
requirement per entity would cost
between $334 and $668 per year, or in
total for all registered entities between
$80,000 and $160,000.
Under these circumstances, the
Administrator of the Animal and Plant
Health Inspection Service has
determined that this action would not
3 The
definition of kill curve would be ‘‘the
results of a dose-response experiment where a
select agent is subjected to increasing amounts of
the inactivating treatment to determine the
minimum conditions required to render it nonviable or to render any nucleic acids that can
produce infectious forms of any select agent virus
as non-infectious.’’
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have a significant economic impact on
a substantial number of small entities.
Executive Order 12372
This program/activity is listed in the
Catalog of Federal Domestic Assistance
under No. 10.025 and is subject to
Executive Order 12372, which requires
intergovernmental consultation with
State and local officials. (See 2 CFR
chapter IV.)
Executive Order 12988
This proposed rule has been reviewed
under Executive Order 12988, Civil
Justice Reform. If this proposed rule is
adopted: (1) All State and local laws and
regulations that are inconsistent with
this rule will be preempted; (2) no
retroactive effect will be given to this
rule; and (3) administrative proceedings
will not be required before parties may
file suit in court challenging this rule.
Paperwork Reduction Act
In accordance with section 3507(d) of
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.), we have
determined that there is burden
associated with this action. We will
publish a separate document in the
Federal Register, announcing our
determination of burden and soliciting
comments on it.
E-Government Act Compliance
The Animal and Plant Health
Inspection Service is committed to
compliance with the E-Government Act
to promote the use of the Internet and
other information technologies, to
provide increased opportunities for
citizen access to Government
information and services, and for other
purposes. For information pertinent to
E-Government Act compliance related
to this proposed rule, please contact Ms.
Kimberly Hardy, APHIS’ Information
Collection Coordinator, at (301) 851–
2727.
List of Subjects
7 CFR Part 331
Agricultural research, Laboratories,
Plant diseases and pests, Reporting and
recordkeeping requirements.
9 CFR Part 121
Agricultural research, Animal
diseases, Laboratories, Medical research,
Reporting and recordkeeping
requirements.
Accordingly, we propose to amend 7
CFR part 331 and 9 CFR part 121 as
follows:
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TITLE 7—AGRICULTURE
PART 331—POSSESSION, USE, AND
TRANSFER OF SELECT AGENTS AND
TOXINS
1. The authority citation for part 331
continues to read as follows:
■
Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80,
and 371.3.
2. Section 331.1 is amended by
adding, in alphabetical order,
definitions of inactivation and kill curve
to read as follows:
■
§ 331.1
Definitions.
*
*
*
*
*
Inactivation. A method to render a
select agent non-viable but retain
characteristic of interest for future use,
or to render any nucleic acids that can
produce infectious forms of any select
agent virus non-infectious for future
use.
*
*
*
*
*
Kill curve. The results of a doseresponse experiment where a select
agent is subjected to increasing amounts
of the inactivating treatment to
determine the minimum conditions
required to render it non-viable, or to
render any nucleic acids that can
produce infectious forms of any select
agent virus as non-infectious.
*
*
*
*
*
■ 3. Section 331.3 is amended as
follows:
■ a. In paragraph (b), by removing the
words ‘‘Peronosclerospora
philippinensis (Peronosclerospora
sacchari);’’, ‘‘Phoma glycinicola
(formerly Pyrenochaeta glycines);’’, and
‘‘Sclerophthora rayssiae;’’
■ b. By revising paragraph (d)(2).
■ c. By adding paragraph (e)(3).
The addition and revision read as
follows:
§ 331.3
PPQ select agents and toxins.
*
*
*
*
*
(d) * * *
(2) Nonviable select agents or
nonfunctional toxins.
(i) Unless waived by the
Administrator, a select agent or
regulated nucleic acids that can produce
infectious forms of any select agent
virus that has been subjected to a
validated inactivation process to remove
viability or infectious form (i.e., the
ability to reproduce or produce disease,
while maintaining cellular structure) is
not excluded from the requirements of
this part until an individual or entity:
(A) Develops a site-specific kill curve
to define conditions of inactivation for
each select agent or regulated nucleic
acids that can produce infectious forms
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of any select agent virus. If there are
strain-to-strain variations in resistance
of a select agent to the inactivation
procedure, then a specific kill curve
must be developed for each strain that
undergoes the inactivation procedure. A
new kill curve must be created upon
any change in procedure or inactivation
equipment.
(B) Develops site-specific standard
operating inactivation procedures to
ensure that the material is inactivated
by a safety margin determined by the
kill curve.
(C) Subjects representative samples of
inactivated select agents or any nucleic
acids that can produce infectious forms
of any select agent viruses to a validated
sterility testing protocol to ensure that
the inactivation method has rendered
the select agent non-viable or regulated
nucleic acids non-infectious.
(D) Any viability of a select agent or
infectivity of regulated nucleic acids
that can produce infectious forms of any
select agent virus that was subjected to
a validated inactivation protocol is
reported to APHIS.
(E) Reviews annually, and revises as
necessary, the following:
(1) The kill curve procedure and
results;
(2) Site-specific standard operating
procedures to ensure that select agents
or regulated nucleic acids that can
produce infectious forms of any select
agent virus are inactivated by a safety
margin; and
(3) The validated sterility testing
protocol used to ensure that the
inactivation method has rendered a
select agent non-viable or regulated
nucleic acids that can produce
infectious forms of any select agent
virus sample non-infectious.
(F) Reviews, and revises as necessary,
documents listed in paragraph
(d)(2)(i)(E) of this section after any
change in principal investigator, change
in protocol, or any reported viability of
a select agent or infectivity of regulated
nucleic acids that can produce
infectious forms of any select agent
viruses previously assessed as inactive.
(ii) Unless waived by the
Administrator, an extract from a select
agent is not excluded from the
requirements of this part until an
individual or entity meets the following
requirements:
(A) Any extract is subjected to a
process that removes all viable cells,
spores, or virus particles.
(B) Any extract is subjected to a
validated sterility testing protocol to
ensure that the inactivation method has
rendered the extract free of a select
agent.
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(C) Any viability of an extract that
was subjected to a validated inactivation
protocol is reported to the responsible
official.
(D) Any viability of a select agent or
infectivity of regulated nucleic acids
that can produce infectious forms of any
select agent virus that was previously
assessed as inactive by their validated
sterility testing protocol is reported to
APHIS.
*
*
*
*
*
(e) * * *
(3) An individual or entity may make
a written request to the Administrator
for reconsideration of a decision
denying an application for the exclusion
of an attenuated strain of a select agent
or a select toxin modified to be less
potent or toxic. The written request for
reconsideration must state the facts and
reasoning upon which the individual or
entity relies to show the decision was
incorrect. The Administrator will grant
or deny the request for reconsideration
as promptly as circumstances allow and
will state, in writing, the reasons for the
decision.
*
*
*
*
*
■ 4. In § 331.5, paragraph (a)(3) is
revised to read as follows:
§ 331.5
Exemptions.
(a) * * *
(3) The identification of the agent or
toxin is reported to APHIS, the
specimen provider, and to other
appropriate authorities when required
by Federal, State, or local law by
telephone, facsimile, or email. This
report must be followed by submission
of APHIS/CDC Form 4 to APHIS within
7 calendar days after identification.
*
*
*
*
*
■ 5. Section 331.7 is amended as
follows:
■ a. By redesignating paragraphs (b)
through (k) as paragraphs (c) through (l),
respectively.
■ b. By adding a new paragraph (b).
The addition reads as follows:
§ 331.7 Registration and related security
risk assessments.
*
*
*
*
*
(b) As a condition of registration, each
entity is required to be in compliance
with the requirements of this part for
select agents and toxins listed on the
registration regardless of whether the
entity is in actual possession of the
select agent or toxin. In regard to toxins,
the entity registered for possession, use,
or transfer of toxins must be in
compliance with the requirements of
this part regardless of the amounts of
toxins currently in possession.
*
*
*
*
*
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6. Section 331.9 is amended as
follows:
■ a. In paragraph (a)(6), by removing the
word ‘‘laboratory’’ and adding the
words ‘‘registered space’’ in its place
and by adding the words ‘‘and the
corrections documented’’ at the end of
the second sentence after the words
‘‘must be corrected’’.
■ b. By adding paragraph (a)(7).
The addition reads as follows:
■
§ 331.9
Responsible official.
(a) * * *
(7) Ensure that individuals are
provided the contact information for the
USDA or HHS Office of Inspector
General Hotline so that they may
anonymously report any biosafety/
biocontainment or security concerns
related to select agents and toxins.
*
*
*
*
*
■ 7. In § 331.10, paragraph (e) is
amended by adding a sentence at the
end of the paragraph to read as follows:
§ 331.10 Restricting access to select
agents and toxins; security risk
assessments.
*
*
*
*
*
(e) * * * A responsible official must
immediately notify the responsible
official of the visiting entity if the
person’s access to select agents or toxins
has been terminated.
*
*
*
*
*
■ 8. Section 331.11 is amended as
follows:
■ a. In paragraph (c)(5), by adding the
word ‘‘keycards,’’ after the word ‘‘keys,’’
and by removing the word ‘‘numbers’’
and adding the word ‘‘permissions’’ in
its place.
■ b. By adding paragraph (c)(11).
■ c. In paragraph (d)(7)(iv), by removing
the word ‘‘and’’.
■ d. By adding paragraph (d)(7)(vi).
■ e. By adding a sentence at the end of
paragraph (h).
The additions read as follows:
§ 331.11
Security.
*
*
*
*
*
(c) * * *
(11) Describe how the entity
authorizes the means of entry into areas
where select agents or toxins are stored
or used to include centralized access
control management systems (e.g.,
keycards) and/or mechanical key
management.
(d) * * *
(7) * * *
(vi) Any loss of computer, hard drive
or other data storage device containing
information that can be used to gain
access to select agents or toxins.
*
*
*
*
*
(h) * * * Drills or exercises must be
documented to include how the drill or
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exercise tested and evaluated the plan,
any problems that were identified and
corrective action(s) taken, and all
individuals who participated in the drill
or exercise.
■ 9. Section 331.12 is amended as
follows:
■ a. By revising paragraph (a).
■ b. By adding a sentence at the end of
paragraph (e).
The addition and revision read as
follows:
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§ 331.12
Biocontainment.
(a) An individual or entity required to
register under this part must develop
and implement a written
biocontainment plan that is
commensurate with the risk of the select
agent or toxin, given its intended use.4
The biocontainment plan must contain
sufficient information and
documentation to describe the
biocontainment procedures for the
select agent or toxin, including any
animals (including arthropods) or plants
intentionally or accidentally exposed to
or infected with a select agent. The
biocontainment procedures specific to
each registered laboratory must be
available to each individual working in
that laboratory. The current
biocontainment plan must be submitted
for initial registration, renewal of
registration, or when requested. The
biocontainment plan must include the
following provisions:
(1) A written risk assessment for each
prescribed procedure involving a select
agent or toxin.
(i) The hazardous characteristics of
the agent or toxin listed on the entity’s
registration, including probable routes
of transmission in the laboratory and in
the environment, infective dose (if
known), stability in the environment,
host range, contribution of any genetic
manipulations, and endemicity.
(ii) Hazards associated with laboratory
procedures related to the select agent or
toxin.
(2) Safeguards in place with
associated containment procedures to
protect registered entity personnel, the
public, and the environment from
exposure to the select agent or toxin
including, but not limited to: Safety
training requirements for registered
entity personnel performing the
procedure; required personal protective
equipment; required containment
equipment including, but not limited to,
biological safety cabinets, arthropod
caging systems, and centrifuge safety
containers; and required physical plant
engineering controls.
4 Technical
assistance and guidance may be
obtained by contacting APHIS.
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(3) Written procedures for
decontamination, with a validated
method, of all contaminated or
potentially contaminated materials
including, but not limited to: Cultures
and other materials related to the
propagation of select agents or toxins,
items related to the analysis of select
agents or toxins, personal protective
equipment, arthropod caging systems
and extracted plant and/or arthropod
tissues.
(4) Written procedures for
decontamination, with a validated
method, of laboratory surfaces and
equipment using manufacturer’s
specification.
(5) Effluent decontamination
procedures, with a validated method,
that describe the treatment of effluent
material contaminated with select
agents or toxins.
(6) Procedures to respond to
emergencies such as spills, sharps
injury, or any other incident involving
select agents and toxins.
(7) Procedures for handling of select
agents and toxins in the same spaces as
non-select agents and toxins in order to
prevent unintentional contamination.
*
*
*
*
*
(e) * * * Drills or exercises must be
documented to include how the drill or
exercise tested and evaluated the plan,
any problems that were identified and
corrective action(s) taken, and all
individuals who participated in the drill
or exercise.
■ 10. Section 331.14 is amended as
follows:
■ a. By adding a sentence at the end of
paragraph (a).
■ b. By adding a sentence at the end of
paragraph (f).
The additions read as follows:
§ 331.14
Incident response.5
(a) * * * The current incident
response plan must be submitted for
initial registration, renewal of
registration, or when requested.
*
*
*
*
*
(f) * * * Drills or exercises must be
documented to include how the drill or
exercise tested and evaluated the plan,
any problems that were identified and
corrective action(s) taken, and all
individuals who participated in the drill
or exercise.
■ 11. Section 331.15 is amended as
follows:
■ a. By revising paragraph (a),
introductory text.
■ b. By revising paragraph (a)(1).
The revisions read as follows:
5 Nothing in this section is meant to supersede or
preempt incident response requirements imposed
by other statutes or regulations.
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§ 331.15
2769
Training.
(a) An individual or entity required to
register under this part must provide
information and training on
biocontainment, security (including
security awareness), incident response,
and agent- and toxin-specific training to:
(1) Each individual with access
approval from the Administrator, within
12 months of that individual’s
anniversary of receiving such approval
or prior to his or her entry into an area
where select agents or toxins are used or
stored, whichever occurs first; and
*
*
*
*
*
■ 12. In § 331.16, paragraph (b),
introductory text, is revised as follows:
§ 331.16
Transfers.
*
*
*
*
*
(b) A transfer may be authorized if:
*
*
*
*
*
■ 13. Section 331.17 is amended as
follows:
■ a. In paragraph (a)(1)(iii), by adding
the words ‘‘or other storage container’’
after the word ‘‘freezer’’.
■ b. By adding paragraph (a)(1)(ix).
■ c. In paragraph (a)(3)(v), by adding the
words ‘‘or other storage container’’ after
the word ‘‘freezer’’.
■ d. By adding paragraph (a)(8).
■ e. By adding a sentence at the end of
paragraph (b).
■ f. By revising paragraph (c).
The additions and revision read as
follows:
§ 331.17
Records.
(a) * * *
(1) * * *
(ix) If destroyed, the quantity (e.g.,
containers, vials, tubes, etc.) of select
agent destroyed, the date of such action,
and by whom.
*
*
*
*
*
(8) For a select agent or an extract
from a select agent that has been
rendered nonviable or regulated nucleic
acids that have been rendered noninfectious:
(i) A written description of the
inactivation process used for rendering
a select agent or an extract from a select
agent nonviable or regulated nucleic
acids non-infectious;
(ii) The sterility testing protocol used
to verify nonviability of a select agent or
an extract from a select agent or noninfectivity of regulated nucleic acids
and the results of the test, including
investigation, of any inactivation
process failures and the corrective
actions taken;
(iii) The name of each individual
performing the inactivation method and
sterility testing protocols;
(iv) The date(s) the inactivation
method and sterility testing protocols
were completed;
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(v) The location where the inactivated
method and sterility testing protocols
were performed; and
(vi) An inactivation certificate that
includes the date of inactivation,
method of inactivation, date of final
sterility testing protocol result, and the
name of the person performing the
inactivation. A copy of the inactivation
certificate must accompany any transfer
of inactivated material.
(b) * * * All written records created
under this part are legible.
(c) Any records that contain
information related to the requirements
of the regulations. Such records may
include, but are not limited to,
biocontainment certifications,
laboratory notebooks, institutional
biosafety and/or animal use committee
minutes and approved protocols, and
records associated with occupational
health and suitability programs. All
records created under this part must be
maintained for 3 years.
TITLE 9—ANIMALS AND ANIMAL
PRODUCTS
PART 121—POSSESSION, USE, AND
TRANSFER OF SELECT AGENTS AND
TOXINS
14. The authority citation for part 121
continues to read as follows:
■
Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80,
and 371.4.
15. Section 121.1 is amended by
adding, in alphabetical order,
definitions of inactivation and kill curve
to read as follows:
■
§ 121.1
Definitions.
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS
*
*
*
*
*
Inactivation. A method to render a
select agent non-viable but retain
characteristic of interest for future use,
or to render any nucleic acids that can
produce infectious forms of any select
agent virus non-infectious for future
use.
*
*
*
*
*
Kill curve. The results of a doseresponse experiment where a select
agent is subjected to increasing amounts
of the inactivating treatment to
determine the minimum conditions
required to render it non-viable, or to
render any nucleic acids that can
produce infectious forms of any select
agent virus as non-infectious.
*
*
*
*
*
■ 16. Section 121.3 is amended as
follows:
■ a. By revising paragraphs (d)(2) and
(d)(3).
■ b. By adding paragraph (d)(4).
■ c. By adding paragraph (e)(3).
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The additions and revisions read as
follows:
§ 121.3
VS select agents and toxins.
*
*
*
*
*
(d) * * *
(2) Nonviable VS select agents or
nonfunctional VS toxins.3
(i) Unless waived by the
Administrator, a select agent or
regulated nucleic acids that can produce
infectious forms of any select agent
virus that has been subjected to a
validated inactivation process to remove
viability or infectious form (i.e., the
ability to reproduce or produce disease,
while maintaining cellular structure) is
not excluded from the requirements of
this part until an entity:
(A) Develops a site-specific kill curve
to define conditions of inactivation for
each select agent or regulated nucleic
acids that can produce infectious forms
of any select agent virus. If there are
strain-to-strain variations in resistance
of a select agent to the inactivation
procedure, then a specific kill curve
must be developed for each strain that
undergoes the inactivation procedure. A
new kill curve must be created upon
any change in procedure or inactivation
equipment.
(B) Develops site-specific standard
operating inactivation procedures to
ensure that the material is inactivated
by a safety margin determined by the
kill curve.
(C) Subjects representative samples of
inactivated select agents or any nucleic
acids that can produce infectious forms
of any select agent viruses to a validated
sterility testing protocol to ensure that
the inactivation method has rendered
the select agent non-viable or regulated
nucleic acids non-infectious.
(D) Any viability of a select agent or
infectivity of regulated nucleic acids
that can produce infectious forms of any
select agent virus that was subjected to
a validated inactivation protocol is
reported to APHIS or CDC.
(E) Reviews annually, and revises as
necessary, the following:
(1) The kill curve procedure and
results;
(2) Site-specific standard operating
procedures to ensure that select agents
or regulated nucleic acids that can
produce infectious forms of any select
agent virus are inactivated by a safety
margin; and
(3) The validated sterility testing
protocol used to ensure that the
inactivation method has rendered a
select agent non-viable or regulated
3 However, the importation and interstate
movement of these nonviable select agents may be
subject to the permit requirements under part 122
of this subchapter.
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nucleic acids that can produce
infectious forms of any select agent
viruses non-infectious.
(F) Reviews, and revises as necessary,
documents listed in paragraph
(d)(2)(i)(E) of this section after any
change in principal investigator, change
in protocol, or any reported viability of
a select agent or infectivity of regulated
nucleic acids that can produce
infectious forms of any select agent
viruses previously assessed as inactive.
(ii) Unless waived by the
Administrator, an extract from a select
agent is not excluded from the
requirements of this part until an
individual or entity meets the following
requirements:
(A) Any extract is subjected to a
process that removes all viable cells,
spores, or virus particles.
(B) Any extract is subjected to a
validated sterility testing protocol to
ensure that the inactivation method has
rendered the extract free of a select
agent.
(C) Any viability of an extract that
was subjected to a validated inactivation
protocol is reported to the responsible
official.
(D) Any viability of a select agent or
infectivity of regulated nucleic acids
that can produce infectious forms of any
select agent virus that was previously
assessed as inactive by their validated
sterility testing protocol is reported to
APHIS or CDC.
(E) Reviews annually, and revises as
necessary, the following:
(1) The kill curve procedure and
results;
(2) Site-specific standard operating
procedures to ensure that select agents
or regulated nucleic acids that can
produce infectious forms of any select
agent viruses are inactivated by a safety
margin; and
(3) The validated sterility testing
protocol used to ensure that the
inactivation method has rendered a
select agent non-viable or regulated
nucleic acids that can produce
infectious forms of any select agent
viruses non-infectious.
(F) Reviews, and revises as necessary,
documents listed in paragraph
(d)(2)(ii)(E) of this section after any
change in principal investigator, change
in protocol, or any reported viability of
a select agent or infectivity of regulated
nucleic acids that can produce
infectious forms of any select agent
virus previously assessed as inactive.
(3) Any low pathogenic strains of
avian influenza virus, avian
paramyxovirus serotype-1 (APMV–1)
viruses which do not meet the criteria
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for Newcastle disease virus,4 including
those identified as pigeon
paramyxovirus-12 5 isolated from a nonpoultry species, all subspecies
Mycoplasma capricolum except
subspecies capripneumoniae
(contagious caprine pleuropneumonia),
and all subspecies Mycoplasma
mycoides except subspecies mycoides
small colony (Mmm SC) (contagious
bovine pleuropneumonia), provided
that the individual or entity can identify
that the agent is within the exclusion
category.
(4) Waste generated during the
delivery of patient care from a patient
infected with a select agent that is
decontaminated with a validated
method within 7 calendar days of the
conclusion of patient care.
(e) * * *
(3) An individual or entity may make
a written request to the Administrator
for reconsideration of a decision
denying an application for the exclusion
of an attenuated strain of a select agent
or a select toxin modified to be less
potent or toxic. The written request for
reconsideration must state the facts and
reasoning upon which the individual or
entity relies to show the decision was
incorrect. The Administrator will grant
or deny the request for reconsideration
as promptly as circumstances allow and
will state, in writing, the reasons for the
decision.
*
*
*
*
*
■ 17. Section 121.4 is amended as
follows:
■ a. In paragraph (b), by removing the
words ‘‘Bacillus anthracis (Pasteur
strain);’’, ‘‘Brucella abortus;’’, and
‘‘Brucella suis;’’.
■ b. In paragraph (c)(1), by redesignating
footnote 4 as footnote 6.
■ c. By revising paragraph (d)(2).
■ d. By adding paragraph (d)(4).
■ e. By adding paragraph (e)(3).
The additions and revision read as
follows:
§ 121.4
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*
Overlap select agents and toxins.
*
*
(d) * * *
*
*
4 An APMV–1 virus isolated from poultry which
has an intracerebral pathogenicity index in day-old
chicks (Gallus gallus) of 0.7 or greater or has an
amino acid sequence at the fusion (F) protein
cleavage site that is consistent with virulent strains
of Newcastle disease virus. A failure to detect a
cleavage site that is consistent with virulent strains
does not confirm the absence of a virulent virus.
5 Pigeon paramyxovirus (PPMV–1) is a speciesadapted APMV–1 virus which is endemic in
pigeons and doves in the United States and can be
identified through monoclonal antibody testing and
demonstration of their characteristic amino acid
signature at the fusion gene cleavage site.
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(2) Nonviable overlap select agents or
nonfunctional overlap toxins.7
(i) Unless waived by the APHIS
Administrator or HHS Secretary, a select
agent or regulated nucleic acids that can
produce infectious forms of any select
agent virus that has been subjected to a
validated inactivation process to remove
viability or infectious form (i.e., the
ability to reproduce or produce disease,
while maintaining cellular structure) is
not excluded from the requirements of
this part until an individual or entity:
(A) Develops a site-specific kill curve
to define conditions of inactivation for
each select agent or regulated nucleic
acids that can produce infectious forms
of any select agent virus. If there are
strain-to-strain variations in resistance
of a select agent to the inactivation
procedure, then a specific kill curve
must be developed for each strain that
undergoes the inactivation procedure. A
new kill curve must be created upon
any change in procedure or inactivation
equipment.
(B) Develops site-specific standard
operating inactivation procedures to
ensure that the material is inactivated
by a safety margin determined by the
kill curve.
(C) Subjects representative samples of
inactivated select agents or any
regulated nucleic acids that can produce
infectious forms of any select agent
viruses to a validated sterility testing
protocol to ensure that the inactivation
method has rendered the select agent
non-viable or regulated nucleic acids
non-infectious.
(D) Reports any viability of a select
agent or infectivity of regulated nucleic
acids that can produce infectious forms
of any select agent virus that was
subjected to a validated inactivation
protocol to the responsible official.
(E) Reviews annually, and revises as
necessary, the following:
(1) The kill curve procedure and
results;
(2) Site-specific standard operating
procedures to ensure that select agents
or regulated nucleic acids that can
produce infectious forms of any select
agent virus are inactivated by a safety
margin; and
(3) The validated sterility testing
protocol used to ensure that the
inactivation method has rendered a
select agent non-viable or regulated
nucleic acids that can produce
infectious forms of any select agent
viruses non-infectious.
(F) Reviews, and revises as necessary,
documents listed in paragraph
(d)(2)(i)(E) of this section after any
change in principal investigator, change
in protocol, or any reported viability of
a select agent or infectivity of regulated
nucleic acids that can produce
infectious forms of any select agent
virus previously assessed as inactive.
(ii) Unless waived by the APHIS
Administrator or HHS Secretary, an
extract from a select agent is not
excluded from the requirements of this
part until an individual or entity meets
the following requirements:
(A) Any extract is subjected to a
process that removes all viable cells,
spores, or virus particles.
(B) Any extract is subjected to a
validated sterility testing protocol to
ensure that the inactivation method has
rendered the extract free of a select
agent.
(C) Any viability of an extract that
was subjected to a validated inactivation
protocol is reported to the responsible
official.
(D) Any viability of a select agent or
infectivity of regulated nucleic acids
that can produce infectious forms of any
select agent virus that was previously
assessed as inactive by the validated
sterility testing protocol is reported to
APHIS or CDC.
*
*
*
*
*
(4) Waste generated during the
delivery of patient care from a patient
infected with a select agent that is
decontaminated with a validated
method within 7 calendar days of the
conclusion of patient care.
(e) * * *
(3) An individual or entity may make
a written request to the Administrator or
HHS Secretary for reconsideration of a
decision denying an application for the
exclusion of an attenuated strain of a
select agent or a select toxin modified to
be less potent or toxic. The written
request for reconsideration must state
the facts and reasoning upon which the
individual or entity relies to show the
decision was incorrect. The
Administrator or HHS Secretary will
grant or deny the request for
reconsideration as promptly as
circumstances allow and will state, in
writing, the reasons for the decision.
*
*
*
*
*
■ 18. Section 121.5 is amended as
follows:
■ a. By revising paragraphs (a)(2) and
(a)(3).
■ b. By adding paragraph (a)(4).
The addition and revisions read as
follows:
7 However, the importation and interstate
movement of these nonviable overlap select agents
may be subject to the permit requirements under
part 122 of this subchapter.
§ 121.5 Exemptions for VS select agents
and toxins.
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(a) * * *
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■
§ 121.6 Exemptions for overlap select
agents and toxins.
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(2) The agent or toxin is secured
against theft, loss, or release during the
period between identification of the
agent or toxin and transfer or
destruction of such agent or toxin, and
any theft, loss, or release of such agent
or toxin is reported;
(3) Unless directed otherwise by the
Administrator, the clinical or diagnostic
specimens collected from a patient
infected with a select agent are
transferred in accordance with § 121.16
or destroyed on-site by a recognized
sterilization or inactivation process
within 7 calendar days after delivery of
patient care has concluded; and
(4) The identification of the agent or
toxin is reported to APHIS or CDC, the
specimen provider, and to other
appropriate authorities when required
by Federal, State, or local law by
telephone, facsimile, or email. This
report must be followed by submission
of APHIS/CDC Form 4 to APHIS or CDC
within 7 calendar days after
identification.
*
*
*
*
*
■ 19. Section 121.6 is amended as
follows:
■ a. In paragraph (a)(2), by removing the
word ‘‘and’’ at the end of the paragraph.
■ b. By redesignating paragraph (a)(3) as
paragraph (a)(4).
■ c. By adding new paragraph (a)(3).
■ d. By revising newly redesignated
paragraph (a)(4).
The addition and revision read as
follows:
§ 121.9
(a) * * *
(3) Unless directed otherwise by the
Administrator or HHS Secretary, the
clinical or diagnostic specimens
collected from a patient infected with a
select agent are transferred in
accordance with § 121.16, or destroyed
on-site by a recognized sterilization or
inactivation process within 7 calendar
days after delivery of patient care has
concluded;
(4) The identification of the agent or
toxin is reported to APHIS or CDC, the
specimen provider, and to other
appropriate authorities when required
by Federal, State, or local law by
telephone, facsimile, or email. This
report must be followed by submission
of APHIS/CDC Form 4 to APHIS within
7 calendar days after identification.
*
*
*
*
*
■ 20. Section 121.7 is amended as
follows:
■ a. By redesignating paragraphs (b)
through (k) as paragraphs (c) through (l),
respectively.
■ b. By adding a new paragraph (b).
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c. In paragraph (c)(3), introductory
text, by redesignating footnote 6 as
footnote 8.
■ d. In paragraph (h)(1), by
redesignating footnote 7 as footnote 9.
The addition reads as follows:
§ 121.7 Registration and related security
risk assessments.
*
*
*
*
*
(b) As a condition of registration, each
entity is required to be in compliance
with the requirements of this part for
select agents and toxins listed on the
registration regardless of whether the
entity is in actual possession of the
select agent or toxin. With regard to
toxins, the entity registered for
possession, use, or transfer of a toxin
must be in compliance with the
requirements of this part regardless of
the amount of toxin currently in
possession.
*
*
*
*
*
§ 121.8
[Amended]
21. In § 121.8, footnote 8 is
redesignated as footnote 10.
■ 22. Section 121.9 is amended as
follows:
■ a. In paragraph (a)(6), by removing the
word ‘‘laboratory’’ and adding the
words ‘‘registered space’’ in its place
and by adding the words ‘‘and the
corrections documented’’ at the end of
the second sentence after the words
‘‘must be corrected’’.
■ b. By adding paragraph (a)(7).
The addition reads as follows:
■
Responsible official.
(a) * * *
(7) Ensure that individuals are
provided the contact information for the
USDA or HHS Office of Inspector
General Hotline so that they may
anonymously report any safety or
security concerns related to select
agents and toxins.
*
*
*
*
*
■ 23. In § 121.10, paragraph (e) is
amended by adding a sentence at the
end of the paragraph to read as follows:
§ 121.10 Restricting access to select
agents and toxins; security risk
assessments.
*
*
*
*
*
(e) * * * A responsible official must
immediately notify the responsible
official of the visited entity if the
person’s access to select agents and
toxins has been terminated.
*
*
*
*
*
■ 24. Section 121.11 is amended as
follows:
■ a. In paragraph (c)(5), by adding the
word ‘‘keycards,’’ after the word ‘‘keys,’’
and by removing the word ‘‘numbers’’
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and adding the word ‘‘permissions’’ in
its place.
■ b. By adding paragraph (c)(11).
■ c. In paragraph (d)(7)(iv), by removing
the word ‘‘and’’.
■ d. By adding paragraph (d)(7)(vi).
■ e. By adding a sentence at the end of
paragraph (h).
The additions read as follows:
§ 121.11
Security.
*
*
*
*
*
(c) * * *
(11) Describe how the entity
authorizes the means of entry into areas
where select agents or toxins are stored
or used to include centralized access
control management systems (e.g.,
keycards) and/or mechanical key
management.
(d) * * *
(7) * * *
(vi) Any loss of computer, hard drive
or other data storage device containing
information that could be used to gain
access to select agents or toxins.
*
*
*
*
*
(h) * * * Drills or exercises must be
documented to include how the drill or
exercise tested and evaluated the plan,
any problems that were identified and
corrective action(s) taken, and all
individuals who participated in the drill
or exercise.
■ 25. Section 121.12 is amended as
follows:
■ a. By revising paragraph (a).
■ b. By removing paragraph (c)(2).
■ c. By redesignating paragraph (c)(3) as
paragraph (c)(2), and removing the
words ‘‘NIH Guidelines for Research
Involving Recombinant DNA
Molecules’’ and replacing them with the
words ‘‘NIH Guidelines for Research
Involving Recombinant or Synthetic
Nucleic Acid Molecules’’.
■ d. By adding a sentence at the end of
paragraph (e).
The addition and revision read as
follows:
§ 121.12
Biosafety.
(a) An individual or entity required to
register under this part must develop
and implement a written biosafety plan
that is commensurate with the risk of
the select agent or toxin, given its
intended use.11 The biosafety plan must
contain sufficient information and
documentation to describe the biosafety
and containment procedures for the
select agent or toxin, including any
animals (including arthropods) or plants
intentionally or accidentally exposed to
or infected with a select agent. Biosafety
and containment procedures specific to
11 Technical assistance and guidance may be
obtained by contacting APHIS.
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each registered laboratory must be
available to each individual working in
that laboratory. The current biosafety
plan must be submitted for initial
registration, renewal of registration, or
when requested. The biosafety plan
must include the following provisions:
(1) A written risk assessment for each
procedure involving a select agent or
toxin that addresses the hazards
associated with the agent or toxin.
(i) The hazardous characteristics of
each agent or toxin listed on the entity’s
registration, including probable routes
of transmission in the laboratory and in
the environment, infective dose (if
known), stability in the environment,
host range, contribution of any genetic
manipulations, and endemicity.
(ii) Hazards associated with laboratory
procedures related to the select agent or
toxin.
(2) Safeguards in place with
associated work practices to protect
registered entity personnel, the public,
and the environment from exposure to
the select agent or toxin including, but
not limited to: Safety training
requirements for registered entity
personnel performing the procedure;
required personal protective equipment
and other safety equipment; required
containment equipment including, but
not limited to, biological safety cabinets,
animal caging systems, and centrifuge
safety containers; and required
engineering controls and other facility
safeguards.
(3) Written procedures for
decontamination, with a validated
method, of all contaminated or
potentially contaminated materials
including, but not limited to: Cultures
and other materials related to the
propagation of select agents or toxins,
items related to the analysis of select
agents and toxins, personal protective
equipment, animal caging systems and
bedding, and animal carcasses or
extracted tissues.
(4) Written procedures for
decontamination, with a validated
method, of laboratory surfaces and
equipment using manufacturer’s
specification.
(5) Effluent decontamination
procedures, with a validated method,
that describe the treatment of effluent
material contaminated with select
agents and toxins.
(6) Procedures to respond to
emergencies such as spills, sharps
injury, or animal bites involving select
agents and toxins.
(7) Procedures for the handling of
select agents and toxins in the same
spaces with non-select agents and toxins
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in order to prevent unintentional
contamination.
*
*
*
*
*
(e) * * * Drills or exercises must be
documented to include how the drill or
exercise tested and evaluated the plan,
any problems identified and corrective
action(s) that were taken, and all
individuals who participated in the drill
or exercise.
■ 26. Section 121.14 is amended as
follows:
■ a. In paragraph (a), by redesignating
footnote 11 as footnote 13, and by
adding a sentence at the end of the
paragraph.
■ b. In paragraph (f), by adding a
sentence at the end of the paragraph.
The additions read as follows:
§ 121.14
Incident response.12
(a) * * * The current incident
response plan must be submitted for
initial registration, renewal of
registration, or when requested.
*
*
*
*
*
(f) * * * Drills or exercises must be
documented to include how the drill or
exercise tested and evaluated the plan,
any problems identified and corrective
action(s) that were taken, and all
individuals who participated in the drill
or exercise.
■ 27. Section 121.15 is amended as
follows:
■ a. By revising paragraphs (a),
introductory text, and (a)(1).
■ b. By adding paragraph (e).
The addition and revisions read as
follows:
§ 121.15
Training.
(a) An individual or entity required to
register under this part must provide
information and training on
biocontainment, biosafety, security
(including security awareness), incident
response, and agent- and toxin-specific
training to:
(1) Each individual with access
approval from the HHS Secretary or
Administrator, within 12 months of that
individual’s anniversary of receiving
such approval or prior to his or her
entry into an area where select agents or
toxins are used or stored, whichever
occurs first; and
*
*
*
*
*
(e) The responsible official must
ensure and document that individuals
are provided the contact information of
the HHS or USDA Office of Inspector
General Hotline so that they may
anonymously report any safety or
security concerns related to select
agents and toxins.
12 Nothing in this section is meant to supersede
or preempt incident response requirements
imposed by other statutes or regulations.
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28. Section § 121.16 is amended as
follows:
■ a. In paragraph (a), by redesignating
footnote 12 as footnote 14.
■ b. By revising paragraph (b),
introductory text.
■ c. By adding paragraph (l).
The addition and revision read as
follows:
■
§ 121.16
Transfers.
*
*
*
*
*
(b) A transfer may be authorized if:
*
*
*
*
*
(l) Transfer the amounts only after the
transferor uses due diligence and
documents that the recipient has a
legitimate need (i.e., prophylactic,
protective, bona fide research, or other
peaceful purpose) to handle or use such
toxins. Information to be documented
includes, but is not limited, to the
recipient information, toxin and amount
transferred, and declaration that the
recipient has legitimate purpose to store
and use such toxins.
■ 29. Section 121.17 is amended as
follows:
■ a. In paragraph (a)(1)(iii), by adding
the words ‘‘or other storage container’’
after the word ‘‘freezer’’.
■ b. By adding paragraph (a)(1)(ix).
■ c. In paragraph (a)(3)(v), by adding the
words ‘‘or other storage container’’ after
the word ‘‘freezer’’.
■ d. By adding paragraph (a)(8).
■ e. By adding a sentence at the end of
paragraph (b).
■ f. By revising paragraph (c).
The additions and revision read as
follows:
§ 121.17
Records.
(a) * * *
(1) * * *
(ix) If destroyed, the quantity (e.g.,
containers, vials, tubes, etc.) of select
agent destroyed, the date of such action,
and by whom.
*
*
*
*
*
(8) For a select agent or an extract
from a select agent that has been
rendered non-viable or regulated
nucleic acids that can produce
infectious forms of any select agent
virus that have been rendered noninfectious through inactivation:
(i) A written description of the
inactivation process used for rendering
a select agent non-viable or regulated
nucleic acids that can produce
infectious forms of any select agent
virus non-infectious;
(ii) The sterility testing protocol used
to verify non-viability of a select agent
or non-infectivity of regulated nucleic
acids that can produce infectious forms
of any select agent virus and the results
of the test, including investigation, of
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any inactivation process failures and the
corrective actions taken;
(iii) The name of each individual
performing the inactivation method and
sterility testing protocols;
(iv) The date(s) the inactivation
method and sterility testing protocols
were completed;
(v) The location where the inactivated
method and sterility testing protocols
were performed; and
(vi) An inactivation certificate that
includes the date of inactivation,
method of inactivation, date of final
sterility testing protocol result, and the
Principal Investigator. A copy of the
inactivation certificate must accompany
any transfer of inactivated material.
(b) * * * All written records created
under this part are legible.
(c) Any records that contain
information related to the requirements
of the regulations. Such records may
include, but are not limited to,
certifications, laboratory notebooks,
institutional biosafety and/or animal use
committee minutes and approved
protocols, and records associated with
occupational health and suitability
programs. All records created under this
part must be maintained for 3 years.
Done in Washington, DC, this 8th day of
January 2016.
Kevin Shea,
Administrator, Animal and Plant Health
Inspection Service.
[FR Doc. 2016–00681 Filed 1–14–16; 4:15 pm]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Grain Inspection, Packers and
Stockyards Administration
7 CFR Part 810
United States Standards for Sunflower
Seed
Grain Inspection, Packers and
Stockyards Administration, USDA.
ACTION: Request for information.
AGENCY:
The United States Department
of Agriculture’s (USDA) Grain
Inspection, Packers, and Stockyards
Administration (GIPSA) is seeking
comment from the public regarding the
United States (U.S.) Standards for
Sunflower Seed under the United States
Grain Standards Act (USGSA). To
ensure that standards and official
grading practices remain relevant,
GIPSA invites interested parties to
comment on whether the current
sunflower seed standards and grading
practices need to be changed.
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS
SUMMARY:
VerDate Sep<11>2014
15:55 Jan 15, 2016
Jkt 238001
We will consider comments we
receive by April 18, 2016.
ADDRESSES: You may submit written or
electronic comments on this proposed
rule to:
• Mail: Irene Omade, GIPSA, USDA,
STOP 3642, 1400 Independence Avenue
SW., Room 2530–B, Washington, DC
20250–3604.
• Fax: (202) 690–2173
• Internet: Go to https://
www.regulations.gov and follow the online instruction for submitting
comments.
All comments will become a matter of
public record and should be identified
as ‘‘U.S. Standards for Sunflower Seed
request for information comments,’’
making reference to the date and page
number of this issue of the Federal
Register. All comments received
become the property of the Federal
government, are a part of the public
record, and will generally be posted to
www.regulations.gov without change. If
you send an email comment directly to
GIPSA without going through
www.regulations.gov, or you submit a
comment to GIPSA via fax, the
originating email address or telephone
number will be automatically captured
and included as part of the comment
that is placed in the public docket and
made available on the Internet. Also, all
personal identifying information (for
example, name, address, etc.)
voluntarily submitted by the commenter
may be publicly accessible. Do not
submit confidential business
information or otherwise sensitive or
protected information.
Electronic submissions should avoid
the use of special characters, avoid any
form of encryption, and be free of any
defects or viruses, since these may
prevent GIPSA from being able to read
and understand, and thus consider your
comment.
GIPSA will post a transcript or report
summarizing each substantive oral
comment that we receive. This would
include comments made at any public
meetings hosted by GIPSA during the
comment period, unless GIPSA
publically announces otherwise.
All comments will also be available
for public inspection at the above
address during regular business hours (7
CFR 1.27(b)). Please call the GIPSA
Management and Budget Services
support staff (202) 720–8479 for an
appointment to view the comments.
FOR FURTHER INFORMATION CONTACT:
Andrew Greenfield at GIPSA, USDA,
1400 Independence Avenue SW.,
Washington. DC 20250; Telephone (202)
720–0277; Fax Number (202) 720–1015;
email Andrew.S.Greenfield@usda.gov..
DATES:
PO 00000
Frm 00013
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Under the
authority of the USGSA (7 U.S.C. 76),
GIPSA establishes standards for
sunflower seed and other grains
regarding kind, class, quality and
condition. The sunflower seed
standards, established by USDA on
September 1, 1984, were last revised in
1988 and appear in the USGSA
regulations at 7 CFR 810.1801 through
810.1804. The standards facilitate
sunflower seed marketing and define
U.S. sunflower seed quality in the
domestic and global marketplace. The
standards define commonly used
industry terms; contain basic principles
governing the application of standards,
such as the type of sample used for a
particular quality analysis; the basis of
determination; and specify grades and
grade requirements. Official procedures
for determining grading factors are
provided in GIPSA’s Grain Inspection
Handbook, Book II, Chapter 11,
‘‘Sunflower Seed’’ which also includes
standardized procedures for additional
quality attributes not used to determine
grade, such as moisture content and
official criteria. Together, the grading
standards and testing procedures allow
buyers and sellers to communicate
quality requirements, compare
sunflower seed quality using equivalent
forms of measurement and assist in
price discovery.
GIPSA’s grading and inspection
services are provided through a network
of federal, state, and private laboratories
that conduct tests to determine the
quality and condition of sunflower seed.
These tests are conducted in accordance
with applicable standards using
approved methodologies and can be
applied at any point in the marketing
chain. Furthermore, the tests yield
rapid, reliable and consistent results. In
addition, GIPSA-issued certificates
describing the quality and condition of
graded sunflower seed are accepted as
prima facie evidence in all Federal
courts. U.S. Standards for Sunflower
Seed and the affiliated grading and
testing services offered by GIPSA verify
that a seller’s sunflower seed meets
specified requirements, and ensure that
customers receive the quality of
sunflower seed they purchased.
In order for U.S. standards and
grading procedures for sunflower seed
to remain relevant, GIPSA is issuing this
request for information to invite
interested parties to submit comments,
ideas, and suggestions on all aspects of
the U.S. Standards for Sunflower Seed
and inspection procedures.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\19JAP1.SGM
19JAP1
Agencies
[Federal Register Volume 81, Number 11 (Tuesday, January 19, 2016)]
[Proposed Rules]
[Pages 2762-2774]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-00681]
========================================================================
Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
========================================================================
Federal Register / Vol. 81, No. 11 / Tuesday, January 19, 2016 /
Proposed Rules
[[Page 2762]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
7 CFR Part 331
9 CFR Part 121
[Docket No. APHIS-2014-0095]
RIN 0579-AE08
Agricultural Bioterrorism Protection Act of 2002; Biennial Review
and Republication of the Select Agent and Toxin List; Amendments to the
Select Agent and Toxin Regulations
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: In accordance with the Agricultural Bioterrorism Protection
Act of 2002, we are proposing to amend and republish the list of select
agents and toxins that have the potential to pose a severe threat to
animal or plant health, or to animal or plant products. The Act
requires the biennial review and republication of the list of select
agents and toxins and the revision of the list as necessary. This
action would implement the findings of the fourth biennial review of
the list. In addition, we are proposing several amendments to the
regulations, including the addition of provisions to address the
inactivation of select agents, provisions addressing biocontainment and
biosafety, and clarification of regulatory language concerning
security, training, incident response, and records. These changes would
increase the usability of the select agent regulations as well as
provide for enhanced program oversight.
DATES: We will consider all comments that we receive on or before March
21, 2016.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to https://www.regulations.gov/#!docketDetail;D=APHIS-2014-0095.
Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2014-0095, 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-2014-
0095 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.
FOR FURTHER INFORMATION CONTACT: Dr. Freeda Isaac, National Director,
Agriculture Select Agent Services, APHIS, 4700 River Road Unit 2,
Riverdale, MD 20737-1231; (301) 851-3300, Option 3.
SUPPLEMENTARY INFORMATION: The Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 (referred to below as the
Bioterrorism Response Act) provides for the regulation of certain
biological agents that have the potential to pose a severe threat to
both human and animal health, to animal health, to plant health, or to
animal and plant products. The Animal and Plant Health Inspection
Service (APHIS) has the primary responsibility for implementing the
provisions of the Act within the United States Department of
Agriculture (USDA). Veterinary Services (VS) select agents and toxins
are those that have been determined to have the potential to pose a
severe threat to animal health or animal products. Plant Protection and
Quarantine (PPQ) select agents and toxins are those that have the
potential to pose a severe threat to plant health or plant products.
Overlap select agents and toxins are those that have been determined to
pose a severe threat to both human and animal health or to human health
and animal products. Overlap select agents are subject to regulation by
both APHIS and the Centers for Disease Control and Prevention (CDC),
which has the primary responsibility for implementing the provisions of
the Bioterrorism Response Act for the Department of Health and Human
Services (HHS).
Subtitle B (which is cited as the ``Agricultural Bioterrorism
Protection Act of 2002'' and referred to below as the Act), section
212(a), provides, in part, that the Secretary of Agriculture (the
Secretary) must establish by regulation a list of each biological agent
and each toxin that the Secretary determines has the potential to pose
a severe threat to animal or plant health, or to animal or plant
products. Paragraph (a)(2) of section 212 requires the Secretary to
review and republish the list every 2 years and to revise the list as
necessary. In this document, we are proposing to amend and republish
the list of select agents and toxins based on the findings of our
fourth biennial review of the list.
In determining whether to include an agent or toxin on the list,
the Act requires that the following criteria be considered:
The effect of exposure to the agent or the toxin on animal
and plant health, and on the production and marketability of animal or
plant products;
The pathogenicity of the agent or the toxin and the
methods by which the agent or toxin is transferred to animals or
plants;
The availability and effectiveness of pharmacotherapies
and prophylaxis to treat and prevent any illness caused by the agent or
toxin; and
Any other criteria that the Secretary considers
appropriate to protect animal or plant health, or animal or plant
products.
We use the term ``select agents and toxins'' throughout the
preamble of this proposed rule. Unless otherwise specified, the term
``select agents and toxins'' will refer to all agents or toxins listed
by APHIS. When it is necessary to specify the type of select agent or
toxin, we will use the following terms: ``PPQ select agents and
toxins'' (for the plant agents and toxins listed in 7 CFR 331.3), ``VS
select agents and toxins'' (for the animal agents and toxins listed in
9 CFR 121.3), or ``overlap select agents and toxins'' (for the overlap
agents and toxins listed in both 9 CFR 121.4 and 42 CFR 73.4).
On February 27, 2015, we published in the Federal Register (80 FR
10627, Docket No. APHIS-2014-0095) an advance notice of proposed
rulemaking
[[Page 2763]]
and request for comments (ANPR) \1\ in order to announce our intention
to review the select agent list. We solicited comments regarding
potential additions and deletions from the list of select agents and
toxins for 60 days ending April 28, 2015. We received 20 comments by
that date. They were from scientists, scientific organizations, a State
government, private individuals, and industry groups. Suggestions in
these comments were used in order to inform our discussions on the
content of the select agent list.
---------------------------------------------------------------------------
\1\ To view the ANPR and the comments we received, go to https://www.regulations.gov/#!docketDetail;D=APHIS-2014-0095.
---------------------------------------------------------------------------
PPQ Select Agents and Toxins
APHIS's PPQ program convened an interagency working group to review
the list of PPQ select agents and toxins and develop recommendations
regarding possible changes to that list. Using the four criteria for
listing found in the Act, economic crop data, current Federal
quarantine notices, and new scientific information, the working group
revisited the currently listed PPQ select agents and toxins and
evaluated a number of new plant pathogens for inclusion on the list.
Based on this review, APHIS is proposing to amend the list of PPQ
select agents and toxins listed in 7 CFR 331.3 by removing three PPQ
select agents and toxins from the list. Specifically, we are proposing
to remove the following:
Peronosclerospora philippinensis (Peronosclerospora
sacchari) and Sclerophthora rayssiae: There are no viable cultures of
these corn pathogens currently held in U.S. laboratories, they are
difficult to grow or maintain, difficult to keep viable during
transport, and would require a large amount of inoculum to infect
fields by artificial means due to the fact that they must spread via
infected plant material; and
Phoma glycinicola (formerly Pyrenochaeta glycines): This
soybean pathogen's natural distribution is limited to two countries in
Africa, it does not spread rapidly in the field, soybean importation
pathways into the United States by which the pathogen might enter are
limited, and while no U.S. soybean variety is immune to this pathogen,
Environmental Protection Agency-approved fungicides are available to
treat any infestation.
VS Select Agents and Toxins
APHIS' VS program also convened an interagency working group to
review the list of VS select agents and toxins and the list of overlap
select agents and toxins in 9 CFR part 121 in order to consider changes
to the lists. Based on the review, APHIS is proposing to remove three
overlap select agents and toxins from the list set out in Sec.
121.4(b):
Bacillus anthracis (Pasteur strain): Historically, the B.
anthracis Pasteur strain has been retained as a select agent to allow
for continued oversight of laboratories in which the accidental (or
intentional) combination of this strain with the excluded Sterne strain
could occur to produce the wild type phenotype B. anthracis de novo.
However, a recent study \2\ indicates that bacterial transformation of
B. subtilis with plasmid DNA is inefficient; indicating that
transformation with bacteria such as B. anthracis (e.g., pXO1 into B.
anthracis Pasteur strain) would also be inefficient. Given that B.
anthracis Pasteur strain does not encode the plasmid which carries the
pathogenic toxin genes, analogous to the Sterne strain which was
excluded from Select Agent oversight in 2003, we believe there is no
potential for high animal mortality rates or for misuse that might
result in social or economic disruption. Therefore, we are proposing
that the Pasteur strain be removed from the overlap select agent list.
---------------------------------------------------------------------------
\2\ C. Johnston, B. Martin, G. Fichant, P. Polard, and J.P.
Claverys. ``Bacterial transformation: distribution, shared
mechanisms and divergent control.'' Nature Reviews Microbiology.
2014. 12: 181-196.
---------------------------------------------------------------------------
Brucella abortus and Brucella suis: While both of these
organisms have been eradicated from the domestic livestock industry,
they are currently endemic in wildlife and feral swine populations in
the United States. However, there is an extensive regulatory control
program in place for B. abortus in the remaining affected Designated
Surveillance Area. APHIS has also recently enacted a national program
to control feral swine that will include surveillance and disease
monitoring for swine brucellosis. Therefore, we believe the effect of
exposure to these agents on animal health and on the production and
marketability of animal products is minimized. We are proposing that
these two Brucella species be removed from the overlap select agent
list. However, Brucella melitensis, as a foreign animal disease agent
not currently found in the United States, would be kept as a VS select
agent.
Accordingly, CDC will also be proposing a parallel change to its
overlap select agent regulations.
Additional Changes
We are proposing to make several changes to the regulations,
including the addition of provisions to address the inactivation of
select agents, provisions addressing biocontainment and biosafety, and
clarification of regulatory language concerning security, training,
incident response, and records. These changes, which are described in
detail below, would increase the usability of the select agent
regulations as well as provide for enhanced program oversight.
Definitions
In 7 CFR 331.1 and 9 CFR 121.1, we are proposing to add definitions
for inactivation and kill curve. We believe these definitions are
necessary as they are included in the additional biocontainment and
biosafety language we are proposing to add to the regulations.
The definition of inactivation would be established as ``a method
to render a select agent non-viable but retain characteristic of
interest for future use, or to render any nucleic acids that can
produce infectious forms of any select agent virus non-infectious for
future use.'' This definition draws a distinction between inactivation
for waste treatment and inactivation of regulated material for future
purposes such as research. The definition of kill curve would be
established as ``the results of a dose-response experiment where a
select agent is subjected to increasing amounts of the inactivating
treatment to determine the minimum conditions required to render it
non-viable or to render any nucleic acids that can produce infectious
forms of any select agent virus as non-infectious.''
Exclusions and Inactivation
We are proposing to amend 7 CFR 331.3(d)(2), 9 CFR 121.3(d)(2), and
9 CFR 121.4(d)(2), which currently exclude nonviable select agents or
nonfunctional toxins from the requirements of the regulations, in order
to clarify our policy that an entity must use a validated method to
render a select agent nonviable or regulated nucleic acids non-
infectious for future use. This means that the method must be
scientifically sound and that it will produce consistent results each
time it is used.
We are proposing that inactivation include the use of one of the
following: The exact conditions of a commonly accepted method that has
been validated as applied (e.g., autoclaving), a published method with
adherence to the exact published conditions (i.e., extrapolations or
deductions are to be avoided), or in-house methods, only if validation
testing includes the specific conditions used and appropriate controls.
[[Page 2764]]
We are also proposing that the entity develop a site-specific kill
curve in order to define conditions of inactivation for each select
agent or regulated nucleic acid. If there are strain-to-strain
variations in the resistance of a select agent to the inactivation
procedure, then a specific kill curve would have to be developed for
each strain that undergoes the inactivation procedure. A new kill curve
would have to be created upon any change in procedure or inactivation
equipment. In addition, a validated sterility testing protocol would
have to be conducted in order to ensure that the inactivation method
has rendered a select agent nonviable or regulated nucleic acids non-
infectious.
In addition, we are proposing that an entity be required to report
any viability of a select agent or infectivity of regulated nucleic
acids that can produce infectious forms of any select agent virus that
was subjected to a validated inactivation protocol to APHIS or CDC.
We are also proposing to require that an entity review annually,
and revise as necessary, the following: (1) The kill curve procedure
and results; (2) site-specific standard operating procedures to ensure
that select agents or regulated nucleic acids that can produce
infectious forms of any select agent virus are inactivated by a safety
margin; and (3) the validated sterility testing protocol used to ensure
that the inactivation method has rendered a select agent non-viable or
regulated nucleic acids that can produce infectious forms of any select
agent viruses non-infectious.
Finally, we are proposing that written records be kept for any
select agent that has been rendered nonviable or regulated nucleic
acids that have been rendered non-infectious. We are particularly
requesting comments regarding whether there are more specific measures
available to demonstrate that a select agent has been rendered
nonviable, or a regulated infectious nucleic acid has been rendered
non-infectious.
We are also proposing to add to 7 CFR 331.3(e), 9 CFR 121.3(e), and
9 CFR 121.4(e) a paragraph stating that an individual or entity may
make a written request to the Administrator for reconsideration of a
decision denying an exclusion application. The written request for
reconsideration would have to state the facts and reasoning upon which
the individual or entity relies to show the decision was incorrect. The
Administrator would grant or deny the request for reconsideration as
promptly as circumstances allow and will state, in writing, the reasons
for the decision. This language was included in previous versions of
the regulations and was erroneously removed by an earlier rulemaking.
Exemptions for Select Agents and Toxins
Sections 7 CFR 331.5, 9 CFR 121.5, and 9 CFR 121.6 concern
conditions under which entities may be exempted from the requirements
of the regulations. Paragraph (a) requires that the identification of
the agent or toxin be reported to APHIS or CDC. Since select agents and
toxins have the potential to pose a severe threat to both human and
animal health, to animal health, to plant health, or to animal and
plant products, clinical and diagnostic laboratories typically have
their initial results confirmed by a registered or certified reference
laboratory. We are proposing to require that in addition to notifying
APHIS or CDC, the reference laboratory inform the specimen provider
upon confirmation of the identification of a select agent or toxin.
This change would clarify our expectations regarding communication and
notification between the reference laboratory and the specimen
provider.
We are also proposing to add language to paragraph (a) in sections
7 CFR 331.5, 9 CFR 121.5, and 9 CFR 121.6 that specifies that entities
may be required to report identification of agents or toxins to other
appropriate authorities when required by Federal, State, or local law.
This language was added to the CDC select agent regulations in a
previous rulemaking, but not to the APHIS regulations and this change
is necessary in order to achieve uniformity across all regulations
associated with the diagnosis and care for individuals infected with a
select agent or toxin. Specifically, we are proposing to add provisions
that state that we do not regulate material containing select agents or
toxins when it is in a patient care setting and is not being collected
or otherwise tested or retained, nor do we regulate waste generated
during delivery of patient care. However, once delivery of patient care
for the select agent or toxin infection has concluded, these specimens
would become subject to the requirements of the regulations. If an
entity cannot meet these requirements, then the material may be
transferred to another entity according to the select agent regulations
or destroyed using an approved method. The decision to retain,
transfer, or destroy any specimens must be made within 7 calendar days
of the conclusion of patient care. These requirements would be set out
in new paragraphs 9 CFR 121.3(d)(4) and 9 CFR 121.4(d)(4).
Registration and Related Security Risk Assessments
The regulations in 7 CFR 331.7 and 9 CFR 121.7 set out registration
requirements for those entities that wish to work with select agents
and toxins and stipulates the individuals within those entities that
must undergo a security risk assessment by the Attorney General.
We are proposing to state that an entity registered to possess,
use, or transfer a select agent or toxin would have to meet the
requirements of the regulations for those select agents and toxins
listed on the entity's official registration regardless of whether the
entity is in possession of those select agents or toxins and without
regard to the amount of select agents or toxins in the entity's
possession. This change would serve to codify existing policy and would
be added as a new paragraph (b).
Responsible Official
The regulations in 7 CFR 331.9 and 9 CFR 121.9 set out requirements
for entities requesting to work with select agents and toxins to
designate a responsible official, who ensures that the entity continues
to meet the requirements of the regulations.
Paragraph (a)(6) requires the responsible official to ensure that
annual inspections are conducted for each location where select agents
or toxins are stored or used in order to determine compliance with the
regulations. The responsible official also must document the results of
each inspection and identify and address any deficiencies.
We are proposing to require that any corrections of deficiencies
found must also be documented. This change is necessary to improve
recordkeeping practices and to provide a more complete account of
facility containment and security procedures. We are also proposing to
replace the word ``laboratory'' with the phrase ``registered space.''
This terminology is more accurate, as registered spaces are not always
laboratories.
We are also proposing to add a new paragraph (a)(7), which would
require the entity's responsible official to provide contact
information for the USDA or HHS Office of Inspector General Hotline, so
that employees and other individuals may anonymously report any
containment or security concerns they may have. Although the select
agent program has established a whistleblower portal on its Web site,
there is currently no requirement for employees at registered entities
to be
[[Page 2765]]
made aware of its existence or how to use it. Adding this requirement
would allow for increased worker involvement in biosafety/
biocontainment and security programs at registered entities and may
also enhance the quality of Federal oversight in this area.
Security Risk Assessments
We are proposing to amend the regulations in 7 CFR 331.10 and 9 CFR
121.10. These regulations establish parameters for restricting access
to select agents and toxins and the process by which individuals may be
approved for access to select agents and toxins after the completion of
a security risk assessment by the Attorney General.
Paragraph (e) states that a person with valid approval from the HHS
Secretary or Administrator to have access to select agents or toxins
may request, through his or her responsible official, that the HHS
Secretary or APHIS Administrator provide their approved access status
to another registered individual or entity for a specified period of
time. We are proposing to also require that the responsible official at
the visiting person's home entity notify the host entity if that
person's approved access to select agents or toxins has been
terminated. This would ensure that an individual whose permissions have
been terminated would not be allowed further access to select agents
and toxins.
Security, Biocontainment/Biosafety, and Incident Response Plans
The regulations require registered entities to develop and
implement a number of plans in order to ensure the safety and security
of the select agents they handle. These are:
A security plan, as described by the regulations in 7 CFR
331.11 and 9 CFR 121.11, that provides for measures sufficient to
safeguard the select agent or toxin against unauthorized access, theft,
loss, or release;
A biocontainment plan, in the case of PPQ select agents,
or a biosafety plan, in the case of VS and overlap select agents, as
described in the regulations in 7 CFR 331.12 and 9 CFR 121.12, that
provides for measures sufficient to contain the select agent or toxin
(e.g., physical structure and features of the entity, and operational
and procedural safeguards); and
An incident response plan, as described in the regulations
in 7 CFR 331.14 and 9 CFR 121.14, that provides for measures that the
registered entity will implement in the event of theft, loss, or
release of a select agent or toxin; inventory discrepancies; security
breaches (including information systems); severe weather and other
natural disasters; workplace violence; bomb threats and suspicious
packages; and emergencies such as fire, gas leak, explosion, power
outage, etc. The response procedures must account for hazards
associated with the select agent or toxin and appropriate actions to
contain such agent or toxin.
All of these plans require annual review and revision as necessary.
Drills or exercises must also be conducted at least annually to test
and evaluate the effectiveness of the plans. The plans must be reviewed
and revised, as necessary, after any drill or exercise and after any
incident. We are proposing to require that these drills or exercises be
documented to include how the drill or exercise tested and evaluated
the plan, any problems identified, any corrective action taken, and the
names of the individuals who participated in the drill or exercise.
This will provide a more thorough accounting of required activities as
well as increasing the efficacy of the plans via testing and entity-
directed improvements. We are proposing to add these requirements to 7
CFR 331.11(h), 331.12(e), 331.14(f), 9 CFR 121.11(h), 121.12(e), and
121.14(f).
We are also proposing to add a requirement that the biocontainment,
biosafety, and incident response plans be submitted for initial
registration, renewal of registration, or when requested. These
additions would be located in 7 CFR 331.12(a), 331.14(a), 9 CFR
121.12(a), and 121.14(a). This change is necessary in order to bring
the requirements for these plans in line with existing requirements for
the security plan.
Details of the changes we are proposing to the security,
biosecurity, and biosafety plans individually may be found below.
Security Plan
Paragraph (c)(5) of 7 CFR 331.11 and 9 CFR 121.11 requires that the
security plan describe procedures for addressing loss or compromise of
keys, passwords, combinations, etc. and protocols for changing access
numbers or locks following staff changes. We are proposing to add
keycards to that list as they are commonly used. We are also proposing
to use the term ``access permissions'' instead of the term ``access
numbers,'' as it covers a broader range of topics.
We are also proposing to add a new paragraph (c)(11) to the
regulations in 7 CFR 331.11 and 9 CFR 121.11. This would require that
the security plan contain a description of how the entity authorizes
the means of entry into areas where select agents or toxins are stored
or used, which would include a description of all centralized access
control management systems (e.g., keycards) and/or mechanical key
management. This requirement would allow us to directly ascertain the
way in which entities allow individuals entry to areas containing
select agents and toxins and potentially identify any weaknesses in
that process.
In the same sections, paragraphs (d)(7)(i) through (d)(7)(v)
encompass a list of activities that individuals with access approval
from the Administrator or the HHS Secretary must immediately report to
the responsible official. We are proposing to add a new paragraph
(d)(7)(vi) to require that the responsible official must be notified of
any loss of computer, hard drive, or other data storage device
containing information that can be used to gain access to select agents
or toxins. Such notification will facilitate notification of the
Federal Bureau of Investigation if deemed necessary by the responsible
official as the loss of such equipment may be criminal in nature.
Biocontainment/Biosafety Plan
Paragraph (a) of 7 CFR 331.12 and 9 CFR 121.12 requires that the
biocontainment or biosafety plan contain sufficient information and
documentation to describe the biosafety and containment procedures for
each select agent or toxin that the registered entity will possess. The
plan must also include a description of the biosafety and containment
procedures for any animals (including arthropods) or plants
intentionally or accidentally exposed to or infected with a select
agent. We are proposing to additionally require that laboratory-
specific biocontainment and/or biosafety manuals must be accessible to
individuals working in those laboratories. This change would help to
foster an enhanced culture of responsibility by ensuring that
appropriate biocontainment and/or biosafety resources are available to
all staff with access to select agents and toxins within a select agent
laboratory.
In the aftermath of recent biosafety incidents involving an
unintentional release of potentially viable anthrax within the CDC's
Roybal Campus, in Atlanta, GA, and the inadvertent cross-contamination
and shipment of a laboratory specimen of low-pathogenic avian influenza
virus with the VS select agent highly pathogenic avian influenza virus,
we believe that the biocontainment and biosafety plans should be
designed according to a site-specific risk assessment in accordance
with the risk posed by a select agent or toxin. Therefore, we are
proposing to
[[Page 2766]]
add specific provisions to the biocontainment and biosafety plans that
would require completion of a written risk assessment for each
procedure. This risk assessment would have to include the following
elements: A description of the safeguards in place to protect entity
personnel, the public, and the environment from exposure to the select
agent or toxin; decontamination procedures; waste management
procedures; and procedures for handling select agents and toxins in the
same spaces as non-select agents and toxins in order to prevent
unintentional cross-contamination.
We are specifically requesting comments regarding any specific
biocontainment or biosafety measures to prevent laboratory acquired
infections or accidental or intentional release of the select agents
and toxins from an entity into the community.
Finally, paragraph (c)(2) of 9 CFR 121.12 requires that entities
should consider the guidance found in the Occupational Safety and
Health Administration regulations in 29 CFR 1910.1200 and 1910.1450. We
are proposing to remove this reference as the information in those
regulations is also contained in the CDC/National Institutes of Health
publication, ``Biosafety in Microbiological and Biomedical
Laboratories,'' which is referenced in paragraph (c)(1) and a second
reference is therefore duplicative.
Training
We are proposing to amend the regulations in 7 CFR 331.15 and 9 CFR
121.15, which concern provision of mandatory training for staff and
visitors who work in or visit areas where select agents or toxins are
handled or stored. We are proposing to require that all individuals who
have received approval to have access to select agents and toxins must
undergo training regardless of whether they have access to those select
agents or toxins. The training would have to be completed within a year
of that individual's approval or prior to entry into an area where
select agents and toxins are used or stored, whichever occurs first.
This change is necessary in order to codify our position regarding
which individuals at registered entities are required to receive
training.
Transfers
We are proposing to amend the regulations in 7 CFR 331.16 and 9 CFR
121.16, which concern the transfer of select agents and toxins to a
registered entity. Specifically, paragraph (b) states that select
agents and toxins may need a permit issued in accordance with 7 CFR
part 330 or 9 CFR part 122. We have determined that a permit for the
importation or interstate movement of a select agent or toxin listed in
7 CFR 331.3, 9 CFR 121.3, or 121.4 is not required for such importation
and/or interstate movement provided that the select agent or toxin is
authorized for transfer in accordance with 7 CFR 331.16(b) or 9 CFR
121.16(b).
Records
The regulations in 7 CFR 331.17 and 9 CFR 121.17 concern required
recordkeeping procedures for regulated entities as those records relate
to select agents and toxins. Paragraph (a)(3)(x) requires that
registered entities record the destruction of any toxins by
specifically noting the quantity of toxin destroyed, the date of such
action, and by whom. However, there is not an equivalent requirement
regarding the destruction of select agents. We are proposing to add
this requirement in order to ensure consistency with the toxin
provisions and ensure proper tracking of select agents from acquisition
to destruction. These requirements would be added in a new paragraph
(a)(1)(ix).
We are also proposing to require that regulated entities maintain
records concerning those select agents that have been rendered
nonviable or regulated nucleic acids that have been rendered non-
infectious. These records would specifically capture the activities
detailed under the heading ``Exclusions and Inactivation'' above. Such
recordkeeping is necessary in order to confirm that an entity has
performed the procedures necessary. The select agent program would then
have the ability to review those records in order to ensure that the
entity is performing all procedures necessary for nonviability or
inactivation. The requirements would be added in a new paragraph (a)(8)
in 7 CFR 331.17 and 9 CFR 121.17.
We are also proposing to state that any records created that
contain information related to an entity's registration or its select
agents and toxins must be provided promptly upon request. This
requirement would be added to revised paragraph (c). Given the wide
variety of entities regulated under the Federal Select Agent Program,
the scope of records readily available for program review will enhance
the ability of the program to evaluate entity biosafety,
biocontainment, security, and incident response programs. Paragraph (c)
in both 7 CFR 331.17 and 9 CFR 121.17 would also be revised to specify
that such records may include, but are not limited to, biocontainment
certifications, laboratory notebooks, institutional biosafety and/or
animal use committee minutes and approved protocols, and records
associated with occupational health and suitability programs.
Finally, paragraph (b) in both 7 CFR 331.17 and 9 CFR 121.17
requires that regulated entities implement a system to ensure that all
records and databases created under this part are accurate, have
controlled access, and that their authenticity may be verified. To
ensure the accuracy of handwritten records, we are proposing to specify
that such records must be legible.
Records for Select Agents in Long-Term Storage
Paragraph (a)(1) in both 7 CFR 331.17 and 9 CFR 121.17 requires
entities to maintain an accurate, current inventory for each select
agent (including viral genetic elements, recombinant and/or synthetic
nucleic acids, and organisms containing recombinant and/or synthetic
nucleic acids) held in long-term storage. We continue to receive
comments critical of that portion of the regulations. Criticism is
typically focused on the belief that a container-based inventory
requirement is not a useful mechanism to track inventory of biological
agents, since small amounts could be stolen without detection and used
to grow larger quantities.
However, the Public Health Security and Bioterrorism Preparedness
and Response Act of 2002 obliges APHIS and CDC to include a requirement
for ``the prompt notification of the Secretary, and appropriate
Federal, State, and local law enforcement agencies, of the theft or
loss of listed agents and toxins'' in the regulations. We are therefore
soliciting comment regarding what regulatory requirement or
requirements should be implemented such that a registered entity could
quickly determine whether a select agent had been lost or stolen from
long-term storage without that registered entity first having an
accurate, current inventory for each select agent held in long-term
storage. Additionally, we are soliciting ideas concerning ways in which
the current regulations could be amended to address the possibility of
theft of a select agent from a container held in long-term storage.
Executive Order 12866 and Regulatory Flexibility Act
This proposed rule has been determined to be not significant for
the purposes of Executive Order 12866 and, therefore, has not been
reviewed by the Office of Management and Budget.
[[Page 2767]]
In accordance with the Regulatory Flexibility Act, we have analyzed
the potential economic effects of this action on small entities. The
analysis is summarized below. Copies of the full analysis are available
by contacting the person listed under FOR FURTHER INFORMATION CONTACT
or on the Regulations.gov Web site (see ADDRESSES above for
instructions for accessing Regulations.gov).
The Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 (Pub. L. 107-188) provides for the regulation of
certain biological agents and toxins that have the potential to pose a
severe threat to human, animal, or plant health, or to animal or plant
products. APHIS has completed its fourth biennial review of select
agent regulations and is proposing changes that would increase their
usability as well as provide for enhanced program oversight. The
proposed amendments include provisions to address the inactivation of
select agents, provisions addressing biosafety, and clarification of
regulatory language concerning security, training, incident response,
and records.
The proposed rule would require that entities develop an agent-
specific kill curve in order to define conditions of inactivation for
each select agent or regulated infectious nucleic acid and maintain
written records of having done so.\3\ Costs of complying with this
amendment are therefore expected to be modest.
---------------------------------------------------------------------------
\3\ The definition of kill curve would be ``the results of a
dose-response experiment where a select agent is subjected to
increasing amounts of the inactivating treatment to determine the
minimum conditions required to render it non-viable or to render any
nucleic acids that can produce infectious forms of any select agent
virus as non-infectious.''
---------------------------------------------------------------------------
Currently, there are 291 entities registered with APHIS and CDC. Of
these entities, there are 240 registered to possess Tier 1 select
agents and toxins, including 78 academic, 29 commercial, 80 State
government, 37 Federal government, and 16 private (non-profit)
institutions, most of which are considered to be small entities. Based
on proposed record keeping and reporting requirements, an additional 10
to 20 hours per year may be required. At an imputed cost of $33.40 per
hour (GS-12, step 2), this additional time requirement per entity would
cost between $334 and $668 per year, or in total for all registered
entities between $80,000 and $160,000.
Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action would
not have a significant economic impact on a substantial number of small
entities.
Executive Order 12372
This program/activity is listed in the Catalog of Federal Domestic
Assistance under No. 10.025 and is subject to Executive Order 12372,
which requires intergovernmental consultation with State and local
officials. (See 2 CFR chapter IV.)
Executive Order 12988
This proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. If this proposed rule is adopted: (1) All State
and local laws and regulations that are inconsistent with this rule
will be preempted; (2) no retroactive effect will be given to this
rule; and (3) administrative proceedings will not be required before
parties may file suit in court challenging this rule.
Paperwork Reduction Act
In accordance with section 3507(d) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), we have determined that there is
burden associated with this action. We will publish a separate document
in the Federal Register, announcing our determination of burden and
soliciting comments on it.
E-Government Act Compliance
The Animal and Plant Health Inspection Service is committed to
compliance with the E-Government Act to promote the use of the Internet
and other information technologies, to provide increased opportunities
for citizen access to Government information and services, and for
other purposes. For information pertinent to E-Government Act
compliance related to this proposed rule, please contact Ms. Kimberly
Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727.
List of Subjects
7 CFR Part 331
Agricultural research, Laboratories, Plant diseases and pests,
Reporting and recordkeeping requirements.
9 CFR Part 121
Agricultural research, Animal diseases, Laboratories, Medical
research, Reporting and recordkeeping requirements.
Accordingly, we propose to amend 7 CFR part 331 and 9 CFR part 121
as follows:
TITLE 7--AGRICULTURE
PART 331--POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS
0
1. The authority citation for part 331 continues to read as follows:
Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80, and 371.3.
0
2. Section 331.1 is amended by adding, in alphabetical order,
definitions of inactivation and kill curve to read as follows:
Sec. 331.1 Definitions.
* * * * *
Inactivation. A method to render a select agent non-viable but
retain characteristic of interest for future use, or to render any
nucleic acids that can produce infectious forms of any select agent
virus non-infectious for future use.
* * * * *
Kill curve. The results of a dose-response experiment where a
select agent is subjected to increasing amounts of the inactivating
treatment to determine the minimum conditions required to render it
non-viable, or to render any nucleic acids that can produce infectious
forms of any select agent virus as non-infectious.
* * * * *
0
3. Section 331.3 is amended as follows:
0
a. In paragraph (b), by removing the words ``Peronosclerospora
philippinensis (Peronosclerospora sacchari);'', ``Phoma glycinicola
(formerly Pyrenochaeta glycines);'', and ``Sclerophthora rayssiae;''
0
b. By revising paragraph (d)(2).
0
c. By adding paragraph (e)(3).
The addition and revision read as follows:
Sec. 331.3 PPQ select agents and toxins.
* * * * *
(d) * * *
(2) Nonviable select agents or nonfunctional toxins.
(i) Unless waived by the Administrator, a select agent or regulated
nucleic acids that can produce infectious forms of any select agent
virus that has been subjected to a validated inactivation process to
remove viability or infectious form (i.e., the ability to reproduce or
produce disease, while maintaining cellular structure) is not excluded
from the requirements of this part until an individual or entity:
(A) Develops a site-specific kill curve to define conditions of
inactivation for each select agent or regulated nucleic acids that can
produce infectious forms
[[Page 2768]]
of any select agent virus. If there are strain-to-strain variations in
resistance of a select agent to the inactivation procedure, then a
specific kill curve must be developed for each strain that undergoes
the inactivation procedure. A new kill curve must be created upon any
change in procedure or inactivation equipment.
(B) Develops site-specific standard operating inactivation
procedures to ensure that the material is inactivated by a safety
margin determined by the kill curve.
(C) Subjects representative samples of inactivated select agents or
any nucleic acids that can produce infectious forms of any select agent
viruses to a validated sterility testing protocol to ensure that the
inactivation method has rendered the select agent non-viable or
regulated nucleic acids non-infectious.
(D) Any viability of a select agent or infectivity of regulated
nucleic acids that can produce infectious forms of any select agent
virus that was subjected to a validated inactivation protocol is
reported to APHIS.
(E) Reviews annually, and revises as necessary, the following:
(1) The kill curve procedure and results;
(2) Site-specific standard operating procedures to ensure that
select agents or regulated nucleic acids that can produce infectious
forms of any select agent virus are inactivated by a safety margin; and
(3) The validated sterility testing protocol used to ensure that
the inactivation method has rendered a select agent non-viable or
regulated nucleic acids that can produce infectious forms of any select
agent virus sample non-infectious.
(F) Reviews, and revises as necessary, documents listed in
paragraph (d)(2)(i)(E) of this section after any change in principal
investigator, change in protocol, or any reported viability of a select
agent or infectivity of regulated nucleic acids that can produce
infectious forms of any select agent viruses previously assessed as
inactive.
(ii) Unless waived by the Administrator, an extract from a select
agent is not excluded from the requirements of this part until an
individual or entity meets the following requirements:
(A) Any extract is subjected to a process that removes all viable
cells, spores, or virus particles.
(B) Any extract is subjected to a validated sterility testing
protocol to ensure that the inactivation method has rendered the
extract free of a select agent.
(C) Any viability of an extract that was subjected to a validated
inactivation protocol is reported to the responsible official.
(D) Any viability of a select agent or infectivity of regulated
nucleic acids that can produce infectious forms of any select agent
virus that was previously assessed as inactive by their validated
sterility testing protocol is reported to APHIS.
* * * * *
(e) * * *
(3) An individual or entity may make a written request to the
Administrator for reconsideration of a decision denying an application
for the exclusion of an attenuated strain of a select agent or a select
toxin modified to be less potent or toxic. The written request for
reconsideration must state the facts and reasoning upon which the
individual or entity relies to show the decision was incorrect. The
Administrator will grant or deny the request for reconsideration as
promptly as circumstances allow and will state, in writing, the reasons
for the decision.
* * * * *
0
4. In Sec. 331.5, paragraph (a)(3) is revised to read as follows:
Sec. 331.5 Exemptions.
(a) * * *
(3) The identification of the agent or toxin is reported to APHIS,
the specimen provider, and to other appropriate authorities when
required by Federal, State, or local law by telephone, facsimile, or
email. This report must be followed by submission of APHIS/CDC Form 4
to APHIS within 7 calendar days after identification.
* * * * *
0
5. Section 331.7 is amended as follows:
0
a. By redesignating paragraphs (b) through (k) as paragraphs (c)
through (l), respectively.
0
b. By adding a new paragraph (b).
The addition reads as follows:
Sec. 331.7 Registration and related security risk assessments.
* * * * *
(b) As a condition of registration, each entity is required to be
in compliance with the requirements of this part for select agents and
toxins listed on the registration regardless of whether the entity is
in actual possession of the select agent or toxin. In regard to toxins,
the entity registered for possession, use, or transfer of toxins must
be in compliance with the requirements of this part regardless of the
amounts of toxins currently in possession.
* * * * *
0
6. Section 331.9 is amended as follows:
0
a. In paragraph (a)(6), by removing the word ``laboratory'' and adding
the words ``registered space'' in its place and by adding the words
``and the corrections documented'' at the end of the second sentence
after the words ``must be corrected''.
0
b. By adding paragraph (a)(7).
The addition reads as follows:
Sec. 331.9 Responsible official.
(a) * * *
(7) Ensure that individuals are provided the contact information
for the USDA or HHS Office of Inspector General Hotline so that they
may anonymously report any biosafety/biocontainment or security
concerns related to select agents and toxins.
* * * * *
0
7. In Sec. 331.10, paragraph (e) is amended by adding a sentence at
the end of the paragraph to read as follows:
Sec. 331.10 Restricting access to select agents and toxins; security
risk assessments.
* * * * *
(e) * * * A responsible official must immediately notify the
responsible official of the visiting entity if the person's access to
select agents or toxins has been terminated.
* * * * *
0
8. Section 331.11 is amended as follows:
0
a. In paragraph (c)(5), by adding the word ``keycards,'' after the word
``keys,'' and by removing the word ``numbers'' and adding the word
``permissions'' in its place.
0
b. By adding paragraph (c)(11).
0
c. In paragraph (d)(7)(iv), by removing the word ``and''.
0
d. By adding paragraph (d)(7)(vi).
0
e. By adding a sentence at the end of paragraph (h).
The additions read as follows:
Sec. 331.11 Security.
* * * * *
(c) * * *
(11) Describe how the entity authorizes the means of entry into
areas where select agents or toxins are stored or used to include
centralized access control management systems (e.g., keycards) and/or
mechanical key management.
(d) * * *
(7) * * *
(vi) Any loss of computer, hard drive or other data storage device
containing information that can be used to gain access to select agents
or toxins.
* * * * *
(h) * * * Drills or exercises must be documented to include how the
drill or
[[Page 2769]]
exercise tested and evaluated the plan, any problems that were
identified and corrective action(s) taken, and all individuals who
participated in the drill or exercise.
0
9. Section 331.12 is amended as follows:
0
a. By revising paragraph (a).
0
b. By adding a sentence at the end of paragraph (e).
The addition and revision read as follows:
Sec. 331.12 Biocontainment.
(a) An individual or entity required to register under this part
must develop and implement a written biocontainment plan that is
commensurate with the risk of the select agent or toxin, given its
intended use.\4\ The biocontainment plan must contain sufficient
information and documentation to describe the biocontainment procedures
for the select agent or toxin, including any animals (including
arthropods) or plants intentionally or accidentally exposed to or
infected with a select agent. The biocontainment procedures specific to
each registered laboratory must be available to each individual working
in that laboratory. The current biocontainment plan must be submitted
for initial registration, renewal of registration, or when requested.
The biocontainment plan must include the following provisions:
---------------------------------------------------------------------------
\4\ Technical assistance and guidance may be obtained by
contacting APHIS.
---------------------------------------------------------------------------
(1) A written risk assessment for each prescribed procedure
involving a select agent or toxin.
(i) The hazardous characteristics of the agent or toxin listed on
the entity's registration, including probable routes of transmission in
the laboratory and in the environment, infective dose (if known),
stability in the environment, host range, contribution of any genetic
manipulations, and endemicity.
(ii) Hazards associated with laboratory procedures related to the
select agent or toxin.
(2) Safeguards in place with associated containment procedures to
protect registered entity personnel, the public, and the environment
from exposure to the select agent or toxin including, but not limited
to: Safety training requirements for registered entity personnel
performing the procedure; required personal protective equipment;
required containment equipment including, but not limited to,
biological safety cabinets, arthropod caging systems, and centrifuge
safety containers; and required physical plant engineering controls.
(3) Written procedures for decontamination, with a validated
method, of all contaminated or potentially contaminated materials
including, but not limited to: Cultures and other materials related to
the propagation of select agents or toxins, items related to the
analysis of select agents or toxins, personal protective equipment,
arthropod caging systems and extracted plant and/or arthropod tissues.
(4) Written procedures for decontamination, with a validated
method, of laboratory surfaces and equipment using manufacturer's
specification.
(5) Effluent decontamination procedures, with a validated method,
that describe the treatment of effluent material contaminated with
select agents or toxins.
(6) Procedures to respond to emergencies such as spills, sharps
injury, or any other incident involving select agents and toxins.
(7) Procedures for handling of select agents and toxins in the same
spaces as non-select agents and toxins in order to prevent
unintentional contamination.
* * * * *
(e) * * * Drills or exercises must be documented to include how the
drill or exercise tested and evaluated the plan, any problems that were
identified and corrective action(s) taken, and all individuals who
participated in the drill or exercise.
0
10. Section 331.14 is amended as follows:
0
a. By adding a sentence at the end of paragraph (a).
0
b. By adding a sentence at the end of paragraph (f).
The additions read as follows:
Sec. 331.14 Incident response.\5\
---------------------------------------------------------------------------
\5\ Nothing in this section is meant to supersede or preempt
incident response requirements imposed by other statutes or
regulations.
---------------------------------------------------------------------------
(a) * * * The current incident response plan must be submitted for
initial registration, renewal of registration, or when requested.
* * * * *
(f) * * * Drills or exercises must be documented to include how the
drill or exercise tested and evaluated the plan, any problems that were
identified and corrective action(s) taken, and all individuals who
participated in the drill or exercise.
0
11. Section 331.15 is amended as follows:
0
a. By revising paragraph (a), introductory text.
0
b. By revising paragraph (a)(1).
The revisions read as follows:
Sec. 331.15 Training.
(a) An individual or entity required to register under this part
must provide information and training on biocontainment, security
(including security awareness), incident response, and agent- and
toxin-specific training to:
(1) Each individual with access approval from the Administrator,
within 12 months of that individual's anniversary of receiving such
approval or prior to his or her entry into an area where select agents
or toxins are used or stored, whichever occurs first; and
* * * * *
0
12. In Sec. 331.16, paragraph (b), introductory text, is revised as
follows:
Sec. 331.16 Transfers.
* * * * *
(b) A transfer may be authorized if:
* * * * *
0
13. Section 331.17 is amended as follows:
0
a. In paragraph (a)(1)(iii), by adding the words ``or other storage
container'' after the word ``freezer''.
0
b. By adding paragraph (a)(1)(ix).
0
c. In paragraph (a)(3)(v), by adding the words ``or other storage
container'' after the word ``freezer''.
0
d. By adding paragraph (a)(8).
0
e. By adding a sentence at the end of paragraph (b).
0
f. By revising paragraph (c).
The additions and revision read as follows:
Sec. 331.17 Records.
(a) * * *
(1) * * *
(ix) If destroyed, the quantity (e.g., containers, vials, tubes,
etc.) of select agent destroyed, the date of such action, and by whom.
* * * * *
(8) For a select agent or an extract from a select agent that has
been rendered nonviable or regulated nucleic acids that have been
rendered non-infectious:
(i) A written description of the inactivation process used for
rendering a select agent or an extract from a select agent nonviable or
regulated nucleic acids non-infectious;
(ii) The sterility testing protocol used to verify nonviability of
a select agent or an extract from a select agent or non-infectivity of
regulated nucleic acids and the results of the test, including
investigation, of any inactivation process failures and the corrective
actions taken;
(iii) The name of each individual performing the inactivation
method and sterility testing protocols;
(iv) The date(s) the inactivation method and sterility testing
protocols were completed;
[[Page 2770]]
(v) The location where the inactivated method and sterility testing
protocols were performed; and
(vi) An inactivation certificate that includes the date of
inactivation, method of inactivation, date of final sterility testing
protocol result, and the name of the person performing the
inactivation. A copy of the inactivation certificate must accompany any
transfer of inactivated material.
(b) * * * All written records created under this part are legible.
(c) Any records that contain information related to the
requirements of the regulations. Such records may include, but are not
limited to, biocontainment certifications, laboratory notebooks,
institutional biosafety and/or animal use committee minutes and
approved protocols, and records associated with occupational health and
suitability programs. All records created under this part must be
maintained for 3 years.
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
PART 121--POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS
0
14. The authority citation for part 121 continues to read as follows:
Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80, and 371.4.
0
15. Section 121.1 is amended by adding, in alphabetical order,
definitions of inactivation and kill curve to read as follows:
Sec. 121.1 Definitions.
* * * * *
Inactivation. A method to render a select agent non-viable but
retain characteristic of interest for future use, or to render any
nucleic acids that can produce infectious forms of any select agent
virus non-infectious for future use.
* * * * *
Kill curve. The results of a dose-response experiment where a
select agent is subjected to increasing amounts of the inactivating
treatment to determine the minimum conditions required to render it
non-viable, or to render any nucleic acids that can produce infectious
forms of any select agent virus as non-infectious.
* * * * *
0
16. Section 121.3 is amended as follows:
0
a. By revising paragraphs (d)(2) and (d)(3).
0
b. By adding paragraph (d)(4).
0
c. By adding paragraph (e)(3).
The additions and revisions read as follows:
Sec. 121.3 VS select agents and toxins.
* * * * *
(d) * * *
(2) Nonviable VS select agents or nonfunctional VS toxins.\3\
---------------------------------------------------------------------------
\3\ However, the importation and interstate movement of these
nonviable select agents may be subject to the permit requirements
under part 122 of this subchapter.
---------------------------------------------------------------------------
(i) Unless waived by the Administrator, a select agent or regulated
nucleic acids that can produce infectious forms of any select agent
virus that has been subjected to a validated inactivation process to
remove viability or infectious form (i.e., the ability to reproduce or
produce disease, while maintaining cellular structure) is not excluded
from the requirements of this part until an entity:
(A) Develops a site-specific kill curve to define conditions of
inactivation for each select agent or regulated nucleic acids that can
produce infectious forms of any select agent virus. If there are
strain-to-strain variations in resistance of a select agent to the
inactivation procedure, then a specific kill curve must be developed
for each strain that undergoes the inactivation procedure. A new kill
curve must be created upon any change in procedure or inactivation
equipment.
(B) Develops site-specific standard operating inactivation
procedures to ensure that the material is inactivated by a safety
margin determined by the kill curve.
(C) Subjects representative samples of inactivated select agents or
any nucleic acids that can produce infectious forms of any select agent
viruses to a validated sterility testing protocol to ensure that the
inactivation method has rendered the select agent non-viable or
regulated nucleic acids non-infectious.
(D) Any viability of a select agent or infectivity of regulated
nucleic acids that can produce infectious forms of any select agent
virus that was subjected to a validated inactivation protocol is
reported to APHIS or CDC.
(E) Reviews annually, and revises as necessary, the following:
(1) The kill curve procedure and results;
(2) Site-specific standard operating procedures to ensure that
select agents or regulated nucleic acids that can produce infectious
forms of any select agent virus are inactivated by a safety margin; and
(3) The validated sterility testing protocol used to ensure that
the inactivation method has rendered a select agent non-viable or
regulated nucleic acids that can produce infectious forms of any select
agent viruses non-infectious.
(F) Reviews, and revises as necessary, documents listed in
paragraph (d)(2)(i)(E) of this section after any change in principal
investigator, change in protocol, or any reported viability of a select
agent or infectivity of regulated nucleic acids that can produce
infectious forms of any select agent viruses previously assessed as
inactive.
(ii) Unless waived by the Administrator, an extract from a select
agent is not excluded from the requirements of this part until an
individual or entity meets the following requirements:
(A) Any extract is subjected to a process that removes all viable
cells, spores, or virus particles.
(B) Any extract is subjected to a validated sterility testing
protocol to ensure that the inactivation method has rendered the
extract free of a select agent.
(C) Any viability of an extract that was subjected to a validated
inactivation protocol is reported to the responsible official.
(D) Any viability of a select agent or infectivity of regulated
nucleic acids that can produce infectious forms of any select agent
virus that was previously assessed as inactive by their validated
sterility testing protocol is reported to APHIS or CDC.
(E) Reviews annually, and revises as necessary, the following:
(1) The kill curve procedure and results;
(2) Site-specific standard operating procedures to ensure that
select agents or regulated nucleic acids that can produce infectious
forms of any select agent viruses are inactivated by a safety margin;
and
(3) The validated sterility testing protocol used to ensure that
the inactivation method has rendered a select agent non-viable or
regulated nucleic acids that can produce infectious forms of any select
agent viruses non-infectious.
(F) Reviews, and revises as necessary, documents listed in
paragraph (d)(2)(ii)(E) of this section after any change in principal
investigator, change in protocol, or any reported viability of a select
agent or infectivity of regulated nucleic acids that can produce
infectious forms of any select agent virus previously assessed as
inactive.
(3) Any low pathogenic strains of avian influenza virus, avian
paramyxovirus serotype-1 (APMV-1) viruses which do not meet the
criteria
[[Page 2771]]
for Newcastle disease virus,\4\ including those identified as pigeon
paramyxovirus-12 \5\ isolated from a non-poultry species, all
subspecies Mycoplasma capricolum except subspecies capripneumoniae
(contagious caprine pleuropneumonia), and all subspecies Mycoplasma
mycoides except subspecies mycoides small colony (Mmm SC) (contagious
bovine pleuropneumonia), provided that the individual or entity can
identify that the agent is within the exclusion category.
---------------------------------------------------------------------------
\4\ An APMV-1 virus isolated from poultry which has an
intracerebral pathogenicity index in day[hyphen]old chicks (Gallus
gallus) of 0.7 or greater or has an amino acid sequence at the
fusion (F) protein cleavage site that is consistent with virulent
strains of Newcastle disease virus. A failure to detect a cleavage
site that is consistent with virulent strains does not confirm the
absence of a virulent virus.
\5\ Pigeon paramyxovirus (PPMV-1) is a species-adapted APMV-1
virus which is endemic in pigeons and doves in the United States and
can be identified through monoclonal antibody testing and
demonstration of their characteristic amino acid signature at the
fusion gene cleavage site.
---------------------------------------------------------------------------
(4) Waste generated during the delivery of patient care from a
patient infected with a select agent that is decontaminated with a
validated method within 7 calendar days of the conclusion of patient
care.
(e) * * *
(3) An individual or entity may make a written request to the
Administrator for reconsideration of a decision denying an application
for the exclusion of an attenuated strain of a select agent or a select
toxin modified to be less potent or toxic. The written request for
reconsideration must state the facts and reasoning upon which the
individual or entity relies to show the decision was incorrect. The
Administrator will grant or deny the request for reconsideration as
promptly as circumstances allow and will state, in writing, the reasons
for the decision.
* * * * *
0
17. Section 121.4 is amended as follows:
0
a. In paragraph (b), by removing the words ``Bacillus anthracis
(Pasteur strain);'', ``Brucella abortus;'', and ``Brucella suis;''.
0
b. In paragraph (c)(1), by redesignating footnote 4 as footnote 6.
0
c. By revising paragraph (d)(2).
0
d. By adding paragraph (d)(4).
0
e. By adding paragraph (e)(3).
The additions and revision read as follows:
Sec. 121.4 Overlap select agents and toxins.
* * * * *
(d) * * *
(2) Nonviable overlap select agents or nonfunctional overlap
toxins.\7\
---------------------------------------------------------------------------
\7\ However, the importation and interstate movement of these
nonviable overlap select agents may be subject to the permit
requirements under part 122 of this subchapter.
---------------------------------------------------------------------------
(i) Unless waived by the APHIS Administrator or HHS Secretary, a
select agent or regulated nucleic acids that can produce infectious
forms of any select agent virus that has been subjected to a validated
inactivation process to remove viability or infectious form (i.e., the
ability to reproduce or produce disease, while maintaining cellular
structure) is not excluded from the requirements of this part until an
individual or entity:
(A) Develops a site-specific kill curve to define conditions of
inactivation for each select agent or regulated nucleic acids that can
produce infectious forms of any select agent virus. If there are
strain-to-strain variations in resistance of a select agent to the
inactivation procedure, then a specific kill curve must be developed
for each strain that undergoes the inactivation procedure. A new kill
curve must be created upon any change in procedure or inactivation
equipment.
(B) Develops site-specific standard operating inactivation
procedures to ensure that the material is inactivated by a safety
margin determined by the kill curve.
(C) Subjects representative samples of inactivated select agents or
any regulated nucleic acids that can produce infectious forms of any
select agent viruses to a validated sterility testing protocol to
ensure that the inactivation method has rendered the select agent non-
viable or regulated nucleic acids non-infectious.
(D) Reports any viability of a select agent or infectivity of
regulated nucleic acids that can produce infectious forms of any select
agent virus that was subjected to a validated inactivation protocol to
the responsible official.
(E) Reviews annually, and revises as necessary, the following:
(1) The kill curve procedure and results;
(2) Site-specific standard operating procedures to ensure that
select agents or regulated nucleic acids that can produce infectious
forms of any select agent virus are inactivated by a safety margin; and
(3) The validated sterility testing protocol used to ensure that
the inactivation method has rendered a select agent non-viable or
regulated nucleic acids that can produce infectious forms of any select
agent viruses non-infectious.
(F) Reviews, and revises as necessary, documents listed in
paragraph (d)(2)(i)(E) of this section after any change in principal
investigator, change in protocol, or any reported viability of a select
agent or infectivity of regulated nucleic acids that can produce
infectious forms of any select agent virus previously assessed as
inactive.
(ii) Unless waived by the APHIS Administrator or HHS Secretary, an
extract from a select agent is not excluded from the requirements of
this part until an individual or entity meets the following
requirements:
(A) Any extract is subjected to a process that removes all viable
cells, spores, or virus particles.
(B) Any extract is subjected to a validated sterility testing
protocol to ensure that the inactivation method has rendered the
extract free of a select agent.
(C) Any viability of an extract that was subjected to a validated
inactivation protocol is reported to the responsible official.
(D) Any viability of a select agent or infectivity of regulated
nucleic acids that can produce infectious forms of any select agent
virus that was previously assessed as inactive by the validated
sterility testing protocol is reported to APHIS or CDC.
* * * * *
(4) Waste generated during the delivery of patient care from a
patient infected with a select agent that is decontaminated with a
validated method within 7 calendar days of the conclusion of patient
care.
(e) * * *
(3) An individual or entity may make a written request to the
Administrator or HHS Secretary for reconsideration of a decision
denying an application for the exclusion of an attenuated strain of a
select agent or a select toxin modified to be less potent or toxic. The
written request for reconsideration must state the facts and reasoning
upon which the individual or entity relies to show the decision was
incorrect. The Administrator or HHS Secretary will grant or deny the
request for reconsideration as promptly as circumstances allow and will
state, in writing, the reasons for the decision.
* * * * *
0
18. Section 121.5 is amended as follows:
0
a. By revising paragraphs (a)(2) and (a)(3).
0
b. By adding paragraph (a)(4).
The addition and revisions read as follows:
Sec. 121.5 Exemptions for VS select agents and toxins.
(a) * * *
[[Page 2772]]
(2) The agent or toxin is secured against theft, loss, or release
during the period between identification of the agent or toxin and
transfer or destruction of such agent or toxin, and any theft, loss, or
release of such agent or toxin is reported;
(3) Unless directed otherwise by the Administrator, the clinical or
diagnostic specimens collected from a patient infected with a select
agent are transferred in accordance with Sec. 121.16 or destroyed on-
site by a recognized sterilization or inactivation process within 7
calendar days after delivery of patient care has concluded; and
(4) The identification of the agent or toxin is reported to APHIS
or CDC, the specimen provider, and to other appropriate authorities
when required by Federal, State, or local law by telephone, facsimile,
or email. This report must be followed by submission of APHIS/CDC Form
4 to APHIS or CDC within 7 calendar days after identification.
* * * * *
0
19. Section 121.6 is amended as follows:
0
a. In paragraph (a)(2), by removing the word ``and'' at the end of the
paragraph.
0
b. By redesignating paragraph (a)(3) as paragraph (a)(4).
0
c. By adding new paragraph (a)(3).
0
d. By revising newly redesignated paragraph (a)(4).
The addition and revision read as follows:
Sec. 121.6 Exemptions for overlap select agents and toxins.
(a) * * *
(3) Unless directed otherwise by the Administrator or HHS
Secretary, the clinical or diagnostic specimens collected from a
patient infected with a select agent are transferred in accordance with
Sec. 121.16, or destroyed on-site by a recognized sterilization or
inactivation process within 7 calendar days after delivery of patient
care has concluded;
(4) The identification of the agent or toxin is reported to APHIS
or CDC, the specimen provider, and to other appropriate authorities
when required by Federal, State, or local law by telephone, facsimile,
or email. This report must be followed by submission of APHIS/CDC Form
4 to APHIS within 7 calendar days after identification.
* * * * *
0
20. Section 121.7 is amended as follows:
0
a. By redesignating paragraphs (b) through (k) as paragraphs (c)
through (l), respectively.
0
b. By adding a new paragraph (b).
0
c. In paragraph (c)(3), introductory text, by redesignating footnote 6
as footnote 8.
0
d. In paragraph (h)(1), by redesignating footnote 7 as footnote 9.
The addition reads as follows:
Sec. 121.7 Registration and related security risk assessments.
* * * * *
(b) As a condition of registration, each entity is required to be
in compliance with the requirements of this part for select agents and
toxins listed on the registration regardless of whether the entity is
in actual possession of the select agent or toxin. With regard to
toxins, the entity registered for possession, use, or transfer of a
toxin must be in compliance with the requirements of this part
regardless of the amount of toxin currently in possession.
* * * * *
Sec. 121.8 [Amended]
0
21. In Sec. 121.8, footnote 8 is redesignated as footnote 10.
0
22. Section 121.9 is amended as follows:
0
a. In paragraph (a)(6), by removing the word ``laboratory'' and adding
the words ``registered space'' in its place and by adding the words
``and the corrections documented'' at the end of the second sentence
after the words ``must be corrected''.
0
b. By adding paragraph (a)(7).
The addition reads as follows:
Sec. 121.9 Responsible official.
(a) * * *
(7) Ensure that individuals are provided the contact information
for the USDA or HHS Office of Inspector General Hotline so that they
may anonymously report any safety or security concerns related to
select agents and toxins.
* * * * *
0
23. In Sec. 121.10, paragraph (e) is amended by adding a sentence at
the end of the paragraph to read as follows:
Sec. 121.10 Restricting access to select agents and toxins; security
risk assessments.
* * * * *
(e) * * * A responsible official must immediately notify the
responsible official of the visited entity if the person's access to
select agents and toxins has been terminated.
* * * * *
0
24. Section 121.11 is amended as follows:
0
a. In paragraph (c)(5), by adding the word ``keycards,'' after the word
``keys,'' and by removing the word ``numbers'' and adding the word
``permissions'' in its place.
0
b. By adding paragraph (c)(11).
0
c. In paragraph (d)(7)(iv), by removing the word ``and''.
0
d. By adding paragraph (d)(7)(vi).
0
e. By adding a sentence at the end of paragraph (h).
The additions read as follows:
Sec. 121.11 Security.
* * * * *
(c) * * *
(11) Describe how the entity authorizes the means of entry into
areas where select agents or toxins are stored or used to include
centralized access control management systems (e.g., keycards) and/or
mechanical key management.
(d) * * *
(7) * * *
(vi) Any loss of computer, hard drive or other data storage device
containing information that could be used to gain access to select
agents or toxins.
* * * * *
(h) * * * Drills or exercises must be documented to include how the
drill or exercise tested and evaluated the plan, any problems that were
identified and corrective action(s) taken, and all individuals who
participated in the drill or exercise.
0
25. Section 121.12 is amended as follows:
0
a. By revising paragraph (a).
0
b. By removing paragraph (c)(2).
0
c. By redesignating paragraph (c)(3) as paragraph (c)(2), and removing
the words ``NIH Guidelines for Research Involving Recombinant DNA
Molecules'' and replacing them with the words ``NIH Guidelines for
Research Involving Recombinant or Synthetic Nucleic Acid Molecules''.
0
d. By adding a sentence at the end of paragraph (e).
The addition and revision read as follows:
Sec. 121.12 Biosafety.
(a) An individual or entity required to register under this part
must develop and implement a written biosafety plan that is
commensurate with the risk of the select agent or toxin, given its
intended use.\11\ The biosafety plan must contain sufficient
information and documentation to describe the biosafety and containment
procedures for the select agent or toxin, including any animals
(including arthropods) or plants intentionally or accidentally exposed
to or infected with a select agent. Biosafety and containment
procedures specific to
[[Page 2773]]
each registered laboratory must be available to each individual working
in that laboratory. The current biosafety plan must be submitted for
initial registration, renewal of registration, or when requested. The
biosafety plan must include the following provisions:
---------------------------------------------------------------------------
\11\ Technical assistance and guidance may be obtained by
contacting APHIS.
---------------------------------------------------------------------------
(1) A written risk assessment for each procedure involving a select
agent or toxin that addresses the hazards associated with the agent or
toxin.
(i) The hazardous characteristics of each agent or toxin listed on
the entity's registration, including probable routes of transmission in
the laboratory and in the environment, infective dose (if known),
stability in the environment, host range, contribution of any genetic
manipulations, and endemicity.
(ii) Hazards associated with laboratory procedures related to the
select agent or toxin.
(2) Safeguards in place with associated work practices to protect
registered entity personnel, the public, and the environment from
exposure to the select agent or toxin including, but not limited to:
Safety training requirements for registered entity personnel performing
the procedure; required personal protective equipment and other safety
equipment; required containment equipment including, but not limited
to, biological safety cabinets, animal caging systems, and centrifuge
safety containers; and required engineering controls and other facility
safeguards.
(3) Written procedures for decontamination, with a validated
method, of all contaminated or potentially contaminated materials
including, but not limited to: Cultures and other materials related to
the propagation of select agents or toxins, items related to the
analysis of select agents and toxins, personal protective equipment,
animal caging systems and bedding, and animal carcasses or extracted
tissues.
(4) Written procedures for decontamination, with a validated
method, of laboratory surfaces and equipment using manufacturer's
specification.
(5) Effluent decontamination procedures, with a validated method,
that describe the treatment of effluent material contaminated with
select agents and toxins.
(6) Procedures to respond to emergencies such as spills, sharps
injury, or animal bites involving select agents and toxins.
(7) Procedures for the handling of select agents and toxins in the
same spaces with non-select agents and toxins in order to prevent
unintentional contamination.
* * * * *
(e) * * * Drills or exercises must be documented to include how the
drill or exercise tested and evaluated the plan, any problems
identified and corrective action(s) that were taken, and all
individuals who participated in the drill or exercise.
0
26. Section 121.14 is amended as follows:
0
a. In paragraph (a), by redesignating footnote 11 as footnote 13, and
by adding a sentence at the end of the paragraph.
0
b. In paragraph (f), by adding a sentence at the end of the paragraph.
The additions read as follows:
Sec. 121.14 Incident response.\12\
---------------------------------------------------------------------------
\12\ Nothing in this section is meant to supersede or preempt
incident response requirements imposed by other statutes or
regulations.
---------------------------------------------------------------------------
(a) * * * The current incident response plan must be submitted for
initial registration, renewal of registration, or when requested.
* * * * *
(f) * * * Drills or exercises must be documented to include how the
drill or exercise tested and evaluated the plan, any problems
identified and corrective action(s) that were taken, and all
individuals who participated in the drill or exercise.
0
27. Section 121.15 is amended as follows:
0
a. By revising paragraphs (a), introductory text, and (a)(1).
0
b. By adding paragraph (e).
The addition and revisions read as follows:
Sec. 121.15 Training.
(a) An individual or entity required to register under this part
must provide information and training on biocontainment, biosafety,
security (including security awareness), incident response, and agent-
and toxin-specific training to:
(1) Each individual with access approval from the HHS Secretary or
Administrator, within 12 months of that individual's anniversary of
receiving such approval or prior to his or her entry into an area where
select agents or toxins are used or stored, whichever occurs first; and
* * * * *
(e) The responsible official must ensure and document that
individuals are provided the contact information of the HHS or USDA
Office of Inspector General Hotline so that they may anonymously report
any safety or security concerns related to select agents and toxins.
0
28. Section Sec. 121.16 is amended as follows:
0
a. In paragraph (a), by redesignating footnote 12 as footnote 14.
0
b. By revising paragraph (b), introductory text.
0
c. By adding paragraph (l).
The addition and revision read as follows:
Sec. 121.16 Transfers.
* * * * *
(b) A transfer may be authorized if:
* * * * *
(l) Transfer the amounts only after the transferor uses due
diligence and documents that the recipient has a legitimate need (i.e.,
prophylactic, protective, bona fide research, or other peaceful
purpose) to handle or use such toxins. Information to be documented
includes, but is not limited, to the recipient information, toxin and
amount transferred, and declaration that the recipient has legitimate
purpose to store and use such toxins.
0
29. Section 121.17 is amended as follows:
0
a. In paragraph (a)(1)(iii), by adding the words ``or other storage
container'' after the word ``freezer''.
0
b. By adding paragraph (a)(1)(ix).
0
c. In paragraph (a)(3)(v), by adding the words ``or other storage
container'' after the word ``freezer''.
0
d. By adding paragraph (a)(8).
0
e. By adding a sentence at the end of paragraph (b).
0
f. By revising paragraph (c).
The additions and revision read as follows:
Sec. 121.17 Records.
(a) * * *
(1) * * *
(ix) If destroyed, the quantity (e.g., containers, vials, tubes,
etc.) of select agent destroyed, the date of such action, and by whom.
* * * * *
(8) For a select agent or an extract from a select agent that has
been rendered non-viable or regulated nucleic acids that can produce
infectious forms of any select agent virus that have been rendered non-
infectious through inactivation:
(i) A written description of the inactivation process used for
rendering a select agent non-viable or regulated nucleic acids that can
produce infectious forms of any select agent virus non-infectious;
(ii) The sterility testing protocol used to verify non-viability of
a select agent or non-infectivity of regulated nucleic acids that can
produce infectious forms of any select agent virus and the results of
the test, including investigation, of
[[Page 2774]]
any inactivation process failures and the corrective actions taken;
(iii) The name of each individual performing the inactivation
method and sterility testing protocols;
(iv) The date(s) the inactivation method and sterility testing
protocols were completed;
(v) The location where the inactivated method and sterility testing
protocols were performed; and
(vi) An inactivation certificate that includes the date of
inactivation, method of inactivation, date of final sterility testing
protocol result, and the Principal Investigator. A copy of the
inactivation certificate must accompany any transfer of inactivated
material.
(b) * * * All written records created under this part are legible.
(c) Any records that contain information related to the
requirements of the regulations. Such records may include, but are not
limited to, certifications, laboratory notebooks, institutional
biosafety and/or animal use committee minutes and approved protocols,
and records associated with occupational health and suitability
programs. All records created under this part must be maintained for 3
years.
Done in Washington, DC, this 8th day of January 2016.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2016-00681 Filed 1-14-16; 4:15 pm]
BILLING CODE 3410-34-P